Biosimilar etanercept: a real world safety and patient related outcomes from a single centre
Keywords:Biosimilar safety, Intended biosimilar Intacept
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.
Culy CR, Keating GM. Etanercept: an updated review of its use in rheumatoid arthritis, psoriatic arthritis and juvenile rheumatoid arthritis. Drugs. 2002;62(17):2493-537.
Eker DM, Jones SD, Levine HL. The therapeutic monoclonal antibody market. MAbs. 2015;7(1):9-14.
Kaida-Yip F, Deshpande K, Saran T et al Biosimilars: Review of current applications, obstacles, and their future in medicine. World J Clin Cases. 2018;6(8):161-6.
Monti S, Todoerti M, Codullo V, Favalli EG, Biggioggero M, Becciolini A, et al. Prevalence of Ankylosing Spondylitis Disease Activity Score (ASDAS) inactive disease in a cohort of patients treated with TNF-alpha inhibitors. Modern Rheumatol. 2018;28(3):542-9.
Sengul I, Akcay‐Yalbuzdag S, Ince B, Goksel‐Karatepe A, Kaya T. Comparison of the DAS 28‐CRP and DAS 28‐ESR in patients with rheumatoid arthritis. Int J Rheumatic Dis. 2015 Jul;18(6):640-5.
Kvien TK, Uhlig T, ØdegÅrd S, Heiberg MS. Epidemiological aspects of rheumatoid arthritis. Annals of the New York academy of Sciences. 2006;1069(1):212-22.
Dean LE, Jones GT, MacDonald AG, Downham C, Sturrock RD, Macfarlane GJ. Global prevalence of ankylosing spondylitis. Rheumatol. 2014;53(4):650-7.
Yoo DH. The rise of biosimilars: potential benefits and drawbacks in rheumatoid arthritis. Expert Rev Clin Immunol. 2014;10:981-3.
Hlavatý T, Krajcovicova A, Šturdík I, Letkovský J, Koller T, Tóth J, et al. Biosimilar infliximab CT-P13 treatment in patients with inflammatory bowel diseases: a one-year, single-center retrospective study. Gastroenterologie a hepatologie. 2016;70(1):27-36.
Schmitz EM, Boekema PJ, Straathof JW, van Renswouw DC, Brunsveld L, Scharnhorst V, et al. Switching from infliximab innovator to biosimilar in patients with inflammatory bowel disease: a 12‐month multicentre observational prospective cohort study. Alimentary Pharmacol Therapeut. 2018;47(3):356-63.
Ebbers HC, Muenzberg M, Schellekens H. The safety of switching between therapeutic proteins. Expert Opinion Biol Therapy. 2012 Nov 1;12(11):1473-85.
Kumar A, Goel A, Lapsiwala M, Goyal M, Dembla G. Clinical experience with two etanercept biosimilars in Indian patients with spondyloarthritis. Indian J Rheumatol. 2017;12(3):139-45.
ENBREL® (etanercept). Prescribing Information. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/etanimm060503LB.pdf. accessed on 29 Dec 2016