Achieving early clinical response was associated with cumulative benefits on disease impact up to 2 years in patients with active psoriatic arthritis treated with bimekizumab

Presentation Author(s):

William Tillett,^1,2 Joseph F. Merola,³ Iain B. McInnes,⁴ Kenneth B. Gordon,⁵ Richard B. Warren,⁶ Patrick Healy,⁷Jérémy Lambert,⁸ Heather Edens,⁹ Barbara Ink,¹⁰ Paola Volpe,¹¹ Laure Gossec¹²

¹Royal National Hospital of Rheumatic Diseases, Bath, UK; ²Department of Life Sciences, Centre for Therapeutic Innovation, University of Bath, Bath, UK; ³Department of Dermatology and Department of Medicine, Division of Rheumatology, Utah Southwestern Medical Center, Dallas, Texas, USA; ⁴College of Medical Veterinary and Life Sciences, University of Glasgow, Glasgow, UK; ⁵Department of Dermatology, Medical College of Wisconsin, Milwaukee, Wisconsin, USA; ⁶Dermatology Centre, Northern Care Alliance, NHS Foundation Trust & Division of Musculoskeletal and Dermatological Sciences, Manchester Academic Health Science Centre, University of Manchester, Manchester, UK; ⁷UCB, Morrisville, North Carolina, USA; ⁸UCB, Colombes, France; ⁹UCB, Smyrna, Georgia, USA; ¹⁰UCB, Slough, UK; ¹¹UOC Reumatologia, P.O. Spirito Santo, Pescara, Italy; ¹²Sorbonne Universite and Pitie-Salpetriere Hospital, Paris, France

 

Abstract or description:

We examine the association between clinical responses at Week (Wk)16 with bimekizumab treatment and the cumulative benefit on patient‑reported disease impact in patients with psoriatic arthritis (PsA) to 2 years.

This post-hoc analysis of BE OPTIMAL (NCT03895203; biologic DMARD [bDMARD]‑naïve) and BE COMPLETE (NCT03896581; TNF inhibitor inadequate response/intolerance [TNFi‑IR]) assessed subcutaneous bimekizumab 160mg every 4 wks in patients with PsA. BE OPTIMAL (Wk52) and BE COMPLETE (Wk16) completers could enter BE VITAL (open-label extension), in which all patients received bimekizumab. Bimekizumab-randomized patients grouped on achievement of ≥50% improvement from baseline in ACR criteria (ACR50), minimal disease activity (MDA), or swollen joint count resolution (SJC=0) at Wk16 (responders vs non-responders). Cumulative disease impact, assessed using remission/low disease activity (REM/LDA) in PsAID-12 total score (≤1.95), was estimated using area under the curve (AUC) to Wk104/Wk88 in BE OPTIMAL/BE COMPLETE. Missing data imputed as NRI.

359/431 (83.3%) and 221/267 (82.8%) bimekizumab-randomized patients completed BE OPTIMAL and BE COMPLETE at Wk104/88 respectively. At Wk16, 189/431 (43.9%; bDMARD-naïve) and 115/267 (43.1%; TNFi-IR) patients achieved ACR50; 194/431 (45.0%) and 117/267 (43.8%) achieved MDA; 206/431 (47.8%) and 122/267 (45.7%) achieved SJC=0, respectively.

A greater proportion of Wk16 ACR50 responders vs non-responders achieved PsAID‑12 REM/LDA at Wk104/88. AUC_0-104/88 for PsAID-12 REM/LDA achievement was greater for Wk16 ACR50 responders vs non-responders, representing a greater percentage of days in REM/LDA to Wk104/88.

Similar trends were observed in Wk16 MDA/SJC=0 responders, who had more cumulative days in PsAID-12 REM/LDA to 2 years vs non-responders. Up to 2 years of bimekizumab treatment, patients who achieved ACR50, MDA, and SJC=0 at Wk16 experienced approximately 9.6/7.3, 10.4/9.6, and 3.5/5.2 (bDMARD-naïve/TNFi-IR) more cumulative months in PsAID-12 REM/LDA than non-responders, respectively.

Achieving clinical responses at Wk16 was associated with cumulative benefits on patient-reported disease impact up to 2 years in patients with PsA treated with bimekizumab.