Sustained Improvements with Bimekizumab in Patient-Reported Symptoms of Axial Spondyloarthritis: 2-Year Results from Two Phase 3 Studies

Helena Marzo-Ortega¹, Philip Mease², Maxime Dougados³, Maureen Dubreuil⁴, Marina Magrey⁵, Martin Rudwaleit⁶, Maria Antonietta D'Agostino⁷, Christine de la Loge⁸, Ute Massow⁹, Vanessa Taieb¹⁰, Diana Voiniciuc¹¹ and Atul Deodhar¹², ¹NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust and Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, United Kingdom, ²Swedish Medical Center/Providence St. Joseph Health; University of Washington School of Medicine, Seattle, WA, ³Rheumatology Department, Cochin Hospital and Clinical Epidemiology and Biostatistics, University of Paris, INSERM (U1153), Paris, France, ⁴Section of Rheumatology, Boston University School of Medicine, Boston, MA, ⁵Case Western Reserve University School of Medicine/University Hospitals, Richfield, OH, ⁶University of Bielefeld, Klinikum Bielefeld, Bielefeld, Germany, ⁷Division of Rheumatology, Fondazione Policlinico Universitario Agostino Gemelli IRCSS, Università Cattolica del Sacro Cuore, Rome, Italy, ⁸UCB Pharma, Brussels, Belgium, ⁹UCB Pharma, Monheim am Rhein, Germany, ¹⁰UCB Pharma, Colombes, France, ¹¹UCB Pharma, Slough, United Kingdom, ¹²Division of Arthritis and Rheumatic Diseases, Oregon Health & Science University, Portland, OR

Meeting: ACR Convergence 2024

Keywords: Fatigue, Morning Stiffness, pain, Patient reported outcomes, spondyloarthritis

Session Information

Date: Saturday, November 16, 2024

Title: SpA Including PsA – Treatment Poster I

Session Type: Poster Session A

Session Time: 10:30AM-12:30PM

Background/Purpose: In the phase 3 studies, BE MOBILE 1 and 2, bimekizumab (BKZ), a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F in addition to IL-17A, demonstrated sustained improvements in spinal pain, morning stiffness, and fatigue up to 52 weeks (wks) in patients (pts) with non-radiographic (nr-) axial spondyloarthritis (axSpA) and radiographic (r-)axSpA (i.e., ankylosing spondylitis).¹

We present 2-year data for pts continuing BKZ treatment in the joint, ongoing open-label extension (OLE) study, BE MOVING.

Methods: In BE MOBILE 1 (NCT03928704) and 2 (NCT03928743), pts were randomized to subcutaneous BKZ 160 mg every 4 wks (Q4W) or placebo (PBO); all received BKZ 160 mg Q4W from Wk 16. Pts completing either study at Wk 52 without meeting withdrawal criteria could enter BE MOVING (NCT04436640).

We report pooled data to Wk 104 across pts with nr-axSpA and r-axSpA from BE MOBILE 1 and 2. Mean values and change from baseline (CfB) in total and nocturnal spinal pain, morning stiffness (mean of Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] questions [Q]5 and Q6), and fatigue (BASDAI Q1 and Functional Assessment of Chronic Illness Therapy [FACIT]-Fatigue subscale scores) are reported (multiple imputation [MI]).

The proportion of pts achieving different thresholds for low total and nocturnal spinal pain (scores < 4 or < 2) or FACIT-Fatigue response (≥8-point increase from baseline in pts with baseline score ≤44)² are reported (non-responder imputation [NRI] and observed case [OC]). The proportion of pts achieving different thresholds for BASDAI Q1 severity, as established in a recent psychometric analysis,² are presented based on MI data.

Results: Of pts originally randomized in BE MOBILE 1 (nr-axSpA) and 2 (r-axSpA), 81.9% (208/254) and 86.1% (286/332) entered BE MOVING at Wk 52, respectively; 189 pts with nr-axSpA and 267 pts with r-axSpA completed Wk 104.

Improvements from baseline to Wk 52 were sustained to Wk 104 for total spinal pain, nocturnal spinal pain, and morning stiffness scores (CfB for all: –4.2 at Wk 52, –4.3 at Wk 104; Figure 1). Results were similar for BASDAI Q1 (CfB: –3.1 at Wk 52; –3.4 at Wk 104). Improved FACIT-Fatigue scores were sustained throughout the OLE (CfB: +9.9 at Wk 52 and Wk 104; Figure 1).

At Wk 52 and Wk 104, >50% of pts had total or nocturnal spinal pain scores < 4 (Figure 2). At the same timepoints, >25% and >35% of pts achieved scores < 2 for total and nocturnal spinal pain, respectively. More than 50% of pts were FACIT-Fatigue responders at Wk 52 and Wk 104 (Figure 2).

According to BASDAI Q1, 51.9% of pts had severe fatigue at baseline. By Wk 52, this decreased to 10.2% and most pts (56.7%) were considered to have mild or no/minimal fatigue. Improvements continued to Wk 104 (Figure 3).

Conclusion: Results from 2 years of treatment with BKZ demonstrated consistently sustained improvements in spinal pain, morning stiffness, and fatigue in pts across the full disease spectrum of axSpA. These findings support the longer-term maintenance of BKZ benefits on clinical symptoms, which are important to pts and have a substantial impact on their daily lives.

References: 1. Mease PJ. ACR 2023 [Poster 0510]; 2. de la Loge C. ICS Ghent 2024 [submitted].

Figure 1. Mean score and change from baseline in spinal pain, morning stiffness and FACIT-Fatigue to Week 104 (MI)

Figure 2. Proportion of patients achieving spinal pain score <4 or <2 and FACIT-Fatigue responders (≥8-point increase from baseline) to Week 104 (NRI, OC)

Figure 3. Proportion of patients achieving thresholds for BASDAI Q1 severity bands to Week 104 (MI)

Disclosures: H. Marzo-Ortega: AbbVie, 2, 6, Amgen, 2, 6, Biogen, 2, 6, Eli Lilly, 2, 6, Janssen, 2, 5, 6, MoonLake, 2, 6, Novartis, 2, 5, 6, Pfizer, 2, 5, 6, Takeda, 2, 6, UCB Pharma, 2, 5, 6; P. Mease: AbbVie, 2, 5, Aclaris Therapeutics, 2, 5, Aclyrin, 2, 5, Amgen, 2, 5, Boehringer Ingelheim, 2, 5, Bristol Myers Squibb, 2, 5, CorEvitas, 2, 5, Galápagos, 2, 5, Gilead, 2, 5, Inmagene, 2, 5, Janssen, 2, 5, Lilly, 2, 5, MoonLake Immunotherapeutics, 2, 5, Novartis, 2, 5, Pfizer Inc, 2, 5, Sun Pharma, 2, 5, UCB, 2, 5; M. Dougados: AbbVie, 2, 5, 6, Eli Lilly, 2, 5, 6, Merck, 2, 5, 6, Novartis, 2, 5, 6, Pfizer, 2, 5, 6, UCB Pharma, 2, 5, 6; M. Dubreuil: Amgen, 2, Pfizer, 5, UCB Pharma, 2; M. Magrey: AbbVie, 2, 5, BMS, 2, 5, Eli Lilly, 2, Novartis, 2, Pfizer, 2, UCB Pharma, 2, 5; 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; M. D'Agostino: AbbVie, 2, 6, Amgen, 2, 6, BMS, 2, 6, Boehringer Ingelheim, 2, 6, Eli Lilly, 2, 6, Galapagos, 2, 6, Janssen, 2, 6, Novartis, 2, 6, Pfizer, 2, 6, UCB Pharma, 2, 6; C. de la Loge: UCB Pharma, 2; U. Massow: UCB Pharma, 3; V. Taieb: UCB Pharma, 3, 11; D. Voiniciuc: UCB Pharma, 7, Veramed, 3; A. Deodhar: AbbVie, 2, 5, 6, BMS, 2, 5, 6, Eli Lilly, 2, 5, 6, Janssen, 2, 5, 6, Novartis, 2, 5, 6, Pfizer, 2, 5, 6, UCB Pharma, 2, 5, 6.

To cite this abstract in AMA style:
Marzo-Ortega H, Mease P, Dougados M, Dubreuil M, Magrey M, Rudwaleit M, D'Agostino M, de la Loge C, Massow U, Taieb V, Voiniciuc D, Deodhar A. Sustained Improvements with Bimekizumab in Patient-Reported Symptoms of Axial Spondyloarthritis: 2-Year Results from Two Phase 3 Studies [abstract]. Arthritis Rheumatol. 2024; 76 (suppl 9). https://acrabstracts.org/abstract/sustained-improvements-with-bimekizumab-in-patient-reported-symptoms-of-axial-spondyloarthritis-2-year-results-from-two-phase-3-studies/. Accessed .

ACR Meeting Abstracts - https://acrabstracts.org/abstract/sustained-improvements-with-bimekizumab-in-patient-reported-symptoms-of-axial-spondyloarthritis-2-year-results-from-two-phase-3-studies/