Patient Outcomes, Preferences, and Attitudes Poster I
Background/Purpose: Izokibep is a unique IL-17A inhibitor with high potency and small molecular size designed to overcome the limitations of monoclonal antibodies. IL-17 is a key driver of the PsA disease process, which greatly impacts patients’ physical function, vitality, social participation, mood, and quality of life. Here, we report 16-week results of izokibep on patient-reported outcomes (PROs) in adult patients with active PsA.
Methods: A prospective, multicenter, randomized, double-blind, placebo-controlled, parallel-groups, dose-finding trial was performed evaluating izokibep 80 mg or 40 mg Q2W administered subcutaneously versus Placebo until Week 16. Patients met CASPAR criteria and had ≥3 swollen and ≥3 tender joints of the 66/68 joint count, and an inadequate response to previous NSAIDs, csDMARDs, or TNF inhibitor therapy. Secondary endpoints studying PROs included the SF-36, HAQ-DI, PsAID-9, DLQI, TSQM-9, and single-item scales for pain, patient-reported global disease activity, and itch. A priori statistical analyses were carried out on all studied PROs with posthoc analyses addressing minimal clinically important differences (MCIDs) for HAQ-DI, PsAID-9, and DLQI. ClinicalTrials.gov registration at NCT04713072.
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