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Apremilast may have some cardiometabolic benefits in patients with psoriasis
The trial, led by Joel M. Gelfand, MD, MSCE, professor of dermatology and epidemiology and vice chair of clinical research in dermatology at the University of Pennsylvania, Philadelphia, found that apremilast (Otezla) has a neutral effect on aortic vascular inflammation in patients with moderate to severe psoriasis.
It also had variable, but generally favorable, associations with 68 cardiometabolic biomarkers tested and associations with reductions in both visceral and subcutaneous fat. Findings of the study were published online in JAMA Dermatology.
Fat reductions maintained at 1-year mark
The researchers found a 5%-6% reduction in subcutaneous and visceral fat at week 16 of the study that was maintained at the 1-year mark. “The fact that it was rock stable a year later is pretty encouraging,” Dr. Gelfand told this news organization.
As for effects on vascular inflammation, Dr. Gelfand said, “The good news is we didn’t find any adverse effects on aortic vascular inflammation, but we didn’t find any beneficial effects either. That was a little disappointing.
“The most surprising thing was really the effects on visceral adiposity,” he added. “I’m not aware of any other drug having demonstrated that effect.”
Michael S. Garshick, MD, a cardiologist with NYU Langone Health in New York, who was not involved with the trial, told this news organization that despite seemingly good epidemiologic evidence in observational studies that by treating psoriasis surrogates of cardiovascular risk can be reduced, this trial, like others before it, failed to reduce aortic vascular inflammation.
The trial does help answer the question of whether apremilast can induce weight loss, he said, something that earlier trials suggested. “This trial confirms that, which is exciting,” he said. The reduction in both visceral and subcutaneous fat “deserves a lot further study.”
Several questions remain, Dr. Garshick said. Both he and Dr. Gelfand pointed to the need for large, placebo-controlled trials. “We still don’t know which medications may be preferrable in psoriasis to reduce [cardiovascular] risk if any at all,” Dr. Garshick said.
Seventy patients enrolled
In total, 70 patients with moderate to severe psoriasis were enrolled, 60 completed week 16, and 39 completed week 52 of the single-arm, open-label trial conducted between April 2017 and August 2021 at seven dermatology sites in the United States.
Participants took 30 mg of apremilast, an oral phosphodiesterase-4 (PDE-4) inhibitor approved for treating psoriasis and psoriatic arthritis, twice daily. Participants’ average age was 47.5 years; most were male (77.1%) and White (82.9%); almost 6% were Black. Average body mass index was 30 kg/m2. Patients could not have received biologics within 90 days of study baseline (or 180 days for ustekinumab [Stelara]).
There was no change in aortic vascular inflammation at week 16 (target to background ratio, −0.02; 95% confidence interval [CI], −0.08 to 0.05; P = .61) or week 52 (target to background ratio, −0.07; 95% CI, −0.15 to 0.01; P = .09) compared with baseline.
“At week 16, there were reductions in levels of interleukin-1b, fetuin A, valine, leucine, and isoleucine,” the authors wrote, adding that at week 52, compared with baseline, “there were reductions in levels of ferritin, cholesterol efflux capacity, beta-hydroxybutyrate, acetone, and ketone bodies, and an increase in levels of apolipoprotein A-1.”
This study highlights the importance of screening, Dr. Garshick said.
He and Dr. Gelfand said people with psoriatic disease tend to be vastly underscreened for cardiovascular risk factors.
Dr. Gelfand said, “If we did what we knew worked – meaning we screened them for diabetes, we screen their cholesterol, we check their blood pressure, and we adequately treated those traditional cardiovascular risk factors, we probably could narrow the gap quite a bit” in terms of the lower life expectancy people face when they have more significant psoriasis.
Celgene was the initial funding sponsor; sponsorship was then transferred to Amgen. The authors designed, executed, analyzed, and reported the study. Celgene provided nonbinding input into study design, and Amgen provided nonbinding input into the reporting of results. Dr. Gelfand reported numerous disclosures with various pharmaceutical companies and organizations. Dr. Garshick reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The trial, led by Joel M. Gelfand, MD, MSCE, professor of dermatology and epidemiology and vice chair of clinical research in dermatology at the University of Pennsylvania, Philadelphia, found that apremilast (Otezla) has a neutral effect on aortic vascular inflammation in patients with moderate to severe psoriasis.
It also had variable, but generally favorable, associations with 68 cardiometabolic biomarkers tested and associations with reductions in both visceral and subcutaneous fat. Findings of the study were published online in JAMA Dermatology.
Fat reductions maintained at 1-year mark
The researchers found a 5%-6% reduction in subcutaneous and visceral fat at week 16 of the study that was maintained at the 1-year mark. “The fact that it was rock stable a year later is pretty encouraging,” Dr. Gelfand told this news organization.
As for effects on vascular inflammation, Dr. Gelfand said, “The good news is we didn’t find any adverse effects on aortic vascular inflammation, but we didn’t find any beneficial effects either. That was a little disappointing.
“The most surprising thing was really the effects on visceral adiposity,” he added. “I’m not aware of any other drug having demonstrated that effect.”
Michael S. Garshick, MD, a cardiologist with NYU Langone Health in New York, who was not involved with the trial, told this news organization that despite seemingly good epidemiologic evidence in observational studies that by treating psoriasis surrogates of cardiovascular risk can be reduced, this trial, like others before it, failed to reduce aortic vascular inflammation.
The trial does help answer the question of whether apremilast can induce weight loss, he said, something that earlier trials suggested. “This trial confirms that, which is exciting,” he said. The reduction in both visceral and subcutaneous fat “deserves a lot further study.”
Several questions remain, Dr. Garshick said. Both he and Dr. Gelfand pointed to the need for large, placebo-controlled trials. “We still don’t know which medications may be preferrable in psoriasis to reduce [cardiovascular] risk if any at all,” Dr. Garshick said.
Seventy patients enrolled
In total, 70 patients with moderate to severe psoriasis were enrolled, 60 completed week 16, and 39 completed week 52 of the single-arm, open-label trial conducted between April 2017 and August 2021 at seven dermatology sites in the United States.
Participants took 30 mg of apremilast, an oral phosphodiesterase-4 (PDE-4) inhibitor approved for treating psoriasis and psoriatic arthritis, twice daily. Participants’ average age was 47.5 years; most were male (77.1%) and White (82.9%); almost 6% were Black. Average body mass index was 30 kg/m2. Patients could not have received biologics within 90 days of study baseline (or 180 days for ustekinumab [Stelara]).
There was no change in aortic vascular inflammation at week 16 (target to background ratio, −0.02; 95% confidence interval [CI], −0.08 to 0.05; P = .61) or week 52 (target to background ratio, −0.07; 95% CI, −0.15 to 0.01; P = .09) compared with baseline.
“At week 16, there were reductions in levels of interleukin-1b, fetuin A, valine, leucine, and isoleucine,” the authors wrote, adding that at week 52, compared with baseline, “there were reductions in levels of ferritin, cholesterol efflux capacity, beta-hydroxybutyrate, acetone, and ketone bodies, and an increase in levels of apolipoprotein A-1.”
This study highlights the importance of screening, Dr. Garshick said.
He and Dr. Gelfand said people with psoriatic disease tend to be vastly underscreened for cardiovascular risk factors.
Dr. Gelfand said, “If we did what we knew worked – meaning we screened them for diabetes, we screen their cholesterol, we check their blood pressure, and we adequately treated those traditional cardiovascular risk factors, we probably could narrow the gap quite a bit” in terms of the lower life expectancy people face when they have more significant psoriasis.
Celgene was the initial funding sponsor; sponsorship was then transferred to Amgen. The authors designed, executed, analyzed, and reported the study. Celgene provided nonbinding input into study design, and Amgen provided nonbinding input into the reporting of results. Dr. Gelfand reported numerous disclosures with various pharmaceutical companies and organizations. Dr. Garshick reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The trial, led by Joel M. Gelfand, MD, MSCE, professor of dermatology and epidemiology and vice chair of clinical research in dermatology at the University of Pennsylvania, Philadelphia, found that apremilast (Otezla) has a neutral effect on aortic vascular inflammation in patients with moderate to severe psoriasis.
It also had variable, but generally favorable, associations with 68 cardiometabolic biomarkers tested and associations with reductions in both visceral and subcutaneous fat. Findings of the study were published online in JAMA Dermatology.
Fat reductions maintained at 1-year mark
The researchers found a 5%-6% reduction in subcutaneous and visceral fat at week 16 of the study that was maintained at the 1-year mark. “The fact that it was rock stable a year later is pretty encouraging,” Dr. Gelfand told this news organization.
As for effects on vascular inflammation, Dr. Gelfand said, “The good news is we didn’t find any adverse effects on aortic vascular inflammation, but we didn’t find any beneficial effects either. That was a little disappointing.
“The most surprising thing was really the effects on visceral adiposity,” he added. “I’m not aware of any other drug having demonstrated that effect.”
Michael S. Garshick, MD, a cardiologist with NYU Langone Health in New York, who was not involved with the trial, told this news organization that despite seemingly good epidemiologic evidence in observational studies that by treating psoriasis surrogates of cardiovascular risk can be reduced, this trial, like others before it, failed to reduce aortic vascular inflammation.
The trial does help answer the question of whether apremilast can induce weight loss, he said, something that earlier trials suggested. “This trial confirms that, which is exciting,” he said. The reduction in both visceral and subcutaneous fat “deserves a lot further study.”
Several questions remain, Dr. Garshick said. Both he and Dr. Gelfand pointed to the need for large, placebo-controlled trials. “We still don’t know which medications may be preferrable in psoriasis to reduce [cardiovascular] risk if any at all,” Dr. Garshick said.
Seventy patients enrolled
In total, 70 patients with moderate to severe psoriasis were enrolled, 60 completed week 16, and 39 completed week 52 of the single-arm, open-label trial conducted between April 2017 and August 2021 at seven dermatology sites in the United States.
Participants took 30 mg of apremilast, an oral phosphodiesterase-4 (PDE-4) inhibitor approved for treating psoriasis and psoriatic arthritis, twice daily. Participants’ average age was 47.5 years; most were male (77.1%) and White (82.9%); almost 6% were Black. Average body mass index was 30 kg/m2. Patients could not have received biologics within 90 days of study baseline (or 180 days for ustekinumab [Stelara]).
There was no change in aortic vascular inflammation at week 16 (target to background ratio, −0.02; 95% confidence interval [CI], −0.08 to 0.05; P = .61) or week 52 (target to background ratio, −0.07; 95% CI, −0.15 to 0.01; P = .09) compared with baseline.
“At week 16, there were reductions in levels of interleukin-1b, fetuin A, valine, leucine, and isoleucine,” the authors wrote, adding that at week 52, compared with baseline, “there were reductions in levels of ferritin, cholesterol efflux capacity, beta-hydroxybutyrate, acetone, and ketone bodies, and an increase in levels of apolipoprotein A-1.”
This study highlights the importance of screening, Dr. Garshick said.
He and Dr. Gelfand said people with psoriatic disease tend to be vastly underscreened for cardiovascular risk factors.
Dr. Gelfand said, “If we did what we knew worked – meaning we screened them for diabetes, we screen their cholesterol, we check their blood pressure, and we adequately treated those traditional cardiovascular risk factors, we probably could narrow the gap quite a bit” in terms of the lower life expectancy people face when they have more significant psoriasis.
Celgene was the initial funding sponsor; sponsorship was then transferred to Amgen. The authors designed, executed, analyzed, and reported the study. Celgene provided nonbinding input into study design, and Amgen provided nonbinding input into the reporting of results. Dr. Gelfand reported numerous disclosures with various pharmaceutical companies and organizations. Dr. Garshick reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM JAMA DERMATOLOGY
Psoriasis, psoriatic arthritis insurance coverage remains restrictive
Insurance coverage for specialty drugs to treat psoriasis and psoriatic arthritis varies extensively among insurance companies and often restricts coverage beyond the drug labels, according to a review of data from commercial health plans in the United States.
Although specialty medications have demonstrated effectiveness for psoriasis and psoriatic arthritis, data on insurance coverage for these indications are limited and costs are often a barrier to treatment, Christine Learned, of Tufts Medical Center, Boston, and colleagues wrote.
In a study published in the Journal of Psoriasis and Psoriatic Arthritis, the researchers used the Tufts Medical Center Specialty Drug Evidence and Coverage database, which includes information on 158 specialty drugs covered by 17 U.S. commercial health plans, to review data on a total of 11 medications indicated for psoriasis (etanercept, adalimumab, certolizumab pegol, secukinumab, ixekizumab, brodalumab, ustekinumab, guselkumab, tildrakizumab, risankizumab, and apremilast) and 11 indicated for psoriatic arthritis (etanercept, adalimumab, certolizumab pegol, golimumab, secukinumab, ixekizumab, ustekinumab, guselkumab, tofacitinib, apremilast, and abatacept) at the time of the study.
Overall, an average of 78.6% and 66.8% of insurance plans were more restrictive than the Food and Drug Association label in coverage of specialty medications for psoriasis and psoriatic arthritis, respectively.
Disease severity affected insurance coverage for psoriasis. The percentage of plans with a body surface area requirement for specialty medications ranged from 11% for apremilast to 39% for tildrakizumab, adalimumab, and certolizumab pegol. The percentage of plans with exceptions for special body locations affected by psoriasis ranged from 6% for risankizumab and brodalumab to 39% for certolizumab pegol. In addition, 6% of plans had Psoriasis Area and Severity Index requirements for etanercept and ixekizumab, and 11% had PASI requirements for adalimumab, certolizumab pegol, and tildrakizumab.
The percentage of plans with prescriber restrictions for both psoriasis and psoriatic arthritis ranged from 33% to 50%.
All 11 medications for psoriatic arthritis were approved as first-line treatments by at least one plan, compared with 3 the 11 medications with indications for psoriasis. However, medications for both psoriasis and psoriatic arthritis were approved mainly as second-line therapies.
Study designs may impact insurance coverage, as randomized, controlled trials are often used as the basis for coverage decisions for psoriasis, while coverage for psoriatic arthritis is more often based on clinical guidelines, the researchers explained.
“Our analysis confirms that variability exists for the indications of psoriasis and psoriatic arthritis,” they wrote.
The comorbidities associated with psoriasis are not always considered in insurance coverage, and coverage complications may contribute to the persistent undertreatment of many patients with psoriasis, the researchers added.
“Insurance restrictions may blunt provider and patient autonomy in selection of specialty medications and have the potential to diminish a provider’s ability to tailor regimens so as to optimize outcomes while minimizing risks,” they emphasized.
The study findings were limited by the inclusion only of publicly available policy information; therefore, some plans’ restrictions may have been missed in the analysis, the researchers said.
The results suggest that patients should review their insurance coverage of specialty drugs when choosing a health plan, and clinicians should factor in a patient’s plan a likely drug access when considering treatment options, they concluded.
The study received no outside funding. Ms. Learned had no relevant financial conflicts to disclose, but two coauthors reported financial relationships with pharmaceutical companies that manufacturer drugs for psoriasis and psoriatic arthritis.
Insurance coverage for specialty drugs to treat psoriasis and psoriatic arthritis varies extensively among insurance companies and often restricts coverage beyond the drug labels, according to a review of data from commercial health plans in the United States.
Although specialty medications have demonstrated effectiveness for psoriasis and psoriatic arthritis, data on insurance coverage for these indications are limited and costs are often a barrier to treatment, Christine Learned, of Tufts Medical Center, Boston, and colleagues wrote.
In a study published in the Journal of Psoriasis and Psoriatic Arthritis, the researchers used the Tufts Medical Center Specialty Drug Evidence and Coverage database, which includes information on 158 specialty drugs covered by 17 U.S. commercial health plans, to review data on a total of 11 medications indicated for psoriasis (etanercept, adalimumab, certolizumab pegol, secukinumab, ixekizumab, brodalumab, ustekinumab, guselkumab, tildrakizumab, risankizumab, and apremilast) and 11 indicated for psoriatic arthritis (etanercept, adalimumab, certolizumab pegol, golimumab, secukinumab, ixekizumab, ustekinumab, guselkumab, tofacitinib, apremilast, and abatacept) at the time of the study.
Overall, an average of 78.6% and 66.8% of insurance plans were more restrictive than the Food and Drug Association label in coverage of specialty medications for psoriasis and psoriatic arthritis, respectively.
Disease severity affected insurance coverage for psoriasis. The percentage of plans with a body surface area requirement for specialty medications ranged from 11% for apremilast to 39% for tildrakizumab, adalimumab, and certolizumab pegol. The percentage of plans with exceptions for special body locations affected by psoriasis ranged from 6% for risankizumab and brodalumab to 39% for certolizumab pegol. In addition, 6% of plans had Psoriasis Area and Severity Index requirements for etanercept and ixekizumab, and 11% had PASI requirements for adalimumab, certolizumab pegol, and tildrakizumab.
The percentage of plans with prescriber restrictions for both psoriasis and psoriatic arthritis ranged from 33% to 50%.
All 11 medications for psoriatic arthritis were approved as first-line treatments by at least one plan, compared with 3 the 11 medications with indications for psoriasis. However, medications for both psoriasis and psoriatic arthritis were approved mainly as second-line therapies.
Study designs may impact insurance coverage, as randomized, controlled trials are often used as the basis for coverage decisions for psoriasis, while coverage for psoriatic arthritis is more often based on clinical guidelines, the researchers explained.
“Our analysis confirms that variability exists for the indications of psoriasis and psoriatic arthritis,” they wrote.
The comorbidities associated with psoriasis are not always considered in insurance coverage, and coverage complications may contribute to the persistent undertreatment of many patients with psoriasis, the researchers added.
“Insurance restrictions may blunt provider and patient autonomy in selection of specialty medications and have the potential to diminish a provider’s ability to tailor regimens so as to optimize outcomes while minimizing risks,” they emphasized.
The study findings were limited by the inclusion only of publicly available policy information; therefore, some plans’ restrictions may have been missed in the analysis, the researchers said.
The results suggest that patients should review their insurance coverage of specialty drugs when choosing a health plan, and clinicians should factor in a patient’s plan a likely drug access when considering treatment options, they concluded.
The study received no outside funding. Ms. Learned had no relevant financial conflicts to disclose, but two coauthors reported financial relationships with pharmaceutical companies that manufacturer drugs for psoriasis and psoriatic arthritis.
Insurance coverage for specialty drugs to treat psoriasis and psoriatic arthritis varies extensively among insurance companies and often restricts coverage beyond the drug labels, according to a review of data from commercial health plans in the United States.
Although specialty medications have demonstrated effectiveness for psoriasis and psoriatic arthritis, data on insurance coverage for these indications are limited and costs are often a barrier to treatment, Christine Learned, of Tufts Medical Center, Boston, and colleagues wrote.
In a study published in the Journal of Psoriasis and Psoriatic Arthritis, the researchers used the Tufts Medical Center Specialty Drug Evidence and Coverage database, which includes information on 158 specialty drugs covered by 17 U.S. commercial health plans, to review data on a total of 11 medications indicated for psoriasis (etanercept, adalimumab, certolizumab pegol, secukinumab, ixekizumab, brodalumab, ustekinumab, guselkumab, tildrakizumab, risankizumab, and apremilast) and 11 indicated for psoriatic arthritis (etanercept, adalimumab, certolizumab pegol, golimumab, secukinumab, ixekizumab, ustekinumab, guselkumab, tofacitinib, apremilast, and abatacept) at the time of the study.
Overall, an average of 78.6% and 66.8% of insurance plans were more restrictive than the Food and Drug Association label in coverage of specialty medications for psoriasis and psoriatic arthritis, respectively.
Disease severity affected insurance coverage for psoriasis. The percentage of plans with a body surface area requirement for specialty medications ranged from 11% for apremilast to 39% for tildrakizumab, adalimumab, and certolizumab pegol. The percentage of plans with exceptions for special body locations affected by psoriasis ranged from 6% for risankizumab and brodalumab to 39% for certolizumab pegol. In addition, 6% of plans had Psoriasis Area and Severity Index requirements for etanercept and ixekizumab, and 11% had PASI requirements for adalimumab, certolizumab pegol, and tildrakizumab.
The percentage of plans with prescriber restrictions for both psoriasis and psoriatic arthritis ranged from 33% to 50%.
All 11 medications for psoriatic arthritis were approved as first-line treatments by at least one plan, compared with 3 the 11 medications with indications for psoriasis. However, medications for both psoriasis and psoriatic arthritis were approved mainly as second-line therapies.
Study designs may impact insurance coverage, as randomized, controlled trials are often used as the basis for coverage decisions for psoriasis, while coverage for psoriatic arthritis is more often based on clinical guidelines, the researchers explained.
“Our analysis confirms that variability exists for the indications of psoriasis and psoriatic arthritis,” they wrote.
The comorbidities associated with psoriasis are not always considered in insurance coverage, and coverage complications may contribute to the persistent undertreatment of many patients with psoriasis, the researchers added.
“Insurance restrictions may blunt provider and patient autonomy in selection of specialty medications and have the potential to diminish a provider’s ability to tailor regimens so as to optimize outcomes while minimizing risks,” they emphasized.
The study findings were limited by the inclusion only of publicly available policy information; therefore, some plans’ restrictions may have been missed in the analysis, the researchers said.
The results suggest that patients should review their insurance coverage of specialty drugs when choosing a health plan, and clinicians should factor in a patient’s plan a likely drug access when considering treatment options, they concluded.
The study received no outside funding. Ms. Learned had no relevant financial conflicts to disclose, but two coauthors reported financial relationships with pharmaceutical companies that manufacturer drugs for psoriasis and psoriatic arthritis.
FROM THE JOURNAL OF PSORIASIS AND PSORIATIC ARTHRITIS
Apremilast alleviates severe psoriasis in some children, data show
not controlled by topical therapy, according to the results of a phase 3 trial.
“Unfortunately, there are limited treatment options for pediatric patients with moderate to severe plaque psoriasis” who do not respond to or cannot use topical therapy, said study investigator Anna Belloni Fortina, MD, speaking at the annual meeting of the European Academy of Dermatology and Venereology.
“In this randomized, placebo-controlled trial, oral apremilast demonstrated effectiveness and was well tolerated,” added Dr. Belloni Fortina, of Azienda Ospedale Università Padova (Italy). “I underline oral because for children, oral administration is better than the injection treatment.”
Key findings
Dubbed the SPROUT study, the trial set a primary endpoint of the percentage of children with a Physician’s Global Assessment (sPGA) response after 16 weeks of treatment or placebo. The sPGA is a 5-point scale ranging from 0 (clear) to 4 (severe). The study enrolled children with an sPGA greater than or equal to 3. Response was defined as a sPGA score of 0 or 1, indicating clear or almost clear skin, with at least a 2-point reduction from baseline values.
At week 16, the primary endpoint was met by 33% of 163 children treated with apremilast versus 11% of 82 children who had been given a placebo, a treatment difference of 21.7% (95% confidence interval, 11.2%-32.1%).
A greater proportion of children treated with apremilast also achieved a major secondary endpoint, a 75% or greater reduction in the Psoriasis Area and Severity Index (PASI-75) (45.4% vs. 16.1%), a treatment difference of 29.4% (95% CI, 17.8%-40.9%).
Results unaffected by weight and age
Regarding apremilast, “it’s important to underline that patients were dosed according to their weight,” Dr. Belloni Fortina said.
A dose of 20 mg twice daily was given to children who weighed between 20 kg and less than 50 kg, and a 30-mg twice-daily dose was given to those who weighed greater than or equal to 50 kg.
When the data were analyzed according to weight, proportionately more children on apremilast saw a sPGA response: 47.4% versus 21.8% in the lower weight and dose range and 19.2% versus 1.6% in the higher weight and dose range.
As for PASI-75, a greater proportion of children on apremilast also responded in both the lower and upper weight ranges, a respective 52.4% and 38.7% of patients, compared with 21.4% and 11% of those treated with placebo.
Data were also evaluated according to age, with a younger (aged 6-11 years) and older (age 12-17 years) group. The mean age of children was 12 years overall. Results showed a similar pattern for weight: The psoriasis of more children treated with apremilast was reduced by both measures, sPGA response, and PASI-75.
Safety of apremilast in children
“The overall safety profile during the placebo-controlled phase was comparable with the known safety profile of apremilast,” Dr. Belloni Fontina reported. “No new safety signals were identified.”
The rate of any adverse event was substantially higher in children given the active treatment, however, at 65% versus 41.3% for placebo.
Rates of severe and serious adverse events were low, at around 1.3%, and similar between the groups.
There was also a low rate of withdrawal because of side effects, although this was higher in the apremilast group (3.1% vs. 1.3%).
The primary reason for withdrawal of apremilast treatment were the most commonly reported adverse events: gastrointestinal disorders, including diarrhea, nausea, upper and lower abdominal pain, and vomiting. Headache, pyrexia, and nasopharyngitis were also reported.
Despite being common, most treatment-related adverse effects resolved within 3 days, Dr. Belloni Fontina said.
Expect further data
Further data from the trial are to be expected, because only the 16-week primary endpoint results have been released so far. The trial also included a 36-week extension phase, during which all children who had originally been randomly assigned to placebo were now eligible to be treated with apremilast, and all those who were originally given the active treatment were able to continue. This extension treatment period means that data will be available for a full year of treatment, and there will also be a further 2-week observational follow-up at the end of the trial.
The study was funded by Amgen. Dr. Belloni Fontina reported acting as an investigator and advisory board member for and receiving honoraria from Amgen, Galderma, Leo Pharma, and Pfizer. She also reported speaking on behalf of Pierre-Fabre and Galderma.
A version of this article first appeared on Medscape.com.
not controlled by topical therapy, according to the results of a phase 3 trial.
“Unfortunately, there are limited treatment options for pediatric patients with moderate to severe plaque psoriasis” who do not respond to or cannot use topical therapy, said study investigator Anna Belloni Fortina, MD, speaking at the annual meeting of the European Academy of Dermatology and Venereology.
“In this randomized, placebo-controlled trial, oral apremilast demonstrated effectiveness and was well tolerated,” added Dr. Belloni Fortina, of Azienda Ospedale Università Padova (Italy). “I underline oral because for children, oral administration is better than the injection treatment.”
Key findings
Dubbed the SPROUT study, the trial set a primary endpoint of the percentage of children with a Physician’s Global Assessment (sPGA) response after 16 weeks of treatment or placebo. The sPGA is a 5-point scale ranging from 0 (clear) to 4 (severe). The study enrolled children with an sPGA greater than or equal to 3. Response was defined as a sPGA score of 0 or 1, indicating clear or almost clear skin, with at least a 2-point reduction from baseline values.
At week 16, the primary endpoint was met by 33% of 163 children treated with apremilast versus 11% of 82 children who had been given a placebo, a treatment difference of 21.7% (95% confidence interval, 11.2%-32.1%).
A greater proportion of children treated with apremilast also achieved a major secondary endpoint, a 75% or greater reduction in the Psoriasis Area and Severity Index (PASI-75) (45.4% vs. 16.1%), a treatment difference of 29.4% (95% CI, 17.8%-40.9%).
Results unaffected by weight and age
Regarding apremilast, “it’s important to underline that patients were dosed according to their weight,” Dr. Belloni Fortina said.
A dose of 20 mg twice daily was given to children who weighed between 20 kg and less than 50 kg, and a 30-mg twice-daily dose was given to those who weighed greater than or equal to 50 kg.
When the data were analyzed according to weight, proportionately more children on apremilast saw a sPGA response: 47.4% versus 21.8% in the lower weight and dose range and 19.2% versus 1.6% in the higher weight and dose range.
As for PASI-75, a greater proportion of children on apremilast also responded in both the lower and upper weight ranges, a respective 52.4% and 38.7% of patients, compared with 21.4% and 11% of those treated with placebo.
Data were also evaluated according to age, with a younger (aged 6-11 years) and older (age 12-17 years) group. The mean age of children was 12 years overall. Results showed a similar pattern for weight: The psoriasis of more children treated with apremilast was reduced by both measures, sPGA response, and PASI-75.
Safety of apremilast in children
“The overall safety profile during the placebo-controlled phase was comparable with the known safety profile of apremilast,” Dr. Belloni Fontina reported. “No new safety signals were identified.”
The rate of any adverse event was substantially higher in children given the active treatment, however, at 65% versus 41.3% for placebo.
Rates of severe and serious adverse events were low, at around 1.3%, and similar between the groups.
There was also a low rate of withdrawal because of side effects, although this was higher in the apremilast group (3.1% vs. 1.3%).
The primary reason for withdrawal of apremilast treatment were the most commonly reported adverse events: gastrointestinal disorders, including diarrhea, nausea, upper and lower abdominal pain, and vomiting. Headache, pyrexia, and nasopharyngitis were also reported.
Despite being common, most treatment-related adverse effects resolved within 3 days, Dr. Belloni Fontina said.
Expect further data
Further data from the trial are to be expected, because only the 16-week primary endpoint results have been released so far. The trial also included a 36-week extension phase, during which all children who had originally been randomly assigned to placebo were now eligible to be treated with apremilast, and all those who were originally given the active treatment were able to continue. This extension treatment period means that data will be available for a full year of treatment, and there will also be a further 2-week observational follow-up at the end of the trial.
The study was funded by Amgen. Dr. Belloni Fontina reported acting as an investigator and advisory board member for and receiving honoraria from Amgen, Galderma, Leo Pharma, and Pfizer. She also reported speaking on behalf of Pierre-Fabre and Galderma.
A version of this article first appeared on Medscape.com.
not controlled by topical therapy, according to the results of a phase 3 trial.
“Unfortunately, there are limited treatment options for pediatric patients with moderate to severe plaque psoriasis” who do not respond to or cannot use topical therapy, said study investigator Anna Belloni Fortina, MD, speaking at the annual meeting of the European Academy of Dermatology and Venereology.
“In this randomized, placebo-controlled trial, oral apremilast demonstrated effectiveness and was well tolerated,” added Dr. Belloni Fortina, of Azienda Ospedale Università Padova (Italy). “I underline oral because for children, oral administration is better than the injection treatment.”
Key findings
Dubbed the SPROUT study, the trial set a primary endpoint of the percentage of children with a Physician’s Global Assessment (sPGA) response after 16 weeks of treatment or placebo. The sPGA is a 5-point scale ranging from 0 (clear) to 4 (severe). The study enrolled children with an sPGA greater than or equal to 3. Response was defined as a sPGA score of 0 or 1, indicating clear or almost clear skin, with at least a 2-point reduction from baseline values.
At week 16, the primary endpoint was met by 33% of 163 children treated with apremilast versus 11% of 82 children who had been given a placebo, a treatment difference of 21.7% (95% confidence interval, 11.2%-32.1%).
A greater proportion of children treated with apremilast also achieved a major secondary endpoint, a 75% or greater reduction in the Psoriasis Area and Severity Index (PASI-75) (45.4% vs. 16.1%), a treatment difference of 29.4% (95% CI, 17.8%-40.9%).
Results unaffected by weight and age
Regarding apremilast, “it’s important to underline that patients were dosed according to their weight,” Dr. Belloni Fortina said.
A dose of 20 mg twice daily was given to children who weighed between 20 kg and less than 50 kg, and a 30-mg twice-daily dose was given to those who weighed greater than or equal to 50 kg.
When the data were analyzed according to weight, proportionately more children on apremilast saw a sPGA response: 47.4% versus 21.8% in the lower weight and dose range and 19.2% versus 1.6% in the higher weight and dose range.
As for PASI-75, a greater proportion of children on apremilast also responded in both the lower and upper weight ranges, a respective 52.4% and 38.7% of patients, compared with 21.4% and 11% of those treated with placebo.
Data were also evaluated according to age, with a younger (aged 6-11 years) and older (age 12-17 years) group. The mean age of children was 12 years overall. Results showed a similar pattern for weight: The psoriasis of more children treated with apremilast was reduced by both measures, sPGA response, and PASI-75.
Safety of apremilast in children
“The overall safety profile during the placebo-controlled phase was comparable with the known safety profile of apremilast,” Dr. Belloni Fontina reported. “No new safety signals were identified.”
The rate of any adverse event was substantially higher in children given the active treatment, however, at 65% versus 41.3% for placebo.
Rates of severe and serious adverse events were low, at around 1.3%, and similar between the groups.
There was also a low rate of withdrawal because of side effects, although this was higher in the apremilast group (3.1% vs. 1.3%).
The primary reason for withdrawal of apremilast treatment were the most commonly reported adverse events: gastrointestinal disorders, including diarrhea, nausea, upper and lower abdominal pain, and vomiting. Headache, pyrexia, and nasopharyngitis were also reported.
Despite being common, most treatment-related adverse effects resolved within 3 days, Dr. Belloni Fontina said.
Expect further data
Further data from the trial are to be expected, because only the 16-week primary endpoint results have been released so far. The trial also included a 36-week extension phase, during which all children who had originally been randomly assigned to placebo were now eligible to be treated with apremilast, and all those who were originally given the active treatment were able to continue. This extension treatment period means that data will be available for a full year of treatment, and there will also be a further 2-week observational follow-up at the end of the trial.
The study was funded by Amgen. Dr. Belloni Fontina reported acting as an investigator and advisory board member for and receiving honoraria from Amgen, Galderma, Leo Pharma, and Pfizer. She also reported speaking on behalf of Pierre-Fabre and Galderma.
A version of this article first appeared on Medscape.com.
FROM EADV 2022
Brodalumab suicide risk similar to other biologics, postmarket study finds
.
The Food and Drug Administration approved brodalumab (Siliq) in 2017 for treatment of moderate to severe plaque psoriasis with a boxed warning for suicidal ideation and behavior and an associated Risk Evaluation and Mitigation Strategies (REMS) program indicating an increased risk of suicidality.
Half a decade later, “the available worldwide data do not support the notion that brodalumab has a unique risk of increased suicides,” senior investigator John Koo, MD, and coinvestigators at the University of California, San Francisco, wrote in a preproof article in JAAD International, noting that postmarketing data are “often considered a better reflection of real-world outcomes than clinical trials.”
The researchers extracted data through the end of 2021 on the number of completed suicides for brodalumab and ten other biologics approved for psoriasis from the FDA’s Adverse Events Reporting System (FAERS), an international publicly available database. The researchers included suicide data on the biologics for all indications.
The authors contacted pharmaceutical companies to determine the total number of patients prescribed each drug, securing mostly “best estimates” data on 5 of the 11 biologics available for psoriasis. The researchers then calculated the number of completed suicides per total number of prescribed patients.
For brodalumab, across 20,871 total prescriptions, there was only one verifiable suicide. It occurred in a Japanese man with terminal cancer and no nearby relatives 36 days after his first dose. The suicide rate for brodalumab was similar to that of ixekizumab, secukinumab, infliximab, and adalimumab.
“Brodalumab is a very efficacious agent and may have the fastest onset of action, yet its usage is minimal compared to the other agents because of this ‘black box’ warning ... despite the fact that it’s the least expensive of any biologic,” Dr. Koo, professor of dermatology and director of the Psoriasis and Skin Treatment Center, University of California, San Francisco, said in an interview.
Dr. Koo, who is board-certified in both dermatology and psychiatry, said he believes the boxed warning was never warranted. All three of the verified completed suicides that occurred during clinical trials of brodalumab for psoriasis were in people who had underlying psychiatric disorders or significant stressors, such as going to jail in one case, and depression and significant isolation in another, he said.
(An analysis of psychiatric adverse events during the psoriasis clinical trials, involving more than 4,000 patients, was published online Oct. 4, 2017, in the Journal of the American Academy of Dermatology.
George Han, MD, PhD, associate professor and director of research and teledermatology at the Zucker School of Medicine at Hofstra/Northwell, New Hyde Park, N.Y., who was not involved in the research, said the new data is reassuring.
“We sometimes put it into context [in thinking and counseling about risk] that in the trials for brodalumab, the number of suicide attempts [versus completed suicides] was not an outlier,” he said. “But it’s hard to know what to make of that, so this piece of knowledge that the postmarketing data show there’s no safety signal should give people a lot of reassurance.”
Dr. Han said he has used the medication, a fully human anti-interleukin 17 receptor A monoclonal antibody, in many patients who “have not done so well on other biologics and it’s been a lifesaver ... a couple who have switched over have maintained the longest level of clearance they’ve had with anything. It’s quite striking.”
The efficacy stems at least partly from its mechanism of blocking all cytokines in the IL-17 family – including those involved in the “feedback loops that perpetuate psoriasis” – rather than just one as other biologics do, Dr. Han said.
Usage of the drug has been hindered by the black box warning and REMS program, not only because of the extra steps required and hesitation potentially evoked, but because samples are not available, and because the “formulary access is not what it could have been otherwise,” he noted.
The Siliq REMS patient enrollment form requires patients to pledge awareness of the fact that suicidal thoughts and behaviors have occurred in treated patients and that they should seek medical attention if they experience suicidal thoughts or new or worsening depression, anxiety, or other mood changes. Prescribers must be certified with the program and must pledge on each enrollment form that they have counseled their patients.
The box warning states that there is no established causal association between treatment with brodalumab and increased risk for suicidal ideation and behaviors (SIB).
Individuals with psoriasis are an “already vulnerable population” who have been shown in reviews and meta-analyses to have a higher prevalence of depression and a higher risk of SIB than those without the disease, Dr. Koo and colleagues wrote in a narrative review published in Cutis .
Regardless of therapy, they wrote in the review, dermatologists should assess for any history of depression and SIB, and evaluate for signs and symptoms of current depression and SIB, referring patients as necessary to primary care or mental health care.
In the psoriasis trials, brodalumab treatment appeared to improve symptoms of depression and anxiety – a finding consistent with the effects reported for other biologic therapies, they wrote.
The first author on the newly published preproof is Samuel Yeroushalmi, BS, a fourth-year medical student at George Washington University, Washington.
Siliq is marketed by Valeant Pharmaceuticals.
Dr. Koo disclosed that he is an adviser/consultant/speaker for numerous pharmaceutical companies, but not those that were involved in the development of brodalumab. Dr. Han said he has relationships with numerous companies, including those that have developed brodalumab and other biologic agents used for psoriasis. The authors declared funding sources as none.
.
The Food and Drug Administration approved brodalumab (Siliq) in 2017 for treatment of moderate to severe plaque psoriasis with a boxed warning for suicidal ideation and behavior and an associated Risk Evaluation and Mitigation Strategies (REMS) program indicating an increased risk of suicidality.
Half a decade later, “the available worldwide data do not support the notion that brodalumab has a unique risk of increased suicides,” senior investigator John Koo, MD, and coinvestigators at the University of California, San Francisco, wrote in a preproof article in JAAD International, noting that postmarketing data are “often considered a better reflection of real-world outcomes than clinical trials.”
The researchers extracted data through the end of 2021 on the number of completed suicides for brodalumab and ten other biologics approved for psoriasis from the FDA’s Adverse Events Reporting System (FAERS), an international publicly available database. The researchers included suicide data on the biologics for all indications.
The authors contacted pharmaceutical companies to determine the total number of patients prescribed each drug, securing mostly “best estimates” data on 5 of the 11 biologics available for psoriasis. The researchers then calculated the number of completed suicides per total number of prescribed patients.
For brodalumab, across 20,871 total prescriptions, there was only one verifiable suicide. It occurred in a Japanese man with terminal cancer and no nearby relatives 36 days after his first dose. The suicide rate for brodalumab was similar to that of ixekizumab, secukinumab, infliximab, and adalimumab.
“Brodalumab is a very efficacious agent and may have the fastest onset of action, yet its usage is minimal compared to the other agents because of this ‘black box’ warning ... despite the fact that it’s the least expensive of any biologic,” Dr. Koo, professor of dermatology and director of the Psoriasis and Skin Treatment Center, University of California, San Francisco, said in an interview.
Dr. Koo, who is board-certified in both dermatology and psychiatry, said he believes the boxed warning was never warranted. All three of the verified completed suicides that occurred during clinical trials of brodalumab for psoriasis were in people who had underlying psychiatric disorders or significant stressors, such as going to jail in one case, and depression and significant isolation in another, he said.
(An analysis of psychiatric adverse events during the psoriasis clinical trials, involving more than 4,000 patients, was published online Oct. 4, 2017, in the Journal of the American Academy of Dermatology.
George Han, MD, PhD, associate professor and director of research and teledermatology at the Zucker School of Medicine at Hofstra/Northwell, New Hyde Park, N.Y., who was not involved in the research, said the new data is reassuring.
“We sometimes put it into context [in thinking and counseling about risk] that in the trials for brodalumab, the number of suicide attempts [versus completed suicides] was not an outlier,” he said. “But it’s hard to know what to make of that, so this piece of knowledge that the postmarketing data show there’s no safety signal should give people a lot of reassurance.”
Dr. Han said he has used the medication, a fully human anti-interleukin 17 receptor A monoclonal antibody, in many patients who “have not done so well on other biologics and it’s been a lifesaver ... a couple who have switched over have maintained the longest level of clearance they’ve had with anything. It’s quite striking.”
The efficacy stems at least partly from its mechanism of blocking all cytokines in the IL-17 family – including those involved in the “feedback loops that perpetuate psoriasis” – rather than just one as other biologics do, Dr. Han said.
Usage of the drug has been hindered by the black box warning and REMS program, not only because of the extra steps required and hesitation potentially evoked, but because samples are not available, and because the “formulary access is not what it could have been otherwise,” he noted.
The Siliq REMS patient enrollment form requires patients to pledge awareness of the fact that suicidal thoughts and behaviors have occurred in treated patients and that they should seek medical attention if they experience suicidal thoughts or new or worsening depression, anxiety, or other mood changes. Prescribers must be certified with the program and must pledge on each enrollment form that they have counseled their patients.
The box warning states that there is no established causal association between treatment with brodalumab and increased risk for suicidal ideation and behaviors (SIB).
Individuals with psoriasis are an “already vulnerable population” who have been shown in reviews and meta-analyses to have a higher prevalence of depression and a higher risk of SIB than those without the disease, Dr. Koo and colleagues wrote in a narrative review published in Cutis .
Regardless of therapy, they wrote in the review, dermatologists should assess for any history of depression and SIB, and evaluate for signs and symptoms of current depression and SIB, referring patients as necessary to primary care or mental health care.
In the psoriasis trials, brodalumab treatment appeared to improve symptoms of depression and anxiety – a finding consistent with the effects reported for other biologic therapies, they wrote.
The first author on the newly published preproof is Samuel Yeroushalmi, BS, a fourth-year medical student at George Washington University, Washington.
Siliq is marketed by Valeant Pharmaceuticals.
Dr. Koo disclosed that he is an adviser/consultant/speaker for numerous pharmaceutical companies, but not those that were involved in the development of brodalumab. Dr. Han said he has relationships with numerous companies, including those that have developed brodalumab and other biologic agents used for psoriasis. The authors declared funding sources as none.
.
The Food and Drug Administration approved brodalumab (Siliq) in 2017 for treatment of moderate to severe plaque psoriasis with a boxed warning for suicidal ideation and behavior and an associated Risk Evaluation and Mitigation Strategies (REMS) program indicating an increased risk of suicidality.
Half a decade later, “the available worldwide data do not support the notion that brodalumab has a unique risk of increased suicides,” senior investigator John Koo, MD, and coinvestigators at the University of California, San Francisco, wrote in a preproof article in JAAD International, noting that postmarketing data are “often considered a better reflection of real-world outcomes than clinical trials.”
The researchers extracted data through the end of 2021 on the number of completed suicides for brodalumab and ten other biologics approved for psoriasis from the FDA’s Adverse Events Reporting System (FAERS), an international publicly available database. The researchers included suicide data on the biologics for all indications.
The authors contacted pharmaceutical companies to determine the total number of patients prescribed each drug, securing mostly “best estimates” data on 5 of the 11 biologics available for psoriasis. The researchers then calculated the number of completed suicides per total number of prescribed patients.
For brodalumab, across 20,871 total prescriptions, there was only one verifiable suicide. It occurred in a Japanese man with terminal cancer and no nearby relatives 36 days after his first dose. The suicide rate for brodalumab was similar to that of ixekizumab, secukinumab, infliximab, and adalimumab.
“Brodalumab is a very efficacious agent and may have the fastest onset of action, yet its usage is minimal compared to the other agents because of this ‘black box’ warning ... despite the fact that it’s the least expensive of any biologic,” Dr. Koo, professor of dermatology and director of the Psoriasis and Skin Treatment Center, University of California, San Francisco, said in an interview.
Dr. Koo, who is board-certified in both dermatology and psychiatry, said he believes the boxed warning was never warranted. All three of the verified completed suicides that occurred during clinical trials of brodalumab for psoriasis were in people who had underlying psychiatric disorders or significant stressors, such as going to jail in one case, and depression and significant isolation in another, he said.
(An analysis of psychiatric adverse events during the psoriasis clinical trials, involving more than 4,000 patients, was published online Oct. 4, 2017, in the Journal of the American Academy of Dermatology.
George Han, MD, PhD, associate professor and director of research and teledermatology at the Zucker School of Medicine at Hofstra/Northwell, New Hyde Park, N.Y., who was not involved in the research, said the new data is reassuring.
“We sometimes put it into context [in thinking and counseling about risk] that in the trials for brodalumab, the number of suicide attempts [versus completed suicides] was not an outlier,” he said. “But it’s hard to know what to make of that, so this piece of knowledge that the postmarketing data show there’s no safety signal should give people a lot of reassurance.”
Dr. Han said he has used the medication, a fully human anti-interleukin 17 receptor A monoclonal antibody, in many patients who “have not done so well on other biologics and it’s been a lifesaver ... a couple who have switched over have maintained the longest level of clearance they’ve had with anything. It’s quite striking.”
The efficacy stems at least partly from its mechanism of blocking all cytokines in the IL-17 family – including those involved in the “feedback loops that perpetuate psoriasis” – rather than just one as other biologics do, Dr. Han said.
Usage of the drug has been hindered by the black box warning and REMS program, not only because of the extra steps required and hesitation potentially evoked, but because samples are not available, and because the “formulary access is not what it could have been otherwise,” he noted.
The Siliq REMS patient enrollment form requires patients to pledge awareness of the fact that suicidal thoughts and behaviors have occurred in treated patients and that they should seek medical attention if they experience suicidal thoughts or new or worsening depression, anxiety, or other mood changes. Prescribers must be certified with the program and must pledge on each enrollment form that they have counseled their patients.
The box warning states that there is no established causal association between treatment with brodalumab and increased risk for suicidal ideation and behaviors (SIB).
Individuals with psoriasis are an “already vulnerable population” who have been shown in reviews and meta-analyses to have a higher prevalence of depression and a higher risk of SIB than those without the disease, Dr. Koo and colleagues wrote in a narrative review published in Cutis .
Regardless of therapy, they wrote in the review, dermatologists should assess for any history of depression and SIB, and evaluate for signs and symptoms of current depression and SIB, referring patients as necessary to primary care or mental health care.
In the psoriasis trials, brodalumab treatment appeared to improve symptoms of depression and anxiety – a finding consistent with the effects reported for other biologic therapies, they wrote.
The first author on the newly published preproof is Samuel Yeroushalmi, BS, a fourth-year medical student at George Washington University, Washington.
Siliq is marketed by Valeant Pharmaceuticals.
Dr. Koo disclosed that he is an adviser/consultant/speaker for numerous pharmaceutical companies, but not those that were involved in the development of brodalumab. Dr. Han said he has relationships with numerous companies, including those that have developed brodalumab and other biologic agents used for psoriasis. The authors declared funding sources as none.
Elbow tenderness and swollen joints
The diagnosis for this case is psoriatic arthritis (PsA). The 2018 American College of Rheumatology/National Psoriasis Foundation guidelines offer current treatment recommendations for this condition. For patients with active PsA who are treatment-naive, treatment recommendations are:
- Tumor necrosis factor (TNF) inhibitors are preferred over oral small molecules (OSMs), interleukin (IL)–17 inhibitors, or IL-12/23 inhibitors
- OSMs are recommended over IL-17 inhibitors or IL-12/23 inhibitors
- Methotrexate is recommended over nonsteroidal anti-inflammatory drugs
- IL-17 inhibitors are recommended over IL-12/23 inhibitors
Treatment recommendations for patients with active PsA despite the use of OSMs are:
- Switching to a TNF inhibitor over another OSM, IL-17 or IL-12/23 inhibitors, abatacept, or tofacitinib
- Switching to an IL-17 inhibitor over another OSM, IL-12/23 inhibitor, abatacept, or tofacitinib
- Switching to an IL-12/23 inhibitor over another OSM, abatacept, or tofacitinib.
International groups, such as the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) and the European League Against Rheumatism (EULAR), have published treatment recommendations as well. These address both PsA and, to a lesser extent, psoriasis. The GRAPPA recommendations consider six domains of involvement (peripheral arthritis, axial disease, enthesitis, dactylitis, skin psoriasis, and nail psoriasis) and use a grid approach to account for various levels of disease activity and severity. The EULAR recommendations use an algorithmic approach that focuses mainly on musculoskeletal manifestations, specifically peripheral arthritis; manifestations, such as dactylitis, enthesitis, and skin and nail involvement, are considered separately.
Psoriasis precedes the onset of PsA in 60%-80% of patients (sometimes by up to 20 years but usually by less than 10 years); but in as many as 15%-20% of patients, arthritis appears before psoriasis. On occasion, arthritis and psoriasis appear simultaneously.
Patients with PsA are typically seronegative for rheumatoid factor and antinuclear antibody; antinuclear antibody titers in persons with PsA do not differ from those of age- and sex-matched controls. C-reactive protein may be elevated but is often normal. Lack of C-reactive protein elevation, however, does not mean that systemic inflammation is absent but rather indicates that a different type of systemic inflammation may be at play for those patients.
Herbert S. Diamond, MD, Professor of Medicine (retired), Temple University School of Medicine, University of Pittsburgh; Chairman, Department of Medicine Emeritus, Western Pennsylvania Hospital, Pittsburgh, PA.
Herbert S. Diamond, MD, has disclosed no relevant financial relationships.
Image Quizzes are fictional or fictionalized clinical scenarios intended to provide evidence-based educational takeaways.
The diagnosis for this case is psoriatic arthritis (PsA). The 2018 American College of Rheumatology/National Psoriasis Foundation guidelines offer current treatment recommendations for this condition. For patients with active PsA who are treatment-naive, treatment recommendations are:
- Tumor necrosis factor (TNF) inhibitors are preferred over oral small molecules (OSMs), interleukin (IL)–17 inhibitors, or IL-12/23 inhibitors
- OSMs are recommended over IL-17 inhibitors or IL-12/23 inhibitors
- Methotrexate is recommended over nonsteroidal anti-inflammatory drugs
- IL-17 inhibitors are recommended over IL-12/23 inhibitors
Treatment recommendations for patients with active PsA despite the use of OSMs are:
- Switching to a TNF inhibitor over another OSM, IL-17 or IL-12/23 inhibitors, abatacept, or tofacitinib
- Switching to an IL-17 inhibitor over another OSM, IL-12/23 inhibitor, abatacept, or tofacitinib
- Switching to an IL-12/23 inhibitor over another OSM, abatacept, or tofacitinib.
International groups, such as the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) and the European League Against Rheumatism (EULAR), have published treatment recommendations as well. These address both PsA and, to a lesser extent, psoriasis. The GRAPPA recommendations consider six domains of involvement (peripheral arthritis, axial disease, enthesitis, dactylitis, skin psoriasis, and nail psoriasis) and use a grid approach to account for various levels of disease activity and severity. The EULAR recommendations use an algorithmic approach that focuses mainly on musculoskeletal manifestations, specifically peripheral arthritis; manifestations, such as dactylitis, enthesitis, and skin and nail involvement, are considered separately.
Psoriasis precedes the onset of PsA in 60%-80% of patients (sometimes by up to 20 years but usually by less than 10 years); but in as many as 15%-20% of patients, arthritis appears before psoriasis. On occasion, arthritis and psoriasis appear simultaneously.
Patients with PsA are typically seronegative for rheumatoid factor and antinuclear antibody; antinuclear antibody titers in persons with PsA do not differ from those of age- and sex-matched controls. C-reactive protein may be elevated but is often normal. Lack of C-reactive protein elevation, however, does not mean that systemic inflammation is absent but rather indicates that a different type of systemic inflammation may be at play for those patients.
Herbert S. Diamond, MD, Professor of Medicine (retired), Temple University School of Medicine, University of Pittsburgh; Chairman, Department of Medicine Emeritus, Western Pennsylvania Hospital, Pittsburgh, PA.
Herbert S. Diamond, MD, has disclosed no relevant financial relationships.
Image Quizzes are fictional or fictionalized clinical scenarios intended to provide evidence-based educational takeaways.
The diagnosis for this case is psoriatic arthritis (PsA). The 2018 American College of Rheumatology/National Psoriasis Foundation guidelines offer current treatment recommendations for this condition. For patients with active PsA who are treatment-naive, treatment recommendations are:
- Tumor necrosis factor (TNF) inhibitors are preferred over oral small molecules (OSMs), interleukin (IL)–17 inhibitors, or IL-12/23 inhibitors
- OSMs are recommended over IL-17 inhibitors or IL-12/23 inhibitors
- Methotrexate is recommended over nonsteroidal anti-inflammatory drugs
- IL-17 inhibitors are recommended over IL-12/23 inhibitors
Treatment recommendations for patients with active PsA despite the use of OSMs are:
- Switching to a TNF inhibitor over another OSM, IL-17 or IL-12/23 inhibitors, abatacept, or tofacitinib
- Switching to an IL-17 inhibitor over another OSM, IL-12/23 inhibitor, abatacept, or tofacitinib
- Switching to an IL-12/23 inhibitor over another OSM, abatacept, or tofacitinib.
International groups, such as the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) and the European League Against Rheumatism (EULAR), have published treatment recommendations as well. These address both PsA and, to a lesser extent, psoriasis. The GRAPPA recommendations consider six domains of involvement (peripheral arthritis, axial disease, enthesitis, dactylitis, skin psoriasis, and nail psoriasis) and use a grid approach to account for various levels of disease activity and severity. The EULAR recommendations use an algorithmic approach that focuses mainly on musculoskeletal manifestations, specifically peripheral arthritis; manifestations, such as dactylitis, enthesitis, and skin and nail involvement, are considered separately.
Psoriasis precedes the onset of PsA in 60%-80% of patients (sometimes by up to 20 years but usually by less than 10 years); but in as many as 15%-20% of patients, arthritis appears before psoriasis. On occasion, arthritis and psoriasis appear simultaneously.
Patients with PsA are typically seronegative for rheumatoid factor and antinuclear antibody; antinuclear antibody titers in persons with PsA do not differ from those of age- and sex-matched controls. C-reactive protein may be elevated but is often normal. Lack of C-reactive protein elevation, however, does not mean that systemic inflammation is absent but rather indicates that a different type of systemic inflammation may be at play for those patients.
Herbert S. Diamond, MD, Professor of Medicine (retired), Temple University School of Medicine, University of Pittsburgh; Chairman, Department of Medicine Emeritus, Western Pennsylvania Hospital, Pittsburgh, PA.
Herbert S. Diamond, MD, has disclosed no relevant financial relationships.
Image Quizzes are fictional or fictionalized clinical scenarios intended to provide evidence-based educational takeaways.
A 45-year-old man presents with complaints of intermittent joint aches to the point that he can no longer golf and has trouble with his handwriting. He has a 6-year history of scalp psoriasis that he has controlled with a salicylic acid shampoo. On physical examination, he has tenderness over both elbows and in his metacarpophalangeal and proximal interphalangeal joints on both hands. Swollen joints are noted in the proximal and distal joints of the right hand. His fingernails show uniform pitting. Neurologic examination shows no sensory deficits or hyperesthesia. Motor examination is unremarkable, as are chest and abdominal findings. Blood pressure is 128/80 mm Hg. Radiographic findings showed periarticular soft-tissue swelling of the distal interphalangeal joints of the right second and fourth fingers and left thumb, although no significant bony abnormalities were observed. There is asymmetric narrowing of the joint space in the interphalangeal joints. Laboratory findings reveal an erythrocyte sedimentation rate of 35 mm/h, negative for rheumatoid factor, negative for antinuclear antibody, and C-reactive protein level of 9 mg/dL.
PsA: Sustained improvement in dactylitis with tofacitinib
Key clinical point: Tofacitinib improved dactylitis irrespective of the location and prevented its emergence in the majority of patients with psoriatic arthritis (PsA).
Major finding: In patients with Dactylitis Severity Scores (DSS) > 0, 10 mg tofacitinib twice daily vs placebo led to greater improvements in DSS for feet and other locations at month 1. By month 6, ≤15% of patients with DSS > 0 and <2% of patients with DSS = 0 reported the presence of dactylitis in all digits in the tofacitinib group.
Study details: Findings are from a post hoc analysis of two phase 3 trials including 710 patients with active PsA and inadequate response to conventional synthetic disease-modifying antirheumatic drugs (OPAL Broaden) or tumor necrosis factor inhibitors (OPAL Beyond) and who received 5/10 mg tofacitinib twice daily or placebo.
Disclosures: This study was sponsored by Pfizer Inc. Three authors declared being employees and shareholders of Pfizer. The other authors reported ties with several sources, including Pfizer.
Source: Orbai AM et al. Effect of tofacitinib on dactylitis and patient-reported outcomes in patients with active psoriatic arthritis: Post-hoc analysis of phase III studies. BMC Rheumatol. 2022;6(1):68 (Sep 1). Doi: 10.1186/s41927-022-00298-4
Key clinical point: Tofacitinib improved dactylitis irrespective of the location and prevented its emergence in the majority of patients with psoriatic arthritis (PsA).
Major finding: In patients with Dactylitis Severity Scores (DSS) > 0, 10 mg tofacitinib twice daily vs placebo led to greater improvements in DSS for feet and other locations at month 1. By month 6, ≤15% of patients with DSS > 0 and <2% of patients with DSS = 0 reported the presence of dactylitis in all digits in the tofacitinib group.
Study details: Findings are from a post hoc analysis of two phase 3 trials including 710 patients with active PsA and inadequate response to conventional synthetic disease-modifying antirheumatic drugs (OPAL Broaden) or tumor necrosis factor inhibitors (OPAL Beyond) and who received 5/10 mg tofacitinib twice daily or placebo.
Disclosures: This study was sponsored by Pfizer Inc. Three authors declared being employees and shareholders of Pfizer. The other authors reported ties with several sources, including Pfizer.
Source: Orbai AM et al. Effect of tofacitinib on dactylitis and patient-reported outcomes in patients with active psoriatic arthritis: Post-hoc analysis of phase III studies. BMC Rheumatol. 2022;6(1):68 (Sep 1). Doi: 10.1186/s41927-022-00298-4
Key clinical point: Tofacitinib improved dactylitis irrespective of the location and prevented its emergence in the majority of patients with psoriatic arthritis (PsA).
Major finding: In patients with Dactylitis Severity Scores (DSS) > 0, 10 mg tofacitinib twice daily vs placebo led to greater improvements in DSS for feet and other locations at month 1. By month 6, ≤15% of patients with DSS > 0 and <2% of patients with DSS = 0 reported the presence of dactylitis in all digits in the tofacitinib group.
Study details: Findings are from a post hoc analysis of two phase 3 trials including 710 patients with active PsA and inadequate response to conventional synthetic disease-modifying antirheumatic drugs (OPAL Broaden) or tumor necrosis factor inhibitors (OPAL Beyond) and who received 5/10 mg tofacitinib twice daily or placebo.
Disclosures: This study was sponsored by Pfizer Inc. Three authors declared being employees and shareholders of Pfizer. The other authors reported ties with several sources, including Pfizer.
Source: Orbai AM et al. Effect of tofacitinib on dactylitis and patient-reported outcomes in patients with active psoriatic arthritis: Post-hoc analysis of phase III studies. BMC Rheumatol. 2022;6(1):68 (Sep 1). Doi: 10.1186/s41927-022-00298-4
PsA: Sustained improvement in dactylitis with tofacitinib
Key clinical point: Tofacitinib improved dactylitis irrespective of the location and prevented its emergence in the majority of patients with psoriatic arthritis (PsA).
Major finding: In patients with Dactylitis Severity Scores (DSS) > 0, 10 mg tofacitinib twice daily vs placebo led to greater improvements in DSS for feet and other locations at month 1. By month 6, ≤15% of patients with DSS > 0 and <2% of patients with DSS = 0 reported the presence of dactylitis in all digits in the tofacitinib group.
Study details: Findings are from a post hoc analysis of two phase 3 trials including 710 patients with active PsA and inadequate response to conventional synthetic disease-modifying antirheumatic drugs (OPAL Broaden) or tumor necrosis factor inhibitors (OPAL Beyond) and who received 5/10 mg tofacitinib twice daily or placebo.
Disclosures: This study was sponsored by Pfizer Inc. Three authors declared being employees and shareholders of Pfizer. The other authors reported ties with several sources, including Pfizer.
Source: Orbai AM et al. Effect of tofacitinib on dactylitis and patient-reported outcomes in patients with active psoriatic arthritis: Post-hoc analysis of phase III studies. BMC Rheumatol. 2022;6(1):68 (Sep 1). Doi: 10.1186/s41927-022-00298-4
Key clinical point: Tofacitinib improved dactylitis irrespective of the location and prevented its emergence in the majority of patients with psoriatic arthritis (PsA).
Major finding: In patients with Dactylitis Severity Scores (DSS) > 0, 10 mg tofacitinib twice daily vs placebo led to greater improvements in DSS for feet and other locations at month 1. By month 6, ≤15% of patients with DSS > 0 and <2% of patients with DSS = 0 reported the presence of dactylitis in all digits in the tofacitinib group.
Study details: Findings are from a post hoc analysis of two phase 3 trials including 710 patients with active PsA and inadequate response to conventional synthetic disease-modifying antirheumatic drugs (OPAL Broaden) or tumor necrosis factor inhibitors (OPAL Beyond) and who received 5/10 mg tofacitinib twice daily or placebo.
Disclosures: This study was sponsored by Pfizer Inc. Three authors declared being employees and shareholders of Pfizer. The other authors reported ties with several sources, including Pfizer.
Source: Orbai AM et al. Effect of tofacitinib on dactylitis and patient-reported outcomes in patients with active psoriatic arthritis: Post-hoc analysis of phase III studies. BMC Rheumatol. 2022;6(1):68 (Sep 1). Doi: 10.1186/s41927-022-00298-4
Key clinical point: Tofacitinib improved dactylitis irrespective of the location and prevented its emergence in the majority of patients with psoriatic arthritis (PsA).
Major finding: In patients with Dactylitis Severity Scores (DSS) > 0, 10 mg tofacitinib twice daily vs placebo led to greater improvements in DSS for feet and other locations at month 1. By month 6, ≤15% of patients with DSS > 0 and <2% of patients with DSS = 0 reported the presence of dactylitis in all digits in the tofacitinib group.
Study details: Findings are from a post hoc analysis of two phase 3 trials including 710 patients with active PsA and inadequate response to conventional synthetic disease-modifying antirheumatic drugs (OPAL Broaden) or tumor necrosis factor inhibitors (OPAL Beyond) and who received 5/10 mg tofacitinib twice daily or placebo.
Disclosures: This study was sponsored by Pfizer Inc. Three authors declared being employees and shareholders of Pfizer. The other authors reported ties with several sources, including Pfizer.
Source: Orbai AM et al. Effect of tofacitinib on dactylitis and patient-reported outcomes in patients with active psoriatic arthritis: Post-hoc analysis of phase III studies. BMC Rheumatol. 2022;6(1):68 (Sep 1). Doi: 10.1186/s41927-022-00298-4
Precision medicine based on peripheral T-lymphocyte phenotyping is effective in the real world
Key clinical point: Patients with psoriatic arthritis (PsA) who received strategic treatment with biological disease-modifying anti-rheumatic drugs (bDMARD) based on peripheral T-lymphocyte phenotyping achieved greater reduction in disease activity than patients who did not undergo phenotyping or bDMARD selection strategy.
Major finding: A significantly higher proportion of patients in the strategic vs standard bDMARD treatment group achieved disease activity of PsA-remission (90.2% vs 67.8%; P = .0132) and minimal disease activity (80.5% vs 60.7%; P = .0464) by month 6.
Study details: Findings are from a real-world, retrospective study that included 97 patients with PsA who received bDMARD for ≥1 year and compared 1-year treatment response between the strategic (n = 41) and standard (n = 56) bDMARD treatment groups.
Disclosures: This work was supported by Research on Rare and Intractable Diseases and Research Grant-In-Aid for Scientific Research by the Ministry of Health, Labor, and Welfare of Japan, and other sources. The authors declared receiving grants, honoraria, speaking fees, or consulting fees from several sources.
Source: Miyagawa I et al. Precision medicine based on the phenotypic differences in peripheral T helper cells in patients with psoriatic arthritis: One year follow-up outcomes. Front Med (Lausanne). 2022;9:934937 (Jul 27). Doi: 10.3389/fmed.2022.934937
Key clinical point: Patients with psoriatic arthritis (PsA) who received strategic treatment with biological disease-modifying anti-rheumatic drugs (bDMARD) based on peripheral T-lymphocyte phenotyping achieved greater reduction in disease activity than patients who did not undergo phenotyping or bDMARD selection strategy.
Major finding: A significantly higher proportion of patients in the strategic vs standard bDMARD treatment group achieved disease activity of PsA-remission (90.2% vs 67.8%; P = .0132) and minimal disease activity (80.5% vs 60.7%; P = .0464) by month 6.
Study details: Findings are from a real-world, retrospective study that included 97 patients with PsA who received bDMARD for ≥1 year and compared 1-year treatment response between the strategic (n = 41) and standard (n = 56) bDMARD treatment groups.
Disclosures: This work was supported by Research on Rare and Intractable Diseases and Research Grant-In-Aid for Scientific Research by the Ministry of Health, Labor, and Welfare of Japan, and other sources. The authors declared receiving grants, honoraria, speaking fees, or consulting fees from several sources.
Source: Miyagawa I et al. Precision medicine based on the phenotypic differences in peripheral T helper cells in patients with psoriatic arthritis: One year follow-up outcomes. Front Med (Lausanne). 2022;9:934937 (Jul 27). Doi: 10.3389/fmed.2022.934937
Key clinical point: Patients with psoriatic arthritis (PsA) who received strategic treatment with biological disease-modifying anti-rheumatic drugs (bDMARD) based on peripheral T-lymphocyte phenotyping achieved greater reduction in disease activity than patients who did not undergo phenotyping or bDMARD selection strategy.
Major finding: A significantly higher proportion of patients in the strategic vs standard bDMARD treatment group achieved disease activity of PsA-remission (90.2% vs 67.8%; P = .0132) and minimal disease activity (80.5% vs 60.7%; P = .0464) by month 6.
Study details: Findings are from a real-world, retrospective study that included 97 patients with PsA who received bDMARD for ≥1 year and compared 1-year treatment response between the strategic (n = 41) and standard (n = 56) bDMARD treatment groups.
Disclosures: This work was supported by Research on Rare and Intractable Diseases and Research Grant-In-Aid for Scientific Research by the Ministry of Health, Labor, and Welfare of Japan, and other sources. The authors declared receiving grants, honoraria, speaking fees, or consulting fees from several sources.
Source: Miyagawa I et al. Precision medicine based on the phenotypic differences in peripheral T helper cells in patients with psoriatic arthritis: One year follow-up outcomes. Front Med (Lausanne). 2022;9:934937 (Jul 27). Doi: 10.3389/fmed.2022.934937
PEST and BMI predict development of PsA in psoriasis patients
Key clinical point: Tools like Psoriasis Epidemiology Screening Tool (PEST) and body mass index (BMI) can predict the 2-year risk of developing psoriatic arthritis (PsA) in patients with psoriasis (PsO).
Major finding: Approximately 10% of patients with PsO developed PsA after 2 years. PEST, BMI, modified Rheumatic Disease Comorbidity Index, work status, alcohol use, and fatigue (area under the curve [AUC] 68.9%; sensitivity 82.9%; specificity 48.8%) were most efficient in predicting PsA development; however, another model including only PEST and BMI produced similar results (AUC 68.8%; sensitivity 92.7%; specificity 36.5%).
Study details: The findings are from a prospective cohort study including 1489 patients with PsO and no prior diagnosis of PsA from the CorEvitas Psoriasis Registry who were followed-up for 24 months.
Disclosures: This study was sponsored by CorEvitas, LLC. Three authors declared being employees of CorEvitas, LLC, and the other authors reported ties with several sources, including CorEvitas.
Source: Ogdie A et al. Prospective cohort study of psoriatic arthritis risk in patients with psoriasis in a real-world psoriasis registry. J Am Acad Dermatol. 2022 (Aug 17). Doi: 10.1016/j.jaad.2022.07.060
Key clinical point: Tools like Psoriasis Epidemiology Screening Tool (PEST) and body mass index (BMI) can predict the 2-year risk of developing psoriatic arthritis (PsA) in patients with psoriasis (PsO).
Major finding: Approximately 10% of patients with PsO developed PsA after 2 years. PEST, BMI, modified Rheumatic Disease Comorbidity Index, work status, alcohol use, and fatigue (area under the curve [AUC] 68.9%; sensitivity 82.9%; specificity 48.8%) were most efficient in predicting PsA development; however, another model including only PEST and BMI produced similar results (AUC 68.8%; sensitivity 92.7%; specificity 36.5%).
Study details: The findings are from a prospective cohort study including 1489 patients with PsO and no prior diagnosis of PsA from the CorEvitas Psoriasis Registry who were followed-up for 24 months.
Disclosures: This study was sponsored by CorEvitas, LLC. Three authors declared being employees of CorEvitas, LLC, and the other authors reported ties with several sources, including CorEvitas.
Source: Ogdie A et al. Prospective cohort study of psoriatic arthritis risk in patients with psoriasis in a real-world psoriasis registry. J Am Acad Dermatol. 2022 (Aug 17). Doi: 10.1016/j.jaad.2022.07.060
Key clinical point: Tools like Psoriasis Epidemiology Screening Tool (PEST) and body mass index (BMI) can predict the 2-year risk of developing psoriatic arthritis (PsA) in patients with psoriasis (PsO).
Major finding: Approximately 10% of patients with PsO developed PsA after 2 years. PEST, BMI, modified Rheumatic Disease Comorbidity Index, work status, alcohol use, and fatigue (area under the curve [AUC] 68.9%; sensitivity 82.9%; specificity 48.8%) were most efficient in predicting PsA development; however, another model including only PEST and BMI produced similar results (AUC 68.8%; sensitivity 92.7%; specificity 36.5%).
Study details: The findings are from a prospective cohort study including 1489 patients with PsO and no prior diagnosis of PsA from the CorEvitas Psoriasis Registry who were followed-up for 24 months.
Disclosures: This study was sponsored by CorEvitas, LLC. Three authors declared being employees of CorEvitas, LLC, and the other authors reported ties with several sources, including CorEvitas.
Source: Ogdie A et al. Prospective cohort study of psoriatic arthritis risk in patients with psoriasis in a real-world psoriasis registry. J Am Acad Dermatol. 2022 (Aug 17). Doi: 10.1016/j.jaad.2022.07.060
Flares increase disease burden in PsA
Key clinical point: Patients with psoriatic arthritis (PsA) who were currently experiencing flares had worse quality of life (QoL), greater disability, and impaired work productivity compared with those who had not experienced flare ever or in the last 12 months.
Major finding: Currently, 168 patients were diagnosed with flare by a physician. Compared with patients who had not experienced flare ever or in the last 12 months, those who were currently experiencing flares had lower QoL scores and higher overall work impairment, disability, and a greater disease impact on patient’s QoL (all P < .01).
Study details: Findings are from the Adelphi PsA Disease Specific Programme, a cross-sectional survey including 2238 patients with PsA and physician-reported flare status data.
Disclosures: The Adelphi SpA IV Disease Specific Programme was funded by Janssen. Two authors declared being employees of Adelphi Real World, and two authors declared being employees of Janssen Pharmaceuticals. The other authors reported receiving research grants and consulting fees from several sources.
Source: Orbai AM et al. Impact of physician-defined flares on quality of life and work impairment: An international survey of 2,238 psoriatic arthritis patients. J Rheumatol. 2022 (Aug 15). Doi: 10.3899/jrheum.211302
Key clinical point: Patients with psoriatic arthritis (PsA) who were currently experiencing flares had worse quality of life (QoL), greater disability, and impaired work productivity compared with those who had not experienced flare ever or in the last 12 months.
Major finding: Currently, 168 patients were diagnosed with flare by a physician. Compared with patients who had not experienced flare ever or in the last 12 months, those who were currently experiencing flares had lower QoL scores and higher overall work impairment, disability, and a greater disease impact on patient’s QoL (all P < .01).
Study details: Findings are from the Adelphi PsA Disease Specific Programme, a cross-sectional survey including 2238 patients with PsA and physician-reported flare status data.
Disclosures: The Adelphi SpA IV Disease Specific Programme was funded by Janssen. Two authors declared being employees of Adelphi Real World, and two authors declared being employees of Janssen Pharmaceuticals. The other authors reported receiving research grants and consulting fees from several sources.
Source: Orbai AM et al. Impact of physician-defined flares on quality of life and work impairment: An international survey of 2,238 psoriatic arthritis patients. J Rheumatol. 2022 (Aug 15). Doi: 10.3899/jrheum.211302
Key clinical point: Patients with psoriatic arthritis (PsA) who were currently experiencing flares had worse quality of life (QoL), greater disability, and impaired work productivity compared with those who had not experienced flare ever or in the last 12 months.
Major finding: Currently, 168 patients were diagnosed with flare by a physician. Compared with patients who had not experienced flare ever or in the last 12 months, those who were currently experiencing flares had lower QoL scores and higher overall work impairment, disability, and a greater disease impact on patient’s QoL (all P < .01).
Study details: Findings are from the Adelphi PsA Disease Specific Programme, a cross-sectional survey including 2238 patients with PsA and physician-reported flare status data.
Disclosures: The Adelphi SpA IV Disease Specific Programme was funded by Janssen. Two authors declared being employees of Adelphi Real World, and two authors declared being employees of Janssen Pharmaceuticals. The other authors reported receiving research grants and consulting fees from several sources.
Source: Orbai AM et al. Impact of physician-defined flares on quality of life and work impairment: An international survey of 2,238 psoriatic arthritis patients. J Rheumatol. 2022 (Aug 15). Doi: 10.3899/jrheum.211302