Davide Giuseppe Ribaldone1, Gian Paolo Caviglia2, Rinaldo Pellicano3, Marta Vernero4, Giorgio Maria Saracco5, Mario Morino2, Marco Astegiano6. 1. General and Specialistic Medicine/Gastroenterology, Città della Salute e della Scienza di Torino, Italy. 2. University of Turin. 3. Gastroenterology and Hepatology, Molinette Hospital-SGAS, Italy. 4. University of Pavia. 5. Division of Gastroenterology, University of Torino. 6. Gastroenterologia-U, Città della Salute e della Scienza di Torino, C.so Bramante 88, 10126 Turin, It.
Abstract
BACKGROUND AND OBJECTIVE: there are no studies in the literature about the effectiveness of adalimumab biosimilar ABP 501 in Crohn's disease. The aim of this study was to evaluate its effectiveness and safety. METHODS: an observational study was performed in Crohn's disease patients treated with ABP 501, with the classic induction and maintenance regimen and in Crohn's disease patients who were switched from the adalimumab originator to ABP 501. RESULTS: eighty-seven patients were included in the study, of which 25 were naïve to the adalimumab originator and 62 were switched to ABP 501. In adalimumab-naïve patients, clinical response at three months was 60% (15/25) and clinical remission at three months was 56% (14/25). At six months, 95.2% (59/62) of the patients switched to ABP 501 were still in therapy, without a significant increase of clinical activity (Harvey-Bradshaw index from 3.4, 95% CI = 2.4-4.4, to 3.8, 95% CI = 2.7-4.9, p = 0.23) and inflammatory biomarkers (C-reactive protein from 4.2 mg/l, 95% CI = 2.5-5.9 mg/l, to 3.6 mg/l, 95% CI = 2.2-5 mg/l, p = 0.32). There were no unexpected adverse events during the study period. CONCLUSIONS: our results support ABP 501 as an effective and well-tolerated drug, with a good interchangeability with its originator for the treatment of Crohn's disease.
BACKGROUND AND OBJECTIVE: there are no studies in the literature about the effectiveness of adalimumab biosimilar ABP 501 in Crohn's disease. The aim of this study was to evaluate its effectiveness and safety. METHODS: an observational study was performed in Crohn's disease patients treated with ABP 501, with the classic induction and maintenance regimen and in Crohn's disease patients who were switched from the adalimumab originator to ABP 501. RESULTS: eighty-seven patients were included in the study, of which 25 were naïve to the adalimumab originator and 62 were switched to ABP 501. In adalimumab-naïve patients, clinical response at three months was 60% (15/25) and clinical remission at three months was 56% (14/25). At six months, 95.2% (59/62) of the patients switched to ABP 501 were still in therapy, without a significant increase of clinical activity (Harvey-Bradshaw index from 3.4, 95% CI = 2.4-4.4, to 3.8, 95% CI = 2.7-4.9, p = 0.23) and inflammatory biomarkers (C-reactive protein from 4.2 mg/l, 95% CI = 2.5-5.9 mg/l, to 3.6 mg/l, 95% CI = 2.2-5 mg/l, p = 0.32). There were no unexpected adverse events during the study period. CONCLUSIONS: our results support ABP 501 as an effective and well-tolerated drug, with a good interchangeability with its originator for the treatment of Crohn's disease.
Authors: Trinidad Montero-Vilchez; Carlos Cuenca-Barrales; Andrea Rodriguez-Tejero; Antonio Martinez-Lopez; Salvador Arias-Santiago; Alejandro Molina-Leyva Journal: J Clin Med Date: 2022-02-15 Impact factor: 4.241
Authors: Martin Wasserbauer; Stepan Hlava; Jiri Drabek; Jan Stovicek; Petra Minarikova; Lenka Nedbalova; Tomas Drasar; Zdena Zadorova; Jiri Dolina; Stefan Konecny; Vladimír Kojecky; Jana Kozeluhova; Pavlina Cernikova; Dita Pichlerova; Barbora Kucerova; Stepan Coufal; Radan Keil Journal: PLoS One Date: 2022-08-08 Impact factor: 3.752