A recent real-world study, PERFUSE, has provided evidence supporting the effectiveness of the adalimumab biosimilar SB5 in treating both new and switched patients with rheumatic or gastrointestinal immune-mediated inflammatory diseases (IMIDs). The study, which analyzed data from 911 patients in France, found similar persistence rates between patients who were new to adalimumab and those who switched from the reference product or another biosimilar.
The study included patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), Crohn's disease (CD), and ulcerative colitis (UC) who initiated treatment with SB5 between October 2018 and October 2020. Researchers collected data on disease activity scores, C-reactive protein (CRP) levels, and dosing information from routine physician visits.
Clinical Outcomes
In adalimumab-naive patients, significant improvements were observed across various disease activity scores at 12 months. Remission or low disease activity rates were 58% for RA, 66% for PsA, 59% for AS, 94% for CD, and 85% for UC. Switched patients maintained stable remission rates from baseline to 12 months. Mean baseline CRP levels, which were initially above the normal range in naive patients, decreased to normal levels at 12 months. In switched patients, CRP levels remained stable within the normal range.
Persistence and Discontinuation
Drug persistence rates at 12 months were comparable between naive and switched patients: 59% and 60% for RA, 65% and 57% for PsA, 56% and 55% for AS, 70% and 63% for CD, and 42% and 56% for UC. However, the reasons for treatment discontinuation differed between the groups. In naive patients, primary and secondary treatment failure were the main reasons for stopping SB5, while in switched patients, the primary reasons were patient decision and adverse events.
Safety Profile
Treatment-emergent adverse events (TEAEs) were reported in 26% of naive patients and 36% of switched patients. The most frequent adverse events leading to discontinuation were related to injection site disorders or skin disorders. Serious adverse events (SAEs) were reported in 14% and 4% of naive and switched patients, respectively. Immunogenicity tests showed that the majority of patients remained negative for antibodies against adalimumab throughout the study.
The authors suggest that discontinuations among switched patients due to adverse events or patient decisions could be attributed to the nocebo effect or the presence of citrate buffer in the SB5 formulation, which has been linked to injection site pain. The study concludes that SB5 provides clinically effective treatment for both gastrointestinal and rheumatic IMIDs in both naive and switched patients, with no loss of disease control observed upon switching. The study design, utilizing the French national healthcare claims database (SNDS), could aid in developing hybrid multicentric cohorts to provide more real-world data.
