While real-world data, such as those derived from the NOR-SWITCH study, have been reassuring about the feasibility of switching patients with inflammatory diseases from reference infliximab (Remicade) to biosimilar CT-P13 (sold as Inflectra and Remsima), some ambiguous data in patients with inflammatory bowel disease (IBD) have raised questions among clinicians about switching in the indications of Crohn disease and ulcerative colitis.
While real-world data, such as those derived from the NOR-SWITCH study, have been reassuring about the feasibility of switching patients with inflammatory diseases from reference infliximab (Remicade) to biosimilar CT-P13 (sold as Inflectra and Remsima), some ambiguous data in patients with inflammatory bowel disease (IBD) have raised questions among clinicians about switching in the indications of Crohn disease (CD) and ulcerative colitis (UC). Now, new evidence—from the largest study to date in patients with IBD who switched to CT-P13—may answer some of those questions.
The prospective, observational, open-label, multicenter cohort study involved a nonmedical switch undertaken at 4 hospitals in Sweden. The 313 patients treated for IBD in these hospitals (195 for CD and 118 for UC), were switched to the biosimilar. The primary endpoint of the study was change in disease activity at 2, 6, and 12 months postswitch.
Patients received written and verbal education about the switch, and their individual regimens, including infusion intervals and concomitant medication, were not altered in connection with the switch. All but 1 patient was receiving maintenance therapy at the time of the switch. A full 12-month follow-up period was completed by 250 patients.
In total, 10 patients (3.2%) discontinued CT-P13 due to disease remission, 23 (7.4%) discontinued due to lack of efficacy, and 15 (4.8%) due to adverse events (AEs). No significant changes in disease activity (as measured by Harvey-Bradshaw Index or Simple Clinical Colitis Activity Index) were observed between baseline and 2, 6, and 12 months after the switch.
Blood test biomarkers of disease activity did not indicate disease worsening after the switch in either the CD group or the UC group. The mean fecal calprotectin value was increased at 1 months in patients with CD, but not at months 6 or 12 (no significant changes in fecal calprotectin were observed in patients with UC). There were no significant changes in quality of life as measured by Short Heatlh Scale at months 2, 6, or 12. Drug trough levels did not change significantly during followup.
AEs of any type occurred in 24.1% of patients with CD and 21.2% of patients with UC. In 15 cases, AEs led to discontinuation. Rash, fatigue, arthralgia, and headache were the most commonly reported AEs. The number of serious AEs during follow-up was 7 (2.2%).
Notably, disease worsening occurred in 14.0% of patients with CD and 13.8% of patients with UC, which is notable in comparison with NOR-SWITCH data, which showed disease worsening in 36.5% of those with CD and 11.9% of those with UC at 12 months.
“In conclusion, we have demonstrated that switching from Remicade to CT-P13 may be done with preserved therapeutic effectiveness and safety in patients with IBD,” wrote the investigators, adding that “the concerns raised by several previous studies, including a potential difference in the efficacy of CT-P13 in CD compared with UC, were refuted.”
Bergqvist V, Kadivar M, Molin D, et al. Switching from originator infliximab to the biosimilar CT-P13 in 313 patients with inflammatory bowel disease. Therap Adv Gastroenterol. 2018;11: 1756284818801244. doi: 10.1177/1756284818801244.