Evidence map›Paper›PMID 35460287›Full record

Trial reportJournal of the European Academy of Dermatology and Venereology : JEADV2022

Tildrakizumab efficacy and safety in patients with psoriasis and concomitant metabolic syndrome: post hoc analysis of 5-year data from reSURFACE 1 and reSURFACE 2.

A P Fernandez, E Dauden, S Gerdes, M G Lebwohl, M A Menter, C L Leonardi, M Gooderham, K Gebauer, Y Tada, J P Lacour and 6 more

2 registry-linked trialsAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Journal of the European Academy of Dermatology and Venereology : JEADV, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing 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.

NCT01722331 phase3completednot on this map

A 64-Week, Phase 3, Randomized, Placebo-Controlled, Parallel Design Study to Evaluate the Efficacy and Safety/Tolerability of Subcutaneous Tildrakizumab (SCH 900222/MK-3222), Followed by an Optional Long-Term Safety Extension Study, in Subjects With Moderate-to-Severe Chronic Plaque Psoriasis (Protocol No. MK-3222-010)

TypeinterventionalSponsorSun Pharmaceutical Industries LimitedRan2012 to 2021Enrolled772ConditionsPlaque PsoriasisArmsTildrakizumab 200 mg, Tildrakizumab 100 mg, Matching Placebo
NCT01729754 phase3completednot on this map

A 52-Week, Phase 3, Randomized, Active Comparator and Placebo-Controlled, Parallel Design Study to Evaluate the Efficacy and Safety/Tolerability of Subcutaneous Tildrakizumab (SCH 900222/MK-3222), Followed by an Optional Long-Term Safety Extension Study, in Subjects With Moderate-to-Severe Chronic Plaque Psoriasis (Protocol No. MK-3222-011)

TypeinterventionalSponsorSun Pharmaceutical Industries LimitedRan2013 to 2021Enrolled1,090ConditionsPlaque PsoriasisArmsTildrakizumab 200 mg, Tildrakizumab 100 mg, Tildrakizumab Placebo, Etanercept Placebo, Etanercept 50 mg
3 · Its place in the literature

Who cites it

12 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
  4. Article
  5. Review
  6. Psoriasis.Nature reviews. Disease primers · 2025
    Review
  7. Article
  8. Article
  9. Article
  10. Review
  11. Review
  12. 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

16 authors.

A P FernandezDepartments of Dermatology and Pathology, Cleveland Clinic, Cleveland, OH, USA.ORCID https://orcid.org/0000-0003-4490-8427
E DaudenDermatology Department, Instituto de Investigación Sanitaria La Princesa (IIS-IP), Madrid, Spain.ORCID https://orcid.org/0000-0002-0676-1260
S GerdesDepartment of Dermatology, Psoriasis-Center, University Medical Center Schleswig-Holstein, Kiel, Germany.ORCID https://orcid.org/0000-0002-6667-7757
M G LebwohlDepartment of Dermatology, Mount Sinai Hospital, New York, NY, USA.
M A MenterDivision of Dermatology, Baylor Scott & White, and Texas A&M College of Medicine, Dallas, TX, USA.
C L LeonardiCentral Dermatology and Saint Louis University School of Medicine, St. Louis, MO, USA.
M GooderhamProbity Medical Research, Peterborough, ON, Canada.ORCID https://orcid.org/0000-0001-8926-0113
K GebauerFremantle Dermatology, Fremantle, WA, Australia.
Y TadaTeikyo University, Tokyo, Japan.ORCID https://orcid.org/0000-0003-3743-135X
J P LacourDepartment of Dermatology, University of Nice Sophia Antipolis, Nice, France.ORCID https://orcid.org/0000-0001-7663-2053
L BianchiDermatology Unit, Tor Vergata University Hospital, Rome, Italy.
A EgebergDepartment of Dermatology, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark.ORCID https://orcid.org/0000-0001-8257-1816
I Pau-CharlesAlmirall R&D, Barcelona, Spain.
A M MendelsohnSun Pharmaceutical Industries, Inc., Princeton, NJ, USA.
S J RozzoSun Pharmaceutical Industries, Inc., Princeton, NJ, USA.
N N MehtaNational Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD, USA.ORCID https://orcid.org/0000-0003-4939-5130

Funding

Almirall R&DMerckSun Pharmaceutical Industries, Inc.
6 · The paper itself

Abstract

backgroundLimited data are available on long-term efficacy and safety of biologics in patients with psoriasis and metabolic syndrome (MetS), a common comorbidity.

objectivesThis analysis updates tildrakizumab efficacy and safety for up to 5 years in patients with and without MetS.

methodsThis was a post hoc analysis of the double-blind, randomized, placebo-controlled, phase 3 reSURFACE 1 (NCT01722331) and reSURFACE 2 (NCT01729754) trials in adult patients with moderate to severe chronic plaque psoriasis. Analyses included data through Week 244 from patients who continuously received tildrakizumab 100 (TIL100) or 200 mg (TIL200) and entered the extension studies, stratified by baseline MetS status. Efficacy was assessed via Psoriasis Area and Severity Index (PASI) scores. Safety was evaluated from exposure-adjusted incidence rates (EAIRs) of treatment-emergent adverse events (TEAEs).

resultsreSURFACE 1 and reSURFACE 2 analyses included 26 and 44 TIL100-treated patients with MetS, 98 and 167 TIL100-treated patients without MetS, 34 and 30 TIL200-treated patients with MetS, and 111 and 130 TIL200-treated patients without MetS, respectively. There were no clinically relevant differences in PASI 75/90/100 response rates at Week 244 between patients with vs without MetS. The proportion of patients with vs without MetS achieving absolute PASI score <3 at Week 244 was 53.8% vs 69.4% and 77.3% vs 80.8% in reSURFACE 1 and 2, respectively, for TIL100-treated patients and 58.8% vs 72.1% and 63.3% vs 72.3%, respectively, for TIL200-treated patients. In both studies, median reduction from baseline PASI score at all time points in patients with vs without MetS was >83% vs >89% for TIL100 and >85% vs >90% for TIL200. Pooled EAIRs of TEAEs, serious TEAEs, and TEAEs of special interest were similar in patients with and without MetS.

conclusionsTildrakizumab maintains efficacy and a favorable safety profile over 5 years in patients with psoriasis regardless of MetS status.

Indexed as

Antibodies, Monoclonal, HumanizedMetabolic SyndromePsoriasisAdultDouble-Blind MethodHumansTreatment OutcomeAntibodies, Monoclonal, Humanizedtildrakizumab

Identifiers

PMID35460287
PMCPMC9545614

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.