Infliximab and its biosimilar produced similar first‐year therapy outcomes in patients with inflammatory bowel disease

Abstract

Aim Tumour necrosis factor α inhibitors (anti‐TNFα) are the main therapy for moderate to severe inflammatory bowel disease (IBD) in children. Biosimilars to the original drug infliximab are now available, but there are few reports on their real‐life use. We compared the outcomes of patients treated with infliximab and its biosimilar, CT‐P13. Methods We collected outcome data on anti‐TNFα‐naive patients who started infliximab in the Children's Hospital, University of Helsinki, Finland, in 2015‐2016. We studied 51 paediatric patients with IBD at a median age of 12 (range 4‐16): 65% had Crohn disease, 23 received the original infliximab drug and 28 received the biosimilar. During 2015, infliximab was introduced to all treatment‐naïve patients, and during 2016, all treatment‐naïve patients received the biosimilar. Results We found no statistically significant differences between the two drug products related to the outcome of the therapy during the first year. There were no significant differences in the trough levels between the treatment groups. Likewise, the proportion of patients with therapy enhancement was comparable between the two treatment groups. Conclusion The first‐year therapy outcomes of infliximab and its biosimilar were comparable. There were no alarming signs of differences in safety.

Biosimilar infliximab in paediatric inflammatory bowel disease: Efficacy, immunogenicity and safety

“…The ESPGHAN Pediatric IBD Porto Group stated that CT‐P13 can be considered as a valid alternative to the originator for induction, and maintenance, of remission in children with IBD who are indicated for IFX treatment 11 . To date, the efficacy of the biosimilar IFX after induction has been assessed in 4 paediatric studies, 22‐25 comprising a total of 186 IBD paediatric patients (144 CD, 28 UC and 14 IBD‐U; Table 1). Biosimilar used was represented by CT‐P13 in all studies.…”

“…Moreover, authors compared new starters on anti‐TNF‐α therapy with historical data from 398 similar patients started on reference IFX in previous UK IBD biologics audit (2011‐2015) 30,31 and found no significant difference in disease response and remission rates at 3 months ( P = .84 and P = .37, respectively). A recently published retrospective study conducted in Finland 25 reported that the first‐year therapy outcomes of reference IFX (n = 23) and biosimilar IFX (n = 28) were comparable in a group of IBD paediatric patients. Clinical responses (assessed by a not well‐specified combination of clinical disease activity assessment, blood inflammatory markers and faecal calprotectin) were observed in 90% of the patients during induction, with no major difference between the two groups.…”

“…The reference lists of all retrieved articles were also reviewed to identify any further relevant studies. After filtering for redundancies and irrelevant results, 8 articles were withheld for review 22‐29 …”

Therapy outcome related to adalimumab trough levels in pediatric patients with inflammatory bowel disease

“…Decisions on management were made at the discretion of the treating physician and were based on the routine use of the clinical symptom index [17], fecal calprotectin [18][19][20], blood inflammatory marker and drug level measurements, and the presence of drug antibodies when appropriate [7,16]. Clinical disease activity was retrospective scored according to Physician Global Assessment (PGA) on a scale of 1-3 [21].…”

“…This is comparable with the management of adult IBD. In Europe, the patent for infliximab expired in 2015 and for adalimumab in 2018, and currently, there are several biosimilars to the original drugs Remicade (Janssen Biologics) and Humira (Abbvie) on the market [5][6][7]. The induction phase of infliximab is six weeks, and the three first doses are administered intravenously usually at 5 mg/kg at weeks 0, 2, and 6.…”