FDA clears at-home risankizumab induction

Week 12 remission reached 56% vs. 30% with placebo, with the FDA revising tuberculosis testing precautions.

By
Teraya Smith
October 23, 2026
2 min

MDSpire News

Overview

The FDA approved subcutaneous risankizumab-rzaa induction for adults with moderately to severely active Crohn’s disease, allowing administration at home with an on-body injector. In the phase 3 AFFIRM trial, risankizumab was superior to placebo for clinical remission and endoscopic response at week 12. Intravenous induction remains an alternative, and the prescribing information includes liver-test monitoring advice and updated tuberculosis-evaluation language.

Background

Crohn’s disease is a chronic inflammatory condition for which the approved regimen provides an additional route for initiating risankizumab treatment. The approval was supported by AFFIRM, a double-blind, placebo-controlled phase 3 trial of 274 adults, approximately 65% of whom had experienced failure of prior advanced therapy. The trial assessed clinical remission and endoscopic response at week 12. Risankizumab is also included among treatment options in the American Gastroenterological Association’s living guideline for moderate-to-severe Crohn’s disease.

Data Highlights

Outcome or regimen	Risankizumab	Placebo
Week-12 clinical remission, overall	56%	30%
Week-12 endoscopic response, overall	43%	15%
Week-12 endoscopic remission, overall	26%	11%
Clinical remission without prior advanced therapy failure	74%	27%
Endoscopic response without prior advanced therapy failure	60%	15%
Clinical remission with prior advanced therapy failure	45%	31%
Endoscopic response with prior advanced therapy failure	33%	15%
Approved subcutaneous induction	720 mg by on-body injector at weeks 0, 2, 4, and 8; subcutaneous maintenance begins at week 12 and is given every 8 weeks
Alternative intravenous induction	600 mg at weeks 0, 4, and 8

Key Findings

In AFFIRM, 274 adults were randomly assigned 2:1 to subcutaneous risankizumab or placebo; about 65% had prior advanced therapy failure.
At week 12, clinical remission was reported in 56% with risankizumab and 30% with placebo; endoscopic response was 43% and 15%, respectively.
Week-12 endoscopic remission occurred in 26% of risankizumab recipients and 11% of placebo recipients.
Among participants without prior advanced therapy failure, clinical remission was 74% versus 27%, and endoscopic response was 60% versus 15%.
Among participants with prior advanced therapy failure, clinical remission was 45% versus 31%, and endoscopic response was 33% versus 15%.
The FDA-approved subcutaneous induction schedule is 720 mg at weeks 0, 2, 4, and 8 using an on-body injector; intravenous induction remains available. The manufacturer reported no new safety risks, and prescribing information advises liver blood tests before, during, and through at least 12 weeks of treatment.

Clinical Implications

The approved subcutaneous schedule permits patients to initiate risankizumab at home using an on-body injector, while intravenous induction remains an alternative. Prescribing information advises liver blood tests before and during treatment and through at least 12 weeks; the FDA also revised tuberculosis precautions across risankizumab indications, allowing clinical judgment on whether pretreatment evaluation is needed rather than requiring testing in every case.

Conclusion

The FDA approval adds a subcutaneous, at-home induction option for adults with moderately to severely active Crohn’s disease, supported by week-12 AFFIRM outcomes. The approved regimen and updated prescribing information specify administration and monitoring details.