Real-World Experience of Adalimumab Biosimilar (ABP501) Use in Patients with Inflammatory Bowel Disease in Europe.

Abstract

Approval of adalimumab biosimilar ABP501 (Amgevita®) for inflammatory bowel disease (IBD) was based upon the principle of extrapolation. Real-world experience of ABP501 utilization in IBD can provide useful information to healthcare providers and patients. 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 "ABP501 initiators" (received ABP501 as first advanced therapy) and "RP-ABP501 switchers" (switched to ABP501 from reference product [RP; Humira®] as first advanced therapy). This analysis included 239 ABP501 initiators and 136 RP-ABP501 switchers. At consultation, initiators had been on ABP501 treatment for a median of 7.5months and switchers had received ABP501 for a median of 7.7months following the switch from a median of 14.0months 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 ABP501 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 ABP501. The most common reason for RP to ABP501 switch was lower healthcare costs. Both patients with IBD and treating physicians reported high levels of satisfaction with ABP501 among initiators and switchers.