Risankizumab Safe, Effective for Long-Term Treatment of Crohn Disease

Crohn’S Disease. Crohn’S Disease Is A Chronic Inflammation Of The Digestive Tube, Affecting Mainly The Ileon, The Colon And The Anus. Crohn’S Disease Is Accompanied Of Deep Ulcerations Of The Digestive Tube Mucosa. It Would Be An Autoimmune Disease. See Image 1523507 For A Masculine Silhouette. (Photo By BSIP/UIG Via Getty Images)
Investigators conducted an open-label extension to evaluate the long-term safety and efficacy of risankizumab for the treatment of moderate to severe Crohn disease.

Study data published in the Journal of Crohn’s and Colitis support the long-term safety and efficacy of risankizumab for the treatment of Crohn disease. In a study of patients who achieved clinical response with short-term risankizumab, long-term response was maintained over a median follow-up period of 33 months. No new safety signals were observed during follow-up.

Results from the phase 2, 52-week, M15-993 study demonstrated the effectiveness of risankizumab for the treatment of moderate to severe Crohn disease (ClinicalTrials.gov Identifier: NCT02031276). To establish the long-term safety profile of the drug, investigators conducted an open-label extension period following the conclusion of the M15-993 study (ClinicalTrials.gov Identifier: NCT02513459).

The open-label study enrolled patients who had achieved clinical response and/or remission with risankizumab by week 52 of the parent trial. During the open-label period, patients received 180 mg of subcutaneous risankizumab every 8 weeks for up to 196 weeks. The primary outcome was long-term safety; adverse events were monitored throughout follow-up. The efficacy of risankizumab was also assessed using a battery of Crohn disease severity measures, including the Crohn Disease Activity Index.

Of the 121 patients initially enrolled in the M15-993 study, 65 entered the open-label extension period beginning in September 2015. Of these 65 enrollees, 12 had achieved clinical response at week 26 of M15-993 and 49 had achieved clinical remission and/or response at week 52. Four patients had lost response to risankizumab at the end of the parent study and were reinduced with 600 mg of intravenous risankizumab every 4 weeks at the start of the open-label period.

Median age of participants was 34.0 years at the start of M15-993; median disease duration was 10.0 years. Just over half (55.4%) of participants were women and 84.6% were White. During the extension period, patients received risankizumab for a median duration of 33.0 months.

The rate of serious adverse events was 24.6 events per 100 patient-years, the majority of which occurred in the gastrointestinal tract. Serious infections, opportunistic infections, and fungal infections were observed at rates of 4.2, 1.8, and 6.6 events per 100 patient-years, respectively. No deaths, malignancies, major adverse cardiovascular events, tuberculosis cases, or herpes zoster infections were observed.

Anti-drug antibodies were observed in 8 patients (12.3%), though none were treatment neutralizing. Treatment efficacy was maintained throughout the study. At week 0 of the open-label period, 72.3% of patients were in clinical remission. At 112 weeks of follow-up, this proportion had increased to 87.5%. The proportion of patients in endoscopic remission remained above 40% throughout follow-up.

Per these data, risankizumab appears to be appropriate for the treatment and long-term maintenance of moderate to severe Crohn disease. No new safety signals were observed during long-term follow-up, though further research in a larger cohort is necessary to confirm findings. “Results from ongoing phase 3 studies…will further inform the efficacy and safety of risankizumab in patients with [Crohn disease],” investigators wrote.

Disclosure: This work was supported by Boehringer Ingelheim and AbbVie. Please see the original reference for a full list of authors’ disclosures. 

Reference

Ferrante M, Feagan BG, Panés J, et al. Long-term safety and efficacy of risankizumab treatment in patients with Crohn’s disease: results from the phase 2 open-label extension study. J Crohns Colitis. Published online June 2, 2021. doi:10.1093/ecco-jcc/jjab093