The retrospective, observational, multicenter study included 141 patients, 96 with ulcerative colitis and 45 with Crohn disease, at 14 centers in Italy.
Since CT-P13 (Inflectra, Remsima), an infliximab biosimilar referencing Remicade, was authorized for use in Europe, numerous studies have investigated the safety and efficacy of the biosimilar in the inflammatory bowel disease (IBD) population. Now, a study of a large outpatient cohort with IBD in Italian primary centers has added to the growing body of data on the long-term efficacy and safety of the biosimilar.
The retrospective, observational, multicenter study included 141 patients, 96 with ulcerative colitis (UC) and 45 with Crohn disease (CD), at 14 centers. The patients initiated the biosimilar between 2015 and 2017. Most of the patients were naïve to anti—tumor necrosis factor (anti-TNF) agents (26% in the UC group and 28.9% in the CD group had previous anti-TNF exposure, and most were given the biosimilar after a loss of response to another anti-TNF).
Patients received CT-P13 at 5 mg/kg via infusion at weeks 0, 2, and 6, and then every 8 weeks thereafter. Dose escalation was used when necessary to maintain remission.
During a median follow-up of 24 (range, 6-24) months, remission, as assessed by Mayo score in the UC group and by the Harvey-Bradshaw Index in the CD group, was achieved by 57.3% of patients in the UC group and 75.6% of patients in the CD group.
Among patients who had previous anti-TNF exposure, 48.0% of patients with UC and 61.5% of patients with CD achieved remission.
Mucosal healing was observed in 75% of the UC group and 84.2% of the CD group, and 96.9% and 97.8% of patients in the respective groups were able to reduce their dose of steroids. In total, 2.1% and 6.7% of patients in each group went on to have IBD-related surgery during the follow-up period.
Only 1 adverse event was reported: A skin reaction occurred in a patient at the time of infusion, leading to an interruption of treatment.
According to the authors, this first Italian study to include a follow-up of 24 months shows the biosimilar’s efficacy and safety in the primary, outpatient IBD setting. Longer-term studies, they add, will be needed to assess switching from the reference to the biosimilar.
Tursi A, Mocci G, Faggiani R, et al. Infliximab biosimilar CT-P13 is effective and safe in treating inflammatory bowel diseases: a real-life, multicenter, observational study in Italian primary inflammatory bowel disease centers. Ann Gastroenterol. 2019;21(4):392-399. doi: 10.20524/aog.2019.0377.