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Long-term Efficacy, Safety, and Immunogenicity of Biosimilar Infliximab After One Year in a Prospective Nationwide
Lorant Gonczi1, Krisztina B Gecse, Zsuzsanna Vegh
11First Department of Medicine, Semmelweis University, Budapest, Hungary; 2First Department of Internal Medicine, University of Szeged, Szeged, Hungary; 3Department of Clinical Studies, Faculty of Health Sciences, Semmelweis University, Budapest, Hungary; 4Department of Gastroenterology, Military Hospital-State Health Centre, Budapest, Hungary; 5First Department of Medicine, Peterfy Hospital, Budapest, Hungary; 6Second Department of Medicine, Zala County Hospital, Zalaegerszeg, Hungary; 7Second Department of Medicine, B-A-Z County and University Teaching Hospital, Miskolc, Hungary; 8Department of Internal Medicine, Csolnoky Ferenc Regional Hospital, Veszprem, Hungary; 9Second Department of Internal Medicine, Semmelweis University, Budapest, Hungary; 10Department of Gastroenterology, University of Debrecen, Debrecen, Hungary; 11Department of Medicine and Gastroenterology, Markusovszky Hospital, Szombathely, Hungary; 12Department of Gastroenterology, Tolna County Teaching Hospital, Szekszard, Hungary; 13Department of Gastroenterology, Janos Hospital, Budapest, Hungary; 14First Department of Medicine, University of Pecs, Pecs, Hungary; 15Department of Laboratory Medicine, Semmelweis University, Budapest, Hungary; and 16Division of Gastroenterology, McGill University, Montreal, Quebec, Canada.
Background:
It has been previously shown that biosimilar infliximab CT-P13 is effective and safe in inducing remission in inflammatory bowel diseases. We report here the 1-year outcomes from a prospective nationwide inflammatory bowel disease cohort.
Methods:
A prospective, nationwide, multicenter, observational cohort was designed to examine the efficacy and safety of CT-P13 in the induction and maintenance treatment of Crohn's disease (CD) and ulcerative colitis (UC). Demographic data were collected and a harmonized monitoring strategy was applied. Clinical remission, response, and biochemical response were evaluated at weeks 14, 30, and 54, respectively. Safety data were registered.
Results:
Three hundred fifty-three consecutive inflammatory bowel disease (209 CD and 144 UC) patients were included, of which 229 patients reached the week 54 endpoint at final evaluation. Age at disease onset: 24/28 years (median, interquartile range: 19-34/22-39) in patients with CD/UC. Forty-nine, 53, 48% and 86, 81 and 65% of patients with CD reached clinical remission and response by weeks 14, 30, and 54, respectively. Clinical remission and response rates were 56, 41, 43% and 74, 66, 50% in patients with UC. Clinical efficacy was influenced by previous anti-tumor necrosis factor (TNF) exposure in patients with a drug holiday beyond 1 year. The mean C-reactive protein level decreased significantly in both CD and UC by week 14 and was maintained throughout the 1-year follow-up (both UC/CD: P < 0.001). Thirty-one (8.8%) patients had infusion reactions and 32 (9%) patients had infections. Antidrug antibody positivity rates were significantly higher throughout patients with previous anti-TNF exposure; concomitant azathioprine prevented antidrug antibody formation in anti-TNF-naive patients with CD.
Conclusions:
Results from this prospective nationwide cohort confirm that CT-P13 is effective and safe in inducing and maintaining long-term remission in both CD and UC. Efficacy was influenced by previous anti-TNF exposure; no new safety signals were detected.
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