Achieving Increasingly Stringent Clinical Disease Control Criteria Is Associated with Greater Improvements in Patient-Centric Measures of Physical Function and Pain in Patients with Active PsA: 16-Week Results from Two Phase 3 Randomized, Placebo-Controlled Studies

Background/Purpose: Examine the association between achieving increasingly stringent clinical disease control criteria and patient-centric measures of physical function and pain in patients with PsA, using data from BE OPTIMAL and BE COMPLETE. Methods: BE OPTIMAL (NCT03895203) and BE COMPLETE (NCT03896581) were phase 3 studies of bimekizumab (BKZ) in patients with active PsA who were bDMARD-naïve or had inadequate response to a tumor necrosis factor inhibitor (TNFi-IR), respectively; BE OPTIMAL included an additional adalimumab reference arm. In this post hoc analysis, all patients who reached specified disease control criteria (ACR: < 20% improvement from baseline, ≥20%–< 50%, ≥50%–< 70%, ≥70%; minimal Disease Activity (MDA): non-MDA, MDA; Disease Activity in Psoriatic Arthritis (DAPSA): high disease activity (HDA), moderate disease activity (MoDA), low disease activity/remission (LDA/REM); Psoriasis Area and Severity Index (PASI): < 50% improvement from baseline, ≥50%–< 75%, ≥75%–< 90%, ≥90%) at Wk 16 were pooled regardless of treatment arm, by study. Associations between achievement of these specified disease control criteria and improvements in patient-reported measures of physical function (Health Assessment Questionnaire Disability Index [HAQ-DI]: scored from 0 [best] to 3 [worst]) and pain (Patient’s Assessment of Arthritis Pain (PtAAP): 0 [best] to 100 [worst]) were assessed; it should be noted that some aspects of these clinical disease control criteria relate to aspects of HAQ-DI and PtAAP. Observed case data reported. Results: The majority of patients completed Wk 16 of each study (bDMARD-naïve: 821/852 [96.4%]; TNFi-IR: 388/400 [97.0%]). Patients achieving higher ACR response thresholds demonstrated sequentially greater mean (95% CI) improvements from baseline in HAQ-DI (bDMARD-naïve: < ACR20: −0.02 [−0.06, 0.02], ACR20–< ACR50: −0.22 [−0.28, −0.15], ACR50–< ACR70: −0.42 [−0.49, −0.35], ACR70: −0.53 [−0.60, −0.45]; TNFi-IR: −0.08 [−0.14, −0.01], −0.32 [−0.40, −0.24], −0.39 ...