Work

Similar Pharmacokinetics of the Adalimumab (Humira®) Biosimilar BI 695501 Whether Administered via Subcutaneous Autoinjector or Prefilled Syringe (VOLTAIRE®-AI and VOLTAIRE®-TAI): Phase 1, Randomized, Open-Label, Parallel-Group Trials

Year: 2018

Type: article

Abstract: BI 695501 has shown similar efficacy, safety, and immunogenicity to the adalimumab reference product, Humira ® . We present two phase 1 studies comparing the pharmacokinetics, safety, and immunogenicity of BI 695501 delivered via autoinjector (AI) vs. prefilled syringe (PFS). Both trials were randomized, open-label, parallel-group studies undertaken in subjects aged ≥ 18–65 years. VOLTAIRE ® -AI (NCT02606903) recruited healthy, Caucasian, male, non-athletic volunteers with BMI ≥ 18 to ≤ 30 kg/m 2 . VOLTAIRE ® -TAI (NCT02899338) recruited healthy men and women with BMI > 17.5 to < 35 kg/m 2 . In both studies, a single dose of BI 695501 40 mg was administered via AI or PFS to the abdomen (VOLTAIRE ® -AI) or thigh (VOLTAIRE ® -TAI). The observation period was 43/57 days and the safety follow-up was 70 days. Co-primary endpoints were AUC 0–1032 or AUC 0–1368 , C max , and AUC 0–∞ . Safety and immunogenicity were assessed. Subjects (VOLTAIRE ® -AI: N = 71; VOLTAIRE ® -TAI: N = 162) were randomized to AI ( n = 35; n = 81) or PFS ( n = 36; n = 81). Baseline characteristics were balanced between treatment groups in each study. Total exposure of BI 695501 was similar for both groups; adjusted geometric mean ratios for AUC 0–∞ , AUC 0–1032 , and C max were 106.17, 104.09, and 114.83%, respectively, for VOLTAIRE ® -AI; 103.19, 101.71 (AUC 0–1368 ), and 100.11% for VOLTAIRE ® -TAI. In both studies, similar immunogenicity was observed between groups in terms of frequency of binding and neutralizing anti-drug antibody-positive subjects. Incidence of adverse events was similar for both groups. Pharmacokinetics and immunogenicity of BI 695501 delivered via AI were similar to administration using a PFS, independent of injection site. No differences are expected between AI and PFS use in clinical practice. Boehringer Ingelheim.

Source: Rheumatology and Therapy

DOI: 10.1007/s40744-018-0119-1