Evidence map›Paper›PMID 35130291›Full record

Trial reportPloS one2022

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

Alexey V Samtsov, Andrey L Bakulev, Vladislav R Khairutdinov, Muza M Kokhan, Tat'yana V Korotaeva, Iskander K Minullin, Olga A Vylegzhanina, Valery V Dubenskiy, Bulat V Khalilov, Alkes A Khotko and 5 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in PloS one, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02762955 (International Multi-center Comparative Randomized Double-blind Clinical Trial of Efficacy and Safety of BCD-057), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.5field-weighted citation impact, top 40% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02762955 phase3completednot on this map

International Multi-center Comparative Randomized Double-blind Clinical Trial of Efficacy and Safety of BCD-057 (Adalimumab Produced by BIOCAD, Russia) and Humira® (Adalimumab Produced by Vetter Pharma-Fertigung Gmbh & Co KG, Germany) in Patients With Moderate to Severe Plaque Psoriasis

TypeinterventionalSponsorBiocadRan2016 to 2018Enrolled344ConditionsPsoriasisArmsBCD-057, Humira®
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 6 citations in OpenAlex.

  1. Switching from Adalimumab Reference Product to and Among Adalimumab Biosimilars Outside the USA: Insights for US Clinicians.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2025
    Review
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors at 11 institutions in 2 countries.

Alexey V SamtsovDepartment of Dermatology, S.M. Kirov Military Medical Academy, Saint-Petersburg, Russia.
Andrey L BakulevDepartment of Dermatology, V.I. Razumovskiy Saratov State Medical University, Saratov, Russia.
Vladislav R KhairutdinovDepartment of Dermatology, S.M. Kirov Military Medical Academy, Saint-Petersburg, Russia.
Muza M KokhanScientific Clinical Department, Ural Research Institute of Dermatovenereology and Immunopathology, Yekaterinburg, Russia.
Tat'yana V KorotaevaSpondyloarthritis and Psoriatic Arthritis Laboratory, V.A. Nasonova Research Institute for Rheumatology, Moscow, Russia.
Iskander K MinullinHead of Institution, Republican Clinical Dermatology and Venereology Clinic, Kazan, Russia.
Olga A VylegzhaninaDiagnostic Center, Siberian Regional Medical Center of the Federal Medical and Biological Agency, Novosibirsk, Russia.
Valery V DubenskiyDermatovenerology Department, Tver State Medical University, Tver, Russia.
Bulat V KhalilovDermatovenerology Department, Kazan State Medical University, Kazan, Russia.
Alkes A KhotkoDepartment of Dermatology, Clinical Dermatology and Venereology Clinic of the Ministry of Healthcare of Krasnodar Region, Krasnodar, Russia.
Olga S ZykovaDepartment of Dermatology, Vitebsk Regional Clinical Center for Dermatology, Venereology and Cosmetology, Vitebsk, Republic of Belarus.
Irina V ChumachenkoDepartment of Dermatology, Mogilev Regional Dermatology and Venereology Clinic, Mogilev, Republic of Belarus.
Alexander M LukyanovDepartment of Dermatology, City Clinical Dermatology and Venereology Clinic, Minsk, Republic of Belarus.
Antonina V ArtemevaClinical research department, JSC BIOCAD, Saint Petersburg, Russia.
Polina P PukhtinskaiaClinical research department, JSC BIOCAD, Saint Petersburg, Russia.ORCID 0000-0001-9790-8207
BIOCAD (Russia) · RUS. M. Kirov Military Medical Academy · RU9th City Clinical Hospital · BYAssociation of Rheumatologists of Russia · RUFederal Medical-Biological Agency · RUKazan State Medical University · RUMinistry of Health of the Russian Federation · RUMogilev State University of Food Technologies · BYSaratov State Medical University · RUTver State Medical University · RUUral Scientific Research Institute of Dermatovenerology and Immunopathology · RU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe 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).

methodsPatients 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.

resultsOverall, 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.

conclusionObtained 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.

Indexed as

AdalimumabAdolescentAdultAgedBiosimilar PharmaceuticalsDouble-Blind MethodFemaleHumansMaleMiddle AgedPsoriasisSeverity of Illness IndexTreatment OutcomeYoung AdultAdalimumabBiosimilar Pharmaceuticals

Identifiers

PMID35130291
PMCPMC8820628
OpenAlexW4210773037

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.