Abstract
Patients suffering from inflammatory bowel diseases (IBD) and treated with originator infliximab are increasingly being switched to biosimilars. Some patients, however, are "reverse switched" to treatment with the originator. Here we assess the prevalence of reverse switching, including its indication and outcomes. In this retrospective multicenter cohort study, data on patients with IBD from 9 hospitals in the Netherlands were collected. All adult patients with IBD were included if they previously had been switched from originator infliximab to the biosimilar CT-P13 and had a follow-up time of at least 52 weeks after the initial switch. The reasons for reverse switching were categorized into worsening gastrointestinal symptoms, adverse effects, or loss of response to CT-P13. Drug persistence was analyzed through survival analyses. A total of 758 patients with IBD were identified. Reverse switching was observed in 75 patients (9.9%). Patients with reverse switching were predominantly female (70.7%). Gastrointestinal symptoms (25.5%) and dermatological symptoms (21.8%) were the most commonly reported reasons for reverse switching. In 9 patients (12.0%), loss of response to CT-P13 was the reason for reverse switching. Improvement of reported symptoms was seen in 73.3% of patients after reverse switching and 7 out of 9 patients (77.8%) with loss of response regained response. Infliximab persistence was equal between patients who were reverse-switched and those who were maintained on CT-P13. Reverse switching occurred in 9.9% of patients, predominantly for biosimilar-attributed adverse effects. Switching back to originator infliximab seems effective in patients who experience adverse effects, worsening gastrointestinal symptoms, or loss of response after switching from originator infliximab to CT-P13.
Highlights
Adult patients diagnosed with Crohn disease or ulcerative colitis who were switched from originator infliximab to CT-P13 with a minimum postswitch follow-up of 52 weeks, regardless of infliximabcontinuation, were eligible for inclusion
Treatment with infliximab was started after a median disease duration of 4.5 years (IQR, 1.1-12.9 years), and patients were switched to CT-P13 after a median of 4.7 years (IQR, 2.6-7.1 years)
During a median follow-up time of 1.50 years (IQR, 1.39-1.98 years), 93 out of the 683 patients (13.6%) who were maintained on CT-P13 discontinued infliximab therapy after a median of 11.0 months (IQR, 5.7-16.8 months)
Summary
The treatment of inflammatory bowel diseases (IBD) is notoriously cumbersome but has improved considerably with the introduction of anti-tumor necrosis factor alpha monoclonal antibodies, such as infliximab and adalimumab.[1]Received for publications November 17, 2020; Editorial Decision December 19, 2020.From the *Department of Gastroenterology and Hepatology, University Medical Centre Utrecht, Utrecht, the Netherlands; †Department of Gastroenterology and Hepatology, Zuyderland Medisch Centrum, Sittard, the Netherlands; ‡Department of Gastroenterology and Hepatology, University Medical Centre Groningen, Groningen, the Netherlands; §Department of Gastroenterology and Hepatology, Catharina Ziekenhuis, Eindhoven, the Netherlands; ¶Department of Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, the Netherlands; ‖Department of Gastroenterology and Hepatology, Elisabeth TweeSteden Ziekenhuis, Tilburg, the Netherlands; **Department of Gastroenterology and Hepatology, St. The treatment of inflammatory bowel diseases (IBD) is notoriously cumbersome but has improved considerably with the introduction of anti-tumor necrosis factor alpha monoclonal antibodies, such as infliximab and adalimumab.[1]. Received for publications November 17, 2020; Editorial Decision December 19, 2020. Patients suffering from inflammatory bowel diseases (IBD) and treated with originator infliximab are increasingly being switched to biosimilars. Some patients are “reverse switched” to treatment with the originator. We assess the prevalence of reverse switching, including its indication and outcomes
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