Adalimumab and ABP 501 in the Treatment of a Large Cohort of Patients with Inflammatory Arthritis: A Real Life Retrospective Analysis

Abstract

The recent introduction of ABP 501, an adalimumab biosimilar, in the treatment of rheumatic diseases was supported by a comprehensive comparability exercise with its originator. On the other hand, observational studies comparing adalimumab and ABP 501 in inflammatory arthritis are still lacking. The main aim of this study is to compare the clinical outcomes of the treatment with adalimumab, both the originator and ABP 501, in a large cohort of patients affected by autoimmune arthritis in a real life setting. We retrospectively analysed the baseline characteristics and the retention rate in a cohort of patients who received at least a course of adalimumab (originator or ABP 501) from January 2003 to December 2020. We stratified the study population according to adalimumab use: naive to original (oADA), naive to ABP 501 (bADA) and switched from original to ABP 501 (sADA). The oADA, bADA and sADA groups included, respectively, 724, 129 and 193 patients. In each group, the majority of patients had a diagnosis of rheumatoid arthritis. The total observation period was 9805.6 patient-months. The 18-month retentions rate in oADA, bADA and sADA was, respectively, 81.5%, 84.0% and 88.0% (p > 0.05). The factors influencing the adalimumab retention rate were an axial spondylarthritis diagnosis (Hazard Ratio (HR) 0.70; p = 0.04), switch from oADA to ABP 501 (HR 0.53; p = 0.02) and year of prescription (HR 1.04; p = 0.04). In this retrospective study, patients naive to the adalimumab originator and its biosimilar ABP 501 showed the same retention rate. Patients switching from the originator to biosimilar had a higher retention rate, even though not statistically significant, when compared to naive.

Differential retention of adalimumab and etanercept biosimilars compared to originator treatments: Results of a retrospective French multicenter study

“…This is concordant with a recent Swedish study focused on the initiation of either biosimilar of ADA and ETN, which demonstrated a hazard ratio of treatment retention at 1 year in favor of SB4 biosimilar of ETN, while no differences had been found between HUMIRA and its biosimilars ( 16 ). For ADA, another study did not find significant differences between bsDMARD and boDMARD at initiation ( 41 ). The difference between molecules in our study is not a consequence of differential retention of each molecule since no difference was observed comparing ADA and ETN.…”

Switching between Originators and Biosimilars in Dermatology: A Systematic Review of Real-World Clinical Studies

“…No significant differences in ADA and infliximab level before and after the switch were detected Overall, the majority of studies evaluating the switch among adalimumab products indicated a similarity in their efficacy and safety profiles. For instance, in the observational retrospective study BIRRA (BIologics Retention Rate Assessment) [13], which enrolled 1046 patients treated with adalimumab (193 patients switched from the originator to the biosimilar), authors found that switchers were more persistent than patients receiving the originator and naïve patients receiving the biosimilar. Similarly, Bruni C et al [14] reported no difference in the control of disease activity, everyday life disability, and safety after switching from the adalimumab originator to SB5 in patients with PsA.…”

“…Fourteen studies [13][14][15][16][17][18][19][20][21][22][23][24][25]49] evaluated the effects in terms of the efficacy and safety derived from the switch among adalimumab products. All studies were carried out in Europe (10/14 in Italy).…”