The Phase 3 BE MOBILE 2 clinical trial sought to evaluate the safety, efficacy, and tolerability of bimekizumab for adult patients with ankylosing spondylitis (AS), an inflammatory disease affecting the joints and spine. According to a news release from biopharmaceutical company UCB, positive top-line data from the study is now available.
To begin, let’s take a look at what bimekizumab is. Dermatology Times describes bimekizumab as an investigational humanized monoclonal immunoglobulin IgG1 antibody which acts as an IL-17F and IL-17A inhibitor. Both IL-17F and IL-17A are cytokines, which often play a role in inflammation throughout the body. Outside of ankylosing spondylitis and axial spondyloarthritis, UCB is also exploring bimekizumab as a potential treatment for plaque psoriasis.
As described above, positive top-line data from the Phase 3 BE MOBILE 2 trial is now available. Altogether, 332 patients with moderate-to-severe AS enrolled. To participate, patients must have previously responded poorly (or not at all) to NSAID therapy or TNFa inhibitors. Interim findings include:
- Bimekizumab was more effective at prompting remission and reducing pain than the placebo.
- The study achieved its primary endpoint (40% improvement from baseline on the ASAS40 scale). Ultimately, this scale explore inflammation, disease progression and activity, and pain.
- So far, the treatment seems relatively safe and well-tolerated.
Ankylosing Spondylitis (AS)
HLA-B, IL1A, ERAP1, and IL23R genes and gene mutations have all been associated with ankylosing spondylitis (AS). However, the genes’ interactions with AS are still being explored; just having a gene mutation, or a family history of AS, does not necessarily mean that someone will have it. In reality, AS is most likely founded on a variety of genetic and environmental factors. AS exists under the umbrella of spondyloarthropathies. You can understand more about AS by breaking down the words: “ankylosing” (when back vertebrae fuse together) and “spondylitis” (inflammation between pelvic and spinal joints). As a result, AS causes chronic spinal inflammation, which may spread to the hips and shoulders.
Outside of joint inflammation, those with AS may also experience uveitis, or uveal inflammation. This may lead to light sensitivity, eye pain and redness, and even vision loss if not addressed.