Abstract
Abstract Background Risankizumab has been recently approved for the treatment of moderate-to-severe Crohn's disease (CD). It is a humanized IgG1 monoclonal antibody that binds to the p19 subunit of IL-23, selectively inhibiting IL-23. Due to the limited available real-world data on its effectiveness, this study aims to assess the short-term effectiveness and safety of risankizumab induction in a large, real-life Italian cohort of CD patients. Methods From September 2023, following AIFA reimbursement, until now, all consecutive CD patients treated with risankizumab in 14 Italian centers were retrospectively enrolled. Only patients who completed the induction phase of risankizumab, with at least a 12-weeks follow-up were included in the final analysis. Clinical characteristics, disease activity scores, steroid usage, and adverse effects were collected. The primary endpoint was steroid-free clinical remission (SFCR) (Harvey Bradshaw Index [HBI] <5) at 12 weeks. Secondary endpoints included clinical response (≥3 point decrease in HBI and/or HBI <5), biochemical remission (CRP≤ 5 mg/L), remission of extra-intestinal manifestations (EIMs), occurrence of disease complications, and adverse events. Results To date, 147 patients have been enrolled, with 67 completing the 12-week follow-up. Of these, 34 (50.7%) patients had received ≥3 biologics, and 38 (56.7%) had previous intestinal resections. Fifty-four patients underwent colonoscopy within the last 6 months before starting risankizumab, exhibiting a mean SES-CD of 10.9±6.0 and a mean Rutgeerts score of 3.1±1.4. The rates of SFCR and clinical response at week 12 were 58.2% (39/67) and 76.1% (51/67) respectively, while 53.7% (22/41) and 65.9% (27/41) in ustekinumab exposed patients. Fecal calprotectin levels decreased from 963.6±1346.0 to 311.8±403.0 at week 12. Thirty-eight patients (56.7%) achieved normal CRP levels at week 12. Clinical remission of rheumatological and dermatological EIMs was observed at week 12 in 16.7% (3/18) and 75.0% (6/8) of patients, respectively. Two patients developed disease complications, including one case of worsening of the disease and one of new fistula development. This latter patient discontinued treatment before week 12. Additionally, two patients (3.0%) experienced minor adverse events after risankizumab administration. No patients underwent surgery during the 12-weeks follow-up. Conclusion In a large cohort of refractory CD patients with multiple prior drug failures, including frequent failures with ustekinumab, nearly 60% achieved SFCR following risankizumab induction. Risankizumab demonstrated good effectiveness in managing dermatological EIMs, but less effectiveness in rheumatological EIMs. The safety profile of risankizumab was consistent with existing literature.
Published Version
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