Real-World Experience of Adalimumab Biosimilar (ABP 501) Use in Patients with Inflammatory Bowel Disease in Europe

• Published in: Advances in therapy 2024, Vol.41 (1), p.331-348
• Main Authors: Jin, Ran, Nduka, Chidozie, Courmier, Delphine, Knight, Hannah, Meadows, Rachael, Piercy, James, Cummings, J. R. F., Radziszewski, Waldemar
• Format: Article
• Language: English
• Subjects: Adalimumab - adverse effects; Biosimilar Pharmaceuticals - therapeutic use; Cardiology; Endocrinology; Europe; Humans; Inflammatory Bowel Diseases - drug therapy; Internal Medicine; Medicine; Medicine & Public Health; Oncology; Original Research; Pharmacology/Toxicology; Quality of Life; Rheumatology; Treatment Outcome
• ISSN: 0741-238X; 1865-8652; 1865-8652
• DOI: 10.1007/s12325-023-02712-w

Introduction Approval of adalimumab biosimilar ABP 501 (Amgevita ® ) for inflammatory bowel disease (IBD) was based upon the principle of extrapolation. Real-world experience of ABP 501 utilization in IBD can provide useful information to healthcare providers and patients. Methods Data were drawn from the 2020–2021 Adelphi IBD Disease Specific Programme™ conducted in five major European countries. Participating gastroenterologists completed a point-in-time survey to provide patient medical record data, and patients voluntarily completed questionnaires to report health-related quality of life (HRQoL). Descriptive analyses were conducted for “ABP 501 initiators” (received ABP 501 as first advanced therapy) and “RP-ABP 501 switchers” (switched to ABP 501 from reference product [RP; Humira ® ] as first advanced therapy). Results This analysis included 239 ABP 501 initiators and 136 RP-ABP 501 switchers. At consultation, initiators had been on ABP 501 treatment for a median of 7.5 months and switchers had received ABP 501 for a median of 7.7 months following the switch from a median of 14.0 months treatment with RP. About 74% of initiators and 89% of switchers were reported by their treating physicians as being in clinical remission. Physicians and patients reported satisfaction with ABP 501 in the range of 92–99% across both groups. Patient self-assessment, including EuroQol visual analogue scale, Short IBD Questionnaire, and Work Productivity and Activity Impairment scores, suggested minimal impairment of HRQoL while on ABP 501. The most common reason for RP to ABP 501 switch was lower healthcare costs. Conclusion Both patients with IBD and treating physicians reported high levels of satisfaction with ABP 501 among initiators and switchers. Plain Language Summary ABP 501 (Amgevita ® ) is the first approved biosimilar to adalimumab originator (Humira ® ), referred to here as the reference product. A biosimilar is a biological product that is highly similar to its reference product in terms of safety, purity, and effectiveness. ABP 501 has been approved for the treatment of certain chronic inflammatory diseases. The approval of ABP 501 for inflammatory disease is based upon the principle of extrapolation, with no clinical trial being conducted in patients with inflammatory bowel disease. Therefore, in this current study, we evaluated the utilization experience of biosimilar ABP 501 in the real-world setting from both physicians’ and patients’ perspectives. We r