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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. AUC0-104/88 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.
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. AUC0-104/88 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.
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