ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 0510

Bimekizumab Treatment Improved Key Patient-Reported Symptoms of Axial Spondyloarthritis Including Spinal Pain, Fatigue, and Morning Stiffness: 52-Week Results from Two Phase 3 Studies

Philip J. Mease1, Maxime Dougados2, Maureen Dubreuil3, Marina Nighat Magrey4, Helena Marzo-Ortega5, Martin Rudwaleit6, Christine de la Loge7, Carmen Fleurinck8, Ute Massow9, Vanessa Taieb10 and Atul Deodhar11, 1Swedish Medical Center/Providence St. Joseph Health and University of Washington School of Medicine, Seattle, WA, 2Department of Rheumatology, Hôpital Cochin, University of Paris Cité, Paris, France, 3Department of Rheumatology, Boston University School of Medicine, Milton, MA, 4Case Western Reserve University, University Hospitals, Cleveland, OH, 5NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust and Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, United Kingdom, 6University of Bielefeld, Klinikum Bielefeld, Bielefeld, Germany, 7UCB Pharma, Brussels, Belgium, 8UCB Pharma, Oosterzele, Belgium, 9UCB Pharma, Monheim am Rhein, Germany, 10UCB Pharma, Colombes, France, 11Division of Arthritis and Rheumatic Disease, Oregon Health & Science University, Portland, OR

Meeting: ACR Convergence 2023

Keywords: , , , ,

Session Information

Date: Sunday, November 12, 2023

Title: (0510–0542) Spondyloarthritis Including Psoriatic Arthritis – Treatment: AxSpA Poster I

Session Type: Poster Session A

Session Time: 9:00AM-11:00AM

Background/Purpose: Bimekizumab (BKZ) is a monoclonal IgG1 antibody that selectively inhibits IL-17F in addition to IL-17A. In the phase 3 studies BE MOBILE 1 and 2, BKZ demonstrated sustained improvements to Week (Wk) 52 in patients (pts) with active non-radiographic (nr-) and radiographic axial spondyloarthritis (r-axSpA; i.e., AS).1,2

Here, we report the impact of BKZ in pts with axSpA on key pt-reported symptoms (spinal pain, stiffness, and fatigue).

Methods: BE MOBILE 1 (NCT03928704) and 2 (NCT03928743) both comprised a 16-wk double-blind period followed by a 36-wk maintenance period. Pts were randomized to receive subcutaneous BKZ 160 mg every 4 wks (Q4W) or placebo (PBO); from Wk 16 all pts received BKZ 160 mg Q4W.

We report mean nocturnal and total spinal pain, and BASDAI morning stiffness (mean of BASDAI questions 5 and 6), as well as mean change from baseline (CfB) in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue scores to Wk 52; missing values were imputed using multiple imputation. Least squares mean difference (LSMD) is reported for FACIT-F at Wk 16. Proportion of pts achieving low levels of pain (total and nocturnal spinal pain score: ≤2 and ≤4) and a meaningful improvement in fatigue (FACIT-F score: ≥8 point increase from baseline [BL]), analyzed post hoc, are also reported; missing values were imputed using non-responder imputation.

Results: 254 pts with nr-axSpA (BKZ: 128; PBO: 126) and 332 with r-axSpA (BKZ: 221; PBO: 111) were randomized; 86.6% (220/254) and 89.8% (298/332) pts completed to Wk 52, respectively. Across both studies, mean BL scores for all reported outcomes indicated high disease burden (Figure 1).

At Wk 16, BKZ-randomized pts achieved greater improvements in mean nocturnal and total spinal pain (nominal), and BASDAI morning stiffness (nominal) vs PBO (all p< 0.001; Figure 1). Mean scores were further improved to Wk 52 among BKZ-randomized pts and among pts who switched from PBO to BKZ at Wk 16 (PBO/BKZ), responses approached those of BKZ-randomized pts. Similarly, at Wk 16 a higher proportion of BKZ- vs PBO-randomized pts achieved low nocturnal and total spinal scores (Figure 2); at Wk 52 these improvements were similar across BKZ-randomized and PBO/BKZ pts.

At Wk 16, BKZ-randomized pts achieved greater improvements in FACIT-F scores vs PBO (mean CfB [nominal p value]: nr-axSpA: 8.5 vs 3.9 [< 0.001]; r-axSpA: 8.4 vs 5.0 [0.015]; LSMD: nr-axSpA: 4.2; r-axSpA: 2.2) with similar improvements at Wk 52 among BKZ-randomized and PBO/BKZ pts (mean CfB: nr-axSpA: 10.9 vs 9.2; r-axSpA: 9.9 vs 9.5). Similarly, a higher proportion of BKZ-randomized pts achieved a ≥8 point improvement from BL compared with PBO at Wk 16 (Figure 3);responses at Wk 52 were similar across PBO/BKZ and BKZ-randomized pts.

Conclusion: BKZ treatment resulted in clinically meaningful improvements in spinal pain, morning stiffness, and fatigue to Wk 52 in pts across the full disease spectrum of axSpA, who had a similar and high disease burden at BL. These findings emphasize the benefit of BKZ on clinical symptoms which are important to pts and have a substantial impact on their daily lives.3

References:1. van der Heijde D. Ann Rheum Dis 2023;82:515–526; 2. Boel A. Ann Rheum Dis. 2019;78:1545–9; 3. Strand V. J Clin Rheumatol 2017;23:383–91.

Supporting image 1

Figure 1. Improvement in mean (A) nocturnal spinal pain, (B) total spinal pain scores, and (C) BASDAI morning stiffness (questions 5 and 6) to Week 52 (MI)

Supporting image 2

Figure 2. Proportion of patients achieving (A) total and (B) nocturnal spinal pain scores ≤2 and ≤4 to Week 52 (NRI)

Supporting image 3

Figure 3. Proportion of patients achieving an increase in FACIT-Fatigue score of ≥8 to Week 52 (NRI)

Disclosures: P. Mease: AbbVie, 2, 5, 6, Acelyrin, 2, Aclaris, 2, Amgen, 2, 5, 6, Boehringer Ingelheim, 2, Bristol Myers Squibb, 2, 5, Eli Lilly, 2, 5, 6, Galapagos, 2, Gilead, 2, GlaxoSmithKline, 2, Inmagene, 2, Janssen, 2, 5, 6, MoonLake Pharma, 2, Novartis, 2, 5, 6, Pfizer, 2, 5, 6, Sun Pharma, 2, 5, UCB Pharma, 2, 5, 6, Ventyx, 2, Xinthera, 2; M. Dougados: AbbVie, 2, 5, 6, Eli Lilly, 2, 5, 6, Merck, 2, 5, 6, Novartis, 2, 5, 6, Pfizer, 3, 5, 6, UCB Pharma, 2, 5, 6; M. Dubreuil: Amgen, 2, Pfizer, 5, UCB Pharma, 2; M. Magrey: AbbVie, 2, Bristol Myers Squibb, 2, Eli Lilly, 2, Novartis, 2, Pfizer Inc, 2, UCB, 5; H. Marzo-Ortega: AbbVie, 2, 6, Biogen, 2, 6, Eli Lilly, 2, 6, Janssen, 2, 5, 6, MoonLake, 2, 6, Novartis, 2, 5, 6, Pfizer, 2, 6, Takeda, 2, 6, UCB Pharma, 2, 5, 6; M. Rudwaleit: AbbVie, 2, 6, Boehringer Ingelheim, 6, Chugai, 6, Eli Lilly, 2, 6, Janssen, 6, Novartis, 2, 6, Pfizer, 6, UCB Pharma, 2, 6; C. de la Loge: UCB Pharma, 2; C. Fleurinck: UCB Pharma, 3; U. Massow: UCB Pharma, 3; V. Taieb: UCB Pharma, 3, 11; A. Deodhar: AbbVie, 2, 5, Amgen, 2, Aurinia, 2, Bristol Myers Squibb, 2, 5, Celgene, 5, Eli Lilly, 2, 5, Janssen, 2, 6, MoonLake, 2, 5, Novartis, 2, 5, 6, Pfizer Inc, 2, 5, 6, UCB, 2, 5.

To cite this abstract in AMA style:

Mease P, Dougados M, Dubreuil M, Magrey M, Marzo-Ortega H, Rudwaleit M, de la Loge C, Fleurinck C, Massow U, Taieb V, Deodhar A. Bimekizumab Treatment Improved Key Patient-Reported Symptoms of Axial Spondyloarthritis Including Spinal Pain, Fatigue, and Morning Stiffness: 52-Week Results from Two Phase 3 Studies [abstract]. Arthritis Rheumatol. 2023; 75 (suppl 9). https://acrabstracts.org/abstract/bimekizumab-treatment-improved-key-patient-reported-symptoms-of-axial-spondyloarthritis-including-spinal-pain-fatigue-and-morning-stiffness-52-week-results-from-two-phase-3-studies/. Accessed .

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/bimekizumab-treatment-improved-key-patient-reported-symptoms-of-axial-spondyloarthritis-including-spinal-pain-fatigue-and-morning-stiffness-52-week-results-from-two-phase-3-studies/