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Investigators sought to analyze adherence, safety, and the clinical outcome in patients treated with the etanercept biosimilar, SB4.
The etanercept biosimilar, SB4 (Benepali), was shown to be effective and well tolerated in adult patients with juvenile idiopathic arthritis (JIA), according to a study published in Arthritis Research and Therapy.1 At the end of the study period, therapy survival was considered comparable to the bio-originator.
“The introduction of biosimilar disease-modifying antirheumatic drugs (bsDMARDs) has the potential to improve patient access to biologic therapy and to improve overall patient outcomes while they can lower the costs in health care,” Kristina Vollbach, MD, associated with the Department of Pediatrics at RWTH Aachen University Hospital in Germany, and colleagues, stated. “Data on the safety and effectiveness of bsDMARDs in JIA are still very sparse; there are still theoretical concerns about biosimilars regarding reduced efficacy, altered immunogenicity, and a different safety profile compared to the bio-originator.”
Investigators sought to analyze adherence, safety, and the clinical outcome in patients treated with the biosimilar. The Juvenile arthritis MTX/Biologics long-term Observation (JuMBO) registry, a long-term cohort study, was utilized to collect data for the analysis. The registry continues to collect information on adult patients with JIA treated with DMARDs who were previously included in the Biologics in Pediatric Rheumatology (BiKeR) registry, both of which provide valuable information on the trajectories of outcomes and clinical data spanning from childhood into adulthood in this patient population.
Efficacy was assessed with the Physician Global Assessment (PhGA), clinical 10-joint Juvenile Arthritis Disease Activity Score (cJADAS10), number of joints with active arthritis, pain, Health Assessment Questionnaire (HAQ), and the patients’ overall wellbeing.
A total of 83 patients were identified to have ever received SB4, of which 74% (n = 77) switched from the etanercept bio-originator due to cost. Only 7.2% (n = 6) of patients received the biosimilar as their first-line biologic DMARD and 37.4% (n = 31) reported being treated with 1 bDMARD before switching to the biosimilar.
The therapy survival of patients treated with SB4 was similar to that of the originator, with 65.1% (n = 54) still being treated with the drug at the end of the study period. Reasons for discontinuation included ineffectiveness, adverse event, and inactive disease.
Efficacy considerations showed improvement over a 24-month period. PhGA, wellbeing, pain, cJADAS10, and HAQ had declined, although not significantly. This may be in part because the initial reason for the switch in most patients was cost-effectiveness.
Although 25.3% (n = 21) of patients reported adverse events (AEs) and 9.6% experiences severe adverse events (SAEs), investigators did not rate any SAE causative related to SB4. The majority of SAEs were either surgical/medical procedures and only 1 infection was reported. Ultimately, 9.6% (n = 8) of patients chose to permanently discontinue SB4 because of AEs.
“Registers such as BiKeR and JuMBO provide valuable data on the safety and efficacy of therapy with DMARD in patients with JIA,” Vollbach concluded. “To avoid long-term consequences of JIA, therapy with a bDMARD is often necessary. Knowledge of the effectiveness and safety of biologics and biosimilars such as SB4 (Benepali) is required in order to optimize therapy and patient outcomes and to reduce costs in the health care system in the long term.”