IL-17A inhibitor, izokibep, shows improvement across patient-reported outcomes for PsA
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PHILADELPHIA — Among patients with psoriatic arthritis, izokibep exhibited clinically significant improvements across various patient reported outcomes, according to findings presented at ACR Convergence 2022.
“Izokibep (Acelyrin, Inc.) is a unique IL-17A inhibitor with very high potency and small molecular size designed to overcome the limitations of monoclonal antibodies,” Peter Taylor, PhD, FRCP, MA, professor and Norman Collisson chair of musculoskeletal sciences at the University of Oxford, and fellow of St. Peter's College, said during the presentation.
The multicenter, double-blind, placebo-controlled, randomized control trial compared 40 mg or 80 mg of izokibep given subcutaneously with placebo over 16 weeks in patients with active psoriatic arthritis. The primary endpoint was ACR50 response at week 16 and the secondary endpoints from patient-reported outcome scores. These included scores from SF-36, HAQ-DI, PsAID-9, DLQI, TSQM-9, single-item scales for pain and patient-reported global disease activity, as well as patient reported itchiness.
Between June 2020 and July 2021, 135 patients were randomized from 28 sites, with 80% being treated with one concomitant conventional synthetic disease-modifying antirheumatic drug, according to the abstract.
The largest treatment effects were seen for PsAID, pain, global disease activity, and TSQM, but all the patient-reported outcomes demonstrated “significant and clinically meaningful” improvements. Taylor and colleagues reported that all subdomains of SF-36 subdomains, excluding Role-Emotional and Social Functioning, showed dose-dependent improvement, and “prominent effects” were seen for Bodily Pain, Role-Physical, Physical Functioning, and Vitality.
For patients receiving 80 mg izokibep, all nine PsAID subdomains significantly improved, with “notable” improvements in sleep, pain and function. Moreover, 80% of patients receiving 80 mg of izokibep demonstrated a DLQI score of five or less compared with 81% of patients receiving 40 mg, and 63% receiving placebo.
When analyzing HAQ-DI scores, 54% of patients treated with 80 mg of izokibep reached minimal clinically important differences (MCID) compared with 43% of patients treated with 40 mg and 26% treated with placebo. According to the poster, PsAID-9 MCID was achieved by 41% of patients treated with 80 mg, 31% treated with 40 mg and 12% treated with placebo.
“In the subpopulation enthesitis on baseline, the effects on PsAID were particularly marked,” Taylor said.
“In conclusion, izokibep demonstrated clinically meaningful, dose-dependent improvements across studied patient reported outcomes. Future studies will further explore the optimum dose regime for izokibep.”
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Taylor P. Abstract 0199. Presented at: ACR Convergence 2022; November 11-14, 2022; Philadelphia (hybrid meeting).
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