Persistent and nonepisodic foot pain in hyperuricemia is associated with ultrasound features of monosodium urate deposition within joints that is responsive to urate-lowering therapy, a case-control study shows.

The research suggests that symptomatic hyperuricemia occurring prior to episodic gout could represent an earlier or alternative disease presentation, reported Yousef Mohammed Alammari, of the department of rheumatology, Tallaght University Hospital, Dublin, and associates.

Furthermore, the researchers wrote in Annals of the Rheumatic Diseases, their findings serve as “potential rationale” for reclassification of the ACR/EULAR 2015 gout classification criteria.

The research team noted that the gout classification criteria from the two rheumatology organizations require a history of a “prior episode of swelling, pain, or tenderness of a peripheral joint/bursa before confirmation either through MSU crystal identification in synovial fluid or through achieving a score of greater than 8 using a predefined scoring system of radiological, laboratory, and clinical features.”

Yet, emerging evidence suggests that foot pain could be a preclinical and clinical phase of gout that might occur prior to a first episodic gout attack, the investigators noted.

The current study involved 16 hyperuricemia individuals with persistent, nonepisodic foot pain who did not fulfill ACR/EULAR 2015 gout classification criteria but received febuxostat 80 mg once daily for 3 months. Controls were 15 individuals with asymptomatic hyperuricemia.

Results showed that double contour sign erosion and tophus occurred in 44%, 37%, and 37% of the cases, respectively, whereas no ultrasound features of gout were seen in the controls.

No significant difference in baseline serum urate was observed between the cases (450 plus or minus 18 mg/dL) and controls (426 plus or minus 7; P = nonsignificant), but at 1- and 3-month time points, serum urate fell in the cases (200 plus or minus 18; P less than 0.001 and 223 plus or minus 28; P less than less than 0.001).

In the cases, baseline 24-hour pain visual analogue score (65 plus or minus 4.9) reduced at 1 month (41 plus or minus 6.6; P = 0.001) and 3 months (33 plus or minus 7.2; P less than 0.001) of urate lowering therapy, as did the 7-day pain visual analogue score (70 plus or minus 4.7) scores (44 plus or minus 7.1; P less than 0.001 at 1 month; 38 plus or minus 8; P less than 0.001 at 3 months).

The Manchester Foot Pain and Disability Index also decreased at 1 month (21 plus or minus 2.9; P = 0.019) and 3 months (17 plus or minus 2.8; P = 0.012).

When the investigators grouped the cases according to the presence (n = 7) or absence (n = 9) of double contour sign on baseline ultrasound, no differences were observed for baseline pain scores.

However, after treatment with ultrasound, 24-hour pain visual analogue scores were significantly lower in double contour positive patients at 1 month and 3 months.

In addition, the researchers found, the 7-day pain visual analogue scores were significantly lower in double contour positive patients at 1 month and 3 months. No significant differences were seen between double contour positive and double contour negative patients in the Manchester Foot Pain and Disability Index or serum urate at 1 or 3 months of ultrasound.

The investigators noted that their findings indicated that persistent, nonepisodic foot pain in hyperuricemia was both associated with ultrasound features of monosodium urate deposition and was responsive to urate lowering therapy.

“Symptomatic hyperuricemia occurring prior to episodic gout therefore represents an earlier or alternative disease presentation,” they wrote. “Changes to the ACR/ EULAR classification criteria to include nonepisodic foot pain in the presence of [ultrasound] features of gout may increase the sensitivity of disease classification at an early stage, leading to improved future treatment strategies and long-term outcomes.”

No disclosures were declared.

SOURCE: Alammari YM et al. Ann Rheum Dis. 2018. doi: 10.1136/annrheumdis-2018-214305.
 

Persistent and nonepisodic foot pain in hyperuricemia is associated with ultrasound features of monosodium urate deposition within joints that is responsive to urate-lowering therapy, a case-control study shows.

The research suggests that symptomatic hyperuricemia occurring prior to episodic gout could represent an earlier or alternative disease presentation, reported Yousef Mohammed Alammari, of the department of rheumatology, Tallaght University Hospital, Dublin, and associates.

Furthermore, the researchers wrote in Annals of the Rheumatic Diseases, their findings serve as “potential rationale” for reclassification of the ACR/EULAR 2015 gout classification criteria.

The research team noted that the gout classification criteria from the two rheumatology organizations require a history of a “prior episode of swelling, pain, or tenderness of a peripheral joint/bursa before confirmation either through MSU crystal identification in synovial fluid or through achieving a score of greater than 8 using a predefined scoring system of radiological, laboratory, and clinical features.”

Yet, emerging evidence suggests that foot pain could be a preclinical and clinical phase of gout that might occur prior to a first episodic gout attack, the investigators noted.

The current study involved 16 hyperuricemia individuals with persistent, nonepisodic foot pain who did not fulfill ACR/EULAR 2015 gout classification criteria but received febuxostat 80 mg once daily for 3 months. Controls were 15 individuals with asymptomatic hyperuricemia.

Results showed that double contour sign erosion and tophus occurred in 44%, 37%, and 37% of the cases, respectively, whereas no ultrasound features of gout were seen in the controls.

No significant difference in baseline serum urate was observed between the cases (450 plus or minus 18 mg/dL) and controls (426 plus or minus 7; P = nonsignificant), but at 1- and 3-month time points, serum urate fell in the cases (200 plus or minus 18; P less than 0.001 and 223 plus or minus 28; P less than less than 0.001).

In the cases, baseline 24-hour pain visual analogue score (65 plus or minus 4.9) reduced at 1 month (41 plus or minus 6.6; P = 0.001) and 3 months (33 plus or minus 7.2; P less than 0.001) of urate lowering therapy, as did the 7-day pain visual analogue score (70 plus or minus 4.7) scores (44 plus or minus 7.1; P less than 0.001 at 1 month; 38 plus or minus 8; P less than 0.001 at 3 months).

The Manchester Foot Pain and Disability Index also decreased at 1 month (21 plus or minus 2.9; P = 0.019) and 3 months (17 plus or minus 2.8; P = 0.012).

When the investigators grouped the cases according to the presence (n = 7) or absence (n = 9) of double contour sign on baseline ultrasound, no differences were observed for baseline pain scores.

However, after treatment with ultrasound, 24-hour pain visual analogue scores were significantly lower in double contour positive patients at 1 month and 3 months.

In addition, the researchers found, the 7-day pain visual analogue scores were significantly lower in double contour positive patients at 1 month and 3 months. No significant differences were seen between double contour positive and double contour negative patients in the Manchester Foot Pain and Disability Index or serum urate at 1 or 3 months of ultrasound.

The investigators noted that their findings indicated that persistent, nonepisodic foot pain in hyperuricemia was both associated with ultrasound features of monosodium urate deposition and was responsive to urate lowering therapy.

“Symptomatic hyperuricemia occurring prior to episodic gout therefore represents an earlier or alternative disease presentation,” they wrote. “Changes to the ACR/ EULAR classification criteria to include nonepisodic foot pain in the presence of [ultrasound] features of gout may increase the sensitivity of disease classification at an early stage, leading to improved future treatment strategies and long-term outcomes.”

No disclosures were declared.

SOURCE: Alammari YM et al. Ann Rheum Dis. 2018. doi: 10.1136/annrheumdis-2018-214305.
 

Persistent and nonepisodic foot pain in hyperuricemia is associated with ultrasound features of monosodium urate deposition within joints that is responsive to urate-lowering therapy, a case-control study shows.

The research suggests that symptomatic hyperuricemia occurring prior to episodic gout could represent an earlier or alternative disease presentation, reported Yousef Mohammed Alammari, of the department of rheumatology, Tallaght University Hospital, Dublin, and associates.

Furthermore, the researchers wrote in Annals of the Rheumatic Diseases, their findings serve as “potential rationale” for reclassification of the ACR/EULAR 2015 gout classification criteria.

The research team noted that the gout classification criteria from the two rheumatology organizations require a history of a “prior episode of swelling, pain, or tenderness of a peripheral joint/bursa before confirmation either through MSU crystal identification in synovial fluid or through achieving a score of greater than 8 using a predefined scoring system of radiological, laboratory, and clinical features.”

Yet, emerging evidence suggests that foot pain could be a preclinical and clinical phase of gout that might occur prior to a first episodic gout attack, the investigators noted.

The current study involved 16 hyperuricemia individuals with persistent, nonepisodic foot pain who did not fulfill ACR/EULAR 2015 gout classification criteria but received febuxostat 80 mg once daily for 3 months. Controls were 15 individuals with asymptomatic hyperuricemia.

Results showed that double contour sign erosion and tophus occurred in 44%, 37%, and 37% of the cases, respectively, whereas no ultrasound features of gout were seen in the controls.

No significant difference in baseline serum urate was observed between the cases (450 plus or minus 18 mg/dL) and controls (426 plus or minus 7; P = nonsignificant), but at 1- and 3-month time points, serum urate fell in the cases (200 plus or minus 18; P less than 0.001 and 223 plus or minus 28; P less than less than 0.001).

In the cases, baseline 24-hour pain visual analogue score (65 plus or minus 4.9) reduced at 1 month (41 plus or minus 6.6; P = 0.001) and 3 months (33 plus or minus 7.2; P less than 0.001) of urate lowering therapy, as did the 7-day pain visual analogue score (70 plus or minus 4.7) scores (44 plus or minus 7.1; P less than 0.001 at 1 month; 38 plus or minus 8; P less than 0.001 at 3 months).

The Manchester Foot Pain and Disability Index also decreased at 1 month (21 plus or minus 2.9; P = 0.019) and 3 months (17 plus or minus 2.8; P = 0.012).

When the investigators grouped the cases according to the presence (n = 7) or absence (n = 9) of double contour sign on baseline ultrasound, no differences were observed for baseline pain scores.

However, after treatment with ultrasound, 24-hour pain visual analogue scores were significantly lower in double contour positive patients at 1 month and 3 months.

In addition, the researchers found, the 7-day pain visual analogue scores were significantly lower in double contour positive patients at 1 month and 3 months. No significant differences were seen between double contour positive and double contour negative patients in the Manchester Foot Pain and Disability Index or serum urate at 1 or 3 months of ultrasound.

The investigators noted that their findings indicated that persistent, nonepisodic foot pain in hyperuricemia was both associated with ultrasound features of monosodium urate deposition and was responsive to urate lowering therapy.

“Symptomatic hyperuricemia occurring prior to episodic gout therefore represents an earlier or alternative disease presentation,” they wrote. “Changes to the ACR/ EULAR classification criteria to include nonepisodic foot pain in the presence of [ultrasound] features of gout may increase the sensitivity of disease classification at an early stage, leading to improved future treatment strategies and long-term outcomes.”

No disclosures were declared.

SOURCE: Alammari YM et al. Ann Rheum Dis. 2018. doi: 10.1136/annrheumdis-2018-214305.
 

LAS VEGAS – There hasn’t been a single corneal abrasion in 860 cases of gynecologic robotic surgery at the University of Texas, Austin, since surgeons and anesthesiologists there started sealing women’s eyes shut with a thick layer of ointment and Tegaderm, instead of the usual small squeeze of ointment and tape, according to Michael T. Breen, MD, a gynecologic surgeon at the university.

M. Alexander Otto/MDedge News

Slathered eyes and Tegaderm are now standard practice at the university. Before the switch was made, there were six corneal abrasions in 231 cases over 6 months. Two of those patients stayed longer in the hospital than they would have otherwise. The changes have eliminated the problem.

The impetus for the switch was a 42-year-old woman who had a robotic hysterectomy. The surgery went fine, but then Dr. Breen had to rush back to the recovery room. The woman was screaming in pain, not from her surgery, but from her left eye.

Corneal abrasions are a well-known risk of surgery because anesthesia decreases tear production and dries the eyes. Robotic gynecologic surgery increases the risk even more, because patients are under longer than with other approaches, and the steep Trendelenburg increases intraocular pressure and eye edema, especially with excess IV fluid.

And “believe it or not, having a pulse oximeter on the dominant hand [also] increases your risk of ocular injury,” Dr. Breen said. Sometimes, patients wake up, go to rub their eyes, and drag the device across their cornea, he said.

The screaming patient – who recovered without permanent damage – prompted Dr. Breen and his colleagues to turn to the literature for solutions. “One was a fully occlusive eye dressing, more than the tape we’ve all been accustomed to, with thick eye ointment application and Tegaderm applying positive pressure to the eye,” he said.

Dr. Michael Breen/University of Texas, Austin

Dr. Breen showed his audience a slide of the setup. “It looks a little unorthodox, but this is how every one of our robotic patients now have their eyes protected. Thick gel which is then covered with a positive pressure Tegaderm,” he said.

Another change was telling patients to keep their hands off their eyes for the first few postop hours, and placing the pulse ox on the nondominant hand. The team already had been decreasing IV fluids as part of their enhanced recovery after surgery protocol, and bringing patients out of steep Trendelenburg as soon as possible.

With the changes, “the rate of corneal abrasions decreased from 2.6% to 0% – and has stayed there,” Dr. Breen said.

There’ve been no allergic reactions to Tegaderm and no eyelid problems. “What we have seen with the simple taping is that, when it comes off, so does some of the eyelid, particularly with geriatric patients. We have not seen that with Tegaderm,” he said.

“Some people use goggles to protect the eyes, and we thought initially that the camera was hitting the face, so we used the Mayo stand to protect it from the camera,” but that didn’t turn out to be the problem, he said. “Goggles actually may make things worse.”

The project had no industry funding, and Dr. Breen had no relevant disclosures.

aotto@mdedge.com
 

SOURCE: Breen MT et al. 2018 AAGL Global Congress, Abstract 16.

LAS VEGAS – There hasn’t been a single corneal abrasion in 860 cases of gynecologic robotic surgery at the University of Texas, Austin, since surgeons and anesthesiologists there started sealing women’s eyes shut with a thick layer of ointment and Tegaderm, instead of the usual small squeeze of ointment and tape, according to Michael T. Breen, MD, a gynecologic surgeon at the university.

M. Alexander Otto/MDedge News

Slathered eyes and Tegaderm are now standard practice at the university. Before the switch was made, there were six corneal abrasions in 231 cases over 6 months. Two of those patients stayed longer in the hospital than they would have otherwise. The changes have eliminated the problem.

The impetus for the switch was a 42-year-old woman who had a robotic hysterectomy. The surgery went fine, but then Dr. Breen had to rush back to the recovery room. The woman was screaming in pain, not from her surgery, but from her left eye.

Corneal abrasions are a well-known risk of surgery because anesthesia decreases tear production and dries the eyes. Robotic gynecologic surgery increases the risk even more, because patients are under longer than with other approaches, and the steep Trendelenburg increases intraocular pressure and eye edema, especially with excess IV fluid.

And “believe it or not, having a pulse oximeter on the dominant hand [also] increases your risk of ocular injury,” Dr. Breen said. Sometimes, patients wake up, go to rub their eyes, and drag the device across their cornea, he said.

The screaming patient – who recovered without permanent damage – prompted Dr. Breen and his colleagues to turn to the literature for solutions. “One was a fully occlusive eye dressing, more than the tape we’ve all been accustomed to, with thick eye ointment application and Tegaderm applying positive pressure to the eye,” he said.

Dr. Michael Breen/University of Texas, Austin

Dr. Breen showed his audience a slide of the setup. “It looks a little unorthodox, but this is how every one of our robotic patients now have their eyes protected. Thick gel which is then covered with a positive pressure Tegaderm,” he said.

Another change was telling patients to keep their hands off their eyes for the first few postop hours, and placing the pulse ox on the nondominant hand. The team already had been decreasing IV fluids as part of their enhanced recovery after surgery protocol, and bringing patients out of steep Trendelenburg as soon as possible.

With the changes, “the rate of corneal abrasions decreased from 2.6% to 0% – and has stayed there,” Dr. Breen said.

There’ve been no allergic reactions to Tegaderm and no eyelid problems. “What we have seen with the simple taping is that, when it comes off, so does some of the eyelid, particularly with geriatric patients. We have not seen that with Tegaderm,” he said.

“Some people use goggles to protect the eyes, and we thought initially that the camera was hitting the face, so we used the Mayo stand to protect it from the camera,” but that didn’t turn out to be the problem, he said. “Goggles actually may make things worse.”

The project had no industry funding, and Dr. Breen had no relevant disclosures.

aotto@mdedge.com
 

SOURCE: Breen MT et al. 2018 AAGL Global Congress, Abstract 16.

LAS VEGAS – There hasn’t been a single corneal abrasion in 860 cases of gynecologic robotic surgery at the University of Texas, Austin, since surgeons and anesthesiologists there started sealing women’s eyes shut with a thick layer of ointment and Tegaderm, instead of the usual small squeeze of ointment and tape, according to Michael T. Breen, MD, a gynecologic surgeon at the university.

M. Alexander Otto/MDedge News

Slathered eyes and Tegaderm are now standard practice at the university. Before the switch was made, there were six corneal abrasions in 231 cases over 6 months. Two of those patients stayed longer in the hospital than they would have otherwise. The changes have eliminated the problem.

The impetus for the switch was a 42-year-old woman who had a robotic hysterectomy. The surgery went fine, but then Dr. Breen had to rush back to the recovery room. The woman was screaming in pain, not from her surgery, but from her left eye.

Corneal abrasions are a well-known risk of surgery because anesthesia decreases tear production and dries the eyes. Robotic gynecologic surgery increases the risk even more, because patients are under longer than with other approaches, and the steep Trendelenburg increases intraocular pressure and eye edema, especially with excess IV fluid.

And “believe it or not, having a pulse oximeter on the dominant hand [also] increases your risk of ocular injury,” Dr. Breen said. Sometimes, patients wake up, go to rub their eyes, and drag the device across their cornea, he said.

The screaming patient – who recovered without permanent damage – prompted Dr. Breen and his colleagues to turn to the literature for solutions. “One was a fully occlusive eye dressing, more than the tape we’ve all been accustomed to, with thick eye ointment application and Tegaderm applying positive pressure to the eye,” he said.

Dr. Michael Breen/University of Texas, Austin

Dr. Breen showed his audience a slide of the setup. “It looks a little unorthodox, but this is how every one of our robotic patients now have their eyes protected. Thick gel which is then covered with a positive pressure Tegaderm,” he said.

Another change was telling patients to keep their hands off their eyes for the first few postop hours, and placing the pulse ox on the nondominant hand. The team already had been decreasing IV fluids as part of their enhanced recovery after surgery protocol, and bringing patients out of steep Trendelenburg as soon as possible.

With the changes, “the rate of corneal abrasions decreased from 2.6% to 0% – and has stayed there,” Dr. Breen said.

There’ve been no allergic reactions to Tegaderm and no eyelid problems. “What we have seen with the simple taping is that, when it comes off, so does some of the eyelid, particularly with geriatric patients. We have not seen that with Tegaderm,” he said.

“Some people use goggles to protect the eyes, and we thought initially that the camera was hitting the face, so we used the Mayo stand to protect it from the camera,” but that didn’t turn out to be the problem, he said. “Goggles actually may make things worse.”

The project had no industry funding, and Dr. Breen had no relevant disclosures.

aotto@mdedge.com
 

SOURCE: Breen MT et al. 2018 AAGL Global Congress, Abstract 16.

Psychosis, a rare manifestation of systemic lupus erythematosus (SLE), generally appears early in the disease course. But treatment can lead to good outcomes for most patients with careful follow-up, according to a large international study.

The findings “confirm and expand upon the results of previous cross-sectional and historical studies of psychosis in SLE,” John G. Hanly, MD, and his associates wrote in Arthritis & Rheumatology.

The prospective study involved 1,826 patients enrolled in the Systemic Lupus International Collaborating Clinics (SLICC) network who were seen at 31 centers across 10 countries, including the United States and Canada.

Patients were followed for an average of 7.4 years, the majority were women (88.8%), almost half the cohort were white (48.8%), and the mean age was 35.1 years, reported Dr. Hanly, of Dalhousie University, Halifax, N.S., and his associates.


The researchers used the American College of Rheumatology definition of psychosis: delusions or hallucinations without insight; (ii) causing clinical distress or impairment in social, occupational or other relevant areas of functioning; (iii) disturbance should not occur exclusively during delirium; (iv) not better accounted for by another mental disorder.

During study follow-up, 28 patients experienced 31 psychotic events (1.53%); 26 of these patients had one event, one patient had two, and one had three events, Dr. Hanly and his associates said.

Using two attribution models, the investigators found that most psychotic events were directly attributed to SLE, and (80%) had their first episode either in the year prior to or within 3 years following a diagnosis of SLE.

The factors positively associated with psychosis on multivariate analysis were African ancestry (hazard ratio, 4.59; 95% confidence interval, 1.79-11.76), previous SLE neuropsychiatric events (HR, 3.59; 95% CI, 1.16-11.14), male sex (HR 3, 95% CI, 1.20-7.50), and younger age at the time of SLE diagnosis (per 10 years, HR, 1.45; 95% CI. 1.01-2.07).

More than 80% of the psychotic events had resolved by the second annual assessment after onset of the event, the investigators reported.

In terms of impact on quality of life, all subscales of the 36-Item Short-Form Health Survey (SF-36) were negatively affected in patients with lupus psychosis.

However, after treatment, patients generated SF-36 scores that showed a “remarkable reversal when averaged over time,” the investigators said.

“Psychosis is an infrequent manifestation of [neuropsychiatric SLE]. Generally, it occurs early after SLE onset and has a significant negative impact on health status,” they concluded. “As determined by patient and physician report, the short- and long-term outlook is good for most patients, though careful follow-up is required.”

Dr. Hanly disclosed grant support from the Canadian Institutes of Health. His associates reported financial support from several entities, including the Basque Government, the Danish Rheumatism Association, the Hopkins Lupus Cohort, and the National Institute for Health Research/Wellcome Trust Birmingham Clinical Research Facility.

SOURCE: Hanly JG et al. Arthritis Rheumatol. 2018. doi: 10.1002/art.40764.

Psychosis, a rare manifestation of systemic lupus erythematosus (SLE), generally appears early in the disease course. But treatment can lead to good outcomes for most patients with careful follow-up, according to a large international study.

The findings “confirm and expand upon the results of previous cross-sectional and historical studies of psychosis in SLE,” John G. Hanly, MD, and his associates wrote in Arthritis & Rheumatology.

The prospective study involved 1,826 patients enrolled in the Systemic Lupus International Collaborating Clinics (SLICC) network who were seen at 31 centers across 10 countries, including the United States and Canada.

Patients were followed for an average of 7.4 years, the majority were women (88.8%), almost half the cohort were white (48.8%), and the mean age was 35.1 years, reported Dr. Hanly, of Dalhousie University, Halifax, N.S., and his associates.


The researchers used the American College of Rheumatology definition of psychosis: delusions or hallucinations without insight; (ii) causing clinical distress or impairment in social, occupational or other relevant areas of functioning; (iii) disturbance should not occur exclusively during delirium; (iv) not better accounted for by another mental disorder.

During study follow-up, 28 patients experienced 31 psychotic events (1.53%); 26 of these patients had one event, one patient had two, and one had three events, Dr. Hanly and his associates said.

Using two attribution models, the investigators found that most psychotic events were directly attributed to SLE, and (80%) had their first episode either in the year prior to or within 3 years following a diagnosis of SLE.

The factors positively associated with psychosis on multivariate analysis were African ancestry (hazard ratio, 4.59; 95% confidence interval, 1.79-11.76), previous SLE neuropsychiatric events (HR, 3.59; 95% CI, 1.16-11.14), male sex (HR 3, 95% CI, 1.20-7.50), and younger age at the time of SLE diagnosis (per 10 years, HR, 1.45; 95% CI. 1.01-2.07).

More than 80% of the psychotic events had resolved by the second annual assessment after onset of the event, the investigators reported.

In terms of impact on quality of life, all subscales of the 36-Item Short-Form Health Survey (SF-36) were negatively affected in patients with lupus psychosis.

However, after treatment, patients generated SF-36 scores that showed a “remarkable reversal when averaged over time,” the investigators said.

“Psychosis is an infrequent manifestation of [neuropsychiatric SLE]. Generally, it occurs early after SLE onset and has a significant negative impact on health status,” they concluded. “As determined by patient and physician report, the short- and long-term outlook is good for most patients, though careful follow-up is required.”

Dr. Hanly disclosed grant support from the Canadian Institutes of Health. His associates reported financial support from several entities, including the Basque Government, the Danish Rheumatism Association, the Hopkins Lupus Cohort, and the National Institute for Health Research/Wellcome Trust Birmingham Clinical Research Facility.

SOURCE: Hanly JG et al. Arthritis Rheumatol. 2018. doi: 10.1002/art.40764.

Psychosis, a rare manifestation of systemic lupus erythematosus (SLE), generally appears early in the disease course. But treatment can lead to good outcomes for most patients with careful follow-up, according to a large international study.

The findings “confirm and expand upon the results of previous cross-sectional and historical studies of psychosis in SLE,” John G. Hanly, MD, and his associates wrote in Arthritis & Rheumatology.

The prospective study involved 1,826 patients enrolled in the Systemic Lupus International Collaborating Clinics (SLICC) network who were seen at 31 centers across 10 countries, including the United States and Canada.

Patients were followed for an average of 7.4 years, the majority were women (88.8%), almost half the cohort were white (48.8%), and the mean age was 35.1 years, reported Dr. Hanly, of Dalhousie University, Halifax, N.S., and his associates.


The researchers used the American College of Rheumatology definition of psychosis: delusions or hallucinations without insight; (ii) causing clinical distress or impairment in social, occupational or other relevant areas of functioning; (iii) disturbance should not occur exclusively during delirium; (iv) not better accounted for by another mental disorder.

During study follow-up, 28 patients experienced 31 psychotic events (1.53%); 26 of these patients had one event, one patient had two, and one had three events, Dr. Hanly and his associates said.

Using two attribution models, the investigators found that most psychotic events were directly attributed to SLE, and (80%) had their first episode either in the year prior to or within 3 years following a diagnosis of SLE.

The factors positively associated with psychosis on multivariate analysis were African ancestry (hazard ratio, 4.59; 95% confidence interval, 1.79-11.76), previous SLE neuropsychiatric events (HR, 3.59; 95% CI, 1.16-11.14), male sex (HR 3, 95% CI, 1.20-7.50), and younger age at the time of SLE diagnosis (per 10 years, HR, 1.45; 95% CI. 1.01-2.07).

More than 80% of the psychotic events had resolved by the second annual assessment after onset of the event, the investigators reported.

In terms of impact on quality of life, all subscales of the 36-Item Short-Form Health Survey (SF-36) were negatively affected in patients with lupus psychosis.

However, after treatment, patients generated SF-36 scores that showed a “remarkable reversal when averaged over time,” the investigators said.

“Psychosis is an infrequent manifestation of [neuropsychiatric SLE]. Generally, it occurs early after SLE onset and has a significant negative impact on health status,” they concluded. “As determined by patient and physician report, the short- and long-term outlook is good for most patients, though careful follow-up is required.”

Dr. Hanly disclosed grant support from the Canadian Institutes of Health. His associates reported financial support from several entities, including the Basque Government, the Danish Rheumatism Association, the Hopkins Lupus Cohort, and the National Institute for Health Research/Wellcome Trust Birmingham Clinical Research Facility.

SOURCE: Hanly JG et al. Arthritis Rheumatol. 2018. doi: 10.1002/art.40764.

SAN DIEGO – Patients with somatic symptom and related disorders can get better in primary care when clinicians use a few key strategies, according to an expert.

When it comes to these disorders, “a lot of our anxiety and gallows humor comes from a place of not knowing what we want to do, how we can treat these individuals,” said Matthew Reed, MD, MPH, a psychiatrist and pain specialist at the University of California, Irvine. “It became more appealing once I learned a little bit more about what was going on with some of these disorders and how I might be able to intervene.”

Dr. Reed spoke at Pain Care for Primary Care, held by the American Pain Society and Global Academy for Medical Education. Global Academy and this news organization are owned by the same company.

Throughout his presentation, Dr. Reed drew upon the listing of somatic symptom and related disorders as outlined in the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5). Among the disorders he discussed:
 

Somatic symptom disorder

This disorder causes significant distress because of at least one somatic symptom and is persistent (lasting over 6 months). A medical illness might be present, and depression and anxiety are common.

“This diagnosis says you have pathology – this somatic disorder – which is making your life miserable,” Dr. Reed said.

He’s often thrilled when patients also have comorbid depression and/or anxiety. “You treat that primary issue, and the somatic disorder melts away,” he said. “It’s harder when you have the pure version of somatic disorder, and there is no anxiety or depressive disorder.”
 

Illness anxiety disorder (formerly known as hypochondriasis)

Patients with this disorder have been preoccupied about having a serious illness for at least 6 months but do not have somatic symptoms. Reassurance typically is not effective, Dr. Reed said. In response to a statement such as “nothing’s wrong,” he said, patients might reply with a statement along the lines of “something’s wrong because I’m suffering.”

Patients with this condition can command “high rates of medical utilization, often pretty inappropriate,” especially if they are VIPs, he said.
 

Conversion disorder (also known as functional neurological symptom disorder)

This is less common than the other disorders. Patients with this condition develop “one or more symptoms of altered voluntary motor or sensory function” that’s “not better explained by another medical condition.”

A “listening ear” and physical therapy can prove helpful, Dr. Reed said.
 

Factitious disorder

Patients with this condition falsify or induce signs of illness, impairment, or injury. “There’s more of an overt feigning of symptoms in order to maintain that sick role,” said Dr. Reed, who cautioned that some people with this condition actually might be suffering.

Protocol can guide treatment

How can these conditions be treated in patients? Dr. Reed pointed to the protocol discussed by Robert McCarron, DO, and embedded in the mnemonic “CARE MD”: Cognitive-behavioral therapy (CBT)/consultation, regular visits, empathy, med-psych interface, and do no harm.

“Reassure them that you value them,” he said. Perhaps say something like: “I get your suffering is real. I’m going to be here to help you. Let’s get you back in a month.” Under CARE MD, the idea of multiple visits is to help the patient develop coping strategies and stop overusing medical care.

Return visits should not be too frequent, Dr. Reed said, and they should be short. Physicians must remember to take care of themselves and other patients, he said, and not spend too much time with these patients. “We need to be compassionate,” he said, but “we don’t need to be compassionate in a way that we don’t have our sanity after clinic.”

As for CBT, Dr. Reed likes to suggest it in a way that doesn’t aggravate patients who are sensitive to the idea that their condition is all in their heads.

Physicians, he said, can say: “Wow, this is really affecting your life. You have 17 specialists working on you. You’ll continue to see them, I know. But I worry. I look at your chart, and we’re missing a whole area of treatment.”

He then mentions CBT. “Other providers may have told you about it,” he’ll say. “I’ve seen such good benefits with CBT, even with patients who were in motor vehicle accidents. It doesn’t matter where it’s coming from. This CBT seems to work.”

Ideally, he said, patients agree to try it.

Dr. Reed had no disclosures.

SAN DIEGO – Patients with somatic symptom and related disorders can get better in primary care when clinicians use a few key strategies, according to an expert.

When it comes to these disorders, “a lot of our anxiety and gallows humor comes from a place of not knowing what we want to do, how we can treat these individuals,” said Matthew Reed, MD, MPH, a psychiatrist and pain specialist at the University of California, Irvine. “It became more appealing once I learned a little bit more about what was going on with some of these disorders and how I might be able to intervene.”

Dr. Reed spoke at Pain Care for Primary Care, held by the American Pain Society and Global Academy for Medical Education. Global Academy and this news organization are owned by the same company.

Throughout his presentation, Dr. Reed drew upon the listing of somatic symptom and related disorders as outlined in the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5). Among the disorders he discussed:
 

Somatic symptom disorder

This disorder causes significant distress because of at least one somatic symptom and is persistent (lasting over 6 months). A medical illness might be present, and depression and anxiety are common.

“This diagnosis says you have pathology – this somatic disorder – which is making your life miserable,” Dr. Reed said.

He’s often thrilled when patients also have comorbid depression and/or anxiety. “You treat that primary issue, and the somatic disorder melts away,” he said. “It’s harder when you have the pure version of somatic disorder, and there is no anxiety or depressive disorder.”
 

Illness anxiety disorder (formerly known as hypochondriasis)

Patients with this disorder have been preoccupied about having a serious illness for at least 6 months but do not have somatic symptoms. Reassurance typically is not effective, Dr. Reed said. In response to a statement such as “nothing’s wrong,” he said, patients might reply with a statement along the lines of “something’s wrong because I’m suffering.”

Patients with this condition can command “high rates of medical utilization, often pretty inappropriate,” especially if they are VIPs, he said.
 

Conversion disorder (also known as functional neurological symptom disorder)

This is less common than the other disorders. Patients with this condition develop “one or more symptoms of altered voluntary motor or sensory function” that’s “not better explained by another medical condition.”

A “listening ear” and physical therapy can prove helpful, Dr. Reed said.
 

Factitious disorder

Patients with this condition falsify or induce signs of illness, impairment, or injury. “There’s more of an overt feigning of symptoms in order to maintain that sick role,” said Dr. Reed, who cautioned that some people with this condition actually might be suffering.

Protocol can guide treatment

How can these conditions be treated in patients? Dr. Reed pointed to the protocol discussed by Robert McCarron, DO, and embedded in the mnemonic “CARE MD”: Cognitive-behavioral therapy (CBT)/consultation, regular visits, empathy, med-psych interface, and do no harm.

“Reassure them that you value them,” he said. Perhaps say something like: “I get your suffering is real. I’m going to be here to help you. Let’s get you back in a month.” Under CARE MD, the idea of multiple visits is to help the patient develop coping strategies and stop overusing medical care.

Return visits should not be too frequent, Dr. Reed said, and they should be short. Physicians must remember to take care of themselves and other patients, he said, and not spend too much time with these patients. “We need to be compassionate,” he said, but “we don’t need to be compassionate in a way that we don’t have our sanity after clinic.”

As for CBT, Dr. Reed likes to suggest it in a way that doesn’t aggravate patients who are sensitive to the idea that their condition is all in their heads.

Physicians, he said, can say: “Wow, this is really affecting your life. You have 17 specialists working on you. You’ll continue to see them, I know. But I worry. I look at your chart, and we’re missing a whole area of treatment.”

He then mentions CBT. “Other providers may have told you about it,” he’ll say. “I’ve seen such good benefits with CBT, even with patients who were in motor vehicle accidents. It doesn’t matter where it’s coming from. This CBT seems to work.”

Ideally, he said, patients agree to try it.

Dr. Reed had no disclosures.

SAN DIEGO – Patients with somatic symptom and related disorders can get better in primary care when clinicians use a few key strategies, according to an expert.

When it comes to these disorders, “a lot of our anxiety and gallows humor comes from a place of not knowing what we want to do, how we can treat these individuals,” said Matthew Reed, MD, MPH, a psychiatrist and pain specialist at the University of California, Irvine. “It became more appealing once I learned a little bit more about what was going on with some of these disorders and how I might be able to intervene.”

Dr. Reed spoke at Pain Care for Primary Care, held by the American Pain Society and Global Academy for Medical Education. Global Academy and this news organization are owned by the same company.

Throughout his presentation, Dr. Reed drew upon the listing of somatic symptom and related disorders as outlined in the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5). Among the disorders he discussed:
 

Somatic symptom disorder

This disorder causes significant distress because of at least one somatic symptom and is persistent (lasting over 6 months). A medical illness might be present, and depression and anxiety are common.

“This diagnosis says you have pathology – this somatic disorder – which is making your life miserable,” Dr. Reed said.

He’s often thrilled when patients also have comorbid depression and/or anxiety. “You treat that primary issue, and the somatic disorder melts away,” he said. “It’s harder when you have the pure version of somatic disorder, and there is no anxiety or depressive disorder.”
 

Illness anxiety disorder (formerly known as hypochondriasis)

Patients with this disorder have been preoccupied about having a serious illness for at least 6 months but do not have somatic symptoms. Reassurance typically is not effective, Dr. Reed said. In response to a statement such as “nothing’s wrong,” he said, patients might reply with a statement along the lines of “something’s wrong because I’m suffering.”

Patients with this condition can command “high rates of medical utilization, often pretty inappropriate,” especially if they are VIPs, he said.
 

Conversion disorder (also known as functional neurological symptom disorder)

This is less common than the other disorders. Patients with this condition develop “one or more symptoms of altered voluntary motor or sensory function” that’s “not better explained by another medical condition.”

A “listening ear” and physical therapy can prove helpful, Dr. Reed said.
 

Factitious disorder

Patients with this condition falsify or induce signs of illness, impairment, or injury. “There’s more of an overt feigning of symptoms in order to maintain that sick role,” said Dr. Reed, who cautioned that some people with this condition actually might be suffering.

Protocol can guide treatment

How can these conditions be treated in patients? Dr. Reed pointed to the protocol discussed by Robert McCarron, DO, and embedded in the mnemonic “CARE MD”: Cognitive-behavioral therapy (CBT)/consultation, regular visits, empathy, med-psych interface, and do no harm.

“Reassure them that you value them,” he said. Perhaps say something like: “I get your suffering is real. I’m going to be here to help you. Let’s get you back in a month.” Under CARE MD, the idea of multiple visits is to help the patient develop coping strategies and stop overusing medical care.

Return visits should not be too frequent, Dr. Reed said, and they should be short. Physicians must remember to take care of themselves and other patients, he said, and not spend too much time with these patients. “We need to be compassionate,” he said, but “we don’t need to be compassionate in a way that we don’t have our sanity after clinic.”

As for CBT, Dr. Reed likes to suggest it in a way that doesn’t aggravate patients who are sensitive to the idea that their condition is all in their heads.

Physicians, he said, can say: “Wow, this is really affecting your life. You have 17 specialists working on you. You’ll continue to see them, I know. But I worry. I look at your chart, and we’re missing a whole area of treatment.”

He then mentions CBT. “Other providers may have told you about it,” he’ll say. “I’ve seen such good benefits with CBT, even with patients who were in motor vehicle accidents. It doesn’t matter where it’s coming from. This CBT seems to work.”

Ideally, he said, patients agree to try it.

Dr. Reed had no disclosures.

LAS VEGAS – Patients experience less right-sided pain after laparoscopic sacrocolpopexy when surgeons use an 8-mm assistant port instead of a 12-mm port, results from a small trial show.

M. Alexander Otto/MDedge News

In the trial, conducted at Loyola University Medical Center in Maywood, Ill.,17 women were randomized to undergo the procedure with an 8-mm assistant port, and 18 with a 12-mm port, both on the right side of the abdomen.

Overall, pain severity was low at 2 weeks postop in both groups at just over 1 point on a 10-point visual analogue scale and not statistically different. However, patients who had a 12-mm assistant port were more likely to report right-sided pain, compared with those who had an 8-mm assistant port (60% vs.18%, P = 0.027).

“I saw a lot of these patients in the clinic at 2 weeks, and even though the overall pain score was low, they kept complaining about a dull, achy pain on the right side. They were using ibuprofen, and some of them had even restricted [their activities] because they were afraid they were going to pop a stitch,” said study lead Yufan B. Chen, MD, a urogynecology fellow at Loyola.

He said the research team thinks the difference in port-site pain “is clinically significant. Even if we had more patients in our study, I think it’s still likely our results would have been the same. Since our study ended, we have stopped using the 12-mm port in most of our cases; we use the 8-mm port for the assistant,” he said at the meeting, sponsored by the American Association of Gynecologic Laparoscopists.

The tradeoff was that there were more needle struggles with the 8-mm port, 3.1/case vs. 0.6/case (P = .004). Surgeons found inserting and withdrawing the Gore-Tex needle through the smaller port more difficult. But there were no needle losses in either group and no differences in operative time – an average of about 95 minutes.

“The larger port size essentially benefits the surgeon more than the patient. This is kind of a common theme in minimally invasive surgery where less is actually more,” he said. Since the study, “we have identified why we have challenges with the needle transport; it’s usually because the needle gets bent, so we just unbend it a little bit with our needle drivers before we remove it,” Dr. Chen said.

Even so, “there may be a role in using the 12-mm port when you have assistants who are not [that] experienced,” he said.

Laparoscopic sacrocolpopexy is done through four ports at Loyola: a 12-mm umbilical port for the scope; two 5-mm ports on the left for the primary surgeon; and the right side port for the assistant, through which the Gore-Tex needle is passed.

In the study, there were no demographic or preop differences between the two groups of women. About 60% were white, with a mean age of 61 years. About 10% of the women had had prior abdominal surgery.

The study received no industry funding, and the investigators had no disclosures.

aotto@mdedge.com

SOURCE: Chen YB et al. 2018 AAGL Global Congress, Abstract 197.

LAS VEGAS – Patients experience less right-sided pain after laparoscopic sacrocolpopexy when surgeons use an 8-mm assistant port instead of a 12-mm port, results from a small trial show.

M. Alexander Otto/MDedge News

In the trial, conducted at Loyola University Medical Center in Maywood, Ill.,17 women were randomized to undergo the procedure with an 8-mm assistant port, and 18 with a 12-mm port, both on the right side of the abdomen.

Overall, pain severity was low at 2 weeks postop in both groups at just over 1 point on a 10-point visual analogue scale and not statistically different. However, patients who had a 12-mm assistant port were more likely to report right-sided pain, compared with those who had an 8-mm assistant port (60% vs.18%, P = 0.027).

“I saw a lot of these patients in the clinic at 2 weeks, and even though the overall pain score was low, they kept complaining about a dull, achy pain on the right side. They were using ibuprofen, and some of them had even restricted [their activities] because they were afraid they were going to pop a stitch,” said study lead Yufan B. Chen, MD, a urogynecology fellow at Loyola.

He said the research team thinks the difference in port-site pain “is clinically significant. Even if we had more patients in our study, I think it’s still likely our results would have been the same. Since our study ended, we have stopped using the 12-mm port in most of our cases; we use the 8-mm port for the assistant,” he said at the meeting, sponsored by the American Association of Gynecologic Laparoscopists.

The tradeoff was that there were more needle struggles with the 8-mm port, 3.1/case vs. 0.6/case (P = .004). Surgeons found inserting and withdrawing the Gore-Tex needle through the smaller port more difficult. But there were no needle losses in either group and no differences in operative time – an average of about 95 minutes.

“The larger port size essentially benefits the surgeon more than the patient. This is kind of a common theme in minimally invasive surgery where less is actually more,” he said. Since the study, “we have identified why we have challenges with the needle transport; it’s usually because the needle gets bent, so we just unbend it a little bit with our needle drivers before we remove it,” Dr. Chen said.

Even so, “there may be a role in using the 12-mm port when you have assistants who are not [that] experienced,” he said.

Laparoscopic sacrocolpopexy is done through four ports at Loyola: a 12-mm umbilical port for the scope; two 5-mm ports on the left for the primary surgeon; and the right side port for the assistant, through which the Gore-Tex needle is passed.

In the study, there were no demographic or preop differences between the two groups of women. About 60% were white, with a mean age of 61 years. About 10% of the women had had prior abdominal surgery.

The study received no industry funding, and the investigators had no disclosures.

aotto@mdedge.com

SOURCE: Chen YB et al. 2018 AAGL Global Congress, Abstract 197.

LAS VEGAS – Patients experience less right-sided pain after laparoscopic sacrocolpopexy when surgeons use an 8-mm assistant port instead of a 12-mm port, results from a small trial show.

M. Alexander Otto/MDedge News

In the trial, conducted at Loyola University Medical Center in Maywood, Ill.,17 women were randomized to undergo the procedure with an 8-mm assistant port, and 18 with a 12-mm port, both on the right side of the abdomen.

Overall, pain severity was low at 2 weeks postop in both groups at just over 1 point on a 10-point visual analogue scale and not statistically different. However, patients who had a 12-mm assistant port were more likely to report right-sided pain, compared with those who had an 8-mm assistant port (60% vs.18%, P = 0.027).

“I saw a lot of these patients in the clinic at 2 weeks, and even though the overall pain score was low, they kept complaining about a dull, achy pain on the right side. They were using ibuprofen, and some of them had even restricted [their activities] because they were afraid they were going to pop a stitch,” said study lead Yufan B. Chen, MD, a urogynecology fellow at Loyola.

He said the research team thinks the difference in port-site pain “is clinically significant. Even if we had more patients in our study, I think it’s still likely our results would have been the same. Since our study ended, we have stopped using the 12-mm port in most of our cases; we use the 8-mm port for the assistant,” he said at the meeting, sponsored by the American Association of Gynecologic Laparoscopists.

The tradeoff was that there were more needle struggles with the 8-mm port, 3.1/case vs. 0.6/case (P = .004). Surgeons found inserting and withdrawing the Gore-Tex needle through the smaller port more difficult. But there were no needle losses in either group and no differences in operative time – an average of about 95 minutes.

“The larger port size essentially benefits the surgeon more than the patient. This is kind of a common theme in minimally invasive surgery where less is actually more,” he said. Since the study, “we have identified why we have challenges with the needle transport; it’s usually because the needle gets bent, so we just unbend it a little bit with our needle drivers before we remove it,” Dr. Chen said.

Even so, “there may be a role in using the 12-mm port when you have assistants who are not [that] experienced,” he said.

Laparoscopic sacrocolpopexy is done through four ports at Loyola: a 12-mm umbilical port for the scope; two 5-mm ports on the left for the primary surgeon; and the right side port for the assistant, through which the Gore-Tex needle is passed.

In the study, there were no demographic or preop differences between the two groups of women. About 60% were white, with a mean age of 61 years. About 10% of the women had had prior abdominal surgery.

The study received no industry funding, and the investigators had no disclosures.

aotto@mdedge.com

SOURCE: Chen YB et al. 2018 AAGL Global Congress, Abstract 197.

LAS VEGAS – Serum albumin is an everyday health marker commonly used for risk assessment in open abdominal procedures, but it’s often not checked before laparoscopic hysterectomies.

M. Alexander Otto/MDedge News

Low levels mean something is off, be it malnutrition, inflammation, chronic disease, or other problems. If it can be normalized before surgery, it should be; women probably will do better, according to investigators from the University of Kentucky, Lexington.

“In minimally invasive gynecologic procedures, we haven’t come to adopt this marker just quite yet. It could be included in the routine battery of tests” at minimal cost. “I think it’s something we should consider,” said ob.gyn. resident Suzanne Lababidi, MD.

The team was curious why serum albumin generally is not a part of routine testing for laparoscopic hysterectomy. The first step was to see if it made a difference, so they reviewed 43,289 cases in the National Surgical Quality Improvement Program database. The women were “par for the course;” 51 years old, on average; and had a mean body mass index of 31.9 kg/m². More than one-third were hypertensive. Mean albumin was in the normal range at 4.1 g/dL, Dr. Lababidi said at the meeting, sponsored by the American Association of Gynecologic Laparoscopists.

Her team did not come up with a cut-point to delay surgery – that’s the goal of further research – but they noticed on linear regression that women with lower preop albumin had higher rates of surgical site infections and intraoperative transfusions, plus higher rates of postop pneumonia; renal failure; urinary tract infection; sepsis; and deep vein thrombosis, among other issues – and even after controlling for hypertension, diabetes, and other comorbidities. The findings met statistical significance.

It’s true that patients with low albumin might have gone into the operating room sicker, but no matter; Dr. Lababidi’s point was that preop serum albumin is something to pay attention to and correct whenever possible before laparoscopic hysterectomies.

“It’s important to realize that albumin is something that can be improved over time.” Preop levels are something to consider for “counseling and optimizing patients to improve surgical outcomes,” she said.

The next step toward an albumin cut-point is to weed out confounders by further stratifying patients based on albumin levels, she said.

The work received no industry funding. Dr. Lababidi had no disclosures.

aotto@mdedge.com

SOURCE: Lababidi S et al. 2018 AAGL Global Congress, Abstract 199.

LAS VEGAS – Serum albumin is an everyday health marker commonly used for risk assessment in open abdominal procedures, but it’s often not checked before laparoscopic hysterectomies.

M. Alexander Otto/MDedge News

Low levels mean something is off, be it malnutrition, inflammation, chronic disease, or other problems. If it can be normalized before surgery, it should be; women probably will do better, according to investigators from the University of Kentucky, Lexington.

“In minimally invasive gynecologic procedures, we haven’t come to adopt this marker just quite yet. It could be included in the routine battery of tests” at minimal cost. “I think it’s something we should consider,” said ob.gyn. resident Suzanne Lababidi, MD.

The team was curious why serum albumin generally is not a part of routine testing for laparoscopic hysterectomy. The first step was to see if it made a difference, so they reviewed 43,289 cases in the National Surgical Quality Improvement Program database. The women were “par for the course;” 51 years old, on average; and had a mean body mass index of 31.9 kg/m². More than one-third were hypertensive. Mean albumin was in the normal range at 4.1 g/dL, Dr. Lababidi said at the meeting, sponsored by the American Association of Gynecologic Laparoscopists.

Her team did not come up with a cut-point to delay surgery – that’s the goal of further research – but they noticed on linear regression that women with lower preop albumin had higher rates of surgical site infections and intraoperative transfusions, plus higher rates of postop pneumonia; renal failure; urinary tract infection; sepsis; and deep vein thrombosis, among other issues – and even after controlling for hypertension, diabetes, and other comorbidities. The findings met statistical significance.

It’s true that patients with low albumin might have gone into the operating room sicker, but no matter; Dr. Lababidi’s point was that preop serum albumin is something to pay attention to and correct whenever possible before laparoscopic hysterectomies.

“It’s important to realize that albumin is something that can be improved over time.” Preop levels are something to consider for “counseling and optimizing patients to improve surgical outcomes,” she said.

The next step toward an albumin cut-point is to weed out confounders by further stratifying patients based on albumin levels, she said.

The work received no industry funding. Dr. Lababidi had no disclosures.

aotto@mdedge.com

SOURCE: Lababidi S et al. 2018 AAGL Global Congress, Abstract 199.

LAS VEGAS – Serum albumin is an everyday health marker commonly used for risk assessment in open abdominal procedures, but it’s often not checked before laparoscopic hysterectomies.

M. Alexander Otto/MDedge News

Low levels mean something is off, be it malnutrition, inflammation, chronic disease, or other problems. If it can be normalized before surgery, it should be; women probably will do better, according to investigators from the University of Kentucky, Lexington.

“In minimally invasive gynecologic procedures, we haven’t come to adopt this marker just quite yet. It could be included in the routine battery of tests” at minimal cost. “I think it’s something we should consider,” said ob.gyn. resident Suzanne Lababidi, MD.

The team was curious why serum albumin generally is not a part of routine testing for laparoscopic hysterectomy. The first step was to see if it made a difference, so they reviewed 43,289 cases in the National Surgical Quality Improvement Program database. The women were “par for the course;” 51 years old, on average; and had a mean body mass index of 31.9 kg/m². More than one-third were hypertensive. Mean albumin was in the normal range at 4.1 g/dL, Dr. Lababidi said at the meeting, sponsored by the American Association of Gynecologic Laparoscopists.

Her team did not come up with a cut-point to delay surgery – that’s the goal of further research – but they noticed on linear regression that women with lower preop albumin had higher rates of surgical site infections and intraoperative transfusions, plus higher rates of postop pneumonia; renal failure; urinary tract infection; sepsis; and deep vein thrombosis, among other issues – and even after controlling for hypertension, diabetes, and other comorbidities. The findings met statistical significance.

It’s true that patients with low albumin might have gone into the operating room sicker, but no matter; Dr. Lababidi’s point was that preop serum albumin is something to pay attention to and correct whenever possible before laparoscopic hysterectomies.

“It’s important to realize that albumin is something that can be improved over time.” Preop levels are something to consider for “counseling and optimizing patients to improve surgical outcomes,” she said.

The next step toward an albumin cut-point is to weed out confounders by further stratifying patients based on albumin levels, she said.

The work received no industry funding. Dr. Lababidi had no disclosures.

aotto@mdedge.com

SOURCE: Lababidi S et al. 2018 AAGL Global Congress, Abstract 199.

LAS VEGAS – The surgical site infection rate was 2.9% among women who received perioperative antibiotics for fibroid surgery, but 7.8% among those who did not, in a review of 1,433 cases at Massachusetts General Hospital and Brigham and Women’s Hospital, Boston.

M. Alexander Otto/MDedge News

That is despite the fact that antibiotic cases were longer – 155 minutes vs. 89 minutes – and had more blood loss, 200 ml vs. 117 ml. Antibiotic cases also had larger specimen weights – 346 g vs. 176 g – and were more likely to have the uterine cavity entered, 30.2% vs. 14.4%.

“Surgical site infections were more common in the no-antibiotics group despite these being less complex cases.” There was “nearly a fivefold increased odds of surgical site infection or any infectious complication when no antibiotics were given,” after controlling for infection risk factors, including smoking and diabetes, said investigator Nisse V. Clark, MD, a minimally invasive gynecologic surgeon affiliated with Massachusetts General Hospital.

There are no perioperative antibiotic guidelines for myomectomies; maybe there should be. Almost 94% of the women in the review did receive antibiotics at the Harvard-affiliated hospitals, but the nationwide average has been pegged at about two-thirds, she said at the meeting, sponsored by the American Association of Gynecologic Laparoscopists.

The antibiotic cases usually received a cephalosporin before surgery, and were about evenly about evenly split between abdominal, robotic, and laparoscopic approaches.

About one-third of the 90 women (6.3%) who did not get antibiotics had hysteroscopic procedures in which antibiotics usually are not given because the peritoneal cavity is not breeched. Most of the rest, however, were laparoscopic cases. It’s unknown why they weren’t given antibiotics. In her own practice, Dr. Clark said preop antibiotics are the rule for laparoscopic myomectomies.

The surgical site infection difference was driven largely by higher incidences of pelvic abscesses and other organ space infections in the no-antibiotic group.

The only significant demographic difference between the two groups was that women who received antibiotics were slightly younger (mean 38 versus 39.7 years). Antibiotic cases were in the hospital a mean of 1 day, compared with 0.2 days in the no-antibiotic group.

In addition to diabetes and smoking, the team adjusted for age, surgery route, body mass index, uterine entry, intraoperative complications, and myoma weight in their multivariate analysis. Still, women in the no-antibiotic group were 4.59 times more likely to have a surgical site infection, 4.76 more likely to have any infectious complication, and almost 8 times more likely to have a major infectious complication. All of the findings were statistically significant.

The study had no industry funding, and Dr. Clark had no disclosures.

aotto@mdedge.com

LAS VEGAS – The surgical site infection rate was 2.9% among women who received perioperative antibiotics for fibroid surgery, but 7.8% among those who did not, in a review of 1,433 cases at Massachusetts General Hospital and Brigham and Women’s Hospital, Boston.

M. Alexander Otto/MDedge News

That is despite the fact that antibiotic cases were longer – 155 minutes vs. 89 minutes – and had more blood loss, 200 ml vs. 117 ml. Antibiotic cases also had larger specimen weights – 346 g vs. 176 g – and were more likely to have the uterine cavity entered, 30.2% vs. 14.4%.

“Surgical site infections were more common in the no-antibiotics group despite these being less complex cases.” There was “nearly a fivefold increased odds of surgical site infection or any infectious complication when no antibiotics were given,” after controlling for infection risk factors, including smoking and diabetes, said investigator Nisse V. Clark, MD, a minimally invasive gynecologic surgeon affiliated with Massachusetts General Hospital.

There are no perioperative antibiotic guidelines for myomectomies; maybe there should be. Almost 94% of the women in the review did receive antibiotics at the Harvard-affiliated hospitals, but the nationwide average has been pegged at about two-thirds, she said at the meeting, sponsored by the American Association of Gynecologic Laparoscopists.

The antibiotic cases usually received a cephalosporin before surgery, and were about evenly about evenly split between abdominal, robotic, and laparoscopic approaches.

About one-third of the 90 women (6.3%) who did not get antibiotics had hysteroscopic procedures in which antibiotics usually are not given because the peritoneal cavity is not breeched. Most of the rest, however, were laparoscopic cases. It’s unknown why they weren’t given antibiotics. In her own practice, Dr. Clark said preop antibiotics are the rule for laparoscopic myomectomies.

The surgical site infection difference was driven largely by higher incidences of pelvic abscesses and other organ space infections in the no-antibiotic group.

The only significant demographic difference between the two groups was that women who received antibiotics were slightly younger (mean 38 versus 39.7 years). Antibiotic cases were in the hospital a mean of 1 day, compared with 0.2 days in the no-antibiotic group.

In addition to diabetes and smoking, the team adjusted for age, surgery route, body mass index, uterine entry, intraoperative complications, and myoma weight in their multivariate analysis. Still, women in the no-antibiotic group were 4.59 times more likely to have a surgical site infection, 4.76 more likely to have any infectious complication, and almost 8 times more likely to have a major infectious complication. All of the findings were statistically significant.

The study had no industry funding, and Dr. Clark had no disclosures.

aotto@mdedge.com

LAS VEGAS – The surgical site infection rate was 2.9% among women who received perioperative antibiotics for fibroid surgery, but 7.8% among those who did not, in a review of 1,433 cases at Massachusetts General Hospital and Brigham and Women’s Hospital, Boston.

M. Alexander Otto/MDedge News

That is despite the fact that antibiotic cases were longer – 155 minutes vs. 89 minutes – and had more blood loss, 200 ml vs. 117 ml. Antibiotic cases also had larger specimen weights – 346 g vs. 176 g – and were more likely to have the uterine cavity entered, 30.2% vs. 14.4%.

“Surgical site infections were more common in the no-antibiotics group despite these being less complex cases.” There was “nearly a fivefold increased odds of surgical site infection or any infectious complication when no antibiotics were given,” after controlling for infection risk factors, including smoking and diabetes, said investigator Nisse V. Clark, MD, a minimally invasive gynecologic surgeon affiliated with Massachusetts General Hospital.

There are no perioperative antibiotic guidelines for myomectomies; maybe there should be. Almost 94% of the women in the review did receive antibiotics at the Harvard-affiliated hospitals, but the nationwide average has been pegged at about two-thirds, she said at the meeting, sponsored by the American Association of Gynecologic Laparoscopists.

The antibiotic cases usually received a cephalosporin before surgery, and were about evenly about evenly split between abdominal, robotic, and laparoscopic approaches.

About one-third of the 90 women (6.3%) who did not get antibiotics had hysteroscopic procedures in which antibiotics usually are not given because the peritoneal cavity is not breeched. Most of the rest, however, were laparoscopic cases. It’s unknown why they weren’t given antibiotics. In her own practice, Dr. Clark said preop antibiotics are the rule for laparoscopic myomectomies.

The surgical site infection difference was driven largely by higher incidences of pelvic abscesses and other organ space infections in the no-antibiotic group.

The only significant demographic difference between the two groups was that women who received antibiotics were slightly younger (mean 38 versus 39.7 years). Antibiotic cases were in the hospital a mean of 1 day, compared with 0.2 days in the no-antibiotic group.

In addition to diabetes and smoking, the team adjusted for age, surgery route, body mass index, uterine entry, intraoperative complications, and myoma weight in their multivariate analysis. Still, women in the no-antibiotic group were 4.59 times more likely to have a surgical site infection, 4.76 more likely to have any infectious complication, and almost 8 times more likely to have a major infectious complication. All of the findings were statistically significant.

The study had no industry funding, and Dr. Clark had no disclosures.

aotto@mdedge.com

Photo courtesy of Amgen

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended expanding marketing authorization for blinatumomab (Blincyto) to include treatment of minimal residual disease (MRD).

The CHMP has recommended approval for blinatumomab as monotherapy for adults with Philadelphia chromosome-negative, CD19-positive, B-cell precursor acute lymphoblastic leukemia (BCP-ALL) in first or second complete remission with MRD greater than or equal to 0.1%.

The CHMP had originally adopted a negative opinion on extending the use of blinatumomab to these patients. However, the committee re-examined its opinion and reversed that decision.

The CHMP has requested that Amgen, the company developing blinatumomab, provide results from ongoing studies to support the new approval.

The CHMP’s recommendations are reviewed by the European Commission (EC), which has the authority to approve medicines for use in the European Union, Norway, Iceland, and Liechtenstein.

The EC usually makes a decision within 67 days of CHMP recommendations.

Blinatumomab is already EC-approved as monotherapy for:

• Adults with Philadelphia chromosome-negative, CD19-positive, relapsed or refractory BCP-ALL.
• Pediatric patients age 1 year or older who have relapsed/refractory, Philadelphia chromosome-negative, CD19-positive BCP-ALL and have received at least two prior therapies or relapsed after allogeneic hematopoietic stem cell transplant.

CHMP’s reversal of opinion

In July, the CHMP recommended against approving blinatumomab to treat patients with MRD based on data from the BLAST trial. Results from this phase 2 trial were published in Blood in April.

The CHMP noted that, although blinatumomab produced MRD negativity in many patients in the BLAST trial, there is no strong evidence that this leads to improved survival.

Given the uncertainty, the CHMP was of the opinion that the benefits of blinatumomab do not outweigh its risks in MRD-positive BCP-ALL patients.

However, Amgen request a re-examination of the CHMP’s opinion, and the CHMP complied.

During the re-examination, the CHMP reviewed all the data and consulted a group of experts.

The experts concluded, and the CHMP agreed, that, although there is no strong evidence of improved survival, the available data indicate a good response to blinatumomab, with around 78% of patients becoming MRD-negative after treatment.

The CHMP also noted that MRD-positive patients have a high risk of relapse and few treatment options.

Therefore, the committee concluded that the benefits of blinatumomab outweigh its risks in this patient population.

The CHMP recommended granting the change to the marketing authorization but also requested that Amgen provide data from ongoing studies of blinatumomab in MRD-positive patients, once those data are available.

Photo courtesy of Amgen

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended expanding marketing authorization for blinatumomab (Blincyto) to include treatment of minimal residual disease (MRD).

The CHMP has recommended approval for blinatumomab as monotherapy for adults with Philadelphia chromosome-negative, CD19-positive, B-cell precursor acute lymphoblastic leukemia (BCP-ALL) in first or second complete remission with MRD greater than or equal to 0.1%.

The CHMP had originally adopted a negative opinion on extending the use of blinatumomab to these patients. However, the committee re-examined its opinion and reversed that decision.

The CHMP has requested that Amgen, the company developing blinatumomab, provide results from ongoing studies to support the new approval.

The CHMP’s recommendations are reviewed by the European Commission (EC), which has the authority to approve medicines for use in the European Union, Norway, Iceland, and Liechtenstein.

The EC usually makes a decision within 67 days of CHMP recommendations.

Blinatumomab is already EC-approved as monotherapy for:

• Adults with Philadelphia chromosome-negative, CD19-positive, relapsed or refractory BCP-ALL.
• Pediatric patients age 1 year or older who have relapsed/refractory, Philadelphia chromosome-negative, CD19-positive BCP-ALL and have received at least two prior therapies or relapsed after allogeneic hematopoietic stem cell transplant.

CHMP’s reversal of opinion

In July, the CHMP recommended against approving blinatumomab to treat patients with MRD based on data from the BLAST trial. Results from this phase 2 trial were published in Blood in April.

The CHMP noted that, although blinatumomab produced MRD negativity in many patients in the BLAST trial, there is no strong evidence that this leads to improved survival.

Given the uncertainty, the CHMP was of the opinion that the benefits of blinatumomab do not outweigh its risks in MRD-positive BCP-ALL patients.

However, Amgen request a re-examination of the CHMP’s opinion, and the CHMP complied.

During the re-examination, the CHMP reviewed all the data and consulted a group of experts.

The experts concluded, and the CHMP agreed, that, although there is no strong evidence of improved survival, the available data indicate a good response to blinatumomab, with around 78% of patients becoming MRD-negative after treatment.

The CHMP also noted that MRD-positive patients have a high risk of relapse and few treatment options.

Therefore, the committee concluded that the benefits of blinatumomab outweigh its risks in this patient population.

The CHMP recommended granting the change to the marketing authorization but also requested that Amgen provide data from ongoing studies of blinatumomab in MRD-positive patients, once those data are available.

Photo courtesy of Amgen

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended expanding marketing authorization for blinatumomab (Blincyto) to include treatment of minimal residual disease (MRD).

The CHMP has recommended approval for blinatumomab as monotherapy for adults with Philadelphia chromosome-negative, CD19-positive, B-cell precursor acute lymphoblastic leukemia (BCP-ALL) in first or second complete remission with MRD greater than or equal to 0.1%.

The CHMP had originally adopted a negative opinion on extending the use of blinatumomab to these patients. However, the committee re-examined its opinion and reversed that decision.

The CHMP has requested that Amgen, the company developing blinatumomab, provide results from ongoing studies to support the new approval.

The CHMP’s recommendations are reviewed by the European Commission (EC), which has the authority to approve medicines for use in the European Union, Norway, Iceland, and Liechtenstein.

The EC usually makes a decision within 67 days of CHMP recommendations.

Blinatumomab is already EC-approved as monotherapy for:

• Adults with Philadelphia chromosome-negative, CD19-positive, relapsed or refractory BCP-ALL.
• Pediatric patients age 1 year or older who have relapsed/refractory, Philadelphia chromosome-negative, CD19-positive BCP-ALL and have received at least two prior therapies or relapsed after allogeneic hematopoietic stem cell transplant.

CHMP’s reversal of opinion

In July, the CHMP recommended against approving blinatumomab to treat patients with MRD based on data from the BLAST trial. Results from this phase 2 trial were published in Blood in April.

The CHMP noted that, although blinatumomab produced MRD negativity in many patients in the BLAST trial, there is no strong evidence that this leads to improved survival.

Given the uncertainty, the CHMP was of the opinion that the benefits of blinatumomab do not outweigh its risks in MRD-positive BCP-ALL patients.

However, Amgen request a re-examination of the CHMP’s opinion, and the CHMP complied.

During the re-examination, the CHMP reviewed all the data and consulted a group of experts.

The experts concluded, and the CHMP agreed, that, although there is no strong evidence of improved survival, the available data indicate a good response to blinatumomab, with around 78% of patients becoming MRD-negative after treatment.

The CHMP also noted that MRD-positive patients have a high risk of relapse and few treatment options.

Therefore, the committee concluded that the benefits of blinatumomab outweigh its risks in this patient population.

The CHMP recommended granting the change to the marketing authorization but also requested that Amgen provide data from ongoing studies of blinatumomab in MRD-positive patients, once those data are available.

SEATTLE – A novel formulation of methylphenidate could provide morning relief to pediatric patients with attention-deficit/hyperactivity disorder, according to results of a pivotal phase 3 classroom trial.

In the study, delayed release/extended release methylphenidate (DR/ER MPH), when taken the night before, improved ADHD symptoms throughout a 12-hour laboratory classroom period – including in the late afternoons and early mornings.

The formulation, also known as Jornay PM, received Food and Drug Administration approval for ADHD in August for patients aged 6 and older. “For kids who have a horrendous time in the morning, getting up out of bed, and getting ready for school, they get up and they’re ready to rock and roll. [The drug] makes the mornings go better,” Ann Childress, MD, said in an interview at the annual meeting of the American Academy of Child and Adolescent Psychiatry.

In a previous phase 3 trial, DR/ER MPH proved beneficial in late afternoon and early morning symptoms in a naturalistic sample over a 3- week treatment course (J Child Adolesc Pharmacol. 2017 Aug 1;27[6]:474-82). The current work sought to show its value in a classroom setting. And in yet another earlier survey, 77% of parents rated early morning functional impairment in children with ADHD as moderate to severe (J Child Adolesc Pharmacol. 2017 Oct 1;27[8]:715-22).

“I have a lot of patients asking me when the medication is coming out, so hopefully it’ll be on the shelves in the spring,” said Dr. Childress, president of the Center for Psychiatry and Behavioral Medicine in Las Vegas.

In the current study, presented by Dr. Childress at the meeting, 117 children aged 6-12 years with ADHD and morning behavioral problems, after a 5-day washout period, were started on an evening DR/ER MPH dose of 20 mg or 40 mg. They were then seen for up to 4 more weeks, and doses optimized (maximum 100 mg/day).


Adjustments also were made in the evening dose schedule to determine an optimal dosing time, which had to range from 6:30 pm to 9:30 pm, at least 1 hour after dinner. Clinicians optimized the dose and timing to achieve maximum symptom control throughout the day (minimum 30% improvement in total symptom score from baseline), while remaining safe and well-tolerated.The participants were then randomized to maintain the current drug dose, or to switch to placebo for 1 week. The primary endpoint was the average of all post-dose SKAMP-CS (Swanson, Kotkin, Agler, M-Flynn, and Pelham combined scale) measurements, as recorded by a trained, independent observer during the 12-hour period on the last classroom day.

There was a significant improvement in the primary measure, with the treatment group averaging 14.8 on the SKAMP-CS, compared with 20.7 for the placebo group (P less than .001). The improved outcomes were steady throughout the day, failing to achieve statistical significance at 8 a.m., but achieving significance in measurements taken at 9 a.m.,10 a.m., 12 p.m., 2 pm, 4 p.m., 6 p.m., and 7 p.m.

The formulation also achieved significant difference in morning and late afternoon measurements of the Parent Rating of Evening and Morning Behavior Scale, Revised (PREMB-R AM and PREMB-R PM). The treatment group scored a mean of 0.9 on PREMB-R AM, compared with 2.7 for placebo (P less than .001), and 6.1 vs. 9.3 in the PREMB-R PM scale (P = .003).

Most treatment emergent adverse events were considered mild or moderate, and occurred in 36.9% of the treatment group and 40.7% of placebo subjects.

The study was funded by Ironshore Pharmaceuticals, which said in a press statement that it plans to launch the drug early next year. In addition to Ironshore, Dr. Childress has served on the advisory board for, consulted for, or received research support from Aevi Genomic Medicine, Akili Interactive, Alcobra, Arbor Pharmaceuticals, Eli Lilly, Forest Laboratories, Lundbeck, KemPharm, Neos Therapeutics, Noven Pharmaceuticals, Otsuka America Pharmaceutical, Pearson, Pfizer, Purdue Pharma, Rhodes Pharmaceuticals, Shire, Sunovion, and Tris Pharma.

SEATTLE – A novel formulation of methylphenidate could provide morning relief to pediatric patients with attention-deficit/hyperactivity disorder, according to results of a pivotal phase 3 classroom trial.

In the study, delayed release/extended release methylphenidate (DR/ER MPH), when taken the night before, improved ADHD symptoms throughout a 12-hour laboratory classroom period – including in the late afternoons and early mornings.

The formulation, also known as Jornay PM, received Food and Drug Administration approval for ADHD in August for patients aged 6 and older. “For kids who have a horrendous time in the morning, getting up out of bed, and getting ready for school, they get up and they’re ready to rock and roll. [The drug] makes the mornings go better,” Ann Childress, MD, said in an interview at the annual meeting of the American Academy of Child and Adolescent Psychiatry.

In a previous phase 3 trial, DR/ER MPH proved beneficial in late afternoon and early morning symptoms in a naturalistic sample over a 3- week treatment course (J Child Adolesc Pharmacol. 2017 Aug 1;27[6]:474-82). The current work sought to show its value in a classroom setting. And in yet another earlier survey, 77% of parents rated early morning functional impairment in children with ADHD as moderate to severe (J Child Adolesc Pharmacol. 2017 Oct 1;27[8]:715-22).

“I have a lot of patients asking me when the medication is coming out, so hopefully it’ll be on the shelves in the spring,” said Dr. Childress, president of the Center for Psychiatry and Behavioral Medicine in Las Vegas.

In the current study, presented by Dr. Childress at the meeting, 117 children aged 6-12 years with ADHD and morning behavioral problems, after a 5-day washout period, were started on an evening DR/ER MPH dose of 20 mg or 40 mg. They were then seen for up to 4 more weeks, and doses optimized (maximum 100 mg/day).


Adjustments also were made in the evening dose schedule to determine an optimal dosing time, which had to range from 6:30 pm to 9:30 pm, at least 1 hour after dinner. Clinicians optimized the dose and timing to achieve maximum symptom control throughout the day (minimum 30% improvement in total symptom score from baseline), while remaining safe and well-tolerated.The participants were then randomized to maintain the current drug dose, or to switch to placebo for 1 week. The primary endpoint was the average of all post-dose SKAMP-CS (Swanson, Kotkin, Agler, M-Flynn, and Pelham combined scale) measurements, as recorded by a trained, independent observer during the 12-hour period on the last classroom day.

There was a significant improvement in the primary measure, with the treatment group averaging 14.8 on the SKAMP-CS, compared with 20.7 for the placebo group (P less than .001). The improved outcomes were steady throughout the day, failing to achieve statistical significance at 8 a.m., but achieving significance in measurements taken at 9 a.m.,10 a.m., 12 p.m., 2 pm, 4 p.m., 6 p.m., and 7 p.m.

The formulation also achieved significant difference in morning and late afternoon measurements of the Parent Rating of Evening and Morning Behavior Scale, Revised (PREMB-R AM and PREMB-R PM). The treatment group scored a mean of 0.9 on PREMB-R AM, compared with 2.7 for placebo (P less than .001), and 6.1 vs. 9.3 in the PREMB-R PM scale (P = .003).

Most treatment emergent adverse events were considered mild or moderate, and occurred in 36.9% of the treatment group and 40.7% of placebo subjects.

The study was funded by Ironshore Pharmaceuticals, which said in a press statement that it plans to launch the drug early next year. In addition to Ironshore, Dr. Childress has served on the advisory board for, consulted for, or received research support from Aevi Genomic Medicine, Akili Interactive, Alcobra, Arbor Pharmaceuticals, Eli Lilly, Forest Laboratories, Lundbeck, KemPharm, Neos Therapeutics, Noven Pharmaceuticals, Otsuka America Pharmaceutical, Pearson, Pfizer, Purdue Pharma, Rhodes Pharmaceuticals, Shire, Sunovion, and Tris Pharma.

SEATTLE – A novel formulation of methylphenidate could provide morning relief to pediatric patients with attention-deficit/hyperactivity disorder, according to results of a pivotal phase 3 classroom trial.

In the study, delayed release/extended release methylphenidate (DR/ER MPH), when taken the night before, improved ADHD symptoms throughout a 12-hour laboratory classroom period – including in the late afternoons and early mornings.

The formulation, also known as Jornay PM, received Food and Drug Administration approval for ADHD in August for patients aged 6 and older. “For kids who have a horrendous time in the morning, getting up out of bed, and getting ready for school, they get up and they’re ready to rock and roll. [The drug] makes the mornings go better,” Ann Childress, MD, said in an interview at the annual meeting of the American Academy of Child and Adolescent Psychiatry.

In a previous phase 3 trial, DR/ER MPH proved beneficial in late afternoon and early morning symptoms in a naturalistic sample over a 3- week treatment course (J Child Adolesc Pharmacol. 2017 Aug 1;27[6]:474-82). The current work sought to show its value in a classroom setting. And in yet another earlier survey, 77% of parents rated early morning functional impairment in children with ADHD as moderate to severe (J Child Adolesc Pharmacol. 2017 Oct 1;27[8]:715-22).

“I have a lot of patients asking me when the medication is coming out, so hopefully it’ll be on the shelves in the spring,” said Dr. Childress, president of the Center for Psychiatry and Behavioral Medicine in Las Vegas.

In the current study, presented by Dr. Childress at the meeting, 117 children aged 6-12 years with ADHD and morning behavioral problems, after a 5-day washout period, were started on an evening DR/ER MPH dose of 20 mg or 40 mg. They were then seen for up to 4 more weeks, and doses optimized (maximum 100 mg/day).


Adjustments also were made in the evening dose schedule to determine an optimal dosing time, which had to range from 6:30 pm to 9:30 pm, at least 1 hour after dinner. Clinicians optimized the dose and timing to achieve maximum symptom control throughout the day (minimum 30% improvement in total symptom score from baseline), while remaining safe and well-tolerated.The participants were then randomized to maintain the current drug dose, or to switch to placebo for 1 week. The primary endpoint was the average of all post-dose SKAMP-CS (Swanson, Kotkin, Agler, M-Flynn, and Pelham combined scale) measurements, as recorded by a trained, independent observer during the 12-hour period on the last classroom day.

There was a significant improvement in the primary measure, with the treatment group averaging 14.8 on the SKAMP-CS, compared with 20.7 for the placebo group (P less than .001). The improved outcomes were steady throughout the day, failing to achieve statistical significance at 8 a.m., but achieving significance in measurements taken at 9 a.m.,10 a.m., 12 p.m., 2 pm, 4 p.m., 6 p.m., and 7 p.m.

The formulation also achieved significant difference in morning and late afternoon measurements of the Parent Rating of Evening and Morning Behavior Scale, Revised (PREMB-R AM and PREMB-R PM). The treatment group scored a mean of 0.9 on PREMB-R AM, compared with 2.7 for placebo (P less than .001), and 6.1 vs. 9.3 in the PREMB-R PM scale (P = .003).

Most treatment emergent adverse events were considered mild or moderate, and occurred in 36.9% of the treatment group and 40.7% of placebo subjects.

The study was funded by Ironshore Pharmaceuticals, which said in a press statement that it plans to launch the drug early next year. In addition to Ironshore, Dr. Childress has served on the advisory board for, consulted for, or received research support from Aevi Genomic Medicine, Akili Interactive, Alcobra, Arbor Pharmaceuticals, Eli Lilly, Forest Laboratories, Lundbeck, KemPharm, Neos Therapeutics, Noven Pharmaceuticals, Otsuka America Pharmaceutical, Pearson, Pfizer, Purdue Pharma, Rhodes Pharmaceuticals, Shire, Sunovion, and Tris Pharma.

Risk stratification tools that omit lumbar puncture accurately classified most well-appearing febrile infants with invasive bacterial infections as being at low risk, results of a recent study show.

The modified Philadelphia criteria were highly sensitive for risk stratifying febrile infants, in a recent validation study based on a large, multicenter sample, investigators report. No infants with bacterial meningitis were classified as low risk using the modified criteria, which do not include routine testing of cerebrospinal fluid (CSF). Two infants with bacterial meningitis, both younger than 28 days old, were classified as low risk using the Rochester criteria, which also avoid routine lumbar puncture, investigators reported.

“Our findings support the use of the modified Philadelphia criteria without routine CSF testing for febrile infants in the second month of life,” the investigators said in their report, published in Pediatrics.

However, to confirm the safety of omitting CSF testing in low-risk febrile infants older than 28 days, a prospective study will be needed, cautioned the researchers, led by Paul L. Aronson, MD, of the department of pediatrics at Yale University in New Haven, Conn.

Nevertheless, some clinicians do not automatically perform CSF testing in infants older than 28 days because of the rarity of bacterial meningitis in that age group, they said in the report.

The study by Dr. Aronson and colleagues was based on data for infants younger than 60 days of age seen in the emergency departments of 9 hospitals between July 2011 and June 2016. The final sample included 135 infants with invasive bacterial infections, including 118 who had bacteremia without meningitis and 17 who had bacterial meningitis, along with 249 matched febrile infant controls.

A total of 25 infants with invasive bacterial infections were classified as low risk by the Rochester criteria, and 11 of those were low risk by the modified Philadelphia criteria, investigators said.

Compared with the modified Philadelphia criteria, the Rochester criteria had a lower sensitivity (81.5% vs. 91.9%; P = 0.01) and a higher specificity (59.8 vs. 34.5%; P less than 0.001).

Out of the 11 infants deemed low risk per the modified Philadelphia criteria, none were diagnosed with bacterial meningitis. By contrast, 2 of the 25 infants who were low risk per the Rochester criteria had bacterial meningitis, and both were younger than or equal to 28 days of age. “Both of these infants would have been classified as high risk per the modified Philadelphia criteria,” Dr. Aronson and his coauthors said.

Based on the findings of this study, caution should be exercised in applying low-risk criteria to infants 28 days of age or younger, according to the investigators.

“Febrile infants discharged from the emergency department without CSF testing should have close outpatient follow-up,” they wrote.

Dr. Aronson and his coauthors reported that they had no relevant disclosures. One coauthor reported serving as an expert witness in malpractice cases involving evaluation of febrile children.

SOURCE: Aronson PL et al. Pediatrics. 13 Nov 2018. doi: 10.1542/peds.2018-1879).

Risk stratification tools that omit lumbar puncture accurately classified most well-appearing febrile infants with invasive bacterial infections as being at low risk, results of a recent study show.

The modified Philadelphia criteria were highly sensitive for risk stratifying febrile infants, in a recent validation study based on a large, multicenter sample, investigators report. No infants with bacterial meningitis were classified as low risk using the modified criteria, which do not include routine testing of cerebrospinal fluid (CSF). Two infants with bacterial meningitis, both younger than 28 days old, were classified as low risk using the Rochester criteria, which also avoid routine lumbar puncture, investigators reported.

“Our findings support the use of the modified Philadelphia criteria without routine CSF testing for febrile infants in the second month of life,” the investigators said in their report, published in Pediatrics.

However, to confirm the safety of omitting CSF testing in low-risk febrile infants older than 28 days, a prospective study will be needed, cautioned the researchers, led by Paul L. Aronson, MD, of the department of pediatrics at Yale University in New Haven, Conn.

Nevertheless, some clinicians do not automatically perform CSF testing in infants older than 28 days because of the rarity of bacterial meningitis in that age group, they said in the report.

The study by Dr. Aronson and colleagues was based on data for infants younger than 60 days of age seen in the emergency departments of 9 hospitals between July 2011 and June 2016. The final sample included 135 infants with invasive bacterial infections, including 118 who had bacteremia without meningitis and 17 who had bacterial meningitis, along with 249 matched febrile infant controls.

A total of 25 infants with invasive bacterial infections were classified as low risk by the Rochester criteria, and 11 of those were low risk by the modified Philadelphia criteria, investigators said.

Compared with the modified Philadelphia criteria, the Rochester criteria had a lower sensitivity (81.5% vs. 91.9%; P = 0.01) and a higher specificity (59.8 vs. 34.5%; P less than 0.001).

Out of the 11 infants deemed low risk per the modified Philadelphia criteria, none were diagnosed with bacterial meningitis. By contrast, 2 of the 25 infants who were low risk per the Rochester criteria had bacterial meningitis, and both were younger than or equal to 28 days of age. “Both of these infants would have been classified as high risk per the modified Philadelphia criteria,” Dr. Aronson and his coauthors said.

Based on the findings of this study, caution should be exercised in applying low-risk criteria to infants 28 days of age or younger, according to the investigators.

“Febrile infants discharged from the emergency department without CSF testing should have close outpatient follow-up,” they wrote.

Dr. Aronson and his coauthors reported that they had no relevant disclosures. One coauthor reported serving as an expert witness in malpractice cases involving evaluation of febrile children.

SOURCE: Aronson PL et al. Pediatrics. 13 Nov 2018. doi: 10.1542/peds.2018-1879).

Risk stratification tools that omit lumbar puncture accurately classified most well-appearing febrile infants with invasive bacterial infections as being at low risk, results of a recent study show.

The modified Philadelphia criteria were highly sensitive for risk stratifying febrile infants, in a recent validation study based on a large, multicenter sample, investigators report. No infants with bacterial meningitis were classified as low risk using the modified criteria, which do not include routine testing of cerebrospinal fluid (CSF). Two infants with bacterial meningitis, both younger than 28 days old, were classified as low risk using the Rochester criteria, which also avoid routine lumbar puncture, investigators reported.

“Our findings support the use of the modified Philadelphia criteria without routine CSF testing for febrile infants in the second month of life,” the investigators said in their report, published in Pediatrics.

However, to confirm the safety of omitting CSF testing in low-risk febrile infants older than 28 days, a prospective study will be needed, cautioned the researchers, led by Paul L. Aronson, MD, of the department of pediatrics at Yale University in New Haven, Conn.

Nevertheless, some clinicians do not automatically perform CSF testing in infants older than 28 days because of the rarity of bacterial meningitis in that age group, they said in the report.

The study by Dr. Aronson and colleagues was based on data for infants younger than 60 days of age seen in the emergency departments of 9 hospitals between July 2011 and June 2016. The final sample included 135 infants with invasive bacterial infections, including 118 who had bacteremia without meningitis and 17 who had bacterial meningitis, along with 249 matched febrile infant controls.

A total of 25 infants with invasive bacterial infections were classified as low risk by the Rochester criteria, and 11 of those were low risk by the modified Philadelphia criteria, investigators said.

Compared with the modified Philadelphia criteria, the Rochester criteria had a lower sensitivity (81.5% vs. 91.9%; P = 0.01) and a higher specificity (59.8 vs. 34.5%; P less than 0.001).

Out of the 11 infants deemed low risk per the modified Philadelphia criteria, none were diagnosed with bacterial meningitis. By contrast, 2 of the 25 infants who were low risk per the Rochester criteria had bacterial meningitis, and both were younger than or equal to 28 days of age. “Both of these infants would have been classified as high risk per the modified Philadelphia criteria,” Dr. Aronson and his coauthors said.

Based on the findings of this study, caution should be exercised in applying low-risk criteria to infants 28 days of age or younger, according to the investigators.

“Febrile infants discharged from the emergency department without CSF testing should have close outpatient follow-up,” they wrote.

Dr. Aronson and his coauthors reported that they had no relevant disclosures. One coauthor reported serving as an expert witness in malpractice cases involving evaluation of febrile children.

SOURCE: Aronson PL et al. Pediatrics. 13 Nov 2018. doi: 10.1542/peds.2018-1879).