Extension Study Shows Cyltezo Has Similar Efficacy, Safety, Immunogenicity as Humira at 2 Years

Results from a phase 3b extension study of Boehringer Ingelheim’s (BI) biosimilar adalimumab, Cyltezo, showed similar safety, efficacy, and immunogenicity to reference adalimumab, Humira.

The study was conducted in patients with moderately to severely active rheumatoid arthritis (RA) who previously completed VOLTAIRE-RA, which was a 58-week, randomized, double-blind, parallel-arm equivalence trial of Cyltezo and US-sourced Humira in 15 sites in 14 countries.

In the open-label extension study (VOLTAIRE-RAext), eligible patients had completed 48 weeks’ treatment with Cyltezo (Group A), 24 weeks each of reference adalimumab and then Cyltezo (Group B), or 48 weeks of reference adalimumab (Group C) in VOLTAIRE-RA.

In total, 430 patients received Cyltezo every 2 weeks for 48 weeks:

• Group A, n = 225
• Group B, n = 103
• Group C, n = 102

Over 2 years, Cyltezo showed similar safety, efficacy, and immunogenicity to Humira, independent of initial treatment in the original trial.

The proportion of patients with drug-related adverse events (AEs)—20.2% overall—was similar across all 3 groups: A (21.3%), B (20.4%), and C (17.6).

Researchers did not identify any new AEs. Most treatment-emergent AEs were minor and of mild to moderate intensity, and most drug-related AEs were similar to Humira’s, such as infections and infestations.

Clinical responses seen at the end of VOLTAIRE-RA were sustained during the extension study, and all efficacy and immunogenicity end points were similar across groups.

Previous research has already demonstrated the structural similarity and comparable functionality of BI’s Cyltezo, which was approved by the FDA in 1997, and Humira. In addition, the VOLTAIRE-PK study established 3-way pharmacokinetic similarity between Cyltezo and both EU- and US-approved Humira, and another study demonstrated that switching from the reference drug to the biosimilar had no impact on efficacy, safety, or immunogenicity.

Reference

Cohen SB, Czeloth N, Lee E, Klimiuk PA, Peter N, Jayadeva G. Long-term safety, efficacy, and immunogenicity of adalimumab biosimilar BI 695501 and adalimumab reference product in patients with moderately-to-severely active rheumatoid arthritis: results from a phase 3b extension study (VOLTAIRE-RAext) [published online August 6, 2019]. Expert Opin Biol Ther. doi: 10.1080/14712598.2019.1645114.