Effectiveness and Safety of CT-P13 (Biosimilar Infliximab) in Patients with Inflammatory Bowel Disease in Real Life at 6 Months

Abstract

BackgroundCT-P13 is a biosimilar of Remicade®, an agent approved in some countries for use in inflammatory bowel disease (IBD). Controlled clinical trials have demonstrated the efficacy and safety of CT-P13 in rheumatic diseases, but not in IBD.AimsTo assess the effectiveness and safety of CT-P13 in IBD patients in real clinical practice.MethodsThis is a prospective observational study in patients with moderate to severe Crohn’s disease or ulcerative colitis treated with CT-P13. The study was performed in one single center. Patients included were naive or switched to anti-TNF treatment from the reference infliximab (Remicade®) to CT-P13. Efficacy and safety were assessed in naive and switched patients who were in remission at the time of the switch at months 3 and 6 of therapy.Results87.5 and 83.9% of switched CD patients who were in remission at the time of the switch continued in remission, and 66.7 and 50% of naive CD patients reached remission, at months 3 and 6. In UC switched cases, 92 and 91.3% of patients in remission at the time of the switch continued in remission, at 3 and 6 months. In naive UC patients, the remission rates were 44.4 and 66.7%, at months 3 and 6. Adverse events occurred in 7.5% of patients during 6 months of study.ConclusionsCT-P13 was efficacious and well tolerated in patients with CD or UC.

Long‐term efficacy and safety of CT‐P13, a biosimilar of infliximab, in patients with inflammatory bowel disease: A retrospective multicenter study

“…Several studies have reported positive results on the efficacy of CT‐P13 and supported its use in the treatment of IBD, which is consistent with our results . A Norwegian prospective observational study showed that 79% of CD and 56% of UC patients achieved remission at week 14 .…”

“…To date, the clinical experiences and evidence using CT‐P13 therapy in IBD patients are still limited. Only a few studies have reported the clinical outcomes of CT‐P13 therapy in IBD, with relatively small sample sizes and short follow‐up periods . Although CT‐P13 has been used in clinical practice since 2012 for the treatment of CD and UC after marketing approval, to the best of our knowledge, long‐term clinical results beyond 1 year of CT‐P13 treatment in patients with IBD has not been reported.…”

Biosimilarity and Interchangeability: Principles and Evidence: A Systematic Review

“…Eight studies reported that switching generally had no noticeable effect, but did not provide a formal statistical analysis of between-group comparisons or based this conclusion on modelling [44, 45, 52, 65, 83, 88–90]. Two studies reported on switching from infliximab originator to biosimilar.…”

“…In terms of safety data after switching, eight studies reported no concerns or similar safety profiles before and after switching [43, 44, 47, 50, 62, 63, 79, 87, 89], six studies reported no general safety data [45, 51, 72, 77, 83, 90], and 12 studies reported adverse events such as injection site pain, acute hypersensitivity reactions, rash and infusion reactions after switching (although most did not provide comparative data from before switching) [46, 48, 49, 52, 54, 58, 65–68, 71, 88]. …”

“…Pain (29 mm vs 38 mm; P  = 0.028) and CRP values (1.95 vs 4.0 mg/L; P  = 0.001) significantly higher during longer follow-upNo significant difference in number of SAEs (2 vs 3), AEs (numbers NR) or infusion reactions (1 vs 1) during follow-up periods. 5 patients discontinued INXNRAla et al 2016 (abstract) [44]With IBD ( N  = 20)20INX RP, duration NRCT-P13, 6 months post-switchMost patients remained in clinical remission or improved during follow-up (actual numbers NR)No significant AEs reported post-switchNRArguelles-Arias et al 2017 [45]With IBD ( N  = 120)98Originator INX, median duration 297 weeks, or INX-naiveCT-P13, follow-up 6 monthsRemained in clinical remission, switched vs naïve, CD, 3 months: 88 vs 67%; 6 months: 84 vs 50%. UC, 3 months: 92 vs 44%; 6 months: 91 vs 67%NR separately for the 2 treatment groupsNRBennett et al 2016 (abstract) [46]With IBD ( N  = 104)104INX RP, median time 162 weeksCT-P13, follow-up 6 monthsPre-switch vs post-switch, median CRP: 2 vs 2 ( P  = 0.81); median DAS: 1 vs 1 ( P  = 0.44); remission: 85 vs 81% ( P  = 0.51)After switch: 4 patients had AEs (2 minor infusion reactions, 2 skin disease); 19 patients stopped treatment (6 electively, 9 loss of response, 4 for other reasons)Pre-switch vs post-switch: 29 vs 27 patients ( P  = 0.88)Benucci et al 2017 [47]With SpA ( N  = 41)41Originator INX, median duration 74 monthsBiosimilar INX, follow-up 6 months6 months before vs 6 months after switch, median BASDAI (2.6 vs 2.7), BASFI (2.2 vs 2.3), ASDAS-CRP (1.3 vs 1.4); DAS28-CRP (2.7 vs 2.7), MASES (0.2 vs 0.4), VAS pain (17 vs 18) (all P  > 0.05).…”