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. 2025 Jun;12(3):469-492.
doi: 10.1007/s40744-025-00755-9. Epub 2025 Mar 11.

Real-World Experience with an Adalimumab Biosimilar (ABP 501) in Patients with Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis and Psoriasis in Europe: Results from the Adelphi Disease Specific Programme

Ran Jin  1   2 , James M Haughton  3 , Emily J Goddard  4 , Delphine Courmier  5 , Waldemar Radziszewski  5 , Rachael H Meadows  3 , James Piercy  3 , Stanley Cohen  6
Affiliations

Real-World Experience with an Adalimumab Biosimilar (ABP 501) in Patients with Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis and Psoriasis in Europe: Results from the Adelphi Disease Specific Programme

Ran Jin et al. Rheumatol Ther. 2025 Jun.

Abstract

Introduction: Biosimilars have provided additional treatment options for patients with immune-mediated inflammatory diseases. This study evaluated the real-world use of adalimumab biosimilar ABP 501 in European patients with rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis (PsA), or psoriasis (PsO).

Methods: Data were drawn from the RA, spondyloarthritis, and PsO Adelphi Disease Specific Programmes (DSP)™, cross-sectional surveys conducted in France, Germany, Italy, Spain, and the UK between January 2020 and February 2022. Physicians completed patient record forms which collected data on demographics, treatment history, and clinical outcomes. Patients voluntarily completed questionnaires self-reporting health-related quality of life. Outcome measures were assessed for patients who initiated ABP 501 as the first advanced therapy (AT, "ABP 501 initiators") and patients who switched to ABP 501 from the first-line AT with reference product (RP) ("RP-ABP 501 switchers") in each indication.

Results: Across disease cohorts, 868 initiators and 428 switchers were analyzed. At time of consultation, physicians reported that 77.1%, 63.2%, 67.8%, and 83.0% of initiators with RA, AS, PsA, and PsO, respectively, presented with mild disease after receiving ABP 501 for a median of 10.4-12.3 months. Among switchers, the most common reasons for switching were related to formulary or financial reasons and insurance restrictions. Most switching patients were assessed by physicians to have mild disease (75.0-87.5% across indications) at time of consultation having received ABP 501 for a median of 11.2-15.3 months. Patients' self-assessment, including EQ-5D and work productivity scores, indicated an overall good state of health while using ABP 501, regardless of indication and prior RP exposure. Overall, more than 89% of physicians and more than 86% patients reported being satisfied with the disease control provided by ABP 501.

Conclusion: Across indications, both physicians and patients reported positive clinical outcomes and high levels of satisfaction with ABP 501 treatment, regardless of prior use of RP.

Keywords: Adalimumab; Ankylosing spondylitis; Biosimilar; Patient-reported outcomes; Physician survey; Psoriasis; Psoriatic arthritis; Real-world; Rheumatoid arthritis; Treatment satisfaction.

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Conflict of interest statement

Declarations. Conflict of Interest: Emily J Goddard, James M Haughton, James Piercy and Rachael H Meadows are employees of Adelphi Real World. Ran Jin and Waldemar Radziszewski are employees of Amgen Inc., Thousand Oaks, CA, USA, and may own stock and/or hold stock options in Amgen Inc. Delphine Courmier was an employee of Amgen Inc., Thousand Oaks, CA, USA at the time of this study. At the time of publication, Delphine Courmier was an employee of Organon, Jersey City, NJ, USA. Stanley Cohen is an investigator and consultant for Amgen. Ethical Approval: The data collection methodology and survey questionnaires were reviewed and approved by the Western Institutional Review Board (protocol numbers #1-1253914-1 [RA 2020 wave], #20210318 [SpA]) or Pearl Institutional Review Board (protocol numbers #21-ADRW-104 [RA 2021/2022 wave], #21-ADRW-124 [PsO]). Data collection was undertaken in line with European Pharmaceutical Marketing Research Association guidelines [28]; and the survey was performed in full accordance with relevant legislation at the time of data collection, including the US Health Insurance Portability and Accountability Act 1996 [29] and Health Information Technology for Economic and Clinical Health Act legislation [30], and in accordance with the principles stated in the Declaration of Helsinki. Using a checkbox, patients provided informed consent take part in the survey, and for the use of their anonymized and aggregated data for research purposes.

Figures

Fig. 1
Fig. 1
Top three physician-reported reasons for switching from adalimumab reference product to ABP 501. a Rheumatoid arthritis (RA) switchers, n = 63. b Ankylosing spondylitis (AS) switchers, n = 79. c Psoriatic arthritis (PsA) switchers, n = 172. d Psoriasis (PsO) switchers, n = 110. Multiple choice answer, options varied between indications
See this image and copyright information in PMC

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