Similar Persistence Rates Between Adalimumab New Starts, Switched Patients

A French real-world study (PERFUSE) found adalimumab biosimilar SB5 was effective in both adalimumab-naive and switched patients with rheumatic or gastrointestinal immune-mediated inflammatory diseases. No loss of disease control was observed in switched patients, and there were no significant differences in persistence rate between naïve and switched patients. The main reasons for treatment discontinuation were primary treatment failure in naive patients and patient decision in switched patients.

Treatment of immune-mediated inflammatory diseases has “evolved thanks to the development of biologics such as adalimumab,” the authors said. Adalimumab is a monoclonal antibody that treats immune-mediated inflammatory diseases by targeting the proinflammatory cytokine tumor necrosis factor (TNF)-α. Biosimilars have been developed to reduce costs and expand access to biologic therapy. The adalimumab biosimilar SB5 was approved by the European Medicines Agency (EMA) in 2017.

According to the authors, because real-world studies are conducted under less controlled settings compared to intervention studies and capture a broader range of patients, they can provide beneficial insights complementary to randomized controlled trials. However, they noted, there is “little published evidence” on real-world use of SB5 thus far.

The study estimated 12-month persistence on SB5 in adalimumab-naive patients and those switched from the reference product or another biosimilar. A total of 911 patients who initiated treatment between October 2018 and October 2020 were included: 116 with rheumatoid arthritis (RA), 78 with psoriatic arthritis (PsA), 313 with ankylosing spondylitis (AS), 316 with Crohn disease (CD), and 88 with ulcerative colitis (UC). Disease activity scores, C-reactive protein levels, and dosing information were collected from patient records of routine physician visits.

Among adalimumab-naive patients, rates of remission or low disease activity at 12 months were 58% for RA, 66% for PsA, 59% for AS, 94% for CD, and 85% for UC, all of which were significant increases from baseline. Specifically, there were improvements in Disease Activity Score 28-joint count using erythrocyte sedimentation rate and C-reactive protein (DAS28-CRP) in patients with RA, Bath Ankylosing Spondylitis Disease Activity index in patients with AS, Harvey-Bradshaw index in patients with CD, and DAS28-CRP in patients with PsA.

Remission rates in switched patients “remained stable” from baseline to 12 months. However, the authors noted a lack of data that precluded statistical analysis in some indications.

In adalimumab-naive patients, mean baseline C-reactive protein (CRP) levels were above the upper limit of normal in all indications at baseline, and had decreased to the normal range at 12 months in all indications. In switched patients, mean CRP was in the normal range at baseline and remained stable in all indications.

Drug persistence rates among naive and switched patients at 12 months were 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. The authors added that very few patients had switched to SB5 from another biosimilar. As such, persistence rates of patients who switched from the reference product were “almost identical” to those of the switched population as a whole.

Although persistence rates were comparable between adalimumab-naive and switched populations, the reasons for discontinuation were different between groups. The main reasons for discontinuation among adalimumab-naive patients were primary and secondary failure, but among switched patients the primary reasons were patient decision and adverse events. The authors proposed that discontinuations among switched patients following adverse events or patient decisions could be due to the nocebo effect or due to the citrate buffer included in the SB5 formulation at the time of the study, as citrate has been associated with injection site pain.

Treatment-emergent adverse events (TEAEs) were reported for 26% of naive patients and 36% of switched patients. The most frequent adverse events leading to discontinuation of SB5 were general and administration site disorders related to the injection itself or skin disorders. Serious AEs were reported for 14% and 4% of naive and switched patients. Two adalimumab-naive patients, both in the AS cohort, discontinued SB5 treatment due to severe AEs (SAEs). None of the SAEs in switched patients led to treatment discontinuation. Data from 95 immunogenicity tests were available. At baseline all of the 28 tests were negative, and 64 of the 67 tests performed post-baseline were negative.

The authors concluded that SB5 “provides clinically effective treatment of both gastrointestinal and rheumatic IMIDs for naïve and switched patients, with no loss of control observed when switching.”They added that their study design, which used the French national healthcare claims database (SNDS) to address gaps in persistence data, could help in developing “hybrid multicentric cohorts integrating SNDS data to provide even more, much anticipated, real-world data.”

Reference

Fautrel B, Bouhnik Y, Salliot C, et al. PERFUSE investigators. Real-world evidence of clinical outcomes of the use of the adalimumab biosimilar SB5 in rheumatic and gastrointestinal immune-mediated inflammatory diseases: 12-month data from the PERFUSE study. Drugs Real World Outcomes. 2024;11(4):573-591. doi:10.1007/s40801-024-00459-6