Risankizumab is a high‐affinity neutralizing anti‐interleukin (IL)‐23 monoclonal antibody:
- has no binding to IL‐12, a cytokine that shares a p40 subunit with IL‐23
- via binding to the p19 subunit of IL‐23, risankizumab inhibits IL‐23 from interacting with the IL‐23 receptor and the subsequent signaling that contributes to various inflammatory pathways (1)
Study evidence has shown that compared with placebo, risankizumab improved clinical remission rates in an induction trial and in a maintenance trial for patients with moderately to severely active ulcerative colitis (2).
NICE states:
- Risankizumab is recommended as an option for treating moderately to severely active ulcerative colitis in adults when conventional or biological treatment cannot be tolerated, or the condition has not responded well enough or has lost response to treatment, only if:
- a tumour necrosis factor (TNF)-alpha inhibitor:
- has not worked (that is the condition has not responded well enough or has lost response to treatment), or
- cannot be tolerated or is not suitable, and
- the company provides it according to the commercial arrangement
The NICE committee states that "...Clinical trial evidence shows that risankizumab is more effective than placebo for treating moderately to severely active ulcerative colitis. Risankizumab has not been directly compared with ustekinumab in a clinical trial in this population. But an indirect comparison suggests that it is similarly effective..."
Reference:
- Pang Y, D'Cunha R, Winzenborg I, Veldman G, Pivorunas V, Wallace K. Risankizumab: Mechanism of action, clinical and translational science. Clin Transl Sci. 2024 Jan;17(1):e13706.
- Louis E, Schreiber S, Panaccione R, et al. Risankizumab for Ulcerative Colitis: Two Randomized Clinical Trials. JAMA. Published online July 22, 2024.
- NICE (August 2024). Risankizumab for treating moderately to severely active ulcerative colitis