Objective:

The article examines the objective, findings, and clinical context described in FDA clears at-home risankizumab induction.

Approach:

• Approval: The FDA approved subcutaneous risankizumab-rzaa (Skyrizi) induction administered at home with an on-body injector.
• Evidence: The approval was supported by AFFIRM, a double-blind, placebo-controlled phase 3 trial that randomly assigned 274 adults 2:1 to risankizumab or placebo.
• Regimen: The approved induction dose 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 alternative.

Key Findings:

• At week 12, clinical remission occurred in 56% of risankizumab recipients and 30% of placebo recipients; endoscopic response occurred in 43% and 15%, respectively.
• Endoscopic remission occurred in 26% of risankizumab recipients versus 11% of placebo recipients.
• About 65% of participants had prior advanced therapy failure.
• The manufacturer reported no new safety risks. Prescribing information advises liver blood tests before and during treatment, including for at least 12 weeks.

Interpretation:

In AFFIRM, subcutaneous risankizumab was superior to placebo for clinical remission and endoscopic response at week 12.

Limitations:

• The supplied context reports outcomes through week 12 and does not provide longer-term trial results.
• The supplied context does not provide detailed adverse-event rates.

Conclusion:

The FDA also revised tuberculosis precautions across risankizumab indications, allowing providers to use clinical judgment about pretreatment evaluation rather than requiring testing before initiation.

Sources:

• AbbVie