Real-world studies evaluating the safety and efficacy of switching to adalimumab biosimilars from the originator product confirmed the safety and efficacy of the biosimilars ABP 501 and SB5.
Two real-world European Union studies confirmed the efficacy of adalimumab biosimilars after switching from the originator product. The findings were presented as part of the EULAR 2022 Congress.
The first abstract reported on the real-world PROPER study,1 which was designed to evaluate the outcomes of switching from reference adalimumab to SB5, a biosimilar from Samsung Bioepis. SB5 is available in the European Union as Imraldi; the FDA approved SB5 July 2019, and it will launch as Hadlima in the United States on or after July 1, 2023.
The study enrolled 1000 patients with immune-mediated inflammatory disease at centers in Belgium, Germany, Ireland, Italy, Spain, and the United Kingdom. Patients with rheumatoid arthritis (RA), axial spondyloarthritis (AxSpA), or psoriatic arthritis (PsA) were switched to SB5 after a minimum of 16 weeks on the reference product and were then followed for 48 weeks after switching to the biosimilar.
The researchers collected data from patient charts for 24 weeks prior to starting SB5 and up to 48 weeks after initiating SB5. The analysis only included 496 patients. Of these, 487 patients completed 48 weeks of follow-up and 397 patients stayed on the biosimilar throughout the study.
Only 20% of patients had received a biologic prior to originator adalimumab. Overall, 15 patients each experienced 1 unrelated serious adverse event (SAE) and 2 patients reported SAEs casually related to SB5.
Ultimately, the analysis found treatment effectiveness was maintained at 48 weeks after switching from originator adalimumab to SB5 among patients with established RA, axSpA, or PsA.
“Episodes of flare were uncommon, and the importance of patient-reported symptoms in recognition of flare is evident. No new safety signals were observed,” the authors concluded.
The second abstract evaluated disease activity after multiple switching from originator adalimumab to its biosimilars.2 Patients with RA, PsA, or ankylosing spondylitis (AS) switched first to ABP 501 and then SB5. ABP 501 is marketed by Amgen as Amgevita in the European Union. In the United States, ABP 501 was the first adalimumab biosimilar approved in September 2016, and it will come to market as Amjevita in January 2023.
During follow-ups visits, the researchers recorded Disease Activity Score-28, Disease Activity in Psoriatic Arthritis score, Bath Ankylosing Spondylitis Disease Activity Index score, and the Health Assessment Questionnaire (HAQ). They evaluated disease activity for the year before switching to the first biosimilar as well as the 36 months during the first and second biosimilars.
A total of 127 patients were evaluated over 3 years. Each biosimilar switch lasted 1 year. Patients with AS had the highest 1-year retention rates with 84.4% for ABP 501 and 82.1% for SB5, followed by patients with RA (78.0% for ABP 501 and 78.7% for SB5) and patients with PsA (76.0% for ABP 501 and 77.5% for SB5).
Disease activity was stable over the 3 years, while comorbid disease and HAQ at baseline were both associated with an increased risk of discontinuation for originator adalimumab. However, the duration of originator adalimumab was positively associated with retention for the biosimilars. Among the patients who discontinued, 76.5% did so due to inefficacy, 27.4% due to the interruption of the biosimilar, and 23.5% due to adverse events.
The researchers found no difference in efficacy between the originator and biosimilars.
“This real-life study confirms the similar efficacy profile of multiple switch [biosimilar adalimumab] with long-term retention and a good safety profile in inflammatory arthritis patients,” they wrote.
1. Müller-Ladner U, Gaffney K, Jadon D, et al. The PROPER study: a 48-week analysis of a pan-EU real-world study of SB5 biosimilar following transition from reference adalimumab in patients with rheumatoid arthritis, axial spondyloarthritis or psoriatic arthritis. Presented at: EULAR 2022 Congress; June 1-4, 2022; Copenhagen, Denmark. Abstract AB0348.
2. Parisi S, Becciolini A, Ditto MC, et al. Efficacy and drug survival after multiple switching from adalimumab originator to the biosimilars ABP501 and SB5: a real-life study. Presented at: EULAR 2022 Congress; June 1-4, 2022; Copenhagen, Denmark. Abstract AB0341.