Being diagnosed with an elevated amyloid-beta biomarker that indicates greater risk of Alzheimer’s disease did not lead to increased consideration of physician-assisted death (PAD), according to an analysis of patients interviewed during clinical trials on cognitive decline.

“Our findings suggest that learning one’s amyloid imaging result does not change baseline attitudes regarding the acceptability of PAD,” wrote Emily A. Largent, PhD, of the department of medical ethics and health policy at the University of Pennsylvania, Philadelphia, and coauthors. The study was published as a research letter in JAMA Neurology.

Participants were recruited from two ongoing clinical trials, one of which included patients with elevated amyloid-beta (n = 50), whereas the other did not (n = 30). All participants completed an interview 4-12 weeks after receiving their biomarker results; 47 and 30 participants, respectively, also completed a follow-up interview at 12 months.

When asked whether they had considered PAD, nearly two-thirds of interviewees with the Alzheimer’s disease biomarker stated that they neither had nor would. Roughly one in five from that group said they would pursue PAD if they began to suffer from cognitive impairment or became a burden on others. Interviewees who did not have elevated amyloid beta, when asked whether a reversed result would have led to PAD or suicide, showed interest in roughly similar proportion to their at-risk counterparts.

The coauthors acknowledged the limitations of their study, including not asking about other end-of-life preferences or perceived quality of life for people with dementia. They also noted that, although their sample mirrors the populations of the two studies they drew from, “its homogeneity limits generalizability.” As such, they stressed that “further research is indicated to better understand end-of-life care preferences among people at increased risk for dementia.”

The study was supported by grants from the Alzheimer’s Association and the National Institute on Aging. One author reported receiving grants from those two organizations during the study; another reported receiving grants from Lilly and Novartis. No other conflicts of interest were reported.

SOURCE: Largent EA et al. JAMA Neurol. 2019 Apr 29. doi: 10.1001/jamaneurol.2019.0797.

Being diagnosed with an elevated amyloid-beta biomarker that indicates greater risk of Alzheimer’s disease did not lead to increased consideration of physician-assisted death (PAD), according to an analysis of patients interviewed during clinical trials on cognitive decline.

“Our findings suggest that learning one’s amyloid imaging result does not change baseline attitudes regarding the acceptability of PAD,” wrote Emily A. Largent, PhD, of the department of medical ethics and health policy at the University of Pennsylvania, Philadelphia, and coauthors. The study was published as a research letter in JAMA Neurology.

Participants were recruited from two ongoing clinical trials, one of which included patients with elevated amyloid-beta (n = 50), whereas the other did not (n = 30). All participants completed an interview 4-12 weeks after receiving their biomarker results; 47 and 30 participants, respectively, also completed a follow-up interview at 12 months.

When asked whether they had considered PAD, nearly two-thirds of interviewees with the Alzheimer’s disease biomarker stated that they neither had nor would. Roughly one in five from that group said they would pursue PAD if they began to suffer from cognitive impairment or became a burden on others. Interviewees who did not have elevated amyloid beta, when asked whether a reversed result would have led to PAD or suicide, showed interest in roughly similar proportion to their at-risk counterparts.

The coauthors acknowledged the limitations of their study, including not asking about other end-of-life preferences or perceived quality of life for people with dementia. They also noted that, although their sample mirrors the populations of the two studies they drew from, “its homogeneity limits generalizability.” As such, they stressed that “further research is indicated to better understand end-of-life care preferences among people at increased risk for dementia.”

The study was supported by grants from the Alzheimer’s Association and the National Institute on Aging. One author reported receiving grants from those two organizations during the study; another reported receiving grants from Lilly and Novartis. No other conflicts of interest were reported.

SOURCE: Largent EA et al. JAMA Neurol. 2019 Apr 29. doi: 10.1001/jamaneurol.2019.0797.

Being diagnosed with an elevated amyloid-beta biomarker that indicates greater risk of Alzheimer’s disease did not lead to increased consideration of physician-assisted death (PAD), according to an analysis of patients interviewed during clinical trials on cognitive decline.

“Our findings suggest that learning one’s amyloid imaging result does not change baseline attitudes regarding the acceptability of PAD,” wrote Emily A. Largent, PhD, of the department of medical ethics and health policy at the University of Pennsylvania, Philadelphia, and coauthors. The study was published as a research letter in JAMA Neurology.

Participants were recruited from two ongoing clinical trials, one of which included patients with elevated amyloid-beta (n = 50), whereas the other did not (n = 30). All participants completed an interview 4-12 weeks after receiving their biomarker results; 47 and 30 participants, respectively, also completed a follow-up interview at 12 months.

When asked whether they had considered PAD, nearly two-thirds of interviewees with the Alzheimer’s disease biomarker stated that they neither had nor would. Roughly one in five from that group said they would pursue PAD if they began to suffer from cognitive impairment or became a burden on others. Interviewees who did not have elevated amyloid beta, when asked whether a reversed result would have led to PAD or suicide, showed interest in roughly similar proportion to their at-risk counterparts.

The coauthors acknowledged the limitations of their study, including not asking about other end-of-life preferences or perceived quality of life for people with dementia. They also noted that, although their sample mirrors the populations of the two studies they drew from, “its homogeneity limits generalizability.” As such, they stressed that “further research is indicated to better understand end-of-life care preferences among people at increased risk for dementia.”

The study was supported by grants from the Alzheimer’s Association and the National Institute on Aging. One author reported receiving grants from those two organizations during the study; another reported receiving grants from Lilly and Novartis. No other conflicts of interest were reported.

SOURCE: Largent EA et al. JAMA Neurol. 2019 Apr 29. doi: 10.1001/jamaneurol.2019.0797.

MAUI, HAWAII – Serious weight loss brings big improvement in psoriatic arthritis in obese patients, at least short term, according to a Swedish, single-arm, prospective, proof-of-concept study.

Bruce Jancin/MDedge News

A dose-response effect was evident: the greater the lost poundage, the bigger the improvement across multiple dimensions of psoriatic arthritis.

The short-term efficacy was eye-catching, especially in view of the well-recognized increased prevalence of obesity in psoriatic arthritis patients. But the jury is still out as to the long-term impact of this nonpharmacologic therapy, Eric M. Ruderman, MD, said at the 2019 Rheumatology Winter Clinical Symposium.

He has spoken with the Swedish investigators and was happy to learn they’re continuing to follow study participants long term.

“That’s going to be the key, right? Because if you do this for 12 weeks, like every other fad crash diet, and then you let the weight go right back on again, you haven’t really accomplished anything. I think the key will be what happens at a year,” according to Dr. Ruderman, professor of medicine and associate chief for clinical affairs in the division of rheumatology at Northwestern University, Chicago.

Bruce Jancin/MDedge News

The study included 46 obese psoriatic arthritis patients who signed on for a structured, medically supervised very-low-energy diet lasting 12-16 weeks, depending upon their baseline obesity level. The commercially available liquid diet (Cambridge Weight Plan Limited) is a type of therapy widely prescribed by Swedish physicians, clocking in at a mere 640 kcal/day.

“I don’t know about you, but I ate that at breakfast this morning,” quipped symposium director Arthur Kavanaugh, MD, professor of medicine at the University of California, San Diego.

Following completion of the strict very-low-energy diet, patients were gradually reintroduced to a less-draconian, solid-food, energy-restricted diet, to be followed through the 12-month mark. The full 12-month protocol was supervised by staff in the obesity unit at Sahlgrenska University Hospital in Gothenburg, Sweden. The 12-month results will be presented at the annual European Congress of Rheumatology in Madrid.

Of the 46 starters, 41 made it to the 6-month follow-up assessment. At that point they’d lost a median of 18.2 kg, or 18.6% of their baseline body weight. Their body mass index had dropped from an average of 35.2 to 29.8 kg/m². And their psoriatic arthritis had improved significantly. For example, their median Disease Activity Score using 28 joint counts based upon C-reactive protein (DAS28-CRP) decreased from 2.9 at baseline to 2.4 at 6 months, with ACR 20, -50, and -70 responses of 51.2%, 34.1%, and 7.3% while disease-directed medications were held constant (Arthritis Res Ther. 2019 Jan 11;21[1]:17. doi: 10.1186/s13075-019-1810-5).

The investigators reported the very-low-energy diet phase was generally well tolerated. A total of 34 of the 41 patients deemed it “easier or much easier” than expected, prompting Dr. Ruderman to comment: “Because they thought it was going to be awful.”

Dr. Ruderman and Dr. Kavanaugh reported serving as consultants to numerous pharmaceutical companies.
 

bjancin@mdedge.com

MAUI, HAWAII – Serious weight loss brings big improvement in psoriatic arthritis in obese patients, at least short term, according to a Swedish, single-arm, prospective, proof-of-concept study.

Bruce Jancin/MDedge News

A dose-response effect was evident: the greater the lost poundage, the bigger the improvement across multiple dimensions of psoriatic arthritis.

The short-term efficacy was eye-catching, especially in view of the well-recognized increased prevalence of obesity in psoriatic arthritis patients. But the jury is still out as to the long-term impact of this nonpharmacologic therapy, Eric M. Ruderman, MD, said at the 2019 Rheumatology Winter Clinical Symposium.

He has spoken with the Swedish investigators and was happy to learn they’re continuing to follow study participants long term.

“That’s going to be the key, right? Because if you do this for 12 weeks, like every other fad crash diet, and then you let the weight go right back on again, you haven’t really accomplished anything. I think the key will be what happens at a year,” according to Dr. Ruderman, professor of medicine and associate chief for clinical affairs in the division of rheumatology at Northwestern University, Chicago.

Bruce Jancin/MDedge News

The study included 46 obese psoriatic arthritis patients who signed on for a structured, medically supervised very-low-energy diet lasting 12-16 weeks, depending upon their baseline obesity level. The commercially available liquid diet (Cambridge Weight Plan Limited) is a type of therapy widely prescribed by Swedish physicians, clocking in at a mere 640 kcal/day.

“I don’t know about you, but I ate that at breakfast this morning,” quipped symposium director Arthur Kavanaugh, MD, professor of medicine at the University of California, San Diego.

Following completion of the strict very-low-energy diet, patients were gradually reintroduced to a less-draconian, solid-food, energy-restricted diet, to be followed through the 12-month mark. The full 12-month protocol was supervised by staff in the obesity unit at Sahlgrenska University Hospital in Gothenburg, Sweden. The 12-month results will be presented at the annual European Congress of Rheumatology in Madrid.

Of the 46 starters, 41 made it to the 6-month follow-up assessment. At that point they’d lost a median of 18.2 kg, or 18.6% of their baseline body weight. Their body mass index had dropped from an average of 35.2 to 29.8 kg/m². And their psoriatic arthritis had improved significantly. For example, their median Disease Activity Score using 28 joint counts based upon C-reactive protein (DAS28-CRP) decreased from 2.9 at baseline to 2.4 at 6 months, with ACR 20, -50, and -70 responses of 51.2%, 34.1%, and 7.3% while disease-directed medications were held constant (Arthritis Res Ther. 2019 Jan 11;21[1]:17. doi: 10.1186/s13075-019-1810-5).

The investigators reported the very-low-energy diet phase was generally well tolerated. A total of 34 of the 41 patients deemed it “easier or much easier” than expected, prompting Dr. Ruderman to comment: “Because they thought it was going to be awful.”

Dr. Ruderman and Dr. Kavanaugh reported serving as consultants to numerous pharmaceutical companies.
 

bjancin@mdedge.com

MAUI, HAWAII – Serious weight loss brings big improvement in psoriatic arthritis in obese patients, at least short term, according to a Swedish, single-arm, prospective, proof-of-concept study.

Bruce Jancin/MDedge News

A dose-response effect was evident: the greater the lost poundage, the bigger the improvement across multiple dimensions of psoriatic arthritis.

The short-term efficacy was eye-catching, especially in view of the well-recognized increased prevalence of obesity in psoriatic arthritis patients. But the jury is still out as to the long-term impact of this nonpharmacologic therapy, Eric M. Ruderman, MD, said at the 2019 Rheumatology Winter Clinical Symposium.

He has spoken with the Swedish investigators and was happy to learn they’re continuing to follow study participants long term.

“That’s going to be the key, right? Because if you do this for 12 weeks, like every other fad crash diet, and then you let the weight go right back on again, you haven’t really accomplished anything. I think the key will be what happens at a year,” according to Dr. Ruderman, professor of medicine and associate chief for clinical affairs in the division of rheumatology at Northwestern University, Chicago.

Bruce Jancin/MDedge News

The study included 46 obese psoriatic arthritis patients who signed on for a structured, medically supervised very-low-energy diet lasting 12-16 weeks, depending upon their baseline obesity level. The commercially available liquid diet (Cambridge Weight Plan Limited) is a type of therapy widely prescribed by Swedish physicians, clocking in at a mere 640 kcal/day.

“I don’t know about you, but I ate that at breakfast this morning,” quipped symposium director Arthur Kavanaugh, MD, professor of medicine at the University of California, San Diego.

Following completion of the strict very-low-energy diet, patients were gradually reintroduced to a less-draconian, solid-food, energy-restricted diet, to be followed through the 12-month mark. The full 12-month protocol was supervised by staff in the obesity unit at Sahlgrenska University Hospital in Gothenburg, Sweden. The 12-month results will be presented at the annual European Congress of Rheumatology in Madrid.

Of the 46 starters, 41 made it to the 6-month follow-up assessment. At that point they’d lost a median of 18.2 kg, or 18.6% of their baseline body weight. Their body mass index had dropped from an average of 35.2 to 29.8 kg/m². And their psoriatic arthritis had improved significantly. For example, their median Disease Activity Score using 28 joint counts based upon C-reactive protein (DAS28-CRP) decreased from 2.9 at baseline to 2.4 at 6 months, with ACR 20, -50, and -70 responses of 51.2%, 34.1%, and 7.3% while disease-directed medications were held constant (Arthritis Res Ther. 2019 Jan 11;21[1]:17. doi: 10.1186/s13075-019-1810-5).

The investigators reported the very-low-energy diet phase was generally well tolerated. A total of 34 of the 41 patients deemed it “easier or much easier” than expected, prompting Dr. Ruderman to comment: “Because they thought it was going to be awful.”

Dr. Ruderman and Dr. Kavanaugh reported serving as consultants to numerous pharmaceutical companies.
 

bjancin@mdedge.com

Most of the online patient education materials provided by eight nationally recognized ob.gyn. societies are written at levels above the readability guidelines set by the American Medical Association, National Institutes of Health, and Department of Health & Human Services, according to Fatimah Z. Fahimuddin, MD, of the University of California, San Francisco, Fresno, and her associates.

aluxum/E+/Getty Images

According to the AMA, NIH, and HHS, all patient education material should be written at or below a sixth-grade reading level.

In a study published in Obstetrics & Gynecology, the investigators analyzed the readability of 410 online patient education documents from the American Association of Gynecologic Laparoscopists, the American College of Obstetricians and Gynecologists, the American Society for Reproductive Medicine, the American Urogynecologic Society, the Association of Reproductive Health Professionals, the Society of Gynecologic Oncology, the Society for Maternal-Fetal Medicine, and Voices for Pelvic Floor Disorders.

The mean Flesch-Kincaid Grade Level score was 8.9 for the 69 obstetrics-related documents analyzed; for the 341 gynecology-related documents, the mean score was 8.7. The American Urogynecologic Society had the most readable documents, with a mean grade level score of 6.4; the American Association of Gynecologic Laparoscopists had the least readable, with a mean grade level score of 12.7. For the other three readability scales utilized in the analysis, mean scores generally ranged in the 8th-12th grade reading levels.

“It is not surprising that writing patient education materials at an appropriate reading level is difficult. With readability scales utilizing syllable count, common words such as ‘menstruation,’ ‘uterus,’ and ‘contractions’ will lead to higher readability scores. Thus, higher reading levels in both specialties is seen and expected,” the investigators wrote. Measures such as the addition of glossaries to define words and visuals to illustrate complex procedures would be helpful for reading comprehension and have been used by other medical societies.

The study authors reported no conflicts of interest.

lfranki@mdedge.com

SOURCE: Fahimuddin FZ et al. Obstet Gynecol. 2019;133:888-94.

Most of the online patient education materials provided by eight nationally recognized ob.gyn. societies are written at levels above the readability guidelines set by the American Medical Association, National Institutes of Health, and Department of Health & Human Services, according to Fatimah Z. Fahimuddin, MD, of the University of California, San Francisco, Fresno, and her associates.

aluxum/E+/Getty Images

According to the AMA, NIH, and HHS, all patient education material should be written at or below a sixth-grade reading level.

In a study published in Obstetrics & Gynecology, the investigators analyzed the readability of 410 online patient education documents from the American Association of Gynecologic Laparoscopists, the American College of Obstetricians and Gynecologists, the American Society for Reproductive Medicine, the American Urogynecologic Society, the Association of Reproductive Health Professionals, the Society of Gynecologic Oncology, the Society for Maternal-Fetal Medicine, and Voices for Pelvic Floor Disorders.

The mean Flesch-Kincaid Grade Level score was 8.9 for the 69 obstetrics-related documents analyzed; for the 341 gynecology-related documents, the mean score was 8.7. The American Urogynecologic Society had the most readable documents, with a mean grade level score of 6.4; the American Association of Gynecologic Laparoscopists had the least readable, with a mean grade level score of 12.7. For the other three readability scales utilized in the analysis, mean scores generally ranged in the 8th-12th grade reading levels.

“It is not surprising that writing patient education materials at an appropriate reading level is difficult. With readability scales utilizing syllable count, common words such as ‘menstruation,’ ‘uterus,’ and ‘contractions’ will lead to higher readability scores. Thus, higher reading levels in both specialties is seen and expected,” the investigators wrote. Measures such as the addition of glossaries to define words and visuals to illustrate complex procedures would be helpful for reading comprehension and have been used by other medical societies.

The study authors reported no conflicts of interest.

lfranki@mdedge.com

SOURCE: Fahimuddin FZ et al. Obstet Gynecol. 2019;133:888-94.

Most of the online patient education materials provided by eight nationally recognized ob.gyn. societies are written at levels above the readability guidelines set by the American Medical Association, National Institutes of Health, and Department of Health & Human Services, according to Fatimah Z. Fahimuddin, MD, of the University of California, San Francisco, Fresno, and her associates.

aluxum/E+/Getty Images

According to the AMA, NIH, and HHS, all patient education material should be written at or below a sixth-grade reading level.

In a study published in Obstetrics & Gynecology, the investigators analyzed the readability of 410 online patient education documents from the American Association of Gynecologic Laparoscopists, the American College of Obstetricians and Gynecologists, the American Society for Reproductive Medicine, the American Urogynecologic Society, the Association of Reproductive Health Professionals, the Society of Gynecologic Oncology, the Society for Maternal-Fetal Medicine, and Voices for Pelvic Floor Disorders.

The mean Flesch-Kincaid Grade Level score was 8.9 for the 69 obstetrics-related documents analyzed; for the 341 gynecology-related documents, the mean score was 8.7. The American Urogynecologic Society had the most readable documents, with a mean grade level score of 6.4; the American Association of Gynecologic Laparoscopists had the least readable, with a mean grade level score of 12.7. For the other three readability scales utilized in the analysis, mean scores generally ranged in the 8th-12th grade reading levels.

“It is not surprising that writing patient education materials at an appropriate reading level is difficult. With readability scales utilizing syllable count, common words such as ‘menstruation,’ ‘uterus,’ and ‘contractions’ will lead to higher readability scores. Thus, higher reading levels in both specialties is seen and expected,” the investigators wrote. Measures such as the addition of glossaries to define words and visuals to illustrate complex procedures would be helpful for reading comprehension and have been used by other medical societies.

The study authors reported no conflicts of interest.

lfranki@mdedge.com

SOURCE: Fahimuddin FZ et al. Obstet Gynecol. 2019;133:888-94.

BALTIMORE – The upfront costs of laparoscopic magnetic sphincter augmentation are higher than those of laparoscopic Nissen fundoplication, but the cost differential can even out over time because the former procedure is associated with lower medical therapy costs after the procedure.

The finding comes from to a prospective observational study from the Allegheny Health Network in Pittsburgh, reported by Shahin Ayazi, MD, at the annual meeting of the American Society of Gastrointestinal Endoscopic Surgeons.

“Magnetic sphincter augmentation (MSA) results in comparable symptom control, proton-pump inhibitor (PPI) elimination rate, and GERD health-related quality of life and Reflux Symptom Index measures compared to values reported for laparoscopic Nissen fundoplication (LNF) in the literature,” said Dr. Ayazi of the University of Rochester (N.Y.). “Unlike reported values for LNF, the majority of patients after MSA were discharged on the same day of surgery.”

Dr. Ayazi reported on 180 patients who had MSA and 1,131 who had LNF over a 2-year period beginning in September 2015 at Allegheny Health, a network of eight hospitals and related facilities in western Pennsylvania and western New York State. The study analyzed Highmark claims data to calculate costs for 12 months before and after surgery in four categories: total procedure payer cost, payer costs of PPI, disease-related costs, and all medical costs.

Dr. Ayazi noted that many payers have been reluctant to cover the costs of MSA because the device costs around $5,000 on average. “There’s also a paucity of data in the literature in regard to the cost analysis of MSA in the management of reflux disease,” he said, adding that this is the first study that uses payer data to analyze the cost of antireflux surgery.

In this study, MSA costs slightly more up front than LNF ($13,522 vs. $13,388, respectively; P = .02). Per-member/per-month (PMPM) costs in the 12 months before their procedures were higher in the MSA group ($305 vs. $233). After surgery, these costs were significantly lower at $104 for MSA patients versus $126 for LNF patients, Dr. Ayazi said.

In the MSA group, 89% of patients were discharged on the same day as surgery, 90.7% said they were satisfied with the outcome, and 91.8% discontinued PPI therapy, Dr. Ayazi said.

He noted the claims data did not provide access to clinical data, Highmark did not provide information on the etiology of the costs differences, and the follow-up for cost analysis is relatively short-term.

During the discussion, Michel Gagner, MD, of Westmount, Quebec, warned against reading too much into the study because of its short duration and gave the example of experience with the laparoscopic adjustable gastric band. “The 10 years after, when you look at the reoperation, the removal, the conversions, some of the disasters in this area – all this needs to be added to the cost, and then when you looked at this, it was no longer cost effective. So I’m wondering if the same story could happen in the next 10 years. You may find that your conclusions are totally reversed.”

Peter Crookes, MD, of the University of Southern California, Los Angeles, challenged the study’s comparison of procedure cost, noting that the trend is toward same-day discharge after LNF, whereas study patients were hospitalized after LNF. Dr. Ayazi noted that the data presented reported procedure cost, not the hospital stay costs, because Highmark did not provide that data.

Lead researcher Blair Jobe, MD, director of the Esophageal and Lung Institute at Allegheny Health Network, added, “The higher initial cost of a LINX (Ethicon) procedure compared to a Nissen fundoplication is perceived as a drawback by insurers, which can make getting insurance approvals challenging. This study suggests that perception may be short sighted in that insurance plans can provide better care for their GERD patients at a similar cost to laparoscopic Nissen fundoplication when you factor in the greater reductions in medical costs after the procedure.”

Dr. Ayazi has no relevant financial relationships to disclose. Dr. Jobe reported he is a consultant for Ethicon.

SOURCE: Ayazi S et al. SAGES 2019, Session SS04.
 

BALTIMORE – The upfront costs of laparoscopic magnetic sphincter augmentation are higher than those of laparoscopic Nissen fundoplication, but the cost differential can even out over time because the former procedure is associated with lower medical therapy costs after the procedure.

The finding comes from to a prospective observational study from the Allegheny Health Network in Pittsburgh, reported by Shahin Ayazi, MD, at the annual meeting of the American Society of Gastrointestinal Endoscopic Surgeons.

“Magnetic sphincter augmentation (MSA) results in comparable symptom control, proton-pump inhibitor (PPI) elimination rate, and GERD health-related quality of life and Reflux Symptom Index measures compared to values reported for laparoscopic Nissen fundoplication (LNF) in the literature,” said Dr. Ayazi of the University of Rochester (N.Y.). “Unlike reported values for LNF, the majority of patients after MSA were discharged on the same day of surgery.”

Dr. Ayazi reported on 180 patients who had MSA and 1,131 who had LNF over a 2-year period beginning in September 2015 at Allegheny Health, a network of eight hospitals and related facilities in western Pennsylvania and western New York State. The study analyzed Highmark claims data to calculate costs for 12 months before and after surgery in four categories: total procedure payer cost, payer costs of PPI, disease-related costs, and all medical costs.

Dr. Ayazi noted that many payers have been reluctant to cover the costs of MSA because the device costs around $5,000 on average. “There’s also a paucity of data in the literature in regard to the cost analysis of MSA in the management of reflux disease,” he said, adding that this is the first study that uses payer data to analyze the cost of antireflux surgery.

In this study, MSA costs slightly more up front than LNF ($13,522 vs. $13,388, respectively; P = .02). Per-member/per-month (PMPM) costs in the 12 months before their procedures were higher in the MSA group ($305 vs. $233). After surgery, these costs were significantly lower at $104 for MSA patients versus $126 for LNF patients, Dr. Ayazi said.

In the MSA group, 89% of patients were discharged on the same day as surgery, 90.7% said they were satisfied with the outcome, and 91.8% discontinued PPI therapy, Dr. Ayazi said.

He noted the claims data did not provide access to clinical data, Highmark did not provide information on the etiology of the costs differences, and the follow-up for cost analysis is relatively short-term.

During the discussion, Michel Gagner, MD, of Westmount, Quebec, warned against reading too much into the study because of its short duration and gave the example of experience with the laparoscopic adjustable gastric band. “The 10 years after, when you look at the reoperation, the removal, the conversions, some of the disasters in this area – all this needs to be added to the cost, and then when you looked at this, it was no longer cost effective. So I’m wondering if the same story could happen in the next 10 years. You may find that your conclusions are totally reversed.”

Peter Crookes, MD, of the University of Southern California, Los Angeles, challenged the study’s comparison of procedure cost, noting that the trend is toward same-day discharge after LNF, whereas study patients were hospitalized after LNF. Dr. Ayazi noted that the data presented reported procedure cost, not the hospital stay costs, because Highmark did not provide that data.

Lead researcher Blair Jobe, MD, director of the Esophageal and Lung Institute at Allegheny Health Network, added, “The higher initial cost of a LINX (Ethicon) procedure compared to a Nissen fundoplication is perceived as a drawback by insurers, which can make getting insurance approvals challenging. This study suggests that perception may be short sighted in that insurance plans can provide better care for their GERD patients at a similar cost to laparoscopic Nissen fundoplication when you factor in the greater reductions in medical costs after the procedure.”

Dr. Ayazi has no relevant financial relationships to disclose. Dr. Jobe reported he is a consultant for Ethicon.

SOURCE: Ayazi S et al. SAGES 2019, Session SS04.
 

BALTIMORE – The upfront costs of laparoscopic magnetic sphincter augmentation are higher than those of laparoscopic Nissen fundoplication, but the cost differential can even out over time because the former procedure is associated with lower medical therapy costs after the procedure.

The finding comes from to a prospective observational study from the Allegheny Health Network in Pittsburgh, reported by Shahin Ayazi, MD, at the annual meeting of the American Society of Gastrointestinal Endoscopic Surgeons.

“Magnetic sphincter augmentation (MSA) results in comparable symptom control, proton-pump inhibitor (PPI) elimination rate, and GERD health-related quality of life and Reflux Symptom Index measures compared to values reported for laparoscopic Nissen fundoplication (LNF) in the literature,” said Dr. Ayazi of the University of Rochester (N.Y.). “Unlike reported values for LNF, the majority of patients after MSA were discharged on the same day of surgery.”

Dr. Ayazi reported on 180 patients who had MSA and 1,131 who had LNF over a 2-year period beginning in September 2015 at Allegheny Health, a network of eight hospitals and related facilities in western Pennsylvania and western New York State. The study analyzed Highmark claims data to calculate costs for 12 months before and after surgery in four categories: total procedure payer cost, payer costs of PPI, disease-related costs, and all medical costs.

Dr. Ayazi noted that many payers have been reluctant to cover the costs of MSA because the device costs around $5,000 on average. “There’s also a paucity of data in the literature in regard to the cost analysis of MSA in the management of reflux disease,” he said, adding that this is the first study that uses payer data to analyze the cost of antireflux surgery.

In this study, MSA costs slightly more up front than LNF ($13,522 vs. $13,388, respectively; P = .02). Per-member/per-month (PMPM) costs in the 12 months before their procedures were higher in the MSA group ($305 vs. $233). After surgery, these costs were significantly lower at $104 for MSA patients versus $126 for LNF patients, Dr. Ayazi said.

In the MSA group, 89% of patients were discharged on the same day as surgery, 90.7% said they were satisfied with the outcome, and 91.8% discontinued PPI therapy, Dr. Ayazi said.

He noted the claims data did not provide access to clinical data, Highmark did not provide information on the etiology of the costs differences, and the follow-up for cost analysis is relatively short-term.

During the discussion, Michel Gagner, MD, of Westmount, Quebec, warned against reading too much into the study because of its short duration and gave the example of experience with the laparoscopic adjustable gastric band. “The 10 years after, when you look at the reoperation, the removal, the conversions, some of the disasters in this area – all this needs to be added to the cost, and then when you looked at this, it was no longer cost effective. So I’m wondering if the same story could happen in the next 10 years. You may find that your conclusions are totally reversed.”

Peter Crookes, MD, of the University of Southern California, Los Angeles, challenged the study’s comparison of procedure cost, noting that the trend is toward same-day discharge after LNF, whereas study patients were hospitalized after LNF. Dr. Ayazi noted that the data presented reported procedure cost, not the hospital stay costs, because Highmark did not provide that data.

Lead researcher Blair Jobe, MD, director of the Esophageal and Lung Institute at Allegheny Health Network, added, “The higher initial cost of a LINX (Ethicon) procedure compared to a Nissen fundoplication is perceived as a drawback by insurers, which can make getting insurance approvals challenging. This study suggests that perception may be short sighted in that insurance plans can provide better care for their GERD patients at a similar cost to laparoscopic Nissen fundoplication when you factor in the greater reductions in medical costs after the procedure.”

Dr. Ayazi has no relevant financial relationships to disclose. Dr. Jobe reported he is a consultant for Ethicon.

SOURCE: Ayazi S et al. SAGES 2019, Session SS04.
 

Financial conflicts of interest were disclosed in just one of six oncology clinical practice guidelines issued in Japan, even though several guideline writers received compensation from pharmaceutical companies, according to results from a study published in JAMA Network Open.

Hiroaki Saito, MD, of Tottori University in Yonago, Japan, and colleagues retrospectively analyzed 2016-2017 payment data from 78 pharmaceutical companies in regard to 326 oncology guideline authors in Japan. Data collected included clinician demographic information, the amount of payments received, types of payments, and information related to disclosure methods.

The team reviewed oncology guidelines for gastric, breast, hepatocellular, pancreatic, lung, and colorectal cancers. Subsequently, they confirmed whether the amount of payment received was in accordance with each guideline’s policy of conflict of interest (COI) disclosure.

“Because no unified and ready-made database encompassing all the companies was available, we obtained each company’s data individually and organized the data into a unified database,” the researchers wrote.

The researchers found that among 326 guideline authors, 255 (78.2%) received compensation from pharmaceutical companies in 2016, with 25.8% receiving over $10,000. In addition, they reported that only the breast cancer guidelines included the authors’ COI disclosures in a detectable matter.

“Guidelines for lung, colorectal, pancreatic, and hepatocellular carcinomas disclosed the financial relationships between the authors and companies anonymously; and the gastric carcinoma [guidelines] did not have a COI disclosure section,” Dr. Saito and his colleagues wrote.

The researchers acknowledged that a key limitation of the study could be measurement error as the findings were dependent on the accuracy of information entered into the database.

The study was funded by the Medical Governance Research Institute and the Waseda Chronicle. The authors reported financial affiliations with Taiho Pharmaceutical and Medical Network Systems.

SOURCE: Saito H et al. JAMA Netw Open. 2019 Apr 26. doi: 10.1001/jamanetworkopen.2019.2834.

Financial conflicts of interest were disclosed in just one of six oncology clinical practice guidelines issued in Japan, even though several guideline writers received compensation from pharmaceutical companies, according to results from a study published in JAMA Network Open.

Hiroaki Saito, MD, of Tottori University in Yonago, Japan, and colleagues retrospectively analyzed 2016-2017 payment data from 78 pharmaceutical companies in regard to 326 oncology guideline authors in Japan. Data collected included clinician demographic information, the amount of payments received, types of payments, and information related to disclosure methods.

The team reviewed oncology guidelines for gastric, breast, hepatocellular, pancreatic, lung, and colorectal cancers. Subsequently, they confirmed whether the amount of payment received was in accordance with each guideline’s policy of conflict of interest (COI) disclosure.

“Because no unified and ready-made database encompassing all the companies was available, we obtained each company’s data individually and organized the data into a unified database,” the researchers wrote.

The researchers found that among 326 guideline authors, 255 (78.2%) received compensation from pharmaceutical companies in 2016, with 25.8% receiving over $10,000. In addition, they reported that only the breast cancer guidelines included the authors’ COI disclosures in a detectable matter.

“Guidelines for lung, colorectal, pancreatic, and hepatocellular carcinomas disclosed the financial relationships between the authors and companies anonymously; and the gastric carcinoma [guidelines] did not have a COI disclosure section,” Dr. Saito and his colleagues wrote.

The researchers acknowledged that a key limitation of the study could be measurement error as the findings were dependent on the accuracy of information entered into the database.

The study was funded by the Medical Governance Research Institute and the Waseda Chronicle. The authors reported financial affiliations with Taiho Pharmaceutical and Medical Network Systems.

SOURCE: Saito H et al. JAMA Netw Open. 2019 Apr 26. doi: 10.1001/jamanetworkopen.2019.2834.

Financial conflicts of interest were disclosed in just one of six oncology clinical practice guidelines issued in Japan, even though several guideline writers received compensation from pharmaceutical companies, according to results from a study published in JAMA Network Open.

Hiroaki Saito, MD, of Tottori University in Yonago, Japan, and colleagues retrospectively analyzed 2016-2017 payment data from 78 pharmaceutical companies in regard to 326 oncology guideline authors in Japan. Data collected included clinician demographic information, the amount of payments received, types of payments, and information related to disclosure methods.

The team reviewed oncology guidelines for gastric, breast, hepatocellular, pancreatic, lung, and colorectal cancers. Subsequently, they confirmed whether the amount of payment received was in accordance with each guideline’s policy of conflict of interest (COI) disclosure.

“Because no unified and ready-made database encompassing all the companies was available, we obtained each company’s data individually and organized the data into a unified database,” the researchers wrote.

The researchers found that among 326 guideline authors, 255 (78.2%) received compensation from pharmaceutical companies in 2016, with 25.8% receiving over $10,000. In addition, they reported that only the breast cancer guidelines included the authors’ COI disclosures in a detectable matter.

“Guidelines for lung, colorectal, pancreatic, and hepatocellular carcinomas disclosed the financial relationships between the authors and companies anonymously; and the gastric carcinoma [guidelines] did not have a COI disclosure section,” Dr. Saito and his colleagues wrote.

The researchers acknowledged that a key limitation of the study could be measurement error as the findings were dependent on the accuracy of information entered into the database.

The study was funded by the Medical Governance Research Institute and the Waseda Chronicle. The authors reported financial affiliations with Taiho Pharmaceutical and Medical Network Systems.

SOURCE: Saito H et al. JAMA Netw Open. 2019 Apr 26. doi: 10.1001/jamanetworkopen.2019.2834.

MAUI, HAWAII – The incidence of methotrexate pneumonitis has been reported as ranging from 3.5% to 7.6% among patients taking the disease-modifying antirheumatic drug. It’s an estimate that Aryeh Fischer, MD, counters with a one-word response: “Nonsense!”

Bruce Jancin/MDedge News

“There’s just no way that methotrexate is causing that much lung disease,” he declared at the 2019 Rheumatology Winter Clinical Symposium.

Dr. Fischer, a rheumatologist with joint appointments to the divisions of rheumatology and pulmonary sciences and critical care medicine at the University of Colorado at Denver, Aurora, noted that his opinion is considered controversial in the pulmonology world.

“I’m not allowed to talk about methotrexate at lung conferences. They stop you at the gate. They’re convinced in lung circles that methotrexate is the worst drug known to mankind,” he said.

Methotrexate pneumonitis is greatly overdiagnosed, Dr. Fischer explained, because it can be extremely difficult to distinguish from an acute flare of interstitial lung disease.

“My take home on methotrexate lung toxicity is this: I would just say, yes, it can occur, but it’s super rare and most often we’re not really sure that it was methotrexate pneumonitis. The diagnosis is not definitive, it’s exclusionary. We know that patients with interstitial lung disease of all types get acute exacerbations, and in idiopathic pulmonary fibrosis it’s actually the leading cause of mortality,” the rheumatologist said.

He highlighted a meta-analysis of 22 randomized, double-blind clinical trials published in 1990-2013 of methotrexate versus placebo or active comparators in 8,584 RA patients. The Irish investigators of that meta-analysis found that methotrexate was associated with a small albeit statistically significant 10% increase in the risk of all adverse respiratory events and an 11% increase in the risk of respiratory infection. However, patients on methotrexate were not at increased risk of mortality because of lung disease. And not a single case of methotrexate pneumonitis was reported after 2002 (Arthritis Rheumatol. 2014 Apr;66[4]:803-12).

Methotrexate pneumonitis is not dose dependent, nor is it related to treatment duration.

“Just because your patient has been on methotrexate for years does not mean they won’t get methotrexate lung toxicity,” he cautioned. “But this is not a chronic fibrotic interstitial lung disease, this is an acute onset of peripheral infiltrates and ground glass opacifications on chest imaging.”

Bronchoalveolar lavage classically shows a hypersensitivity pneumonitis with lymphocytosis. Transbronchial or surgical lung biopsy may show an organizing pneumonia or airway-based nonnecrotizing granulomas, again indicative of a hypersensitivity reaction.

Because the diagnostic picture is so often cloudy, Dr. Fischer generally tries to avoid methotrexate in patients with moderate or severe interstitial lung disease. “I have the luxury of avoiding it because we have so many great arthritis drugs these days,” he noted.

“That being said, the notion that we’re going to stop methotrexate in an 80-year-old who’s been on it for years and has mild bibasilar fibrotic interstitial lung disease so that her lung doc can sleep better at night is not very helpful for our patients. If the patient is doing well on methotrexate and the interstitial lung disease is mild, I continue [the methotrexate],” Dr. Fischer said.

He reported receiving research grants from Boehringer Ingelheim and Corbus Pharmaceuticals and serving as a consultant to Boehringer Ingelheim and other pharmaceutical companies.

bjancin@mdedge.com

MAUI, HAWAII – The incidence of methotrexate pneumonitis has been reported as ranging from 3.5% to 7.6% among patients taking the disease-modifying antirheumatic drug. It’s an estimate that Aryeh Fischer, MD, counters with a one-word response: “Nonsense!”

Bruce Jancin/MDedge News

“There’s just no way that methotrexate is causing that much lung disease,” he declared at the 2019 Rheumatology Winter Clinical Symposium.

Dr. Fischer, a rheumatologist with joint appointments to the divisions of rheumatology and pulmonary sciences and critical care medicine at the University of Colorado at Denver, Aurora, noted that his opinion is considered controversial in the pulmonology world.

“I’m not allowed to talk about methotrexate at lung conferences. They stop you at the gate. They’re convinced in lung circles that methotrexate is the worst drug known to mankind,” he said.

Methotrexate pneumonitis is greatly overdiagnosed, Dr. Fischer explained, because it can be extremely difficult to distinguish from an acute flare of interstitial lung disease.

“My take home on methotrexate lung toxicity is this: I would just say, yes, it can occur, but it’s super rare and most often we’re not really sure that it was methotrexate pneumonitis. The diagnosis is not definitive, it’s exclusionary. We know that patients with interstitial lung disease of all types get acute exacerbations, and in idiopathic pulmonary fibrosis it’s actually the leading cause of mortality,” the rheumatologist said.

He highlighted a meta-analysis of 22 randomized, double-blind clinical trials published in 1990-2013 of methotrexate versus placebo or active comparators in 8,584 RA patients. The Irish investigators of that meta-analysis found that methotrexate was associated with a small albeit statistically significant 10% increase in the risk of all adverse respiratory events and an 11% increase in the risk of respiratory infection. However, patients on methotrexate were not at increased risk of mortality because of lung disease. And not a single case of methotrexate pneumonitis was reported after 2002 (Arthritis Rheumatol. 2014 Apr;66[4]:803-12).

Methotrexate pneumonitis is not dose dependent, nor is it related to treatment duration.

“Just because your patient has been on methotrexate for years does not mean they won’t get methotrexate lung toxicity,” he cautioned. “But this is not a chronic fibrotic interstitial lung disease, this is an acute onset of peripheral infiltrates and ground glass opacifications on chest imaging.”

Bronchoalveolar lavage classically shows a hypersensitivity pneumonitis with lymphocytosis. Transbronchial or surgical lung biopsy may show an organizing pneumonia or airway-based nonnecrotizing granulomas, again indicative of a hypersensitivity reaction.

Because the diagnostic picture is so often cloudy, Dr. Fischer generally tries to avoid methotrexate in patients with moderate or severe interstitial lung disease. “I have the luxury of avoiding it because we have so many great arthritis drugs these days,” he noted.

“That being said, the notion that we’re going to stop methotrexate in an 80-year-old who’s been on it for years and has mild bibasilar fibrotic interstitial lung disease so that her lung doc can sleep better at night is not very helpful for our patients. If the patient is doing well on methotrexate and the interstitial lung disease is mild, I continue [the methotrexate],” Dr. Fischer said.

He reported receiving research grants from Boehringer Ingelheim and Corbus Pharmaceuticals and serving as a consultant to Boehringer Ingelheim and other pharmaceutical companies.

bjancin@mdedge.com

MAUI, HAWAII – The incidence of methotrexate pneumonitis has been reported as ranging from 3.5% to 7.6% among patients taking the disease-modifying antirheumatic drug. It’s an estimate that Aryeh Fischer, MD, counters with a one-word response: “Nonsense!”

Bruce Jancin/MDedge News

“There’s just no way that methotrexate is causing that much lung disease,” he declared at the 2019 Rheumatology Winter Clinical Symposium.

Dr. Fischer, a rheumatologist with joint appointments to the divisions of rheumatology and pulmonary sciences and critical care medicine at the University of Colorado at Denver, Aurora, noted that his opinion is considered controversial in the pulmonology world.

“I’m not allowed to talk about methotrexate at lung conferences. They stop you at the gate. They’re convinced in lung circles that methotrexate is the worst drug known to mankind,” he said.

Methotrexate pneumonitis is greatly overdiagnosed, Dr. Fischer explained, because it can be extremely difficult to distinguish from an acute flare of interstitial lung disease.

“My take home on methotrexate lung toxicity is this: I would just say, yes, it can occur, but it’s super rare and most often we’re not really sure that it was methotrexate pneumonitis. The diagnosis is not definitive, it’s exclusionary. We know that patients with interstitial lung disease of all types get acute exacerbations, and in idiopathic pulmonary fibrosis it’s actually the leading cause of mortality,” the rheumatologist said.

He highlighted a meta-analysis of 22 randomized, double-blind clinical trials published in 1990-2013 of methotrexate versus placebo or active comparators in 8,584 RA patients. The Irish investigators of that meta-analysis found that methotrexate was associated with a small albeit statistically significant 10% increase in the risk of all adverse respiratory events and an 11% increase in the risk of respiratory infection. However, patients on methotrexate were not at increased risk of mortality because of lung disease. And not a single case of methotrexate pneumonitis was reported after 2002 (Arthritis Rheumatol. 2014 Apr;66[4]:803-12).

Methotrexate pneumonitis is not dose dependent, nor is it related to treatment duration.

“Just because your patient has been on methotrexate for years does not mean they won’t get methotrexate lung toxicity,” he cautioned. “But this is not a chronic fibrotic interstitial lung disease, this is an acute onset of peripheral infiltrates and ground glass opacifications on chest imaging.”

Bronchoalveolar lavage classically shows a hypersensitivity pneumonitis with lymphocytosis. Transbronchial or surgical lung biopsy may show an organizing pneumonia or airway-based nonnecrotizing granulomas, again indicative of a hypersensitivity reaction.

Because the diagnostic picture is so often cloudy, Dr. Fischer generally tries to avoid methotrexate in patients with moderate or severe interstitial lung disease. “I have the luxury of avoiding it because we have so many great arthritis drugs these days,” he noted.

“That being said, the notion that we’re going to stop methotrexate in an 80-year-old who’s been on it for years and has mild bibasilar fibrotic interstitial lung disease so that her lung doc can sleep better at night is not very helpful for our patients. If the patient is doing well on methotrexate and the interstitial lung disease is mild, I continue [the methotrexate],” Dr. Fischer said.

He reported receiving research grants from Boehringer Ingelheim and Corbus Pharmaceuticals and serving as a consultant to Boehringer Ingelheim and other pharmaceutical companies.

bjancin@mdedge.com

The Diagnosis: Thallium-Induced Alopecia 

At the time of presentation, a punch biopsy specimen of the scalp revealed nonscarring alopecia with increased catagen hairs; follicular miniaturization; peribulbar lymphoid infiltrates; and fibrous tract remnants containing melanin, lymphocytes, and occasional mast cells (Figure 1). The differential diagnosis included alopecia areata, syphilis, and toxin-mediated anagen effluvium (AE). Given the abrupt onset affecting multiple individuals in an industrial environment, heavy metal poisoning was suspected. Blood and urine testing was negative, but a few months had elapsed since exposure. Several months after his initial presentation, the patient reported problems with his teeth, thin brittle nails, and resolution of the visual changes. Photographs sent by the patient revealed darkening and degeneration of the gingival margin (Figure 2). 

Environmental review revealed the patient was working on a demolition site of a 150-year-old electrical plant near a river. Inundation of rainfall caused a river swell and subsequent flooding of the work site. The patient reported working for more than 2 months in knee-deep muddy water, and he noted that water for consumption and showers was procured on-site from a well-based source that may have been contaminated by the floodwaters.  

Acute nonscarring alopecia can be an AE or telogen effluvium (TE), also known as telogen defluvium. The key distinguishing factor is the mode of injury.¹ In TE, medications, stress, hormonal shifts, or inflammation induce a synchronized and abrupt transition of hairs from anagen phase to catagen phase, a committed step that then must fully cycle through the telogen phase, culminating in the simultaneous shedding of numerous telogen hairs approximately 3 to 4 months later. Conversely, AE is caused by a sudden insult to the metabolic machinery of the hair matrix. Affected follicles rapidly produce thinner weaker shafts yielding Pohl-Pinkus constrictions or pencil point-shaped fractures that shed approximately 1 to 2 months after injury. The 10% of scalp hairs in the resting telogen phase have no matrix and thus are unaffected. Some etiologies can cause either AE or TE, depending on the dose and intensity of the insult. Common causes of AE include alopecia areata and syphilis, both consisting of abrupt severe bulbar inflammation.¹ Other causes include chemotherapy, particularly antimetabolites, alkylating agents, and mitotic inhibitors; radiation; medications (eg, isoniazid); severe protein malnutrition; toxic chemicals (eg, boron/boric acid); and heavy metals (eg, thallium, mercury).  

Thallium is one of the most common causes of heavy metal poisoning and is particularly dangerous due to its colorless, tasteless, and odorless characteristics. Although its common use as a rodenticide has dramatically decreased in the United States after it was banned in 1965, it is still used in this fashion in other countries and has a notable industrial presence, particularly in electronics, superconductors, and low-temperature thermometers. Accidental poisoning of a graduate chemistry student during copper research has been reported,² highlighting that thallium can be inhaled, ingested, or absorbed through the skin. Thallium is even present in mycoplasma agar plates, the ingestion of which has resulted in poisoning.³  

Systemic symptoms of thallium poisoning include somnolence, weakness, nausea, vomiting, stomatitis, abdominal pain, diarrhea, tachycardia, hypertension, and polyneuropathy.^4-7 Neuropathy often manifests as painful acral dysesthesia and paresthesia, perioral numbness, optic neuropathy causing visual changes, and encephalopathy. Cutaneous findings include diffuse alopecia of the scalp and eyebrows, perioral dermatitis, glossitis, diffuse hyperpigmentation, oral hyperpigmentation (often as a stippled lead line along the gingival margin with subsequent alveolar damage and resorption), melanonychia, palmoplantar keratoderma, acneform or pustular eruption, and nail changes including Mees lines.^2,4,5,7-9 Rarely, major organ failure and death may result.¹⁰ 

Toxin panels may not include thallium, and urine and serum tests may be negative if too much time has transpired since the acute exposure. Hair or nail analysis has proved useful in subacute cases¹¹; however, most laboratories require a pencil-thick segment of hair cut at the roots and bundled, weighing at least 500 mg. Thallium poisoning is treated with activated charcoal, Prussian blue, and blood purification therapies (eg, hemodialysis, hemoperfusion, hemofiltration).^4,7 Cutaneous findings typically resolve, but neuropathic changes may persist.

The Diagnosis: Thallium-Induced Alopecia 

At the time of presentation, a punch biopsy specimen of the scalp revealed nonscarring alopecia with increased catagen hairs; follicular miniaturization; peribulbar lymphoid infiltrates; and fibrous tract remnants containing melanin, lymphocytes, and occasional mast cells (Figure 1). The differential diagnosis included alopecia areata, syphilis, and toxin-mediated anagen effluvium (AE). Given the abrupt onset affecting multiple individuals in an industrial environment, heavy metal poisoning was suspected. Blood and urine testing was negative, but a few months had elapsed since exposure. Several months after his initial presentation, the patient reported problems with his teeth, thin brittle nails, and resolution of the visual changes. Photographs sent by the patient revealed darkening and degeneration of the gingival margin (Figure 2). 

Environmental review revealed the patient was working on a demolition site of a 150-year-old electrical plant near a river. Inundation of rainfall caused a river swell and subsequent flooding of the work site. The patient reported working for more than 2 months in knee-deep muddy water, and he noted that water for consumption and showers was procured on-site from a well-based source that may have been contaminated by the floodwaters.  

Acute nonscarring alopecia can be an AE or telogen effluvium (TE), also known as telogen defluvium. The key distinguishing factor is the mode of injury.¹ In TE, medications, stress, hormonal shifts, or inflammation induce a synchronized and abrupt transition of hairs from anagen phase to catagen phase, a committed step that then must fully cycle through the telogen phase, culminating in the simultaneous shedding of numerous telogen hairs approximately 3 to 4 months later. Conversely, AE is caused by a sudden insult to the metabolic machinery of the hair matrix. Affected follicles rapidly produce thinner weaker shafts yielding Pohl-Pinkus constrictions or pencil point-shaped fractures that shed approximately 1 to 2 months after injury. The 10% of scalp hairs in the resting telogen phase have no matrix and thus are unaffected. Some etiologies can cause either AE or TE, depending on the dose and intensity of the insult. Common causes of AE include alopecia areata and syphilis, both consisting of abrupt severe bulbar inflammation.¹ Other causes include chemotherapy, particularly antimetabolites, alkylating agents, and mitotic inhibitors; radiation; medications (eg, isoniazid); severe protein malnutrition; toxic chemicals (eg, boron/boric acid); and heavy metals (eg, thallium, mercury).  

Thallium is one of the most common causes of heavy metal poisoning and is particularly dangerous due to its colorless, tasteless, and odorless characteristics. Although its common use as a rodenticide has dramatically decreased in the United States after it was banned in 1965, it is still used in this fashion in other countries and has a notable industrial presence, particularly in electronics, superconductors, and low-temperature thermometers. Accidental poisoning of a graduate chemistry student during copper research has been reported,² highlighting that thallium can be inhaled, ingested, or absorbed through the skin. Thallium is even present in mycoplasma agar plates, the ingestion of which has resulted in poisoning.³  

Systemic symptoms of thallium poisoning include somnolence, weakness, nausea, vomiting, stomatitis, abdominal pain, diarrhea, tachycardia, hypertension, and polyneuropathy.^4-7 Neuropathy often manifests as painful acral dysesthesia and paresthesia, perioral numbness, optic neuropathy causing visual changes, and encephalopathy. Cutaneous findings include diffuse alopecia of the scalp and eyebrows, perioral dermatitis, glossitis, diffuse hyperpigmentation, oral hyperpigmentation (often as a stippled lead line along the gingival margin with subsequent alveolar damage and resorption), melanonychia, palmoplantar keratoderma, acneform or pustular eruption, and nail changes including Mees lines.^2,4,5,7-9 Rarely, major organ failure and death may result.¹⁰ 

Toxin panels may not include thallium, and urine and serum tests may be negative if too much time has transpired since the acute exposure. Hair or nail analysis has proved useful in subacute cases¹¹; however, most laboratories require a pencil-thick segment of hair cut at the roots and bundled, weighing at least 500 mg. Thallium poisoning is treated with activated charcoal, Prussian blue, and blood purification therapies (eg, hemodialysis, hemoperfusion, hemofiltration).^4,7 Cutaneous findings typically resolve, but neuropathic changes may persist.

The Diagnosis: Thallium-Induced Alopecia 

At the time of presentation, a punch biopsy specimen of the scalp revealed nonscarring alopecia with increased catagen hairs; follicular miniaturization; peribulbar lymphoid infiltrates; and fibrous tract remnants containing melanin, lymphocytes, and occasional mast cells (Figure 1). The differential diagnosis included alopecia areata, syphilis, and toxin-mediated anagen effluvium (AE). Given the abrupt onset affecting multiple individuals in an industrial environment, heavy metal poisoning was suspected. Blood and urine testing was negative, but a few months had elapsed since exposure. Several months after his initial presentation, the patient reported problems with his teeth, thin brittle nails, and resolution of the visual changes. Photographs sent by the patient revealed darkening and degeneration of the gingival margin (Figure 2). 

Environmental review revealed the patient was working on a demolition site of a 150-year-old electrical plant near a river. Inundation of rainfall caused a river swell and subsequent flooding of the work site. The patient reported working for more than 2 months in knee-deep muddy water, and he noted that water for consumption and showers was procured on-site from a well-based source that may have been contaminated by the floodwaters.  

Acute nonscarring alopecia can be an AE or telogen effluvium (TE), also known as telogen defluvium. The key distinguishing factor is the mode of injury.¹ In TE, medications, stress, hormonal shifts, or inflammation induce a synchronized and abrupt transition of hairs from anagen phase to catagen phase, a committed step that then must fully cycle through the telogen phase, culminating in the simultaneous shedding of numerous telogen hairs approximately 3 to 4 months later. Conversely, AE is caused by a sudden insult to the metabolic machinery of the hair matrix. Affected follicles rapidly produce thinner weaker shafts yielding Pohl-Pinkus constrictions or pencil point-shaped fractures that shed approximately 1 to 2 months after injury. The 10% of scalp hairs in the resting telogen phase have no matrix and thus are unaffected. Some etiologies can cause either AE or TE, depending on the dose and intensity of the insult. Common causes of AE include alopecia areata and syphilis, both consisting of abrupt severe bulbar inflammation.¹ Other causes include chemotherapy, particularly antimetabolites, alkylating agents, and mitotic inhibitors; radiation; medications (eg, isoniazid); severe protein malnutrition; toxic chemicals (eg, boron/boric acid); and heavy metals (eg, thallium, mercury).  

Thallium is one of the most common causes of heavy metal poisoning and is particularly dangerous due to its colorless, tasteless, and odorless characteristics. Although its common use as a rodenticide has dramatically decreased in the United States after it was banned in 1965, it is still used in this fashion in other countries and has a notable industrial presence, particularly in electronics, superconductors, and low-temperature thermometers. Accidental poisoning of a graduate chemistry student during copper research has been reported,² highlighting that thallium can be inhaled, ingested, or absorbed through the skin. Thallium is even present in mycoplasma agar plates, the ingestion of which has resulted in poisoning.³  

Systemic symptoms of thallium poisoning include somnolence, weakness, nausea, vomiting, stomatitis, abdominal pain, diarrhea, tachycardia, hypertension, and polyneuropathy.^4-7 Neuropathy often manifests as painful acral dysesthesia and paresthesia, perioral numbness, optic neuropathy causing visual changes, and encephalopathy. Cutaneous findings include diffuse alopecia of the scalp and eyebrows, perioral dermatitis, glossitis, diffuse hyperpigmentation, oral hyperpigmentation (often as a stippled lead line along the gingival margin with subsequent alveolar damage and resorption), melanonychia, palmoplantar keratoderma, acneform or pustular eruption, and nail changes including Mees lines.^2,4,5,7-9 Rarely, major organ failure and death may result.¹⁰ 

Toxin panels may not include thallium, and urine and serum tests may be negative if too much time has transpired since the acute exposure. Hair or nail analysis has proved useful in subacute cases¹¹; however, most laboratories require a pencil-thick segment of hair cut at the roots and bundled, weighing at least 500 mg. Thallium poisoning is treated with activated charcoal, Prussian blue, and blood purification therapies (eg, hemodialysis, hemoperfusion, hemofiltration).^4,7 Cutaneous findings typically resolve, but neuropathic changes may persist.

Adults with nonalcoholic fatty liver disease (NAFLD) were more likely to implement the Mediterranean diet when they had greater nutritional knowledge and skills, family support, nutritional care, and positive reinforcement in the media, according to an in-depth study of 19 patients.

snyferok/ThinkStock

Barriers to adopting the diet included “an obesogenic environment, life stressors, and demand for convenience. Poor understanding of the causes and significance of NAFLD adversely affected readiness to change dietary habits,” wrote Laura Haigh of Newcastle University in Newcastle Upon Tyne, England, and associates. The study, which included both standard quantitative methods and semistructured interviews, was published in Clinical Gastroenterology and Hepatology.

The Mediterranean diet emphasizes vegetables, legumes, fish, fruits, whole grains, nuts, and olive oil in lieu of processed foods, sweets, saturated fats, and red meat. This diet has been definitively shown to improve insulin sensitivity and steatosis, even when patients do not lose weight. This has sparked interest in its use for NAFLD disease, but keys to its successful adoption in Northern Europe are not well understood.

Therefore, the researchers recruited 19 NAFLD patients from a tertiary care center in the United Kingdom for a 12-week Mediterranean diet intervention. Most were female, white, in their late 50s, obese, and had type 2 diabetes. “Participants were taught behavioral strategies through the provision of shopping lists, meal planners, and recipes. No advice was given on calorie allowances or physical activities,” the investigators noted.

By using a 14-point assessment tool, they found that dietary adherence rose significantly at 12 weeks, compared with baseline (P = .006). In all, 79% of patients lost weight (mean, 2.4 kg; P = .001 versus baseline), and 72% significantly increased their serum level of HDL cholesterol. Interviews linked successful adoption of the diet with diverse factors, such as believing that NAFLD is lifestyle associated, realizing that healthier nutrition can improve health outcomes, and having access to transportation and budget grocery stories. Patients generally saw the Mediterranean diet as flexible and affordable, but they struggled to adopt it if they worked irregular hours, experienced substantial life stress or were very busy, or tended to eat for self-reward or self-comfort.

Other cited barriers included “diet saboteurs” (including spouses), the plethora of unhealthy foods available in patients’ environments, low nutritional or medical knowledge, and cultural, social, or taste incompatibility, the researchers reported. Taken together, the findings underscore “the futility of a one-size-fits-all approach” when implementing the Mediterranean diet in this population, they concluded. Instead, their patients valued a collaborative, tailored approach – ideally one that incorporated in-person and group-based treatment, as well as online support.

Funders included the North East of England hub of the Allied Health Professions Research Network, the Elucidating Pathways of Steatohepatitis consortium, the Horizon 2020 Framework Program of the European Union, and the Newcastle NIHR Biomedical Research Centre. The researchers reported having no conflicts of interest.

SOURCE: Haigh L et al. Clin Gastroenterol Hepatol. 2018 Oct 31. doi: 10.1016/j.cgh.2018.10.044.

Adults with nonalcoholic fatty liver disease (NAFLD) were more likely to implement the Mediterranean diet when they had greater nutritional knowledge and skills, family support, nutritional care, and positive reinforcement in the media, according to an in-depth study of 19 patients.

snyferok/ThinkStock

Barriers to adopting the diet included “an obesogenic environment, life stressors, and demand for convenience. Poor understanding of the causes and significance of NAFLD adversely affected readiness to change dietary habits,” wrote Laura Haigh of Newcastle University in Newcastle Upon Tyne, England, and associates. The study, which included both standard quantitative methods and semistructured interviews, was published in Clinical Gastroenterology and Hepatology.

The Mediterranean diet emphasizes vegetables, legumes, fish, fruits, whole grains, nuts, and olive oil in lieu of processed foods, sweets, saturated fats, and red meat. This diet has been definitively shown to improve insulin sensitivity and steatosis, even when patients do not lose weight. This has sparked interest in its use for NAFLD disease, but keys to its successful adoption in Northern Europe are not well understood.

Therefore, the researchers recruited 19 NAFLD patients from a tertiary care center in the United Kingdom for a 12-week Mediterranean diet intervention. Most were female, white, in their late 50s, obese, and had type 2 diabetes. “Participants were taught behavioral strategies through the provision of shopping lists, meal planners, and recipes. No advice was given on calorie allowances or physical activities,” the investigators noted.

By using a 14-point assessment tool, they found that dietary adherence rose significantly at 12 weeks, compared with baseline (P = .006). In all, 79% of patients lost weight (mean, 2.4 kg; P = .001 versus baseline), and 72% significantly increased their serum level of HDL cholesterol. Interviews linked successful adoption of the diet with diverse factors, such as believing that NAFLD is lifestyle associated, realizing that healthier nutrition can improve health outcomes, and having access to transportation and budget grocery stories. Patients generally saw the Mediterranean diet as flexible and affordable, but they struggled to adopt it if they worked irregular hours, experienced substantial life stress or were very busy, or tended to eat for self-reward or self-comfort.

Other cited barriers included “diet saboteurs” (including spouses), the plethora of unhealthy foods available in patients’ environments, low nutritional or medical knowledge, and cultural, social, or taste incompatibility, the researchers reported. Taken together, the findings underscore “the futility of a one-size-fits-all approach” when implementing the Mediterranean diet in this population, they concluded. Instead, their patients valued a collaborative, tailored approach – ideally one that incorporated in-person and group-based treatment, as well as online support.

Funders included the North East of England hub of the Allied Health Professions Research Network, the Elucidating Pathways of Steatohepatitis consortium, the Horizon 2020 Framework Program of the European Union, and the Newcastle NIHR Biomedical Research Centre. The researchers reported having no conflicts of interest.

SOURCE: Haigh L et al. Clin Gastroenterol Hepatol. 2018 Oct 31. doi: 10.1016/j.cgh.2018.10.044.

Adults with nonalcoholic fatty liver disease (NAFLD) were more likely to implement the Mediterranean diet when they had greater nutritional knowledge and skills, family support, nutritional care, and positive reinforcement in the media, according to an in-depth study of 19 patients.

snyferok/ThinkStock

Barriers to adopting the diet included “an obesogenic environment, life stressors, and demand for convenience. Poor understanding of the causes and significance of NAFLD adversely affected readiness to change dietary habits,” wrote Laura Haigh of Newcastle University in Newcastle Upon Tyne, England, and associates. The study, which included both standard quantitative methods and semistructured interviews, was published in Clinical Gastroenterology and Hepatology.

The Mediterranean diet emphasizes vegetables, legumes, fish, fruits, whole grains, nuts, and olive oil in lieu of processed foods, sweets, saturated fats, and red meat. This diet has been definitively shown to improve insulin sensitivity and steatosis, even when patients do not lose weight. This has sparked interest in its use for NAFLD disease, but keys to its successful adoption in Northern Europe are not well understood.

Therefore, the researchers recruited 19 NAFLD patients from a tertiary care center in the United Kingdom for a 12-week Mediterranean diet intervention. Most were female, white, in their late 50s, obese, and had type 2 diabetes. “Participants were taught behavioral strategies through the provision of shopping lists, meal planners, and recipes. No advice was given on calorie allowances or physical activities,” the investigators noted.

By using a 14-point assessment tool, they found that dietary adherence rose significantly at 12 weeks, compared with baseline (P = .006). In all, 79% of patients lost weight (mean, 2.4 kg; P = .001 versus baseline), and 72% significantly increased their serum level of HDL cholesterol. Interviews linked successful adoption of the diet with diverse factors, such as believing that NAFLD is lifestyle associated, realizing that healthier nutrition can improve health outcomes, and having access to transportation and budget grocery stories. Patients generally saw the Mediterranean diet as flexible and affordable, but they struggled to adopt it if they worked irregular hours, experienced substantial life stress or were very busy, or tended to eat for self-reward or self-comfort.

Other cited barriers included “diet saboteurs” (including spouses), the plethora of unhealthy foods available in patients’ environments, low nutritional or medical knowledge, and cultural, social, or taste incompatibility, the researchers reported. Taken together, the findings underscore “the futility of a one-size-fits-all approach” when implementing the Mediterranean diet in this population, they concluded. Instead, their patients valued a collaborative, tailored approach – ideally one that incorporated in-person and group-based treatment, as well as online support.

Funders included the North East of England hub of the Allied Health Professions Research Network, the Elucidating Pathways of Steatohepatitis consortium, the Horizon 2020 Framework Program of the European Union, and the Newcastle NIHR Biomedical Research Centre. The researchers reported having no conflicts of interest.

SOURCE: Haigh L et al. Clin Gastroenterol Hepatol. 2018 Oct 31. doi: 10.1016/j.cgh.2018.10.044.

The intravenous formulation of the TNF inhibitor golimumab (Simponi Aria) produced durable responses and no new safety signals through 1 year of treatment in patients with active psoriatic arthritis, according to follow-up results of a randomized clinical trial.

The improvements in joint disease, skin disease, and health-related quality of life seen at 24 weeks in the phase 3 GO-VIBRANT study were maintained at this 52-week follow-up, according to M. Elaine Husni, MD, of the Cleveland Clinic, and coinvestigators.

Patients who crossed over to golimumab treatment after 24 weeks of placebo had similar rates of clinical response at 52 weeks, while patients receiving concomitant methotrexate had similar ACR response rates, compared with patients on golimumab monotherapy, Dr. Husni and colleagues reported.

Many patients who were not ACR20 responders at week 52 nevertheless had improvements in skin disease, enthesitis, and dactylitis, an exploratory analysis showed.

“These factors may have contributed to these patients remaining in the trial and continuing golimumab therapy despite not achieving an ACR20 response,” wrote Dr. Husni and coauthors. The report is in Arthritis Care & Research.

The Food and Drug Administration approved a once-monthly subcutaneous formulation of golimumab (Simponi) in 2009 for treatment of moderate to severe active psoriatic arthritis, rheumatoid arthritis, and active ankylosing spondylitis. The intravenous formulation of this TNF inhibitor (Simponi Aria) received a psoriatic arthritis indication in 2017 based on GO-VIBRANT data. Published results at the time showed that compared with placebo, intravenous golimumab given as a 2-mg/kg infusion at weeks 0, 4, and then every 8 weeks produced greater improvements in psoriatic arthritis signs and symptoms and less radiographic progression through week 24 of the study, and had adverse events consistent with other TNF inhibitors, according to investigators.

The follow-up report includes efficacy and safety data for golimumab-treated patients beyond 24 weeks, as well as data for patients on the placebo arm, who crossed over to receive golimumab at week 24, week 28, and then every 8 weeks thereafter.


The results show ACR response rates were maintained from week 24 to 52 in golimumab-treated patients, and were similar in the placebo crossover patients. The ACR20, ACR50, and ACR70 response rates in the golimumab group were 76.8%, 58.1%, and 38.6%, respectively, while in the crossover group, they were 77.0%, 53.6%, and 33.9%, respectively.

Radiographic progression was measured using van der Heijde-Sharp (vdH-S) score with modifications for psoriatic arthritis. The mean change in vdH-S score at 24 weeks was –0.4 and 2.0 in the golimumab and placebo groups, respectively; by week 52, the mean change was –0.5 and 0.8 for golimumab and placebo crossover.

Infection was the most common adverse event throughout 60 weeks of safety evaluation, occurring in 22.8% of all golimumab-treated patients, investigators said. Four infusion reactions occurred following golimumab administration, though none were considered serious or severe.

The GO-VIBRANT study, which comprised 480 adults, had limited follow-up and was not powered to identify rare safety events, investigators said.

“However, the totality of results through 1 year of the GO-VIBRANT study show a durable response to IV golimumab 2 mg/kg across several clinical efficacy, HRQoL, and radiographic endpoints with no new safety signals,” they concluded.

Study authors reported disclosures with AbbVie, Amgen, Bristol-Myers Squibb, Eli Lilly, Horizon, Janssen, Novartis, Pfizer, Sanofi, and UCB. Several study authors reported current or former employment with Janssen Research & Development and stock or stock options in Johnson & Johnson.

SOURCE: Husni ME et al. Arthritis Care Res. 2019 Apr 12. doi: 10.1002/acr.23905.

The intravenous formulation of the TNF inhibitor golimumab (Simponi Aria) produced durable responses and no new safety signals through 1 year of treatment in patients with active psoriatic arthritis, according to follow-up results of a randomized clinical trial.

The improvements in joint disease, skin disease, and health-related quality of life seen at 24 weeks in the phase 3 GO-VIBRANT study were maintained at this 52-week follow-up, according to M. Elaine Husni, MD, of the Cleveland Clinic, and coinvestigators.

Patients who crossed over to golimumab treatment after 24 weeks of placebo had similar rates of clinical response at 52 weeks, while patients receiving concomitant methotrexate had similar ACR response rates, compared with patients on golimumab monotherapy, Dr. Husni and colleagues reported.

Many patients who were not ACR20 responders at week 52 nevertheless had improvements in skin disease, enthesitis, and dactylitis, an exploratory analysis showed.

“These factors may have contributed to these patients remaining in the trial and continuing golimumab therapy despite not achieving an ACR20 response,” wrote Dr. Husni and coauthors. The report is in Arthritis Care & Research.

The Food and Drug Administration approved a once-monthly subcutaneous formulation of golimumab (Simponi) in 2009 for treatment of moderate to severe active psoriatic arthritis, rheumatoid arthritis, and active ankylosing spondylitis. The intravenous formulation of this TNF inhibitor (Simponi Aria) received a psoriatic arthritis indication in 2017 based on GO-VIBRANT data. Published results at the time showed that compared with placebo, intravenous golimumab given as a 2-mg/kg infusion at weeks 0, 4, and then every 8 weeks produced greater improvements in psoriatic arthritis signs and symptoms and less radiographic progression through week 24 of the study, and had adverse events consistent with other TNF inhibitors, according to investigators.

The follow-up report includes efficacy and safety data for golimumab-treated patients beyond 24 weeks, as well as data for patients on the placebo arm, who crossed over to receive golimumab at week 24, week 28, and then every 8 weeks thereafter.


The results show ACR response rates were maintained from week 24 to 52 in golimumab-treated patients, and were similar in the placebo crossover patients. The ACR20, ACR50, and ACR70 response rates in the golimumab group were 76.8%, 58.1%, and 38.6%, respectively, while in the crossover group, they were 77.0%, 53.6%, and 33.9%, respectively.

Radiographic progression was measured using van der Heijde-Sharp (vdH-S) score with modifications for psoriatic arthritis. The mean change in vdH-S score at 24 weeks was –0.4 and 2.0 in the golimumab and placebo groups, respectively; by week 52, the mean change was –0.5 and 0.8 for golimumab and placebo crossover.

Infection was the most common adverse event throughout 60 weeks of safety evaluation, occurring in 22.8% of all golimumab-treated patients, investigators said. Four infusion reactions occurred following golimumab administration, though none were considered serious or severe.

The GO-VIBRANT study, which comprised 480 adults, had limited follow-up and was not powered to identify rare safety events, investigators said.

“However, the totality of results through 1 year of the GO-VIBRANT study show a durable response to IV golimumab 2 mg/kg across several clinical efficacy, HRQoL, and radiographic endpoints with no new safety signals,” they concluded.

Study authors reported disclosures with AbbVie, Amgen, Bristol-Myers Squibb, Eli Lilly, Horizon, Janssen, Novartis, Pfizer, Sanofi, and UCB. Several study authors reported current or former employment with Janssen Research & Development and stock or stock options in Johnson & Johnson.

SOURCE: Husni ME et al. Arthritis Care Res. 2019 Apr 12. doi: 10.1002/acr.23905.

The intravenous formulation of the TNF inhibitor golimumab (Simponi Aria) produced durable responses and no new safety signals through 1 year of treatment in patients with active psoriatic arthritis, according to follow-up results of a randomized clinical trial.

The improvements in joint disease, skin disease, and health-related quality of life seen at 24 weeks in the phase 3 GO-VIBRANT study were maintained at this 52-week follow-up, according to M. Elaine Husni, MD, of the Cleveland Clinic, and coinvestigators.

Patients who crossed over to golimumab treatment after 24 weeks of placebo had similar rates of clinical response at 52 weeks, while patients receiving concomitant methotrexate had similar ACR response rates, compared with patients on golimumab monotherapy, Dr. Husni and colleagues reported.

Many patients who were not ACR20 responders at week 52 nevertheless had improvements in skin disease, enthesitis, and dactylitis, an exploratory analysis showed.

“These factors may have contributed to these patients remaining in the trial and continuing golimumab therapy despite not achieving an ACR20 response,” wrote Dr. Husni and coauthors. The report is in Arthritis Care & Research.

The Food and Drug Administration approved a once-monthly subcutaneous formulation of golimumab (Simponi) in 2009 for treatment of moderate to severe active psoriatic arthritis, rheumatoid arthritis, and active ankylosing spondylitis. The intravenous formulation of this TNF inhibitor (Simponi Aria) received a psoriatic arthritis indication in 2017 based on GO-VIBRANT data. Published results at the time showed that compared with placebo, intravenous golimumab given as a 2-mg/kg infusion at weeks 0, 4, and then every 8 weeks produced greater improvements in psoriatic arthritis signs and symptoms and less radiographic progression through week 24 of the study, and had adverse events consistent with other TNF inhibitors, according to investigators.

The follow-up report includes efficacy and safety data for golimumab-treated patients beyond 24 weeks, as well as data for patients on the placebo arm, who crossed over to receive golimumab at week 24, week 28, and then every 8 weeks thereafter.


The results show ACR response rates were maintained from week 24 to 52 in golimumab-treated patients, and were similar in the placebo crossover patients. The ACR20, ACR50, and ACR70 response rates in the golimumab group were 76.8%, 58.1%, and 38.6%, respectively, while in the crossover group, they were 77.0%, 53.6%, and 33.9%, respectively.

Radiographic progression was measured using van der Heijde-Sharp (vdH-S) score with modifications for psoriatic arthritis. The mean change in vdH-S score at 24 weeks was –0.4 and 2.0 in the golimumab and placebo groups, respectively; by week 52, the mean change was –0.5 and 0.8 for golimumab and placebo crossover.

Infection was the most common adverse event throughout 60 weeks of safety evaluation, occurring in 22.8% of all golimumab-treated patients, investigators said. Four infusion reactions occurred following golimumab administration, though none were considered serious or severe.

The GO-VIBRANT study, which comprised 480 adults, had limited follow-up and was not powered to identify rare safety events, investigators said.

“However, the totality of results through 1 year of the GO-VIBRANT study show a durable response to IV golimumab 2 mg/kg across several clinical efficacy, HRQoL, and radiographic endpoints with no new safety signals,” they concluded.

Study authors reported disclosures with AbbVie, Amgen, Bristol-Myers Squibb, Eli Lilly, Horizon, Janssen, Novartis, Pfizer, Sanofi, and UCB. Several study authors reported current or former employment with Janssen Research & Development and stock or stock options in Johnson & Johnson.

SOURCE: Husni ME et al. Arthritis Care Res. 2019 Apr 12. doi: 10.1002/acr.23905.

BALTIMORE – U.S. pediatricians feel comfortable providing patients with preventive information and travel advice related to Zika, but few feel prepared when it comes to testing and management of infants exposed prenatally to Zika infections, a study found.

Aunt_Spray/Thinkstock

“Areas where pediatricians were less likely to report preparedness included recommending testing, providing data to the Centers for Disease Control and Prevention’s Zika Pregnancy Registry, managing infants exposed to Zika prenatally, and informing parents of social services for Zika-infected infants,” senior author Amy J. Houtrow, MD, MPH, PhD, and colleagues reported at the Pediatric Academic Societies annual meeting.

“Results indicate that additional education efforts are needed to grow the overall Zika knowledge of pediatricians and boost preparedness, particularly around recommending Zika testing and providing data to CDC,” they concluded.

But these findings are not surprising given how rare congenital Zika virus syndrome is, explained Dr. Houtrow, an associate professor of physical medicine and rehabilitation and pediatrics at the University of Pittsburgh.

“For most rare conditions, pediatricians report better general than specific knowledge,” Dr. Houtrow said in an interview. “We expect pediatricians have a broad range of knowledge for a multitude of conditions and to be well versed in the care of infants and children with common conditions, coupled with the ability to access knowledge and expertise about rarer conditions such as congenital Zika syndrome.”

Dr. Houtrow and associates drew their findings from the 2018 AAP Periodic Survey of Fellows, which includes both primary care physicians and neonatologists. The survey’s response rate was 42%, with 672 of 1,599 surveys returned, but the researchers limited their analysis to 576 postresidency respondents who were providing direct patient care.

Overall, 39% of physicians reported being knowledgeable about Zika virus, and 47% said they wanted to learn more. More than half of responding doctors (57%) reported feeling moderately or very prepared when it came to informing patients of preventive measures to reduce risk of Zika infection, and nearly half (49%) felt confident about giving patients travel advice.

However, physicians’ preparedness gradually dropped for clinical situations requiring more direct experience with Zika. For example, 37% felt moderately or very prepared to provide clinical referrals for infant patients with an infection, and 33% felt prepared to talk with pregnant women about the risks of birth defects from Zika infection.

Just one in five physicians (22%) felt prepared for recommending Zika virus testing, and 16% felt prepared about providing data to the CDC’s U.S. Zika Pregnancy Registry or managing infants who had been prenatally exposed to Zika infection. Only 15% felt they had the preparedness to tell parents about social services for Zika-affected infants.

Preparedness did not differ by gender, specialty, practice setting, hours worked per week, or population density (urban, rural and suburban). However, differences did appear based on respondents’ age and U.S. region.

Older doctors reported greater knowledge about Zika than younger doctors. Compared with those aged 39 years or younger, those aged 40-49 and 50-59 reported feeling more knowledgeable (adjusted odds ratio, 1.74 and 1.72, respectively; P less than .05). The odds of feeling more knowledgeable was nearly triple among those aged at least 60 years, compared with those under 40 (aOR, 2.92; P less than .001).

Those practicing in the Northeast United States (aOR, 2.19; P less than .01) and in the South (aOR, 1.74; P less than .05) also reported feeling more knowledgeable than those in the West or Midwest.

“This makes sense because infants with a history of prenatal exposure to the Zika Virus are more likely to be seen in practices with more immigrants from the Caribbean and Latin America,” Dr. Houtrow said in an interview.

“There is definitely an opportunity to improve the dissemination of information about Zika virus to pediatricians, but the urgency of the need for education about Zika virus has diminished because the rates of new congenital Zika syndrome have dropped,” she continued.

Study limitations include the inability to generalize the findings beyond U.S. members of the AAP and the possibility that nonrespondents differed from respondents in terms of Zika knowledge and preparedness.

The research was funded by the AAP and CDC.

BALTIMORE – U.S. pediatricians feel comfortable providing patients with preventive information and travel advice related to Zika, but few feel prepared when it comes to testing and management of infants exposed prenatally to Zika infections, a study found.

Aunt_Spray/Thinkstock

“Areas where pediatricians were less likely to report preparedness included recommending testing, providing data to the Centers for Disease Control and Prevention’s Zika Pregnancy Registry, managing infants exposed to Zika prenatally, and informing parents of social services for Zika-infected infants,” senior author Amy J. Houtrow, MD, MPH, PhD, and colleagues reported at the Pediatric Academic Societies annual meeting.

“Results indicate that additional education efforts are needed to grow the overall Zika knowledge of pediatricians and boost preparedness, particularly around recommending Zika testing and providing data to CDC,” they concluded.

But these findings are not surprising given how rare congenital Zika virus syndrome is, explained Dr. Houtrow, an associate professor of physical medicine and rehabilitation and pediatrics at the University of Pittsburgh.

“For most rare conditions, pediatricians report better general than specific knowledge,” Dr. Houtrow said in an interview. “We expect pediatricians have a broad range of knowledge for a multitude of conditions and to be well versed in the care of infants and children with common conditions, coupled with the ability to access knowledge and expertise about rarer conditions such as congenital Zika syndrome.”

Dr. Houtrow and associates drew their findings from the 2018 AAP Periodic Survey of Fellows, which includes both primary care physicians and neonatologists. The survey’s response rate was 42%, with 672 of 1,599 surveys returned, but the researchers limited their analysis to 576 postresidency respondents who were providing direct patient care.

Overall, 39% of physicians reported being knowledgeable about Zika virus, and 47% said they wanted to learn more. More than half of responding doctors (57%) reported feeling moderately or very prepared when it came to informing patients of preventive measures to reduce risk of Zika infection, and nearly half (49%) felt confident about giving patients travel advice.

However, physicians’ preparedness gradually dropped for clinical situations requiring more direct experience with Zika. For example, 37% felt moderately or very prepared to provide clinical referrals for infant patients with an infection, and 33% felt prepared to talk with pregnant women about the risks of birth defects from Zika infection.

Just one in five physicians (22%) felt prepared for recommending Zika virus testing, and 16% felt prepared about providing data to the CDC’s U.S. Zika Pregnancy Registry or managing infants who had been prenatally exposed to Zika infection. Only 15% felt they had the preparedness to tell parents about social services for Zika-affected infants.

Preparedness did not differ by gender, specialty, practice setting, hours worked per week, or population density (urban, rural and suburban). However, differences did appear based on respondents’ age and U.S. region.

Older doctors reported greater knowledge about Zika than younger doctors. Compared with those aged 39 years or younger, those aged 40-49 and 50-59 reported feeling more knowledgeable (adjusted odds ratio, 1.74 and 1.72, respectively; P less than .05). The odds of feeling more knowledgeable was nearly triple among those aged at least 60 years, compared with those under 40 (aOR, 2.92; P less than .001).

Those practicing in the Northeast United States (aOR, 2.19; P less than .01) and in the South (aOR, 1.74; P less than .05) also reported feeling more knowledgeable than those in the West or Midwest.

“This makes sense because infants with a history of prenatal exposure to the Zika Virus are more likely to be seen in practices with more immigrants from the Caribbean and Latin America,” Dr. Houtrow said in an interview.

“There is definitely an opportunity to improve the dissemination of information about Zika virus to pediatricians, but the urgency of the need for education about Zika virus has diminished because the rates of new congenital Zika syndrome have dropped,” she continued.

Study limitations include the inability to generalize the findings beyond U.S. members of the AAP and the possibility that nonrespondents differed from respondents in terms of Zika knowledge and preparedness.

The research was funded by the AAP and CDC.

BALTIMORE – U.S. pediatricians feel comfortable providing patients with preventive information and travel advice related to Zika, but few feel prepared when it comes to testing and management of infants exposed prenatally to Zika infections, a study found.

Aunt_Spray/Thinkstock

“Areas where pediatricians were less likely to report preparedness included recommending testing, providing data to the Centers for Disease Control and Prevention’s Zika Pregnancy Registry, managing infants exposed to Zika prenatally, and informing parents of social services for Zika-infected infants,” senior author Amy J. Houtrow, MD, MPH, PhD, and colleagues reported at the Pediatric Academic Societies annual meeting.

“Results indicate that additional education efforts are needed to grow the overall Zika knowledge of pediatricians and boost preparedness, particularly around recommending Zika testing and providing data to CDC,” they concluded.

But these findings are not surprising given how rare congenital Zika virus syndrome is, explained Dr. Houtrow, an associate professor of physical medicine and rehabilitation and pediatrics at the University of Pittsburgh.

“For most rare conditions, pediatricians report better general than specific knowledge,” Dr. Houtrow said in an interview. “We expect pediatricians have a broad range of knowledge for a multitude of conditions and to be well versed in the care of infants and children with common conditions, coupled with the ability to access knowledge and expertise about rarer conditions such as congenital Zika syndrome.”

Dr. Houtrow and associates drew their findings from the 2018 AAP Periodic Survey of Fellows, which includes both primary care physicians and neonatologists. The survey’s response rate was 42%, with 672 of 1,599 surveys returned, but the researchers limited their analysis to 576 postresidency respondents who were providing direct patient care.

Overall, 39% of physicians reported being knowledgeable about Zika virus, and 47% said they wanted to learn more. More than half of responding doctors (57%) reported feeling moderately or very prepared when it came to informing patients of preventive measures to reduce risk of Zika infection, and nearly half (49%) felt confident about giving patients travel advice.

However, physicians’ preparedness gradually dropped for clinical situations requiring more direct experience with Zika. For example, 37% felt moderately or very prepared to provide clinical referrals for infant patients with an infection, and 33% felt prepared to talk with pregnant women about the risks of birth defects from Zika infection.

Just one in five physicians (22%) felt prepared for recommending Zika virus testing, and 16% felt prepared about providing data to the CDC’s U.S. Zika Pregnancy Registry or managing infants who had been prenatally exposed to Zika infection. Only 15% felt they had the preparedness to tell parents about social services for Zika-affected infants.

Preparedness did not differ by gender, specialty, practice setting, hours worked per week, or population density (urban, rural and suburban). However, differences did appear based on respondents’ age and U.S. region.

Older doctors reported greater knowledge about Zika than younger doctors. Compared with those aged 39 years or younger, those aged 40-49 and 50-59 reported feeling more knowledgeable (adjusted odds ratio, 1.74 and 1.72, respectively; P less than .05). The odds of feeling more knowledgeable was nearly triple among those aged at least 60 years, compared with those under 40 (aOR, 2.92; P less than .001).

Those practicing in the Northeast United States (aOR, 2.19; P less than .01) and in the South (aOR, 1.74; P less than .05) also reported feeling more knowledgeable than those in the West or Midwest.

“This makes sense because infants with a history of prenatal exposure to the Zika Virus are more likely to be seen in practices with more immigrants from the Caribbean and Latin America,” Dr. Houtrow said in an interview.

“There is definitely an opportunity to improve the dissemination of information about Zika virus to pediatricians, but the urgency of the need for education about Zika virus has diminished because the rates of new congenital Zika syndrome have dropped,” she continued.

Study limitations include the inability to generalize the findings beyond U.S. members of the AAP and the possibility that nonrespondents differed from respondents in terms of Zika knowledge and preparedness.

The research was funded by the AAP and CDC.