BIMEKIZUMAB IMPROVES SIGNS AND SYMPTOMS INCLUDING INFLAMMATION IN PATIENTS WITH ACTIVE ANKYLOSING SPONDYLITIS: 24-WEEK EFFICACY & SAFETY FROM A PHASE 3, MULTICENTER, RANDOMIZED, PLACEBO CONTROLLED STUDY
Authors: Désirée van der Heijde et al.
Bimekizumab is a monoclonal antibody that exerts a dual inhibition of IL-17A and IL-17F. A phase II study showed efficacy of this drug in patients with ankylosing spondylitis (AS). Here, the authors report the results of a phase III study in AS with Bimekizumab with a 16 week double blind placebo controlled phase and a 36 week extension period, whereby all patients received Bimekizumab after week 16. The primary endpoint ASAS40 was reached in 44.8% in the Bimekizumab group and 22.5% in placebo, which was statistically significant. Also, all the secondary endpoints were met. At week 24 almost 50% of the patients with Bimekizumab reached ASDAS <2.1, indicating low disease activity. In MRI studies, a significant reduction of inflammation in SI joints and spine (SPARCC MRI SIJ score, Spine Berlin score) was found for Bimekizumab vs placebo. The safety profile was as expected from anti-IL-17 inhibitor treatment with no new or unexpected safety signals.
Treatment with Bimekizumab, a dual inhibitor of IL-17A and IL-17F, resulted in a significant improvement of primary and secondary outcomes in this phase III placebo controlled trial and also reduced inflammation of SI joints and spine in MRI. Since IL-17F is expressed in the skin and also in the synovium, the inhibition of IL-17F in addition to IL-17A may have additional treatment effects in axSpA but also PsA. Whether dual inhibition is more effective than IL-17A inhibition alone, however, remains to be shown for these diseases.