AB0391 Similar pharmacokinetics, safety and tolerability of the adalimumab biosimilar candidate BI 695501 administered subcutaneously via prefilled syringe (PFS) or autoinjector (AI) (voltaire®-ai). (15th June 2017)

• Record Type: Journal Article
• Authors: Ramael, S; Moschetti, V; Peter, N; Sonderegger, I; Wiebe, S; Liedert, B
• Is Part Of: Annals of the rheumatic diseases. Volume 76(2017)Supplement 2
• Page Start: 1185
• Page End: 1185
• Publication Date: 2017-06-15
• Subjects: Rheumatism -- Periodicals; 616.723005
• DOI: 10.1136/annrheumdis-2017-eular.3507
• Languages: English
• ISSNs: 0003-4967

Abstract

Abstract : 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/m 2 . 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