TY - ABST
T1 - POS0247 RESOLUTION OF ENTHESITIS AND PERIPHERAL ARTHRITIS WITH BIMEKIZUMAB IN PATIENTS WITH AXIAL SPODYLOARTHRITIS: WEEK 52 RESULTS FROM THE BE MOBILE 1 AND BE MOBILE 2 PHASE 3 STUDIES
AU - Ramiro, S.
AU - Poddubnyy, D.
AU - Mease, P. J.
AU - López-Medina, C.
AU - Fleurinck, C.
AU - Kim, M.
AU - Massow, U.
AU - Taieb, V.
AU - Kragstrup, T. W.
AU - Mcgonagle, D.
PY - 2023
Y1 - 2023
N2 - Background A history of enthesitis or peripheral arthritis has been reported in gt;30pts) with axial spondyloarthritis (axSpA),[1] both of which contribute to disease burden. Bimekizumab (BKZ), a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F in addition to IL-17A, has demonstrated efficacy in phase 3 parallel studies in pts with non-radiographic (nr-)axSpA (BE MOBILE 1) and radiographic axSpA (r-axSpA i.e. ankylosing spondylitis; BE MOBILE 2).[2,3]Objectives To evaluate the impact of BKZ on the main peripheral manifestations of axSpA, to Week (Wk) 52.Methods Pts in BE MOBILE 1 (NCT03928704; nr-axSpA) met Assessment of SpondyloArthritis International Society (ASAS) classification criteria, pts in BE MOBILE 2 (NCT03928743; r-axSpA) met both modified New York and ASAS criteria. Pts were randomised to receive subcutaneous BKZ 160 mg every 4 wks (Q4W) or placebo (PBO) to Wk 16. From Wk 16 all pts received BKZ 160 mg Q4W.[2] Among pts with enthesitis (Maastricht Ankylosing Spondylitis Enthesitis [MASES]gt;0), at least one swollen joint (SJCgt;0), or at least one tender joint (TJCgt;0) at baseline (BL), we report mean change from baseline (CfB) using multiple imputation (MI). Pts ( achieving complete resolution of enthesitis (MASES=0 in pts with MASES gt;0 at BL) and peripheral arthritis (SJC=0 in pts with SJC gt;0 at BL, assessed in 44 joints) using non-responder imputation, is also reported.Results At BL, 73.2axSpA pts (BKZ: 94/128, PBO: 92/126) and 59.9axSpA pts (BKZ: 132/221, PBO: 67/111) had enthesitis; peripheral arthritis (SJC gt;0) was present in 34.6BKZ: 45/128, PBO: 43/126) and 19.9BKZ: 44/221, PBO: 22/111) of nr-axSpA and r-axSpA pts, respectively. BL MASES, SJC and TJC were largely similar between treatment arms (Table 1). Across the axSpA spectrum, greater mean CfB in MASES was achieved with BKZ vs PBO at Wk 16; improvements continued to Wk 52 with continuous BKZ and in pts switching from PBO to BKZ at Wk 16 (Table 1). Similarly, gt;506 vs lt;33 by Wk 52, responses of PBO/BKZ-switchers approached those of BKZ pts (Figure 1). At Wk 16, greater mean CfB in SJC and TJC was achieved with BKZ vs PBO-randomised pts with nr-axSpA. Improvements largely continued to Wk 52 with BKZ for both continuous BKZ and PBO/BKZ-switcher pts (Table 1). Resolution of peripheral arthritis was achieved by gt;57% of BKZ vs gt;41randomised pts at Wk 16; by Wk 52, proportions were similar among continuous BKZ and PBO/BKZ-switcher pts (Figure 1).Conclusion BKZ treatment resulted in sustained improvements in peripheral manifestations across the axSpA spectrum. Resolution of enthesitis was achieved in ~half of BKZ-treated pts by Wk 52; a similar pattern was observed for peripheral arthritis, with more than half of pts achieving resolution to Wk 52.References [1]López-Medina C. RMD Open 2021;7(1):e001450;[2]Baraliakos X. Arthritis Rheumatol 2022;74(suppl 9);[3]Boel A. Ann Rheum Dis 2019;78:1545textendash9.View this table:Table 1. Mean BL and CfB in enthesitis and peripheral arthritis [MI]Acknowledgements: This study was funded by UCB Pharma. Medical writing support was provided by Costello Medical, funded by UCB Pharma.Disclosure of Interests Sofia Ramiro Consultant of: AbbVie, Eli Lilly, Novartis, Pfizer, Sanofi and UCB Pharma, Grant/research support from: AbbVie, Galapagos, MSD, Novartis, Pfizer and UCB Pharma, Denis Poddubnyy Speakers bureau: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer and UCB Pharma, Consultant of: AbbVie, Biocad, Eli Lilly, Gilead, GSK, MSD, Moonlake, Novartis, Pfizer, Samsung Bioepis and UCB Pharma, Grant/research support from: AbbVie, Eli Lilly, MSD, Novartis and Pfizer, Philip J Mease Speakers bureau: AbbVie, Amgen, Eli Lilly, Janssen, Novartis, Pfizer and UCB Pharma, Consultant of: AbbVie, Acelyrin, Aclaris, Amgen, Bristol-Myers Squibb, Boehringer Ingelheim, Eli Lilly, Galapagos, Gilead, GSK, Janssen, MoonLake Pharma, Novartis, Pfizer, Sun Pharma and UCB Pharma, Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, Eli Lilly, Gilead, Janssen, Novartis, Pfizer, Sun Pharma and UCB Pharma, Clementina López-Medina Speakers bureau: AbbVie, Eli Lilly, Janssen, MSD, Novartis, and UCB Pharma, Consultant of: Eli Lilly, Novartis and UCB Pharma, Grant/research support from: AbbVie, Eli Lilly, Novartis and UCB Pharma, Carmen Fleurinck Employee of: Employee of UCB Pharma, Mindy Kim Employee of: Employee of UCB Pharma, Ute Massow Employee of: Employee of UCB Pharma, Vanessa Taieb Employee of: Employee of UCB Pharma, Tue Wenzel Kragstrup Speakers bureau: AbbVie, Bristol-Myers Squibb, Eli Lilly, Novartis, Pfizer and UCB Pharma, Consultant of: Bristol-Myers Squibb, Eli Lilly, Gilead and UCB Pharma, Grant/research support from: Gilead, Dennis McGonagle Speakers bureau: AbbVie, Celgene, Janssen, Merck, Novartis, Pfizer and UCB Pharma, Consultant of: AbbVie, Celgene, Janssen, Merck, Novartis, Pfizer and UCB Pharma, Grant/research support from: AbbVie, Celgene, Janssen, Merck, Novartis and Pfizer.
AB - Background A history of enthesitis or peripheral arthritis has been reported in gt;30pts) with axial spondyloarthritis (axSpA),[1] both of which contribute to disease burden. Bimekizumab (BKZ), a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F in addition to IL-17A, has demonstrated efficacy in phase 3 parallel studies in pts with non-radiographic (nr-)axSpA (BE MOBILE 1) and radiographic axSpA (r-axSpA i.e. ankylosing spondylitis; BE MOBILE 2).[2,3]Objectives To evaluate the impact of BKZ on the main peripheral manifestations of axSpA, to Week (Wk) 52.Methods Pts in BE MOBILE 1 (NCT03928704; nr-axSpA) met Assessment of SpondyloArthritis International Society (ASAS) classification criteria, pts in BE MOBILE 2 (NCT03928743; r-axSpA) met both modified New York and ASAS criteria. Pts were randomised to receive subcutaneous BKZ 160 mg every 4 wks (Q4W) or placebo (PBO) to Wk 16. From Wk 16 all pts received BKZ 160 mg Q4W.[2] Among pts with enthesitis (Maastricht Ankylosing Spondylitis Enthesitis [MASES]gt;0), at least one swollen joint (SJCgt;0), or at least one tender joint (TJCgt;0) at baseline (BL), we report mean change from baseline (CfB) using multiple imputation (MI). Pts ( achieving complete resolution of enthesitis (MASES=0 in pts with MASES gt;0 at BL) and peripheral arthritis (SJC=0 in pts with SJC gt;0 at BL, assessed in 44 joints) using non-responder imputation, is also reported.Results At BL, 73.2axSpA pts (BKZ: 94/128, PBO: 92/126) and 59.9axSpA pts (BKZ: 132/221, PBO: 67/111) had enthesitis; peripheral arthritis (SJC gt;0) was present in 34.6BKZ: 45/128, PBO: 43/126) and 19.9BKZ: 44/221, PBO: 22/111) of nr-axSpA and r-axSpA pts, respectively. BL MASES, SJC and TJC were largely similar between treatment arms (Table 1). Across the axSpA spectrum, greater mean CfB in MASES was achieved with BKZ vs PBO at Wk 16; improvements continued to Wk 52 with continuous BKZ and in pts switching from PBO to BKZ at Wk 16 (Table 1). Similarly, gt;506 vs lt;33 by Wk 52, responses of PBO/BKZ-switchers approached those of BKZ pts (Figure 1). At Wk 16, greater mean CfB in SJC and TJC was achieved with BKZ vs PBO-randomised pts with nr-axSpA. Improvements largely continued to Wk 52 with BKZ for both continuous BKZ and PBO/BKZ-switcher pts (Table 1). Resolution of peripheral arthritis was achieved by gt;57% of BKZ vs gt;41randomised pts at Wk 16; by Wk 52, proportions were similar among continuous BKZ and PBO/BKZ-switcher pts (Figure 1).Conclusion BKZ treatment resulted in sustained improvements in peripheral manifestations across the axSpA spectrum. Resolution of enthesitis was achieved in ~half of BKZ-treated pts by Wk 52; a similar pattern was observed for peripheral arthritis, with more than half of pts achieving resolution to Wk 52.References [1]López-Medina C. RMD Open 2021;7(1):e001450;[2]Baraliakos X. Arthritis Rheumatol 2022;74(suppl 9);[3]Boel A. Ann Rheum Dis 2019;78:1545textendash9.View this table:Table 1. Mean BL and CfB in enthesitis and peripheral arthritis [MI]Acknowledgements: This study was funded by UCB Pharma. Medical writing support was provided by Costello Medical, funded by UCB Pharma.Disclosure of Interests Sofia Ramiro Consultant of: AbbVie, Eli Lilly, Novartis, Pfizer, Sanofi and UCB Pharma, Grant/research support from: AbbVie, Galapagos, MSD, Novartis, Pfizer and UCB Pharma, Denis Poddubnyy Speakers bureau: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer and UCB Pharma, Consultant of: AbbVie, Biocad, Eli Lilly, Gilead, GSK, MSD, Moonlake, Novartis, Pfizer, Samsung Bioepis and UCB Pharma, Grant/research support from: AbbVie, Eli Lilly, MSD, Novartis and Pfizer, Philip J Mease Speakers bureau: AbbVie, Amgen, Eli Lilly, Janssen, Novartis, Pfizer and UCB Pharma, Consultant of: AbbVie, Acelyrin, Aclaris, Amgen, Bristol-Myers Squibb, Boehringer Ingelheim, Eli Lilly, Galapagos, Gilead, GSK, Janssen, MoonLake Pharma, Novartis, Pfizer, Sun Pharma and UCB Pharma, Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, Eli Lilly, Gilead, Janssen, Novartis, Pfizer, Sun Pharma and UCB Pharma, Clementina López-Medina Speakers bureau: AbbVie, Eli Lilly, Janssen, MSD, Novartis, and UCB Pharma, Consultant of: Eli Lilly, Novartis and UCB Pharma, Grant/research support from: AbbVie, Eli Lilly, Novartis and UCB Pharma, Carmen Fleurinck Employee of: Employee of UCB Pharma, Mindy Kim Employee of: Employee of UCB Pharma, Ute Massow Employee of: Employee of UCB Pharma, Vanessa Taieb Employee of: Employee of UCB Pharma, Tue Wenzel Kragstrup Speakers bureau: AbbVie, Bristol-Myers Squibb, Eli Lilly, Novartis, Pfizer and UCB Pharma, Consultant of: Bristol-Myers Squibb, Eli Lilly, Gilead and UCB Pharma, Grant/research support from: Gilead, Dennis McGonagle Speakers bureau: AbbVie, Celgene, Janssen, Merck, Novartis, Pfizer and UCB Pharma, Consultant of: AbbVie, Celgene, Janssen, Merck, Novartis, Pfizer and UCB Pharma, Grant/research support from: AbbVie, Celgene, Janssen, Merck, Novartis and Pfizer.
U2 - 10.1136/annrheumdis-2023-eular.831
DO - 10.1136/annrheumdis-2023-eular.831
M3 - Conference abstract in journal
SN - 0003-4967
VL - 82
SP - 358
EP - 359
JO - Annals of the Rheumatic Diseases
JF - Annals of the Rheumatic Diseases
IS - Suppl 1
T2 - EULAR 2023
Y2 - 31 May 2023
ER -