Drug Survival of Risankizumab vs Other Biologics After 25 Months of Treatment Among Patients With Psoriatic Arthritis: An Interim Analysis of the VALUE Study

Abstract

Background/Purpose: Risankizumab (RZB) is an approved, optimized inhibitor of IL-23 for treating adults with moderate-to-severe plaque psoriasis (PsO), psoriatic arthritis (PsA), Crohn’s disease and ulcerative colitis. VALUE is a post-marketing observational study (PMOS) assessing the durability of response of RZB in real world practice. In this post hoc analysis, we report the interim drug survival of RZB and other biologic therapies (OtherBios) in a subgroup of patients with PsO and concomitant PsA.

Methods: VALUE (NCT03982394) is a multi-country, prospective PMOS.  This post hoc analysis includes data from the subset of patients with PsO who were also diagnosed with concomitant PsA by a rheumatologist. Drug survival, defined as patients staying on the biologic they initiated at study enrollment, was assessed using the proportion of patients with treatment substance changes, and the cumulative probability of treatment changes. Treatment results were compared as RZB vs OtherBios at 25 months and RZB vs TNFα inhibitor (TNFi) vs IL-17i at 25 months. Results are reported from an interim database lock on 09 December 2024. All enrolled patients who received at least one dose of study medication were included in this treatment substance change analysis. Propensity score matching (PSM) with a 1:1 ratio using greedy algorithm and exact match for biologic-naive/biologic-experienced status was used to account for group imbalances. Nominal P values are reported.

Results: This interim analysis included 255 (RZB) and 207 (OtherBios) patients diagnosed with PsO and concomitant PsA. Patients treated with RZB were older (53.5 years vs 49.3 years, P < 0.05) and had more severe skin disease as assessed by baseline psoriasis area and severity index (RZB vs OtherBios), (15.0 vs 13.1, P < 0.05), and body surface area (24.0% vs 19.1%, P < 0.05) than patients treated with OtherBios. Differences were balanced in the PSM set and results from PSM set are shown below.

Patients receiving RZB were significantly less likely to require a treatment substance change than those receiving OtherBios (12.6% vs 30.3%, P <0.05) at month 25 of treatment. The probability of treatment substance change (95% CI) at month 25 based on the Kaplan-Meier curve for time to first treatment substance change was 0.11 (0.06, 0.17) for patients receiving RZB vs 0.31 (0.23, 0.41) for patients receiving OtherBios (P < 0.05).

In assessing drug survival by mechanism of action (RZB as reference vs TNFi vs IL-17i) at 25 months, patients receiving RZB were less likely to require a treatment substance change (12.6% vs. 43.8% vs 26.4%, P <0.05). The probability of treatment substance change (95% CI) at month 25 based on the Kaplan-Meier curve for time to first treatment change was 0.11 (0.06, 0.19) in the RZB group, 0.44 (0.28, 0.63) in the TNFi group, and 0.28 (0.18, 0.44) in the IL-17i group (P < 0.05).

Conclusion: Patients with PsO and concomitant PsA who were treated with RZB in real-world practice had higher drug survival and were less likely to require treatment changes compared to patients receiving OtherBios including TNFi and IL-17i.