Control of Inflammation and Sustained Improvements in Patient-Reported Outcomes in Patients With Psoriatic Arthritis: Bimekizumab Two-Year Results From Two Phase 3 Studies

Objective: To assess two-year impact of bimekizumab on patient-reported outcomes (PROs), and their association with objective measures of inflammation, in patients with psoriatic arthritis (PsA) who were biologic disease-modifying antirheumatic drug (bDMARD)-naïve or had tumor necrosis factor inhibitor inadequate response or intolerance (TNFi-IR). Methods: BE OPTIMAL (NCT03895203; bDMARD-naïve) and BE COMPLETE (NCT03896581; TNFi-IR) were phase 3 studies that assessed subcutaneous bimekizumab 160 mg every four weeks. Both were double-blind, placebo-controlled to week16, then placebo patients switched to bimekizumab. BE OPTIMAL week52 or BE COMPLETE week16 completers could enter BE VITAL (NCT04009499; open-label extension), where all patients received bimekizumab. PROs, disease impact (Psoriatic Arthritis Impact of Disease-12 questionnaire [PsAID-12]), and their association with inflammation (assessed using swollen joint count [SJC]) are reported to year 2. Results: Among 712 bDMARD-naïve and 400 TNFi-IR patients, bimekizumab resulted in long-term sustained improvements in PROs for pain, fatigue, and function (Health Assessment Questionnaire–Disability Index) to year 2. Mean change from baseline (year 2) in bimekizumab-randomized patients for pain and disease impact (PsAID-12) was −33.9 to −29.2 and −2.5 to −2.2, respectively. An achievement of SJC = 0 was associated with the greatest reduction in pain. Decreased SJC was associated with improved pain, fatigue, function, and reduced disease impact to year 2. By year 2, 44.4% to 54.3% of patients originally randomized to placebo or bimekizumab reported no or low disease impact (PsAID-12 ≤1.95), and 88.0% to 92.0% of bimekizumab-randomized patients achieved a patient acceptable symptom state for disease impact (PsAID-12 ≤4), associated with concurrent improvement in SJC and skin involvement. Conclusion: Bimekizumab treatment resulted in sustained clinically meaningful improvements in PROs and reduced disease impact to two years in bDMARD-naïve and TNFi-IR patients with PsA. Stringent inflammation control was associated with symptom relief and reduced disease impact. (Figure presented.).