BACKGROUND AND AIMS: Long-term data regarding switching from originator infliximab to biosimilar CT-P13 are sparse. Concerns about increased immunogenicity after switching have been raised. We aimed to study the effectiveness, safety and immunogenicity after switching from originator infliximab to CT-P13 in a real-world IBD population with 18 months prospective follow-up. METHODS: All adult IBD patients treated with originator infliximab at the Department of Gastroenterology, Oslo University Hospital, were switched to CT-P13 and followed prospectively for 18 months. The primary endpoints were (i) the proportion of patients remaining on CT-P13 18 months after switching and (ii) immunogenicity during 18 months after switching. The secondary endpoints included (i) adverse events, (ii) changes in disease activity, C-reactive protein, anaemia, faecal calprotectin, infliximab dose and interval and p-infliximab. RESULTS: In total, 143 IBD patients were switched, 99 with Crohn's disease and 44 with ulcerative colitis. Altogether, 130 (91%) remained on CT-P13 throughout 18 months. Two patients developed ADAs at moderate level and discontinued CT-P13. Another 10 patients discontinued CT-P13 (two due to loss of response without ADAs, four due to adverse events, and four in remission and a personal wish to stop). There was no overall change in disease activity scores or in the other studied variables except for p-infliximab, which increased significantly. CONCLUSIONS: The present study provides valuable evidence for the safety and effectiveness of switching from originator to biosimilar infliximab over a prolonged period of 18 months and demonstrates that switching was well tolerated and did not affect the long term clinical outcome.
BACKGROUND AND AIMS: Long-term data regarding switching from originator infliximab to biosimilar CT-P13 are sparse. Concerns about increased immunogenicity after switching have been raised. We aimed to study the effectiveness, safety and immunogenicity after switching from originator infliximab to CT-P13 in a real-world IBD population with 18 months prospective follow-up. METHODS: All adult IBDpatients treated with originator infliximab at the Department of Gastroenterology, Oslo University Hospital, were switched to CT-P13 and followed prospectively for 18 months. The primary endpoints were (i) the proportion of patients remaining on CT-P13 18 months after switching and (ii) immunogenicity during 18 months after switching. The secondary endpoints included (i) adverse events, (ii) changes in disease activity, C-reactive protein, anaemia, faecal calprotectin, infliximab dose and interval and p-infliximab. RESULTS: In total, 143 IBDpatients were switched, 99 with Crohn's disease and 44 with ulcerative colitis. Altogether, 130 (91%) remained on CT-P13 throughout 18 months. Two patients developed ADAs at moderate level and discontinued CT-P13. Another 10 patients discontinued CT-P13 (two due to loss of response without ADAs, four due to adverse events, and four in remission and a personal wish to stop). There was no overall change in disease activity scores or in the other studied variables except for p-infliximab, which increased significantly. CONCLUSIONS: The present study provides valuable evidence for the safety and effectiveness of switching from originator to biosimilar infliximab over a prolonged period of 18 months and demonstrates that switching was well tolerated and did not affect the long term clinical outcome.
Authors: Nerea Martín-Gutiérrez; José Germán Sánchez-Hernández; Noemí Rebollo; Alejandra F Pordomingo; Fernando Muñoz; María José Otero Journal: Eur J Hosp Pharm Date: 2020-10-28
Authors: Nikolas Plevris; Gareth R Jones; Philip W Jenkinson; Mathew Lyons; Cher S Chuah; Lynne M Merchant; Rebecca J Pattenden; Eleanor F Watson; Gwo-Tzer Ho; Colin L Noble; Shahida Din; Alan G Shand; Ian D Arnott; Charlie W Lees Journal: Dig Dis Sci Date: 2018-12-07 Impact factor: 3.487
Authors: Rosa Giuliani; Josep Tabernero; Fatima Cardoso; Keith Hanson McGregor; Malvika Vyas; Elisabeth G E de Vries Journal: ESMO Open Date: 2019-03-06
Authors: Vibeke Strand; Joao Gonçalves; Timothy P Hickling; Heather E Jones; Lisa Marshall; John D Isaacs Journal: BioDrugs Date: 2020-02 Impact factor: 5.807