DOI: http://dx.doi.org/10.18203/2319-2003.ijbcp20191571

Biosimilar etanercept: a real world safety and patient related outcomes from a single centre

Prasan Deep Rath, Swetal Chandraprakash Pandey

Abstract


Background: Biosimilars are expected to provide affordable and quality treatment equivalent to the biologics in various rheumatic disorders. Presently, the data available on the safety and effectiveness of biosimilars is very scarce. The objective of the present study was to assess the safety profile of intended biosimilar of etanercept developed by Intas pharmaceuticals Ltd. (Intacept) in Rheumatoid arthritis (RA), spondyloarthropathy (SpA), ankylosing Spondylitis (AS), juvenile idiopathic arthritis (JIA) and psoriatic arthritis (PsA).

Methods: In single center, retrospective observational study, all patients were enrolled in routine clinical practice     who received Intended biosimilar of Etanercept (Intacept) and the following data was collected. Basic demographic profile, disease and duration of therapy, any adverse event, patient’s global assessment of disease activity on visual analogue scale (0 to 100), patient’s overall experience with Intended biosimilar etanercept (Intacept).

Results: Total 70 patients were enrolled (41males and 29 females) having RA (42), AS (11), SpA (13), JIA (2) AND PsA (2). The mean duration of follow up was 8±1.7 months. 10% patients reported adverse events like injection site pain (4.29%), fever (2.86%), redness (1.42%) and weight gain (1.42%). 45% patients had LTBI screen positive and were initiated on chemoprophylaxis with Rifampicin and INH 4weeks prior to Intacept. About 24% of patients dropped due to various reasons like affordability issue (5.7%), inadequate response (8.6%), no response (10%) and side effects (5.7%). 51.4% patients observed more than 50% improvement in global disease activity with Intacept while 10% patients did not get any response with the treatment. 77.2% patients perceived the overall therapy with Intacept as excellent, very good, good or OK while 22.8% patients rated Intacept therapy as non-satisfactory.

Conclusions: The study leads to the conclusion that Intended biosimilar of etanercept (Intacept) was safe and well tolerated in various rheumatic disorders in a real-world scenario.


Keywords


Biosimilar safety, Intended biosimilar Intacept

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