Año 2020 / Volumen 112 / Número 3
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Año 2020 / Volumen 112 / Número 3

Original

Effectiveness and safety of adalimumab biosimilar ABP 501 in Crohn’s disease: an observational study

195-200

Davide Giuseppe Ribaldone, Gian Paolo Caviglia, Rinaldo Pellicano, Marta Vernero, Giorgio Maria Saracco, Mario Morino, Marco Astegiano,

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.

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Asociación Española de Ecografía Digestiva Sociedad Española de Endoscopia Digestiva Sociedad Española de Patología Digestiva
The Spanish Journal of Gastroenterology is the official organ of the Sociedad Española de Patología Digestiva, the Sociedad Española de Endoscopia Digestiva and the Asociación Española de Ecografía Digestiva
© 2020 The Spanish Journal of Gastroenterology