The study, conducted at a hospital in Spain from 2015 to 2017, included all 100 patients who were switched to the biosimilar from the reference infliximab when the hospital transitioned to using the lower-cost product.
While it is becoming more common to switch patients with inflammatory bowel disease (IBD) to biosimilar CT-P13 (Inflectra, Remsima) from the reference infliximab (Remicade), long-term follow-up data is lacking. However, in one newly published study from a single-center, researchers reported that, at 2 years, most patients who switched continued on the biosimilar.
The study, conducted at a hospital in Spain from 2015 to 2017, included all 100 patients with moderate to severe Crohn disease (CD) (n = 64) or ulcerative colitis (UC) (n = 36) who were switched to the biosimilar from the reference infliximab when the hospital transitioned to using the lower-cost biosimilar.
The study’s primary end point was to analyze loss of response to infliximab after the switch.
The investigators found that, at 2 years, 72% of patients remained on the biosimilar. In total, 15% discontinued after loss of response, 4% discontinued due to adverse events (AEs), and 8% discontinued due to remission. One patient who achieved remission was switched to a different biologic after developing episcleritis. A total of 22% of patients required dose escalation during the follow-up period.
At the beginning of the study, 78% of patients were in remission. At 12, 18, and 24 months, 69.6%, 69.9%, and 68.5%, respectively, remained in remission. Among those who lost response, there was a median time to discontinuation of 15 months (range, 8-24).
By disease type, at 2 years, 25% of the patients with CD had discontinued (10 for loss of response, 3 because of clinical remission, 2 because of AEs, and 1 because of another medical indication). In the UC group, 33.33% of patients had discontinued at 2 years (5 for loss of response, 5 because of remission, and 2 because of AEs).
A total of 14% of patients experienced AEs, which included skin reactions, asthenia, headache, paresthesia during infusion, and other AEs. Six patients were admitted to the hospital for AEs.
Two patients, both in the CD group, developed antidrug antibodies over 18 months of follow-up. One of these patients achieved remission and discontinued treatment, while the other switched to adalimumab.
According to the authors, this study demonstrates the long-term efficacy of CT-P13 after a switch, and they add that the tranistion to the biosimilar saved the healthcare system €3000 (US $3379.50) per patient per year.
Reference
Veloz MFG, Jiménex MB, Delgado TV, et al. Long-term follow up after switching from original infliximab to an infliximab biosimilar: real-world data [published online June 18, 2019]. Therap Adv Gastroenterol. doi: 10.1177/1756284819858052.
Julie Reed: Why 2024 Is Important for Biosimilars
April 17th 2024Julie Reed, executive director of the Biosimilars Forum, showcases how the biosimilar industry is expected to develop throughout 2024, including major policy changes and hope for continued improvement in market share for adalimumab biosimilars.
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.
What Clinicians Need to Know About Using Biosimilars to Treat IBD
April 13th 2024A review article, intended to act as a guide for clinicians, summarizes the available infliximab and adalimumab biosimilars for treating inflammatory bowel disease (IBD) as well as others that are coming down the pipeline.
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.
Meta-Analysis Confirms Similar Safety, Efficacy Between Adalimumab Biosimilars, Humira
April 6th 2024A systematic review and meta-analysis of 7 randomized controlled trials found no significant differences in efficacy and safety indicators between adalimumab biosimilars and the reference product (Humira) for treatment of moderate to severe psoriasis.