Journal Article

Long-term data on the proposed adalimumab biosimilar BCD-057 in patients with moderate to severe psoriasis: A randomized controlled trial

Pukhtinskaia, Polina P., Khalilov, Bulat V., Lukyanov, Alexander M., Artemeva, Antonina V., Khairutdinov, Vladislav R., Samtsov, Alexey V., Minullin, Iskander K., Bakulev, Andrey L., Dubenskiy, Valery V., Zykova, Olga S., Kokhan, Muza M., Chumachenko, Irina V., Korotaeva, Tat’yana V., Khotko, Alkes A., Vylegzhanina, Olga A.

2022

Overview

The objective of this study was to demonstrate that BCD-057 is similar to innovator adalimumab (iADA) in terms of efficacy, safety, and pharmacokinetics in steady state in the target population of patients with moderate to severe plaque psoriasis (NCT02762955). Patients were randomized in 1:1 ratio to receive 80 mg of BCD-057 or iADA at week 0 and 40 mg thereafter every other week from week 1. At week 24 patients from iADA group were re-randomized (1:1) to continue iADA or to be switched to BCD-057. The primary efficacy endpoint was 75% improvement in Psoriasis Area and Severity Index from baseline (PASI 75), secondary endpoints included PASI percent improvement and relative change in affected Body Surface Area (BSA) from baseline at weeks 16, 24, 33, and 55. Safety was assessed through monitoring of adverse events (AEs) and antidrug antibodies. Pharmacokinetics was evaluated at steady state. Overall, 346 adult patients were included in the study (174/172 patients in BCD-057/iADA arms, respectively). At week 16 PASI 75 was achieved by 60.34% and 63.37% of patients in BCD-057 and iADA arms, respectively (p = 0.5622). Bounds of the calculated 95% confidence interval (CI) for the difference between PASI 75 responses in arms [-13.26%; 7.2%] fall within the equivalence margin [-15% to 15%] demonstrating equivalent efficacy of BCD-057 and iADA. At week 55 81.61%, 85.56%, and 80.49% of patients in BCD-057, iADA and iADA/BCD-057 arms achieved PASI 75. Comparison of the secondary endpoints did not show significant differences between arms. A comparable pharmacokinetics was shown at steady state. Safety profiles and proportions of patients with antidrug antibodies were similar between arms. The switch from the iADA to BCD-057 did not affect the immunogenicity profile. Obtained data demonstrate that BCD-057 and iADA are highly similar in clinical efficacy, pharmacokinetics, safety, and immunogenicity in patients with moderate to severe plaque psoriasis.

• Publisher: Public Library of Science,Public Library of Science (PLoS)
• Subject: Adalimumab / Adalimumab - chemistry / Adalimumab - therapeutic use / Adolescent / Adult / Aged / Antibodies / Biological products / Biology and Life Sciences / Biosimilar Pharmaceuticals - pharmacokinetics / Biosimilar Pharmaceuticals - therapeutic use / Care and treatment / Clinical trials / Complications and side effects / Confidence intervals / Dermatology / Double-Blind Method / Equivalence / Female / Humans / Immunogenicity / Male / Medicine and Health Sciences / Middle Aged / Monoclonal antibodies / Patient outcomes / Patients / Pharmacokinetics / Pharmacology / Prostate cancer / Psoriasis / Psoriasis - drug therapy / Psoriasis - immunology / Psoriasis - metabolism / Psoriasis - pathology / Psoriatic arthritis / Safety / Severity of Illness Index / Skin diseases / Steady state / TNF inhibitors / Treatment Outcome / Young Adult