Systematic analysis of injection-site pain and reactions caused by subcutaneous administration of the adalimumab biosimilar FKB327 versus the adalimumab reference product via different delivery methods

Abstract

Introduction/Study objectives: FKB327 is a biosimilar of the adalimumab reference product. Studies in healthy subjects and patients with rheumatoid arthritis demonstrated biosimilarity between FKB327 and the reference product in safety profile, efficacy and immunogenicity. FKB327 formulation excipients differ from the citrate-containing formulation of the reference product, and injection-site pain differences have been reported. The current analysis examines pooled data to assess the amount of injection-site pain resulting from injecting FKB327 using a prefilled syringe, autoinjector, or vial/syringe versus the reference product. Methods: Data from four studies were pooled to compare injection-site pain upon subcutaneous administration of FKB327 versus the reference product. Pooled data were analysed to compare FKB327 with the reference product and to compare the autoinjector, pre-filled syringe and vial/syringe. Results: Data were analysed from 2007 assessments in 1,001 subjects. A linear mixed model of the injection-site pain visual analogue scale score across all studies showed a 12.6-point lower pain score for FKB327 versus the reference product (95% confidence interval, –14.3 to –10.8; p > 0.001). The autoinjector pain score was 4.4 points lower than the vial/syringe (95% confidence interval, –5.9 to –2.8; p > 0.001) and 1.7 points lower than the pre-filled syringe (95% confidence interval, –3.3 to –0.1; p = 0.035). No statistically significant differences were identified for gender, age, body weight, needle gauge, or injection site. Conclusion: FKB327 showed less injection-site pain compared with the reference product. No statistically significant differences were seen in injection-site reactions or related adverse events between FKB327 and the reference product or among FKB327 injection methods.