In a poster presentation at the virtual Crohn’s & Colitis Congress, which took place on 20‒22 January 2022, a study describing real-world utilization of adalimumab biosimilar ABP 501 in patients with inflammatory bowel disease (IBD) in Europe was presented [1].
The aim of the study was to describe the demographics and clinical characteristics, as well as patient-reported outcomes of IBD patients receiving ABP 501. Data were collected via the Adelphi Inflammatory Bowel Disease Specific Programme (IBD-DSP), a point-in-time survey of physicians and their ulcerative colitis (UC) and Crohn’s disease (CD) patients. The data was collected in five countries (France, Germany, Italy, Spain, and the UK) between April and June 2021.
A total of 82 physicians reported data on 396 patients (189 UC and 207 CD), which included 239 initiators and 157 switchers. The main reason for switching to the biosimilar was cost. Before beginning treatment with ABP 501, 84% of initiators and 54% of switchers had deteriorating disease, while most patients (96% initiators and 98% switchers) were either improving or had stable disease status at the time of reporting. In fact, at the time of consultation, 74% of initiators and 88% of switchers were in clinical remission, as reported by the physicians.
The authors concluded that when ABP 501 was used as initial or continuing adalimumab therapy in the real-world setting to treat patients with IBD the majority of patients reached clinical remission. In addition, ‘over 90% of physicians and patients were satisfied with the ABP 501 treatment regimen’.
ABP 501 was approved as Amjevita in the US in September 2016 [2] and as Amgevita in the European Union in March 2017 [3]. However, despite multiple adalimumab biosimilars having been approved in the US and Europe for use in IBD [2, 3] effectiveness and safety data in IBD remains scarce. This study is therefore an important addition to the increasing amount of data showing that switching to adalimumab biosimilars is both safe and effective.
Conflict of interest
The authors of the poster [1] reported conflict of interest, including being an employee of Amgen. For full details of the authors’ conflict of interest, see the poster [1].
Editor’s comment
It should be noted that data of the study presented in this article was published as a poster and presented at a conference. These data and conclusions should be considered as preliminary until published in a peer-reviewed journal.
Readers interested to learn more about real-world data for biosimilars are invited to visit www.gabi-journal.net to view the following manuscript published in GaBI Journal:
Biosimilars in Italy: what do real-world data reveal?
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References
1. Jin R, Nduka C, Courmier D, et al. Real-world utilization of adalimumab biosimilar ABP 501 in patients with inflammatory bowel disease in Europe. Crohn’s and Colitis Congress; 20-22 January 2022; Las Vegas, USA.
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Feb 11]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-approved-in-the-US
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Feb 11]. Available from: www.gabionline.net/biosimilars/general/biosimilars-approved-in-europe
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Source: Crohn’s and Colitis Congress
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