The US Food and Drug Administration (FDA) approved a subcutaneous induction regimen for risankizumab-rzaa (Skyrizi) in adults with moderately to severely active Crohn's disease. The approval allows patients to self-administer treatment at home using an on-body injector.
The decision was supported by results from the phase 3 AFFIRM trial, in which subcutaneous risankizumab demonstrated superiority over placebo for clinical remission and endoscopic response at week 12.
In the double-blind, placebo-controlled trial, researchers randomly assigned 274 adults 2:1 to risankizumab or placebo. About 65% of them had previously experienced advanced therapy failure, defined as an inadequate response, loss of response, or intolerance to biologics or Janus kinase inhibitors.
At week 12, clinical remission occurred in 56% of patients receiving risankizumab vs. 30% of those receiving placebo. Endoscopic response rates were 43% vs. 15%, while endoscopic remission occurred in 26% vs. 11%, respectively. Clinical remission was defined as a Crohn's Disease Activity Index score below 150, while endoscopic response required a greater than 50% reduction in the Simplified Endoscopic Activity Score for Crohn's Disease (or at least a 2-point reduction for isolated ileal disease with a baseline score of 4).
Among patients without prior advanced therapy failure, clinical remission reached 74% with risankizumab vs. 27% with placebo, and endoscopic response occurred in 60% vs. 15%. Among patients with prior advanced therapy failure, clinical remission was 45% vs. 31%, and endoscopic response was 33% vs. 15%.
The approved subcutaneous induction regimen consists of 720 mg administered via an on-body injector at weeks 0, 2, 4, and 8, followed by subcutaneous maintenance dosing starting at week 12 administered every 8 weeks thereafter. Intravenous induction (600 mg at weeks 0, 4, and 8) remains available as an alternative initiation option.
The drug's manufacturer reported no new safety risks. Prescribing information advises healthcare providers to conduct liver blood tests before, during, and up to at least 12 weeks of treatment.
Additionally, the FDA updated the prescribing information across all risankizumab indications regarding tuberculosis precautions. The revised label allows providers to use clinical judgment when determining whether pretreatment tuberculosis evaluation is necessary, removing any requirement for mandatory testing prior to initiation.
Source: AbbVie
