Efficacy and safety of switching from reference adalimumab to CT-P17 (100 mg/ml): 52-week randomized, double-blind study in rheumatoid arthritis.

Abstract

OBJECTIVE:

To compare the safety and efficacy of switching from reference adalimumab to adalimumab biosimilar CT-P17 with continuing reference adalimumab/CT-P17 in active RA.

METHODS:

This double-blind, phase III study randomized (1:1) subjects with active RA to receive 40 mg (100 mg/ml) CT-P17 or European Union-sourced reference adalimumab subcutaneously every 2 weeks (Q2W) until week (W) 24 [treatment period (TP) 1]. Thereafter, subjects receiving reference adalimumab were randomized (1:1) to continue reference adalimumab or switch to CT-P17 from W26 (both Q2W until W48; TP2). Subjects receiving CT-P17 in TP1 continued CT-P17. W0-W24 results were previously reported; we present W26-W52 findings. End points were efficacy (including joint damage progression), pharmacokinetics, safety and immunogenicity.

RESULTS:

Of 607 subjects who initiated TP2 treatment, 303 continued CT-P17, 153 continued reference adalimumab and 151 switched to CT-P17. Efficacy improvements up to W24 were maintained during TP2; efficacy was comparable among groups. At W52, 20% improvement in ACR response rates were 80.5% (continued CT-P17), 77.8% (continued reference adalimumab) and 82.2% (switched to CT-P17). Joint damage progression was minimal. Mean trough serum adalimumab concentrations were similar among groups. CT-P17 and reference adalimumab safety profiles were numerically similar and switching did not affect immunogenicity. At W52, 28.4% (continued CT-P17), 27.0% (continued reference adalimumab) and 28.3% (switched to CT-P17) of subjects were anti-drug antibody-positive.

CONCLUSION:

Efficacy, pharmacokinetics, safety and immunogenicity of CT-P17 and reference adalimumab were comparable after 1 year of treatment, including after switching from reference adalimumab to CT-P17.

TRIAL REGISTRATION:

ClinicalTrials.gov, http://clinicaltrials.gov, NCT03789292.

• Authors: Daniel E Furst, Janusz Jaworski, Rafal Wojciechowski, Piotr Wiland, Anna Dudek, Marek Krogulec, Slawomir Jeka, Agnieszka Zielinska, Jakub Trefler, Katarzyna Bartnicka-Maslowska, Magdalena Krajewska-Wlodarczyk, Piotr A Klimiuk, Sang Joon Lee, Sung Hyun Kim, Yun Ju Bae, Go Eun Yang, Jae Kyoung Yoo, Jonathan Kay, Edward Keystone
• Journal: Rheumatology (Oxford, England) (Rheumatology (Oxford)) Vol. 61 Issue 4 Pg. 1385-1395 (04 11 2022) ISSN: 1462-0332 [Electronic] England
• PMID: 34142111 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © The Author(s) 2021. Published by Oxford University Press on behalf of the British Society for Rheumatology.

Chemical References

• Antirheumatic Agents
• Biosimilar Pharmaceuticals
• Adalimumab

Topics

• Adalimumab (adverse effects)
• Antirheumatic Agents (adverse effects)
• Arthritis, Rheumatoid (diagnostic imaging, drug therapy)
• Biosimilar Pharmaceuticals (adverse effects)
• Double-Blind Method
• Humans
• Tomography, X-Ray Computed
• Treatment Outcome