Evidence map›Paper›PMID 40048101›Full record

Trial reportAdvances in therapy2025

A Randomised, Double-Blind Trial to Compare the Efficacy, Safety, and Immunogenicity of the Biosimilar Ustekinumab FYB202 with Reference Ustekinumab in Patients with Moderate-to-Severe Plaque Psoriasis.

Kim Papp, Sigrid Balser, Katrin Nopora, Piotr Rewerski, Brigitte Freudensprung, Michael Trieb

Registry-linked trialAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
PubMed Full text at PMC Publisher
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. It is linked to trial NCT04595409 (A Randomised, Double-blind, Parallel-group, Phase 3 Study to Compare the Efficacy, Safety, and Immunogenicity of the Proposed Biosimilar Ustekinumab FYB202 to Stelara® in Patients With Moderate-to-Severe Plaque Psoriasis), which is not on this map. Cited by 4 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 3 pooled it
–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.

NCT04595409 phase3completednot on this map

A Randomised, Double-blind, Parallel-group, Phase 3 Study to Compare the Efficacy, Safety, and Immunogenicity of the Proposed Biosimilar Ustekinumab FYB202 to Stelara® in Patients With Moderate-to-Severe Plaque Psoriasis

TypeinterventionalSponsorBioeq GmbHRan2020 to 2022Enrolled392ConditionsPlaque PsoriasisArmsFYB202 (Proposed ustekinumab biosimilar), Stelara® (Ustekinumab)
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Review
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

6 authors.

Kim PappAlliance Clinical Trials and Probity Medical Research, Waterloo, ON, Canada.
Sigrid BalserFormycon AG, Fraunhoferstr. 15, 82152, Martinsried/Planegg, Germany. sigrid.balser@formycon.com.ORCID 0000-0002-9548-1550
Katrin NoporaFormycon AG, Fraunhoferstr. 15, 82152, Martinsried/Planegg, Germany.
Piotr RewerskiDiamond Clinic, Krakow, Poland.
Brigitte FreudensprungFormycon AG, Fraunhoferstr. 15, 82152, Martinsried/Planegg, Germany.
Michael TriebFormycon AG, Fraunhoferstr. 15, 82152, Martinsried/Planegg, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionBiosimilars allow more patients access to affordable treatment options and help reduce the financial burden on healthcare systems. This multicentre trial compared the efficacy, safety, and immunogenicity of the approved biosimilar ustekinumab FYB202 with reference ustekinumab.

methodsEligible patients were ≥ 18 years old with stable moderate-to-severe plaque psoriasis for ≥ 6 months and inadequate treatment response to or intolerance of ≥ 1 previous systemic treatment. Patients were randomised (1:1) to double-blind treatment with FYB202 or reference ustekinumab; patients in the reference group who achieved Psoriasis Area and Severity Index (PASI) 75 percent improvement at week 28 were re-randomised to FYB202 or reference product. The primary efficacy endpoint was percent improvement in PASI score from baseline to week 12. Therapeutic equivalence was demonstrated if, depending on the regulatory requirement with respect to the significance level, the two-sided 95% and 90% confidence intervals (CIs) were within the pre-defined equivalence intervals of ± 11% and ± 10%, respectively.

resultsA total of 392 patients were randomised to FYB202 (n = 197) or reference ustekinumab (n = 195). Baseline characteristics were well balanced between groups. Mean percent improvement in PASI score at week 12 was equivalent between FYB202 and reference ustekinumab with an estimated least-squares mean treatment difference of 3.27% and the two-sided 95% (- 0.90%, 7.44%) and 90% (- 0.22%, 6.77%) CIs fully contained within the pre-defined equivalence margins. Safety and immunogenicity profiles were comparable between groups. Switching from reference product to FYB202 had no clinically relevant effect on efficacy, safety, or immunogenicity.

conclusionFYB202 demonstrated therapeutic equivalence to reference ustekinumab in patients with moderate-to-severe plaque psoriasis.

trial registrationNCT04595409; EudraCT 2019-004364-21.

Indexed as

Biosimilar PharmaceuticalsDermatologic AgentsPsoriasisUstekinumabAdultAgedDouble-Blind MethodFemaleHumansMaleMiddle AgedSeverity of Illness IndexTherapeutic EquivalencyTreatment OutcomeBiosimilar PharmaceuticalsDermatologic AgentsUstekinumabBiosimilarPsoriasisRandomised controlled trialTherapeutic equivalenceUstekinumab

Identifiers

PMID40048101
PMCPMC12006271

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.