PMO-33 Infliximab biosimilar switching – can you switch more than once?

Abstract

<h3>Introduction</h3> With the increasing availability of biosimilar infliximab (IFX) products, there is a drive to lower costs without compromising patient outcomes. Switching from originator to biosimilar biologics has been shown to be safe and effective in patients with inflammatory bowel disease (IBD), but less is known about the safety and efficacy of switching between multiple biosimilar brands. The aim of this study was to report the outcomes of patients undergoing a biosimilar IFX switch for the first time (Remsima® to Zessly®) compared to those patients that have undergone a previous originator to biosimilar IFX switch (Remicade® to Remsima® to Zessly®), in a real-life IBD cohort. <h3>Methods</h3> A retrospective cohort study was carried out, and eligible patients were identified through a in-house database. All patients on treatment with Remsima® were eligible for the switch to Zessly®. The primary aim of the study was to assess the clinical outcomes (in terms of continuation of therapy, loss of response and achievement of remission allowing cessation of biologic therapy) between the two patient groups, over a six month period following their switch to Zessly®. Secondary outcomes measured were infusion reactions and rates of hospitalisation for an acute flare. <h3>Results</h3> A total of 147 patients were eligible for and underwent the biosimilar-to-biosimilar switch; median age was 41 (IQR 28-56), 95 (64.6%) were male, and 107 (72.8%) had Crohn’s Disease. Of the total cohort, 96 (65.3%) were undergoing their first biosimilar switch (Remsima® to Zessly®), whereas 51 (34.7%) were undergoing their second biosimilar switch (Remicade® to Remsima® to Zessly®). In those with one versus two biologic switches, there were no differences seen in the number of patients being able to continue Zessly® (79.2% vs 80.4%, p=0.861), loss of response to Zessly® (11.5% vs 5.9%, p=0.273), or achievement of remission on Zessly® resulting in cessation of therapy (1.0% vs 0%, p=0.465). None of the patients from either group experienced any infusion-related reactions. There was no difference in hospitalisation in the six months following biologic switch (3.1% vs 2.0%, p=0.680). <h3>Conclusions</h3> This real-life, single centre, short-term evaluation demonstrated that switching between biosimilar IFX brands appears to be as safe and effective as switching from originator to biosimilar IFX. A larger randomised-controlled study would be needed to confirm both the safety and effectiveness of switching between multiple biosimilar brands to substantiate the results of this evaluation.