Outcome of adult patients with JIA treated with the biosimilar Benepali®: results of the biologic register JuMBO.

BACKGROUND: To analyze therapy adherence, safety, and outcome in adult patients with juvenile idiopathic arthritis (JIA) treated with the etanercept biosimilar Benepali® (Biogen Inc, Cambridge, USA). METHODS: Data from the prospective registry, JuMBO (Juvenile arthritis MTX/Biologics long-term Observation), were used for the analysis. JuMBO is a long-term observational cohort study. It follows adult patients with JIA who were formerly included in the national JIA biologic register (BiKeR Registry). Both registries provide individual trajectories of clinical data and outcomes from childhood to adulthood in JIA patients treated with disease-modifying anti-rheumatic drugs (DMARDs). RESULTS: Eighty-three patients from the German JuMBO registry were treated with Benepali®. Of these, 74% had switched from Enbrel® (Pfizer Inc., NYC, USA) the originator of etanercept to Benepali® for cost reasons. Therapy survival of patients treated with Benepali® in comparison to Enbrel® in patients matched by significant parameters was comparable. Adverse events (AE) were reported in 25.3% and serious adverse events (SAE) in 9.6% of patients. Physicians rated no SAE causative related to Benepali®. The majority of SAEs were surgical/medical procedures and there was only one infection. All efficacy parameters (cJADAS-10, Physician Global Assessment, number of joints with active arthritis, patients' overall well-being, pain, and HAQ) demonstrated improvement over 24 months (p-values were not significant). 9.6% of patients permanently discontinued Benepali® because of an AE. CONCLUSIONS: Tolerability and effectiveness of the biosimilar Benepali® were satisfactory and therapy survival was comparable to the originator. Further data on therapy with biologics and biosimilars such as Benepali® must be collected by registries such as BiKeR and JuMBO in order to optimize therapy and patient outcomes and to reduce costs in the health system in the long term.

Preference, satisfaction and usability of subcutaneously administered methotrexate for rheumatoid arthritis or psoriatic arthritis: results of a postmarketing surveillance study with a high-concentration formulation.

BACKGROUND/OBJECTIVES: This postmarketing surveillance study assessed the preference, satisfaction, usability, and tolerability of subcutaneous self-administration of a high-concentration (50 mg/ml) ready-to-use formulation of methotrexate (MTX) in patients with rheumatoid arthritis or psoriatic arthritis. METHODS: The study enrolled 403 patients with rheumatoid or psoriatic arthritis. The first injection was administered by the attending physician or nurse, followed by five self-administered injections at weekly intervals. The high-concentration formulation consisted of a prefilled syringe with MTX 50 mg/ml solution and a pre-attached needle. Questionnaires were used to document outcomes. RESULTS: The overall assessment was 'very good' and 'good' in 87.6% of the patients and in 92.8% of the physicians/study nurses. Availability and use of a pre-attached needle was considered as very advantageous and advantageous by 91.8% of the patients and 88.8% of the physicians/study nurses. A total of 96% of the patients described the feeling of the injection as comfortable or tolerable. Patients reported that self-administration led to a feeling of more independence (89.1%) and an improved quality of life (83.6%). A total of 109 patients reported previous self-administration of low-concentration MTX formulations; 94.5% of them stated that they would prefer the high-concentration MTX formulation in the future. The formulation was generally well tolerated. Physicians' expectations concerning the benefit of switching to MTX self-administration was met in 92.8% of the patients. A total of 96.3% of the patients were considered suitable for subcutaneous self-administration of the MTX formulation. CONCLUSIONS: The 50 mg/ml prefilled syringe appears to be a valuable treatment option for patients with rheumatoid and psoriatic arthritis in need of MTX. This is supported by the strong appreciation of the patients as well as their attending healthcare professionals for its convenience and tolerability. The results confirm the findings and experience from a clinical study performed in Germany in 2009, which showed that 93% of the patients prefer the 50 mg/ml prefilled syringe with a pre-attached needle.