Real-World Effectiveness of Risankizumab for Moderate-to-Severe Plaque Psoriasis by Sub-populations: Interim Analysis from VALUE at 37 Months

This 37-month interim analysis provides an updated assessment of the overall effectiveness of risankizumab (RZB) compared with other approved biologics (OtherBios) for the treatment of psoriasis and examines RZB’s effectiveness across different patient sub-populations. The proportions of patients achieving ≥ 90% improvement in Psoriasis Area and Severity Index (PASI 90), PASI 100, PASI ≤ 1, and Dermatology Life Quality Index of 0 or 1 (DLQI 0/1), at 37 months are reported. Effectiveness was assessed in biologic-naive (bio-naive) patients, bio-experienced (bio-exp) patients, patients with high-impact area (HIA) involvement, and patients stratified by body surface area (BSA). Results are reported using modified nonresponder imputation, in which switching or discontinuing the initiated biologic due to ineffectiveness or intolerability was considered a treatment failure for subsequent visits. Propensity score matching (PSM) was employed to account for baseline characteristics imbalances. Nominal P values are reported. Overall, 1850 patients received RZB, and 927 patients received OtherBios. The mean (SD) baseline PASI was 14.9 (9.0) and 14.0 (9.1) in the RZB and OtherBios group, respectively. At 37 months, PASI 90 (RZB versus OtherBios) was achieved by 72.1% versus 52.3% of all patients, 81.8% versus 56.5% of bio-naive patients, 62.0% versus 45.6% of bio-exp patients, 68.3% versus 42.7% of patients with BSA < 10%, 73.9% versus 57.9% of patients with BSA ≥ 10%, 72.1% versus 53.0% of patients with HIA involvement, 67.8% versus 42.9% of patients with HIA involvement and BSA < 10%, and 73.9% versus 59.0% of patients with HIA involvement and BSA ≥ 10% (all nominal P < 0.0001). Similar patterns were observed for PASI 100, PASI ≤ 1, and DLQI 0/1. No new safety signals were identified. Results were similar in the PSM population. RZB demonstrated greater effectiveness, durability of response, and quality of life across patient sub-populations compared with OtherBios in this 37-month interim analysis. ClinicalTrials.gov Identifier: NCT03982394. This study examined the real-world effectiveness of risankizumab in treating psoriasis compared with other approved biologic medications over a 37-month period. Twice as many patients received risankizumab as other approved biologic medications. The study measured improvements in skin symptoms and quality of life. At 37 months, more patients treated with risankizumab had clear or almost clear skin and reported better quality of life than patients treated with other approved biologic medications. This was true regardless of whether patients had previously used biologic treatments, were new to biologic therapy, or were eligible for systemic treatments according to the International Psoriasis Council classification. No new safety concerns were identified for risankizumab or other approved biologic medications. The current analysis of this study demonstrates that risankizumab is more effective compared with other approved biologic medications in clinical practice. This study is ongoing, and final results will be reported later.