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/Study objectives: FKB327 is a biosimilar of the adalimumab referenceproduct. Studies in healthy subjects and patients with rheumatoid arthritis demonstratedbiosimilarity between FKB327 and the reference product in safety profile, efficacy andimmunogenicity. FKB327 formulation excipients differ from the citrate-containingformulation of the reference product, and injection-site pain differences have beenreported. The current analysis examines pooled data to assess the amount ofinjection-site pain resulting from injecting FKB327 using a prefilled syringe,autoinjector, or vial/syringe versus the reference product. Methods: Data from fourstudies were pooled to compare injection-site pain upon subcutaneous administration ofFKB327 versus the reference product. Pooled data were analysed to compare FKB327 withthe reference product and to compare the autoinjector, pre-filled syringe andvial/syringe. Results: Data were analysed from 2007 assessments in 1,001 subjects. Alinear mixed model of the injection-site pain visual analogue scale score across allstudies showed a 12.6-point lower pain score for FKB327 versus the reference product(95% confidence interval, –14.3 to –10.8; p &gt; 0.001). The autoinjector pain score was4.4 points lower than the vial/syringe (95% confidence interval, –5.9 to –2.8; p &gt;0.001) and 1.7 points lower than the pre-filled syringe (95% confidence interval, –3.3to –0.1; p = 0.035). No statistically significant differences were identified forgender, age, body weight, needle gauge, or injection site. Conclusion: FKB327 showedless injection-site pain compared with the reference product. No statisticallysignificant differences were seen in injection-site reactions or related adverse eventsbetween FKB327 and the reference product or among FKB327 injection methods.

gabi journal

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