Risankizumab for Ulcerative Colitis Two Randomized Clinical Trials

JAMA. 2024;332:881-897 doi: 10.1001/jama.2024.12414

Louis et al. demonstrated risankizumab to significantly improve clinical remission rates compared to placebo in both an induction trial and in a maintenance trial for patients with moderately to severely active ulcerative colitis.

August 2024

Mease et al. assessed the comparative effectiveness of bimekizumab and risankizumab in patients with PsA over 52 weeks using a matching-adjusted indirect comparison (MAIC). The study included patients who were biologic disease-modifying anti-rheumatic drug (bDMARD) naïve or had a prior inadequate response or intolerance to tumour necrosis factor inhibitors (TNFi-IR).

July 2024

Risankizumab versus ustekinumab for moderate-to-severe Crohn’s disease

N Engl J Med. 2024 Jul 18;391(3):213-223. DOI 10.1056/NEJMoa2314585

Risankizumab was noninferior to ustekinumab with respect to clinical remission at Week 24, and superior with respect to endoscopic remission at Week 48. This study aimed to present data from SEQUENCE, a direct head-to-head trial assessing the efficacy and safety of risankizumab vs ustekinumab in patients with moderate-to-severe CD, in whom at least one anti-TNF treatment had failed.

This post hoc analysis provides additional support for the utility of risankizumab therapy in patients with moderately to severely active CD. Investigators examined the efficacy of risankizumab for providing early symptom relief, along with the prognostic value of early symptom relief for achieving future clinical and endoscopic endpoints.

June 2024

Subcutaneous risankizumab maintenance therapy results in durable improvement in clinical and endoscopic outcomes over one year in patients with moderately to severely active Crohn’s disease. Endpoint achievement tended to be achieved in a higher proportion of patients treated with 360mg risankizumab than 160mg risankizumab, and both doses were higher when compared to placebo.

May 2024

Shu, et al. identified 37 preferred terms as unexpected AEs following risankizumab treatment, and found 48 AEs with an increased risk of risankizumab-induced AE severity. They also identified that risankizumab signal strengths were significantly higher in eight system organ classes.

Kwatra et al. found that risankizumab significantly improves clinical signs and symptoms of enthesitis and/or dactylitis in PsA patients, with substantial and sustained efficacy observed up to 52 weeks. Furthermore, these improvements were met by meaningful gains in patient reported outcomes.

April 2024

Risankizumab therapy was associated with significant and sustained improvement in multiple disease domains from Week 52 through Week 100, compared with placebo. Kristensen et al. investigated the safety, efficacy and tolerability of 100-week risankizumab therapy in PsA patients with previous inadequate response to ≥1 csDMARD, using data from KEEPsAKE 1 trial.

October 2023

The results of this study show that anti-IL-12/23, JAK inhibitors, and anti-TNF-α were associated with slightly higher risk of MACE compared with placebo. The risk was no different between biologic treatments, and the magnitude of risk did not differ between IMID type.

September 2023

The majority of patients receiving persistent risankizumab therapy achieved clear or clear/almost clear skin at 12 months and patients reported significant reductions in DLQI scores, PROs (fatigue, skin pain, overall itch), and work and activity impairment.