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.
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
This article originally appeared on Gastroenterology Advisor