CT-P13, Reference Infliximab, and Adalimumab Demonstrate Similar Safety and Efficacy in CD

The study sought to assess the efficacy, tolerability, and safety of CT-P13 versus its reference and versus adalimumab in patients with Crohn disease (CD).
Kelly Davio
July 31, 2019
Anti–tumor necrosis factor (anti-TNF) agents are an important therapy for patients with Crohn disease (CD), but given the cost of anti-TNFs, use of these agents to treat some European patients with inflammatory bowel disease has been limited. A recent study from Poland—one such nation where patients have historically had limited access to biologics but where access has increased with the introduction of biosimilars—showed that the cost-saving biosimilar infliximab CT-P13 (Inflectra, Remsima) had comparable safety and efficacy to both its reference and to adalimumab in patients with CD.

The retrospective, single-center study included a cohort of 286 Polish patients with CD. The study sought to assess the efficacy, tolerability, and safety of the biosimilar versus its reference and versus adalimumab. Patients had moderate or severe CD and an insufficient response to standard therapy. Patients were assigned to receive reference infliximab (n = 82), the biosimilar (n = 109), or adalimumab (n = 95); patients treated prior to 2014 received the reference, and those treated after, due to a change in hospital funding, were given either adalimumab or the biosimilar based on their previous treatment (more than 30% of patients had received prior anti-TNF therapy) and on patient preference.

At 12 months, there were no statistically significant differences among the reference infliximab, biosimilar, and adalimumab groups, respectively, on the following criteria:
  • The proportion of patients achieving clinical response: 95%, 94%, and 87%
  • The proportion of patients achieving clinical remission: 76%, 81%, and 70%
  • The proportion of patients achieving glucocorticoid-free remission: 78%, 72%, and 74%
There was a similar relapse rate between patients receiving the biosimilar (54%) and adalimumab (61%), but more patients who received reference infliximab (83%) experienced relapses during 1 year of observation, and this difference reached statistical significance (P <.001).

Adverse events (AEs) were reported in 15% of the reference group, 17% of the biosimilar group, and 9% of the adalimumab group. The most commonly reported AEs were skin reactions.

According to the authors, this study has demonstrated the safety and efficacy of the biosimilar in comparison with both its reference and with adalimumab, not only with induction, but also during 1 year of therapy, and relapse rates were lower with the biosimilar than with the reference infliximab.

Reference
Kaniewska M, Rosolowski M, Rydzewska G. The efficacy, tolerability and safety of infliximab biosimilar in comparison to originator biologic and adalimumab in patients with Crohn’s disease [published online July 17, 2019]. Pol Arch Intern Med. doi: 10.20452/pamw.14901.

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