1/26/2022
Bimekizumab is a first-of-its-kind dual IL-17 inhibitor that targets both IL-17A and IL-17F, two cytokines known to drive inflammation. The novel biologic has shown promising initial results in a pair of ongoing phase III trials for ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA).
In the BE MOBILE 1 study, which involves 240 adults with active nr-axSpA, bimekizumab has demonstrated a statistically significant and clinically meaningful improvement over placebo at week 16 in the proportion of patients who have achieved an ASAS40 response (an improvement of 40% or more).2,3 The BE MOBILE 2 study, which involves 332 adults with active AS, has also met its primary endpoint as measured by the proportion of patients who have achieved an ASAS40 response at week 16, when compared to placebo.1
Both studies are ongoing and will ultimately run for 52 weeks.
“The positive findings from the BE MOBILE 1 study provide clear evidence supporting bimekizumab in the treatment of nr-axSpA, and suggest that targeting IL-17F in addition to IL-17A may be a promising treatment approach for this painful, chronic rheumatic condition that often starts in young adulthood,” said rheumatologist Atul Deodhar, MD, a member of SAA’s Medical and Scientific Advisory Board.2
Bimekizumab is also currently being reviewed by the FDA for the treatment of moderate-to-severe plaque psoriasis in adults. Its efficacy and safety have not been established for any indication in the U.S. The pharmaceutical company UCB, which developed the medication, plans to submit applications for bimekizumab for the treatment of axial spondyloarthritis in late 2022.2
- Positive Top-Line Results for Bimekizumab in Phase 3 Ankylosing Spondylitis Trial (prnewswire.com)
- Positive Top-Line Results for bimekizumab in Phase 3 Non-Radiographic Axial Spondyloarthritis Study
3. The ASAS Response Criteria (ASAS 40) is defined as an improvement of at least 40%, and an absolute improvement of at least 10 units on a 0-100 scale, in at least three of the following domains: Patient Global Assessment, Pain Assessment, Function (BASFI), and Inflammation (last 2 questions of BASDAI).
By:
Spondylitis Association of America