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Numerous clinical trials have established that various biologic and oral small-molecule therapies are efficacious in patients with psoriasis. However, as there are limited head-to-head trials, healthcare providers may compare results across multiple trials when providing treatment recommendations. Direct comparisons among agents are challenging because psoriasis trials differ in terms of study design, patient population, and data analysis methodologies. Longterm clinical trials present additional challenges because the number of patients enrolled generally declines over time. The missing patient data that might occur, coupled with the speciffc approach used to substitute or impute that missing data, might introduce bias and skew efficacy results. In this review, we discuss how variations in study design and analytical methodologies affect effcacy outcomes in clinical trials. We also review published trials of biologic and oral small-molecule therapies for psoriasis to illustrate how issues related to missing data and choices in data imputation methodologies can affect the interpretation of effcacy outcomes. Imputation methodologies discussed include nonresponder imputation, modified nonresponder imputation, treatment failure rules, last observation carried forward, modified baseline observation carried forward, and multiple imputation. This review provides a foundation for the healthcare provider's critical evaluation of the psoriasis literature and emphasizes the importance of considering the level of evidence provided in a clinical trial when making treatment decisions. [ABSTRACT FROM AUTHOR]

Aim: In the global phase 3 POETYK PSO-1 and PSO-2 trials, significantly greater proportions of deucravacitinib-treated patients met the coprimary endpoints (PASI 75, sPGA 0/1) at Week 16 versus placebo or apremilast-treated patients. This analysis evaluated onset of action and maintenance of response in patients randomized to deucravacitinib and placebo only., Methods: Adults with moderate to severe plaque psoriasis at baseline were randomized 1:2:1 to oral placebo, deucravacitinib, or apremilast. Onset of action was determined through changes from baseline in mean PASI, BSA, BSA × sPGA, and DLQI. Maintenance of response was assessed using PASI 75, PASI 90, PASI 100, sPGA 0/1, and sPGA 0 response rates through Week 52 in patients who were treated continuously with deucravacitinib, crossed over from placebo to deucravacitinib at Week 16, or received deucravacitinib and achieved PASI 75 by Week 24., Results: Deucravacitinib showed significantly higher increases in mean percent change from baseline in PASI versus placebo by Week 1. Significant improvement versus placebo was observed in all other efficacy measures by Week 8. Efficacy with deucravacitinib was maintained through Week 52., Conclusion: Deucravacitinib displayed efficacy as early as 1 week and clinical responses were maintained over 52 weeks in patients with moderate to severe plaque psoriasis.

Objectives: Deucravacitinib is a novel, oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor belonging to a distinct class of enzyme inhibitors. In a phase 2 trial in psoriatic arthritis (NCT03881059), deucravacitinib was significantly more efficacious than placebo across multiple endpoints, including achieving minimal disease activity (MDA). This post hoc analysis further evaluated the achievement of individual components of the MDA criteria with deucravacitinib treatment and the time course of responses in the phase 2 trial., Methods: Patients (N = 203) were randomized 1:1:1 to once daily treatment with placebo, deucravacitinib 6 mg, or deucravacitinib 12 mg. The proportions of patients achieving MDA and each of the 7 individual MDA components through week 16 were assessed., Results: At baseline, although some patients met criteria for individual MDA components, none of the patients met the composite MDA criterion, and all components were balanced overall across treatment arms. Treatment with deucravacitinib was associated with a numerically greater mean reduction from baseline in all MDA components vs placebo over 16 weeks of treatment. At week 16, a greater percentage of patients treated with either dose of deucravacitinib vs placebo achieved the threshold criteria for meeting MDA in each of the components., Conclusions: More patients treated with deucravacitinib met each of the MDA components vs placebo, along with a higher rate of MDA response, after 16 weeks of treatment., (© The Author(s) 2024. Published by Oxford University Press on behalf of the British Society for Rheumatology.)