Evidence map›Paper›PMID 39932677›Full record

Trial reportAdvances in therapy2025

Repeated Switching Between CT-P17 and EU Reference Adalimumab in Patients with Moderate-to-Severe Chronic Plaque Psoriasis: A Randomized, Double-Blind, Active-Controlled, Phase 3, Interchangeability Study.

Mark G Lebwohl, John Y Koo, Janusz Jaworski, Jakub Trefler, Stefan Daniluk, Anna Dudek, Wojciech Baran, Witold Owczarek, Joanna Kolinek, Paweł Brzewski and 10 more

Erratum issued Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase III
In one paragraph

Trial report in Advances in therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT05495568 (A Randomized, Active-Controlled, Double-Blind, Phase 3 Study to Compare Pharmacokinetics, Efficacy, and Safety of CT-P17 With Humira in Patients With Moderate to Severe Chronic Plaque Psoriasis), 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
–field-weighted citation impact
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.

NCT05495568 phase3completednot on this map

A Randomized, Active-Controlled, Double-Blind, Phase 3 Study to Compare Pharmacokinetics, Efficacy, and Safety of CT-P17 With Humira in Patients With Moderate to Severe Chronic Plaque Psoriasis

TypeinterventionalSponsorCelltrionRan2022 to 2024Enrolled367ConditionsModerate to Severe Chronic Plaque PsoriasisArmsCT-P17, EU-approved Humira
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  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. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

20 authors.

Mark G LebwohlIcahn School of Medicine at Mount Sinai, New York, NY, USA.
John Y KooUCSF Psoriasis and Skin Treatment Center, San Francisco, CA, USA.
Janusz JaworskiCentrum Medyczne Reuma Park, Warsaw, Poland.
Jakub TreflerReuma Centrum, Warsaw, Poland.ORCID 0009-0003-3912-3518
Stefan DanilukClinicMed Daniluk, Nowak Sp.K, Białystok, Poland.
Anna DudekCentrum Medyczne AMED, Warsaw, Poland.
Wojciech BaranDepartment of Dermatology, Venereology and Allergology, Wroclaw Medical University, Wroclaw, Poland.
Witold OwczarekRoyalderm/Department of Dermatology, Military Institute of Medicine-National Research Institute, Warsaw, Poland.
Joanna KolinekMedycyna Kliniczna, Warsaw, Poland.
Paweł BrzewskiSpecjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy, Krakow, Poland.
Mariusz SikoraNational Institute of Geriatrics, Rheumatology and Rehabilitation, Warsaw, Poland.
Marek KrogulecRheumatology Clinic NZOZ Lecznica MAK-MED, Nadarzyn, Poland.
SungHyun KimCelltrion, Inc., Incheon, Republic of Korea.ORCID 0000-0003-3898-0393
YunJu BaeCelltrion, Inc., Incheon, Republic of Korea.ORCID 0009-0002-3827-6742
DaBee JeonCelltrion, Inc., Incheon, Republic of Korea.
EunJin ChoiCelltrion, Inc., Incheon, Republic of Korea.
JungBin ChaCelltrion, Inc., Incheon, Republic of Korea.
HyunJin LeeCelltrion, Inc., Incheon, Republic of Korea.
SuJin ChoiCelltrion, Inc., Incheon, Republic of Korea.
David M PariserEastern Virginia Medical School and Virginia Clinical Research, Inc., 6160 Kempsville Circle, Suite 200A, Norfolk, VA, 23502, USA. dpariser@pariserderm.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThis study aimed to demonstrate the interchangeability of biosimilar CT-P17 and European Union reference adalimumab (EU-adalimumab) in a repeated-switch scenario.

methodsIn this ongoing, randomized, double-blind, active-controlled, phase 3 study, adults with moderate-to-severe plaque psoriasis received 80 mg EU-adalimumab on day 1, then 40 mg 1 week later and every other week until week 11. At week 13, patients were randomized (1:1, via an interactive web response system) to continue EU-adalimumab ("continuous" group) or undergo repeated switches between CT-P17 and EU-adalimumab ("switching" group). Dosing was via subcutaneous administration. The primary endpoints were area under the concentration-time curve and maximum serum concentration between weeks 25 and 27 (AUC

resultsThe first patient provided signed informed consent on November 7, 2022. Week 27 visits were completed by August 14, 2023. Of 367 patients enrolled, 346 were randomized (switching group, n = 172; continuous group, n = 174). The ratios of least squares means between groups and associated 90% confidence intervals (CIs) for AUC

conclusionsWeek 27 primary PK results demonstrated bioequivalence, and the overall study results supported the interchangeability of CT-P17 and EU-adalimumab.

trial registrationClinicalTrials.gov, NCT05495568.

Indexed as

AdalimumabBiosimilar PharmaceuticalsDrug SubstitutionPsoriasisAdultAntibodies, Monoclonal, HumanizedDouble-Blind MethodFemaleHumansMaleMiddle AgedSeverity of Illness IndexTherapeutic EquivalencyAdalimumabAntibodies, Monoclonal, HumanizedBiosimilar PharmaceuticalsCT-P17AdalimumabBiosimilarCT-P17EfficacyInterchangeabilityPharmacokinetics

Identifiers

PMID39932677
PMCPMC11868361

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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.