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

PLoS One. 2022 Feb 7;17(2):e0263214. doi: 10.1371/journal.pone.0263214. eCollection 2022.

Abstract

Introduction: 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).

Methods: 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.

Results: 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.

Conclusion: 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.

Publication types

  • Clinical Trial, Phase III
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adalimumab* / chemistry
  • Adalimumab* / therapeutic use
  • Adolescent
  • Adult
  • Aged
  • Biosimilar Pharmaceuticals / pharmacokinetics
  • Biosimilar Pharmaceuticals / therapeutic use*
  • Double-Blind Method
  • Female
  • Humans
  • Male
  • Middle Aged
  • Psoriasis / drug therapy*
  • Psoriasis / immunology
  • Psoriasis / metabolism
  • Psoriasis / pathology
  • Severity of Illness Index
  • Treatment Outcome
  • Young Adult

Substances

  • Biosimilar Pharmaceuticals
  • Adalimumab

Associated data

  • ClinicalTrials.gov/NCT02762955

Grants and funding

The study was funded by JSC BIOCAD, BCD-057 developer and manufacturer. JSC BIOCAD was responsible for the study design, data collection and analysis, decision to publish, and preparation of the manuscript. All authors were involved in data collection. All data were analyzed in accordance with the clinical study protocol. All authors had full access to the study data, made the decision to publish the manuscript in its current form, and prepared the manuscript. AVA and PPP are employees of JSC BIOCAD (clinical research scientists) responsible for the initial draft of the manuscript and its finalization after revisions of other authors. The specific roles of these authors are articulated in the ‘author contributions’ section.