Efficacy and safety of switching from reference adalimumab to CT-P17 (100 mg/ml): 52-week randomized, double-blind study in rheumatoid arthritis.
CT-P17
adalimumab
biosimilar
efficacy
immunogenicity
rheumatoid arthritis
safety
switching
tumour necrosis factor inhibitors
Journal
Rheumatology (Oxford, England)
ISSN: 1462-0332
Titre abrégé: Rheumatology (Oxford)
Pays: England
ID NLM: 100883501
Informations de publication
Date de publication:
11 04 2022
11 04 2022
Historique:
received:
08
03
2021
revised:
17
05
2021
pubmed:
19
6
2021
medline:
14
4
2022
entrez:
18
6
2021
Statut:
ppublish
Résumé
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. 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. 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. 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. ClinicalTrials.gov, http://clinicaltrials.gov, NCT03789292.
Identifiants
pubmed: 34142111
pii: 6303620
doi: 10.1093/rheumatology/keab460
pmc: PMC8996790
doi:
Substances chimiques
Antirheumatic Agents
0
Biosimilar Pharmaceuticals
0
Adalimumab
FYS6T7F842
Banques de données
ClinicalTrials.gov
['NCT03789292']
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1385-1395Commentaires et corrections
Type : CommentIn
Informations de copyright
© The Author(s) 2021. Published by Oxford University Press on behalf of the British Society for Rheumatology.
Références
Arthritis Rheumatol. 2018 Jun;70(6):832-840
pubmed: 29439289
Clin Transl Sci. 2021 Jul;14(4):1280-1291
pubmed: 33503313
Arthritis Res Ther. 2019 Dec 12;21(1):281
pubmed: 31831079
Ann Rheum Dis. 2015 Mar;74(3):513-8
pubmed: 24326008
Arthritis Res Ther. 2021 Feb 5;23(1):51
pubmed: 33546755
BioDrugs. 2020 Dec;34(6):809-823
pubmed: 33119861
Ann Rheum Dis. 2018 Jun;77(6):914-921
pubmed: 29514803
Arthritis Res Ther. 2019 Mar 29;21(1):84
pubmed: 30922373
Ann Rheum Dis. 2017 Oct;76(10):1679-1687
pubmed: 28584187
Br J Clin Pharmacol. 2021 Nov;87(11):4323-4333
pubmed: 33822406
Br J Clin Pharmacol. 2020 Nov;86(11):2274-2285
pubmed: 32363771