Rheumatology News

In a case that spotlights the importance of comprehensive financial controls in medical offices, a leading New York City emergency medicine physician stands accused of using his business credit card to steal nearly $1.5 million from his clinical practice and spend it on cash advances, personal travel, lavish pet services, and more.

Michael Lucchesi, MD, who had served as chairman of Emergency Medicine at SUNY Downstate Medical Center in New York City, was arraigned on July 9 and pleaded not guilty. Dr. Lucchesi’s attorney, Earl Ward, did not respond to messages from this news organization, but he told the New York Post that “the funds he used were not stolen funds.”

Dr. Lucchesi, who’s in his late 60s, faces nine counts of first- and second-degree grand larceny, first-degree falsifying business records, and third-degree criminal tax fraud. According to a press statement from the district attorney of Kings County, which encompasses the borough of Brooklyn, Dr. Lucchesi is accused of using his clinical practice’s business card for cash advances (about $115,000), high-end pet care ($176,000), personal travel ($348,000), gym membership and personal training ($109,000), catering ($52,000), tuition payments for his children ($46,000), and other expenses such as online shopping, flowers, liquor, and electronics.

Most of the alleged pet care spending — $120,000 — went to the Green Leaf Pet Resort, which has two locations in New Jersey, including one with “56 acres of nature and lots of tail wagging.” Some of the alleged spending on gym membership was at the New York Sports Clubs chain, where monthly membership tops out at $139.99.

The alleged spending occurred between 2016 and 2023 and was discovered by SUNY Downstate during an audit. Dr. Lucchesi reportedly left his position at the hospital, where he made $399,712 in 2022 as a professor, according to public records.

“As a high-ranking doctor at this vital healthcare institution, this defendant was entrusted with access to significant funds, which he allegedly exploited, stealing more than 1 million dollars to pay for a lavish lifestyle,” District Attorney Eric Gonzalez said in a statement.

SUNY Downstate is in a fight for its life amid efforts by New York Governor Kathy Hochul to shut it down. According to The New York Times, it is the only state-run hospital in New York City.

Dr. Lucchesi, who had previously served as the hospital’s chief medical officer and acting head, was released without bail. His next court date is September 25, 2024.
 

Size of Alleged Theft Is ‘Very Unusual’

David P. Weber, JD, DBA, a professor and fraud specialist at Salisbury University, Salisbury, Maryland, told this news organization that the fraudulent use of a business or purchase credit card is a form of embezzlement and “one of the most frequently seen types of frauds against organizations.”

William J. Kresse, JD, MSA, CPA/CFF, who studies fraud at Governors State University in University Park, Illinois, noted in an interview with this news organization that the high amount of alleged fraud in this case is “very unusual,” as is the period it is said to have occurred (over 6 years).

Mr. Kresse highlighted a 2024 report by the Association of Certified Fraud Examiners, which found that the median fraud loss in healthcare, on the basis of 117 cases, is $100,000. The most common form of fraud in the industry is corruption (47%), followed by billing (38%), noncash theft such as inventory (22%), and expense reimbursement (21%).

The details of the current case suggest that “SUNY Downstate had weak or insufficient internal controls to prevent this type of fraud,” Salisbury University’s Mr. Weber said. “However, research also makes clear that the tenure and position of the perpetrator play a significant role in the size of the fraud. Internal controls are supposed to apply to all employees, but the higher in the organization the perpetrator is, the easier it can be to engage in fraud.”
 

Even Small Medical Offices Can Act to Prevent Fraud

What can be done to prevent this kind of fraud? “Each employee should be required to submit actual receipts or scanned copies, and the reimbursement requests should be reviewed and inputted by a separate department or office of the organization to ensure that the expenses are legitimate,” Mr. Weber said. “In addition, all credit card statements should be available for review by the organization either simultaneously with the bill going to the employee or available for audit or review at any time without notification to the employee. Expenses that are in certain categories should be prohibited automatically and coded to the card so such a charge is rejected by the credit card bank.”

Smaller businesses — like many medical practices — may not have the manpower to handle these roles. In that case, Mr. Weber said, “The key is segregation or separation of duties. The bookkeeper cannot be the person receiving the bank statements, the payments from patients, and the invoices from vendors. There needs to be at least one other person in the loop to have some level of control.”

One strategy, he said, “is that the practice should institute a policy that only the doctor or owner of the practice can receive the mail, not the bookkeeper. Even if the practice leader does not actually review the bank statements, simply opening them before handing them off to the bookkeeper can provide a level of deterrence [since] the employee may get caught if someone else is reviewing the bank statements.”
 

A version of this article first appeared on Medscape.com.

In a case that spotlights the importance of comprehensive financial controls in medical offices, a leading New York City emergency medicine physician stands accused of using his business credit card to steal nearly $1.5 million from his clinical practice and spend it on cash advances, personal travel, lavish pet services, and more.

Michael Lucchesi, MD, who had served as chairman of Emergency Medicine at SUNY Downstate Medical Center in New York City, was arraigned on July 9 and pleaded not guilty. Dr. Lucchesi’s attorney, Earl Ward, did not respond to messages from this news organization, but he told the New York Post that “the funds he used were not stolen funds.”

Dr. Lucchesi, who’s in his late 60s, faces nine counts of first- and second-degree grand larceny, first-degree falsifying business records, and third-degree criminal tax fraud. According to a press statement from the district attorney of Kings County, which encompasses the borough of Brooklyn, Dr. Lucchesi is accused of using his clinical practice’s business card for cash advances (about $115,000), high-end pet care ($176,000), personal travel ($348,000), gym membership and personal training ($109,000), catering ($52,000), tuition payments for his children ($46,000), and other expenses such as online shopping, flowers, liquor, and electronics.

Most of the alleged pet care spending — $120,000 — went to the Green Leaf Pet Resort, which has two locations in New Jersey, including one with “56 acres of nature and lots of tail wagging.” Some of the alleged spending on gym membership was at the New York Sports Clubs chain, where monthly membership tops out at $139.99.

The alleged spending occurred between 2016 and 2023 and was discovered by SUNY Downstate during an audit. Dr. Lucchesi reportedly left his position at the hospital, where he made $399,712 in 2022 as a professor, according to public records.

“As a high-ranking doctor at this vital healthcare institution, this defendant was entrusted with access to significant funds, which he allegedly exploited, stealing more than 1 million dollars to pay for a lavish lifestyle,” District Attorney Eric Gonzalez said in a statement.

SUNY Downstate is in a fight for its life amid efforts by New York Governor Kathy Hochul to shut it down. According to The New York Times, it is the only state-run hospital in New York City.

Dr. Lucchesi, who had previously served as the hospital’s chief medical officer and acting head, was released without bail. His next court date is September 25, 2024.
 

Size of Alleged Theft Is ‘Very Unusual’

David P. Weber, JD, DBA, a professor and fraud specialist at Salisbury University, Salisbury, Maryland, told this news organization that the fraudulent use of a business or purchase credit card is a form of embezzlement and “one of the most frequently seen types of frauds against organizations.”

William J. Kresse, JD, MSA, CPA/CFF, who studies fraud at Governors State University in University Park, Illinois, noted in an interview with this news organization that the high amount of alleged fraud in this case is “very unusual,” as is the period it is said to have occurred (over 6 years).

Mr. Kresse highlighted a 2024 report by the Association of Certified Fraud Examiners, which found that the median fraud loss in healthcare, on the basis of 117 cases, is $100,000. The most common form of fraud in the industry is corruption (47%), followed by billing (38%), noncash theft such as inventory (22%), and expense reimbursement (21%).

The details of the current case suggest that “SUNY Downstate had weak or insufficient internal controls to prevent this type of fraud,” Salisbury University’s Mr. Weber said. “However, research also makes clear that the tenure and position of the perpetrator play a significant role in the size of the fraud. Internal controls are supposed to apply to all employees, but the higher in the organization the perpetrator is, the easier it can be to engage in fraud.”
 

Even Small Medical Offices Can Act to Prevent Fraud

What can be done to prevent this kind of fraud? “Each employee should be required to submit actual receipts or scanned copies, and the reimbursement requests should be reviewed and inputted by a separate department or office of the organization to ensure that the expenses are legitimate,” Mr. Weber said. “In addition, all credit card statements should be available for review by the organization either simultaneously with the bill going to the employee or available for audit or review at any time without notification to the employee. Expenses that are in certain categories should be prohibited automatically and coded to the card so such a charge is rejected by the credit card bank.”

Smaller businesses — like many medical practices — may not have the manpower to handle these roles. In that case, Mr. Weber said, “The key is segregation or separation of duties. The bookkeeper cannot be the person receiving the bank statements, the payments from patients, and the invoices from vendors. There needs to be at least one other person in the loop to have some level of control.”

One strategy, he said, “is that the practice should institute a policy that only the doctor or owner of the practice can receive the mail, not the bookkeeper. Even if the practice leader does not actually review the bank statements, simply opening them before handing them off to the bookkeeper can provide a level of deterrence [since] the employee may get caught if someone else is reviewing the bank statements.”
 

A version of this article first appeared on Medscape.com.

In a case that spotlights the importance of comprehensive financial controls in medical offices, a leading New York City emergency medicine physician stands accused of using his business credit card to steal nearly $1.5 million from his clinical practice and spend it on cash advances, personal travel, lavish pet services, and more.

Michael Lucchesi, MD, who had served as chairman of Emergency Medicine at SUNY Downstate Medical Center in New York City, was arraigned on July 9 and pleaded not guilty. Dr. Lucchesi’s attorney, Earl Ward, did not respond to messages from this news organization, but he told the New York Post that “the funds he used were not stolen funds.”

Dr. Lucchesi, who’s in his late 60s, faces nine counts of first- and second-degree grand larceny, first-degree falsifying business records, and third-degree criminal tax fraud. According to a press statement from the district attorney of Kings County, which encompasses the borough of Brooklyn, Dr. Lucchesi is accused of using his clinical practice’s business card for cash advances (about $115,000), high-end pet care ($176,000), personal travel ($348,000), gym membership and personal training ($109,000), catering ($52,000), tuition payments for his children ($46,000), and other expenses such as online shopping, flowers, liquor, and electronics.

Most of the alleged pet care spending — $120,000 — went to the Green Leaf Pet Resort, which has two locations in New Jersey, including one with “56 acres of nature and lots of tail wagging.” Some of the alleged spending on gym membership was at the New York Sports Clubs chain, where monthly membership tops out at $139.99.

The alleged spending occurred between 2016 and 2023 and was discovered by SUNY Downstate during an audit. Dr. Lucchesi reportedly left his position at the hospital, where he made $399,712 in 2022 as a professor, according to public records.

“As a high-ranking doctor at this vital healthcare institution, this defendant was entrusted with access to significant funds, which he allegedly exploited, stealing more than 1 million dollars to pay for a lavish lifestyle,” District Attorney Eric Gonzalez said in a statement.

SUNY Downstate is in a fight for its life amid efforts by New York Governor Kathy Hochul to shut it down. According to The New York Times, it is the only state-run hospital in New York City.

Dr. Lucchesi, who had previously served as the hospital’s chief medical officer and acting head, was released without bail. His next court date is September 25, 2024.
 

Size of Alleged Theft Is ‘Very Unusual’

David P. Weber, JD, DBA, a professor and fraud specialist at Salisbury University, Salisbury, Maryland, told this news organization that the fraudulent use of a business or purchase credit card is a form of embezzlement and “one of the most frequently seen types of frauds against organizations.”

William J. Kresse, JD, MSA, CPA/CFF, who studies fraud at Governors State University in University Park, Illinois, noted in an interview with this news organization that the high amount of alleged fraud in this case is “very unusual,” as is the period it is said to have occurred (over 6 years).

Mr. Kresse highlighted a 2024 report by the Association of Certified Fraud Examiners, which found that the median fraud loss in healthcare, on the basis of 117 cases, is $100,000. The most common form of fraud in the industry is corruption (47%), followed by billing (38%), noncash theft such as inventory (22%), and expense reimbursement (21%).

The details of the current case suggest that “SUNY Downstate had weak or insufficient internal controls to prevent this type of fraud,” Salisbury University’s Mr. Weber said. “However, research also makes clear that the tenure and position of the perpetrator play a significant role in the size of the fraud. Internal controls are supposed to apply to all employees, but the higher in the organization the perpetrator is, the easier it can be to engage in fraud.”
 

Even Small Medical Offices Can Act to Prevent Fraud

What can be done to prevent this kind of fraud? “Each employee should be required to submit actual receipts or scanned copies, and the reimbursement requests should be reviewed and inputted by a separate department or office of the organization to ensure that the expenses are legitimate,” Mr. Weber said. “In addition, all credit card statements should be available for review by the organization either simultaneously with the bill going to the employee or available for audit or review at any time without notification to the employee. Expenses that are in certain categories should be prohibited automatically and coded to the card so such a charge is rejected by the credit card bank.”

Smaller businesses — like many medical practices — may not have the manpower to handle these roles. In that case, Mr. Weber said, “The key is segregation or separation of duties. The bookkeeper cannot be the person receiving the bank statements, the payments from patients, and the invoices from vendors. There needs to be at least one other person in the loop to have some level of control.”

One strategy, he said, “is that the practice should institute a policy that only the doctor or owner of the practice can receive the mail, not the bookkeeper. Even if the practice leader does not actually review the bank statements, simply opening them before handing them off to the bookkeeper can provide a level of deterrence [since] the employee may get caught if someone else is reviewing the bank statements.”
 

A version of this article first appeared on Medscape.com.

VIENNA — It may have been a while since there have been any major breakthroughs in the treatment of systemic lupus erythematosus (SLE), but there are high hopes that this is a situation that may be about to change, experts agreed at the annual European Congress of Rheumatology.

“It’s an incredibly vivid area of development,” Laurent Arnaud, MD, PhD, professor of rheumatology at the University of Strasbourg in Strasbourg, France, said during one of the first sessions of the meeting. He reported that there were at least 17 phase 2 and 14 phase 3 trials that were expected to start within the next few years, all with investigational agents that target different immune cells or pathways that have been implicated in the pathogenesis of SLE.

Sara Freeman/Medscape Medical News

In a systematic review published last year, Dr. Arnaud and coauthors found that there were 92 investigational biologic or novel targeted agents in various phases of clinical testing. This included B-cell–targeting agents such as ianalumab, plasma cell-targeting agents such as daratumumab, and drugs with novel mechanisms of action such as KPG-818, which targets the CRL4-Cereblon (CRBN) E3 ubiquitin ligase complex. Phase 2 data on all three of these investigational agents were presented during various sessions at EULAR 2024, all with positive results, suggesting that their further development in SLE is worth pursuing.

There are of course “many more candidates in the pipeline,” Dr. Arnaud said. “I’m very happy that I think we are going to see great days for lupus right in front of our eyes.”
 

Targeting B Cells

Drugs that target B cells have been at the forefront of lupus treatment for several years, as David Isenberg, MD, professor of rheumatology at University College London, pointed out during an interview for EULAR TV.

“It’s clearly important to target the cells which are likely to be causing the problem in lupus, and in the main, that tends to be B cells,” he said.

Dr. Isenberg, who is renowned for his work with the B-cell–targeting agent rituximab, added: “But we know that obviously T cells integrate with B cells, so anything which interrupts the link between the T cell and the B cell is likely to be important.”
 

Chimeric Antigen Receptor (CAR) T-Cell Therapy ‘Revolution’

One new way of targeting B cells is with CAR T-cell therapy, which David D’Cruz , MD, PhD, a consultant rheumatologist for Guy’s and St. Thomas’ Hospital NHS Foundation Trust in London, picked as one of the “most striking” topics highlighted at EULAR 2024.

This is “truly personalized medicine,” Dr. D’Cruz said. This is an autologous therapy because a patient’s T cells are removed by leukapheresis, transfected with a CAR T vector directed against a component of the B cell, and then returned to them.

“I do feel that we’re on the cusp of a major revolution,” Dr. D’Cruz told this news organization. Not only in lupus but also in other rheumatic conditions that have proved really difficult to treat, such as systemic sclerosis and myositis, he said.

“Basically, it’s a very powerful B-cell–depleting tool, but it’s much more profound B-cell–depleting tool than, for example, rituximab or belimumab,” explained Dr. D’Cruz. “What you’re doing is reprogramming T cells to attack the B cells.”

Although rituximab and belimumab clear all the B cells in the circulation, there are still some cells left behind in the bone marrow, “and it’s very difficult to get rid of those,” Dr. D’Cruz said. “What CAR T-cell therapy appears to do is wipe out all the CD19-positive B cells everywhere, in the blood and the tissue. So you get a really profound B-cell depletion.”

Eric Morand, MBBS, PhD, head of rheumatology at Monash Health in Melbourne, Australia, told this news organization that there was obviously “a lot of buzz” about CAR T-cell therapy.

Sara Freeman/Medscape Medical News

“We’re waiting to see if the exciting data from Erlangen can be reproduced in other centers with other CAR T products to show that it is a universal effect. We haven’t seen that yet, but I think we will by next year.”

Cost and expertise are two major considerations and potential limiting factors, however, as Dr. D’Cruz and Dr. Isenberg both pointed out in separate interviews with this news organization.

Dr. D’Cruz said: “It’s very expensive, it takes a while, and it doesn’t always work is what I’m hearing. It’s usually successful, but again, a little bit depends on the technique and the people doing the process.”

Dr. Isenberg said: “CAR T-cell therapy is, I think, very exciting because it does look to be quite promising. But as it costs 350,000 euros per patient, I don’t think that it is going to be widely adopted.”

Even if it could be afforded by certain centers in the West, he added, this just would not be feasible in poorer nations. “So, we’ve got to find other effective, cheaper ways to go,” Dr. Isenberg said.

“I think there are some very interesting ideas with monoclonal antibodies which target at least two different targets — one on the B cell, one on the T cell — and that could well be the way to take this forward,” he suggested.
 

Ianalumab ‘Double Blocking’ B Cells

Another way could be to develop more potent B-cell–depleting drugs, as Nancy Agmon-Levin , MD, head of the Clinical Immunology, Angioedema and Allergy Unit, Lupus and Autoimmune Diseases Clinic, at Sheba Medical Center, Tel Aviv University in Tel Aviv, Israel, reported during one of the clinical abstract sessions at EULAR 2024.

Dr. Agmon-Levin presented data on 67 individuals with SLE who had participated in a multicenter phase 2 study of ianalumab, a fully human immunoglobulin (Ig) G1 monoclonal antibody that results in a “double blocking of the B-cell lineage.”

Ianalumab targets the B-cell–activating factor receptor (BAFFR), but what makes it distinct from other BAFF-targeting drugs is that it has had a fructose molecule removed from its Fc portion, which renders it more likely to trigger antibody-dependent cellular cytotoxicity.

“This is a B-cell depletion therapy,” Agmon-Levin said, but it also blocks BAFFR-mediated survival of B cells, so the subsequent recuperation process of BAFFR-expressing B cells is affected, leading to continued B-cell depletion.

The phase 2 study she presented consisted of an initial 28-week, double-blind period, during which time participants had been randomly allocated to receive either subcutaneous injections of ianalumab 300 mg or a matching placebo every 4 weeks. This was followed by a 24-week, open-label period where all participants were treated with ianalumab, and then an off-treatment, minimal follow-up period that lasted up to 68 weeks, with continued data collection for safety.

The primary outcome measure was a composite of meeting criteria for the SLE Responder Index 4 and a sustained reduction in corticosteroid use at 28 weeks. This was achieved in 15 of the 34 (44.1%) people treated with ianalumab vs only 3 (9.1%) of the 33 people who had been given a placebo.

Dr. Agmon-Levin reported that the effect on this outcome was sustained to the end of the open-label period, at 1 year, in 15 (45.5%) of 33 participants who had continued treatment with ianalumab and achieved in 13 (40.6%) of 32 participants who had switched from placebo to ianalumab treatment.

Moreover, longer durations of treatment were associated with a host of improved outcomes, Dr. Agmon-Levin said: “Treatment was improved along the 52 weeks, and we can see from the LLDAS [Lupus Low Disease Activity State], DORIS [Definition Of Remission In SLE], and SRI-6 and -8 that as you continue the therapy, you improve the outcomes.”

The potential benefits of ianalumab in the treatment of SLE and lupus nephritis will now be further examined in the phase 3 SIRIUS-SLE1 , SIRIUS-SLE2, and SIRIUS-LN trials, which are estimated to provide initial results in 2027 and complete in early 2029 or 2030.
 

Targeting Plasma Cells With Daratumumab

Another drug showing signs that it might be useful as a treatment for SLE is daratumumab, as Tobias Alexander, MD, of Charité — Universitätsmedizin Berlin, reported during one of the late-breaking abstract sessions at EULAR 2024.

“Daratumumab is a human, first-in-class anti-CD38 antibody that efficiently depletes plasma cells,” Dr. Alexander said. CD38 is both a receptor and an enzyme, and while it is found on the surface of most immune cells, it’s particularly expressed by plasma cells, he added.

Daratumumab is not a total newcomer, however, as it’s already approved for the treatment of multiple myeloma under the trade name Darzalex. The rationale for using it in SLE comes from two case reports, Dr. Alexander explained. The first, published in 2020 in The New England Journal of Medicine, involved two patients with severe and life-threatening lupus who were given off-label treatment for a period of 4 weeks and experienced good clinical and serologic responses. The second, published last year in Nature Medicine, involved six patients with refractory lupus nephritis, five of whom had a clinical response at 6 months.

“On this background, we conducted an investigator-initiated trial, which was an open-label, single-center, proof-of-concept study,” Dr. Alexander said. A total of 10 female patients whose ages ranged from 24 to 43 years were included in the phase 2 trial that was dubbed DARALUP. For inclusion, all had to have a Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) of four or more for clinical manifestations, have been treated with at least two prior disease-modifying drugs to no avail, and be anti–double-stranded DNA (anti-dsDNA) antibody positive. Dr. Alexander reported that the median baseline SLEDAI-2K score was 12 and ranged from 8 to 20, with the number of prior therapies ranging from two to nine.

Daratumumab was given at a dose of 1800 mg via subcutaneous injection every week for 8 weeks. This is the same dose that is used to treat multiple myeloma, Dr. Alexander explained, although the dosing is not stopped. The reason for stopping after 8 weeks in the current trial was to be able to see what happened once the treatment was stopped. The follow-up was for 36 weeks.

Dr. Alexander reported that there was a “very dramatic and significant” effect on the primary endpoint of a reduction in anti-dsDNA antibody levels, decreasing from a median of 166.3 U/mL at baseline to 61.1 U/mL at week 12 (P = .002). Alongside, there was a reduction in the SLEDAI-2K score from 12 to 4 within 12 weeks, which was sustained at the 36-week follow-up assessment. Improvements in skin, joint, kidney, and level of proteinuria were also seen.

Although all patients experienced adverse events, none were serious. Infections and infestations (mostly nasopharyngitis, COVID-19, and gastroenteritis) were the most common, experienced by 80% of the participants; 70% had injection site reactions or fatigue, 60% had gastrointestinal symptoms, 50% had a fall of IgG < 5 g/L, 40% had headache, and 20% had back pain.

“This is a positive trial. I think we could demonstrate that [daratumumab] produced very strong, rapid, and durable clinical improvements,” Dr. Alexander said. “We think that targeting CD38 is relevant; plasma cells had been depleted based on the reduction of anti-dsDNA antibodies,” he added.

From the audience, however, Peter Nash, MBBS, of Griffith University in Brisbane, Australia, questioned whether the results could be attributed to “a steroid effect” because patients had been treated with oral dexamethasone throughout the study.

Dr. Alexander noted that steroid use had been part of the treatment schedule but acknowledged it was a possible confounder.

“I think we can be confident that [daratumumab] had a major effect on plasma cells decreasing…because we see that also the vaccine titers decreased,” Dr. Alexander said. “Time will tell, but even more important is the durability of the responses over time, which you don’t achieve under steroids.”
 

KPG-818’s Novel Mechanism of Action

Elsewhere at EULAR 2024, positive results of another phase 2 study involving a drug with an entirely different mechanism of action, KPG-818, were reported in a poster presentation. KPG-818 modulates CRBN, which results in the degradation of two transcription factors (Aiolos and Ikaros) that are involved in the development, maturation, and proliferation of innate and adaptive immune cells and have been linked to genetic risk in SLE, according to the poster’s authors. It is currently in development for the treatment of SLE, Behçet disease, inflammatory bowel disease, multiple myeloma, and non-Hodgkin lymphoma.

Yao Wang, MD, chief medical officer of KPG-818’s developer Kangpu Biopharmaceuticals, Hefei, China, and associates found that oral doses of 0.15 or 0.6 mg KPG-818 were “generally well-tolerated” and produced immunomodulatory changes that could be beneficial in people with SLE over a 12-week treatment period.

“Only two new agents have been approved for the treatment of SLE in the past five decades in USA and Europe,” Dr. Wang and team wrote, which highlights “a significant unmet need for more effective and safe treatment options.”

They believe that KPG-818 might well fit the bill based on the results of their study, in which 35 of 37 recruited patients completed the treatment. Compared with placebo, they observed reduced numbers of total B cells, Aiolos+ T and B cells, and increased Treg cells.

SLEDAI-2K and Cutaneous Lupus Erythematosus Disease Area and Severity Index activity scores in the 0.15-mg group were improved relative to baseline and placebo.

“The proof-of-concept findings suggest a favorable benefit/risk ratio in SLE for KPG-818,” Dr. Wang and coauthors said, supporting its further development in SLE.
 

Need for Treatments

Dr. Isenberg told this news organization that both daratumumab and KPG-818 would be welcome additions as treatment options if further trials proved their worth.

“The great frustration about lupus is that, compared to patients with rheumatoid arthritis, the choice has been so limited,” Dr. Isenberg said. Aside from rituximab (Rituxan) and belimumab (Benlysta), which are used with certain restrictions, there are no other biologic targeted treatments available in the United Kingdom. Anifrolumab (Saphnelo) has a license in the United States and some European countries but is not yet available for him to use in his practice.

Daratumumab and KPG-818 are “different types of molecules, and if they work that will be great. It would be nice to have the choice,” Dr. Isenberg said. “Whether they will be as effective as I think rituximab is, I don’t know, but these are some very encouraging results.”

Of course, these are all phase 2 trials, and the “big problem” is that such positive results do not always translate when it comes to phase 3, as Dr. D’Cruz told this news organization.

“Until a few years ago, there had been about 25 or 30 industry-led trails, and they’d all failed, except for belimumab and anifrolumab,” Dr. D’Cruz said. These drugs were found to work and be generally safe in phase 1 and 2 trials, but “when they come to phase 3, they all seem to fail, and we don’t know why.”

These are large global studies, D’Cruz added, observing that problems with patient selection, steroid use, and choice of outcome measures were possible factors for why the EXPLORER and LUNAR studies had shown no benefit for rituximab despite the drug being widely used to treat SLE.

Dr. Isenberg, who has coauthored an article on the topic of why drugs seem to fail at the final hurdle, noted: “I think it has a lot to do with the nature of the disease. It’s a complicated disease.” From having “savvy physicians doing the trials for you” to the placebo response, there are “a whole bunch or reasons why these things haven’t worked in lupus.”

Dr. Morand commented: “We’ve got many programs in phase 2 and 3, and because there’s so many, they’re all facing recruitment challenges, and as a consequence of so much activity, every program is going a little slower than hoped for.”

As for other drugs on the horizon, Dr. Morand noted: “We’re very optimistic about things like litifilimab and deucravacitinib; that’s two examples that are in phase 3. Earlier in the program of development, [there are] a huge range of targets being addressed. The future looks bright. But we might have to wait a while.”

Dr. Arnaud has consulted for AstraZeneca, AbbVie, Alpine Immune Sciences, Biogen, Bristol Myers Squibb, Boehringer Ingelheim, Chugai Pharmaceutical, GlaxoSmithKline, Grifols, Janssen, Kezar Life Sciences, LFB, Lilly, Medac, Merck, Novartis, Pfizer, Roche, and UCB. Dr. Isenberg has served as an adviser to Merck Serono, AstraZeneca, Eli Lilly, Servier, and ImmuPharma. Any honoraria received is passed on to a local arthritis charity connected to his hospital. Dr. D’Cruz has served as a consultant and advisory board member for GlaxoSmithKline and CSL Vifor. Dr. Morand has received research support, consultancy fees, or both from multiple pharmaceutical companies paid to his institution including AbbVie, Amgen, AstraZeneca, Biogen, Bristol Myers Squibb, Eli Lilly, EMD Serono, Dragonfly, Genentech, GlaxoSmithKline, Janssen, Novartis, RemeGen, Takeda, UCB, and Zenas. The ianalumab trial presented by Dr. Agmon-Levin was sponsored by Novartis Pharma; however, she reported having no conflicts of interest. The DARALUP study was an investigator-initiated trial supported by Janssen. Dr. Alexander has received consulting fees, study support, honoraria, and travel grants from various pharmaceutical companies including AbbVie, Amgen, AstraZeneca, Bayer, GlaxoSmithKline, Janssen, and Lilly. Dr. Nash has consulted for The Rheumatology Education Group Consultants. The KPG-818 study reported by Dr. Wang was sponsored by Kangpu Biopharmaceuticals.
 

A version of this article first appeared on Medscape.com.

VIENNA — It may have been a while since there have been any major breakthroughs in the treatment of systemic lupus erythematosus (SLE), but there are high hopes that this is a situation that may be about to change, experts agreed at the annual European Congress of Rheumatology.

“It’s an incredibly vivid area of development,” Laurent Arnaud, MD, PhD, professor of rheumatology at the University of Strasbourg in Strasbourg, France, said during one of the first sessions of the meeting. He reported that there were at least 17 phase 2 and 14 phase 3 trials that were expected to start within the next few years, all with investigational agents that target different immune cells or pathways that have been implicated in the pathogenesis of SLE.

Sara Freeman/Medscape Medical News

In a systematic review published last year, Dr. Arnaud and coauthors found that there were 92 investigational biologic or novel targeted agents in various phases of clinical testing. This included B-cell–targeting agents such as ianalumab, plasma cell-targeting agents such as daratumumab, and drugs with novel mechanisms of action such as KPG-818, which targets the CRL4-Cereblon (CRBN) E3 ubiquitin ligase complex. Phase 2 data on all three of these investigational agents were presented during various sessions at EULAR 2024, all with positive results, suggesting that their further development in SLE is worth pursuing.

There are of course “many more candidates in the pipeline,” Dr. Arnaud said. “I’m very happy that I think we are going to see great days for lupus right in front of our eyes.”
 

Targeting B Cells

Drugs that target B cells have been at the forefront of lupus treatment for several years, as David Isenberg, MD, professor of rheumatology at University College London, pointed out during an interview for EULAR TV.

“It’s clearly important to target the cells which are likely to be causing the problem in lupus, and in the main, that tends to be B cells,” he said.

Dr. Isenberg, who is renowned for his work with the B-cell–targeting agent rituximab, added: “But we know that obviously T cells integrate with B cells, so anything which interrupts the link between the T cell and the B cell is likely to be important.”
 

Chimeric Antigen Receptor (CAR) T-Cell Therapy ‘Revolution’

One new way of targeting B cells is with CAR T-cell therapy, which David D’Cruz , MD, PhD, a consultant rheumatologist for Guy’s and St. Thomas’ Hospital NHS Foundation Trust in London, picked as one of the “most striking” topics highlighted at EULAR 2024.

This is “truly personalized medicine,” Dr. D’Cruz said. This is an autologous therapy because a patient’s T cells are removed by leukapheresis, transfected with a CAR T vector directed against a component of the B cell, and then returned to them.

“I do feel that we’re on the cusp of a major revolution,” Dr. D’Cruz told this news organization. Not only in lupus but also in other rheumatic conditions that have proved really difficult to treat, such as systemic sclerosis and myositis, he said.

“Basically, it’s a very powerful B-cell–depleting tool, but it’s much more profound B-cell–depleting tool than, for example, rituximab or belimumab,” explained Dr. D’Cruz. “What you’re doing is reprogramming T cells to attack the B cells.”

Although rituximab and belimumab clear all the B cells in the circulation, there are still some cells left behind in the bone marrow, “and it’s very difficult to get rid of those,” Dr. D’Cruz said. “What CAR T-cell therapy appears to do is wipe out all the CD19-positive B cells everywhere, in the blood and the tissue. So you get a really profound B-cell depletion.”

Eric Morand, MBBS, PhD, head of rheumatology at Monash Health in Melbourne, Australia, told this news organization that there was obviously “a lot of buzz” about CAR T-cell therapy.

Sara Freeman/Medscape Medical News

“We’re waiting to see if the exciting data from Erlangen can be reproduced in other centers with other CAR T products to show that it is a universal effect. We haven’t seen that yet, but I think we will by next year.”

Cost and expertise are two major considerations and potential limiting factors, however, as Dr. D’Cruz and Dr. Isenberg both pointed out in separate interviews with this news organization.

Dr. D’Cruz said: “It’s very expensive, it takes a while, and it doesn’t always work is what I’m hearing. It’s usually successful, but again, a little bit depends on the technique and the people doing the process.”

Dr. Isenberg said: “CAR T-cell therapy is, I think, very exciting because it does look to be quite promising. But as it costs 350,000 euros per patient, I don’t think that it is going to be widely adopted.”

Even if it could be afforded by certain centers in the West, he added, this just would not be feasible in poorer nations. “So, we’ve got to find other effective, cheaper ways to go,” Dr. Isenberg said.

“I think there are some very interesting ideas with monoclonal antibodies which target at least two different targets — one on the B cell, one on the T cell — and that could well be the way to take this forward,” he suggested.
 

Ianalumab ‘Double Blocking’ B Cells

Another way could be to develop more potent B-cell–depleting drugs, as Nancy Agmon-Levin , MD, head of the Clinical Immunology, Angioedema and Allergy Unit, Lupus and Autoimmune Diseases Clinic, at Sheba Medical Center, Tel Aviv University in Tel Aviv, Israel, reported during one of the clinical abstract sessions at EULAR 2024.

Dr. Agmon-Levin presented data on 67 individuals with SLE who had participated in a multicenter phase 2 study of ianalumab, a fully human immunoglobulin (Ig) G1 monoclonal antibody that results in a “double blocking of the B-cell lineage.”

Ianalumab targets the B-cell–activating factor receptor (BAFFR), but what makes it distinct from other BAFF-targeting drugs is that it has had a fructose molecule removed from its Fc portion, which renders it more likely to trigger antibody-dependent cellular cytotoxicity.

“This is a B-cell depletion therapy,” Agmon-Levin said, but it also blocks BAFFR-mediated survival of B cells, so the subsequent recuperation process of BAFFR-expressing B cells is affected, leading to continued B-cell depletion.

The phase 2 study she presented consisted of an initial 28-week, double-blind period, during which time participants had been randomly allocated to receive either subcutaneous injections of ianalumab 300 mg or a matching placebo every 4 weeks. This was followed by a 24-week, open-label period where all participants were treated with ianalumab, and then an off-treatment, minimal follow-up period that lasted up to 68 weeks, with continued data collection for safety.

The primary outcome measure was a composite of meeting criteria for the SLE Responder Index 4 and a sustained reduction in corticosteroid use at 28 weeks. This was achieved in 15 of the 34 (44.1%) people treated with ianalumab vs only 3 (9.1%) of the 33 people who had been given a placebo.

Dr. Agmon-Levin reported that the effect on this outcome was sustained to the end of the open-label period, at 1 year, in 15 (45.5%) of 33 participants who had continued treatment with ianalumab and achieved in 13 (40.6%) of 32 participants who had switched from placebo to ianalumab treatment.

Moreover, longer durations of treatment were associated with a host of improved outcomes, Dr. Agmon-Levin said: “Treatment was improved along the 52 weeks, and we can see from the LLDAS [Lupus Low Disease Activity State], DORIS [Definition Of Remission In SLE], and SRI-6 and -8 that as you continue the therapy, you improve the outcomes.”

The potential benefits of ianalumab in the treatment of SLE and lupus nephritis will now be further examined in the phase 3 SIRIUS-SLE1 , SIRIUS-SLE2, and SIRIUS-LN trials, which are estimated to provide initial results in 2027 and complete in early 2029 or 2030.
 

Targeting Plasma Cells With Daratumumab

Another drug showing signs that it might be useful as a treatment for SLE is daratumumab, as Tobias Alexander, MD, of Charité — Universitätsmedizin Berlin, reported during one of the late-breaking abstract sessions at EULAR 2024.

“Daratumumab is a human, first-in-class anti-CD38 antibody that efficiently depletes plasma cells,” Dr. Alexander said. CD38 is both a receptor and an enzyme, and while it is found on the surface of most immune cells, it’s particularly expressed by plasma cells, he added.

Daratumumab is not a total newcomer, however, as it’s already approved for the treatment of multiple myeloma under the trade name Darzalex. The rationale for using it in SLE comes from two case reports, Dr. Alexander explained. The first, published in 2020 in The New England Journal of Medicine, involved two patients with severe and life-threatening lupus who were given off-label treatment for a period of 4 weeks and experienced good clinical and serologic responses. The second, published last year in Nature Medicine, involved six patients with refractory lupus nephritis, five of whom had a clinical response at 6 months.

“On this background, we conducted an investigator-initiated trial, which was an open-label, single-center, proof-of-concept study,” Dr. Alexander said. A total of 10 female patients whose ages ranged from 24 to 43 years were included in the phase 2 trial that was dubbed DARALUP. For inclusion, all had to have a Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) of four or more for clinical manifestations, have been treated with at least two prior disease-modifying drugs to no avail, and be anti–double-stranded DNA (anti-dsDNA) antibody positive. Dr. Alexander reported that the median baseline SLEDAI-2K score was 12 and ranged from 8 to 20, with the number of prior therapies ranging from two to nine.

Daratumumab was given at a dose of 1800 mg via subcutaneous injection every week for 8 weeks. This is the same dose that is used to treat multiple myeloma, Dr. Alexander explained, although the dosing is not stopped. The reason for stopping after 8 weeks in the current trial was to be able to see what happened once the treatment was stopped. The follow-up was for 36 weeks.

Dr. Alexander reported that there was a “very dramatic and significant” effect on the primary endpoint of a reduction in anti-dsDNA antibody levels, decreasing from a median of 166.3 U/mL at baseline to 61.1 U/mL at week 12 (P = .002). Alongside, there was a reduction in the SLEDAI-2K score from 12 to 4 within 12 weeks, which was sustained at the 36-week follow-up assessment. Improvements in skin, joint, kidney, and level of proteinuria were also seen.

Although all patients experienced adverse events, none were serious. Infections and infestations (mostly nasopharyngitis, COVID-19, and gastroenteritis) were the most common, experienced by 80% of the participants; 70% had injection site reactions or fatigue, 60% had gastrointestinal symptoms, 50% had a fall of IgG < 5 g/L, 40% had headache, and 20% had back pain.

“This is a positive trial. I think we could demonstrate that [daratumumab] produced very strong, rapid, and durable clinical improvements,” Dr. Alexander said. “We think that targeting CD38 is relevant; plasma cells had been depleted based on the reduction of anti-dsDNA antibodies,” he added.

From the audience, however, Peter Nash, MBBS, of Griffith University in Brisbane, Australia, questioned whether the results could be attributed to “a steroid effect” because patients had been treated with oral dexamethasone throughout the study.

Dr. Alexander noted that steroid use had been part of the treatment schedule but acknowledged it was a possible confounder.

“I think we can be confident that [daratumumab] had a major effect on plasma cells decreasing…because we see that also the vaccine titers decreased,” Dr. Alexander said. “Time will tell, but even more important is the durability of the responses over time, which you don’t achieve under steroids.”
 

KPG-818’s Novel Mechanism of Action

Elsewhere at EULAR 2024, positive results of another phase 2 study involving a drug with an entirely different mechanism of action, KPG-818, were reported in a poster presentation. KPG-818 modulates CRBN, which results in the degradation of two transcription factors (Aiolos and Ikaros) that are involved in the development, maturation, and proliferation of innate and adaptive immune cells and have been linked to genetic risk in SLE, according to the poster’s authors. It is currently in development for the treatment of SLE, Behçet disease, inflammatory bowel disease, multiple myeloma, and non-Hodgkin lymphoma.

Yao Wang, MD, chief medical officer of KPG-818’s developer Kangpu Biopharmaceuticals, Hefei, China, and associates found that oral doses of 0.15 or 0.6 mg KPG-818 were “generally well-tolerated” and produced immunomodulatory changes that could be beneficial in people with SLE over a 12-week treatment period.

“Only two new agents have been approved for the treatment of SLE in the past five decades in USA and Europe,” Dr. Wang and team wrote, which highlights “a significant unmet need for more effective and safe treatment options.”

They believe that KPG-818 might well fit the bill based on the results of their study, in which 35 of 37 recruited patients completed the treatment. Compared with placebo, they observed reduced numbers of total B cells, Aiolos+ T and B cells, and increased Treg cells.

SLEDAI-2K and Cutaneous Lupus Erythematosus Disease Area and Severity Index activity scores in the 0.15-mg group were improved relative to baseline and placebo.

“The proof-of-concept findings suggest a favorable benefit/risk ratio in SLE for KPG-818,” Dr. Wang and coauthors said, supporting its further development in SLE.
 

Need for Treatments

Dr. Isenberg told this news organization that both daratumumab and KPG-818 would be welcome additions as treatment options if further trials proved their worth.

“The great frustration about lupus is that, compared to patients with rheumatoid arthritis, the choice has been so limited,” Dr. Isenberg said. Aside from rituximab (Rituxan) and belimumab (Benlysta), which are used with certain restrictions, there are no other biologic targeted treatments available in the United Kingdom. Anifrolumab (Saphnelo) has a license in the United States and some European countries but is not yet available for him to use in his practice.

Daratumumab and KPG-818 are “different types of molecules, and if they work that will be great. It would be nice to have the choice,” Dr. Isenberg said. “Whether they will be as effective as I think rituximab is, I don’t know, but these are some very encouraging results.”

Of course, these are all phase 2 trials, and the “big problem” is that such positive results do not always translate when it comes to phase 3, as Dr. D’Cruz told this news organization.

“Until a few years ago, there had been about 25 or 30 industry-led trails, and they’d all failed, except for belimumab and anifrolumab,” Dr. D’Cruz said. These drugs were found to work and be generally safe in phase 1 and 2 trials, but “when they come to phase 3, they all seem to fail, and we don’t know why.”

These are large global studies, D’Cruz added, observing that problems with patient selection, steroid use, and choice of outcome measures were possible factors for why the EXPLORER and LUNAR studies had shown no benefit for rituximab despite the drug being widely used to treat SLE.

Dr. Isenberg, who has coauthored an article on the topic of why drugs seem to fail at the final hurdle, noted: “I think it has a lot to do with the nature of the disease. It’s a complicated disease.” From having “savvy physicians doing the trials for you” to the placebo response, there are “a whole bunch or reasons why these things haven’t worked in lupus.”

Dr. Morand commented: “We’ve got many programs in phase 2 and 3, and because there’s so many, they’re all facing recruitment challenges, and as a consequence of so much activity, every program is going a little slower than hoped for.”

As for other drugs on the horizon, Dr. Morand noted: “We’re very optimistic about things like litifilimab and deucravacitinib; that’s two examples that are in phase 3. Earlier in the program of development, [there are] a huge range of targets being addressed. The future looks bright. But we might have to wait a while.”

Dr. Arnaud has consulted for AstraZeneca, AbbVie, Alpine Immune Sciences, Biogen, Bristol Myers Squibb, Boehringer Ingelheim, Chugai Pharmaceutical, GlaxoSmithKline, Grifols, Janssen, Kezar Life Sciences, LFB, Lilly, Medac, Merck, Novartis, Pfizer, Roche, and UCB. Dr. Isenberg has served as an adviser to Merck Serono, AstraZeneca, Eli Lilly, Servier, and ImmuPharma. Any honoraria received is passed on to a local arthritis charity connected to his hospital. Dr. D’Cruz has served as a consultant and advisory board member for GlaxoSmithKline and CSL Vifor. Dr. Morand has received research support, consultancy fees, or both from multiple pharmaceutical companies paid to his institution including AbbVie, Amgen, AstraZeneca, Biogen, Bristol Myers Squibb, Eli Lilly, EMD Serono, Dragonfly, Genentech, GlaxoSmithKline, Janssen, Novartis, RemeGen, Takeda, UCB, and Zenas. The ianalumab trial presented by Dr. Agmon-Levin was sponsored by Novartis Pharma; however, she reported having no conflicts of interest. The DARALUP study was an investigator-initiated trial supported by Janssen. Dr. Alexander has received consulting fees, study support, honoraria, and travel grants from various pharmaceutical companies including AbbVie, Amgen, AstraZeneca, Bayer, GlaxoSmithKline, Janssen, and Lilly. Dr. Nash has consulted for The Rheumatology Education Group Consultants. The KPG-818 study reported by Dr. Wang was sponsored by Kangpu Biopharmaceuticals.
 

A version of this article first appeared on Medscape.com.

VIENNA — It may have been a while since there have been any major breakthroughs in the treatment of systemic lupus erythematosus (SLE), but there are high hopes that this is a situation that may be about to change, experts agreed at the annual European Congress of Rheumatology.

“It’s an incredibly vivid area of development,” Laurent Arnaud, MD, PhD, professor of rheumatology at the University of Strasbourg in Strasbourg, France, said during one of the first sessions of the meeting. He reported that there were at least 17 phase 2 and 14 phase 3 trials that were expected to start within the next few years, all with investigational agents that target different immune cells or pathways that have been implicated in the pathogenesis of SLE.

Sara Freeman/Medscape Medical News

In a systematic review published last year, Dr. Arnaud and coauthors found that there were 92 investigational biologic or novel targeted agents in various phases of clinical testing. This included B-cell–targeting agents such as ianalumab, plasma cell-targeting agents such as daratumumab, and drugs with novel mechanisms of action such as KPG-818, which targets the CRL4-Cereblon (CRBN) E3 ubiquitin ligase complex. Phase 2 data on all three of these investigational agents were presented during various sessions at EULAR 2024, all with positive results, suggesting that their further development in SLE is worth pursuing.

There are of course “many more candidates in the pipeline,” Dr. Arnaud said. “I’m very happy that I think we are going to see great days for lupus right in front of our eyes.”
 

Targeting B Cells

Drugs that target B cells have been at the forefront of lupus treatment for several years, as David Isenberg, MD, professor of rheumatology at University College London, pointed out during an interview for EULAR TV.

“It’s clearly important to target the cells which are likely to be causing the problem in lupus, and in the main, that tends to be B cells,” he said.

Dr. Isenberg, who is renowned for his work with the B-cell–targeting agent rituximab, added: “But we know that obviously T cells integrate with B cells, so anything which interrupts the link between the T cell and the B cell is likely to be important.”
 

Chimeric Antigen Receptor (CAR) T-Cell Therapy ‘Revolution’

One new way of targeting B cells is with CAR T-cell therapy, which David D’Cruz , MD, PhD, a consultant rheumatologist for Guy’s and St. Thomas’ Hospital NHS Foundation Trust in London, picked as one of the “most striking” topics highlighted at EULAR 2024.

This is “truly personalized medicine,” Dr. D’Cruz said. This is an autologous therapy because a patient’s T cells are removed by leukapheresis, transfected with a CAR T vector directed against a component of the B cell, and then returned to them.

“I do feel that we’re on the cusp of a major revolution,” Dr. D’Cruz told this news organization. Not only in lupus but also in other rheumatic conditions that have proved really difficult to treat, such as systemic sclerosis and myositis, he said.

“Basically, it’s a very powerful B-cell–depleting tool, but it’s much more profound B-cell–depleting tool than, for example, rituximab or belimumab,” explained Dr. D’Cruz. “What you’re doing is reprogramming T cells to attack the B cells.”

Although rituximab and belimumab clear all the B cells in the circulation, there are still some cells left behind in the bone marrow, “and it’s very difficult to get rid of those,” Dr. D’Cruz said. “What CAR T-cell therapy appears to do is wipe out all the CD19-positive B cells everywhere, in the blood and the tissue. So you get a really profound B-cell depletion.”

Eric Morand, MBBS, PhD, head of rheumatology at Monash Health in Melbourne, Australia, told this news organization that there was obviously “a lot of buzz” about CAR T-cell therapy.

Sara Freeman/Medscape Medical News

“We’re waiting to see if the exciting data from Erlangen can be reproduced in other centers with other CAR T products to show that it is a universal effect. We haven’t seen that yet, but I think we will by next year.”

Cost and expertise are two major considerations and potential limiting factors, however, as Dr. D’Cruz and Dr. Isenberg both pointed out in separate interviews with this news organization.

Dr. D’Cruz said: “It’s very expensive, it takes a while, and it doesn’t always work is what I’m hearing. It’s usually successful, but again, a little bit depends on the technique and the people doing the process.”

Dr. Isenberg said: “CAR T-cell therapy is, I think, very exciting because it does look to be quite promising. But as it costs 350,000 euros per patient, I don’t think that it is going to be widely adopted.”

Even if it could be afforded by certain centers in the West, he added, this just would not be feasible in poorer nations. “So, we’ve got to find other effective, cheaper ways to go,” Dr. Isenberg said.

“I think there are some very interesting ideas with monoclonal antibodies which target at least two different targets — one on the B cell, one on the T cell — and that could well be the way to take this forward,” he suggested.
 

Ianalumab ‘Double Blocking’ B Cells

Another way could be to develop more potent B-cell–depleting drugs, as Nancy Agmon-Levin , MD, head of the Clinical Immunology, Angioedema and Allergy Unit, Lupus and Autoimmune Diseases Clinic, at Sheba Medical Center, Tel Aviv University in Tel Aviv, Israel, reported during one of the clinical abstract sessions at EULAR 2024.

Dr. Agmon-Levin presented data on 67 individuals with SLE who had participated in a multicenter phase 2 study of ianalumab, a fully human immunoglobulin (Ig) G1 monoclonal antibody that results in a “double blocking of the B-cell lineage.”

Ianalumab targets the B-cell–activating factor receptor (BAFFR), but what makes it distinct from other BAFF-targeting drugs is that it has had a fructose molecule removed from its Fc portion, which renders it more likely to trigger antibody-dependent cellular cytotoxicity.

“This is a B-cell depletion therapy,” Agmon-Levin said, but it also blocks BAFFR-mediated survival of B cells, so the subsequent recuperation process of BAFFR-expressing B cells is affected, leading to continued B-cell depletion.

The phase 2 study she presented consisted of an initial 28-week, double-blind period, during which time participants had been randomly allocated to receive either subcutaneous injections of ianalumab 300 mg or a matching placebo every 4 weeks. This was followed by a 24-week, open-label period where all participants were treated with ianalumab, and then an off-treatment, minimal follow-up period that lasted up to 68 weeks, with continued data collection for safety.

The primary outcome measure was a composite of meeting criteria for the SLE Responder Index 4 and a sustained reduction in corticosteroid use at 28 weeks. This was achieved in 15 of the 34 (44.1%) people treated with ianalumab vs only 3 (9.1%) of the 33 people who had been given a placebo.

Dr. Agmon-Levin reported that the effect on this outcome was sustained to the end of the open-label period, at 1 year, in 15 (45.5%) of 33 participants who had continued treatment with ianalumab and achieved in 13 (40.6%) of 32 participants who had switched from placebo to ianalumab treatment.

Moreover, longer durations of treatment were associated with a host of improved outcomes, Dr. Agmon-Levin said: “Treatment was improved along the 52 weeks, and we can see from the LLDAS [Lupus Low Disease Activity State], DORIS [Definition Of Remission In SLE], and SRI-6 and -8 that as you continue the therapy, you improve the outcomes.”

The potential benefits of ianalumab in the treatment of SLE and lupus nephritis will now be further examined in the phase 3 SIRIUS-SLE1 , SIRIUS-SLE2, and SIRIUS-LN trials, which are estimated to provide initial results in 2027 and complete in early 2029 or 2030.
 

Targeting Plasma Cells With Daratumumab

Another drug showing signs that it might be useful as a treatment for SLE is daratumumab, as Tobias Alexander, MD, of Charité — Universitätsmedizin Berlin, reported during one of the late-breaking abstract sessions at EULAR 2024.

“Daratumumab is a human, first-in-class anti-CD38 antibody that efficiently depletes plasma cells,” Dr. Alexander said. CD38 is both a receptor and an enzyme, and while it is found on the surface of most immune cells, it’s particularly expressed by plasma cells, he added.

Daratumumab is not a total newcomer, however, as it’s already approved for the treatment of multiple myeloma under the trade name Darzalex. The rationale for using it in SLE comes from two case reports, Dr. Alexander explained. The first, published in 2020 in The New England Journal of Medicine, involved two patients with severe and life-threatening lupus who were given off-label treatment for a period of 4 weeks and experienced good clinical and serologic responses. The second, published last year in Nature Medicine, involved six patients with refractory lupus nephritis, five of whom had a clinical response at 6 months.

“On this background, we conducted an investigator-initiated trial, which was an open-label, single-center, proof-of-concept study,” Dr. Alexander said. A total of 10 female patients whose ages ranged from 24 to 43 years were included in the phase 2 trial that was dubbed DARALUP. For inclusion, all had to have a Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) of four or more for clinical manifestations, have been treated with at least two prior disease-modifying drugs to no avail, and be anti–double-stranded DNA (anti-dsDNA) antibody positive. Dr. Alexander reported that the median baseline SLEDAI-2K score was 12 and ranged from 8 to 20, with the number of prior therapies ranging from two to nine.

Daratumumab was given at a dose of 1800 mg via subcutaneous injection every week for 8 weeks. This is the same dose that is used to treat multiple myeloma, Dr. Alexander explained, although the dosing is not stopped. The reason for stopping after 8 weeks in the current trial was to be able to see what happened once the treatment was stopped. The follow-up was for 36 weeks.

Dr. Alexander reported that there was a “very dramatic and significant” effect on the primary endpoint of a reduction in anti-dsDNA antibody levels, decreasing from a median of 166.3 U/mL at baseline to 61.1 U/mL at week 12 (P = .002). Alongside, there was a reduction in the SLEDAI-2K score from 12 to 4 within 12 weeks, which was sustained at the 36-week follow-up assessment. Improvements in skin, joint, kidney, and level of proteinuria were also seen.

Although all patients experienced adverse events, none were serious. Infections and infestations (mostly nasopharyngitis, COVID-19, and gastroenteritis) were the most common, experienced by 80% of the participants; 70% had injection site reactions or fatigue, 60% had gastrointestinal symptoms, 50% had a fall of IgG < 5 g/L, 40% had headache, and 20% had back pain.

“This is a positive trial. I think we could demonstrate that [daratumumab] produced very strong, rapid, and durable clinical improvements,” Dr. Alexander said. “We think that targeting CD38 is relevant; plasma cells had been depleted based on the reduction of anti-dsDNA antibodies,” he added.

From the audience, however, Peter Nash, MBBS, of Griffith University in Brisbane, Australia, questioned whether the results could be attributed to “a steroid effect” because patients had been treated with oral dexamethasone throughout the study.

Dr. Alexander noted that steroid use had been part of the treatment schedule but acknowledged it was a possible confounder.

“I think we can be confident that [daratumumab] had a major effect on plasma cells decreasing…because we see that also the vaccine titers decreased,” Dr. Alexander said. “Time will tell, but even more important is the durability of the responses over time, which you don’t achieve under steroids.”
 

KPG-818’s Novel Mechanism of Action

Elsewhere at EULAR 2024, positive results of another phase 2 study involving a drug with an entirely different mechanism of action, KPG-818, were reported in a poster presentation. KPG-818 modulates CRBN, which results in the degradation of two transcription factors (Aiolos and Ikaros) that are involved in the development, maturation, and proliferation of innate and adaptive immune cells and have been linked to genetic risk in SLE, according to the poster’s authors. It is currently in development for the treatment of SLE, Behçet disease, inflammatory bowel disease, multiple myeloma, and non-Hodgkin lymphoma.

Yao Wang, MD, chief medical officer of KPG-818’s developer Kangpu Biopharmaceuticals, Hefei, China, and associates found that oral doses of 0.15 or 0.6 mg KPG-818 were “generally well-tolerated” and produced immunomodulatory changes that could be beneficial in people with SLE over a 12-week treatment period.

“Only two new agents have been approved for the treatment of SLE in the past five decades in USA and Europe,” Dr. Wang and team wrote, which highlights “a significant unmet need for more effective and safe treatment options.”

They believe that KPG-818 might well fit the bill based on the results of their study, in which 35 of 37 recruited patients completed the treatment. Compared with placebo, they observed reduced numbers of total B cells, Aiolos+ T and B cells, and increased Treg cells.

SLEDAI-2K and Cutaneous Lupus Erythematosus Disease Area and Severity Index activity scores in the 0.15-mg group were improved relative to baseline and placebo.

“The proof-of-concept findings suggest a favorable benefit/risk ratio in SLE for KPG-818,” Dr. Wang and coauthors said, supporting its further development in SLE.
 

Need for Treatments

Dr. Isenberg told this news organization that both daratumumab and KPG-818 would be welcome additions as treatment options if further trials proved their worth.

“The great frustration about lupus is that, compared to patients with rheumatoid arthritis, the choice has been so limited,” Dr. Isenberg said. Aside from rituximab (Rituxan) and belimumab (Benlysta), which are used with certain restrictions, there are no other biologic targeted treatments available in the United Kingdom. Anifrolumab (Saphnelo) has a license in the United States and some European countries but is not yet available for him to use in his practice.

Daratumumab and KPG-818 are “different types of molecules, and if they work that will be great. It would be nice to have the choice,” Dr. Isenberg said. “Whether they will be as effective as I think rituximab is, I don’t know, but these are some very encouraging results.”

Of course, these are all phase 2 trials, and the “big problem” is that such positive results do not always translate when it comes to phase 3, as Dr. D’Cruz told this news organization.

“Until a few years ago, there had been about 25 or 30 industry-led trails, and they’d all failed, except for belimumab and anifrolumab,” Dr. D’Cruz said. These drugs were found to work and be generally safe in phase 1 and 2 trials, but “when they come to phase 3, they all seem to fail, and we don’t know why.”

These are large global studies, D’Cruz added, observing that problems with patient selection, steroid use, and choice of outcome measures were possible factors for why the EXPLORER and LUNAR studies had shown no benefit for rituximab despite the drug being widely used to treat SLE.

Dr. Isenberg, who has coauthored an article on the topic of why drugs seem to fail at the final hurdle, noted: “I think it has a lot to do with the nature of the disease. It’s a complicated disease.” From having “savvy physicians doing the trials for you” to the placebo response, there are “a whole bunch or reasons why these things haven’t worked in lupus.”

Dr. Morand commented: “We’ve got many programs in phase 2 and 3, and because there’s so many, they’re all facing recruitment challenges, and as a consequence of so much activity, every program is going a little slower than hoped for.”

As for other drugs on the horizon, Dr. Morand noted: “We’re very optimistic about things like litifilimab and deucravacitinib; that’s two examples that are in phase 3. Earlier in the program of development, [there are] a huge range of targets being addressed. The future looks bright. But we might have to wait a while.”

Dr. Arnaud has consulted for AstraZeneca, AbbVie, Alpine Immune Sciences, Biogen, Bristol Myers Squibb, Boehringer Ingelheim, Chugai Pharmaceutical, GlaxoSmithKline, Grifols, Janssen, Kezar Life Sciences, LFB, Lilly, Medac, Merck, Novartis, Pfizer, Roche, and UCB. Dr. Isenberg has served as an adviser to Merck Serono, AstraZeneca, Eli Lilly, Servier, and ImmuPharma. Any honoraria received is passed on to a local arthritis charity connected to his hospital. Dr. D’Cruz has served as a consultant and advisory board member for GlaxoSmithKline and CSL Vifor. Dr. Morand has received research support, consultancy fees, or both from multiple pharmaceutical companies paid to his institution including AbbVie, Amgen, AstraZeneca, Biogen, Bristol Myers Squibb, Eli Lilly, EMD Serono, Dragonfly, Genentech, GlaxoSmithKline, Janssen, Novartis, RemeGen, Takeda, UCB, and Zenas. The ianalumab trial presented by Dr. Agmon-Levin was sponsored by Novartis Pharma; however, she reported having no conflicts of interest. The DARALUP study was an investigator-initiated trial supported by Janssen. Dr. Alexander has received consulting fees, study support, honoraria, and travel grants from various pharmaceutical companies including AbbVie, Amgen, AstraZeneca, Bayer, GlaxoSmithKline, Janssen, and Lilly. Dr. Nash has consulted for The Rheumatology Education Group Consultants. The KPG-818 study reported by Dr. Wang was sponsored by Kangpu Biopharmaceuticals.
 

A version of this article first appeared on Medscape.com.

TOPLINE:

Since 2014, opioid use for autoimmune rheumatic diseases decreased by 15% annually while other management modalities increased or stabilized.

METHODOLOGY:

• Researchers analyzed de-identified US claims data from the MarketScan Database from 2007-2021.
• The study included nearly 142,000 patients with autoimmune rheumatic diseases: 10,927 with ankylosing spondylitis (AS); 21,438 with psoriatic arthritis (PsA); 71,393 with rheumatoid arthritis (RA); 16,718 with Sjögren disease; 18,018 with systemic lupus erythematosus; and 3468 with systemic sclerosis.
• Primary outcome was opioid use annual trends, with secondary outcomes including trends in the use of anticonvulsants, antidepressants, skeletal muscle relaxants, nonsteroidal anti-inflammatory drugs (NSAIDs), topical pain medications, and physical or occupational therapy.

TAKEAWAY:

• The incidence of opioid use increased annually by 4% until 2014 and decreased annually by 15% after 2014.
• NSAID use increased 2% annually until 2014, then declined by 5% afterward.
• The proportion of patients utilizing physical therapy or anticonvulsants doubled from 2008 to 2020.
• NSAID prescriptions were highest in AS, PsA, and RA, while they were lowest in Sjögren disease and systemic sclerosis.

IN PRACTICE:

“Our work, along with the published literature, highlights the need for future studies to evaluate the effectiveness of pain management modality changes over time and to understand the possible effects that changes have had on outcomes such as quality of life, disability, health status, and function,” wrote the authors of the study. 

SOURCE:

The study was led by Titilola Falasinnu, PhD, Stanford University School of Medicine, Stanford, California. It was published online in The Lancet Rheumatology. 

LIMITATIONS:

The study relied on administrative claims data, which did not contain information on use of over-the-counter medications like NSAIDs and topical analgesics. The study did not include the duration of pain treatment modalities, making it difficult to differentiate between acute and chronic use. The analysis did not include race or ethnicity, which is important for understanding pain outcomes across different sociodemographic groups.

DISCLOSURES:

The study was supported by grants from the National Institute of Arthritis and Musculoskeletal and Skin Diseases. 

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Since 2014, opioid use for autoimmune rheumatic diseases decreased by 15% annually while other management modalities increased or stabilized.

METHODOLOGY:

• Researchers analyzed de-identified US claims data from the MarketScan Database from 2007-2021.
• The study included nearly 142,000 patients with autoimmune rheumatic diseases: 10,927 with ankylosing spondylitis (AS); 21,438 with psoriatic arthritis (PsA); 71,393 with rheumatoid arthritis (RA); 16,718 with Sjögren disease; 18,018 with systemic lupus erythematosus; and 3468 with systemic sclerosis.
• Primary outcome was opioid use annual trends, with secondary outcomes including trends in the use of anticonvulsants, antidepressants, skeletal muscle relaxants, nonsteroidal anti-inflammatory drugs (NSAIDs), topical pain medications, and physical or occupational therapy.

TAKEAWAY:

• The incidence of opioid use increased annually by 4% until 2014 and decreased annually by 15% after 2014.
• NSAID use increased 2% annually until 2014, then declined by 5% afterward.
• The proportion of patients utilizing physical therapy or anticonvulsants doubled from 2008 to 2020.
• NSAID prescriptions were highest in AS, PsA, and RA, while they were lowest in Sjögren disease and systemic sclerosis.

IN PRACTICE:

“Our work, along with the published literature, highlights the need for future studies to evaluate the effectiveness of pain management modality changes over time and to understand the possible effects that changes have had on outcomes such as quality of life, disability, health status, and function,” wrote the authors of the study. 

SOURCE:

The study was led by Titilola Falasinnu, PhD, Stanford University School of Medicine, Stanford, California. It was published online in The Lancet Rheumatology. 

LIMITATIONS:

The study relied on administrative claims data, which did not contain information on use of over-the-counter medications like NSAIDs and topical analgesics. The study did not include the duration of pain treatment modalities, making it difficult to differentiate between acute and chronic use. The analysis did not include race or ethnicity, which is important for understanding pain outcomes across different sociodemographic groups.

DISCLOSURES:

The study was supported by grants from the National Institute of Arthritis and Musculoskeletal and Skin Diseases. 

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Since 2014, opioid use for autoimmune rheumatic diseases decreased by 15% annually while other management modalities increased or stabilized.

METHODOLOGY:

• Researchers analyzed de-identified US claims data from the MarketScan Database from 2007-2021.
• The study included nearly 142,000 patients with autoimmune rheumatic diseases: 10,927 with ankylosing spondylitis (AS); 21,438 with psoriatic arthritis (PsA); 71,393 with rheumatoid arthritis (RA); 16,718 with Sjögren disease; 18,018 with systemic lupus erythematosus; and 3468 with systemic sclerosis.
• Primary outcome was opioid use annual trends, with secondary outcomes including trends in the use of anticonvulsants, antidepressants, skeletal muscle relaxants, nonsteroidal anti-inflammatory drugs (NSAIDs), topical pain medications, and physical or occupational therapy.

TAKEAWAY:

• The incidence of opioid use increased annually by 4% until 2014 and decreased annually by 15% after 2014.
• NSAID use increased 2% annually until 2014, then declined by 5% afterward.
• The proportion of patients utilizing physical therapy or anticonvulsants doubled from 2008 to 2020.
• NSAID prescriptions were highest in AS, PsA, and RA, while they were lowest in Sjögren disease and systemic sclerosis.

IN PRACTICE:

“Our work, along with the published literature, highlights the need for future studies to evaluate the effectiveness of pain management modality changes over time and to understand the possible effects that changes have had on outcomes such as quality of life, disability, health status, and function,” wrote the authors of the study. 

SOURCE:

The study was led by Titilola Falasinnu, PhD, Stanford University School of Medicine, Stanford, California. It was published online in The Lancet Rheumatology. 

LIMITATIONS:

The study relied on administrative claims data, which did not contain information on use of over-the-counter medications like NSAIDs and topical analgesics. The study did not include the duration of pain treatment modalities, making it difficult to differentiate between acute and chronic use. The analysis did not include race or ethnicity, which is important for understanding pain outcomes across different sociodemographic groups.

DISCLOSURES:

The study was supported by grants from the National Institute of Arthritis and Musculoskeletal and Skin Diseases. 

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

About 40% of patients with osteoarthritis (OA) and 36% with rheumatoid arthritis (RA) screened positive for anxiety, depression, and/or fibromyalgia as part of routine visits to an academic medical center, and these comorbidities were linked to poorer patient status measures, highlighting the need for routine screening in clinical practice. 

METHODOLOGY:

• This retrospective cross-sectional study analyzed the prevalence of anxiety, depression, and fibromyalgia in 366 patients with OA (mean age, 66.6 years) and 488 patients with RA (mean age, 56.9 years) who were in routine care at an academic center from 2011 to 2022.
• All participants were required to have complete Multidimensional Health Assessment Questionnaire (MDHAQ) data available for the analysis.
• The MDHAQ included indices to assess the overall patient status and screen for anxiety, depression, and fibromyalgia.
• The overall patient status was measured using the Routine Assessment of Patient Index Data 3 (RAPID3), which comprised the physical function, pain, and patient global scores.
• The prevalence of each comorbidity and its association with patient status was analyzed using unadjusted and age-adjusted odds ratios (ORs) and 95% CIs.

TAKEAWAY:

• Among the patients with OA, 40.4% were screened positive for at least one of the three indices indicating patient distress (anxiety, depression, and fibromyalgia). Among patients with RA, the proportion was 36.3%.
• Among the patients who screened positive for at least one index, about 20% screened positive for all three indices related to anxiety, depression, and fibromyalgia.
• In patients with OA, a poorer patient status (RAPID3, ≥ 12 vs < 12) increased the likelihood of anxiety (OR, 3.93; 95% CI, 2.24-7.23), depression (OR, 3.79; 95% CI, 2.01-7.73), and fibromyalgia (OR, 6.70; 95% CI, 3.36-14.99).
• Similarly, the odds of all three comorbidities increased in the patients with RA who had worsened patient status.

IN PRACTICE:

“Screening for [anxiety, depression, and/or fibromyalgia] can be incorporated feasibly into routine clinical care using a single MDHAQ to better inform health professionals concerning patient status, prognosis, and response to treatments,” the authors wrote.

SOURCE:

The study was led by Juan Schmukler, MD, Rush University Medical Center, Chicago, and was published online on July 16, 2024, in ACR Open Rheumatology. 

LIMITATIONS:

The analyses were cross-sectional, and whether anxiety, depression, and fibromyalgia had preceded or followed the onset of OA or RA was not known. Information on the clinical variables associated with anxiety, depression, and fibromyalgia, such as body mass index, medication history, and other comorbid conditions, was not available. All the patients were seen at a single rheumatology site, which may have limited the generalizability of the observations. 

DISCLOSURES:

This study did not disclose any sources of funding. One author disclosed receiving grants from the National Institute of Arthritis and Musculoskeletal and Skin Diseases. One author reported numerous financial relationships with companies in the medical industry, and another reported holding a copyright and trademark on MDHAQ and RAPID3. 

This article was created using several editorial tools, including AI, as a part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

About 40% of patients with osteoarthritis (OA) and 36% with rheumatoid arthritis (RA) screened positive for anxiety, depression, and/or fibromyalgia as part of routine visits to an academic medical center, and these comorbidities were linked to poorer patient status measures, highlighting the need for routine screening in clinical practice. 

METHODOLOGY:

• This retrospective cross-sectional study analyzed the prevalence of anxiety, depression, and fibromyalgia in 366 patients with OA (mean age, 66.6 years) and 488 patients with RA (mean age, 56.9 years) who were in routine care at an academic center from 2011 to 2022.
• All participants were required to have complete Multidimensional Health Assessment Questionnaire (MDHAQ) data available for the analysis.
• The MDHAQ included indices to assess the overall patient status and screen for anxiety, depression, and fibromyalgia.
• The overall patient status was measured using the Routine Assessment of Patient Index Data 3 (RAPID3), which comprised the physical function, pain, and patient global scores.
• The prevalence of each comorbidity and its association with patient status was analyzed using unadjusted and age-adjusted odds ratios (ORs) and 95% CIs.

TAKEAWAY:

• Among the patients with OA, 40.4% were screened positive for at least one of the three indices indicating patient distress (anxiety, depression, and fibromyalgia). Among patients with RA, the proportion was 36.3%.
• Among the patients who screened positive for at least one index, about 20% screened positive for all three indices related to anxiety, depression, and fibromyalgia.
• In patients with OA, a poorer patient status (RAPID3, ≥ 12 vs < 12) increased the likelihood of anxiety (OR, 3.93; 95% CI, 2.24-7.23), depression (OR, 3.79; 95% CI, 2.01-7.73), and fibromyalgia (OR, 6.70; 95% CI, 3.36-14.99).
• Similarly, the odds of all three comorbidities increased in the patients with RA who had worsened patient status.

IN PRACTICE:

“Screening for [anxiety, depression, and/or fibromyalgia] can be incorporated feasibly into routine clinical care using a single MDHAQ to better inform health professionals concerning patient status, prognosis, and response to treatments,” the authors wrote.

SOURCE:

The study was led by Juan Schmukler, MD, Rush University Medical Center, Chicago, and was published online on July 16, 2024, in ACR Open Rheumatology. 

LIMITATIONS:

The analyses were cross-sectional, and whether anxiety, depression, and fibromyalgia had preceded or followed the onset of OA or RA was not known. Information on the clinical variables associated with anxiety, depression, and fibromyalgia, such as body mass index, medication history, and other comorbid conditions, was not available. All the patients were seen at a single rheumatology site, which may have limited the generalizability of the observations. 

DISCLOSURES:

This study did not disclose any sources of funding. One author disclosed receiving grants from the National Institute of Arthritis and Musculoskeletal and Skin Diseases. One author reported numerous financial relationships with companies in the medical industry, and another reported holding a copyright and trademark on MDHAQ and RAPID3. 

This article was created using several editorial tools, including AI, as a part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

About 40% of patients with osteoarthritis (OA) and 36% with rheumatoid arthritis (RA) screened positive for anxiety, depression, and/or fibromyalgia as part of routine visits to an academic medical center, and these comorbidities were linked to poorer patient status measures, highlighting the need for routine screening in clinical practice. 

METHODOLOGY:

• This retrospective cross-sectional study analyzed the prevalence of anxiety, depression, and fibromyalgia in 366 patients with OA (mean age, 66.6 years) and 488 patients with RA (mean age, 56.9 years) who were in routine care at an academic center from 2011 to 2022.
• All participants were required to have complete Multidimensional Health Assessment Questionnaire (MDHAQ) data available for the analysis.
• The MDHAQ included indices to assess the overall patient status and screen for anxiety, depression, and fibromyalgia.
• The overall patient status was measured using the Routine Assessment of Patient Index Data 3 (RAPID3), which comprised the physical function, pain, and patient global scores.
• The prevalence of each comorbidity and its association with patient status was analyzed using unadjusted and age-adjusted odds ratios (ORs) and 95% CIs.

TAKEAWAY:

• Among the patients with OA, 40.4% were screened positive for at least one of the three indices indicating patient distress (anxiety, depression, and fibromyalgia). Among patients with RA, the proportion was 36.3%.
• Among the patients who screened positive for at least one index, about 20% screened positive for all three indices related to anxiety, depression, and fibromyalgia.
• In patients with OA, a poorer patient status (RAPID3, ≥ 12 vs < 12) increased the likelihood of anxiety (OR, 3.93; 95% CI, 2.24-7.23), depression (OR, 3.79; 95% CI, 2.01-7.73), and fibromyalgia (OR, 6.70; 95% CI, 3.36-14.99).
• Similarly, the odds of all three comorbidities increased in the patients with RA who had worsened patient status.

IN PRACTICE:

“Screening for [anxiety, depression, and/or fibromyalgia] can be incorporated feasibly into routine clinical care using a single MDHAQ to better inform health professionals concerning patient status, prognosis, and response to treatments,” the authors wrote.

SOURCE:

The study was led by Juan Schmukler, MD, Rush University Medical Center, Chicago, and was published online on July 16, 2024, in ACR Open Rheumatology. 

LIMITATIONS:

The analyses were cross-sectional, and whether anxiety, depression, and fibromyalgia had preceded or followed the onset of OA or RA was not known. Information on the clinical variables associated with anxiety, depression, and fibromyalgia, such as body mass index, medication history, and other comorbid conditions, was not available. All the patients were seen at a single rheumatology site, which may have limited the generalizability of the observations. 

DISCLOSURES:

This study did not disclose any sources of funding. One author disclosed receiving grants from the National Institute of Arthritis and Musculoskeletal and Skin Diseases. One author reported numerous financial relationships with companies in the medical industry, and another reported holding a copyright and trademark on MDHAQ and RAPID3. 

This article was created using several editorial tools, including AI, as a part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

People with knee osteoarthritis and symptoms for less than 1 year benefit more from exercise therapy than do those with longer symptom duration, especially when long-term outcomes are considered.

METHODOLOGY:

• Researchers conducted an individual participant data meta-analysis using data from the OA Trial Bank, including 1769 participants (mean age, 65.1 years; 66% women) with knee osteoarthritis from 10 randomized controlled trials.
• The participants were categorized on the basis of their symptom duration: ≤ 1 year, > 1 and ≤ 2 years, and > 2 years.
• This study included an exercise therapy group comprising land- and water-based therapeutic exercise interventions and a control group comprising no exercise or sham treatment.
• The primary outcomes were self-reported pain and physical function, standardized to a 0-100 scale, at short-term (closest to 3 months) and long-term (closest to 12 months) follow-ups.

TAKEAWAY:

• The overall pain and physical function associated with osteoarthritis improved in the exercise therapy group at both short- and long-term follow-ups compared with in the control group.
• Exercise therapy led to a greater improvement in short-term (mean difference [MD], −3.57; P = .028) and long-term (MD, −8.33; P < .001) pain among participants with a symptom duration ≤ 1 year vs > 1 year.
• Similarly, those with a symptom duration ≤ 2 years vs > 2 years who underwent exercise therapy showed greater benefits in terms of short-term (P = .001) and long-term (P < .001) pain.
• Exercise therapy improved long-term physical function in those with a symptom duration ≤ 1 year vs > 1 year (MD, −5.46; P = .005) and ≤ 2 years vs > 2 years (MD, −4.56; P = .001).

IN PRACTICE:

“Exercise should be encouraged as early as possible once symptoms emerge in the disease process to take advantage of its effects in potentially [slowing] disease progression within the suggested ‘window of opportunity,’ ” the authors wrote.

SOURCE:

The study was led by Marienke van Middelkoop, PhD, Erasmus MC Medical University, Rotterdam, the Netherlands. It was published online in Osteoarthritis and Cartilage.

LIMITATIONS:

The dataset of most studies included in the meta-analysis lacked information on the radiographic severity of osteoarthritis. The relatively short follow-up time hindered interpreting the impact of exercise on the long-term progression of osteoarthritis. The reliance on patient recall for recording symptom duration may have led to misclassification.

DISCLOSURES:

The Netherlands Organisation for Health Research and Development supported this study. Three authors received funding from the Dutch Arthritis Society for the program grant Center of Excellence “OA prevention and early treatment – OA Pearl.” One author declared receiving royalties for the UpToDate knee osteoarthritis clinical guidelines.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

People with knee osteoarthritis and symptoms for less than 1 year benefit more from exercise therapy than do those with longer symptom duration, especially when long-term outcomes are considered.

METHODOLOGY:

• Researchers conducted an individual participant data meta-analysis using data from the OA Trial Bank, including 1769 participants (mean age, 65.1 years; 66% women) with knee osteoarthritis from 10 randomized controlled trials.
• The participants were categorized on the basis of their symptom duration: ≤ 1 year, > 1 and ≤ 2 years, and > 2 years.
• This study included an exercise therapy group comprising land- and water-based therapeutic exercise interventions and a control group comprising no exercise or sham treatment.
• The primary outcomes were self-reported pain and physical function, standardized to a 0-100 scale, at short-term (closest to 3 months) and long-term (closest to 12 months) follow-ups.

TAKEAWAY:

• The overall pain and physical function associated with osteoarthritis improved in the exercise therapy group at both short- and long-term follow-ups compared with in the control group.
• Exercise therapy led to a greater improvement in short-term (mean difference [MD], −3.57; P = .028) and long-term (MD, −8.33; P < .001) pain among participants with a symptom duration ≤ 1 year vs > 1 year.
• Similarly, those with a symptom duration ≤ 2 years vs > 2 years who underwent exercise therapy showed greater benefits in terms of short-term (P = .001) and long-term (P < .001) pain.
• Exercise therapy improved long-term physical function in those with a symptom duration ≤ 1 year vs > 1 year (MD, −5.46; P = .005) and ≤ 2 years vs > 2 years (MD, −4.56; P = .001).

IN PRACTICE:

“Exercise should be encouraged as early as possible once symptoms emerge in the disease process to take advantage of its effects in potentially [slowing] disease progression within the suggested ‘window of opportunity,’ ” the authors wrote.

SOURCE:

The study was led by Marienke van Middelkoop, PhD, Erasmus MC Medical University, Rotterdam, the Netherlands. It was published online in Osteoarthritis and Cartilage.

LIMITATIONS:

The dataset of most studies included in the meta-analysis lacked information on the radiographic severity of osteoarthritis. The relatively short follow-up time hindered interpreting the impact of exercise on the long-term progression of osteoarthritis. The reliance on patient recall for recording symptom duration may have led to misclassification.

DISCLOSURES:

The Netherlands Organisation for Health Research and Development supported this study. Three authors received funding from the Dutch Arthritis Society for the program grant Center of Excellence “OA prevention and early treatment – OA Pearl.” One author declared receiving royalties for the UpToDate knee osteoarthritis clinical guidelines.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

People with knee osteoarthritis and symptoms for less than 1 year benefit more from exercise therapy than do those with longer symptom duration, especially when long-term outcomes are considered.

METHODOLOGY:

• Researchers conducted an individual participant data meta-analysis using data from the OA Trial Bank, including 1769 participants (mean age, 65.1 years; 66% women) with knee osteoarthritis from 10 randomized controlled trials.
• The participants were categorized on the basis of their symptom duration: ≤ 1 year, > 1 and ≤ 2 years, and > 2 years.
• This study included an exercise therapy group comprising land- and water-based therapeutic exercise interventions and a control group comprising no exercise or sham treatment.
• The primary outcomes were self-reported pain and physical function, standardized to a 0-100 scale, at short-term (closest to 3 months) and long-term (closest to 12 months) follow-ups.

TAKEAWAY:

• The overall pain and physical function associated with osteoarthritis improved in the exercise therapy group at both short- and long-term follow-ups compared with in the control group.
• Exercise therapy led to a greater improvement in short-term (mean difference [MD], −3.57; P = .028) and long-term (MD, −8.33; P < .001) pain among participants with a symptom duration ≤ 1 year vs > 1 year.
• Similarly, those with a symptom duration ≤ 2 years vs > 2 years who underwent exercise therapy showed greater benefits in terms of short-term (P = .001) and long-term (P < .001) pain.
• Exercise therapy improved long-term physical function in those with a symptom duration ≤ 1 year vs > 1 year (MD, −5.46; P = .005) and ≤ 2 years vs > 2 years (MD, −4.56; P = .001).

IN PRACTICE:

“Exercise should be encouraged as early as possible once symptoms emerge in the disease process to take advantage of its effects in potentially [slowing] disease progression within the suggested ‘window of opportunity,’ ” the authors wrote.

SOURCE:

The study was led by Marienke van Middelkoop, PhD, Erasmus MC Medical University, Rotterdam, the Netherlands. It was published online in Osteoarthritis and Cartilage.

LIMITATIONS:

The dataset of most studies included in the meta-analysis lacked information on the radiographic severity of osteoarthritis. The relatively short follow-up time hindered interpreting the impact of exercise on the long-term progression of osteoarthritis. The reliance on patient recall for recording symptom duration may have led to misclassification.

DISCLOSURES:

The Netherlands Organisation for Health Research and Development supported this study. Three authors received funding from the Dutch Arthritis Society for the program grant Center of Excellence “OA prevention and early treatment – OA Pearl.” One author declared receiving royalties for the UpToDate knee osteoarthritis clinical guidelines.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

This transcript has been edited for clarity. 

Hi. I’m Art Caplan. I’m at the Division of Medical Ethics at New York University Grossman School of Medicine in New York City. 

There are many things screwy with our healthcare system. Many of you [reading] this are dealing with bureaucracy, paperwork, all sorts of constraints, restraints, and requirements that sometimes make the practice of medicine, or even nursing, difficult.

I don’t think I’ve seen anything screwier, from a moral point of view, than the system we have that allows for preauthorization by third-party payers, or insurers, in order to give care to patients. It’s pretty clear that a third-party payer has a conflict of interest. It’s simple: They don’t want to spend money.

Their goal as profit-making companies is to reduce what it is that they’re going to authorize. That clearly is driving how the preauthorization process works. We’re not getting a neutral review by third parties of the appropriateness of treatment recommendations or somebody saying, this is the standard of care and this is what ought to happen.

We’re letting the people who have the pocketbooks and the wallets have prior approval of what the doctor thinks is correct. That is really not the way to practice medicine. 

We now have more evidence about what really is going on. A doctor was recently interviewed by ProPublica and said that she had worked for Cigna as a reviewer. Basically, the message she got from that insurer was to speed it up, go fast, and basically “deny, deny, deny” when she got requests. Those are her words, not mine.

We get a peek under the tent of how this works, and Dr. Day is basically saying she had to leave because she just didn’t feel that it was evidence-driven. It was driven by concerns about who’s going to lose money or make money.

If you want to check to see whether something is appropriate, the question becomes, who ought to do prior review? 

Who does it now? Sometimes doctors. Sometimes nurses who aren’t in the specialty where the request is coming in for preapproval. I’ve even seen situations where some companies use nurses in other countries, such as the Philippines, to do preapproval. They send them information, like a clip, to use to deny things that basically is boilerplate language, whatever the request is.

Looming up now, some insurers are starting to think, well, maybe artificial intelligence could do it. Just review the written request, trigger certain responses on the part of the artificial intelligence — it can deny the claims just as well as a human — and maybe it’s even cheaper to set up that system for the insurer.

This is ethically nuts. We need to have a system where doctors’ judgments drive what patients get. You listen to doctors, as I do, about preapproval access and they say patients sometimes give up trying to get what they think is needed. Continuity of care is interrupted if they have to keep making requests all the time.

There are adverse events when the thing that the doctor thought was most appropriate isn’t approved and something else is used that is less safe or less efficacious. It isn’t in patient interest to have the person with the wallet saying, this is what we think you need, and then having unqualified people or even automated intelligence with no accountability and no transparency get involved in preauthorization.

This system costs us money because middlemen are doing all this work. It basically becomes one of the huge scandals, in my view, of our health system, that doctors don’t ultimately decide what the patient needs. A preauthorizing third party or robot, without transparency, without accountability, and behind closed doors second-guesses what’s going on.

I’m Art Caplan at the Division of Medical Ethics at the New York University Grossman School of Medicine.

Arthur L. Caplan, Director, Division of Medical Ethics, New York University Langone Medical Center, New York, New York, has disclosed the following relevant financial relationships: Served as a director, officer, partner, employee, advisor, consultant, or trustee for Johnson & Johnson’s Panel for Compassionate Drug Use (unpaid position). Serves as a contributing author and advisor for Medscape.

A version of this article first appeared on Medscape.com.

This transcript has been edited for clarity. 

Hi. I’m Art Caplan. I’m at the Division of Medical Ethics at New York University Grossman School of Medicine in New York City. 

There are many things screwy with our healthcare system. Many of you [reading] this are dealing with bureaucracy, paperwork, all sorts of constraints, restraints, and requirements that sometimes make the practice of medicine, or even nursing, difficult.

I don’t think I’ve seen anything screwier, from a moral point of view, than the system we have that allows for preauthorization by third-party payers, or insurers, in order to give care to patients. It’s pretty clear that a third-party payer has a conflict of interest. It’s simple: They don’t want to spend money.

Their goal as profit-making companies is to reduce what it is that they’re going to authorize. That clearly is driving how the preauthorization process works. We’re not getting a neutral review by third parties of the appropriateness of treatment recommendations or somebody saying, this is the standard of care and this is what ought to happen.

We’re letting the people who have the pocketbooks and the wallets have prior approval of what the doctor thinks is correct. That is really not the way to practice medicine. 

We now have more evidence about what really is going on. A doctor was recently interviewed by ProPublica and said that she had worked for Cigna as a reviewer. Basically, the message she got from that insurer was to speed it up, go fast, and basically “deny, deny, deny” when she got requests. Those are her words, not mine.

We get a peek under the tent of how this works, and Dr. Day is basically saying she had to leave because she just didn’t feel that it was evidence-driven. It was driven by concerns about who’s going to lose money or make money.

If you want to check to see whether something is appropriate, the question becomes, who ought to do prior review? 

Who does it now? Sometimes doctors. Sometimes nurses who aren’t in the specialty where the request is coming in for preapproval. I’ve even seen situations where some companies use nurses in other countries, such as the Philippines, to do preapproval. They send them information, like a clip, to use to deny things that basically is boilerplate language, whatever the request is.

Looming up now, some insurers are starting to think, well, maybe artificial intelligence could do it. Just review the written request, trigger certain responses on the part of the artificial intelligence — it can deny the claims just as well as a human — and maybe it’s even cheaper to set up that system for the insurer.

This is ethically nuts. We need to have a system where doctors’ judgments drive what patients get. You listen to doctors, as I do, about preapproval access and they say patients sometimes give up trying to get what they think is needed. Continuity of care is interrupted if they have to keep making requests all the time.

There are adverse events when the thing that the doctor thought was most appropriate isn’t approved and something else is used that is less safe or less efficacious. It isn’t in patient interest to have the person with the wallet saying, this is what we think you need, and then having unqualified people or even automated intelligence with no accountability and no transparency get involved in preauthorization.

This system costs us money because middlemen are doing all this work. It basically becomes one of the huge scandals, in my view, of our health system, that doctors don’t ultimately decide what the patient needs. A preauthorizing third party or robot, without transparency, without accountability, and behind closed doors second-guesses what’s going on.

I’m Art Caplan at the Division of Medical Ethics at the New York University Grossman School of Medicine.

Arthur L. Caplan, Director, Division of Medical Ethics, New York University Langone Medical Center, New York, New York, has disclosed the following relevant financial relationships: Served as a director, officer, partner, employee, advisor, consultant, or trustee for Johnson & Johnson’s Panel for Compassionate Drug Use (unpaid position). Serves as a contributing author and advisor for Medscape.

A version of this article first appeared on Medscape.com.

This transcript has been edited for clarity. 

Hi. I’m Art Caplan. I’m at the Division of Medical Ethics at New York University Grossman School of Medicine in New York City. 

There are many things screwy with our healthcare system. Many of you [reading] this are dealing with bureaucracy, paperwork, all sorts of constraints, restraints, and requirements that sometimes make the practice of medicine, or even nursing, difficult.

I don’t think I’ve seen anything screwier, from a moral point of view, than the system we have that allows for preauthorization by third-party payers, or insurers, in order to give care to patients. It’s pretty clear that a third-party payer has a conflict of interest. It’s simple: They don’t want to spend money.

Their goal as profit-making companies is to reduce what it is that they’re going to authorize. That clearly is driving how the preauthorization process works. We’re not getting a neutral review by third parties of the appropriateness of treatment recommendations or somebody saying, this is the standard of care and this is what ought to happen.

We’re letting the people who have the pocketbooks and the wallets have prior approval of what the doctor thinks is correct. That is really not the way to practice medicine. 

We now have more evidence about what really is going on. A doctor was recently interviewed by ProPublica and said that she had worked for Cigna as a reviewer. Basically, the message she got from that insurer was to speed it up, go fast, and basically “deny, deny, deny” when she got requests. Those are her words, not mine.

We get a peek under the tent of how this works, and Dr. Day is basically saying she had to leave because she just didn’t feel that it was evidence-driven. It was driven by concerns about who’s going to lose money or make money.

If you want to check to see whether something is appropriate, the question becomes, who ought to do prior review? 

Who does it now? Sometimes doctors. Sometimes nurses who aren’t in the specialty where the request is coming in for preapproval. I’ve even seen situations where some companies use nurses in other countries, such as the Philippines, to do preapproval. They send them information, like a clip, to use to deny things that basically is boilerplate language, whatever the request is.

Looming up now, some insurers are starting to think, well, maybe artificial intelligence could do it. Just review the written request, trigger certain responses on the part of the artificial intelligence — it can deny the claims just as well as a human — and maybe it’s even cheaper to set up that system for the insurer.

This is ethically nuts. We need to have a system where doctors’ judgments drive what patients get. You listen to doctors, as I do, about preapproval access and they say patients sometimes give up trying to get what they think is needed. Continuity of care is interrupted if they have to keep making requests all the time.

There are adverse events when the thing that the doctor thought was most appropriate isn’t approved and something else is used that is less safe or less efficacious. It isn’t in patient interest to have the person with the wallet saying, this is what we think you need, and then having unqualified people or even automated intelligence with no accountability and no transparency get involved in preauthorization.

This system costs us money because middlemen are doing all this work. It basically becomes one of the huge scandals, in my view, of our health system, that doctors don’t ultimately decide what the patient needs. A preauthorizing third party or robot, without transparency, without accountability, and behind closed doors second-guesses what’s going on.

I’m Art Caplan at the Division of Medical Ethics at the New York University Grossman School of Medicine.

Arthur L. Caplan, Director, Division of Medical Ethics, New York University Langone Medical Center, New York, New York, has disclosed the following relevant financial relationships: Served as a director, officer, partner, employee, advisor, consultant, or trustee for Johnson & Johnson’s Panel for Compassionate Drug Use (unpaid position). Serves as a contributing author and advisor for Medscape.

A version of this article first appeared on Medscape.com.

Among patients who presented to a combined pediatric rheumatology/dermatology clinic (RDC) at the University of California, San Francisco (UCSF), 24% presented without a confirmed diagnosis, and only 41% received a diagnosis during their first clinic visit, results from a retrospective cohort study showed.

“This finding highlights the complexity of patients referred to this clinic,” the study’s first author, Jessica Crockett, a fourth-year medical student at UCSF, told this news organization following the annual meeting of the Society for Pediatric Dermatology, where the study was presented during a poster session. “Integrated care models such as rheumatology/dermatology clinics (RDCs) have been shown to facilitate complete clinical evaluations, establish new or revised diagnoses, and streamline care for adult patients with complex autoimmune skin diseases. However, few pediatric RDCs exist nationwide, and data therefore is quite limited.”

To advance the understanding of pediatric RDC practice patterns, the influence of the care model on patient care, and professional development for trainees and clinicians, Ms. Crockett collaborated with senior author Kelly Cordoro, MD, professor of dermatology and pediatrics at UCSF, and colleagues to evaluate a cohort of 71 patients who received care at the UCSF pediatric RDC. The clinic, which was launched in 2017, includes two dermatologists, two rheumatologists, trainees, a social worker, and a nurse. Team members participate in a preclinic conference to review patient data and images, discuss relevant literature, and develop an approach to each patient.

In a separate part of the study, the researchers distributed a survey to 17 pediatric dermatologists who participate in unique RDCs in North America. Respondents were asked to describe the variability of clinical operations, participants, administrative/clinical support, and educational value for participating physicians and trainees.

Of the 71 patients cared for at the UCSF pediatric RDC, 69% were female, 44% were White, 51% were aged 13-21 years, 42% were aged 3-12 years, and 7% were aged 0-11 years at their first clinic visit. The top four primary RDC diagnoses were linear morphea (33%), lupus (23%), psoriasis (13%), and juvenile dermatomyositis (10%).

Nearly one in four patients (17, or 24%) presented to the RDC without a confirmed diagnosis. A diagnosis was established at the first RDC visit for 7 of these 17 patients (41%). Among 54 patients who presented with an established diagnosis, the first RDC visit confirmed the diagnosis for 52 (96%) and revised it for 2 (4%). “Initial pediatric RDC evaluation significantly influenced patient care by confirming or revising preexisting diagnoses, rendering new diagnoses, and streamlining additional laboratory and imaging recommendations,” the researchers wrote in their poster.

The evaluation also resulted in modified disease management in the form of systemic medication changes or dosage adjustments as well as the initiation of novel therapies. For example, systemic medication changes were made during the first RDC visit in 34 of the 46 patients (74%) who were on systemic medication at presentation.

“Seeing complex patients together in real time allows specialists and other team members (social work, nursing, PT/OT, for example) to share ideas, communicate clearly to families, and efficiently develop recommendations,” Ms. Crockett said of the UCSF pediatric RDC. “Exposure to other specialists while caring for patients enhances medical knowledge, communication skills, and professional competency of faculty and trainees alike.”

In the survey portion of the study, each of the 17 dermatologists reported that the pediatric RDC is valuable for patient care, and 88% believed the RDC was a valuable use of their time. However, only 59% of respondents reported having administrative support, and only 29% had a dedicated clinic coordinator or navigator.

“We were surprised to find that only a quarter of pediatric RDCs incorporate an educational conference,” Dr. Cordoro told this news organization. “We have found that assembling the care team prior to seeing patients to review clinical data, discuss relevant literature, and define the clinical questions for each patient is an integral part of the clinical operation. The trainees are involved in these conference presentations, and it really enhances their understanding of the complex diagnoses we manage in this clinic and the issues faced by affected children and families. The preclinical conference increases efficiency, positively influences patient care, and supports professional development for all participants.”

The study was indirectly supported by a fellowship grant awarded to Ms. Crockett from the Pediatric Dermatology Research Alliance. The researchers reported having no relevant disclosures.

A version of this article appeared on Medscape.com.

Among patients who presented to a combined pediatric rheumatology/dermatology clinic (RDC) at the University of California, San Francisco (UCSF), 24% presented without a confirmed diagnosis, and only 41% received a diagnosis during their first clinic visit, results from a retrospective cohort study showed.

“This finding highlights the complexity of patients referred to this clinic,” the study’s first author, Jessica Crockett, a fourth-year medical student at UCSF, told this news organization following the annual meeting of the Society for Pediatric Dermatology, where the study was presented during a poster session. “Integrated care models such as rheumatology/dermatology clinics (RDCs) have been shown to facilitate complete clinical evaluations, establish new or revised diagnoses, and streamline care for adult patients with complex autoimmune skin diseases. However, few pediatric RDCs exist nationwide, and data therefore is quite limited.”

To advance the understanding of pediatric RDC practice patterns, the influence of the care model on patient care, and professional development for trainees and clinicians, Ms. Crockett collaborated with senior author Kelly Cordoro, MD, professor of dermatology and pediatrics at UCSF, and colleagues to evaluate a cohort of 71 patients who received care at the UCSF pediatric RDC. The clinic, which was launched in 2017, includes two dermatologists, two rheumatologists, trainees, a social worker, and a nurse. Team members participate in a preclinic conference to review patient data and images, discuss relevant literature, and develop an approach to each patient.

In a separate part of the study, the researchers distributed a survey to 17 pediatric dermatologists who participate in unique RDCs in North America. Respondents were asked to describe the variability of clinical operations, participants, administrative/clinical support, and educational value for participating physicians and trainees.

Of the 71 patients cared for at the UCSF pediatric RDC, 69% were female, 44% were White, 51% were aged 13-21 years, 42% were aged 3-12 years, and 7% were aged 0-11 years at their first clinic visit. The top four primary RDC diagnoses were linear morphea (33%), lupus (23%), psoriasis (13%), and juvenile dermatomyositis (10%).

Nearly one in four patients (17, or 24%) presented to the RDC without a confirmed diagnosis. A diagnosis was established at the first RDC visit for 7 of these 17 patients (41%). Among 54 patients who presented with an established diagnosis, the first RDC visit confirmed the diagnosis for 52 (96%) and revised it for 2 (4%). “Initial pediatric RDC evaluation significantly influenced patient care by confirming or revising preexisting diagnoses, rendering new diagnoses, and streamlining additional laboratory and imaging recommendations,” the researchers wrote in their poster.

The evaluation also resulted in modified disease management in the form of systemic medication changes or dosage adjustments as well as the initiation of novel therapies. For example, systemic medication changes were made during the first RDC visit in 34 of the 46 patients (74%) who were on systemic medication at presentation.

“Seeing complex patients together in real time allows specialists and other team members (social work, nursing, PT/OT, for example) to share ideas, communicate clearly to families, and efficiently develop recommendations,” Ms. Crockett said of the UCSF pediatric RDC. “Exposure to other specialists while caring for patients enhances medical knowledge, communication skills, and professional competency of faculty and trainees alike.”

In the survey portion of the study, each of the 17 dermatologists reported that the pediatric RDC is valuable for patient care, and 88% believed the RDC was a valuable use of their time. However, only 59% of respondents reported having administrative support, and only 29% had a dedicated clinic coordinator or navigator.

“We were surprised to find that only a quarter of pediatric RDCs incorporate an educational conference,” Dr. Cordoro told this news organization. “We have found that assembling the care team prior to seeing patients to review clinical data, discuss relevant literature, and define the clinical questions for each patient is an integral part of the clinical operation. The trainees are involved in these conference presentations, and it really enhances their understanding of the complex diagnoses we manage in this clinic and the issues faced by affected children and families. The preclinical conference increases efficiency, positively influences patient care, and supports professional development for all participants.”

The study was indirectly supported by a fellowship grant awarded to Ms. Crockett from the Pediatric Dermatology Research Alliance. The researchers reported having no relevant disclosures.

A version of this article appeared on Medscape.com.

Among patients who presented to a combined pediatric rheumatology/dermatology clinic (RDC) at the University of California, San Francisco (UCSF), 24% presented without a confirmed diagnosis, and only 41% received a diagnosis during their first clinic visit, results from a retrospective cohort study showed.

“This finding highlights the complexity of patients referred to this clinic,” the study’s first author, Jessica Crockett, a fourth-year medical student at UCSF, told this news organization following the annual meeting of the Society for Pediatric Dermatology, where the study was presented during a poster session. “Integrated care models such as rheumatology/dermatology clinics (RDCs) have been shown to facilitate complete clinical evaluations, establish new or revised diagnoses, and streamline care for adult patients with complex autoimmune skin diseases. However, few pediatric RDCs exist nationwide, and data therefore is quite limited.”

To advance the understanding of pediatric RDC practice patterns, the influence of the care model on patient care, and professional development for trainees and clinicians, Ms. Crockett collaborated with senior author Kelly Cordoro, MD, professor of dermatology and pediatrics at UCSF, and colleagues to evaluate a cohort of 71 patients who received care at the UCSF pediatric RDC. The clinic, which was launched in 2017, includes two dermatologists, two rheumatologists, trainees, a social worker, and a nurse. Team members participate in a preclinic conference to review patient data and images, discuss relevant literature, and develop an approach to each patient.

In a separate part of the study, the researchers distributed a survey to 17 pediatric dermatologists who participate in unique RDCs in North America. Respondents were asked to describe the variability of clinical operations, participants, administrative/clinical support, and educational value for participating physicians and trainees.

Of the 71 patients cared for at the UCSF pediatric RDC, 69% were female, 44% were White, 51% were aged 13-21 years, 42% were aged 3-12 years, and 7% were aged 0-11 years at their first clinic visit. The top four primary RDC diagnoses were linear morphea (33%), lupus (23%), psoriasis (13%), and juvenile dermatomyositis (10%).

Nearly one in four patients (17, or 24%) presented to the RDC without a confirmed diagnosis. A diagnosis was established at the first RDC visit for 7 of these 17 patients (41%). Among 54 patients who presented with an established diagnosis, the first RDC visit confirmed the diagnosis for 52 (96%) and revised it for 2 (4%). “Initial pediatric RDC evaluation significantly influenced patient care by confirming or revising preexisting diagnoses, rendering new diagnoses, and streamlining additional laboratory and imaging recommendations,” the researchers wrote in their poster.

The evaluation also resulted in modified disease management in the form of systemic medication changes or dosage adjustments as well as the initiation of novel therapies. For example, systemic medication changes were made during the first RDC visit in 34 of the 46 patients (74%) who were on systemic medication at presentation.

“Seeing complex patients together in real time allows specialists and other team members (social work, nursing, PT/OT, for example) to share ideas, communicate clearly to families, and efficiently develop recommendations,” Ms. Crockett said of the UCSF pediatric RDC. “Exposure to other specialists while caring for patients enhances medical knowledge, communication skills, and professional competency of faculty and trainees alike.”

In the survey portion of the study, each of the 17 dermatologists reported that the pediatric RDC is valuable for patient care, and 88% believed the RDC was a valuable use of their time. However, only 59% of respondents reported having administrative support, and only 29% had a dedicated clinic coordinator or navigator.

“We were surprised to find that only a quarter of pediatric RDCs incorporate an educational conference,” Dr. Cordoro told this news organization. “We have found that assembling the care team prior to seeing patients to review clinical data, discuss relevant literature, and define the clinical questions for each patient is an integral part of the clinical operation. The trainees are involved in these conference presentations, and it really enhances their understanding of the complex diagnoses we manage in this clinic and the issues faced by affected children and families. The preclinical conference increases efficiency, positively influences patient care, and supports professional development for all participants.”

The study was indirectly supported by a fellowship grant awarded to Ms. Crockett from the Pediatric Dermatology Research Alliance. The researchers reported having no relevant disclosures.

A version of this article appeared on Medscape.com.

Colchicine is an effective treatment for most pediatric patients with complex aphthous stomatitis (CAS), results from a small retrospective study showed.

“Complex aphthous stomatitis in children is typically treated with topical supportive care, which is often not effective,” one of the study investigators, Ananya Shah, a third-year medical student at the University of Rochester School of Medicine & Dentistry, Rochester, New York, told this news organization following the Society for Pediatric Dermatology annual meeting, where the study was presented during a poster session. “There is limited research on CAS and its treatment in children. Colchicine is often used for treatment of CAS in adults, but its use in children has not been studied.”

Ms. Shah, in collaboration with Hilary Kunkel, MD, Nessa Aghazadeh, MD, and Megha Tollefson, MD, of the Department of Dermatology, Mayo Clinic, Rochester, Minnesota, retrospectively reviewed the charts of 20 children diagnosed with CAS who were treated with colchicine, an anti-inflammatory drug often used to treat gout, at the clinic between 2000 and 2023. Treatment responses were defined as no response, partial response, and complete response. Half of the patients were girls, and their median age at presentation was 5 years.

Ulcers were most commonly located in the buccal mucosa (80%), followed by the gingiva (50%), the mucosal lip (50%), and the palate (40%). Nearly all patients (95%) reported that the CAS caused difficulties with eating or drinking. Other effects on their quality of life included weight loss (35%), bleeding (30%), and difficulty brushing teeth (25%). “I was surprised by how much CAS impacts pediatric patients’ quality of life,” Ms. Shah said. “Almost all of the patients experienced trouble with basic activities of daily living, including eating and drinking. In addition, CAS negatively impacted mental health and led to missed school for patients.”

The researchers had follow-up data on responses to colchicine for 14 of the 20 patients. Of these, 12 (86%) had symptom improvement, 5 (36%) had a complete response, 8 (57%) had a partial response, and 1 (7%) did not respond. Nine patients (64%) experienced side effects. Of these, six had diarrhea, two had nausea, and one had constipation.

“Colchicine should be considered as a treatment in pediatric patients who have refractory complex aphthous stomatitis as it is generally well tolerated with minimal side effects,” Ms. Shah said. She acknowledged certain limitations of the study, including its single-center, retrospective design.

The researchers reported having no relevant disclosures.

A version of this article first appeared on Medscape.com.

Colchicine is an effective treatment for most pediatric patients with complex aphthous stomatitis (CAS), results from a small retrospective study showed.

“Complex aphthous stomatitis in children is typically treated with topical supportive care, which is often not effective,” one of the study investigators, Ananya Shah, a third-year medical student at the University of Rochester School of Medicine & Dentistry, Rochester, New York, told this news organization following the Society for Pediatric Dermatology annual meeting, where the study was presented during a poster session. “There is limited research on CAS and its treatment in children. Colchicine is often used for treatment of CAS in adults, but its use in children has not been studied.”

Ms. Shah, in collaboration with Hilary Kunkel, MD, Nessa Aghazadeh, MD, and Megha Tollefson, MD, of the Department of Dermatology, Mayo Clinic, Rochester, Minnesota, retrospectively reviewed the charts of 20 children diagnosed with CAS who were treated with colchicine, an anti-inflammatory drug often used to treat gout, at the clinic between 2000 and 2023. Treatment responses were defined as no response, partial response, and complete response. Half of the patients were girls, and their median age at presentation was 5 years.

Ulcers were most commonly located in the buccal mucosa (80%), followed by the gingiva (50%), the mucosal lip (50%), and the palate (40%). Nearly all patients (95%) reported that the CAS caused difficulties with eating or drinking. Other effects on their quality of life included weight loss (35%), bleeding (30%), and difficulty brushing teeth (25%). “I was surprised by how much CAS impacts pediatric patients’ quality of life,” Ms. Shah said. “Almost all of the patients experienced trouble with basic activities of daily living, including eating and drinking. In addition, CAS negatively impacted mental health and led to missed school for patients.”

The researchers had follow-up data on responses to colchicine for 14 of the 20 patients. Of these, 12 (86%) had symptom improvement, 5 (36%) had a complete response, 8 (57%) had a partial response, and 1 (7%) did not respond. Nine patients (64%) experienced side effects. Of these, six had diarrhea, two had nausea, and one had constipation.

“Colchicine should be considered as a treatment in pediatric patients who have refractory complex aphthous stomatitis as it is generally well tolerated with minimal side effects,” Ms. Shah said. She acknowledged certain limitations of the study, including its single-center, retrospective design.

The researchers reported having no relevant disclosures.

A version of this article first appeared on Medscape.com.

Colchicine is an effective treatment for most pediatric patients with complex aphthous stomatitis (CAS), results from a small retrospective study showed.

“Complex aphthous stomatitis in children is typically treated with topical supportive care, which is often not effective,” one of the study investigators, Ananya Shah, a third-year medical student at the University of Rochester School of Medicine & Dentistry, Rochester, New York, told this news organization following the Society for Pediatric Dermatology annual meeting, where the study was presented during a poster session. “There is limited research on CAS and its treatment in children. Colchicine is often used for treatment of CAS in adults, but its use in children has not been studied.”

Ms. Shah, in collaboration with Hilary Kunkel, MD, Nessa Aghazadeh, MD, and Megha Tollefson, MD, of the Department of Dermatology, Mayo Clinic, Rochester, Minnesota, retrospectively reviewed the charts of 20 children diagnosed with CAS who were treated with colchicine, an anti-inflammatory drug often used to treat gout, at the clinic between 2000 and 2023. Treatment responses were defined as no response, partial response, and complete response. Half of the patients were girls, and their median age at presentation was 5 years.

Ulcers were most commonly located in the buccal mucosa (80%), followed by the gingiva (50%), the mucosal lip (50%), and the palate (40%). Nearly all patients (95%) reported that the CAS caused difficulties with eating or drinking. Other effects on their quality of life included weight loss (35%), bleeding (30%), and difficulty brushing teeth (25%). “I was surprised by how much CAS impacts pediatric patients’ quality of life,” Ms. Shah said. “Almost all of the patients experienced trouble with basic activities of daily living, including eating and drinking. In addition, CAS negatively impacted mental health and led to missed school for patients.”

The researchers had follow-up data on responses to colchicine for 14 of the 20 patients. Of these, 12 (86%) had symptom improvement, 5 (36%) had a complete response, 8 (57%) had a partial response, and 1 (7%) did not respond. Nine patients (64%) experienced side effects. Of these, six had diarrhea, two had nausea, and one had constipation.

“Colchicine should be considered as a treatment in pediatric patients who have refractory complex aphthous stomatitis as it is generally well tolerated with minimal side effects,” Ms. Shah said. She acknowledged certain limitations of the study, including its single-center, retrospective design.

The researchers reported having no relevant disclosures.

A version of this article first appeared on Medscape.com.

Eat as fast as you can whenever you can.

That was the med student mindset around food, as Catherine Harmon Toomer, MD, discovered during her school years. “Without a good system in place to counter that,” she explains, “unhealthy eating can get out of control, and that’s what happened to me.”

After med school, things got worse for Dr. Toomer. By her second year in practice as a family medicine physician, she’d gained a lot of weight and had been diagnosed with type 2 diabetes and cardiomyopathy. At 36, she went into congestive heart failure and was told she likely had 5 years to live.

A moment she described as “a huge wake-up call.”

Dr. Toomer is far from alone in her struggles to balance working in medicine and eating healthfully.

“Physicians face unique stresses because of the ubiquity of junk food in the clinical setting, easy use of food as a reward and stress reliever, and lack of time to create better wellness habits while counseling patients to do exactly that,” said John La Puma, MD, FACP, internist and cofounder of ChefMD and founder of Chef Clinic.

There is also the culture of medicine, which Dr. Toomer said looks down on self-care. “Even with break times, patient needs come before our own.” So, you sit down to eat, and there’s an emergency. Your clinic closes for lunch, but the phones still ring, and patients continue to email questions. Charting is also so time-consuming that “everything else gets put on the back burner.”

Sticking to a nutritious diet in this context can feel hopeless. But it isn’t. Really. Here are some doctor-tested, real-life ways you can nourish yourself while getting it all done.
 

Something Is Always Better Than Nothing

Sure, you might not be able to eat a balanced lunch or dinner while at work, conceded Amy Margulies, RD, LDN, owner of The Rebellious RD. But try to focus on the bigger picture and take small steps.

First, make sure you eat something, Ms. Margulies advised. “Skipping meals can lead to overeating later and negatively impact energy levels and concentration.”

Lisa Andrews, MEd, RD, LD, owner of Sound Bites Nutrition, recalled one of her patients, a gastrointestinal surgeon with reactive hypoglycemia and fatigue. “She was experiencing energy crashes mid-afternoon,” she said. It was only after starting to eat every 4-5 hours that her patient felt better.

Of course, this is easier said than done. “When you are running from one patient to the other and trying to keep on time with your schedule, there is very little time for eating and no time at all for cooking or even heating up food,” recalled Hélène Bertrand, MD, author of Low Back Pain: 3 Steps to Relief in 2 Minutes.

But during her 55 years as a family medicine physician, Dr. Bertrand found ways to improve (if not perfect) the situation. She lunched on nuts or seeds during the day or grabbed a 95% cacao chocolate bar — higher in antioxidants and lower in sugar than a candy bar.

If you don’t have time for breakfast, try drinking a complete protein shake while driving to work, Dr. Toomer recommended. “It’s not ideal, but it’s better than nothing.” Similarly, if the only way you’ll eat a high-protein, lower-carb snack like hummus is with potato chips, go for it, she said.

Basically, don’t be type A striving for perfection. Take good enough when you can and balance the rest when you have time.
 

Torpedo Temptation

From free treats in the break room to always-present pizza for residents, high-fat, high-sugar, low-nutrient fare is a constant temptation. “I worked with a physician who would bring a balanced lunch to work every day, then find whatever sweet was around for his afternoon treat,” recalled Ms. Margulies.“The cookies, cakes, and donuts were starting to add up — and stopping at one wasn’t working for him.”

What did work was Ms. Margulies’ suggestion to bring a single serving of dark chocolate and fruit to savor during a longer break. “Bringing your favorite treats in appropriate portions can help you stick with your plan throughout the day,” she explained, and you’ll have an easier time resisting what’s in the break room. “When you desire a treat, tell yourself you have what you need and don’t need to indulge in the ‘free food’ just because it’s there. You have power over your choices.”

How about tricking yourself into perceiving cherry tomatoes as treats? That might be unusual, but one of Dr. La Puma’s physician patients did just that, displaying the produce in a candy dish on his office counter. Not only did this strategy help remind him to snack healthfully, it also prompted his patients to ask about eating better, he said.
 

Preparation Is Still Underrated

Many people find meal prepping intimidating. But it doesn’t need to be complicated. For instance, try purchasing precut veggies, cooked chicken breasts, or other healthy convenience options. You can then combine them in packable containers to prep a few meals at a time. For less busy weeks, consider cooking the protein yourself and whipping up basic sauces (like pesto and vinaigrette) to jazz up your meals.

“I worked with a resident who was gaining weight each month,” recalled Ms. Margulies. “She would skip lunch, grab a random snack, then wait until she got home to eat anything she could find.”

Encouraged by Ms. Margulies, she prepared and portioned one or two balanced dinners each week, which she’d later reheat. She also bought fresh and dried fruit and high-protein snacks, keeping single servings in her car to eat on the way home.

Similarly, Jess DeGore, RD, LDN, CDCES, CHWC, a diabetes educator and owner of Dietitian Jess Nutrition, recalled an ob.gyn. client who constantly skipped meals and relied on vending machine snacks. To combat her resulting energy crashes, she followed Ms. DeGore’s advice to prep workday lunches (like quinoa salads) over the weekend and bring fruit and nut snacks to work.
 

Automate as Much as You Can

If healthy is already on hand, you’ll eat healthy, said Ms. Andrews. Build up a snack stash focusing on fiber and protein. Tote a lunch bag with a cooler pack if needed. Some suggestions:

• Oatmeal packets
• Individual Greek yogurt cups or drinkable yogurts
• Protein bars
• Protein shakes
• Fresh fruit
• Fresh veggie sticks
• Nuts, dried chickpeas, or edamame
• Trail mix
• Single servings of hummus, nut butter, or guacamole
• Dried seaweed snacks
• Whole grain crackers
• Hard-boiled eggs
• String cheese
• Peanut butter sandwich
• 95% cacao chocolate bar

Try a Meal Delivery Service

Meal delivery services can be pricey, but potentially worth the expense. By bringing meals or having them sent to your office, you won’t have to find time to go to the cafeteria and stand in line, noted Janese S. Laster, MD, an internal medicine, gastroenterology, obesity medicine, and nutrition physician and founder of Gut Theory Total Digestive Care. Instead, “you’ll have something to warm up and eat while writing notes or in between patients,” she said. Plus, “you won’t have an excuse to skip meals.”

Hydration Yes, Junk Drinks No

The following can be filed in the Doctors-Know-It-But-Don’t-Always-Do-It section: “Hunger can be mistaken for thirst,” said Ms. Margulies. “Staying hydrated will help you better assess whether you’re hungry or thirsty.” Choose water over soda or energy drinks, she added, to hydrate your body without unnecessary extra sugars, sugar substitutes, calories, caffeine, or sodium — all of which can affect how you feel.

Advocate for Your Health

Convincing your institution to make changes might be difficult or even impossible, but consider asking your workplace to implement initiatives like these to boost provider nutrition, suggested Jabe Brown, BHSc (Nat), founder of Melbourne Functional Medicine:

• Establish protected break times when doctors can step away from their duties to eat
• Add more nutritious cafeteria options, like salads, whole grains, and lean proteins
• Overhaul vending machine offerings
• Offer educational workshops on nutrition

Be Tenacious About Good Eating

For Dr. Toomer, that meant taking several years off from work to improve her health. After losing more than 100 pounds, she founded TOTAL Weight Care Institute to help other healthcare professionals follow in her footsteps.

For you, the path toward a healthier diet might be gradual — grabbing a more nutritious snack, spending an extra hour per week on food shopping or prep, remembering a water bottle. Whatever it looks like, make realistic lifestyle tweaks that work for you.

Maybe even try that apple-a-day thing.
 

A version of this article first appeared on Medscape.com.

Eat as fast as you can whenever you can.

That was the med student mindset around food, as Catherine Harmon Toomer, MD, discovered during her school years. “Without a good system in place to counter that,” she explains, “unhealthy eating can get out of control, and that’s what happened to me.”

After med school, things got worse for Dr. Toomer. By her second year in practice as a family medicine physician, she’d gained a lot of weight and had been diagnosed with type 2 diabetes and cardiomyopathy. At 36, she went into congestive heart failure and was told she likely had 5 years to live.

A moment she described as “a huge wake-up call.”

Dr. Toomer is far from alone in her struggles to balance working in medicine and eating healthfully.

“Physicians face unique stresses because of the ubiquity of junk food in the clinical setting, easy use of food as a reward and stress reliever, and lack of time to create better wellness habits while counseling patients to do exactly that,” said John La Puma, MD, FACP, internist and cofounder of ChefMD and founder of Chef Clinic.

There is also the culture of medicine, which Dr. Toomer said looks down on self-care. “Even with break times, patient needs come before our own.” So, you sit down to eat, and there’s an emergency. Your clinic closes for lunch, but the phones still ring, and patients continue to email questions. Charting is also so time-consuming that “everything else gets put on the back burner.”

Sticking to a nutritious diet in this context can feel hopeless. But it isn’t. Really. Here are some doctor-tested, real-life ways you can nourish yourself while getting it all done.
 

Something Is Always Better Than Nothing

Sure, you might not be able to eat a balanced lunch or dinner while at work, conceded Amy Margulies, RD, LDN, owner of The Rebellious RD. But try to focus on the bigger picture and take small steps.

First, make sure you eat something, Ms. Margulies advised. “Skipping meals can lead to overeating later and negatively impact energy levels and concentration.”

Lisa Andrews, MEd, RD, LD, owner of Sound Bites Nutrition, recalled one of her patients, a gastrointestinal surgeon with reactive hypoglycemia and fatigue. “She was experiencing energy crashes mid-afternoon,” she said. It was only after starting to eat every 4-5 hours that her patient felt better.

Of course, this is easier said than done. “When you are running from one patient to the other and trying to keep on time with your schedule, there is very little time for eating and no time at all for cooking or even heating up food,” recalled Hélène Bertrand, MD, author of Low Back Pain: 3 Steps to Relief in 2 Minutes.

But during her 55 years as a family medicine physician, Dr. Bertrand found ways to improve (if not perfect) the situation. She lunched on nuts or seeds during the day or grabbed a 95% cacao chocolate bar — higher in antioxidants and lower in sugar than a candy bar.

If you don’t have time for breakfast, try drinking a complete protein shake while driving to work, Dr. Toomer recommended. “It’s not ideal, but it’s better than nothing.” Similarly, if the only way you’ll eat a high-protein, lower-carb snack like hummus is with potato chips, go for it, she said.

Basically, don’t be type A striving for perfection. Take good enough when you can and balance the rest when you have time.
 

Torpedo Temptation

From free treats in the break room to always-present pizza for residents, high-fat, high-sugar, low-nutrient fare is a constant temptation. “I worked with a physician who would bring a balanced lunch to work every day, then find whatever sweet was around for his afternoon treat,” recalled Ms. Margulies.“The cookies, cakes, and donuts were starting to add up — and stopping at one wasn’t working for him.”

What did work was Ms. Margulies’ suggestion to bring a single serving of dark chocolate and fruit to savor during a longer break. “Bringing your favorite treats in appropriate portions can help you stick with your plan throughout the day,” she explained, and you’ll have an easier time resisting what’s in the break room. “When you desire a treat, tell yourself you have what you need and don’t need to indulge in the ‘free food’ just because it’s there. You have power over your choices.”

How about tricking yourself into perceiving cherry tomatoes as treats? That might be unusual, but one of Dr. La Puma’s physician patients did just that, displaying the produce in a candy dish on his office counter. Not only did this strategy help remind him to snack healthfully, it also prompted his patients to ask about eating better, he said.
 

Preparation Is Still Underrated

Many people find meal prepping intimidating. But it doesn’t need to be complicated. For instance, try purchasing precut veggies, cooked chicken breasts, or other healthy convenience options. You can then combine them in packable containers to prep a few meals at a time. For less busy weeks, consider cooking the protein yourself and whipping up basic sauces (like pesto and vinaigrette) to jazz up your meals.

“I worked with a resident who was gaining weight each month,” recalled Ms. Margulies. “She would skip lunch, grab a random snack, then wait until she got home to eat anything she could find.”

Encouraged by Ms. Margulies, she prepared and portioned one or two balanced dinners each week, which she’d later reheat. She also bought fresh and dried fruit and high-protein snacks, keeping single servings in her car to eat on the way home.

Similarly, Jess DeGore, RD, LDN, CDCES, CHWC, a diabetes educator and owner of Dietitian Jess Nutrition, recalled an ob.gyn. client who constantly skipped meals and relied on vending machine snacks. To combat her resulting energy crashes, she followed Ms. DeGore’s advice to prep workday lunches (like quinoa salads) over the weekend and bring fruit and nut snacks to work.
 

Automate as Much as You Can

If healthy is already on hand, you’ll eat healthy, said Ms. Andrews. Build up a snack stash focusing on fiber and protein. Tote a lunch bag with a cooler pack if needed. Some suggestions:

• Oatmeal packets
• Individual Greek yogurt cups or drinkable yogurts
• Protein bars
• Protein shakes
• Fresh fruit
• Fresh veggie sticks
• Nuts, dried chickpeas, or edamame
• Trail mix
• Single servings of hummus, nut butter, or guacamole
• Dried seaweed snacks
• Whole grain crackers
• Hard-boiled eggs
• String cheese
• Peanut butter sandwich
• 95% cacao chocolate bar

Try a Meal Delivery Service

Meal delivery services can be pricey, but potentially worth the expense. By bringing meals or having them sent to your office, you won’t have to find time to go to the cafeteria and stand in line, noted Janese S. Laster, MD, an internal medicine, gastroenterology, obesity medicine, and nutrition physician and founder of Gut Theory Total Digestive Care. Instead, “you’ll have something to warm up and eat while writing notes or in between patients,” she said. Plus, “you won’t have an excuse to skip meals.”

Hydration Yes, Junk Drinks No

The following can be filed in the Doctors-Know-It-But-Don’t-Always-Do-It section: “Hunger can be mistaken for thirst,” said Ms. Margulies. “Staying hydrated will help you better assess whether you’re hungry or thirsty.” Choose water over soda or energy drinks, she added, to hydrate your body without unnecessary extra sugars, sugar substitutes, calories, caffeine, or sodium — all of which can affect how you feel.

Advocate for Your Health

Convincing your institution to make changes might be difficult or even impossible, but consider asking your workplace to implement initiatives like these to boost provider nutrition, suggested Jabe Brown, BHSc (Nat), founder of Melbourne Functional Medicine:

• Establish protected break times when doctors can step away from their duties to eat
• Add more nutritious cafeteria options, like salads, whole grains, and lean proteins
• Overhaul vending machine offerings
• Offer educational workshops on nutrition

Be Tenacious About Good Eating

For Dr. Toomer, that meant taking several years off from work to improve her health. After losing more than 100 pounds, she founded TOTAL Weight Care Institute to help other healthcare professionals follow in her footsteps.

For you, the path toward a healthier diet might be gradual — grabbing a more nutritious snack, spending an extra hour per week on food shopping or prep, remembering a water bottle. Whatever it looks like, make realistic lifestyle tweaks that work for you.

Maybe even try that apple-a-day thing.
 

A version of this article first appeared on Medscape.com.

Eat as fast as you can whenever you can.

That was the med student mindset around food, as Catherine Harmon Toomer, MD, discovered during her school years. “Without a good system in place to counter that,” she explains, “unhealthy eating can get out of control, and that’s what happened to me.”

After med school, things got worse for Dr. Toomer. By her second year in practice as a family medicine physician, she’d gained a lot of weight and had been diagnosed with type 2 diabetes and cardiomyopathy. At 36, she went into congestive heart failure and was told she likely had 5 years to live.

A moment she described as “a huge wake-up call.”

Dr. Toomer is far from alone in her struggles to balance working in medicine and eating healthfully.

“Physicians face unique stresses because of the ubiquity of junk food in the clinical setting, easy use of food as a reward and stress reliever, and lack of time to create better wellness habits while counseling patients to do exactly that,” said John La Puma, MD, FACP, internist and cofounder of ChefMD and founder of Chef Clinic.

There is also the culture of medicine, which Dr. Toomer said looks down on self-care. “Even with break times, patient needs come before our own.” So, you sit down to eat, and there’s an emergency. Your clinic closes for lunch, but the phones still ring, and patients continue to email questions. Charting is also so time-consuming that “everything else gets put on the back burner.”

Sticking to a nutritious diet in this context can feel hopeless. But it isn’t. Really. Here are some doctor-tested, real-life ways you can nourish yourself while getting it all done.
 

Something Is Always Better Than Nothing

Sure, you might not be able to eat a balanced lunch or dinner while at work, conceded Amy Margulies, RD, LDN, owner of The Rebellious RD. But try to focus on the bigger picture and take small steps.

First, make sure you eat something, Ms. Margulies advised. “Skipping meals can lead to overeating later and negatively impact energy levels and concentration.”

Lisa Andrews, MEd, RD, LD, owner of Sound Bites Nutrition, recalled one of her patients, a gastrointestinal surgeon with reactive hypoglycemia and fatigue. “She was experiencing energy crashes mid-afternoon,” she said. It was only after starting to eat every 4-5 hours that her patient felt better.

Of course, this is easier said than done. “When you are running from one patient to the other and trying to keep on time with your schedule, there is very little time for eating and no time at all for cooking or even heating up food,” recalled Hélène Bertrand, MD, author of Low Back Pain: 3 Steps to Relief in 2 Minutes.

But during her 55 years as a family medicine physician, Dr. Bertrand found ways to improve (if not perfect) the situation. She lunched on nuts or seeds during the day or grabbed a 95% cacao chocolate bar — higher in antioxidants and lower in sugar than a candy bar.

If you don’t have time for breakfast, try drinking a complete protein shake while driving to work, Dr. Toomer recommended. “It’s not ideal, but it’s better than nothing.” Similarly, if the only way you’ll eat a high-protein, lower-carb snack like hummus is with potato chips, go for it, she said.

Basically, don’t be type A striving for perfection. Take good enough when you can and balance the rest when you have time.