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.
Reference
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.
Spanish Real-World Study: Adalimumab Biosimilar MSB11022 Safe, Effective in IBD
May 18th 2024A real-world study in Spain on inflammatory bowel disease (IBD) patients found no meaningful changes in clinical or biochemical markers or differences in effectiveness between the adalimumab originator and the biosimilar MSB11022 (Idacio; Fresenius Kabi) in adalimumab-naïve patients.
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.
Patients With IBD Experience Nocebo Effect Post Mandatory Switch to Biosimilar
May 11th 2024In Canada, a study on patients with inflammatory bowel disease (IBD) switching to infliximab or adalimumab biosimilars found no change in clinical remission or antidrug antibodies after 24 weeks, but 13% experienced the nocebo effect, leading to one-fifth discontinuing therapy.
Biosimilars Gastroenterology Roundup for January 2024—Podcast Edition
February 4th 2024On this episode of Not So Different, we reminisce on all the major gastroenterology news from January, which brought several reports quantifying how the gastroenterology biosimilar market is progressing and marked the 1-year anniversary of adalimumab biosimilar competition in the US.
Eye on Pharma: EU Ustekinumab Approval; New Golimumab Data; Evernorth Adds Humira Biosimilar
April 29th 2024The European Union gained a new ustekinumab biosimilar; Alvotech released positive results from a clinical trial evaluating a golimumab biosimilar and the reference products (Simponi and Simponi Aria), and Evernorth announced that it is set to cover an adalimumab biosimilar at zero cost to patients.