Importance Defining on-treatment remission in plaque psoriasis is important for benchmarking patient responses to therapies. This also helps to facilitate shared understanding, align treatment expectations, and enable more effective psoriasis management. Objective To establish a consensus-based definition of on-treatment remission for plaque psoriasis through a multistage Delphi initiative. Evidence Review The Remission Workgroup from the medical board and scientific advisory board of the National Psoriasis Foundation engaged various stakeholders, both US based and international, to participate in the consensus process. Following a working group meeting to determine the overall consensus approach, a systematic review of remission definitions in the current literature was performed. This review helped to inform the content of consensus materials. The consensus effort involved 2 stages: pre-Delphi interviews and surveys to inform the Delphi questions, followed by a Delphi exercise with physicians to define on-treatment remission for plaque psoriasis. Outcome measures considered included body surface area (BSA), Investigator Global Assessment (IGA), the product of the Physician Global Assessment and body surface area (PGA x BSA), and Psoriasis Area and Severity Index (PASI) score at various cutoff levels and time points. Findings The consensus process involved 92 stakeholders, including dermatologists, rheumatologists, researchers, patients, payers, and life sciences professionals. In the pre-Delphi interviews and surveys, patients emphasized that on-treatment remission meant the absence of psoriasis signs and symptoms while recieving therapy. Payers expressed that defining remission is important for long-term treatment coverage. Following the Delphi exercise and discussion with participating physicians specializing in psoriatic disease management, on-treatment remission in plaque psoriasis was defined as patients maintaining a BSA of 0% or IGA of 0 for at least 6 months while on treatment. Conclusions and Relevance Through a Delphi consensus process, on-treatment remission for plaque psoriasis was defined as patients maintaining a BSA involvement of 0% or IGA of 0 for at least 6 months while on treatment. This clear and standardized benchmark is applicable to both research and practice settings.

Defining on-treatment remission in plaque psoriasis is important for benchmarking patient responses to therapies. This also helps to facilitate shared understanding, align treatment expectations, and enable more effective psoriasis management. To establish a consensus-based definition of on-treatment remission for plaque psoriasis through a multistage Delphi initiative. The Remission Workgroup from the medical board and scientific advisory board of the National Psoriasis Foundation engaged various stakeholders, both US based and international, to participate in the consensus process. Following a working group meeting to determine the overall consensus approach, a systematic review of remission definitions in the current literature was performed. This review helped to inform the content of consensus materials. The consensus effort involved 2 stages: pre-Delphi interviews and surveys to inform the Delphi questions, followed by a Delphi exercise with physicians to define on-treatment remission for plaque psoriasis. Outcome measures considered included body surface area (BSA), Investigator Global Assessment (IGA), the product of the Physician Global Assessment and body surface area (PGA × BSA), and Psoriasis Area and Severity Index (PASI) score at various cutoff levels and time points. The consensus process involved 92 stakeholders, including dermatologists, rheumatologists, researchers, patients, payers, and life sciences professionals. In the pre-Delphi interviews and surveys, patients emphasized that on-treatment remission meant the absence of psoriasis signs and symptoms while recieving therapy. Payers expressed that defining remission is important for long-term treatment coverage. Following the Delphi exercise and discussion with participating physicians specializing in psoriatic disease management, on-treatment remission in plaque psoriasis was defined as patients maintaining a BSA of 0% or IGA of 0 for at least 6 months while on treatment. Through a Delphi consensus process, on-treatment remission for plaque psoriasis was defined as patients maintaining a BSA involvement of 0% or IGA of 0 for at least 6 months while on treatment. This clear and standardized benchmark is applicable to both research and practice settings.

INTRODUCTION:Psoriasis is a chronic inflammatory condition affecting the skin, joints, and several other organ systems with significant disease burden. Bimekizumab is the first monoclonal antibody targeting both interleukin (IL)-17A and interleukin-17F and has demonstrated efficacy for treating moderate to severe psoriasis. Limited guidelines exist for incorporating this drug into clinical practice. The purpose of this study was for a panel of experts in psoriasis management to synthesize current literature and provide consensus statements with guidance on use of bimekizumab. METHODS:A comprehensive literature search of PubMed, Scopus, and Google Scholar was completed for English-language original research articles on the use of bimekizumab for moderate to severe psoriasis and psoriatic arthritis. A panel of nine dermatologists with significant expertise in treatment of psoriasis gathered to review the articles and create consensus statements on this new medication. A modified Delphi process was used to approve each statement and a strength of recommendation was assigned using Strength of Recommendation Taxonomy criteria. RESULTS:The literature search produced 102 articles that met criteria. A thorough screening of the studies for relevance to the research question resulted in 19 articles. These were distributed to all panelists for review prior to a roundtable discussion. The panel unanimously voted to adopt 14 consensus statements and recommendations, 12 of which were given a strength of "A", one of which was given a strength of "B", and one of which was given a strength of "C". CONCLUSION:Bimekizumab results in rapid and long-lasting clinical improvement for patients with moderate to severe plaque psoriasis and psoriatic arthritis. It has demonstrated superior efficacy when compared to several other biologics. The safety profile is consistent with other biologics, except for an increased incidence of oropharyngeal candidiasis.

Importance:Office-based phototherapy is cost-effective for psoriasis but difficult to access. Home-based phototherapy is patient preferred but has limited clinical data, particularly in patients with darker skin. Objective:To compare the effectiveness of home- vs office-based narrowband UV-B phototherapy for psoriasis. Design, Setting, and Participants:The Light Treatment Effectiveness study was an investigator-initiated, pragmatic, open-label, parallel-group, multicenter, noninferiority randomized clinical trial embedded in routine care at 42 academic and private clinical dermatology practices in the US. Enrollment occurred from March 1, 2019, to December 4, 2023, with follow-up through June 2024. Participants were 12 years and older with plaque or guttate psoriasis who were candidates for home- and office-based phototherapy. Interventions:Participants were randomized to receive a home narrowband UV-B machine with guided mode dosimetry or routine care with office-based narrowband UV-B for 12 weeks, followed by an additional 12-week observation period. Main Outcomes and Measures:The coprimary effectiveness outcomes were Physician Global Assessment (PGA) dichotomized as clear/almost clear skin (score of ≤1) at the end of the intervention period and Dermatology Life Quality Index (DLQI) score of 5 or lower (no to small effect on quality of life) at week 12. Results:Of 783 patients enrolled (mean [SD] age, 48.0 [15.5] years; 376 [48.0%] female), 393 received home-based phototherapy and 390 received office-based phototherapy, with 350 (44.7%) having skin phototype (SPT) I/II, 350 (44.7%) having SPT III/IV, and 83 (10.6%) having SPT V/VI. A total of 93 patients (11.9%) were receiving systemic treatment. At baseline, mean (SD) PGA was 2.7 (0.8) and DLQI was 12.2 (7.2). At week 12, 129 patients (32.8%) receiving home-based phototherapy and 100 patients (25.6%) receiving office-based phototherapy achieved clear/almost clear skin, and 206 (52.4%) and 131 (33.6%) achieved DLQI of 5 or lower, respectively. Home-based phototherapy was noninferior to office-based phototherapy for PGA and DLQI in the overall population and across all SPTs. Home-based phototherapy, compared to office-based phototherapy, was associated with better treatment adherence (202 patients [51.4%] vs 62 patients [15.9%]; P < .001), lower burden of indirect costs to patients, and more episodes of persistent erythema (466 of 7957 treatments [5.9%] vs 46 of 3934 treatments [1.2%]; P < .001). Both treatments were well tolerated with no discontinuations due to adverse events. Conclusions and Relevance:In this randomized clinical trial, home-based phototherapy was as effective as office-based phototherapy for plaque or guttate psoriasis in everyday clinical practice and had less burden to patients. Trial Registration:ClinicalTrials.gov Identifier: NCT03726489.

Dougher, Meaghan C. MD*; Hurley, Peter Emmett MD†; Kalb, Robert E. MD‡; Helm, Thomas N. MD§ Author Information

Psoriasis is an inflammatory disease associated with premature mortality, largely explained by an excess risk of cardiovascular (CV) events (Elmets et al, 2019; Gelfand et al, 2006). Dermatology and cardiology guidelines define psoriasis as a CV risk enhancer warranting more intensive management of traditional CV risk factors (Elmets et al, 2019; Grundy et al, 2019). However, identification and management of these risk factors in patients with psoriasis are insufficient, resulting in preventable morbidity and mortality (Eder et al, 2018).

Background Safe and effective biosimilar medications have the potential to significantly increase access to these valuable drugs. The two current biosimilars available in dermatology in the United States (US) are infliximab and rituximab which were Food and Drug Administration (FDA) approved in 2016 and 2018 respectively. There has been significant interest in this topic as a number of biosimilar versions of adalimumab will be available in 2023. Objective This review will discuss biosimilar basics and the experience with biosimilars used in dermatology in the US, Asia, and Europe. Methods All articles in Ovid/Medline from 2015 to Feb 2023 on biosimilars were reviewed with a particular emphasis on medications used in dermatology. Other reports from pharmaceutical manufacturers and blogs following the development of the biosimilar industry provided key insights. Results Biosimilars have been able to produce significant savings and market share increases, particularly in Europe, where there has been a longer experience. The specifics depend on drug prescribing practices and incentives in the individual country. This degree of savings and market share increases have not been realized with the current biosimilars available in the US. Conclusion While biosimilars have resulted in significant savings compared to originator drugs, it is clear that prescribing incentives and physician education are crucial in achieving these savings. To what degree biosimilar market share will increase in the US remains to be determined.

* Albany Medical College, Albany, NY; † Beutner Laboratories, Buffalo, NY; and ‡ Department of Dermatology, State University of New York at Buffalo Jacobs School of Medicine, Buffalo, NY. Correspondence: Melissa Warne, MD, 280 Quail Street Apartment #3, Albany, NY 12208 (e-mail:[email protected]). The authors declare no conflicts of interest.

ImportancePsoriasis is an inflammatory condition associated with metabolic and cardiovascular disease. Apremilast, a phosphodiesterase 4 inhibitor, is commonly used for psoriasis and can cause weight loss.ObjectiveTo determine the association between apremilast and aortic vascular inflammation as assessed by 18F-fluorodeoxyglucose positron emission tomography/computed tomography (FDG-PET/CT), cardiometabolic markers (primary outcomes at week 16), and abdominal fat composition.Design, Setting, and ParticipantsA single-arm, open-label, interventional, nonrandomized clinical trial in which the imaging and laboratory outcomes were measured by an investigator who was blinded to time was conducted between April 11, 2017, and August 17, 2021, at 7 dermatology sites in the United States. A total of 101 patients with moderate to severe psoriasis were screened, 70 enrolled, 60 completed week 16, and 39 completed week 52.InterventionApremilast, 30 mg, twice daily.Main Outcomes and MeasuresAortic vascular inflammation (measured by FDG-PET/CT), 68 cardiometabolic biomarkers, and abdominal fat composition (measured by CT) at week 16 and week 52 compared with baseline.ResultsThe mean (SD) age of the 70 patients was 47.5 (14.6) years, 54 were male (77.1%), 4 were Black (5.7%), and 58 were White (82.9%). There was no change in aortic vascular inflammation at week 16 (target to background ratio, −0.02; 95% CI, −0.08 to 0.05; P = .61) or week 52 (target to background ratio, −0.07; 95% CI, −0.15 to 0.01; P = .09) compared with baseline. At week 16, potentially beneficial decreases in interleukin 1b, valine, leucine, isoleucine, fetuin A, and branched-chain amino acids were observed. At week 52 compared with baseline, potentially beneficial decreases in ferritin, β-hydroxybutyrate, acetone, and ketone bodies, with an increase in apolipoprotein A-1, were observed, but there was a reduction in cholesterol efflux. There was an approximately 5% to 6% reduction in subcutaneous and visceral adiposity at week 16 that was maintained at week 52.Conclusions and RelevanceThe findings of this nonrandomized clinical trial suggest that apremilast has a neutral association with aortic vascular inflammation, variable but generally beneficial associations with a subset of cardiometabolic biomarkers, and associations with reductions in visceral and subcutaneous fat, indicating that the drug may have an overall benefit for patients with cardiometabolic disease and psoriasis.Trial RegistrationClinicalTrials.gov Identifier: NCT03082729

Importance:Psoriasis is an inflammatory condition associated with metabolic and cardiovascular disease. Apremilast, a phosphodiesterase 4 inhibitor, is commonly used for psoriasis and can cause weight loss.Objective:To determine the association between apremilast and aortic vascular inflammation as assessed by 18F-fluorodeoxyglucose positron emission tomography/computed tomography (FDG-PET/CT), cardiometabolic markers (primary outcomes at week 16), and abdominal fat composition.Design, Setting, and Participants:A single-arm, open-label, interventional, nonrandomized clinical trial in which the imaging and laboratory outcomes were measured by an investigator who was blinded to time was conducted between April 11, 2017, and August 17, 2021, at 7 dermatology sites in the United States. A total of 101 patients with moderate to severe psoriasis were screened, 70 enrolled, 60 completed week 16, and 39 completed week 52.Intervention:Apremilast, 30 mg, twice daily.Main Outcomes and Measures:Aortic vascular inflammation (measured by FDG-PET/CT), 68 cardiometabolic biomarkers, and abdominal fat composition (measured by CT) at week 16 and week 52 compared with baseline.Results:The mean (SD) age of the 70 patients was 47.5 (14.6) years, 54 were male (77.1%), 4 were Black (5.7%), and 58 were White (82.9%). There was no change in aortic vascular inflammation at week 16 (target to background ratio, -0.02; 95% CI, -0.08 to 0.05; P = .61) or week 52 (target to background ratio, -0.07; 95% CI, -0.15 to 0.01; P = .09) compared with baseline. At week 16, potentially beneficial decreases in interleukin 1b, valine, leucine, isoleucine, fetuin A, and branched-chain amino acids were observed. At week 52 compared with baseline, potentially beneficial decreases in ferritin, β-hydroxybutyrate, acetone, and ketone bodies, with an increase in apolipoprotein A-1, were observed, but there was a reduction in cholesterol efflux. There was an approximately 5% to 6% reduction in subcutaneous and visceral adiposity at week 16 that was maintained at week 52.Conclusions and Relevance:The findings of this nonrandomized clinical trial suggest that apremilast has a neutral association with aortic vascular inflammation, variable but generally beneficial associations with a subset of cardiometabolic biomarkers, and associations with reductions in visceral and subcutaneous fat, indicating that the drug may have an overall benefit for patients with cardiometabolic disease and psoriasis.Trial Registration:ClinicalTrials.gov Identifier: NCT03082729.

Psoriasis is a lifelong disease and its prevalence in older adults continues to increase as the population ages. Therefore, it is important for physicians to understand the management of the disease in this population. While the management of psoriasis in older adults is similar to the management of patients below the age of 65 years, there are special considerations when treating older patients. Older patients may have more comorbidities, more immunosuppression, and are often taking additional medications that can interact with those being used to treat psoriasis. Safer and more effective treatment options for psoriasis have been introduced in recent years, particularly injectable biological agents. Unfortunately, older patients with psoriasis are oftentimes underrepresented in the clinical trials for these new medications. Subsequent studies have focused on the safety and efficacy of these medications in older adults. The results of these studies demonstrate that biologic agents are well tolerated in older patients and are more effective in treating psoriasis than conventional systemic therapies. In addition, new small-molecule agents such as apremilast also offer an effective and safe treatment option for older patients with psoriasis. The results of these studies can help guide physicians with incorporating these newer medications into the treatment regimen of older psoriasis patients. Despite the proven safety and efficacy of biologic agents, their frequency of use in elderly patients is still almost half of that in non-elderly patients.

Background: As biosimilars have become available in various parts of the world, the International Psoriasis Council has reviewed aspects of their use. Objective: To provide consensus statements from the Biosimilar Working Group about the use of biosimilars in patients with psoriasis. Methods: A semiqualitative structured process was employed to approve the consensus statements on biosimilars using the nominal group technique. The final statements were validated by a survey of the paricipants. The approval of the consensus statements was predefined as >80% positive opinions. Results: A consensus was reached in 36/38 statements regarding regulatory considerations, extrapolation of indication, interchangeability, substitution at the pharmacy level, pharmacovigilance, traceability, naming, biosimilar policy, education, and cost of biosimilars. Example statements include “Switching a stable patient from a reference product to a biosimilar product is appropriate if the patient and physician agree to do so” and “Patients and patients' organisations should be involved in all decision making and policy development about the use of biosimilars.” Conclusion: The International Psoriasis Council Biosimilar Working Group provides consensus statements for the use of biosimilars in the treatment of patients with psoriasis. We suggest that these statements provide global guidance to clinicians, healthcare organizations, pharmaceutical companies, regulators, and patients regarding the development and use of biosimilars in patients with psoriasis.

Background: There are limited data about the impact of narrowband ultraviolet B phototherapy on patient-reported measures of health-related quality of life. Objective: To evaluate the impact of adalimumab and phototherapy on health-related quality of life. Methods: We examined patient-reported outcomes from a multicenter, randomized, placebo-controlled trial (ClinicalTrials. gov no. NCT01553058). The Dermatology Life Quality Index and EQ-5D-3L were evaluated every 4 weeks. Results: We enrolled 97 patients: 30.9% were female, mean age was 43.5 years (standard deviation, 14.0), and median Psoriasis Area and Severity Index score was 16.7 (interquartile range, 13.9-21.6). At week 12, patients being treated with adalimumab (odds ratio [OR], 2.88; 95% confidence interval [CI], 1.02-8.17) and phototherapy (OR, 8.83; 95% CI, 2.47-31.57) were more likely to achieve the minimal clinically important difference in the Dermatology Life Quality Index compared with those receiving placebo. There were higher odds of achieving the minimal clinically important difference for the EQ-5D-3L Index score when comparing phototherapy versus placebo (OR, 9.78; 95% CI, 2.99-31.95) and phototherapy versus adalimumab (OR, 4.07; 95% CI, 1.42-11.70). Limitations: Small sample size, secondary analysis, generalizability. Conclusion: Phototherapy and adalimumab both improve skin-related quality of life and overall health-related quality of life compared with placebo in patients with psoriasis; however, patients treated with phototherapy achieved more improvement in overall health-related quality of life compared with patients treated with adalimumab.

We examined patient reported outcomes (PROs) as secondary outcomes from a multicenter, randomized placebo-controlled trial designed to measure changes in cardiovascular disease markers over 12 weeks (NCT01553058). Patients were randomized (1:1:1) to adalimumab, placebo injections or narrowband ultraviolet B phototherapy. The Dermatology Life Quality Index (DLQI) and EQ-5D, were evaluated every 4 weeks. We enrolled 97 patients: 30.9% female, mean(SD) age 43.5(14.0) years, median(IQR) duration of disease 13(6-25) years, median(IQR) PASI 16.7(13.9-21.6), 9.7% reported psoriatic arthritis. Baseline DLQI, EQ-5D index, and EQ-VAS scores were similar in all three groups. Patients treated with both adalimumab and phototherapy achieved a clinically meaningful improvement in quality of life, as measured by the mean change(SD) in DLQI at week 12 compared to baseline [adalimumab:-7.0(7.7), phototherapy:-8.1(5.6)] and EQ-VAS [adalimumab:11.7(31.9), phototherapy:10.1(36.8)]. At week 12, patients treated with phototherapy were more likely to report no effect of psoriasis on quality of life measured by the DLQI as compared to placebo (OR:7.41, 95%CI:1.85-29.66), and compared to adalimumab (OR:2.47, 95%CI:0.85-7.19), the latter of which was not statistically significant. Only patients treated with phototherapy were more likely to report no problems in the pain dimension of the EQ-5D compared to placebo (OR:5.97, 95%CI:1.95-18.33). These results suggest that phototherapy and adalimumab have similar improvements in health-related quality of life. Larger studies are necessary to determine non-inferiority or superiority of phototherapy compared to adalimumab on PROs.

Our objective was to compare therapeutic response among patients with early-onset psoriasis (EOP) and late-onset psoriasis (LOP) receiving adalimumab, etanercept, infliximab, ustekinumab, or methotrexate in the Psoriasis Longitudinal Assessment and Registry (PSOLAR).

Health-related quality of life (HRQoL) measures provide patient-centred evaluations of response to treatment. In the 12-week, Phase III PSO-ABLE study, fixed-combination calcipotriol 50 μg/g as hydrate (Cal) plus betamethasone 0.5 mg/g as dipropionate (BD) aerosol foam was significantly more effective for the treatment of psoriasis than Cal/BD gel.

Background: Psoriasis is a chronic inflammatory disease associated with dyslipidemia, cardiovascular events, and mortality. We aimed to assess and compare the effect of treatment of moderate-to-severe psoriasis with adalimumab or phototherapy on vascular inflammation and cardiovascular biomarkers. Methods and Results: Randomized, double-blind, trial of adalimumab, phototherapy, and placebo (1:1:1) for 12 weeks, with crossover to adalimumab for 52 weeks total. Outcomes included vascular inflammation by 18 F-fluorodeoxyglucose positron emission tomography/computed tomography and biomarkers of inflammation, insulin resistance, and lipoproteins. Ninety-seven patients were randomized, 92 completed the randomized controlled trial portion; 81 entered the adalimumab extension with 61 completing 52 weeks of adalimumab. There was no difference in change in vascular inflammation at week 12 in the adalimumab group (change compared with placebo, 0.64%; 95% confidence interval, −5.84% to 7.12%) or the phototherapy group (−1.60%; 95% confidence interval, −6.78% to 3.59%) or after 52-week adalimumab treatment (0.02% compared with initiation; 95% confidence interval, −2.85% to 2.90%). Both adalimumab and phototherapy decreased inflammation by serum CRP, interleukin-6. Only adalimumab reduced tumor necrosis factor and glycoprotein acetylation at 12 and 52 weeks. Neither had an impact on metabolic markers (insulin, adiponectin, and leptin). Only phototherapy increased high-density lipoprotein-p at 12 weeks. At 52-week of adalimumab cholesterol efflux and high-density lipoprotein-p were reduced. Conclusions: Adalimumab reduced key markers of inflammation including glycoprotein acetylation compared with phototherapy with no effect on glucose metabolism and vascular inflammation, and potential adverse effects on high-density lipoprotein. Glycoprotein acetylation improvement may partially explain the beneficial effects of adalimumab seen in observational studies. Larger studies with more detailed phenotyping of vascular disease should assess the comparative differences in the effects of adalimumab and phototherapy seen in our study. Clinical Trial Registration : URL: https://www.clinicaltrials.gov . Unique identifiers: NCT01866592 and NCT01553058.