FRI0115 Indirect standardised assessment of injection site pain following subcutaneous administration of citrate-free formulation of adalimumab and its biosimilar abp 501

Background In randomised double-blind studies in patients with rheumatoid arthritis (RA) and psoriasis (PsO), ABP 501, an approved adalimumab biosimilar, had significantly lower injection site pain (ISP) perception compared with the citrate-containing formulation (CCF) of adalimumab reference product (RP) (40 mg/0.8 mL); however, there have been no direct or indirect comparisons of ISP perception between ABP 501 and the CFF of the RP (40 mg/0.4 mL). Objectives To demonstrate that pain perception after injection of both the ABP 501 formulation and the CFF-RP formulation was lower than after CCF-RP. Methods We analysed ISP perception data after injection from two ABP 501 phase 3 studies, one in patients with RA (NCT01970475) and another in patients with PsO (NCT01970488) and 2 citrate-free RP formulation studies (NCT01561313, NCT01502423) where the “control” group received the CCF-RP. In all studies, patients were equally randomised between the 2 treatment arms. Patients were asked to rate the ISP perception on a visual analogue scale (VAS) on which the current pain level was marked from 0 cm (no pain) to 10 cm (worst possible pain). We calculated Cohen’s d-statistic for difference in ISP perception with ABP 501 compared with CCF-RP for the 2 ABP 501 studies. Similar comparisons were performed between the ISP perception associated with CFF-RF and CCF-RF. These measures were subsequently compared in a descriptive manner. Results Both ABP 501 and CFF-RF were associated with lower ISP perception after injection with maximum reduction observed immediately post-injection. The 95% confidence intervals of relative reduction in ISP perception for ABP 501 formulation and the CFF-RP (table 1) were provided descriptively. Conclusions Compared with CCF-RP, both ABP 501 and CFF-RP were associated with lower injection site pain perception. Reference [1] Nash P, et al. Rheumatol Ther2016;3(2):257–270. Disclosure of Interest E. Krishnan Shareholder of: Amgen Inc., Employee of: Amgen Inc., N. Zhang Shareholder of: Amgen Inc., Employee of: Amgen Inc., H. Wang Shareholder of: Amgen Inc., Employee of: Amgen Inc., R. Kaushik Shareholder of: Amgen Inc., Employee of: Amgen Inc.