REAL-WORLD UTILIZATION OF ADALIMUMAB BIOSIMILAR (ABP 501) IN PATIENTS WITH INFLAMMATORY BOWEL DISEASE IN EUROPE

Abstract

Abstract OBJECTIVE ABP 501 (AMGEVITA®) was the first approved biosimilar to adalimumab reference product (RP) by the European Medicines Agency and has been marketed in the European Union since 2018. Additional real-world data on its efficacy and safety, particularly for treating patients with inflammatory bowel disease (IBD), an indication approved on the basis of extrapolation, has the possibility of addressing barriers to utilization. METHODS This was a retrospective analysis of data collected between April and June 2021 from the Adelphi IBD Disease Specific Programme (DSP) covering ulcerative colitis (UC) and Crohn’s disease (CD) in Germany, France, Spain, Italy, and United Kingdom. Gastroenterologists provided data on demographics, clinical characteristics, treatment history, and treatment satisfaction. Patients had the option to complete the short IBD questionnaire (SIBDQ) aimed at measuring the burden of disease, work productivity and activity impairment (WPAI) questionnaire, and to indicate their assessment of treatment satisfaction. Descriptive analyses were conducted; continuous variables were reported as means or medians, categorical variables as number of patients and percentages. RESULTS 82 physicians reported data on 396 patients (189 UC and 207 CD): 239 initiated ABP 501 as first advanced therapy (AT) (initiators), 157 switched to ABP 501 from RP with no prior use of other AT (switchers) (Table). Median time from IBD diagnosis to initiation of ABP 501 was 13.9 months for initiators with median time on ABP 501 being 7.5 months at the time of data collection. Switchers previously received RP for a median of 14.1 months and had been on ABP 501 for a median time of 7.7 months since switching. The main reasons for switching from RP to ABP 501 were related to the potential to lower healthcare cost. At the time of reporting, more than two-thirds (67% initiators, 83% switchers) had mild disease, more than three-quarters were in clinical remission (74% initiators, 88% switchers), and a majority were in improving or stable disease status (96% initiators, 98% switchers). Mean SIBDQ scores (56 vs. 59) and overall work impairment (4.7% vs. 3.2%) were similar across initiators and switchers, respectively. Physicians and patients (>90% each of initiators and switchers) reported being satisfied with current treatment with ABP 501. CONCLUSION ABP 501 was used as initial or continuing adalimumab therapy in the real-world setting to treat patients with IBD. At least three-fourths of patients currently on ABP 501 were in clinical remission, with a higher proportion in the switching group. Both physicians and patients reported very high levels of satisfaction with treatment.