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Introduction: Lebrikizumab, a high-affinity IgG4 monoclonal antibody that selectively inhibits interleukin-13 with high binding affinity and slow dissociation rate, prevents the formation of the interleukin-4Rα/interleukin-13Rα1 heterodimer receptor signaling complex. Here we report the impact of lebrikizumab on responses to two non-live vaccines in adult patients with moderate-to-severe atopic dermatitis (AD)., Methods: ADopt-VA (NCT04626297) was a double-blind, placebo-controlled, parallel-group, 16-week, phase 3 randomized study to assess the impact of lebrikizumab treatment on non-live vaccine immune responses, and efficacy and safety of lebrikizumab compared with placebo. Eligible patients included adults from 18 to 55 years of age with moderate-to-severe chronic AD who were randomly assigned 1:1 to lebrikizumab 250 mg every 2 weeks or placebo and stratified according to disease severity. The primary endpoints were the development of a booster response to tetanus toxoid and a positive antibody response to meningococcal conjugate vaccine (MCV), 4 weeks after administration of the corresponding vaccine., Results: At week 16, 73.6% of patients in the lebrikizumab group (n = 78/106) achieved Tdap booster response compared with 73.4% of patients in the placebo group (n = 58/79). MCV vaccine response was observed in 86.9% of patients in the lebrikizumab group (n = 86/99) and 75.0% of patients in the placebo group (n = 60/80). At week 16, IGA 0,1 with ≥ 2-point improvement from baseline was achieved by 40.6% (n = 51/125) of patients treated with lebrikizumab and 18.9% (n = 23/122) of patients who received placebo (p < 0.001). There was a higher proportion of patients achieving EASI 75 at week 16 in the lebrikizumab-treated patients (58.0%, n = 72/125) compared with placebo (32.7%, n = 40/122, p < 0.001)., Conclusions: Treatment with lebrikizumab did not impact response to non-live vaccines Tdap and MCV in this study. Lebrikizumab treatment had a significant degree of efficacy compared to placebo across multiple endpoints., Trial Registration: ClinicalTrials.gov identifier NCT04626297., (© 2024. The Author(s).)

Introduction: Skin involvement in patients with psoriatic arthritis (PsA) worsens the severity and burden of disease. Ixekizumab (IXE), a selective interleukin (IL)-17A antagonist, was compared to placebo (PBO) in the SPIRIT-P1 (NCT01695239) and SPIRIT-P2 (NCT02349295) studies in patients with PsA and evidence of plaque psoriasis. This post hoc analysis reports musculoskeletal, skin, and nail outcomes through week 24 in patients from SPIRIT-P1 and SPIRIT-P2, stratified by mild, moderate, or psoriasis at baseline., Methods: This post hoc analysis pooled patients from SPIRIT-P1 and SPIRIT-P2 who were randomly assigned to PBO or IXE 80 mg every 4 weeks (Q4W) or every 2 weeks (Q2W). Efficacy outcomes were analyzed through week 24 by baseline psoriasis severity, defined by percent body surface area (BSA) affected; mild = BSA < 3%, moderate = 3% ≤ BSA ≤ 10%, severe = BSA > 10%. The primary outcomes assessed were the proportion of patients achieving American College of Rheumatology (ACR)20, ACR50, and ACR70 responses. Secondary outcomes included musculoskeletal, disease activity, skin and nail, and health-related quality-of-life measures., Results: Similar proportions of patients achieved ACR20/ACR50/ACR70 over time across all severity subgroups and treatment arms. More than one-third of IXE-treated patients achieved ACR20 at week 4, or ACR50 at week 24, with no significant differences according to psoriasis severity at baseline. Disease activity outcomes were similar through week 24 with both IXEQ4W and IXEQ2W, regardless of psoriasis severity at baseline. There were no significant differences over 24 weeks in the proportions of IXE-treated patients with mild, moderate, or severe baseline psoriasis who achieved Minimal Disease Activity (MDA). Across all severity subgroups, IXE demonstrated Psoriasis Area Severity Index 100 response as early as week 4, and approximately one-third of IXE-treated patients achieved total skin clearance at week 24., Conclusion: IXE demonstrated rapid and consistent efficacy in joint, skin, and nail for patients with PsA, regardless of baseline psoriasis severity., Trial Registration: SPIRIT-P1 (NCT01695239), SPIRIT-P2 (NCT02349295)., (© 2024. The Author(s).)

Introduction: Ixekizumab, a highly selective interleukin-17A monoclonal antibody, was approved for the treatment of moderate-to-severe psoriasis (PsO) in 2016. Limited real-world data are available on its effectiveness from a patient's perspective shortly (2 to 4 weeks) after initiation and upon continuation for 24 weeks., Objective: To describe patient-reported clinical and quality-of-life outcomes after initiating ixekizumab using data collected from the United States Taltz® Customer Support Program., Methods: This was a 24-week prospective, observational study of commercially insured diagnosis-confirmed adults with PsO. Surveys were completed at weeks 0 (baseline), 2, 4, 8, 12, and 24 and included the Patient Report of Extent of Psoriasis Involvement questionnaire to assess the extent of body surface area (BSA) affected by PsO, itch and pain numeric rating scales, Patient Global Assessment of Disease Severity (PatGA), and Dermatology Life Quality Index (DLQI)., Results: 523 patients were included in the analysis. Proportions of patients with ≤ 2% BSA involvement were 34.5%, 40.1%, 50.9%, and 79.9% at weeks 0, 2, 4, and 24, respectively; 54.8% and 75.1% achieved National Psoriasis Foundation preferred (BSA ≤ 1%) and acceptable (BSA ≤ 3% or ≥ 75% improvement) responses at week 12, respectively. Improvements of ≥ 4 points in itch and pain were seen by week 2 in 21.1% and 28.0% of patients, respectively, which increased to 63.1% and 64.8% at week 24. Proportions of patients with PatGA scores of 0 (clear) or 1 were 13.4%, 24.1%, 34.0%, and 69.6% at weeks 0, 2, 4, and 24, respectively; and proportions with DLQI total scores of 0 or 1 [no or minimal impact] were 8.4%, 17.6%, 27.3%, and 53.8% at weeks 0, 2, 4, and 24, respectively., Conclusion: Patient-reported improvements in BSA, itch, skin pain, dermatology-specific quality of life, and overall PsO severity were seen as early as 2 weeks after initiation and continued through week 24., (© 2023. The Author(s).)

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., (© 2021. The Author(s).)