122 The outcomes of an adalimumab biosimilar switch in paediatric rheumatological patients. (15th December 2021)

• Record Type: Journal Article
• Authors: Rajani, Kalindi; LaCoss, Elaine; Cheng, Fan
• Is Part Of: Archives of disease in childhood. Volume 106(2021)Supplement 3
• Page Start: A45
• Page End: A45
• Publication Date: 2021-12-15
• Subjects: Children -- Diseases -- Periodicals; Infants -- Diseases -- Periodicals; 618.920005
• DOI: 10.1136/archdischild-2021-gosh.122
• Languages: English
• ISSNs: 0003-9888

Abstract

Abstract : The availability of the adalimumab biosimilar has granted the NHS an opportunity to advocate the use of best value biological medicines. However, evidence of using biosimilars in children for rheumatological conditions is scarce. In 2019, existing patients on the originator (Humira) at a tertiary paediatric hospital were switched to the biosimilar (Amgevita) where clinically appropriate. This review investigated the tolerability of paediatric rheumatology patients who underwent the biosimilar switch. Methods: Electronic patient records of patients who underwent the biosimilar switch for rheumatological conditions were reviewed retrospectively. Data was collected between November 2019 and July 2021. Indication for therapy, demographics, duration of therapy and reported intolerable adverse events were collated. Result: 164 patients (3–15 years old) were recruited. 134 patients (82%) tolerated the biosimilar without any intolerable adverse events. 30 patients (18%) reported intolerable adverse events requiring intervention, of which 19 patients reverted to the originator and 11 patients switched to alternative therapy. Diagnoses included juvenile idiopathic arthritis (n=23), uveitis (n=4), Blau syndrome (n=1) juvenile dermatomyositis (n=1) and Takayasu arteritis (n=1). Average treatment duration on a biosimilar prior to intervention was 7.5 months (2–20 months). Reasons for reverting to the originator were disease flare/loss of disease control (n=16), injection site reaction (n=9), psoriatic type rash (n=2), mouth ulcers (n=1) and unknown (n=2). Of those reverted to the originator, 4 patients were subsequently switched to alternative therapies (tocilizumab n=3 and etanercept n=1). Reported reasons included disease flare (n= 2), mouth ulcers (n=1) and psoriatic rash (n=1). Conclusion: Amgevita is well-tolerated by children with rheumatological conditions. The rate of adverse effects is equivocal to reports in adults: a study conducted in a UK adult rheumatology centre found 19.4% required intervention after biosimilar switch. Further studies are needed in a larger cohort to identify long term tolerability of biosimilars in paediatric rheumatological patients.