Year 2020 / Volume 112 / Number 3
Original
Effectiveness and safety of adalimumab biosimilar ABP 501 in Crohn’s disease: an observational study

195-200

DOI: 10.17235/reed.2020.6693/2019

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

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.
Share Button
New comment
Comments
No comments for this article
References
1. Jones JL, Nguyen GC, Benchimol EI, Bernstein CN, Bitton A, Kaplan GG, et al. The Impact of Inflammatory Bowel Disease in Canada 2018: Quality of Life. J Can Assoc Gastroenterol. 2019 Feb 2;2(Supplement_1):S42–8.
2. Di Candido F, Fiorino G, Spadaccini M, Danese S, Spinelli A. Are Surgical Rates Decreasing In The Biological Era In IBD? Curr Drug Targets. 2019 Apr 26;20.
3. Colombel J, Sandborn WJ, Rutgeerts P, Enns R, Hanauer SB, Panaccione R, et al. Adalimumab for Maintenance of Clinical Response and Remission in Patients With Crohn’s Disease: The CHARM Trial. Gastroenterology. 2007 Jan;132(1):52–65.
4. Loftus E V, Reinisch W, Panaccione R, Berg S, Alperovich G, Bereswill M, et al. Adalimumab Effectiveness Up to Six Years in Adalimumab-naïve Patients with Crohn’s Disease: Results of the PYRAMID Registry. Inflamm Bowel Dis. 2019 Aug 20;25(9):1522–31.
5. Lawton J, Achit H, Pouillon L, Boschetti E, Demore B, Matton T, et al. Cost-of-illness of inflammatory bowel disease patients treated with anti-tumour necrosis factor: A French large single-centre experience. United Eur Gastroenterol J. 2019 Aug 20;7(7):908–13.
6. Cohen S, Genovese MC, Choy E, Perez-Ruiz F, Matsumoto A, Pavelka K, et al. Efficacy and safety of the biosimilar ABP 501 compared with adalimumab in patients with moderate to severe rheumatoid arthritis: a randomised, double-blind, phase III equivalence study. Ann Rheum Dis. 2017 Oct;76(10):1679–87.
7. Papp K, Bachelez H, Costanzo A, Foley P, Gooderham M, Kaur P, et al. Clinical similarity of biosimilar ABP 501 to adalimumab in the treatment of patients with moderate to severe plaque psoriasis: A randomized, double-blind, multicenter, phase III study. J Am Acad Dermatol. 2017 Jun;76(6):1093–102.
8. Fiorino G, Danese S. The biosimilar road in inflammatory bowel disease: the right way? Best Pract Res Clin Gastroenterol. 2014 Jun;28(3):465–71.
9. Lee H. Is Extrapolation of the Safety and Efficacy Data in One Indication to Another Appropriate for Biosimilars? AAPS J. 2014 Jan 11;16(1):22–6.
10. Feagan BG, Choquette D, Ghosh S, Gladman DD, Ho V, Meibohm B, et al. The challenge of indication extrapolation for infliximab biosimilars. Biologicals. 2014 Jul;42(4):177–83.
11. Kaur P, Chow V, Zhang N, Moxness M, Kaliyaperumal A, Markus R. A randomised, single-blind, single-dose, three-arm, parallel-group study in healthy subjects to demonstrate pharmacokinetic equivalence of ABP 501 and adalimumab. Ann Rheum Dis. 2017 Mar;76(3):526–33.
12. Gomollón F, Dignass A, Annese V, Tilg H, Van Assche G, Lindsay JO, et al. 3rd European Evidence-based Consensus on the Diagnosis and Management of Crohn’s Disease 2016: Part 1: Diagnosis and Medical Management. J Crohn’s Colitis. 2017 Jan;11(1):3–25.
13. Vermeire S, Schreiber S, Sandborn WJ, Dubois C, Rutgeerts P. Correlation Between the Crohn’s Disease Activity and Harvey–Bradshaw Indices in Assessing Crohn’s Disease Severity. Clin Gastroenterol Hepatol. 2010 Apr;8(4):357–63.
14. Yarur AJ, Kanagala V, Stein DJ, Czul F, Quintero MA, Agrawal D, et al. Higher infliximab trough levels are associated with perianal fistula healing in patients with Crohn’s disease. Aliment Pharmacol Ther. 2017 Apr;45(7):933–40.
15. Schellekens H. Bioequivalence and the immunogenicity of biopharmaceuticals. Nat Rev Drug Discov. 2002 Jun;1(6):457–62.
16. Hanauer SB, Sandborn WJ, Rutgeerts P, Fedorak RN, Lukas M, MacIntosh D, et al. Human Anti–Tumor Necrosis Factor Monoclonal Antibody (Adalimumab) in Crohn’s Disease: the CLASSIC-I Trial. Gastroenterology. 2006 Feb;130(2):323–33.
17. Tanaka H, Kamata N, Yamada A, Endo K, Fujii T, Yoshino T, et al. Long-term retention of adalimumab treatment and associated prognostic factors for 1189 patients with Crohn’s disease. J Gastroenterol Hepatol. 2018 May;33(5):1031–8.
18. Kamat N, Kedia S, Ghoshal UC, Nehra A, Makharia G, Sood A, et al. Effectiveness and safety of adalimumab biosimilar in inflammatory bowel disease: A multicenter study. Indian J Gastroenterol. 2019 Feb 15;38(1):44–54.
19. Buer LCT, Moum BA, Cvancarova M, Warren DJ, Medhus AW, Høivik ML. Switching from Remicade® to Remsima® is well tolerated and feasible: a prospective, open-label study. J Crohn’s Colitis. 2016 Sep 22;11(3):jjw166.
Related articles

Letter

Hepatosplenic T-cell lymphoma and inflammatory bowel disease

DOI: 10.17235/reed.2023.9472/2023

Letter

Anal neoplasia and perianal Crohn’s disease: myth or reality?

DOI: 10.17235/reed.2021.8317/2021

Letter

Apoptotic colopathy as a manifestation of Good’s syndrome

DOI: 10.17235/reed.2021.8297/2021

Original

Radon exposure and inflammatory bowel disease in a radon prone area

DOI: 10.17235/reed.2021.8239/2021

Review

Inflammatory bowel disease and solid organ transplantation

DOI: 10.17235/reed.2020.7361/2020

Editorial

Is celiac disease really associated with inflammatory bowel disease?

DOI: 10.17235/reed.2019.6779/2019

Original

Megacolon in inflammatory bowel disease: response to infliximab

DOI: 10.17235/reed.2020.6394/2019

Editorial

Diet in the etiology of inflammatory bowel disease

DOI: 10.17235/reed.2018.6119/2018

Case Report

Serrated Lesions in patients with Inflammatory Bowel Disease.

DOI: 10.17235/reed.2019.5910/2018

Editorial

Online social networks and inflammatory bowel disease

DOI: 10.17235/reed.2018.5496/2018

Letter to the Editor

Idiopathic portal hypertension with regard to thiopurine treatment

DOI: 10.17235/reed.2018.5256/2017

Editorial

Specialist care in the management of inflammatory bowel disease

DOI: 10.17235/reed.2016.4628/2016

Citation tools
Ribaldone D, Caviglia G, Pellicano R, Vernero M, Saracco G, Morino M, et all. Effectiveness and safety of adalimumab biosimilar ABP 501 in Crohn’s disease: an observational study. 6693/2019


Download to a citation manager

Download the citation for this article by clicking on one of the following citation managers:

Metrics
This article has received 959 visits.
This article has been downloaded 762 times.

Statistics from Dimensions


Statistics from Plum Analytics

Publication history

Received: 18/10/2019

Accepted: 19/11/2019

Online First: 14/02/2020

Published: 05/03/2020

Article revision time: 24 days

Article Online First time: 119 days

Article editing time: 139 days


Share
This article has been rated by 5 readers.
Reader rating:
Valora este artículo:




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
Cookie policy Privacy Policy Legal Notice © Copyright 2023 y Creative Commons. The Spanish Journal of Gastroenterology