New long-term data on bimekizumab in psoriatic arthritis and axial spondyloarthritis presented at EULAR 2023
UCB, a global biopharmaceutical company, announced new long-term 52-week data from three Phase III studies BE COMPLETE with its long-term extension study, BE MOBILE 1 and BE MOBILE 2 – evaluating the efficacy and safety profile of bimekizumab, an inhibitor of IL-17F in addition to IL-17A, in adults with active psoriatic arthritis (PsA), active non-radiographic axial spondyloarthritis (nr-axSpA) and active ankylosing spondylitis (AS), also known as radiographic axSpA (r-axSpA), respectively
These results from the bimekizumab phase III program in PsA and axSpA are being presented at the European Congress of Rheumatology, EULAR 2023, in Milan, Italy, May 31–June 3. The safety and efficacy of bimekizumab in PsA, nr-axSpA and r-axSpA have not been established, and it is not approved for use in PsA, nr-axSpA or AS by any regulatory authority worldwide.
“Psoriatic arthritis and axial spondyloarthritis are chronic and progressive inflammatory diseases requiring long-term management. The new long-term bimekizumab data presented at EULAR 2023 showed sustained clinical responses across multiple disease manifestations and patient populations up to one year. These results reinforce our belief in bimekizumab as a potential new future treatment for patients living with psoriatic arthritis and axial spondyloarthritis,” said Emmanuel Caeymaex, Executive Vice President, Immunology and U.S. Solutions, UCB.
Bimekizumab 52-week PsA data: patients with prior inadequate response to tumour necrosis factor inhibitors (TNFi-IR);:Key 52-week results from the BE COMPLETE open-label extension study (BE VITAL) are shared below and build on the previously announced 16-week results from the BE COMPLETE study and 52-week results from the BE OPTIMAL study.
“The long-term data from BE COMPLETE showed that over six out of 10 patients continuously treated with bimekizumab achieved complete skin clearance and almost one in two had minimal disease activity at week 52. These results complement the previously reported 52-week results from the BE OPTIMAL study and highlight the consistent and sustained response seen with bimekizumab in both biologic-naïve and TNF inhibitor-experienced patients with psoriatic arthritis,” said Professor Iain McInnes, University of Glasgow, College of Medicinal Veterinary and Life Sciences, Glasgow, Scotland.
American College of Rheumatology (ACR) 50: At week 52, 51.7 percent of psoriatic arthritis patients (TNFi-IR) continuously treated with bimekizumab (160 mg every four weeks [Q4W]; n=267), and 40.6 percent of patients who switched from placebo to bimekizumab at week 16 (n=133) achieved ACR50.1±.(Non-responder imputation). Complete Skin Clearance (PASI100): At week 52, in patients with baseline psoriasis greater than 3 percent body surface area, 65.9 percent of patients continuously treated with bimekizumab (n=176) and 60.2 percent of patients who switched from placebo to bimekizumab at week 16 (n=88) achieved complete skin clearance (PASI100).1±. Minimal Disease Activity (MDA): At week 52, 47.2 percent (n=126/267) of patients continuously treated with bimekizumab and 33.1 percent (n=44/133) of patients who switched from placebo to bimekizumab achieved MDA.1±.
Over 52 weeks, 62.6 percent (n=243/388) of patients treated with bimekizumab had greater than 1 treatment emergent adverse event (TEAE) and 5.9 percent (n=23/388) reported a serious TEAE. Candida infections were reported by 6.4 percent (n=25/388) of patients receiving bimekizumab with all cases reported as mild or moderate and none reported as systemic.
Bimekizumab 52-week axSpA data: inflammation of the sacroiliac joints and spine and peripheral manifestations; Key 52-week results from the phase III BE MOBILE 1 and BE MOBILE 2 studies evaluating the effect of bimekizumab on inflammatory lesions of the sacroiliac joints (SIJ) and spine as measured objectively by magnetic resonance imaging (MRI), and on the main peripheral manifestations of axSpA are shared below and build on previously announced 16-week and 52-week results from BE MOBILE 1 and BE MOBILE 2.
“Treatment with bimekizumab versus placebo reduced inflammation of the spine and sacroiliac joints as detected by magnetic resonance imaging. In the two studies, approximately one in two patients with MRI inflammation at baseline achieved MRI remission at week 16, which was sustained out to week 52,” said Xenofon Baraliakos, Professor of Internal Medicine and Rheumatology, Ruhr-University Bochum, Bochum, Germany.
Inflammation SIJ: At week 52, in the BE MOBILE 1 imaging sub-study, 80.0 percent (n=32/40) of patients with inflammation at baseline receiving continuous bimekizumab and 57.1 percent (n=20/35) who switched from placebo to bimekizumab at week 16 achieved remission in inflammatory lesions of the SIJs (Spondyloarthritis Research Consortium of Canada [SPARCC SIJ<2]); in be mobile 2, 75.7 percent (n="28/37)" receiving bimekizumab and 66.7 percent (n="12/18)" who switched from placebo to bimekizumab at week 16 achieved remission in inflammatory lesions of the sij.2¥.>Inflammation Spine: At week 52, in the BE MOBILE 1 imaging sub-study, 40.0 percent (n=6/15) of patients with inflammation at baseline receiving continuous bimekizumab and 27.3 percent (n=3/11) who switched from placebo to bimekizumab at week 16 achieved remission (Berlin Spine less than 2); in BE MOBILE 2, 76.7 percent (n=23/30) receiving continuous bimekizumab and 62.5 percent (n=10/16) who switched from placebo to bimekizumab at week 16 achieved remission.2¥. Enthesitis: At week 52, in BE MOBILE 1, 54.3 percent of patients receiving continuous bimekizumab (n=94) and 44.6 percent who switched from placebo to bimekizumab (n=92) at week 16 achieved resolution of enthesitis (Maastricht Ankylosing Spondylitis Enthesitis=0); in BE MOBILE 2, 50.8 percent receiving continuous bimekizumab (n=132) and 46.3 percent who switched from placebo to bimekizumab at week 16 (n=67) achieved resolution of enthesitis.3± . Peripheral arthritis: At week 52, in BE MOBILE 1, 62.2 percent of patients receiving continuous bimekizumab (n=45) and 65.1 percent who switched from placebo to bimekizumab at week 16 (n=43) achieved resolution (Swollen Joint Count=0); in BE MOBILE 2, 72.7 percent receiving continuous bimekizumab (n=44) and 81.8 percent who switched from placebo to bimekizumab at week 16 (n=22) achieved resolution (Swollen Joint Count=0).3±.
In addition, in the largest pool of bimekizumab phase IIb and phase III data available, the exposure-adjusted incidence rate of uveitis in patients with axSpA treated with bimekizumab (160 mg Q4W) remains low at 1.2/100 patient-years. In this pooled data, the total bimekizumab exposure was 2,034.4 patient years (N=848) and 15.3 percent of patients (n=130) had a history of uveitis. All uveitis TEAEs reported were mild to moderate and one event led to discontinuation.
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