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

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

doi:10.1093/rheumatology/keab460

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

Rheumatology (Oxford). 2022 Apr 11;61(4):1385-1395. doi: 10.1093/rheumatology/keab460.

Authors

Daniel E Furst^{1

2

3}, Janusz Jaworski⁴, Rafal Wojciechowski⁵, Piotr Wiland⁶, Anna Dudek⁷, Marek Krogulec⁸, Slawomir Jeka⁹, Agnieszka Zielinska¹⁰, Jakub Trefler¹¹, Katarzyna Bartnicka-Maslowska¹², Magdalena Krajewska-Wlodarczyk¹³, Piotr A Klimiuk¹⁴, Sang Joon Lee¹⁵, Sung Hyun Kim¹⁵, Yun Ju Bae¹⁵, Go Eun Yang¹⁵, Jae Kyoung Yoo¹⁵, Jonathan Kay^{16

17}, Edward Keystone¹⁸

Affiliations

¹ Division of Rheumatology, Department of Medicine, University of California, Los Angeles, Los Angeles, CA.
² Division of Rheumatology, Department of Medicine, University of Washington, Seattle, WA, USA.
³ Department of Medicine, University of Florence, Florence, Italy.
⁴ Department of Rheumatology, Reumatika-Centrum Reumatologii, Warsaw.
⁵ Department of Rheumatology and Connective Tissue Diseases, University Hospital No 2, Bydgoszcz.
⁶ Department of Rheumatology and Internal Diseases, Medical University, Wrocław.
⁷ Department of Rheumatology, Centrum Medyczne AMED, Warsaw.
⁸ Rheumatology Clinic, NZOZ Lecznica MAK-MED, Nadarzyn.
⁹ Department of Rheumatology and Connective Tissue Diseases, Nasz Lekarz Przychodnie Medyczne, Toruń.
¹⁰ Medycyna Kliniczna.
¹¹ Reuma Centrum, Warsaw.
¹² Department of Rheumatology, Centrum Medyczne Amed, Łódź.
¹³ Department of Internal Medicine, University of Warmia and Mazury, Olsztyn.
¹⁴ Department of Rheumatology and Internal Diseases, Medical University of Bialystok and Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk, Białystok, Poland.
¹⁵ Clinical Development Division, Celltrion, Inc., Incheon, Republic of Korea.
¹⁶ Division of Rheumatology, Department of Medicine, University of Massachusetts Medical School and UMass Memorial Medical Center.
¹⁷ Division of Epidemiology, Department of Population and Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, USA.
¹⁸ Department of Rheumatology, University of Toronto, Toronto, ON, Canada.

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.

Keywords: CT-P17; adalimumab; biosimilar; efficacy; immunogenicity; rheumatoid arthritis; safety; switching; tumour necrosis factor inhibitors.

Publication types

Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

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

Substances

Antirheumatic Agents
Biosimilar Pharmaceuticals
Adalimumab

Associated data

ClinicalTrials.gov/NCT03789292