Pos1103 bimekizumab Maintained Improvements in Efficacy Endpoints and Had a Consistent Safety Profile Through 52 Weeks in Patients With Non-Radiographic and Radiographic Axial Spondyloarthritis: Results From Two Parallel Phase 3 Studies

Abstract

BackgroundBimekizumab (BKZ), a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F in addition to IL-17A, met all primary/secondary endpoints at Week (Wk) 16 in patients (pts) with active non-radiographic axial spondyloarthritis (nr-axSpA) and radiographic axSpA (r-axSpA; i.e., ankylosing spondylitis), in the parallel phase 3 BE MOBILE 1 and 2 studies, respectively.[1,2]ObjectivesTo assess efficacy and safety of BKZ in these pts up to Wk 52.MethodsBE MOBILE 1 (NCT03928704) and 2 (NCT03928743) both involved a 16-wk placebo (PBO)-controlled and 36-wk maintenance period.[1,2]Pts were randomised to subcutaneous BKZ 160 mg Q4W (BKZ) or to PBO then BKZ from Wk 16 (PBO/BKZ).Results220/254 (86.6%) randomised pts with nr-axSpA and 298/332 (89.8%) with r-axSpA completed Wk 52. Efficacy was sustained to Wk 52 in both studies (Table 1). ASAS40 responses in BKZ-randomised pts increased from Wk 16 (nr-axSpA: 47.7%; r-axSpA: 44.8%; non-responder imputation [NRI]) to Wk 52 (60.9%; 58.4%; NRI) with high levels of efficacy across TNFi-naïve and TNFi-IR populations (Table 1). At Wk 52, ASDAS <2.1 was achieved by 61.6% and 57.1%, and ASDAS <1.3 by 25.2% and 23.4%, of BKZ-randomised pts with nr-axSpA and r-axSpA, respectively (Figure 1). Wk 16 reductions from baseline in objective signs of inflammation (MRI, hs-CRP), and improvements in function (BASFI) and ASQoL, were maintained through 52 wks. Efficacy at Wk 52 was similar in PBO/BKZ-treated and BKZ-randomised pts (Table 1).At Wk 52, 75.0% (183/244) of pts with nr-axSpA and 75.5% (249/330) of pts with r-axSpA had ≥1 treatment-emergent adverse event (TEAE) on BKZ; the most frequent (% pts) TEAEs by preferred term (MedDRA v19.0) were nasopharyngitis (nr-axSpa: 12.3%; r-axSpA 9.1%) and upper respiratory tract infection (9.4%; 6.4%); few COVID-19 infections were reported (7.0%; 2.1%). Incidence (pts/100 pt years) of serious TEAEs were low (4.4; 7.1); no major adverse cardiovascular events, active tuberculosis cases, serious COVID-19 infections, or deaths were reported. Most incidences of fungal infection (19.6; 14.9; none serious or systemic) wereCandida(12.8; 8.3) and mild to moderate; two pts in both studies discontinued the study due toCandidainfections. Incidence of IBD (1.0; 1.0) and uveitis (1.5; 2.4) were low.ConclusionAcross the axSpA spectrum, BKZ resulted in sustained efficacy to Wk 52. No new safety signals were observed, consistent with the Wk 24 safety profile.[1,2]References[1]Deodhar A. Ann Rheum Dis 2022;81:772–3; 2.[2]van der Heijde D. Ann Rheum Dis 2022;81:12–3.Table 1.Efficacy at Wk 52Mean (SE), unless statedBE MOBILE 1BE MOBILE 2PBO→BKZ N=126BKZ N=128PBO→BKZ N=111BKZ N=221ASAS40[NRI]n (%)64 (50.8)78 (60.9)76 (68.5)129 (58.4)ASAS40 in TNFi-naïve[NRI]n (%)58 (53.2)a73 (61.9)b67 (71.3)c108 (58.7)dASAS40 in TNFi-IRe[NRI]n (%)6 (35.3)f5 (50.0)g9 (52.9)f21 (56.8)hASAS20[NRI]n (%)88 (69.8)94 (73.4)89 (80.2)158 (71.5)ASAS PR[NRI]n (%)38 (30.2)38 (29.7)41 (36.9)66 (29.9)ASAS 5/6[NRI]n (%)65 (51.6)71 (55.5)74 (66.7)124 (56.1)BASDAI CfB[MI]–3.5 (0.2)–3.9 (0.2)–4.0 (0.2)–3.6 (0.1)BASFI CfB[MI]–2.6 (0.2)–3.0 (0.2)–2.8 (0.2)–2.8 (0.1)ASDAS-MI[NRI]n (%)37 (29.4)47 (36.7)49 (44.1)71 (32.1)Nocturnal spinal pain CfB[MI]–4.1 (0.2)–4.3 (0.3)–4.6 (0.3)–4.1 (0.2)ASQoL CfB[MI]–5.3 (0.4)–5.9 (0.4)–5.6 (0.4)–5.7 (0.3)SF-36 PCS CfB[MI]11.4 (0.9)12.2 (0.9)12.3 (0.9)12.0 (0.6)BASMI CfB[MI]–0.4 (0.1)–0.6 (0.1)–0.7 (0.1)–0.7 (0.1)Total resolution of enthesitisi[NRI]n (%)41 (44.6)j51 (54.3)c31 (46.3)k67 (50.8)lASDAS-CRP CfB[MI]–1.6 (0.1)–1.8 (0.1)–1.9 (0.1)–1.7 (0.1)SPARCC MRI SIJ score CfB[OC]mMean (SD)–6.4 (10.7)n–7.6 (10.5)o–2.8 (6.1)p–4.7 (8.2)qBerlin MRI spine score CfB[OC]mMean (SD)–0.4 (2.0)k–0.7 (2.5)r–2.1 (3.4)p–2.4 (3.9)shs-CRP, mg/L [MI]Median2.21.72.02.3RS. n:a109,b118,c94,d184;eMax 1 TNFi; n:f17,g10,h37;iMASES=0 in pts with MASES >0 at BL; n:j92,k67;l132;mMRI sub-study; n:n70,o82,p48,q90,r79,s89.AcknowledgementsThis study was funded by UCB Pharma. Medical writing support was provided by Costello Medical, funded by UCB Pharma.Disclosure of InterestsXenofon 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, Atul Deodhar Speakers bureau: Janssen, Novartis and Pfizer, Consultant of: AbbVie, Amgen, Aurinia, BMS, Eli Lilly, Janssen, MoonLake, Novartis, Pfizer and UCB Pharma, Grant/research support from: AbbVie, BMS, Celgene, Eli Lilly, MoonLake, Novartis, Pfizer and UCB Pharma, Désirée van der Heijde Consultant of: AbbVie, Bayer, BMS, Cyxone, Eisai, Galapagos, Gilead, GSK, Janssen, Eli Lilly, Novartis, Pfizer and UCB Pharma, Employee of: Director of Imaging Rheumatology BV, Marina Magrey Consultant of: AbbVie, Eli Lilly, Novartis, Pfizer and UCB Pharma, Grant/research support from: AbbVie and UCB Pharma, Walter P Maksymowych Consultant of: AbbVie, BMS, Boehringer-Ingelheim, Celgene, Eli Lilly, Galapagos, Janssen, Novartis, Pfizer and UCB Pharma, Grant/research support from: AbbVie and Pfizer; educational grants from AbbVie, Janssen, Novartis and Pfizer, Employee of: Chief Medical Officer for CARE ARTHRITIS, Tetsuya Tomita Speakers bureau: AbbVie, Astellas, BMS, Eisai, Eli Lilly, Janssen, Kyowa Kirin, Mitsubishi-Tanabe, Novartis and Pfizer, Consultant of: AbbVie, Eli Lilly, Gilead, Novartis and Pfizer, Huji Xu Speakers bureau: AbbVie, Janssen, Novartis, Pfizer and UCB Pharma, Consultant of: AbbVie, Beigene, BioMap, IASO, Pfizer and UCB Pharma, Employee of: Clinical investigator for Peking-Tsinghua Center for Life Sciences, Marga Oortgiesen Shareholder of: UCB Pharma, Employee of: UCB Pharma, Ute Massow Employee of: UCB Pharma, Carmen Fleurinck Employee of: UCB Pharma, Alicia Ellis Employee of: UCB Pharma, Thomas Vaux Employee of: UCB Pharma, julie smith Employee of: UCB Pharma, Alexander Marten Employee of: UCB Pharma, Lianne S. Gensler Consultant of: AbbVie, Acelyrin, Eli Lilly, Fresenius Kabi, Janssen, Novartis, Pfizer and UCB Pharma, Grant/research support from: Novartis and UCB Pharma paid to institution.

Bimekizumab treatment in biologic DMARD-naïve patients with active psoriatic arthritis: 52-week efficacy and safety results from the phase III, randomised, placebo-controlled, active reference BE OPTIMAL study

“…The rate of Candida infections observed with BKZ treatment to Week 52 in BE OPTIMAL was consistent with those reported to Week 52 in the BE COMPLETE sister study and its OLE, BE VITAL, and the phase IIb trial of BKZ in PsA to three years. 19 21 Rates were also similar to those reported in axial spondyloarthritis, 22 and lower than those reported in psoriasis. 23 …”