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.

July 2024

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

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.

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.

Maintenance treatment with risankizumab was associated with an improvement in coprimary endpoints of clinical remission and endoscopic response in patients with Crohn’s disease compared with placebo.

Risankizumab was effective and well tolerated as induction therapy in patients with moderately to severely active Crohn’s disease, though there were no significant differences in efficacy between 600mg and 1200mg doses.

April 2024

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.

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.

Treatment with risankizumab showed significantly greater efficacy over adalimumab in providing substantial skin clearance in patients with moderate-to-severe chronic plaque PsO. This study aimed to assess the safety and efficacy of risankizumab compared with adalimumab in an active-comparator Phase 3 trial.