FDA clears at-home risankizumab induction

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

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The FDA approved subcutaneous risankizumab induction for adults with moderately to severely active Crohn's disease, allowing at-home administration with an on-body injector.
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In the phase 3 AFFIRM trial, 274 adults were randomly assigned 2:1 to risankizumab or placebo, and about 65% had prior advanced therapy failure.
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At week 12, clinical remission occurred in 56% of risankizumab recipients and 30% of placebo recipients; endoscopic response occurred in 43% and 15%, respectively.
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The approved induction regimen is 720 mg at weeks 0, 2, 4, and 8, followed by subcutaneous maintenance every 8 weeks starting at week 12; intravenous induction remains an option.
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Prescribing information advises liver blood tests before, during, and for at least 12 weeks of treatment, and permits clinical judgment on pretreatment tuberculosis evaluation.

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