P464 Switching from the originator infliximab to biosimilar CT-P13 did not change the quality of life and clinical efficacy for IBD patients in stable remission in daily clinical practice (interim analysis). (16th January 2018) - Pierik, M J
Abstract: Background: The infliximab biosimilar CT-P13 (Remsima ® ) has been approved for all indications of the originator Remicade ® based on extrapolation of data, without clinical data in IBD patients. Since the EMA approval, several studies show that CT-P13 is safe and effective for IBD patients 1, 2 ; however, they did not include quality of life data (QoL). The objective of this study is to demonstrate that the QoL, efficacy and safety in patients with ulcerative colitis (UC) or Crohn's disease (CD) is non-inferior after switching from originator to CT-P13. Methods: This is an open-label, non-inferiority, multi-centre study including 208 IBD subjects in stable remission who serve as their own control. Data collected before first CT-P13 infusion serve as baseline. The primary parameter QoL measured by IBDQ (range 32 (worst)–224 (best)) was compared between v2 (after 2 infusions of CT-P13) and baseline. The clinical efficacy measured by SSCAI (UC) or HBI (CD) as well as safety were compared between v4 (after 6 infusions of CT-P13) and baseline. This abstract presents the interim data for both phases. Results: In 12 centres, 119 patients (42 UC; 77 CD) completed phase 1 and 47 (21 UC; 26 CD) phase 2. Mean ( ± stdev) age was 50 ± 15 years (50% male) and mean duration of infliximab treatment at baseline was 4.6 ± 3.1 years. Mean ( ± SEM) changes in IBDQ at v2 and v4 compared with originator were, respectively. −0.6 ± 4.4 and −5.4 ± 4.3 for UC and −2.7 ± 2.5 and −1.0 ± 5.5 for CD patients. Mean ( ± SEM) changes in SCCAI at v2 and v4 compared with originator were, respectively, 0.2 ± 0.3 and 0.1 ± 0.3. Mean ( ± SEM) changes in HBI at v2 and v4 compared with originator were, respectively 0.2 ± 0.3 and 0.5 ± 0.7. In total 53 adverse events (19 UC, 34 CD) were reported including three non-related SAEs (melanoma, subarachnoid haemorrhage, hospitalisation with fever). Conclusions: These preliminary data of this prospective, non-interventional study suggest that the QoL and clinical efficacy did not significantly change for IBD patients in stable remission switched from the originator infliximab to CT-P13 in daily clinical practice. Tolerability was also similar. This study is sponsored by Mundipharma Pharmaceuticals BV. References: 1. Jorgensen KK et al. Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority trial. Lancet, 2017;389:2304–2316. 2. Komaki Y et al. Systematic review with meta-analysis: the efficacy and safety of CT-P13, a biosimilar of anti-tumour necrosis factor-α agent (infliximab), in inflammatory bowel diseases. Aliment Pharmacol. Therapeut, 2017.