P471 Efficacy and safety of switching from reference infliximab to biosimilar infliximab in patients with inflammatory bowel disease: first French experience
Soret P.-A.*1,2, Prieux-Klotz C.1, Avouac J.3, Molto A.3, Dior M.1, Brieau B.1, Dreanic J.1, Camus M.1, Barret M.1, Coriat R.1, Conort O.4, Chast F.4, Goulvestre C.5, Le Jeunne C.6, Dougados M.3, Nahon S.2, Chaussade S.1, Abitbol V.1
1Cochin Hospital, Department of Gastroenterology, Paris, France 2Le Raincy-Montfermeil Hospital, Department of Gastroenterology, Montfermeil, France 3Cochin Hospital, Department of Rheumatology, Paris, France 4Cochin Hospital, Department of Pharmacy, Paris, France 5Cochin Hospital, Department of Biology, Paris, France 6Cochin Hospital, Department of Internal Medicine, Paris, France
Infliximab is widely used for induction and maintenance therapy in inflammatory bowel diseases (IBD). Reference infliximab (Remicade®) was the first anti-TNF available, but its costs are high, placing a strain on healthcare system. CT-P13 is a biosimilar of Remicade® with expected savings of 30%. No data is available in France regarding switching from reference infliximab to CT-P13. We aimed to assess efficacy and safety of switching from reference infliximab to CT-P13 in IBD.
From September 30, 2015 to March 30, 2016, a switch to CT-P13 (Inflectra®) and inclusion in a prospective observational study were proposed to all Remicade®-treated patients in our hospital (IBD, rheumatologic diseases, uveitis). Patients had to be on maintenance therapy (>3 Remicade® infusions) with stable treatment. Information was given and non-opposition was required. Data were collected in a anonymous questionnaire at baseline (2 infusions before the switch) and at each biosimilar infusion. Primary endpoint was the rate of patients still treated with Inflectra® after 3 infusions. Secondary endpoints were clinical activity, infliximab trough levels (ITL), anti-infliximab antibodies changes. A closeout visit was performed in July 2016. IBD activity was assessed with Mayo score [ulcerative colitis (UC)] or Harvey-Bradshaw [Crohn's disease (CD)]. ITL and anti-infliximab antibodies were measured before the first and the third CT-P13 infusion. Changes from baseline were analyzed with univariate analysis (Fisher or Mann-Whitney).
Overall, 268 consecutive patients were enrolled. Among them, 64 had IBD: one patient refused the switch and 63 [33 women, aged 34.5 (29–44), 42 CD, 21 UC] were included. At inclusion, duration of Remicade® therapy was 34.8 (14–74) months. Three infusions after the switch, 60 (95.2%) were still on Inflectra®. One patient stopped Inflectra® for pregnancy and 2 had IBD relapse: one was switched back to Remicade® and one to adalimumab. In July 2016, 8.4 (7.9–8.9) months after the switch, 2 more patients had stopped CT-P13 for suspected adverse event (purpura) while 55 (87.3%) remained treated with CT-P13. No allergic infusion reaction was reported. Changes from baseline were not significant: Mayo score (p=0.95), Harvey-Bradshaw (p=0.14), infliximab dose (p=0.71) and ITL [baseline (5.9±5 μg/mL); 3rd infusion (7.8±6μg/mL) (p=0.09)]. No patient developed anti-infliximab antibodies after the switch.
This prospective observational study suggests that the switch from reference infliximab to CT-P13 does not change IBD evolution. After 3 infusions, 95.2% patients remained on CT-P13 treatment. No changes in clinical activity, infliximab doses and ITL were observed. No anti-infliximab antibodies appeared.