Vaccination recommendations for adults receiving biologics and oral therapies for psoriasis and psoriatic arthritis: Delphi consensus from the medical board of the National Psoriasis Foundation.

BACKGROUND: For psoriatic patients who need to receive nonlive or live vaccines, evidence-based recommendations are needed regarding whether to pause or continue systemic therapies for psoriasis and/or psoriatic arthritis. OBJECTIVE: To evaluate literature regarding vaccine efficacy and safety and to generate consensus-based recommendations for adults receiving systemic therapies for psoriasis and/or psoriatic arthritis receiving nonlive or live vaccines. METHODS: Using a modified Delphi process, 22 consensus statements were developed by the National Psoriasis Foundation Medical Board and COVID-19 Task Force, and infectious disease experts. RESULTS: Key recommendations include continuing most oral and biologic therapies without modification for patients receiving nonlive vaccines; consider interruption of methotrexate for nonlive vaccines. For patients receiving live vaccines, discontinue most oral and biologic medications before and after administration of live vaccine. Specific recommendations include discontinuing most biologic therapies, except for abatacept, for 2-3 half-lives before live vaccine administration and deferring next dose 2-4 weeks after live vaccination. LIMITATIONS: Studies regarding infection rates after vaccination are lacking. CONCLUSION: Interruption of antipsoriatic oral and biologic therapies is generally not necessary for patients receiving nonlive vaccines. Temporary interruption of oral and biologic therapies before and after administration of live vaccines is recommended in most cases.

Methotrexate for inflammatory skin disease in pediatric patients: Consensus treatment guidelines.

Methotrexate (MTX) is a readily accessible drug, first used in 1948 and employed for a wide variety of indications since then. However, despite widespread off-label use, FDA labeling does not include approved indications for the use of MTX for many inflammatory skin diseases in pediatric patients, including morphea, psoriasis, atopic dermatitis, and alopecia areata, among others. Without published treatment guidelines, some clinicians may be hesitant to use MTX off-label, or uncomfortable prescribing MTX in this population. To address this unmet need, an expert consensus committee was convened to develop evidence- and consensus-based guidelines for use of MTX to treat pediatric inflammatory skin disease. Clinicians with experience and expertise in clinical research, drug development, and treating inflammatory skin disease in pediatric patients with MTX were recruited. Five committees were created based on major topic areas: (1) indications and contraindications, (2) dosing, (3) interactions with immunizations and medications, (4) adverse effects (potential for and management of), and (5) monitoring needs. Pertinent questions were generated and addressed by the relevant committee. The entire group participated in a modified Delphi process to establish agreement on recommendations for each question. The committee developed 46 evidence- and consensus-based recommendations, each with >70% agreement among members, across all five topics. These are presented in tables and text, along with a discussion of supporting literature, and level of evidence. These evidence- and consensus-based recommendations will support safe and effective use of MTX for the underserved population of pediatric patients who may benefit from this valuable, time-honored medication.

National Psoriasis Foundation Telemedicine Task Force guidance for management of psoriatic disease via telemedicine.

Telemedicine emerged as an alternative care delivery system used to offer effective long-term management to patients with chronic, inflammatory conditions such as psoriatic disease. Teledermatology can provide reliable clinical information through thorough history-taking and virtual evaluations that include patient-provided images and disease activity assessment tools that may help accurately diagnose and manage patients with psoriasis. The integration of validated screening tools for psoriatic arthritis and effective teledermatology practices may improve access to specialists, thus avoiding preventable delays in the diagnosis and treatment of patients with psoriatic arthritis. Although the provision of telehealthcare should not completely replace high quality, in-person dermatologic or rheumatologic visits, the convenience and collaborative nature of teledermatology may lead to expanded access and expedited care in the appropriate setting, whether it be in a virtual or in-person visit.

Proportions of Biologic Discontinuation Among Psoriasis Patients With Metabolic Comorbidities.

Background: Among psoriasis patients, the presence of metabolic comorbidities associates with poorer response to biologics. How the presence of comorbidity impacts treatment patterns with biologics is not fully understood. Methods: Adult patients in the CorEvitas Psoriasis Registry were included if they initiated biologic therapy between 5/2015-12/2019 and had a 6-month follow-up visit. The frequency of biologic discontinuations by 6-months were calculated by metabolic comorbidity status (current obesity and histories of hypertension [HTN], diabetes [DM], and hyperlipidemia [HLD]) for all patients and by drug class (tumor necrosis factor inhibitors [TNFi], interleukin-17i [IL-17i], and IL-23i or IL-12/23i). Results: Among the 2924 participants, discontinuations were more frequent in those with obesity (17%, P < .01) or DM (20%, P < .001) compared to those without these (13% and 14%, respectively). Discontinuations were similar for those with and without histories of HTN or HLD. Frequencies of discontinuation for each biologic class were: TNFi (26%), IL-17i (16%), and IL-23i or IL-12/23i (9%). Among TNFi initiators, the proportions of discontinuations were greater in the presence of obesity (30%, P < .05), DM (34%, P < .05), or HTN (34%, P < .01) compared to those without (22%, 24%, and 22%, respectively). Of the IL-23i or IL-12/23i initiators, discontinuations were more frequent in those with obesity (11%, P < .01) or with DM (13%, P < .05) compared to those without (7% and 8%, respectively). Discontinuations did not statistically differ between comorbidity groups in IL-17i initiators. Conclusion: Comorbid disease status, especially obesity and DM, should be assessed at biologic initiation as it may predict a less optimal clinical outcome.

Cardiometabolic multimorbidity is common among patients with psoriasis and is associated with poorer outcomes compared to those without comorbidity.

BACKGROUND: Associations between cardiometabolic multimorbidity and response to therapy in psoriasis are unknown. OBJECTIVE: Determine the associations of multimorbidity with response to biologic treatment in psoriasis patients. METHODS: CorEvitas Psoriasis Registry participants who initiated biologic therapy and had 6-month follow-up were stratified by 0, 1, 2+ comorbidities (diabetes, hypertension, hyperlipidemia). Adjusted odds ratios (95% CIs) were calculated overall and separately by biologic class (TNFi, IL-17i, IL-12/23i + IL-23i), to assess the likelihood of achieving response for the 1 and 2+ groups vs. 0. RESULTS: Of 2,923 patients, 49.5%, 24.7% and 25.8% reported 0, 1 and 2+ comorbidities, respectively. Overall, likelihood of PASI75 was 18% (OR = 0.82; 95%CI: 0.67, 1.00) and 23% (OR = 0.77; 95%CI: 0.63, 0.96) lower in those with 1 and 2+ comorbidities, respectively, vs. 0. In those who initiated IL-17i, odds of PASI75 and PAS90 were 34% (OR = 0.66; 95%CI: 0.48-0.91) and 35% (OR = 0.65; 95%CI: 0.47-0.91) lower in the 2+ multimorbidity cohort. No significant associations were found among users of TNFi or IL-12/23i + IL-23i groups in the multimorbidity group. LIMITATIONS: Patients may not be representative of all psoriasis patients. CONCLUSION: Multimorbidity in psoriasis may decrease the likelihood of achieving treatment response to biologic therapy and should be considered when discussing treatment expectations with patients.

Cardiac and Sudomotor Autonomic Function in Subjects with Psoriasis With and Without Metabolic Syndrome.

Purpose: Studies have shown that subjects with psoriasis (PsO) are associated with an increased risk of developing metabolic syndrome (MetS), diabetes, and cardiovascular disease. In addition, MetS and diabetes are associated with autonomic dysfunction (AD). The aim of this study was to investigate cardiac and sudomotor autonomic function in subjects with PsO and without diabetes. Methods: A cross-sectional study was performed in 20 subjects with PsO, compared with age- and sex-matched 21 healthy controls, and 20 subjects with MetS. Subjects underwent skin evaluation by dermatologist, glycated hemoglobin (HbA1c), insulin, glucose, and lipid levels, sudomotor function testing with Sudoscan™ device (Impeto Medical, Paris, France), and cardiac autonomic function testing with ANSAR device (ANX 3.0; ANSAR Group, Inc., Philadelphia, PA). Quality of Life (QOL) and peripheral neurologic function were also assessed. Results: Participants with PsO were significantly more obese, had higher levels of fasting insulin and triglycerides, and were more insulin resistant when compared to controls. Subjects with PsO showed significantly worse cardiac autonomic function when compared to control and MetS groups. Sudomotor function and QOL scores were similar between the groups. Subgroup analysis of PsO subjects without MetS criteria (n = 15) showed persistent significantly deteriorated cardiac autonomic function when compared to the other two groups. Conclusion: This study suggests an association between PsO and cardiac AD, independent of the presence of overt dysglycemia and MetS. Additional larger studies are needed to clarify the significance of these findings and the relationship between PsO, AD, and metabolic disease.

Physical activity engagement and responses to exercise in plaque psoriasis: a multifactorial investigation of influential factors.

BACKGROUND: Psoriasis may increase the risk of physical inactivity, but few studies have evaluated the etiology. OBJECTIVE: To identify barriers to and predictors of physical activity in psoriasis. METHODS: Twenty individuals with psoriasis (PsO) and 23 controls recorded activity with accelerometers and completed self-paced 20-min treadmill bouts. Questionnaires on self-efficacy for exercise (SEE), pruritus, and dermatology life quality index (DLQI) were completed. Psoriasis severity was measured via body surface area (BSA), psoriasis area and severity index (PASI), and investigator's global assessment (IGA). RESULTS: No differences in moderate-vigorous activity existed between PsO and controls (ANCOVA means: 26 ± 4 versus 27 ± 4 min, p = .802). Relative to controls, PsO selected treadmill speeds that were 13-18% slower and experienced more pruritus while exercising. Among the PsO group, PASI, BSA, IGA, and DLQI showed inverse correlations with vigorous activity (partial rhos= -0.55 to -0.62, p < .05). Likewise, BSA, IGA, DLQI, and pruritus were inversely correlated with footsteps (partial rhos= -0.47 to -0.62, p < .05). SEE was consistently positively correlated with activity levels among PsO (partial rhos ≥0.60 for moderate activity, vigorous activity, and footsteps). CONCLUSION: Individuals with extensive psoriasis and poorer SEE engage in less vigorous activity and take fewer footsteps. Among other factors, pruritus is a novel explanation.

Demographics, Disease Characteristics, and Patient-Reported Outcomes Among Patients with Psoriasis Who Initiated Guselkumab in CorEvitas' Psoriasis Registry.

INTRODUCTION: Guselkumab is approved for the treatment of both moderate-to-severe plaque psoriasis and active psoriatic arthritis (PsA) in the USA. However, little is known about patients initiating guselkumab in a real-world setting. The objective of this study was to describe baseline characteristics among patients with plaque psoriasis who initiated guselkumab at or after enrollment in CorEvitas' Psoriasis Registry. METHODS: Adult patients who initiated guselkumab in the Psoriasis Registry between July 18, 2017 and November 6, 2018 were included. Demographics, disease characteristics, and patient-reported outcome measures (PROMs) were assessed at the time of guselkumab initiation (baseline). Patients with psoriasis were stratified according to the number of previously received biologics (0 to 4+) for comparison. A subset of patients with psoriasis and concomitant dermatologist-diagnosed PsA were stratified into biologic-naïve and biologic-experienced groups. RESULTS: Among 687 patients with psoriasis who initiated guselkumab, biologic-naïve patients and those with four or more prior biologics had the most severe disease and the worst PROM scores at baseline. Among 251 patients with concomitant dermatologist-diagnosed PsA, biologic-naïve patients had more severe disease and worse PROM scores than biologic-experienced patients. CONCLUSIONS: These findings highlight important differences in baseline characteristics according to biologic experience among patients with plaque psoriasis with or without concomitant PsA initiating guselkumab in a real-world setting.