POS0805 SUSTAINED IMPROVEMENTS WITH BIMEKIZUMAB IN PATIENT-REPORTED SYMPTOMS OF AXIAL SPONDYLOARTHRITIS: 2-YEAR RESULTS FROM TWO PHASE 3 STUDIES
Authors: H. Marzo-Ortega, P. J. Mease, M. Dougados, M. Dubreuil, M. Magrey, M. Rudwaleit, M. A. D’agostino, C. De la Loge, C. Fleurinck, U. Massow, V. Taieb, A. Deodhar
Journal: Annals of the Rheumatic Diseases (2024)

<h3>Background:</h3> Bimekizumab (BKZ) is a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F in addition to IL-17A. In the phase 3 studies, BE MOBILE 1 and 2, BKZ demonstrated sustained improvements in key symptoms (including 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), respectively. [1] <h3>Objectives:</h3> To assess the impact of BKZ on spinal pain, morning stiffness and fatigue over 2 years in pts across the full disease spectrum of axSpA. <h3>Methods:</h3> In BE MOBILE 1 (NCT03928704) and 2 (NCT03928743), pts were randomised to receive subcutaneous BKZ 160 mg every 4 wks (Q4W) or placebo (PBO); from Wk 16, all pts received BKZ 160 mg Q4W. At Wk 52, those who completed either study without meeting any withdrawal criteria were eligible to be enrolled into BE MOVING (NCT04436640), an ongoing, open-label extension (OLE). We report 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 scores), to Wk 104 using multiple imputation (MI). We also report the proportion of pts achieving total and nocturnal spinal pain scores &lt;2, indicating minimal (score =1) or no (score =0) back pain, and &lt;4, based on the BE MOBILE 1 and 2 study inclusion criteria of spinal pain ≥4 according to BASDAI Q2, and FACIT-Fatigue responders (proportion achieving ≥8-point increase from baseline, in pts with baseline score ≤44) to Wk 104 using non-responder imputation (NRI) and observed case (OC). Data are pooled for all randomised pts with nr-axSpA and r-axSpA in BE MOBILE 1 and 2. <h3>Results:</h3> Of 254 nr-axSpA pts and 332 r-axSpA pts originally randomised to BKZ or PBO in BE MOBILE 1 and 2, respectively, 494 (84.3%) pts entered BE MOVING at Wk 52. By July 2023, 189 nr-axSpA pts and 267 r-axSpA pts had completed Wk 104. Baseline symptoms were comparable between treatment groups (Figure 1). Improvements from baseline at 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 fatigue (CfB: –3.1 at Wk 52; –3.4 at Wk 104). Improved FACIT-Fatigue scores were also sustained throughout the OLE (CfB: +9.9 at Wk 52 and Wk 104; Figure 1). From Wk 52 through Wk 104, &gt;50% of pts achieved total and nocturnal spinal pain scores &lt;4, and &gt;25% and &gt;35% achieved total and nocturnal spinal pain scores &lt;2, respectively (NRI and OC; Figure 2). More than 50% of pts were considered FACIT-Fatigue responders from Wk 52 through Wk 104 (Figure 2). Results were similar across pts with nr-axSpA and r-axSpA. <h3>Conclusion:</h3> Results from 2 years of treatment with BKZ demonstrated consistently sustained improvements in spinal pain, morning stiffness and fatigue in pts with r-axSpA and nr-axSpA. These findings emphasise the longer-term benefit of BKZ on clinical symptoms, which are important to pts and have a substantial impact on their daily lives. <h3>REFERENCES:</h3> [1] Mease PJ. ACR 2023 [Poster 0510]. <h3>Acknowledgements:</h3> Funded by UCB Pharma. Medical writing support provided by Costello Medical and funded by UCB Pharma. <h3>Disclosure of Interests:</h3> Helena Marzo-Ortega Speakers' bureau from AbbVie, Amgen, Biogen, Eli Lilly, Janssen, Novartis, Pfizer, Takeda and UCB Pharma, Consultant of Amgen, Eli Lilly, Janssen, MoonLake, Novartis, Pfizer and UCB Pharma, Research grants from Janssen, Novartis, Pfizer and UCB Pharma, Philip J. Mease Speakers' bureau fees from AbbVie, Amgen, Eli Lilly, Janssen, Novartis, Pfizer and UCB Pharma, Consulting fees from AbbVie, Acelyrin, Aclaris, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Eli Lilly, Galapagos, Gilead, GSK, Janssen, MoonLake, Novartis, Pfizer, Sun Pharma, Takeda, UCB Pharma and Ventyx, Research grants from AbbVie, Acelyrin, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Gilead, Janssen, Novartis, Pfizer, Sun Pharma and UCB Pharma, Maxime Dougados Speaker fees from AbbVie, Eli Lilly, Merck, Novartis, Pfizer and UCB Pharma, Consultancy fees from AbbVie, Eli Lilly, Merck, Novartis, Pfizer and UCB Pharma, Research grants from AbbVie, Eli Lilly, Merck, Novartis, Pfizer and UCB Pharma, Maureen Dubreuil Consulting fees (e.g. advisory boards) from Amgen and UCB Pharma, Educational grant from Pfizer paid to institution, Marina Magrey Consultancy fees from AbbVie, Bristol-Myers Squibb, Eli Lilly, Novartis, Pfizer and UCB Pharma, Research grants from AbbVie, Bristol-Myers Squibb and UCB Pharma, Martin Rudwaleit Speakers' bureau from AbbVie, Boehringer Ingelheim, Chugai, Eli Lilly, Janssen, Novartis, Pfizer and UCB Pharma, Consultant for AbbVie, Eli Lilly, Novartis and UCB Pharma, Maria Antonietta D'Agostino Speaking honoraria and/or consultancy fees from Amgen, AbbVie, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, Janssen, Galapagos Novartis, Pfizer and UCB Pharma, Christine de la Loge Consultant for UCB Pharma, Carmen Fleurinck Shareholder of UCB Pharma, Employee of UCB Pharma, Ute Massow Employee of UCB Pharma, Vanessa Taieb Shareholder of UCB Pharma, Employee of UCB Pharma, Atul Deodhar Speaker for Eli Lilly, Janssen, Novartis, Pfizer and UCB Pharma, Consultant for AbbVie, Bristol-Myers Squibb, Eli Lilly, Janssen, MoonLake, Novartis, Pfizer and UCB Pharma, Grant/research support from Bristol-Myers Squibb, Celgene, Eli Lilly, Novartis, Pfizer and UCB Pharma.