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P382 Comparison of efficacy and safety of biosimilar infliximab to originator infliximab in children with inflammatory bowel disease

R. Muhammed*, L. Whyte, S. Protheroe, R. Bremner, W. Haller, T. Wong

Birmingham Children’s Hospital, Gastroenterology, Birmingham, United Kingdom

Background

CT-P13 is the biosimilar infliximab approved for use in Europe and it is marketed in the UK in 2 brand names, Remsima (NAPP pharmaceuticals) and Inflectra (Hospira pharmaceuticals). The European Medicines Authority (EMA) has approved CT-P13 for all the indications of originator infliximab (Remicade, MSD Immunology). No clinical trials in paediatric inflammatory bowel disease (IBD) of biosimilar infliximab are completed till date. We have compared the efficacy and safety of biosimilar infliximab to the originator infliximab in our clinical practice.

Methods

Clinical and laboratory data of patients receiving infliximab from January 2015 to date were collected from patient records and electronic case records.

Results

We have used biosimilar infliximab (Inflectra) for all new starters of infliximab treatment in our unit since July 2015. Before that all patients on treatment with infliximab were receiving originator infliximab (Remicade).24 patients (18 with Crohn’s disease (CD) and 6 with ulcerative colitis (UC)) were started on Inflectra this year. 17 patients (14 patients with CD and 3 with UC) were started on Remicade from January to July this year. A total of 72 Inflectra infusions were administered compared with 96 infusions of Remicade. Median number of infusions per patient was 3 and 6 respectively for Inflectra and Remicade. 1 patient receiving Inflectra had a major infusion reaction needing a switch of treatment to adalimumab. This was comparable to the incidence of major infusion reaction in patients receiving Remicade (1/17). 5/18 (28%) patients with CD on treatment with Inflectra needed dose or frequency escalation of infusions. Clinical remission was achieved in 5/8 (63%) patients receiving Inflectra treatment. 10/14 (71%) children with Crohn’s disease on treatment with Remicade achieved clinical remission. Dose or frequency escalation was needed in 3/14 (21%) patients on Remicade. 2/5 (40%) patients with UC achieved clinical remission using Inflectra.2/3 (67%) patients with UC on Remicade achieved clinical remission. Cost of Inflectra is less than that of Remicade (100 mg vial of Inflectra costs approximately £210 and 100 mg vial of Remicade costs approximately £350). Results are summarised in Table 1.

Table 1. Comparison of patients with IBD on treatment with Remicade and Inflectra

Patients on treatment with RemicadePatients on treatment with Inflectra
Number of patients17 (CD 14, UC 3)24 (CD 18, UC 6)
Total number of infusions9672
Number of infusions per patient median (range)6 (2–8)3 (1–6)
Major infusion reaction1/17 (6%)1/24 (4%)
Patients with CD on Azathioprine12/14 (86%)15/18 (83%)
Patients with CD needing dose escalation3/14 (21%)5/18 (28%)
Patients with CD in remission10/14 (71%)5/8 (63%)
Patients with UC in remission2/3 (67%)2/5 (40%)
Drug cost of 6 month’s treatment (200 mg dose per infusion)£3500£2100

Conclusion

In our clinical practice, the efficacy and safety of biosimilar infliximab (Inflectra) is comparable to the originator infliximab with significant cost savings offered by the use of biosimilar infliximab.