Background PK bioequivalence of BI 695501, an adalimumab biosimilar candidate, and the adalimumab originator was demonstrated previously (VOLTAIRE®-PK: Wynne et al., Expert Opin Investig Drugs 2016;25:1361–70). Administration in chronic inflammatory diseases benefits from patient-friendly PFSs or AIs, the development of which requires assessment of PK, safety, immunogenicity, and local tolerability.
Objectives To compare PK, safety, immunogenicity, and tolerability of BI 695501 after subcutaneous (SC) injection using either a PFS or an AI.
Methods In this 16-week randomised, single-dose, open-label, parallel-group study (NCT02606903), 40mg BI 695501 was administered either via PFS or AI in healthy, Caucasian, male, non-athletic volunteers aged 18–65 years with body mass index (BMI) of ≥18 to ≤30 kg/m2. The study end points included AUC0–1032, Cmax, and AUC0–∞, analysed using an ANOVA model with fixed effects for treatment and BMI group. Safety assessment included the proportion of subjects with drug-related adverse events (AEs). Immunogenicity parameters were: proportion of subjects with binding/neutralising anti-drug antibodies (ADAs), and ADA titers.
Results Seventy-one volunteers were randomised: PFS, n=36; AI, n=35. Key demographic and baseline characteristics were well balanced between the treatment groups. PK end point results are shown in Table 1. Estimates for AI/PFS geometric mean (gMean) ratios were within the standard bioequivalence acceptance range (80–125%). Mean plasma concentration-time profiles and total exposure for BI 695501 administered via PFS or AI were similar over the observation period; treatment-emergent AEs (TEAEs) and administration site conditions (ASC) are shown in Table 2.
Similar frequencies of patients tested positive for ADAs (57.6% in the PFS group and 51.5% in the AI group), and for neutralising antibodies (33.3%% in the PFS group and 30.3% in the AI group) at the end of the study.
Conclusions PK, safety, tolerability, and immunogenicity of BI 695501 after SC injection with a PFS or an AI were comparable.
Disclosure of Interest : S. Ramael: None declared, V. Moschetti Employee of: Boehringer Ingelheim, N. Peter Employee of: Boehringer Ingelheim, I. Sonderegger Employee of: Boehringer Ingelheim, S. Wiebe Employee of: Boehringer Ingelheim, B. Liedert Employee of: Boehringer Ingelheim