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Topical treatments remain a good option for psoriasis
LAS VEGAS – in mild cases of psoriasis.
Topicals often are a worthwhile complement to even the most advanced systemic medications, according to Linda Stein Gold, MD, director of clinical research in the department of dermatology at the Henry Ford Health System, Detroit.
Speaking at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar, she pointed out that as the variety of vehicles for topical treatments has grown, so has the need to pay attention to the potency of these treatments. “Traditionally, we had thought we had to use a thick ointment to drive the drug in and get the best efficacy,” she said. “But we’ve changed our thought process.”
For example, betamethasone dipropionate 0.05%, now comes in multiple types of ointments and creams, with different potency classes, including Diprolene ointment, 0.05%, Diprosone cream, 0.05%, Diprolene cream AF, 0.05%, and Diprolene cream, 0.05%, as well as a lotion and an emollient spray.
“It’s the same active drug, but different vehicles absolutely change the potency of the drug,” Dr. Stein Gold said.
So which is the most potent? She said you can’t tell just by the vehicle. In this case, the most potent forms – in the “superpotent” class 1 – are Diprolene cream, 0.05%, and Diprolene ointment, 0.05%. (The National Psoriasis Foundation has a potency chart for topical psoriasis medications.)
She also recommended considering combination therapy with tazarotene. Tazarotene, a vitamin A derivative, is associated with a variety of side effects in 10%-30% of patients, including pruritus, erythema, irritation, skin pain, psoriasis worsening, and burning/stinging. But combination therapy with topical corticosteroids can reduce adverse effects, and it boosts efficacy as well, Dr. Stein Gold said.
She added that tazarotene can be a tool against acne. The 0.1% cream and gel formulations are approved by the Food and Drug Administration for treating acne; the 0.05% cream and gel forms are approved only for psoriasis. “Both concentrations work well and hit the different pillars of the pathogenesis of acne,” she said.
In addition, Dr. Stein Gold noted that she led two 2018 studies that found a fixed combination of halobetasol propionate 0.01% and tazarotene 0.045% lotion in moderate to severe plaque psoriasis was associated with significant reductions in the severity of the clinical signs of psoriasis, and minimal safety concerns (J Am Acad Dermatol. 2018 Aug;79[2]:287-93).
As for the future in topical treatment for psoriasis, she said researchers are exploring phosphodiesterase-4 inhibitors, Janus kinase inhibitors, and aryl hydrocarbon receptor agonists.
Dr. Stein Gold disclosed speaker bureau relationships with Galderma, Leo, Valeant, Novartis, Celgene and Allergan; consulting for Sol‐Gel, Galderma, Leo, Novan, Valeant, Dermira, Novartis, Celgene, Allergan, Foamix, Promius, Anacor and Medimetriks; receiving grant/research support from Galderma, Leo, Novan, Valeant, Dermira, Novartis, Celgene, Allergan and Foamix; and serving on scientific advisory boards for Galderma, Leo, Novan, Valeant, Dermira, Novartis, Celgene, Allergan, Foamix and Promius.
SDEF and this news organization are owned by the same parent company.
LAS VEGAS – in mild cases of psoriasis.
Topicals often are a worthwhile complement to even the most advanced systemic medications, according to Linda Stein Gold, MD, director of clinical research in the department of dermatology at the Henry Ford Health System, Detroit.
Speaking at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar, she pointed out that as the variety of vehicles for topical treatments has grown, so has the need to pay attention to the potency of these treatments. “Traditionally, we had thought we had to use a thick ointment to drive the drug in and get the best efficacy,” she said. “But we’ve changed our thought process.”
For example, betamethasone dipropionate 0.05%, now comes in multiple types of ointments and creams, with different potency classes, including Diprolene ointment, 0.05%, Diprosone cream, 0.05%, Diprolene cream AF, 0.05%, and Diprolene cream, 0.05%, as well as a lotion and an emollient spray.
“It’s the same active drug, but different vehicles absolutely change the potency of the drug,” Dr. Stein Gold said.
So which is the most potent? She said you can’t tell just by the vehicle. In this case, the most potent forms – in the “superpotent” class 1 – are Diprolene cream, 0.05%, and Diprolene ointment, 0.05%. (The National Psoriasis Foundation has a potency chart for topical psoriasis medications.)
She also recommended considering combination therapy with tazarotene. Tazarotene, a vitamin A derivative, is associated with a variety of side effects in 10%-30% of patients, including pruritus, erythema, irritation, skin pain, psoriasis worsening, and burning/stinging. But combination therapy with topical corticosteroids can reduce adverse effects, and it boosts efficacy as well, Dr. Stein Gold said.
She added that tazarotene can be a tool against acne. The 0.1% cream and gel formulations are approved by the Food and Drug Administration for treating acne; the 0.05% cream and gel forms are approved only for psoriasis. “Both concentrations work well and hit the different pillars of the pathogenesis of acne,” she said.
In addition, Dr. Stein Gold noted that she led two 2018 studies that found a fixed combination of halobetasol propionate 0.01% and tazarotene 0.045% lotion in moderate to severe plaque psoriasis was associated with significant reductions in the severity of the clinical signs of psoriasis, and minimal safety concerns (J Am Acad Dermatol. 2018 Aug;79[2]:287-93).
As for the future in topical treatment for psoriasis, she said researchers are exploring phosphodiesterase-4 inhibitors, Janus kinase inhibitors, and aryl hydrocarbon receptor agonists.
Dr. Stein Gold disclosed speaker bureau relationships with Galderma, Leo, Valeant, Novartis, Celgene and Allergan; consulting for Sol‐Gel, Galderma, Leo, Novan, Valeant, Dermira, Novartis, Celgene, Allergan, Foamix, Promius, Anacor and Medimetriks; receiving grant/research support from Galderma, Leo, Novan, Valeant, Dermira, Novartis, Celgene, Allergan and Foamix; and serving on scientific advisory boards for Galderma, Leo, Novan, Valeant, Dermira, Novartis, Celgene, Allergan, Foamix and Promius.
SDEF and this news organization are owned by the same parent company.
LAS VEGAS – in mild cases of psoriasis.
Topicals often are a worthwhile complement to even the most advanced systemic medications, according to Linda Stein Gold, MD, director of clinical research in the department of dermatology at the Henry Ford Health System, Detroit.
Speaking at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar, she pointed out that as the variety of vehicles for topical treatments has grown, so has the need to pay attention to the potency of these treatments. “Traditionally, we had thought we had to use a thick ointment to drive the drug in and get the best efficacy,” she said. “But we’ve changed our thought process.”
For example, betamethasone dipropionate 0.05%, now comes in multiple types of ointments and creams, with different potency classes, including Diprolene ointment, 0.05%, Diprosone cream, 0.05%, Diprolene cream AF, 0.05%, and Diprolene cream, 0.05%, as well as a lotion and an emollient spray.
“It’s the same active drug, but different vehicles absolutely change the potency of the drug,” Dr. Stein Gold said.
So which is the most potent? She said you can’t tell just by the vehicle. In this case, the most potent forms – in the “superpotent” class 1 – are Diprolene cream, 0.05%, and Diprolene ointment, 0.05%. (The National Psoriasis Foundation has a potency chart for topical psoriasis medications.)
She also recommended considering combination therapy with tazarotene. Tazarotene, a vitamin A derivative, is associated with a variety of side effects in 10%-30% of patients, including pruritus, erythema, irritation, skin pain, psoriasis worsening, and burning/stinging. But combination therapy with topical corticosteroids can reduce adverse effects, and it boosts efficacy as well, Dr. Stein Gold said.
She added that tazarotene can be a tool against acne. The 0.1% cream and gel formulations are approved by the Food and Drug Administration for treating acne; the 0.05% cream and gel forms are approved only for psoriasis. “Both concentrations work well and hit the different pillars of the pathogenesis of acne,” she said.
In addition, Dr. Stein Gold noted that she led two 2018 studies that found a fixed combination of halobetasol propionate 0.01% and tazarotene 0.045% lotion in moderate to severe plaque psoriasis was associated with significant reductions in the severity of the clinical signs of psoriasis, and minimal safety concerns (J Am Acad Dermatol. 2018 Aug;79[2]:287-93).
As for the future in topical treatment for psoriasis, she said researchers are exploring phosphodiesterase-4 inhibitors, Janus kinase inhibitors, and aryl hydrocarbon receptor agonists.
Dr. Stein Gold disclosed speaker bureau relationships with Galderma, Leo, Valeant, Novartis, Celgene and Allergan; consulting for Sol‐Gel, Galderma, Leo, Novan, Valeant, Dermira, Novartis, Celgene, Allergan, Foamix, Promius, Anacor and Medimetriks; receiving grant/research support from Galderma, Leo, Novan, Valeant, Dermira, Novartis, Celgene, Allergan and Foamix; and serving on scientific advisory boards for Galderma, Leo, Novan, Valeant, Dermira, Novartis, Celgene, Allergan, Foamix and Promius.
SDEF and this news organization are owned by the same parent company.
EXPERT ANALYSIS FROM SDEF LAS VEGAS DERMATOLOGY SEMINAR
Etanercept bests methotrexate for PsA; combo adds little benefit
CHICAGO – Etanercept monotherapy showed greater efficacy, compared with methotrexate monotherapy for the treatment of psoriatic arthritis, and combining the two agents provided no benefit over etanercept alone for most outcomes in the randomized, controlled, international, phase 3 SEAM-PsA study.
A 20% improvement in American College of Rheumatology criteria at week 24 – the primary endpoint of the study – was significantly greater in 284 patients treated with etanercept monotherapy and in 283 patients treated with combination etanercept and methotrexate than in 284 patients treated with methotrexate monotherapy (60.9% and 65.0% vs. 50.7%, respectively), Philip J. Mease, MD, of the Swedish Medical Center and the University of Washington, Seattle, and his colleagues reported in a late-breaking poster on the SEAM-PsA (Etanercept and Methotrexate in Subjects with Psoriatic Arthritis) study at the annual meeting of the American College of Rheumatology.
The key secondary endpoint of minimal disease activity response at week 24 also was significantly greater in the etanercept monotherapy and combination groups than in the methotrexate monotherapy group (35.9% and 35.7% vs. 22.9%, respectively), the investigators noted.
Additionally, at week 48, the etanercept monotherapy group and combination group both showed less radiographic progression than did the methotrexate monotherapy arm (mean change in modified total Sharp score from baseline, –0.04 and –0.01 vs. 0.08).
Overall, the etanercept monotherapy group and combination therapy group had similar results, with some differences in skin outcomes. Treatment was well tolerated, and except for more nausea occurring with methotrexate, adverse event rates were similar in the three study arms. No new safety signals were observed.
“The most common serious adverse events were infections and infestations, which occurred in 1.1% of patients in the methotrexate monotherapy arm, 2.8% of patients in the etanercept monotherapy arm, and 2.5% of patients in the combination therapy arm,” they wrote.
Study participants were biologic-naive adults with active PsA and no prior methotrexate treatment for their disease. They had a mean age of 48.4 years, most were white, and median disease duration was 0.6 years.
They were randomized to receive either 50 mg subcutaneous injections of etanercept plus oral placebo weekly, 50 mg subcutaneous etanercept plus 20 mg oral methotrexate weekly, or 20 mg oral methotrexate plus placebo injections weekly; the groups were well balanced with respect to baseline characteristics, the investigators said.
Rescue therapy of etanercept plus methotrexate was given after 24 weeks in patients with less than 20% improvement in tender joint counts and swollen joint counts from baseline.
“Agents used to treat PsA include disease-modifying antirheumatic drugs such as methotrexate and tumor necrosis factor inhibitors, but how to optimally use these agents to treat PsA is unknown,” they wrote, explaining that while methotrexate is widely used in this setting, little clinical evidence exists to guide its use, and that while tumor necrosis factor inhibitors have shown efficacy in PsA, the benefit of adding methotrexate remains unclear.
The current findings, however, demonstrate that adding methotrexate does not appear to increase the efficacy of etanercept monotherapy for most outcomes.
An exception was with combination therapy for some skin-related outcomes, including percent improvement in psoriasis-affected body surface area and percentage of patients with “status clear or almost clear,” they said.
Further, methotrexate monotherapy in this study appeared to have some “meaningful efficacy for both articular and nonarticular PsA symptoms,” the investigators noted.
“These results provide information of practical value for clinical practice when considering treatment option for PsA,” they concluded.
The study was supported by Amgen. Dr. Mease reported receiving research grants, speaker fees, and/or consulting fees from AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Galapagos, Genentech, Janssen Pharmaceuticals, Eli Lilly, Novartis, Pfizer, Sun Pharmaceutical, and UCB.
SOURCE: Mease PJ et al. Arthritis Rheumatol. 2018;70(Suppl 10): Abstract L11.
CHICAGO – Etanercept monotherapy showed greater efficacy, compared with methotrexate monotherapy for the treatment of psoriatic arthritis, and combining the two agents provided no benefit over etanercept alone for most outcomes in the randomized, controlled, international, phase 3 SEAM-PsA study.
A 20% improvement in American College of Rheumatology criteria at week 24 – the primary endpoint of the study – was significantly greater in 284 patients treated with etanercept monotherapy and in 283 patients treated with combination etanercept and methotrexate than in 284 patients treated with methotrexate monotherapy (60.9% and 65.0% vs. 50.7%, respectively), Philip J. Mease, MD, of the Swedish Medical Center and the University of Washington, Seattle, and his colleagues reported in a late-breaking poster on the SEAM-PsA (Etanercept and Methotrexate in Subjects with Psoriatic Arthritis) study at the annual meeting of the American College of Rheumatology.
The key secondary endpoint of minimal disease activity response at week 24 also was significantly greater in the etanercept monotherapy and combination groups than in the methotrexate monotherapy group (35.9% and 35.7% vs. 22.9%, respectively), the investigators noted.
Additionally, at week 48, the etanercept monotherapy group and combination group both showed less radiographic progression than did the methotrexate monotherapy arm (mean change in modified total Sharp score from baseline, –0.04 and –0.01 vs. 0.08).
Overall, the etanercept monotherapy group and combination therapy group had similar results, with some differences in skin outcomes. Treatment was well tolerated, and except for more nausea occurring with methotrexate, adverse event rates were similar in the three study arms. No new safety signals were observed.
“The most common serious adverse events were infections and infestations, which occurred in 1.1% of patients in the methotrexate monotherapy arm, 2.8% of patients in the etanercept monotherapy arm, and 2.5% of patients in the combination therapy arm,” they wrote.
Study participants were biologic-naive adults with active PsA and no prior methotrexate treatment for their disease. They had a mean age of 48.4 years, most were white, and median disease duration was 0.6 years.
They were randomized to receive either 50 mg subcutaneous injections of etanercept plus oral placebo weekly, 50 mg subcutaneous etanercept plus 20 mg oral methotrexate weekly, or 20 mg oral methotrexate plus placebo injections weekly; the groups were well balanced with respect to baseline characteristics, the investigators said.
Rescue therapy of etanercept plus methotrexate was given after 24 weeks in patients with less than 20% improvement in tender joint counts and swollen joint counts from baseline.
“Agents used to treat PsA include disease-modifying antirheumatic drugs such as methotrexate and tumor necrosis factor inhibitors, but how to optimally use these agents to treat PsA is unknown,” they wrote, explaining that while methotrexate is widely used in this setting, little clinical evidence exists to guide its use, and that while tumor necrosis factor inhibitors have shown efficacy in PsA, the benefit of adding methotrexate remains unclear.
The current findings, however, demonstrate that adding methotrexate does not appear to increase the efficacy of etanercept monotherapy for most outcomes.
An exception was with combination therapy for some skin-related outcomes, including percent improvement in psoriasis-affected body surface area and percentage of patients with “status clear or almost clear,” they said.
Further, methotrexate monotherapy in this study appeared to have some “meaningful efficacy for both articular and nonarticular PsA symptoms,” the investigators noted.
“These results provide information of practical value for clinical practice when considering treatment option for PsA,” they concluded.
The study was supported by Amgen. Dr. Mease reported receiving research grants, speaker fees, and/or consulting fees from AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Galapagos, Genentech, Janssen Pharmaceuticals, Eli Lilly, Novartis, Pfizer, Sun Pharmaceutical, and UCB.
SOURCE: Mease PJ et al. Arthritis Rheumatol. 2018;70(Suppl 10): Abstract L11.
CHICAGO – Etanercept monotherapy showed greater efficacy, compared with methotrexate monotherapy for the treatment of psoriatic arthritis, and combining the two agents provided no benefit over etanercept alone for most outcomes in the randomized, controlled, international, phase 3 SEAM-PsA study.
A 20% improvement in American College of Rheumatology criteria at week 24 – the primary endpoint of the study – was significantly greater in 284 patients treated with etanercept monotherapy and in 283 patients treated with combination etanercept and methotrexate than in 284 patients treated with methotrexate monotherapy (60.9% and 65.0% vs. 50.7%, respectively), Philip J. Mease, MD, of the Swedish Medical Center and the University of Washington, Seattle, and his colleagues reported in a late-breaking poster on the SEAM-PsA (Etanercept and Methotrexate in Subjects with Psoriatic Arthritis) study at the annual meeting of the American College of Rheumatology.
The key secondary endpoint of minimal disease activity response at week 24 also was significantly greater in the etanercept monotherapy and combination groups than in the methotrexate monotherapy group (35.9% and 35.7% vs. 22.9%, respectively), the investigators noted.
Additionally, at week 48, the etanercept monotherapy group and combination group both showed less radiographic progression than did the methotrexate monotherapy arm (mean change in modified total Sharp score from baseline, –0.04 and –0.01 vs. 0.08).
Overall, the etanercept monotherapy group and combination therapy group had similar results, with some differences in skin outcomes. Treatment was well tolerated, and except for more nausea occurring with methotrexate, adverse event rates were similar in the three study arms. No new safety signals were observed.
“The most common serious adverse events were infections and infestations, which occurred in 1.1% of patients in the methotrexate monotherapy arm, 2.8% of patients in the etanercept monotherapy arm, and 2.5% of patients in the combination therapy arm,” they wrote.
Study participants were biologic-naive adults with active PsA and no prior methotrexate treatment for their disease. They had a mean age of 48.4 years, most were white, and median disease duration was 0.6 years.
They were randomized to receive either 50 mg subcutaneous injections of etanercept plus oral placebo weekly, 50 mg subcutaneous etanercept plus 20 mg oral methotrexate weekly, or 20 mg oral methotrexate plus placebo injections weekly; the groups were well balanced with respect to baseline characteristics, the investigators said.
Rescue therapy of etanercept plus methotrexate was given after 24 weeks in patients with less than 20% improvement in tender joint counts and swollen joint counts from baseline.
“Agents used to treat PsA include disease-modifying antirheumatic drugs such as methotrexate and tumor necrosis factor inhibitors, but how to optimally use these agents to treat PsA is unknown,” they wrote, explaining that while methotrexate is widely used in this setting, little clinical evidence exists to guide its use, and that while tumor necrosis factor inhibitors have shown efficacy in PsA, the benefit of adding methotrexate remains unclear.
The current findings, however, demonstrate that adding methotrexate does not appear to increase the efficacy of etanercept monotherapy for most outcomes.
An exception was with combination therapy for some skin-related outcomes, including percent improvement in psoriasis-affected body surface area and percentage of patients with “status clear or almost clear,” they said.
Further, methotrexate monotherapy in this study appeared to have some “meaningful efficacy for both articular and nonarticular PsA symptoms,” the investigators noted.
“These results provide information of practical value for clinical practice when considering treatment option for PsA,” they concluded.
The study was supported by Amgen. Dr. Mease reported receiving research grants, speaker fees, and/or consulting fees from AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Galapagos, Genentech, Janssen Pharmaceuticals, Eli Lilly, Novartis, Pfizer, Sun Pharmaceutical, and UCB.
SOURCE: Mease PJ et al. Arthritis Rheumatol. 2018;70(Suppl 10): Abstract L11.
REPORTING FROM THE ACR ANNUAL MEETING
Key clinical point: Etanercept monotherapy shows greater efficacy versus methotrexate monotherapy for psoriatic arthritis.
Major finding: A total of 60.9% achieved a 20% improvement in American College of Rheumatology criteria with etanercept monotherapy, compared with 65.0% on combination therapy and 50.7% on methotrexate monotherapy.
Study details: A randomized, controlled, phase 3 study of 851 patients.
Disclosures: The study was supported by Amgen. Dr. Mease reported receiving research grants, speaker fees, and/or consulting fees from AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Galapagos, Genentech, Janssen Pharmaceuticals, Eli Lilly, Novartis, Pfizer, Sun Pharmaceutical, and UCB.
Source: Mease PJ et al. Arthritis Rheumatol. 2018;70(Suppl 10): Abstract L11.
Comorbidities are important in psoriasis care
LAS VEGAS – Pay attention to comorbidities in your psoriasis patients because there may not be anyone else doing so.
“Many of our patients don’t have primary care physicians; many are untreated for psoriasis. They come to a clinical trial to get treated – some of them may not have insurance – so it is important for us to watch for these comorbidities,” Kristina C. Duffin, MD, said at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.
Yet, that does not seem to be happening consistently, according to Dr. Duffin, of the department of dermatology at the University of Utah, Salt Lake City. One in five dermatologists admitted to never screening or referring their psoriasis patients for management of cardiovascular risks in a 2015 survey (J Am Acad Dermatol. 2015 doi: 10.1016/j.jaad.2015.07.029).
Often patients at the start of biologic therapy are counseled about the risk for developing tuberculosis, yet the lifetime risk for doing so in the United States is 0.3%. Similarly, patients are often counseled on the risk for developing lymphoma, even though the excess risk for developing lymphoma that can be attributed to psoriasis treatment is 7.9 per 100,000 psoriasis patients per year. That screening seems to be driven by warnings issued in direct-to-consumer advertising, Dr. Duffin suggested.
“Although psoriasis patients have an increased relative risk of lymphoma, the absolute risk attributable to psoriasis is low,” Dr. Duffin pointed out.
Some of the comorbidities she advised dermatologists to watch for are described below.
Psoriatic arthritis
Psoriatic arthritis is the most important psoriasis comorbidity, Dr. Duffin said. Between 20% and 30% of psoriasis patients will develop psoriatic arthritis.
In a study of 1,511 patients in 48 centers in Germany, 21% of psoriasis patients were diagnosed with psoriatic arthritis and of those, more than 95% had active arthritis and 53% had five or more affected joints (Br J Dermatol. 2009;160[5]:1040-7).
The GRAPPA app is an easy, free screening tool for psoriatic arthritis; patients who score 3 or more out of 5 items on the psoriasis epidemiology screening tool (PEST) are deemed positive for psoriatic arthritis, Dr. Duffin noted.
Cardiovascular disease
Psoriasis patients are at increased risk of myocardial infarction, stroke, cardiovascular death, diabetes, and chronic kidney disease, Dr. Duffin said. In fact, CV risk from severe psoriasis is similar to the risk conferred by diabetes.
She added that there is epidemiologic evidence for CV risk modification with several of the biologics approved for psoriasis.
Hypertension
Hypertension is prevalent and more severe in psoriasis patients, Dr. Duffin said, citing a 2011 case-control study of electronic medical records at the University of California, Davis. Psoriasis patients with hypertension were 5 times more likely than patients without psoriasis to be on one antihypertensive medication, 9.5 times more likely to be on two, and almost 20 times more likely to be on four antihypertensive medications (PLoS One. 2011 Mar 29;6[3]:e18227. doi: 10.1371/journal.pone.0018227).
Importantly, few primary care physicians and cardiologists are aware of the increased risk for hypertension in psoriasis patients.
Less than half (45%) of primary care physicians and 57% of cardiologists reported they were aware that psoriasis was associated with worse cardiovascular outcome, and only 43% of physicians reported screening psoriasis patients for hypertension starting at age 20 years, according to a 2012 survey of 251 physicians (J Am Acad Dermatol. 2012 Sep;67[3]:357-62).
Dr. Duffin called on dermatologists to ensure that the primary care physicians they work with understand these increased risks.
“Commit to including a comment in consultation letters or letters back to primary care physicians that talks about the cardiovascular risks of the disease,” she said.
Dr. Duffin reported that she is a consultant and has received grant or contracted research support for many companies that manufacture dermatologic therapies.
SDEF and this news organization are owned by the same parent company.
LAS VEGAS – Pay attention to comorbidities in your psoriasis patients because there may not be anyone else doing so.
“Many of our patients don’t have primary care physicians; many are untreated for psoriasis. They come to a clinical trial to get treated – some of them may not have insurance – so it is important for us to watch for these comorbidities,” Kristina C. Duffin, MD, said at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.
Yet, that does not seem to be happening consistently, according to Dr. Duffin, of the department of dermatology at the University of Utah, Salt Lake City. One in five dermatologists admitted to never screening or referring their psoriasis patients for management of cardiovascular risks in a 2015 survey (J Am Acad Dermatol. 2015 doi: 10.1016/j.jaad.2015.07.029).
Often patients at the start of biologic therapy are counseled about the risk for developing tuberculosis, yet the lifetime risk for doing so in the United States is 0.3%. Similarly, patients are often counseled on the risk for developing lymphoma, even though the excess risk for developing lymphoma that can be attributed to psoriasis treatment is 7.9 per 100,000 psoriasis patients per year. That screening seems to be driven by warnings issued in direct-to-consumer advertising, Dr. Duffin suggested.
“Although psoriasis patients have an increased relative risk of lymphoma, the absolute risk attributable to psoriasis is low,” Dr. Duffin pointed out.
Some of the comorbidities she advised dermatologists to watch for are described below.
Psoriatic arthritis
Psoriatic arthritis is the most important psoriasis comorbidity, Dr. Duffin said. Between 20% and 30% of psoriasis patients will develop psoriatic arthritis.
In a study of 1,511 patients in 48 centers in Germany, 21% of psoriasis patients were diagnosed with psoriatic arthritis and of those, more than 95% had active arthritis and 53% had five or more affected joints (Br J Dermatol. 2009;160[5]:1040-7).
The GRAPPA app is an easy, free screening tool for psoriatic arthritis; patients who score 3 or more out of 5 items on the psoriasis epidemiology screening tool (PEST) are deemed positive for psoriatic arthritis, Dr. Duffin noted.
Cardiovascular disease
Psoriasis patients are at increased risk of myocardial infarction, stroke, cardiovascular death, diabetes, and chronic kidney disease, Dr. Duffin said. In fact, CV risk from severe psoriasis is similar to the risk conferred by diabetes.
She added that there is epidemiologic evidence for CV risk modification with several of the biologics approved for psoriasis.
Hypertension
Hypertension is prevalent and more severe in psoriasis patients, Dr. Duffin said, citing a 2011 case-control study of electronic medical records at the University of California, Davis. Psoriasis patients with hypertension were 5 times more likely than patients without psoriasis to be on one antihypertensive medication, 9.5 times more likely to be on two, and almost 20 times more likely to be on four antihypertensive medications (PLoS One. 2011 Mar 29;6[3]:e18227. doi: 10.1371/journal.pone.0018227).
Importantly, few primary care physicians and cardiologists are aware of the increased risk for hypertension in psoriasis patients.
Less than half (45%) of primary care physicians and 57% of cardiologists reported they were aware that psoriasis was associated with worse cardiovascular outcome, and only 43% of physicians reported screening psoriasis patients for hypertension starting at age 20 years, according to a 2012 survey of 251 physicians (J Am Acad Dermatol. 2012 Sep;67[3]:357-62).
Dr. Duffin called on dermatologists to ensure that the primary care physicians they work with understand these increased risks.
“Commit to including a comment in consultation letters or letters back to primary care physicians that talks about the cardiovascular risks of the disease,” she said.
Dr. Duffin reported that she is a consultant and has received grant or contracted research support for many companies that manufacture dermatologic therapies.
SDEF and this news organization are owned by the same parent company.
LAS VEGAS – Pay attention to comorbidities in your psoriasis patients because there may not be anyone else doing so.
“Many of our patients don’t have primary care physicians; many are untreated for psoriasis. They come to a clinical trial to get treated – some of them may not have insurance – so it is important for us to watch for these comorbidities,” Kristina C. Duffin, MD, said at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.
Yet, that does not seem to be happening consistently, according to Dr. Duffin, of the department of dermatology at the University of Utah, Salt Lake City. One in five dermatologists admitted to never screening or referring their psoriasis patients for management of cardiovascular risks in a 2015 survey (J Am Acad Dermatol. 2015 doi: 10.1016/j.jaad.2015.07.029).
Often patients at the start of biologic therapy are counseled about the risk for developing tuberculosis, yet the lifetime risk for doing so in the United States is 0.3%. Similarly, patients are often counseled on the risk for developing lymphoma, even though the excess risk for developing lymphoma that can be attributed to psoriasis treatment is 7.9 per 100,000 psoriasis patients per year. That screening seems to be driven by warnings issued in direct-to-consumer advertising, Dr. Duffin suggested.
“Although psoriasis patients have an increased relative risk of lymphoma, the absolute risk attributable to psoriasis is low,” Dr. Duffin pointed out.
Some of the comorbidities she advised dermatologists to watch for are described below.
Psoriatic arthritis
Psoriatic arthritis is the most important psoriasis comorbidity, Dr. Duffin said. Between 20% and 30% of psoriasis patients will develop psoriatic arthritis.
In a study of 1,511 patients in 48 centers in Germany, 21% of psoriasis patients were diagnosed with psoriatic arthritis and of those, more than 95% had active arthritis and 53% had five or more affected joints (Br J Dermatol. 2009;160[5]:1040-7).
The GRAPPA app is an easy, free screening tool for psoriatic arthritis; patients who score 3 or more out of 5 items on the psoriasis epidemiology screening tool (PEST) are deemed positive for psoriatic arthritis, Dr. Duffin noted.
Cardiovascular disease
Psoriasis patients are at increased risk of myocardial infarction, stroke, cardiovascular death, diabetes, and chronic kidney disease, Dr. Duffin said. In fact, CV risk from severe psoriasis is similar to the risk conferred by diabetes.
She added that there is epidemiologic evidence for CV risk modification with several of the biologics approved for psoriasis.
Hypertension
Hypertension is prevalent and more severe in psoriasis patients, Dr. Duffin said, citing a 2011 case-control study of electronic medical records at the University of California, Davis. Psoriasis patients with hypertension were 5 times more likely than patients without psoriasis to be on one antihypertensive medication, 9.5 times more likely to be on two, and almost 20 times more likely to be on four antihypertensive medications (PLoS One. 2011 Mar 29;6[3]:e18227. doi: 10.1371/journal.pone.0018227).
Importantly, few primary care physicians and cardiologists are aware of the increased risk for hypertension in psoriasis patients.
Less than half (45%) of primary care physicians and 57% of cardiologists reported they were aware that psoriasis was associated with worse cardiovascular outcome, and only 43% of physicians reported screening psoriasis patients for hypertension starting at age 20 years, according to a 2012 survey of 251 physicians (J Am Acad Dermatol. 2012 Sep;67[3]:357-62).
Dr. Duffin called on dermatologists to ensure that the primary care physicians they work with understand these increased risks.
“Commit to including a comment in consultation letters or letters back to primary care physicians that talks about the cardiovascular risks of the disease,” she said.
Dr. Duffin reported that she is a consultant and has received grant or contracted research support for many companies that manufacture dermatologic therapies.
SDEF and this news organization are owned by the same parent company.
REPORTING FROM SDEF LAS VEGAS DERMATOLOGY SEMINAR
Over one-third of psoriasis patients have PsA
Over one-third of psoriasis patients have PsA
About two-thirds of patients with psoriasis in a national registry also had psoriatic arthritis (PsA) and/or psoriasis in at least one challenging-to-treat (CTT) area, and one-quarter had both, according to Kristina Callis Duffin, MD, of the University of Utah, Salt Lake City, and her associates.
Their analysis included 2,042 psoriasis patients who were enrolled in the Corrona Psoriasis Registry between April 2015 and May 2018 and initiated biologic treatment during that time. The mean age was 49.6 years, 80% of the patients were white, and 51% were obese. Mean disease duration was 19.9 years and 89.2% of the patients had moderate to severe disease. CTT areas include the scalp, nails, and palmoplantar areas.
A total of 784 people in the cohort (38.4%) had PsA, 778 (38.1%) had scalp psoriasis, 326 (16.0%) had nail psoriasis, 223 (10.9%) had palmoplantar psoriasis, and 535 (26.2%) had both PsA and psoriasis in at least two CTT areas. The most common combinations were PsA plus scalp psoriasis and PsA plus nail and scalp psoriasis.
“These results indicate a need to further characterize patients with psoriasis who have PsA and CTT areas and evaluate the impact of these factors to better understand their treatment needs,” the investigators noted.
The Corrona registry has been supported by numerous pharmaceutical companies, and the study authors reported numerous financial relationships with industry; two authors are Novartis employees.
Secukinumab effective for slowing radiographic progression in active PsA
Treatment with secukinumab significantly reduced radiographic progression in patients with active PsA, according to Désirée van der Heijde, MD, PhD, professor of rheumatology at Leiden University Medical Center, and her associates.
The results come from an analysis of the FUTURE 5 trial, a study of 996 patients with active PsA despite previous NSAID treatment, disease-modifying antirheumatic drug treatment, or anti–tumor necrosis factor (TNF) therapy. Patients were randomized to receive 300 mg subcutaneous secukinumab with loading dose, 150 mg secukinumab with loading dose, 150 mg secukinumab without loading dose, or placebo, at baseline; weeks 1, 2, 3, and 4; then every 4 weeks.
After 24 weeks, the mean change in van der Heijde–modified Total Sharp Score for PsA was 0.08 for the 300-mg secukinumab group (P less than .01), 0.17 for the 150-mg secukinumab with loading dose group (P less than .05), a reduction of 0.09 for the 150-mg secukinumab without loading dose group (P less than .01), and 0.50 for the placebo group. Lower radiographic progression was seen regardless of prior anti-TNF or concomitant methotrexate treatment.
The study was funded by Novartis. The study authors reported financial disclosures with numerous companies; five authors are Novartis employees.
Tildrakizumab sustains efficacy in plaque psoriasis treatment after 1 year
Nearly all patients receiving the interleukin-23 inhibitor tildrakizumab for the treatment of moderate to severe plaque psoriasis maintained or improved their Psoriasis Area and Severity Index (PASI) response rate after 52 weeks of treatment, compared with their response after 28 weeks.
The analysis, conducted by Boni E. Elewski, MD, of the University of Alabama at Birmingham, and her associates, included 352 patients who received 100 mg tildrakizumab and 313 who received 200 mg tildrakizumab. Treatment was received at baseline, at 4 weeks, and then every 12 weeks afterward.
At week 28, the proportions of patients achieving PASI 100, PASI 90-99, PASI 75-89, and PASI 50-74 at week 28 were 25.9%, 38.4%, 25.3%, and 10.5%, respectively, among those treated with the 100-mg dose. The proportions were 24.6%, 24.3%, 19.5%, and 31.6%, respectively, among those treated with the 200-mg dose.
In patients who achieved at least PASI 90 on either dose at week 28, 88.9%-89.4% maintained that response at week 52. For patients with PASI 75-89, 39.3%-40.4% maintained that response and 33.7%-41.0% achieved a PASI 90 response. At week 52, in patients with PASI 50-74, 20.2%-29.7% achieved at least a PASI 90, 52.5%-64.9% achieved PASI 75, and only 2.6% of patients on either dose had fallen below PASI 50.
Four study authors reported being clinical investigators on studies sponsored by Merck and Sun Pharmaceuticals; five authors are employees of Sun Pharmaceuticals.
Halobetasol/tazarotene combination most effective for plaque psoriasis treatment
A fixed combination of halobetasol propionate 0.01% and tazarotene 0.045% lotion provided a synergistic effect over either component on its own for the treatment of plaque psoriasis, according to Leon H. Kircik, MD, of Indiana University, Indianapolis, and his associates.
The investigators performed a post hoc analysis of 212 patients with moderate to severe plaque psoriasis randomized to receive either the halobetasol/tazarotene combination, halobetasol only, tazarotene only, or vehicle only for 8 weeks, with follow-up at 12 weeks. Treatment success was based on the proportion of patients who achieved at least a 2-grade improvement in the Investigator Global Assessment (IGA) score, IGA scores of “clear” or “almost clear,” and percent change from baseline in IGA multiplied by Body Surface Area (BSA) composite score (IGAxBSA). “Synergy was calculated by summing up the contribution of the individual active ingredients (HP and TAZ) to overall efficacy and comparing to the efficacy achieved with HP/TAZ lotion relative to vehicle,” the authors explained.
Relative to vehicle, treatment success for halobetasol/tazarotene after 8 weeks was 42.8%, 23.6% for halobetasol alone, and 9.0% for tazarotene alone. After 12 weeks, the difference was 31.3%, 14.1%, and 5.9%, respectively. The percent change in IGAxBSA scores from baseline after 8 weeks, relative to vehicle, were 51.6%, 37.3%, and 3.3%, respectively. After 12 weeks, the change was 47.3%, 25.7%, and 8.6%, respectively.
After 8 weeks, the synergy ratio for treatment success and IGAxBSA scores for the halobetasol/tazarotene combination was 1.3. After 12 weeks, the synergy ratio for treatment success was 1.6 and the ratio for IGAxBSA scores was 1.4.
“By combining two agents into one once-daily formulation, this novel formulation reduces the number of product applications and may help patient adherence,” the study authors noted.
Dr. Kircik reported serving as a consultant and investigator for Valeant Pharmaceuticals. One study author is an employee of Bausch Health and Ortho Dermatologics, and another is an employee of Dow Pharmaceutical Sciences (a division of Valeant).
Brodalumab demonstrates low immunogenicity in moderate to severe psoriasis
The immunogenicity of brodalumab in patients with moderate to severe plaque psoriasis was low and did not compromise the efficacy or safety profile of the drug, according to Kristian Reich, MD, of Dermatologikum Berlin and SCIderm Research Institute in Hamburg, Germany, and his associates.
Data from a 12-week, phase 2 trial with a 352-week, open-label extension and three 52-week phase 3 trials were included in the analysis. Antidrug antibodies (ADAs) were tested, and positive samples were further analyzed for neutralizing ADAs by a cell-based assay.
Out of the 4,461 patients who received brodalumab, 122 (2.7%) were positive for ADAs after starting brodalumab. The incidence rate ranged from 1.9% to 3.4% between all dosing groups (140 mg, 210 mg, variable dosing, and 210 mg of brodalumab after ustekinumab). In 58 (1.4%) of patients, ADAs were transient. No patients had neutralizing ADAs, and no evidence of altered pharmacokinetics, loss of efficacy, or changes in the safety profile of brodalumab in subjects positive for ADAs was seen.
No significant difference was seen in the incidence rate of hypersensitivity or injection site reactions in brodalumab, compared with placebo or ustekinumab. The most common injection site reactions were injection site pain, erythema, and bruising.
The study was supported by Amgen. The study authors reported numerous disclosures. Two authors are employees of Leo Pharma, one author is a former employee of the company.
Secukinumab improves patient-reported outcomes in CTT psoriasis
Treatment with secukinumab significantly improved patient-reported outcomes such as fatigue, itch, pain, and quality of life measures in patients with CTT psoriasis after 6 months, according to Jerry Bagel, MD, of the Psoriasis Treatment Center of Central New Jersey, East Windsor, and his associates.
A total of 68 patients with psoriasis localized to at least one CTT area who were enrolled in the Corrona Psoriasis Registry from April 15, 2015, through May 10, 2018, and were receiving secukinumab for the entirety of the 6-month study period were included in the analysis. Patient-reported outcomes included in the analysis were fatigue, itch, pain, Dermatology Quality of Life Index (DLQI) score, and Work Productivity and Activity Impairment (WPAI) scale.
The mean age at enrollment was 51.2 years and almost 80% of patients were white. Mean psoriasis duration was 21.8 years and nearly half had PsA.
Visual analog scale scores improved over baseline for fatigue (mean, 23.2 vs. 33.2; P = .01), itch (20.9 vs. 49.6; P less than .0001), and pain (12.1 vs. 33.8; P less than .0001). DLQI scores also improved (2.9 vs. 8.1; P less than .0001), and the proportion of patients who reported that psoriasis had at least a moderate effect on their life was reduced after 6 months (22.1% vs. 59.7%; P less than .0001).
Based on WPAI results, patients experienced significant improvements in the percentage of daily activities impaired (mean, 9.5% vs 17.5%; P = .0075); of the 42 patients who were employed, both impairment percentage (3.7% vs. 11.2%; P = .0148) and percentage of work hours affected (4.9% vs. 11.9%; P = .0486) were reduced from baseline.
“These results are consistent with previous reports from secukinumab clinical trials; however, additional real-world studies are needed to evaluate the long-term effectiveness of secukinumab for improving [patient-reported outcomes] in patients with psoriasis in CTT areas,” the authors noted.
The Corrona registry has been supported by numerous pharmaceutical companies, and several study authors reported various disclosures with industry. Two authors are Novartis employees. The study was supported by Novartis; the company participated in the interpretation of data and review and approval of the abstract.
These posters were presented at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar. SDEF and this news organization are owned by the same parent company.
Over one-third of psoriasis patients have PsA
About two-thirds of patients with psoriasis in a national registry also had psoriatic arthritis (PsA) and/or psoriasis in at least one challenging-to-treat (CTT) area, and one-quarter had both, according to Kristina Callis Duffin, MD, of the University of Utah, Salt Lake City, and her associates.
Their analysis included 2,042 psoriasis patients who were enrolled in the Corrona Psoriasis Registry between April 2015 and May 2018 and initiated biologic treatment during that time. The mean age was 49.6 years, 80% of the patients were white, and 51% were obese. Mean disease duration was 19.9 years and 89.2% of the patients had moderate to severe disease. CTT areas include the scalp, nails, and palmoplantar areas.
A total of 784 people in the cohort (38.4%) had PsA, 778 (38.1%) had scalp psoriasis, 326 (16.0%) had nail psoriasis, 223 (10.9%) had palmoplantar psoriasis, and 535 (26.2%) had both PsA and psoriasis in at least two CTT areas. The most common combinations were PsA plus scalp psoriasis and PsA plus nail and scalp psoriasis.
“These results indicate a need to further characterize patients with psoriasis who have PsA and CTT areas and evaluate the impact of these factors to better understand their treatment needs,” the investigators noted.
The Corrona registry has been supported by numerous pharmaceutical companies, and the study authors reported numerous financial relationships with industry; two authors are Novartis employees.
Secukinumab effective for slowing radiographic progression in active PsA
Treatment with secukinumab significantly reduced radiographic progression in patients with active PsA, according to Désirée van der Heijde, MD, PhD, professor of rheumatology at Leiden University Medical Center, and her associates.
The results come from an analysis of the FUTURE 5 trial, a study of 996 patients with active PsA despite previous NSAID treatment, disease-modifying antirheumatic drug treatment, or anti–tumor necrosis factor (TNF) therapy. Patients were randomized to receive 300 mg subcutaneous secukinumab with loading dose, 150 mg secukinumab with loading dose, 150 mg secukinumab without loading dose, or placebo, at baseline; weeks 1, 2, 3, and 4; then every 4 weeks.
After 24 weeks, the mean change in van der Heijde–modified Total Sharp Score for PsA was 0.08 for the 300-mg secukinumab group (P less than .01), 0.17 for the 150-mg secukinumab with loading dose group (P less than .05), a reduction of 0.09 for the 150-mg secukinumab without loading dose group (P less than .01), and 0.50 for the placebo group. Lower radiographic progression was seen regardless of prior anti-TNF or concomitant methotrexate treatment.
The study was funded by Novartis. The study authors reported financial disclosures with numerous companies; five authors are Novartis employees.
Tildrakizumab sustains efficacy in plaque psoriasis treatment after 1 year
Nearly all patients receiving the interleukin-23 inhibitor tildrakizumab for the treatment of moderate to severe plaque psoriasis maintained or improved their Psoriasis Area and Severity Index (PASI) response rate after 52 weeks of treatment, compared with their response after 28 weeks.
The analysis, conducted by Boni E. Elewski, MD, of the University of Alabama at Birmingham, and her associates, included 352 patients who received 100 mg tildrakizumab and 313 who received 200 mg tildrakizumab. Treatment was received at baseline, at 4 weeks, and then every 12 weeks afterward.
At week 28, the proportions of patients achieving PASI 100, PASI 90-99, PASI 75-89, and PASI 50-74 at week 28 were 25.9%, 38.4%, 25.3%, and 10.5%, respectively, among those treated with the 100-mg dose. The proportions were 24.6%, 24.3%, 19.5%, and 31.6%, respectively, among those treated with the 200-mg dose.
In patients who achieved at least PASI 90 on either dose at week 28, 88.9%-89.4% maintained that response at week 52. For patients with PASI 75-89, 39.3%-40.4% maintained that response and 33.7%-41.0% achieved a PASI 90 response. At week 52, in patients with PASI 50-74, 20.2%-29.7% achieved at least a PASI 90, 52.5%-64.9% achieved PASI 75, and only 2.6% of patients on either dose had fallen below PASI 50.
Four study authors reported being clinical investigators on studies sponsored by Merck and Sun Pharmaceuticals; five authors are employees of Sun Pharmaceuticals.
Halobetasol/tazarotene combination most effective for plaque psoriasis treatment
A fixed combination of halobetasol propionate 0.01% and tazarotene 0.045% lotion provided a synergistic effect over either component on its own for the treatment of plaque psoriasis, according to Leon H. Kircik, MD, of Indiana University, Indianapolis, and his associates.
The investigators performed a post hoc analysis of 212 patients with moderate to severe plaque psoriasis randomized to receive either the halobetasol/tazarotene combination, halobetasol only, tazarotene only, or vehicle only for 8 weeks, with follow-up at 12 weeks. Treatment success was based on the proportion of patients who achieved at least a 2-grade improvement in the Investigator Global Assessment (IGA) score, IGA scores of “clear” or “almost clear,” and percent change from baseline in IGA multiplied by Body Surface Area (BSA) composite score (IGAxBSA). “Synergy was calculated by summing up the contribution of the individual active ingredients (HP and TAZ) to overall efficacy and comparing to the efficacy achieved with HP/TAZ lotion relative to vehicle,” the authors explained.
Relative to vehicle, treatment success for halobetasol/tazarotene after 8 weeks was 42.8%, 23.6% for halobetasol alone, and 9.0% for tazarotene alone. After 12 weeks, the difference was 31.3%, 14.1%, and 5.9%, respectively. The percent change in IGAxBSA scores from baseline after 8 weeks, relative to vehicle, were 51.6%, 37.3%, and 3.3%, respectively. After 12 weeks, the change was 47.3%, 25.7%, and 8.6%, respectively.
After 8 weeks, the synergy ratio for treatment success and IGAxBSA scores for the halobetasol/tazarotene combination was 1.3. After 12 weeks, the synergy ratio for treatment success was 1.6 and the ratio for IGAxBSA scores was 1.4.
“By combining two agents into one once-daily formulation, this novel formulation reduces the number of product applications and may help patient adherence,” the study authors noted.
Dr. Kircik reported serving as a consultant and investigator for Valeant Pharmaceuticals. One study author is an employee of Bausch Health and Ortho Dermatologics, and another is an employee of Dow Pharmaceutical Sciences (a division of Valeant).
Brodalumab demonstrates low immunogenicity in moderate to severe psoriasis
The immunogenicity of brodalumab in patients with moderate to severe plaque psoriasis was low and did not compromise the efficacy or safety profile of the drug, according to Kristian Reich, MD, of Dermatologikum Berlin and SCIderm Research Institute in Hamburg, Germany, and his associates.
Data from a 12-week, phase 2 trial with a 352-week, open-label extension and three 52-week phase 3 trials were included in the analysis. Antidrug antibodies (ADAs) were tested, and positive samples were further analyzed for neutralizing ADAs by a cell-based assay.
Out of the 4,461 patients who received brodalumab, 122 (2.7%) were positive for ADAs after starting brodalumab. The incidence rate ranged from 1.9% to 3.4% between all dosing groups (140 mg, 210 mg, variable dosing, and 210 mg of brodalumab after ustekinumab). In 58 (1.4%) of patients, ADAs were transient. No patients had neutralizing ADAs, and no evidence of altered pharmacokinetics, loss of efficacy, or changes in the safety profile of brodalumab in subjects positive for ADAs was seen.
No significant difference was seen in the incidence rate of hypersensitivity or injection site reactions in brodalumab, compared with placebo or ustekinumab. The most common injection site reactions were injection site pain, erythema, and bruising.
The study was supported by Amgen. The study authors reported numerous disclosures. Two authors are employees of Leo Pharma, one author is a former employee of the company.
Secukinumab improves patient-reported outcomes in CTT psoriasis
Treatment with secukinumab significantly improved patient-reported outcomes such as fatigue, itch, pain, and quality of life measures in patients with CTT psoriasis after 6 months, according to Jerry Bagel, MD, of the Psoriasis Treatment Center of Central New Jersey, East Windsor, and his associates.
A total of 68 patients with psoriasis localized to at least one CTT area who were enrolled in the Corrona Psoriasis Registry from April 15, 2015, through May 10, 2018, and were receiving secukinumab for the entirety of the 6-month study period were included in the analysis. Patient-reported outcomes included in the analysis were fatigue, itch, pain, Dermatology Quality of Life Index (DLQI) score, and Work Productivity and Activity Impairment (WPAI) scale.
The mean age at enrollment was 51.2 years and almost 80% of patients were white. Mean psoriasis duration was 21.8 years and nearly half had PsA.
Visual analog scale scores improved over baseline for fatigue (mean, 23.2 vs. 33.2; P = .01), itch (20.9 vs. 49.6; P less than .0001), and pain (12.1 vs. 33.8; P less than .0001). DLQI scores also improved (2.9 vs. 8.1; P less than .0001), and the proportion of patients who reported that psoriasis had at least a moderate effect on their life was reduced after 6 months (22.1% vs. 59.7%; P less than .0001).
Based on WPAI results, patients experienced significant improvements in the percentage of daily activities impaired (mean, 9.5% vs 17.5%; P = .0075); of the 42 patients who were employed, both impairment percentage (3.7% vs. 11.2%; P = .0148) and percentage of work hours affected (4.9% vs. 11.9%; P = .0486) were reduced from baseline.
“These results are consistent with previous reports from secukinumab clinical trials; however, additional real-world studies are needed to evaluate the long-term effectiveness of secukinumab for improving [patient-reported outcomes] in patients with psoriasis in CTT areas,” the authors noted.
The Corrona registry has been supported by numerous pharmaceutical companies, and several study authors reported various disclosures with industry. Two authors are Novartis employees. The study was supported by Novartis; the company participated in the interpretation of data and review and approval of the abstract.
These posters were presented at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar. SDEF and this news organization are owned by the same parent company.
Over one-third of psoriasis patients have PsA
About two-thirds of patients with psoriasis in a national registry also had psoriatic arthritis (PsA) and/or psoriasis in at least one challenging-to-treat (CTT) area, and one-quarter had both, according to Kristina Callis Duffin, MD, of the University of Utah, Salt Lake City, and her associates.
Their analysis included 2,042 psoriasis patients who were enrolled in the Corrona Psoriasis Registry between April 2015 and May 2018 and initiated biologic treatment during that time. The mean age was 49.6 years, 80% of the patients were white, and 51% were obese. Mean disease duration was 19.9 years and 89.2% of the patients had moderate to severe disease. CTT areas include the scalp, nails, and palmoplantar areas.
A total of 784 people in the cohort (38.4%) had PsA, 778 (38.1%) had scalp psoriasis, 326 (16.0%) had nail psoriasis, 223 (10.9%) had palmoplantar psoriasis, and 535 (26.2%) had both PsA and psoriasis in at least two CTT areas. The most common combinations were PsA plus scalp psoriasis and PsA plus nail and scalp psoriasis.
“These results indicate a need to further characterize patients with psoriasis who have PsA and CTT areas and evaluate the impact of these factors to better understand their treatment needs,” the investigators noted.
The Corrona registry has been supported by numerous pharmaceutical companies, and the study authors reported numerous financial relationships with industry; two authors are Novartis employees.
Secukinumab effective for slowing radiographic progression in active PsA
Treatment with secukinumab significantly reduced radiographic progression in patients with active PsA, according to Désirée van der Heijde, MD, PhD, professor of rheumatology at Leiden University Medical Center, and her associates.
The results come from an analysis of the FUTURE 5 trial, a study of 996 patients with active PsA despite previous NSAID treatment, disease-modifying antirheumatic drug treatment, or anti–tumor necrosis factor (TNF) therapy. Patients were randomized to receive 300 mg subcutaneous secukinumab with loading dose, 150 mg secukinumab with loading dose, 150 mg secukinumab without loading dose, or placebo, at baseline; weeks 1, 2, 3, and 4; then every 4 weeks.
After 24 weeks, the mean change in van der Heijde–modified Total Sharp Score for PsA was 0.08 for the 300-mg secukinumab group (P less than .01), 0.17 for the 150-mg secukinumab with loading dose group (P less than .05), a reduction of 0.09 for the 150-mg secukinumab without loading dose group (P less than .01), and 0.50 for the placebo group. Lower radiographic progression was seen regardless of prior anti-TNF or concomitant methotrexate treatment.
The study was funded by Novartis. The study authors reported financial disclosures with numerous companies; five authors are Novartis employees.
Tildrakizumab sustains efficacy in plaque psoriasis treatment after 1 year
Nearly all patients receiving the interleukin-23 inhibitor tildrakizumab for the treatment of moderate to severe plaque psoriasis maintained or improved their Psoriasis Area and Severity Index (PASI) response rate after 52 weeks of treatment, compared with their response after 28 weeks.
The analysis, conducted by Boni E. Elewski, MD, of the University of Alabama at Birmingham, and her associates, included 352 patients who received 100 mg tildrakizumab and 313 who received 200 mg tildrakizumab. Treatment was received at baseline, at 4 weeks, and then every 12 weeks afterward.
At week 28, the proportions of patients achieving PASI 100, PASI 90-99, PASI 75-89, and PASI 50-74 at week 28 were 25.9%, 38.4%, 25.3%, and 10.5%, respectively, among those treated with the 100-mg dose. The proportions were 24.6%, 24.3%, 19.5%, and 31.6%, respectively, among those treated with the 200-mg dose.
In patients who achieved at least PASI 90 on either dose at week 28, 88.9%-89.4% maintained that response at week 52. For patients with PASI 75-89, 39.3%-40.4% maintained that response and 33.7%-41.0% achieved a PASI 90 response. At week 52, in patients with PASI 50-74, 20.2%-29.7% achieved at least a PASI 90, 52.5%-64.9% achieved PASI 75, and only 2.6% of patients on either dose had fallen below PASI 50.
Four study authors reported being clinical investigators on studies sponsored by Merck and Sun Pharmaceuticals; five authors are employees of Sun Pharmaceuticals.
Halobetasol/tazarotene combination most effective for plaque psoriasis treatment
A fixed combination of halobetasol propionate 0.01% and tazarotene 0.045% lotion provided a synergistic effect over either component on its own for the treatment of plaque psoriasis, according to Leon H. Kircik, MD, of Indiana University, Indianapolis, and his associates.
The investigators performed a post hoc analysis of 212 patients with moderate to severe plaque psoriasis randomized to receive either the halobetasol/tazarotene combination, halobetasol only, tazarotene only, or vehicle only for 8 weeks, with follow-up at 12 weeks. Treatment success was based on the proportion of patients who achieved at least a 2-grade improvement in the Investigator Global Assessment (IGA) score, IGA scores of “clear” or “almost clear,” and percent change from baseline in IGA multiplied by Body Surface Area (BSA) composite score (IGAxBSA). “Synergy was calculated by summing up the contribution of the individual active ingredients (HP and TAZ) to overall efficacy and comparing to the efficacy achieved with HP/TAZ lotion relative to vehicle,” the authors explained.
Relative to vehicle, treatment success for halobetasol/tazarotene after 8 weeks was 42.8%, 23.6% for halobetasol alone, and 9.0% for tazarotene alone. After 12 weeks, the difference was 31.3%, 14.1%, and 5.9%, respectively. The percent change in IGAxBSA scores from baseline after 8 weeks, relative to vehicle, were 51.6%, 37.3%, and 3.3%, respectively. After 12 weeks, the change was 47.3%, 25.7%, and 8.6%, respectively.
After 8 weeks, the synergy ratio for treatment success and IGAxBSA scores for the halobetasol/tazarotene combination was 1.3. After 12 weeks, the synergy ratio for treatment success was 1.6 and the ratio for IGAxBSA scores was 1.4.
“By combining two agents into one once-daily formulation, this novel formulation reduces the number of product applications and may help patient adherence,” the study authors noted.
Dr. Kircik reported serving as a consultant and investigator for Valeant Pharmaceuticals. One study author is an employee of Bausch Health and Ortho Dermatologics, and another is an employee of Dow Pharmaceutical Sciences (a division of Valeant).
Brodalumab demonstrates low immunogenicity in moderate to severe psoriasis
The immunogenicity of brodalumab in patients with moderate to severe plaque psoriasis was low and did not compromise the efficacy or safety profile of the drug, according to Kristian Reich, MD, of Dermatologikum Berlin and SCIderm Research Institute in Hamburg, Germany, and his associates.
Data from a 12-week, phase 2 trial with a 352-week, open-label extension and three 52-week phase 3 trials were included in the analysis. Antidrug antibodies (ADAs) were tested, and positive samples were further analyzed for neutralizing ADAs by a cell-based assay.
Out of the 4,461 patients who received brodalumab, 122 (2.7%) were positive for ADAs after starting brodalumab. The incidence rate ranged from 1.9% to 3.4% between all dosing groups (140 mg, 210 mg, variable dosing, and 210 mg of brodalumab after ustekinumab). In 58 (1.4%) of patients, ADAs were transient. No patients had neutralizing ADAs, and no evidence of altered pharmacokinetics, loss of efficacy, or changes in the safety profile of brodalumab in subjects positive for ADAs was seen.
No significant difference was seen in the incidence rate of hypersensitivity or injection site reactions in brodalumab, compared with placebo or ustekinumab. The most common injection site reactions were injection site pain, erythema, and bruising.
The study was supported by Amgen. The study authors reported numerous disclosures. Two authors are employees of Leo Pharma, one author is a former employee of the company.
Secukinumab improves patient-reported outcomes in CTT psoriasis
Treatment with secukinumab significantly improved patient-reported outcomes such as fatigue, itch, pain, and quality of life measures in patients with CTT psoriasis after 6 months, according to Jerry Bagel, MD, of the Psoriasis Treatment Center of Central New Jersey, East Windsor, and his associates.
A total of 68 patients with psoriasis localized to at least one CTT area who were enrolled in the Corrona Psoriasis Registry from April 15, 2015, through May 10, 2018, and were receiving secukinumab for the entirety of the 6-month study period were included in the analysis. Patient-reported outcomes included in the analysis were fatigue, itch, pain, Dermatology Quality of Life Index (DLQI) score, and Work Productivity and Activity Impairment (WPAI) scale.
The mean age at enrollment was 51.2 years and almost 80% of patients were white. Mean psoriasis duration was 21.8 years and nearly half had PsA.
Visual analog scale scores improved over baseline for fatigue (mean, 23.2 vs. 33.2; P = .01), itch (20.9 vs. 49.6; P less than .0001), and pain (12.1 vs. 33.8; P less than .0001). DLQI scores also improved (2.9 vs. 8.1; P less than .0001), and the proportion of patients who reported that psoriasis had at least a moderate effect on their life was reduced after 6 months (22.1% vs. 59.7%; P less than .0001).
Based on WPAI results, patients experienced significant improvements in the percentage of daily activities impaired (mean, 9.5% vs 17.5%; P = .0075); of the 42 patients who were employed, both impairment percentage (3.7% vs. 11.2%; P = .0148) and percentage of work hours affected (4.9% vs. 11.9%; P = .0486) were reduced from baseline.
“These results are consistent with previous reports from secukinumab clinical trials; however, additional real-world studies are needed to evaluate the long-term effectiveness of secukinumab for improving [patient-reported outcomes] in patients with psoriasis in CTT areas,” the authors noted.
The Corrona registry has been supported by numerous pharmaceutical companies, and several study authors reported various disclosures with industry. Two authors are Novartis employees. The study was supported by Novartis; the company participated in the interpretation of data and review and approval of the abstract.
These posters were presented at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar. SDEF and this news organization are owned by the same parent company.
FROM SDEF LAS VEGAS DERMATOLOGY SEMINAR
FDA approves adalimumab biosimilar Hyrimoz
The Food and Drug Administration has approved the adalimumab biosimilar Hyrimoz (adalimumab-adaz) for a variety of conditions, according to Sandoz, the drug’s manufacturer and a division of Novartis.
FDA approval for Hyrimoz is based on a randomized, double-blind, three-arm, parallel biosimilarity study that demonstrated equivalence for all primary pharmacokinetic parameters, according to the press release. A second study confirmed these results in patients with moderate to severe plaque psoriasis, with Hyrimoz having a safety profile similar to that of adalimumab. Hyrimoz was approved in Europe in July 2018.
Hyrimoz has been approved to treat rheumatoid arthritis, juvenile idiopathic arthritis in patients aged 4 years and older, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis, and plaque psoriasis. The most common adverse events associated with the drug, according to the label, are infections, injection site reactions, headache, and rash.
Hyrimoz is the third adalimumab biosimilar approved by the FDA.
“Biosimilars can help people suffering from chronic, debilitating conditions gain expanded access to important medicines that may change the outcome of their disease. With the FDA approval of Hyrimoz, Sandoz is one step closer to offering U.S. patients with autoimmune diseases the same critical access already available in Europe,” Stefan Hendriks, global head of biopharmaceuticals at Sandoz, said in the press release.
Find the full press release on the Novartis website.
The Food and Drug Administration has approved the adalimumab biosimilar Hyrimoz (adalimumab-adaz) for a variety of conditions, according to Sandoz, the drug’s manufacturer and a division of Novartis.
FDA approval for Hyrimoz is based on a randomized, double-blind, three-arm, parallel biosimilarity study that demonstrated equivalence for all primary pharmacokinetic parameters, according to the press release. A second study confirmed these results in patients with moderate to severe plaque psoriasis, with Hyrimoz having a safety profile similar to that of adalimumab. Hyrimoz was approved in Europe in July 2018.
Hyrimoz has been approved to treat rheumatoid arthritis, juvenile idiopathic arthritis in patients aged 4 years and older, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis, and plaque psoriasis. The most common adverse events associated with the drug, according to the label, are infections, injection site reactions, headache, and rash.
Hyrimoz is the third adalimumab biosimilar approved by the FDA.
“Biosimilars can help people suffering from chronic, debilitating conditions gain expanded access to important medicines that may change the outcome of their disease. With the FDA approval of Hyrimoz, Sandoz is one step closer to offering U.S. patients with autoimmune diseases the same critical access already available in Europe,” Stefan Hendriks, global head of biopharmaceuticals at Sandoz, said in the press release.
Find the full press release on the Novartis website.
The Food and Drug Administration has approved the adalimumab biosimilar Hyrimoz (adalimumab-adaz) for a variety of conditions, according to Sandoz, the drug’s manufacturer and a division of Novartis.
FDA approval for Hyrimoz is based on a randomized, double-blind, three-arm, parallel biosimilarity study that demonstrated equivalence for all primary pharmacokinetic parameters, according to the press release. A second study confirmed these results in patients with moderate to severe plaque psoriasis, with Hyrimoz having a safety profile similar to that of adalimumab. Hyrimoz was approved in Europe in July 2018.
Hyrimoz has been approved to treat rheumatoid arthritis, juvenile idiopathic arthritis in patients aged 4 years and older, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis, and plaque psoriasis. The most common adverse events associated with the drug, according to the label, are infections, injection site reactions, headache, and rash.
Hyrimoz is the third adalimumab biosimilar approved by the FDA.
“Biosimilars can help people suffering from chronic, debilitating conditions gain expanded access to important medicines that may change the outcome of their disease. With the FDA approval of Hyrimoz, Sandoz is one step closer to offering U.S. patients with autoimmune diseases the same critical access already available in Europe,” Stefan Hendriks, global head of biopharmaceuticals at Sandoz, said in the press release.
Find the full press release on the Novartis website.
Psoriasis adds to increased risk of cardiovascular procedures, surgery in patients with hypertension
compared with patients with hypertension alone.
“The results suggested that hypertensive patients with concurrent psoriasis experienced an earlier and more aggressive disease progression of hypertension, compared with general hypertensive patients,” Hsien-Yi Chiu, MD, PhD, from the department of dermatology at the National Taiwan University Hospital in Hsinchu, Taiwan, and his colleagues wrote in the Journal of Dermatology. “Thus, patients with hypertension and psoriasis should be considered for more aggressive strategies for prevention of primary [cardiovascular disease] and more intense assessments for cardiovascular interventions needed to improve [cardiovascular disease] outcome in these patients.”
They performed a nationwide cohort study of patients in the Taiwan National Health Insurance Research Database with new onset hypertension from 2005 to 2006. Those with psoriasis (4,039 patients) were matched by age and sex to patients in the database who were diagnosed with hypertension but not psoriasis; the mean follow-up was 5.62 years. Their mean age was 58 years and about 31% of the psoriasis cohort were female. They were divided into groups based on psoriasis severity (mild and severe psoriasis) and type (psoriasis with and without arthritis). Researchers noted patients with both psoriasis and hypertension also had higher rates of cerebrovascular disease, coronary heart disease, hyperlipidemia, and diabetes mellitus during the year prior to the study.
The outcome measured was having a cardiovascular procedure (percutaneous coronary intervention with/without stenting or percutaneous transluminal coronary angioplasty and transcatheter radiofrequency ablation for arrhythmia) and cardiovascular surgery (coronary artery bypass grafting and other surgery for heart valves, arrhythmia, cerebrovascular disease, peripheral vessels, and the aorta).
Patients with both psoriasis and hypertension were at an increased risk for having a cardiovascular procedure and surgery (adjusted hazard ratio, 1.28; 95% confidence interval, 1.07-1.53), compared with patients with only hypertension. The risk of this outcome was also increased among patients with severe psoriasis or psoriatic arthritis, compared with patients who had mild psoriasis (aHR, 1.22; 95% CI, 0.98-1.51) and with patients with psoriasis but not arthritis (aHR, 1.15; 95% CI, 0.84-1.58); however, the results did not reach statistical significance after adjustment, which the researchers attributed to the small subgroup size.
“Another possible explanation was that the observed increased requirement for cardiovascular procedure and surgery in patients with severe psoriasis was mediated by a complex interplay among inflammation, traditional risk factors for [cardiovascular disease], and antirheumatic drugs, which probably attenuate the effects conferred by psoriasis,” the authors wrote.
Limitations in the study included reliance on administrative claims data for psoriasis diagnosis, unavailability of some details of the cardiovascular procedures and surgery, lack of blood pressure data to identify hypertension severity, as well as unmeasured factors and confounders. Further, “comparative occurrence of a requirement for cardiovascular procedure and surgery in the two groups may be influenced by a competing risk for death,” the researchers noted.
This study was supported in part through grants by the National Taiwan University Hospital, Asia-Pacific La Roche–Posay Foundation 2014, and the Ministry of Science and Technology. Dr. Chiu is on the speaker’s bureau for AbbVie, Janssen Pharmaceuticals, Novartis, Eli Lilly and Pfizer. Another author has conducted clinical trials for or received fees for being a consultant or speaker for companies that include Abbvie, Boehringer Ingelheim, and Celgene. The remaining authors reported no relevant conflicts of interest.
SOURCE: Chiu H-Y et al. J Dermatol. 2018 Oct 16. doi: 10.1111/1346-8138.14654.
compared with patients with hypertension alone.
“The results suggested that hypertensive patients with concurrent psoriasis experienced an earlier and more aggressive disease progression of hypertension, compared with general hypertensive patients,” Hsien-Yi Chiu, MD, PhD, from the department of dermatology at the National Taiwan University Hospital in Hsinchu, Taiwan, and his colleagues wrote in the Journal of Dermatology. “Thus, patients with hypertension and psoriasis should be considered for more aggressive strategies for prevention of primary [cardiovascular disease] and more intense assessments for cardiovascular interventions needed to improve [cardiovascular disease] outcome in these patients.”
They performed a nationwide cohort study of patients in the Taiwan National Health Insurance Research Database with new onset hypertension from 2005 to 2006. Those with psoriasis (4,039 patients) were matched by age and sex to patients in the database who were diagnosed with hypertension but not psoriasis; the mean follow-up was 5.62 years. Their mean age was 58 years and about 31% of the psoriasis cohort were female. They were divided into groups based on psoriasis severity (mild and severe psoriasis) and type (psoriasis with and without arthritis). Researchers noted patients with both psoriasis and hypertension also had higher rates of cerebrovascular disease, coronary heart disease, hyperlipidemia, and diabetes mellitus during the year prior to the study.
The outcome measured was having a cardiovascular procedure (percutaneous coronary intervention with/without stenting or percutaneous transluminal coronary angioplasty and transcatheter radiofrequency ablation for arrhythmia) and cardiovascular surgery (coronary artery bypass grafting and other surgery for heart valves, arrhythmia, cerebrovascular disease, peripheral vessels, and the aorta).
Patients with both psoriasis and hypertension were at an increased risk for having a cardiovascular procedure and surgery (adjusted hazard ratio, 1.28; 95% confidence interval, 1.07-1.53), compared with patients with only hypertension. The risk of this outcome was also increased among patients with severe psoriasis or psoriatic arthritis, compared with patients who had mild psoriasis (aHR, 1.22; 95% CI, 0.98-1.51) and with patients with psoriasis but not arthritis (aHR, 1.15; 95% CI, 0.84-1.58); however, the results did not reach statistical significance after adjustment, which the researchers attributed to the small subgroup size.
“Another possible explanation was that the observed increased requirement for cardiovascular procedure and surgery in patients with severe psoriasis was mediated by a complex interplay among inflammation, traditional risk factors for [cardiovascular disease], and antirheumatic drugs, which probably attenuate the effects conferred by psoriasis,” the authors wrote.
Limitations in the study included reliance on administrative claims data for psoriasis diagnosis, unavailability of some details of the cardiovascular procedures and surgery, lack of blood pressure data to identify hypertension severity, as well as unmeasured factors and confounders. Further, “comparative occurrence of a requirement for cardiovascular procedure and surgery in the two groups may be influenced by a competing risk for death,” the researchers noted.
This study was supported in part through grants by the National Taiwan University Hospital, Asia-Pacific La Roche–Posay Foundation 2014, and the Ministry of Science and Technology. Dr. Chiu is on the speaker’s bureau for AbbVie, Janssen Pharmaceuticals, Novartis, Eli Lilly and Pfizer. Another author has conducted clinical trials for or received fees for being a consultant or speaker for companies that include Abbvie, Boehringer Ingelheim, and Celgene. The remaining authors reported no relevant conflicts of interest.
SOURCE: Chiu H-Y et al. J Dermatol. 2018 Oct 16. doi: 10.1111/1346-8138.14654.
compared with patients with hypertension alone.
“The results suggested that hypertensive patients with concurrent psoriasis experienced an earlier and more aggressive disease progression of hypertension, compared with general hypertensive patients,” Hsien-Yi Chiu, MD, PhD, from the department of dermatology at the National Taiwan University Hospital in Hsinchu, Taiwan, and his colleagues wrote in the Journal of Dermatology. “Thus, patients with hypertension and psoriasis should be considered for more aggressive strategies for prevention of primary [cardiovascular disease] and more intense assessments for cardiovascular interventions needed to improve [cardiovascular disease] outcome in these patients.”
They performed a nationwide cohort study of patients in the Taiwan National Health Insurance Research Database with new onset hypertension from 2005 to 2006. Those with psoriasis (4,039 patients) were matched by age and sex to patients in the database who were diagnosed with hypertension but not psoriasis; the mean follow-up was 5.62 years. Their mean age was 58 years and about 31% of the psoriasis cohort were female. They were divided into groups based on psoriasis severity (mild and severe psoriasis) and type (psoriasis with and without arthritis). Researchers noted patients with both psoriasis and hypertension also had higher rates of cerebrovascular disease, coronary heart disease, hyperlipidemia, and diabetes mellitus during the year prior to the study.
The outcome measured was having a cardiovascular procedure (percutaneous coronary intervention with/without stenting or percutaneous transluminal coronary angioplasty and transcatheter radiofrequency ablation for arrhythmia) and cardiovascular surgery (coronary artery bypass grafting and other surgery for heart valves, arrhythmia, cerebrovascular disease, peripheral vessels, and the aorta).
Patients with both psoriasis and hypertension were at an increased risk for having a cardiovascular procedure and surgery (adjusted hazard ratio, 1.28; 95% confidence interval, 1.07-1.53), compared with patients with only hypertension. The risk of this outcome was also increased among patients with severe psoriasis or psoriatic arthritis, compared with patients who had mild psoriasis (aHR, 1.22; 95% CI, 0.98-1.51) and with patients with psoriasis but not arthritis (aHR, 1.15; 95% CI, 0.84-1.58); however, the results did not reach statistical significance after adjustment, which the researchers attributed to the small subgroup size.
“Another possible explanation was that the observed increased requirement for cardiovascular procedure and surgery in patients with severe psoriasis was mediated by a complex interplay among inflammation, traditional risk factors for [cardiovascular disease], and antirheumatic drugs, which probably attenuate the effects conferred by psoriasis,” the authors wrote.
Limitations in the study included reliance on administrative claims data for psoriasis diagnosis, unavailability of some details of the cardiovascular procedures and surgery, lack of blood pressure data to identify hypertension severity, as well as unmeasured factors and confounders. Further, “comparative occurrence of a requirement for cardiovascular procedure and surgery in the two groups may be influenced by a competing risk for death,” the researchers noted.
This study was supported in part through grants by the National Taiwan University Hospital, Asia-Pacific La Roche–Posay Foundation 2014, and the Ministry of Science and Technology. Dr. Chiu is on the speaker’s bureau for AbbVie, Janssen Pharmaceuticals, Novartis, Eli Lilly and Pfizer. Another author has conducted clinical trials for or received fees for being a consultant or speaker for companies that include Abbvie, Boehringer Ingelheim, and Celgene. The remaining authors reported no relevant conflicts of interest.
SOURCE: Chiu H-Y et al. J Dermatol. 2018 Oct 16. doi: 10.1111/1346-8138.14654.
FROM THE JOURNAL OF DERMATOLOGY
Key clinical point: More aggressive cardiovascular disease preventive strategies should be considered in patients with hypertension who also have psoriasis.
Major finding: Patients with both psoriasis and hypertension were at an increased risk for requiring a cardiovascular procedure and surgery (adjusted hazard ratio, 1.28), compared with patients with hypertension alone.
Study details: A retrospective cohort study evaluated risk of this outcome in 4,039 patients with psoriasis and hypertension, compared with patients who had hypertension, matched for age and sex.
Disclosures: This study was supported in part through grants by the National Taiwan University Hospital Hsin-Chu Branch, Asia-Pacific La Roche–Posay Foundation 2014, and the Ministry of Science and Technology. Dr. Chiu is on the speaker’s bureau for companies including AbbVie, Novartis, and Eli Lilly. Another author has conducted clinical trials for or received fees for being a consultant or speaker for Abbvie, Boehringer Ingelheim, Celgene, Janssen Pharmaceuticals, Eli Lilly, Galderma, Novartis, and Pfizer. The other authors reported no relevant conflicts of interest.
Source: Chiu H-Y et al. J Dermatol. 2018 Oct 16. doi:10.1111/1346-8138.14654.
ACR readies first-ever guidelines on managing reproductive health in rheumatology
CHICAGO – Help is on the way for rheumatologists who may feel out of their depth regarding reproductive health issues in their patients.
for internal review in draft form. Lisa R. Sammaritano, MD, a leader of the expert panel that developed the evidence-based recommendations, shared highlights of the forthcoming guidelines at the annual meeting of the American College of Rheumatology.
“Our patients, fortunately, are pursuing pregnancy more often now than in years past. One of the key messages of the guidelines is that patients really do want to discuss these topics with their rheumatologist, even though that often does not happen now. What patients told us [in the guideline-development process] is their rheumatologist knows them better than their gynecologist or any of their other doctors because we have followed them for a long period of time and we understand their disease and their symptoms. They really want our input on questions about contraception, when to plan a pregnancy, and medication use,” said Dr. Sammaritano of the Hospital for Special Surgery and Cornell University in New York.
The guidelines were created over the course of a year and a half with extensive input from ob.gyns., as well as a patient panel. The project included a systematic review of more than 300 published studies in which guideline panelists attempt to find answers to an initial list of 370 questions. Dr. Sammaritano predicted that the guidelines will prove to be useful not only for rheumatologists, but for their colleagues in ob.gyn. as well. Just as rheumatologists likely haven’t kept up with the sea changes that have occurred in ob.gyn. since their medical school days, most ob.gyns. know little about rheumatic diseases.
“There’s room for education on both sides,” she observed in an interview. “I have had to write letters to gynecologists to get them to put my patients with antiphospholipid antibodies on a contraceptive that includes a progestin because the labeling says, ‘May increase risk of thrombosis.’ And yet if you look at the literature, most of the progestins do not increase the risk of thrombosis, even in patients who are already at increased risk because of a genetic prothrombotic abnormality. I practically had to sign my life away to get a gynecologist to put a progestin-containing IUD in my patient, whereas the risk of thrombosis to my patient with an unplanned pregnancy would have been 10-fold or 100-fold higher. Unplanned pregnancy is dangerous for patients with our diseases.”
And yet, she noted, half of all pregnancies in the United States are unplanned. Among women with rheumatic diseases, the proportion may well be even higher in light of their documented low rate of utilization of effective contraception.
A publication date for the guidelines won’t be set until the review is completed, but the plan is to issue three separate documents. One will address reproductive health outside of pregnancy, with key topics to include contraception, fertility preservation, menopause, and hormone replacement therapy. The second document will focus on pregnancy management, with special attention devoted to women with lupus or antiphospholipid antibodies because they are at particularly high risk of adverse pregnancy outcomes. The third document will be devoted to medications, covering issues including which medications can be continued during pregnancy and when to safely stop the ones that can’t. This section will address both maternal and paternal use of rheumatologic medications, the latter being a topic below the radar of ob.gyns.
The three medications whose paternal use in pregnancy generate the most questions in clinical practice are methotrexate, cyclophosphamide, and sulfasalazine.
“I cannot tell you how many times I’ve been asked whether male patients with rheumatic diseases need to stop their methotrexate before they plan to father a child – that’s been a big one. The answer is they don’t need to stop, but that’s a conditional recommendation because the product label still says to stop it 3 months before. But that’s based on theoretical concerns, and all the data support a lack of teratogenicity for men using methotrexate prior to and during pregnancy,” Dr. Sammaritano said.
Men on cyclophosphamide absolutely have to stop the drug 3 months before pregnancy because the drug causes DNA fragmentation in the sperm. Sulfasalazine is known to impair male fertility. The ACR guidelines will recommend that men continue the drug, but if pregnancy doesn’t occur within a reasonable time, then it’s appropriate to get a semen analysis rather than stopping sulfasalazine unnecessarily.
American College of Obstetricians and Gynecologists guidelines now recommend long-acting reversible contraception, including IUDs and progestin implants, as first-line contraception for all women. The ACR draft guidelines strongly recommend the same.
“That is new. The use of this form of contraception in women with rheumatic diseases is quite low. In general, our patients don’t use contraception as often as other women, and when they do, they don’t use effective contraception. There are many theories as to why that may be: perhaps it’s a focus on the more immediate issues of their rheumatic disease that doesn’t allow their rheumatologist to get to the point of discussing contraception,” according to Dr. Sammaritano.
Many rheumatologists will be pleasantly surprised to learn that the problem of increased risk of pelvic inflammatory disease associated with earlier-generation IUDs is no longer an issue with the current devices. And contrary to a misconception among some ob.gyns., autoimmune disease will not cause a woman to reject her IUD.
The ACR guidelines recommend continuing hydroxychloroquine in lupus patients during pregnancy – and considering starting the drug in those not already on it – because of strong evidence supporting both safety and benefit for mother and baby.
“We are recommending the use of low-dose aspirin for patients with lupus and antiphospholipid antibodies because those two conditions increase the risk for preeclampsia, and the ob.gyns. routinely use low-dose aspirin starting toward the end of the first trimester as preventive therapy. Large studies show that it reduces the risk,” she continued.
Dr. Sammaritano cautioned that the literature on the use of rheumatologic medications in pregnancy and breast feeding is generally weak – and in the case of the new oral small molecule JAK inhibitors, essentially nonexistent.
“A lot of our recommendations are conditional because we did not feel that the data support a strong recommendation. But you have to do something. As long as you communicate the idea that we’re doing the best we can with what information is available, I think patients will respond to that,” the rheumatologist said.
She reported having no financial conflicts regarding her presentation.
CHICAGO – Help is on the way for rheumatologists who may feel out of their depth regarding reproductive health issues in their patients.
for internal review in draft form. Lisa R. Sammaritano, MD, a leader of the expert panel that developed the evidence-based recommendations, shared highlights of the forthcoming guidelines at the annual meeting of the American College of Rheumatology.
“Our patients, fortunately, are pursuing pregnancy more often now than in years past. One of the key messages of the guidelines is that patients really do want to discuss these topics with their rheumatologist, even though that often does not happen now. What patients told us [in the guideline-development process] is their rheumatologist knows them better than their gynecologist or any of their other doctors because we have followed them for a long period of time and we understand their disease and their symptoms. They really want our input on questions about contraception, when to plan a pregnancy, and medication use,” said Dr. Sammaritano of the Hospital for Special Surgery and Cornell University in New York.
The guidelines were created over the course of a year and a half with extensive input from ob.gyns., as well as a patient panel. The project included a systematic review of more than 300 published studies in which guideline panelists attempt to find answers to an initial list of 370 questions. Dr. Sammaritano predicted that the guidelines will prove to be useful not only for rheumatologists, but for their colleagues in ob.gyn. as well. Just as rheumatologists likely haven’t kept up with the sea changes that have occurred in ob.gyn. since their medical school days, most ob.gyns. know little about rheumatic diseases.
“There’s room for education on both sides,” she observed in an interview. “I have had to write letters to gynecologists to get them to put my patients with antiphospholipid antibodies on a contraceptive that includes a progestin because the labeling says, ‘May increase risk of thrombosis.’ And yet if you look at the literature, most of the progestins do not increase the risk of thrombosis, even in patients who are already at increased risk because of a genetic prothrombotic abnormality. I practically had to sign my life away to get a gynecologist to put a progestin-containing IUD in my patient, whereas the risk of thrombosis to my patient with an unplanned pregnancy would have been 10-fold or 100-fold higher. Unplanned pregnancy is dangerous for patients with our diseases.”
And yet, she noted, half of all pregnancies in the United States are unplanned. Among women with rheumatic diseases, the proportion may well be even higher in light of their documented low rate of utilization of effective contraception.
A publication date for the guidelines won’t be set until the review is completed, but the plan is to issue three separate documents. One will address reproductive health outside of pregnancy, with key topics to include contraception, fertility preservation, menopause, and hormone replacement therapy. The second document will focus on pregnancy management, with special attention devoted to women with lupus or antiphospholipid antibodies because they are at particularly high risk of adverse pregnancy outcomes. The third document will be devoted to medications, covering issues including which medications can be continued during pregnancy and when to safely stop the ones that can’t. This section will address both maternal and paternal use of rheumatologic medications, the latter being a topic below the radar of ob.gyns.
The three medications whose paternal use in pregnancy generate the most questions in clinical practice are methotrexate, cyclophosphamide, and sulfasalazine.
“I cannot tell you how many times I’ve been asked whether male patients with rheumatic diseases need to stop their methotrexate before they plan to father a child – that’s been a big one. The answer is they don’t need to stop, but that’s a conditional recommendation because the product label still says to stop it 3 months before. But that’s based on theoretical concerns, and all the data support a lack of teratogenicity for men using methotrexate prior to and during pregnancy,” Dr. Sammaritano said.
Men on cyclophosphamide absolutely have to stop the drug 3 months before pregnancy because the drug causes DNA fragmentation in the sperm. Sulfasalazine is known to impair male fertility. The ACR guidelines will recommend that men continue the drug, but if pregnancy doesn’t occur within a reasonable time, then it’s appropriate to get a semen analysis rather than stopping sulfasalazine unnecessarily.
American College of Obstetricians and Gynecologists guidelines now recommend long-acting reversible contraception, including IUDs and progestin implants, as first-line contraception for all women. The ACR draft guidelines strongly recommend the same.
“That is new. The use of this form of contraception in women with rheumatic diseases is quite low. In general, our patients don’t use contraception as often as other women, and when they do, they don’t use effective contraception. There are many theories as to why that may be: perhaps it’s a focus on the more immediate issues of their rheumatic disease that doesn’t allow their rheumatologist to get to the point of discussing contraception,” according to Dr. Sammaritano.
Many rheumatologists will be pleasantly surprised to learn that the problem of increased risk of pelvic inflammatory disease associated with earlier-generation IUDs is no longer an issue with the current devices. And contrary to a misconception among some ob.gyns., autoimmune disease will not cause a woman to reject her IUD.
The ACR guidelines recommend continuing hydroxychloroquine in lupus patients during pregnancy – and considering starting the drug in those not already on it – because of strong evidence supporting both safety and benefit for mother and baby.
“We are recommending the use of low-dose aspirin for patients with lupus and antiphospholipid antibodies because those two conditions increase the risk for preeclampsia, and the ob.gyns. routinely use low-dose aspirin starting toward the end of the first trimester as preventive therapy. Large studies show that it reduces the risk,” she continued.
Dr. Sammaritano cautioned that the literature on the use of rheumatologic medications in pregnancy and breast feeding is generally weak – and in the case of the new oral small molecule JAK inhibitors, essentially nonexistent.
“A lot of our recommendations are conditional because we did not feel that the data support a strong recommendation. But you have to do something. As long as you communicate the idea that we’re doing the best we can with what information is available, I think patients will respond to that,” the rheumatologist said.
She reported having no financial conflicts regarding her presentation.
CHICAGO – Help is on the way for rheumatologists who may feel out of their depth regarding reproductive health issues in their patients.
for internal review in draft form. Lisa R. Sammaritano, MD, a leader of the expert panel that developed the evidence-based recommendations, shared highlights of the forthcoming guidelines at the annual meeting of the American College of Rheumatology.
“Our patients, fortunately, are pursuing pregnancy more often now than in years past. One of the key messages of the guidelines is that patients really do want to discuss these topics with their rheumatologist, even though that often does not happen now. What patients told us [in the guideline-development process] is their rheumatologist knows them better than their gynecologist or any of their other doctors because we have followed them for a long period of time and we understand their disease and their symptoms. They really want our input on questions about contraception, when to plan a pregnancy, and medication use,” said Dr. Sammaritano of the Hospital for Special Surgery and Cornell University in New York.
The guidelines were created over the course of a year and a half with extensive input from ob.gyns., as well as a patient panel. The project included a systematic review of more than 300 published studies in which guideline panelists attempt to find answers to an initial list of 370 questions. Dr. Sammaritano predicted that the guidelines will prove to be useful not only for rheumatologists, but for their colleagues in ob.gyn. as well. Just as rheumatologists likely haven’t kept up with the sea changes that have occurred in ob.gyn. since their medical school days, most ob.gyns. know little about rheumatic diseases.
“There’s room for education on both sides,” she observed in an interview. “I have had to write letters to gynecologists to get them to put my patients with antiphospholipid antibodies on a contraceptive that includes a progestin because the labeling says, ‘May increase risk of thrombosis.’ And yet if you look at the literature, most of the progestins do not increase the risk of thrombosis, even in patients who are already at increased risk because of a genetic prothrombotic abnormality. I practically had to sign my life away to get a gynecologist to put a progestin-containing IUD in my patient, whereas the risk of thrombosis to my patient with an unplanned pregnancy would have been 10-fold or 100-fold higher. Unplanned pregnancy is dangerous for patients with our diseases.”
And yet, she noted, half of all pregnancies in the United States are unplanned. Among women with rheumatic diseases, the proportion may well be even higher in light of their documented low rate of utilization of effective contraception.
A publication date for the guidelines won’t be set until the review is completed, but the plan is to issue three separate documents. One will address reproductive health outside of pregnancy, with key topics to include contraception, fertility preservation, menopause, and hormone replacement therapy. The second document will focus on pregnancy management, with special attention devoted to women with lupus or antiphospholipid antibodies because they are at particularly high risk of adverse pregnancy outcomes. The third document will be devoted to medications, covering issues including which medications can be continued during pregnancy and when to safely stop the ones that can’t. This section will address both maternal and paternal use of rheumatologic medications, the latter being a topic below the radar of ob.gyns.
The three medications whose paternal use in pregnancy generate the most questions in clinical practice are methotrexate, cyclophosphamide, and sulfasalazine.
“I cannot tell you how many times I’ve been asked whether male patients with rheumatic diseases need to stop their methotrexate before they plan to father a child – that’s been a big one. The answer is they don’t need to stop, but that’s a conditional recommendation because the product label still says to stop it 3 months before. But that’s based on theoretical concerns, and all the data support a lack of teratogenicity for men using methotrexate prior to and during pregnancy,” Dr. Sammaritano said.
Men on cyclophosphamide absolutely have to stop the drug 3 months before pregnancy because the drug causes DNA fragmentation in the sperm. Sulfasalazine is known to impair male fertility. The ACR guidelines will recommend that men continue the drug, but if pregnancy doesn’t occur within a reasonable time, then it’s appropriate to get a semen analysis rather than stopping sulfasalazine unnecessarily.
American College of Obstetricians and Gynecologists guidelines now recommend long-acting reversible contraception, including IUDs and progestin implants, as first-line contraception for all women. The ACR draft guidelines strongly recommend the same.
“That is new. The use of this form of contraception in women with rheumatic diseases is quite low. In general, our patients don’t use contraception as often as other women, and when they do, they don’t use effective contraception. There are many theories as to why that may be: perhaps it’s a focus on the more immediate issues of their rheumatic disease that doesn’t allow their rheumatologist to get to the point of discussing contraception,” according to Dr. Sammaritano.
Many rheumatologists will be pleasantly surprised to learn that the problem of increased risk of pelvic inflammatory disease associated with earlier-generation IUDs is no longer an issue with the current devices. And contrary to a misconception among some ob.gyns., autoimmune disease will not cause a woman to reject her IUD.
The ACR guidelines recommend continuing hydroxychloroquine in lupus patients during pregnancy – and considering starting the drug in those not already on it – because of strong evidence supporting both safety and benefit for mother and baby.
“We are recommending the use of low-dose aspirin for patients with lupus and antiphospholipid antibodies because those two conditions increase the risk for preeclampsia, and the ob.gyns. routinely use low-dose aspirin starting toward the end of the first trimester as preventive therapy. Large studies show that it reduces the risk,” she continued.
Dr. Sammaritano cautioned that the literature on the use of rheumatologic medications in pregnancy and breast feeding is generally weak – and in the case of the new oral small molecule JAK inhibitors, essentially nonexistent.
“A lot of our recommendations are conditional because we did not feel that the data support a strong recommendation. But you have to do something. As long as you communicate the idea that we’re doing the best we can with what information is available, I think patients will respond to that,” the rheumatologist said.
She reported having no financial conflicts regarding her presentation.
REPORTING FROM THE ACR ANNUAL MEETING
Flu vaccination lags among patients with psoriasis
Psoriasis patients are more vulnerable to systemic infections, including influenza-related pneumonia, but a new study shows that they are less likely to receive the influenza vaccine than patients with RA.
Vaccination rates were higher in psoriasis patients aged over 50 years, those who were female, and those with other chronic medical conditions, however.
Megan H. Noe, MD, of the department of dermatology at the University of Pennsylvania, Philadelphia, and her coauthors referred to recent evidence suggesting that psoriasis involves systemic inflammation that increase the risk of comorbidities and that hospitalization rates for serious infections, including lower respiratory tract infections and pneumonia, are higher among adults with psoriasis than those who do not have psoriasis.
drawing from administrative and commercial claims data from OptumInsight Clinformatics Data Mart. They examined all adult patients with psoriasis, RA, or chronic hypertension who required oral antihypertensive medication. The study population included individuals tracked during the 2010-2011 flu season and 24 months prior (September 2008 to March 2011). This year was chosen because it was labeled as a “typical” season by the Centers for Disease Control and Prevention.
The primary outcome was a claim for an influenza vaccine, and covariates included age, length of residency, gender, and a clinical history of a range of conditions known to be associated with greater risk of influenza complications.
The population included 17,078 patients with psoriasis, 21,832 with RA, and 496,972 with chronic hypertension. After controlling for sex and age, the probability of getting a flu vaccine was similar between psoriasis and hypertension patients, but RA patients were more likely to be vaccinated than patients with psoriasis (odds ratio, 1.08; 95% confidence interval, 1.03-1.13). But the likelihood varied with age: 30-year-old patients with RA were more likely than a 30-year-old psoriasis patient to get a flu shot (OR, 1.30; 95% CI, 1.18-1.45), while a 70-year-old patient with RA was about as likely to get the flu vaccine as a 70-year-old patient with psoriasis.
Female psoriasis patients were more likely to get a flu shot than males (OR, 1.29; 95% CI, 1.20-1.38). Among the psoriasis patients, having some medical comorbidities were linked to a greater likelihood of being vaccinated, including asthma (OR, 1.58; 95% CI, 1.40-1.77), chronic liver disease (OR, 1.23; 95%, 1.03-1.47), diabetes (OR, 1.48; 95% CI, 1.36-1.63), HIV (OR, 3.68; 95% CI, 2.06-6.57), history of malignancy (OR, 1.21; 95% CI, 1.09-1.34), and psoriatic arthritis (OR, 1.40; 95% CI, 1.25-1.58).
There was no association between the use of an oral systemic therapy or biologic treatment and vaccination rates.
The authors suggested that psoriasis patients, especially younger ones, may not get adequate counseling on the value of the flu vaccine from their physicians. Studies have shown that, among the American public, health care providers are the most influential source of information about the flu vaccine. Among younger patients, the dermatologist may be a psoriasis patient’s primary health care provider, so it is important for dermatologists to counsel patients about the recommended vaccines, the authors wrote.
“Further research understanding why adults with psoriasis do not receive recommended vaccinations will help to create targeted interventions to improve vaccination rates and decrease hospitalizations in adults with psoriasis,” they concluded.
The study relied on administrative claims, so the results may not be generalizable to patients with insurance types other than those in the database or who are uninsured, the authors noted.
This study was funded by the National Psoriasis Foundation, the Dermatology Foundation, and the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Noe and three other authors did not report any disclosures, the fifth author reported multiple disclosures related to various pharmaceutical companies.
SOURCE: Noe MH et al. J Invest Dermatol. 2018 Oct 10. doi: 10.1016/j.jid.2018.09.012.
Psoriasis patients are more vulnerable to systemic infections, including influenza-related pneumonia, but a new study shows that they are less likely to receive the influenza vaccine than patients with RA.
Vaccination rates were higher in psoriasis patients aged over 50 years, those who were female, and those with other chronic medical conditions, however.
Megan H. Noe, MD, of the department of dermatology at the University of Pennsylvania, Philadelphia, and her coauthors referred to recent evidence suggesting that psoriasis involves systemic inflammation that increase the risk of comorbidities and that hospitalization rates for serious infections, including lower respiratory tract infections and pneumonia, are higher among adults with psoriasis than those who do not have psoriasis.
drawing from administrative and commercial claims data from OptumInsight Clinformatics Data Mart. They examined all adult patients with psoriasis, RA, or chronic hypertension who required oral antihypertensive medication. The study population included individuals tracked during the 2010-2011 flu season and 24 months prior (September 2008 to March 2011). This year was chosen because it was labeled as a “typical” season by the Centers for Disease Control and Prevention.
The primary outcome was a claim for an influenza vaccine, and covariates included age, length of residency, gender, and a clinical history of a range of conditions known to be associated with greater risk of influenza complications.
The population included 17,078 patients with psoriasis, 21,832 with RA, and 496,972 with chronic hypertension. After controlling for sex and age, the probability of getting a flu vaccine was similar between psoriasis and hypertension patients, but RA patients were more likely to be vaccinated than patients with psoriasis (odds ratio, 1.08; 95% confidence interval, 1.03-1.13). But the likelihood varied with age: 30-year-old patients with RA were more likely than a 30-year-old psoriasis patient to get a flu shot (OR, 1.30; 95% CI, 1.18-1.45), while a 70-year-old patient with RA was about as likely to get the flu vaccine as a 70-year-old patient with psoriasis.
Female psoriasis patients were more likely to get a flu shot than males (OR, 1.29; 95% CI, 1.20-1.38). Among the psoriasis patients, having some medical comorbidities were linked to a greater likelihood of being vaccinated, including asthma (OR, 1.58; 95% CI, 1.40-1.77), chronic liver disease (OR, 1.23; 95%, 1.03-1.47), diabetes (OR, 1.48; 95% CI, 1.36-1.63), HIV (OR, 3.68; 95% CI, 2.06-6.57), history of malignancy (OR, 1.21; 95% CI, 1.09-1.34), and psoriatic arthritis (OR, 1.40; 95% CI, 1.25-1.58).
There was no association between the use of an oral systemic therapy or biologic treatment and vaccination rates.
The authors suggested that psoriasis patients, especially younger ones, may not get adequate counseling on the value of the flu vaccine from their physicians. Studies have shown that, among the American public, health care providers are the most influential source of information about the flu vaccine. Among younger patients, the dermatologist may be a psoriasis patient’s primary health care provider, so it is important for dermatologists to counsel patients about the recommended vaccines, the authors wrote.
“Further research understanding why adults with psoriasis do not receive recommended vaccinations will help to create targeted interventions to improve vaccination rates and decrease hospitalizations in adults with psoriasis,” they concluded.
The study relied on administrative claims, so the results may not be generalizable to patients with insurance types other than those in the database or who are uninsured, the authors noted.
This study was funded by the National Psoriasis Foundation, the Dermatology Foundation, and the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Noe and three other authors did not report any disclosures, the fifth author reported multiple disclosures related to various pharmaceutical companies.
SOURCE: Noe MH et al. J Invest Dermatol. 2018 Oct 10. doi: 10.1016/j.jid.2018.09.012.
Psoriasis patients are more vulnerable to systemic infections, including influenza-related pneumonia, but a new study shows that they are less likely to receive the influenza vaccine than patients with RA.
Vaccination rates were higher in psoriasis patients aged over 50 years, those who were female, and those with other chronic medical conditions, however.
Megan H. Noe, MD, of the department of dermatology at the University of Pennsylvania, Philadelphia, and her coauthors referred to recent evidence suggesting that psoriasis involves systemic inflammation that increase the risk of comorbidities and that hospitalization rates for serious infections, including lower respiratory tract infections and pneumonia, are higher among adults with psoriasis than those who do not have psoriasis.
drawing from administrative and commercial claims data from OptumInsight Clinformatics Data Mart. They examined all adult patients with psoriasis, RA, or chronic hypertension who required oral antihypertensive medication. The study population included individuals tracked during the 2010-2011 flu season and 24 months prior (September 2008 to March 2011). This year was chosen because it was labeled as a “typical” season by the Centers for Disease Control and Prevention.
The primary outcome was a claim for an influenza vaccine, and covariates included age, length of residency, gender, and a clinical history of a range of conditions known to be associated with greater risk of influenza complications.
The population included 17,078 patients with psoriasis, 21,832 with RA, and 496,972 with chronic hypertension. After controlling for sex and age, the probability of getting a flu vaccine was similar between psoriasis and hypertension patients, but RA patients were more likely to be vaccinated than patients with psoriasis (odds ratio, 1.08; 95% confidence interval, 1.03-1.13). But the likelihood varied with age: 30-year-old patients with RA were more likely than a 30-year-old psoriasis patient to get a flu shot (OR, 1.30; 95% CI, 1.18-1.45), while a 70-year-old patient with RA was about as likely to get the flu vaccine as a 70-year-old patient with psoriasis.
Female psoriasis patients were more likely to get a flu shot than males (OR, 1.29; 95% CI, 1.20-1.38). Among the psoriasis patients, having some medical comorbidities were linked to a greater likelihood of being vaccinated, including asthma (OR, 1.58; 95% CI, 1.40-1.77), chronic liver disease (OR, 1.23; 95%, 1.03-1.47), diabetes (OR, 1.48; 95% CI, 1.36-1.63), HIV (OR, 3.68; 95% CI, 2.06-6.57), history of malignancy (OR, 1.21; 95% CI, 1.09-1.34), and psoriatic arthritis (OR, 1.40; 95% CI, 1.25-1.58).
There was no association between the use of an oral systemic therapy or biologic treatment and vaccination rates.
The authors suggested that psoriasis patients, especially younger ones, may not get adequate counseling on the value of the flu vaccine from their physicians. Studies have shown that, among the American public, health care providers are the most influential source of information about the flu vaccine. Among younger patients, the dermatologist may be a psoriasis patient’s primary health care provider, so it is important for dermatologists to counsel patients about the recommended vaccines, the authors wrote.
“Further research understanding why adults with psoriasis do not receive recommended vaccinations will help to create targeted interventions to improve vaccination rates and decrease hospitalizations in adults with psoriasis,” they concluded.
The study relied on administrative claims, so the results may not be generalizable to patients with insurance types other than those in the database or who are uninsured, the authors noted.
This study was funded by the National Psoriasis Foundation, the Dermatology Foundation, and the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Noe and three other authors did not report any disclosures, the fifth author reported multiple disclosures related to various pharmaceutical companies.
SOURCE: Noe MH et al. J Invest Dermatol. 2018 Oct 10. doi: 10.1016/j.jid.2018.09.012.
FROM THE JOURNAL OF INVESTIGATIVE DERMATOLOGY
Key clinical point: Despite vulnerability to complications, fewer psoriasis patients received the vaccine, compared with RA patients.
Major finding: Patients with RA were 8% more likely to receive a flu vaccine than patients with psoriasis.
Study details: A retrospective cohort study of 535,882 subjects with psoriasis, RA, or hypertension.
Disclosures: This study was funded by the National Psoriasis Foundation, the Dermatology Foundation, and the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Four authors did not report any disclosures; the fifth author reported multiple disclosures related to various pharmaceutical companies.
Source: Noe MH et al. J Invest Dermatol. 2018 Oct 10. doi: 10.1016/j.jid.2018.09.012.
IL inhibitor options move psoriasis treatment forward
Psoriasis patients have many options, and more are on the way, according to J. Mark Jackson, MD, of the University of Louisville, Ky.
“Know the information regarding each [treatment] to best care for your patients,” Dr. Jackson said in a presentation at the annual Coastal Dermatology Symposium.
Dr. Jackson particularly addressed the interleukin (IL)-17 inhibitors (brodalumab, ixekizumab, and secukinumab) and the IL-23 inhibitors (guselkumab, risankizumab, and tildrakizumab).
Complete clearance rates can reach 50% and higher over the long term when treating patients with IL-17 inhibitors, but patients must maintain regular dosing to maintain a response, he said.
Overall, comparisons of IL-17 inhibitors with etanercept, adalimumab, and ustekinumab “demonstrate better efficacy with no evidence of compromising safety,” he noted.
For example, secukinumab demonstrated significantly superior results when compared with ustekinumab in a randomized trial (J Am Acad Dermatol. 2015;73: 400-9). After 16 weeks of treatment, 79% of secukinumab patients achieved a 90% reduction in Psoriasis Area and Severity Index score (PASI 90) versus 58% of ustekinumab patients, he said, and the drug safety profile was consistent with the pivotal phase 3 studies of secukinumab.
Concerns persist about increased risk of inflammatory bowel disease, Crohn’s disease, and ulcerative colitis in patients taking secukinumab and other IL-17 inhibitors, but data indicate that rates are low. The risk is low “and may be related to psoriasis and not the therapy,” he explained.
Ixekizumab has been associated with more injection site reactions than secukinumab, but these tend to be mild, Dr. Jackson said. Advantages of ixekizumab are that it works quickly and has demonstrated effectiveness against genital, palmoplantar, scalp, and nail psoriasis, he added.
Brodalumab also works quickly, but it has the unique inclusion of a Risk Evaluation and Mitigation Strategies (REMS) program because of suicidal ideation and behavior in clinical trials, he noted, adding that there are more data showing rates are low and the REMS program is easier to deal with than the isotretinoin REMS. The increased risk of superficial Staphylococcus and Candida infections are noted on IL-17 inhibitor labels, but this has not been a significant issue in trials or clinical practice, he said.
What is also exciting about the IL-17 inhibitors are the approvals of ixekizumab and secukinumab for patients with psoriatic arthritis (PsA), with both agents demonstrating the ability to inhibit the structural progression of joint damage over time, Dr. Jackson commented. These data seem to be on par with that of the TNF-inhibitors, although time will tell how this bears out clinically, he noted.
IL-23 inhibitors guselkumab, tildrakizumab, and risankizumab (not yet approved) have shown similar effectiveness and are well tolerated by patients, with few injection site reactions or adverse events reported, Dr. Jackson said. The dosing regimens of each of these drugs, administered subcutaneously, are easy to follow: Treatment starts with an initial dose of either 100 mg (guselkumab and tildrakizumab) or 150 mg (risankizumab), which is followed by doses at 4 weeks and then doses every 8 weeks (guselkumab) or 12 weeks (tildrakizumab and risankizumab).
For example, in a comparison study of risankizumab with a dosage of 150 mg subcutaneously at week 0, 4, then every 12 weeks, 75% of risankizumab patients achieved PASI 90 at 16 weeks and 82% at 52 weeks, compared with 42% and 44%, respectively, for adalimumab patients.
In addition, the IL-23 inhibitors have demonstrated some benefits for PsA patients in clinical trials, but they are not currently indicated for PsA, he said.
Dr. Jackson disclosed having received research, honoraria, consulting, and/or other support from AbbVie, Accuitis, Aclaris, Celgene, Dr. Reddy’s, Galderma, Janssen, Lilly, Medimetriks, Novartis, Pfizer, Promius, Ralexar, Sienna, and TopMD.
The meeting is jointly presented by the University of Louisville and Global Academy for Medical Education. This publication and Global Academy for Medical Education are both owned by Frontline Medical Communications.
Psoriasis patients have many options, and more are on the way, according to J. Mark Jackson, MD, of the University of Louisville, Ky.
“Know the information regarding each [treatment] to best care for your patients,” Dr. Jackson said in a presentation at the annual Coastal Dermatology Symposium.
Dr. Jackson particularly addressed the interleukin (IL)-17 inhibitors (brodalumab, ixekizumab, and secukinumab) and the IL-23 inhibitors (guselkumab, risankizumab, and tildrakizumab).
Complete clearance rates can reach 50% and higher over the long term when treating patients with IL-17 inhibitors, but patients must maintain regular dosing to maintain a response, he said.
Overall, comparisons of IL-17 inhibitors with etanercept, adalimumab, and ustekinumab “demonstrate better efficacy with no evidence of compromising safety,” he noted.
For example, secukinumab demonstrated significantly superior results when compared with ustekinumab in a randomized trial (J Am Acad Dermatol. 2015;73: 400-9). After 16 weeks of treatment, 79% of secukinumab patients achieved a 90% reduction in Psoriasis Area and Severity Index score (PASI 90) versus 58% of ustekinumab patients, he said, and the drug safety profile was consistent with the pivotal phase 3 studies of secukinumab.
Concerns persist about increased risk of inflammatory bowel disease, Crohn’s disease, and ulcerative colitis in patients taking secukinumab and other IL-17 inhibitors, but data indicate that rates are low. The risk is low “and may be related to psoriasis and not the therapy,” he explained.
Ixekizumab has been associated with more injection site reactions than secukinumab, but these tend to be mild, Dr. Jackson said. Advantages of ixekizumab are that it works quickly and has demonstrated effectiveness against genital, palmoplantar, scalp, and nail psoriasis, he added.
Brodalumab also works quickly, but it has the unique inclusion of a Risk Evaluation and Mitigation Strategies (REMS) program because of suicidal ideation and behavior in clinical trials, he noted, adding that there are more data showing rates are low and the REMS program is easier to deal with than the isotretinoin REMS. The increased risk of superficial Staphylococcus and Candida infections are noted on IL-17 inhibitor labels, but this has not been a significant issue in trials or clinical practice, he said.
What is also exciting about the IL-17 inhibitors are the approvals of ixekizumab and secukinumab for patients with psoriatic arthritis (PsA), with both agents demonstrating the ability to inhibit the structural progression of joint damage over time, Dr. Jackson commented. These data seem to be on par with that of the TNF-inhibitors, although time will tell how this bears out clinically, he noted.
IL-23 inhibitors guselkumab, tildrakizumab, and risankizumab (not yet approved) have shown similar effectiveness and are well tolerated by patients, with few injection site reactions or adverse events reported, Dr. Jackson said. The dosing regimens of each of these drugs, administered subcutaneously, are easy to follow: Treatment starts with an initial dose of either 100 mg (guselkumab and tildrakizumab) or 150 mg (risankizumab), which is followed by doses at 4 weeks and then doses every 8 weeks (guselkumab) or 12 weeks (tildrakizumab and risankizumab).
For example, in a comparison study of risankizumab with a dosage of 150 mg subcutaneously at week 0, 4, then every 12 weeks, 75% of risankizumab patients achieved PASI 90 at 16 weeks and 82% at 52 weeks, compared with 42% and 44%, respectively, for adalimumab patients.
In addition, the IL-23 inhibitors have demonstrated some benefits for PsA patients in clinical trials, but they are not currently indicated for PsA, he said.
Dr. Jackson disclosed having received research, honoraria, consulting, and/or other support from AbbVie, Accuitis, Aclaris, Celgene, Dr. Reddy’s, Galderma, Janssen, Lilly, Medimetriks, Novartis, Pfizer, Promius, Ralexar, Sienna, and TopMD.
The meeting is jointly presented by the University of Louisville and Global Academy for Medical Education. This publication and Global Academy for Medical Education are both owned by Frontline Medical Communications.
Psoriasis patients have many options, and more are on the way, according to J. Mark Jackson, MD, of the University of Louisville, Ky.
“Know the information regarding each [treatment] to best care for your patients,” Dr. Jackson said in a presentation at the annual Coastal Dermatology Symposium.
Dr. Jackson particularly addressed the interleukin (IL)-17 inhibitors (brodalumab, ixekizumab, and secukinumab) and the IL-23 inhibitors (guselkumab, risankizumab, and tildrakizumab).
Complete clearance rates can reach 50% and higher over the long term when treating patients with IL-17 inhibitors, but patients must maintain regular dosing to maintain a response, he said.
Overall, comparisons of IL-17 inhibitors with etanercept, adalimumab, and ustekinumab “demonstrate better efficacy with no evidence of compromising safety,” he noted.
For example, secukinumab demonstrated significantly superior results when compared with ustekinumab in a randomized trial (J Am Acad Dermatol. 2015;73: 400-9). After 16 weeks of treatment, 79% of secukinumab patients achieved a 90% reduction in Psoriasis Area and Severity Index score (PASI 90) versus 58% of ustekinumab patients, he said, and the drug safety profile was consistent with the pivotal phase 3 studies of secukinumab.
Concerns persist about increased risk of inflammatory bowel disease, Crohn’s disease, and ulcerative colitis in patients taking secukinumab and other IL-17 inhibitors, but data indicate that rates are low. The risk is low “and may be related to psoriasis and not the therapy,” he explained.
Ixekizumab has been associated with more injection site reactions than secukinumab, but these tend to be mild, Dr. Jackson said. Advantages of ixekizumab are that it works quickly and has demonstrated effectiveness against genital, palmoplantar, scalp, and nail psoriasis, he added.
Brodalumab also works quickly, but it has the unique inclusion of a Risk Evaluation and Mitigation Strategies (REMS) program because of suicidal ideation and behavior in clinical trials, he noted, adding that there are more data showing rates are low and the REMS program is easier to deal with than the isotretinoin REMS. The increased risk of superficial Staphylococcus and Candida infections are noted on IL-17 inhibitor labels, but this has not been a significant issue in trials or clinical practice, he said.
What is also exciting about the IL-17 inhibitors are the approvals of ixekizumab and secukinumab for patients with psoriatic arthritis (PsA), with both agents demonstrating the ability to inhibit the structural progression of joint damage over time, Dr. Jackson commented. These data seem to be on par with that of the TNF-inhibitors, although time will tell how this bears out clinically, he noted.
IL-23 inhibitors guselkumab, tildrakizumab, and risankizumab (not yet approved) have shown similar effectiveness and are well tolerated by patients, with few injection site reactions or adverse events reported, Dr. Jackson said. The dosing regimens of each of these drugs, administered subcutaneously, are easy to follow: Treatment starts with an initial dose of either 100 mg (guselkumab and tildrakizumab) or 150 mg (risankizumab), which is followed by doses at 4 weeks and then doses every 8 weeks (guselkumab) or 12 weeks (tildrakizumab and risankizumab).
For example, in a comparison study of risankizumab with a dosage of 150 mg subcutaneously at week 0, 4, then every 12 weeks, 75% of risankizumab patients achieved PASI 90 at 16 weeks and 82% at 52 weeks, compared with 42% and 44%, respectively, for adalimumab patients.
In addition, the IL-23 inhibitors have demonstrated some benefits for PsA patients in clinical trials, but they are not currently indicated for PsA, he said.
Dr. Jackson disclosed having received research, honoraria, consulting, and/or other support from AbbVie, Accuitis, Aclaris, Celgene, Dr. Reddy’s, Galderma, Janssen, Lilly, Medimetriks, Novartis, Pfizer, Promius, Ralexar, Sienna, and TopMD.
The meeting is jointly presented by the University of Louisville and Global Academy for Medical Education. This publication and Global Academy for Medical Education are both owned by Frontline Medical Communications.
FROM THE COASTAL DERMATOLOGY SYMPOSIUM
Adalimumab safety update finds no new signals
not included in the previous 2009 analysis; their evaluation of data from these 18 trials found no new safety signals, they reported in the British Journal of Dermatology.
Adverse event incidence rates were expressed as events per 100 patient-years of exposure to adalimumab and, among the 3,727 patients who were aged 18 years or older and had moderate to severe plaque psoriasis for at least 6 months, there were 5,430 patient-years of cumulative exposure at the December 2015 cutoff date.
There were 3,798 treatment-related events altogether (70 events/100 patient-years); 269 events (5 events/100 patient-years ) led to discontinuation of treatment. The rates for serious adverse events and serious infections were 8.4 and 1.8 events per 100 patient-years, respectively; the most common types of serious infections were pneumonia and cellulitis.
The rates of the most frequently reported adverse events were comparable with those in the 2009 data set, with the most common being nasopharyngitis, upper respiratory tract infection, and headache. Furthermore, the rates of serious adverse events, serious infections, and malignancies were also stable, even with the increasing adalimumab exposure, and these were mostly consistent with what has been seen in large real-world registries.
The researchers did note that the rates of melanoma and nonmelanoma skin cancer were higher than would be expected in the general population, but they suspected this was at least partly because these psoriasis patients were receiving more frequent skin examinations and more skin cancers were being detected. (Incidence rates for these two cancers were stable during 2009-2015).
The analysis had certain limitations, such as a lack of a long-term comparator group. Also, while some patients continue to receive adalimumab for more than 10 years, the maximum duration of treatment in this analysis was only 5.5 years. Finally, the population in these clinical trials may differ from that seen in general practice settings because of the inclusion/exclusion criteria.
Six authors of the study reported multiple disclosures with pharmaceutical companies, including serving as a consultant, speaker, and/or adviser for, receiving honoraria from, and/or receiving grant/research support from AbbVie, which developed adalimumab and funded/advised this study; two authors are AbbVie employees, one is a former employee.
SOURCE: Leonardi C et al. Br J Dermatol. 2018 Aug 31. doi: 10.1111/bjd.17084.
not included in the previous 2009 analysis; their evaluation of data from these 18 trials found no new safety signals, they reported in the British Journal of Dermatology.
Adverse event incidence rates were expressed as events per 100 patient-years of exposure to adalimumab and, among the 3,727 patients who were aged 18 years or older and had moderate to severe plaque psoriasis for at least 6 months, there were 5,430 patient-years of cumulative exposure at the December 2015 cutoff date.
There were 3,798 treatment-related events altogether (70 events/100 patient-years); 269 events (5 events/100 patient-years ) led to discontinuation of treatment. The rates for serious adverse events and serious infections were 8.4 and 1.8 events per 100 patient-years, respectively; the most common types of serious infections were pneumonia and cellulitis.
The rates of the most frequently reported adverse events were comparable with those in the 2009 data set, with the most common being nasopharyngitis, upper respiratory tract infection, and headache. Furthermore, the rates of serious adverse events, serious infections, and malignancies were also stable, even with the increasing adalimumab exposure, and these were mostly consistent with what has been seen in large real-world registries.
The researchers did note that the rates of melanoma and nonmelanoma skin cancer were higher than would be expected in the general population, but they suspected this was at least partly because these psoriasis patients were receiving more frequent skin examinations and more skin cancers were being detected. (Incidence rates for these two cancers were stable during 2009-2015).
The analysis had certain limitations, such as a lack of a long-term comparator group. Also, while some patients continue to receive adalimumab for more than 10 years, the maximum duration of treatment in this analysis was only 5.5 years. Finally, the population in these clinical trials may differ from that seen in general practice settings because of the inclusion/exclusion criteria.
Six authors of the study reported multiple disclosures with pharmaceutical companies, including serving as a consultant, speaker, and/or adviser for, receiving honoraria from, and/or receiving grant/research support from AbbVie, which developed adalimumab and funded/advised this study; two authors are AbbVie employees, one is a former employee.
SOURCE: Leonardi C et al. Br J Dermatol. 2018 Aug 31. doi: 10.1111/bjd.17084.
not included in the previous 2009 analysis; their evaluation of data from these 18 trials found no new safety signals, they reported in the British Journal of Dermatology.
Adverse event incidence rates were expressed as events per 100 patient-years of exposure to adalimumab and, among the 3,727 patients who were aged 18 years or older and had moderate to severe plaque psoriasis for at least 6 months, there were 5,430 patient-years of cumulative exposure at the December 2015 cutoff date.
There were 3,798 treatment-related events altogether (70 events/100 patient-years); 269 events (5 events/100 patient-years ) led to discontinuation of treatment. The rates for serious adverse events and serious infections were 8.4 and 1.8 events per 100 patient-years, respectively; the most common types of serious infections were pneumonia and cellulitis.
The rates of the most frequently reported adverse events were comparable with those in the 2009 data set, with the most common being nasopharyngitis, upper respiratory tract infection, and headache. Furthermore, the rates of serious adverse events, serious infections, and malignancies were also stable, even with the increasing adalimumab exposure, and these were mostly consistent with what has been seen in large real-world registries.
The researchers did note that the rates of melanoma and nonmelanoma skin cancer were higher than would be expected in the general population, but they suspected this was at least partly because these psoriasis patients were receiving more frequent skin examinations and more skin cancers were being detected. (Incidence rates for these two cancers were stable during 2009-2015).
The analysis had certain limitations, such as a lack of a long-term comparator group. Also, while some patients continue to receive adalimumab for more than 10 years, the maximum duration of treatment in this analysis was only 5.5 years. Finally, the population in these clinical trials may differ from that seen in general practice settings because of the inclusion/exclusion criteria.
Six authors of the study reported multiple disclosures with pharmaceutical companies, including serving as a consultant, speaker, and/or adviser for, receiving honoraria from, and/or receiving grant/research support from AbbVie, which developed adalimumab and funded/advised this study; two authors are AbbVie employees, one is a former employee.
SOURCE: Leonardi C et al. Br J Dermatol. 2018 Aug 31. doi: 10.1111/bjd.17084.
FROM THE BRITISH JOURNAL OF DERMATOLOGY