Session Information
Session Type: Poster Session D
Session Time: 1:00PM-3:00PM
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 [−0.49, −0.29], −0.69 [−0.79, −0.58]; Figure 1A) and PtAAP scores (bDMARD-naïve: < ACR20: −0.1 [−2.3, 2.0], ACR20–< ACR50: −21.1 [−24.0, −18.1], ACR50–< ACR70: −33.8 [−37.6, −30.0], ACR70: −48.5 [−52.1, −44.9]; TNFi-IR: −2.7 [−5.9, 0.5], −23.9 [−28.2, −19.5], −37.4 [−43.0, −31.8], −50.5 [−56.3, −44.8]; Figure 1B) in both studies. Similar results were seen with MDA and DAPSA (Figure 1). Patients achieving ≥PASI50 also exhibited greater improvements versus the < PASI50 group in both studies (Figure 1).
Conclusion: Patients with active PsA who achieved increasingly stringent disease control criteria at Wk 16, as evaluated by clinicians, reported greater improvements in their HAQ-DI (physical function) and PtAAP (pain) scores, regardless of whether they were bDMARD-naïve (BE OPTIMAL) or TNFi-IR (BE COMPLETE).
To cite this abstract in AMA style:
Walsh J, Coates L, Mease P, Merola J, Nash P, Ogdie A, Tillett W, Gisondi P, Ink B, Assudani D, Bajracharya R, Lambert J, Taieb V, Willems D, Erik L. 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 [abstract]. Arthritis Rheumatol. 2022; 74 (suppl 9). https://acrabstracts.org/abstract/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-wee/. Accessed .« Back to ACR Convergence 2022
ACR Meeting Abstracts - https://acrabstracts.org/abstract/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-wee/