Long-term Efficacy, Safety, and Immunogenicity of Biosimilar Infliximab after One Year in a Prospective Nationwide Cohort
| Autor: | Árpád V. Patai, Zsuzsanna Vegh, Laszlo Lakatos, Zsuzsanna Kurti, László Bene, Beáta Gasztonyi, Ágnes Salamon, Balázs Szalay, Tamas Szamosi, János Banai, Mariann Rutka, Tamás Molnár, Mária Papp, Pál Miheller, Klaudia Farkas, Krisztina Gecse, Zoltán Szepes, Peter L. Lakatos, Gábor Tamás Tóth, Tunde Kristof, Ferenc Nagy, Áron Vincze, Károly Palatka, Barbara D. Lovasz, Lorant Gonczi, Petra A. Golovics |
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| Přispěvatelé: | Gastroenterology and Hepatology, AGEM - Digestive immunity |
| Jazyk: | angličtina |
| Rok vydání: | 2017 |
| Předmět: |
Adult
Male medicine.medical_specialty therapeutic drug monitoring efficacy Azathioprine Klinikai orvostudományok Inflammatory bowel disease 03 medical and health sciences Young Adult 0302 clinical medicine Gastrointestinal Agents Internal medicine antidrug antibody medicine trough level Immunology and Allergy Humans Prospective Studies Prospective cohort study Biosimilar Pharmaceuticals ulcerative colitis Crohn's disease Hungary business.industry Tumor Necrosis Factor-alpha Remission Induction Gastroenterology Antibodies Monoclonal Orvostudományok medicine.disease Inflammatory Bowel Diseases Ulcerative colitis Infliximab side effects C-Reactive Protein Treatment Outcome 030220 oncology & carcinogenesis Cohort Trough level 030211 gastroenterology & hepatology Female Drug Monitoring biosimilar business infliximab medicine.drug |
| Zdroj: | Inflammatory bowel diseases, 23(11), 1908-1915. John Wiley and Sons Inc. |
| ISSN: | 1078-0998 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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