2118: 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

Jessica Walsh¹, Laura Coates², Philip J Mease³, Joseph Merola⁴, Peter Nash⁵, Alexis Ogdie⁶, William Tillett⁷, Paolo Gisondi⁸, Barbara Ink⁹, Deepak Assudani⁹, Rajan Bajracharya⁹, Jérémy Lambert¹⁰, Vanessa Taieb¹¹, Damon Willems¹² and Lars Erik¹³, ¹University of Utah, Salt Lake City, UT, ²Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK, Oxford, England, United Kingdom, ³Swedish Medical Center/Providence St. Joseph Health, Seattle, WA, ⁴Brigham and Women's Hospital, Harvard Medical School, Boston, MA, ⁵School of Medicine, Griffith University, Sunshine Coast, Australia, ⁶Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, ⁷Royal National Hospital for Rheumatic Diseases, Bath, United Kingdom, ⁸Dermatology and Venereology, Department of Medicine, Università di Verona, Verona, Italy, Verona, ⁹UCB Pharma, Slough, United Kingdom, ¹⁰UCB Pharma, Colombes, France, Irigny, France, ¹¹UCB Pharma, Colombes, France, ¹²UCB Pharma, Brussels, Belgium, ¹³Bispebjerg-Frederiksberg Hospital, Vedbæk, Denmark

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).

Disclosures: J. Walsh, AbbVie, Amgen, Lilly, Novartis, Pfizer, UCB, Celgene, Janssen, Merck; L. Coates, AbbVie, Amgen, Boehringer-Ingelheim, Bristol-Myers Squibb (BMS), Eli Lilly, Gilead, Galapagos, Janssen, Medac, Novartis, Pfizer, UCB, Celgene, Biogen, Moonlake, GlaxoSmithKlein (GSK); P. Mease, AbbVie, Amgen, Janssen, Novartis, Pfizer Inc, UCB, Sun Pharma, Eli Lilly, Bristol-Myers Squibb(BMS), Celgene, Genentech; J. Merola, Novartis, Pfizer, Sun Pharma, UCB Pharma, Bristol-Myers Squibb(BMS), AbbVie, Dermavant, Eli Lilly, Janssen, Arena, Biogen; P. Nash, AbbVie, Eli Lilly, Janssen, Gilead, Bristol-Myers Squibb (BMS), Celgene; A. Ogdie, AbbVie, Amgen, Novartis, Pfizer Inc, Bristol-Myers Squibb, Celgene, Janssen, CorEvitas, Gilead Sciences, Eli Lilly, GlaxoSmithKline, Happify Health, UCB; W. Tillett, AbbVie, Amgen, Eli Lilly, Janssen, MSD, Novartis, Pfizer, UCB; P. Gisondi, AbbVie, Abiogen, Almirall, Celgene, Eli Lilly, Janssen, LEO Pharma, Merck/MSD, Novartis, Otsuka, Pfizer, Pierre Fabre, Sanofi, UCB Pharma; B. Ink, UCB Pharma, GlaxoSmithKlein(GSK); D. Assudani, UCB Pharma; R. Bajracharya, UCB Pharma; J. Lambert, UCB Pharma; V. Taieb, UCB Pharma; D. Willems, UCB Pharma; L. Erik, AbbVie/Abbott, Amgen, Biogen, Bristol-Myers Squibb(BMS), Eli Lilly, Gilead, Janssen, Merck/MSD, Novartis, Novo Nordisk, Pfizer, UCB Pharma.