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  • OP0019 BIMEKIZUMAB IN PATIENTS WITH ACTIVE ANKYLOSING SPONDYLITIS: 24-WEEK EFFICACY & SAFETY FROM BE MOBILE 2, A PHASE 3, MULTICENTRE, RANDOMISED, PLACEBO-CONTROLLED STUDY

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AxSpA drug treatment: new and old drugs
OP0019 BIMEKIZUMAB IN PATIENTS WITH ACTIVE ANKYLOSING SPONDYLITIS: 24-WEEK EFFICACY & SAFETY FROM BE MOBILE 2, A PHASE 3, MULTICENTRE, RANDOMISED, PLACEBO-CONTROLLED STUDY
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  1. D. Van der Heijde1,
  2. X. Baraliakos2,
  3. M. Dougados3,
  4. M. Brown4,
  5. D. Poddubnyy5,
  6. F. Van den Bosch6,
  7. N. Haroon7,
  8. H. Xu8,
  9. T. Tomita9,
  10. L. S. Gensler10,
  11. M. Oortgiesen11,
  12. C. Fleurinck12,
  13. T. Vaux13,
  14. A. Marten14,
  15. A. Deodhar15
  1. 1Leiden University Medical Center, Department of Rheumatology, Leiden, Netherlands
  2. 2Ruhr-University Bochum, Rheumazentrum Ruhrgebiet Herne, Bochum, Germany
  3. 3Université de Paris, Department of Rheumatology – Hôpital Cochin, Assistance Publique – Hôpitaux de Paris, INSERM (U1153): Clinical epidemiology and biostatistics, PRES Sorbonne Paris-Cité, Paris, France
  4. 4Genomics England, N/A, London, United Kingdom
  5. 5Charité – Universitätsmedizin Berlin, Department of Gastroenterology, Infectious Diseases and Rheumatology, Berlin, Germany
  6. 6Ghent University and VIB Centre for Inflammation Research, Department of Internal Medicine and Paediatrics, Ghent, Belgium
  7. 7University of Toronto, University Health Network, Toronto, Canada
  8. 8Shanghai Changzheng Hospital, Affiliated to Second Military Medical University, Department of Rheumatology and Immunology, Shanghai, China
  9. 9Osaka University Graduate School of Medicine, Department of Orthopaedic Biomaterial Science, Osaka, Japan
  10. 10University of California San Francisco, Department of Rheumatology, San Francisco, United States of America
  11. 11UCB Pharma, N/A, Raleigh, United States of America
  12. 12UCB Pharma, N/A, Brussels, Belgium
  13. 13UCB Pharma, N/A, Slough, United Kingdom
  14. 14UCB Pharma, N/A, Monheim, Germany
  15. 15Oregon Health & Science University, Division of Arthritis and Rheumatic Diseases, Portland, United States of America

Abstract

Background Bimekizumab (BKZ) is a monoclonal IgG1 antibody that selectively inhibits IL-17F in addition to IL-17A. In a phase 2b study, BKZ showed rapid and sustained efficacy and was well tolerated up to 156 weeks (wks) in patients (pts) with active ankylosing spondylitis (AS).1,2

Objectives To assess efficacy and safety of BKZ vs placebo (PBO) in pts with active AS up to Wk 24 in the ongoing pivotal phase 3 study, BE MOBILE 2.

Methods BE MOBILE 2 (NCT03928743) comprises a 16-wk double-blind, PBO-controlled period and 36-wk maintenance period. Pts were aged ≥18 yrs, met modified New York criteria and had active AS (BASDAI ≥4, spinal pain ≥4) at BL. Pts were randomised 2:1, BKZ 160 mg Q4W:PBO. From Wk 16, all pts received BKZ 160 mg Q4W. Primary and secondary efficacy endpoints were assessed at Wk 16.

Results Of 332 randomised pts (BKZ: 221; PBO: 111), 322 (97.0%) completed Wk 16 and 313 (94.3%) Wk 24. BL characteristics were comparable between groups: mean age 40.4 yrs, symptom duration 13.5 yrs; 72.3% pts male, 85.5% HLA-B27+, 16.3% TNFi-experienced. At Wk 16, the primary (ASAS40: 44.8% BKZ vs 22.5% PBO; p<0.001) and all ranked secondary endpoints were met (Table 1). Responses with BKZ were rapid, including in PBO pts who switched to BKZ at Wk 16, and increased to Wk 24 (Figure 1; Table 1). Substantial reductions of hs-CRP by Wk 2 and MRI SIJ and spine inflammation by Wk 16 were achieved with BKZ vs PBO (Table 1). At Wk 24, ≥50% pts had achieved ASDAS <2.1 (Figure 1).

View this table:
Table 1.

Efficacy at Wks 16 and 24

Over 16 wks, 120/221 (54.3%) BKZ pts had ≥1 TEAE vs 48/111 (43.2%) PBO; three most frequent on BKZ were nasopharyngitis (BKZ: 7.7%; PBO: 3.6%), headache (4.1%; 4.5%) and oral candidiasis (4.1%; 0%). No systemic candidiasis was observed. Up to 16 wks, incidence of SAEs was low (1.8%; 0.9%); no MACE or deaths were reported; 2 (0.9%) IBD cases occurred in pts on BKZ.

Conclusion Dual inhibition of IL-17A and IL-17F with BKZ in pts with active AS resulted in rapid, clinically relevant improvements in efficacy outcomes vs PBO. No new safety signals were observed.1,2

References [1]van der Heijde D. Ann Rheum Dis 2020;79:595–604; 2. Gensler L. Arthritis Rheumatol 2021;73(suppl 10):0491.

Figure

Acknowledgements This study was funded by UCB Pharma. Editorial services were provided by Costello Medical.

Disclosure of Interests Désirée van der Heijde Consultant of: AbbVie, Bayer, BMS, Cyxone, Eisai, Galapagos, Gilead, Glaxo-Smith-Kline, Janssen, Lilly, Novartis, Pfizer, UCB Pharma, Employee of: Imaging Rheumatology BV (Director), Xenofon Baraliakos Speakers bureau: AbbVie, BMS, Chugai, Eli Lilly, Galapagos, Gilead, MSD, Novartis, Pfizer, and UCB Pharma, Paid instructor for: AbbVie, BMS, Chugai, Eli Lilly, Galapagos, Gilead, MSD, Novartis, Pfizer, and UCB Pharma, Consultant of: AbbVie, BMS, Chugai, Eli Lilly, Galapagos, Gilead, MSD, Novartis, Pfizer, and UCB Pharma, Maxime Dougados Consultant of: AbbVie, Eli Lilly, Novartis, Merck, Pfizer, and UCB Pharma, Grant/research support from: AbbVie, Eli Lilly, Novartis, Pfizer, and UCB Pharma, Matt Brown Speakers bureau: Novartis, Consultant of: Pfizer, Clementia, Ipsen, Regeneron, Grey Wolf Therapeutics, Grant/research support from: UCB Pharma, Denis Poddubnyy Speakers bureau: AbbVie, BMS, Eli Lilly, MSD, Novartis, Pfizer, and UCB Pharma, Consultant of: AbbVie, Biocad, Eli Lilly, Gilead, GSK, MSD, Novartis, Pfizer, Samsung Bioepis, and UCB Pharma, Grant/research support from: AbbVie, MSD, Novartis, and Pfizer, Filip van den Bosch Speakers bureau: AbbVie, Bristol Myers-Squibb, Celgene, Janssen, Merck, Novartis, Pfizer and UCB Pharma, Consultant of: AbbVie, Amgen, Eli Lilly, Galapagos, Janssen, Merck, Novartis, Pfizer and UCB Pharma, Nigil Haroon Consultant of: AbbVie, Amgen, Janssen, Merck, Novartis and UCB Pharma, Huji Xu: None declared, Tetsuya Tomita Speakers bureau: AbbVie, Astellas, Bristol-Myers Squibb, Eisai, Eli Lilly, Janssen, Kyowa Kirin, Mitsubishi-Tanabe, Novartis, and Pfizer, Consultant of: AbbVie, Eli Lilly, Gilead, Novartis, and Pfizer, Lianne S. Gensler Consultant of: AbbVie, Eli Lilly, Gilead, GSK, Novartis, Pfizer, and UCB Pharma, Grant/research support from: Novartis, Pfizer, and UCB Pharma; paid to institution, Marga Oortgiesen Employee of: UCB Pharma, Carmen Fleurinck Employee of: UCB Pharma, Thomas Vaux Employee of: UCB Pharma, Alexander Marten Employee of: UCB Pharma, Atul Deodhar Speakers bureau: Janssen, Novartis, and Pfizer; consultant of AbbVie, Amgen, Aurinia, BMS, Celgene, Eli Lilly, GSK, Janssen, MoonLake, Novartis, Pfizer, and UCB Pharma, Grant/research support from: AbbVie, Eli Lilly, GSK, Novartis, Pfizer, and UCB Pharma.

https://doi.org/10.1136/annrheumdis-2022-eular.2441

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