Bimekizumab and other biologics for moderate to severe psoriasis: Systematic literature review and meta-analysis of real-world PASI 100 response over time

Introduction: Complete skin clearance is increasingly achievable for individuals with moderate to severe psoriasis treated with biologic therapies.1 Although real-world evidence (RWE) is often used to complement clinical trial data, the existing evidence largely comprises individual observational studies, resulting in uncertainty regarding how complete skin clearance is achieved in routine clinical practice. Here, a systematic literature review (SLR) and meta-analysis were used to analyze real-world achievement of 100% improvement in Psoriasis Area and Severity Index (PASI 100), by generating standardized PASI 100 response profiles over time for different biologics. Procedure/study: An SLR of published RWE studies evaluating biologic therapies for moderate to severe psoriasis was conducted using MEDLINE and Embase (2020–2025). Real-world PASI 100 responses were analyzed for adults with psoriasis treated with bimekizumab (BKZ), guselkumab (GUS), ixekizumab (IXE), risankizumab (RIS), secukinumab (SEC) and tildrakizumab (TIL). Analyses for each biologic were conducted separately using a mixed-effects logistic regression model. Time was modeled using natural splines to allow for nonlinear trends. Study was included as a random intercept to account for between-study differences and summarized using the estimated random-effects standard deviation (τ). Model-estimated PASI 100 response rates with 95% confidence intervals (CI) were generated from Weeks 4–52 for each biologic. Results: Overall, 165 real-world publications were identified; following review, 77 publications from >35 countries were included. In total, 94 biologic datasets were analyzed. Across included publications, 41.9–68.9% of patients were biologic-naïve. The highest modeled responses (numerically) were observed for BKZ across all analyzed time points. There was variation in the relative order of responses for other biologics at each time point. At Week 4, model-estimated PASI 100 responses ranged 5.6% (95% CI: 3.7–8.5%)–29.4% (24.9–34.3%) across biologics; at Week 16, estimates ranged 28.1% (22.2–34.8%)–65.9% (60.8–70.6%). By Week 52, PASI 100 estimates ranged 46.8% (40.8–52.9%)–79.9% (73.2–85.3%). Substantial biologic-specific between-study heterogeneity was observed. Conclusion: This analysis synthesized real-world PASI 100 responses for biologic therapies in moderate to severe psoriasis. Numerically, bimekizumab showed the highest estimated PASI 100 response rates from the earliest time point (Week 4) through to Week 52. Descriptively, this suggests that bimekizumab had earlier and higher-level responses than other biologics over time. Given that no formal between-treatment comparisons were performed, these results establish a foundation for future comparative effectiveness RWE studies.