Evidence map›Paper›PMID 33985942›Full record

Trial reportAnnals of the rheumatic diseases2021

Efficacy and safety of tildrakizumab in patients with active psoriatic arthritis: results of a randomised, double-blind, placebo-controlled, multiple-dose, 52-week phase IIb study.

Philip J Mease, Saima Chohan, Ferran J Garcia Fructuoso, Michael E Luggen, Proton Rahman, Siba P Raychaudhuri, Richard C Chou, Alan M Mendelsohn, Stephen J Rozzo, Alice Gottlieb

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

Trial report in Annals of the rheumatic diseases, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02980692 (A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Phase 2b Study to Demonstrate the Safety and Efficacy of Tildrakizumab in Subjects With Active Psoriatic Arthritis), which is not on this map. Cited by 35 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 6 pooled it
11.1field-weighted citation impact, top 1% 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.

NCT02980692 phase2completednot on this map

A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Phase 2b Study to Demonstrate the Safety and Efficacy of Tildrakizumab in Subjects With Active Psoriatic Arthritis

TypeinterventionalSponsorSun Pharmaceutical Industries LimitedRan2017 to 2019Enrolled391ConditionsActive Psoriatic ArthritisArmsSUNPG1623 I, SUNPG1623 II, SUNPG1623 III, SUNPG1623 IV, PLACEBO
3 · Its place in the literature

Who cites it

35 citing papers in PubMed, 6 syntheses or guidelines pooled it, 83 citations in OpenAlex.

  1. Pooled it
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  10. Psoriatic Arthritis: From Diagnosis to Treatment.Journal of clinical medicine · 2025
    Review
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  18. State of the Art Review on the Treatment of Psoriatic Disease.Mediterranean journal of rheumatology · 2024
    Review
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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

10 authors at 8 institutions in 3 countries.

Philip J MeaseRheumatology Research, Swedish Medical Center, Seattle, Washington, USA pmease@philipmease.com.ORCID 0000-0002-6620-0457
Saima ChohanArizona Arthritis and Rheumatology Research, PLLC, Phoenix, Arizona, USA.
Ferran J Garcia FructuosoHospital CIMA Sanitas, Barcelona, Spain.
Michael E LuggenCincinnati Rheumatic Disease Study Group, Cincinnati, Ohio, USA.
Proton RahmanMedicine, Eastern Health and Memorial University, St. Johns, Newfoundland, Canada.
Siba P RaychaudhuriDivision of Rheumatology, Allergy and Clinical Immunology, University of California School of Medicine, Davis, California, USA.ORCID 0000-0001-7594-6528
Richard C ChouDivision of Allergy, Immunology and Rheumatology, University at Buffalo School of Medicine and Biomedical Sciences, Buffalo, New York, USA.
Alan M MendelsohnSun Pharmaceutical Industries, Princeton, New Jersey, USA.
Stephen J RozzoSun Pharmaceutical Industries, Princeton, New Jersey, USA.
Alice GottliebDepartment of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
Sun Pharma (United States) · USHospital Sanitas CIMA · ESIcahn School of Medicine at Mount Sinai · USMemorial University of Newfoundland · CASacramento VA Medical Center · USSwedish Medical Center · USUniversity at Buffalo, State University of New York · USUniversity of Cincinnati Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo evaluate efficacy and safety of the anti-interleukin-23p19 monoclonal antibody tildrakizumab in patients with psoriatic arthritis (PsA).

methodsIn this randomised, double-blind, placebo-controlled, phase IIb study, patients with active PsA were randomised 1:1:1:1:1 to tildrakizumab 200 mg every 4 weeks (Q4W); tildrakizumab 200, 100 or 20 mg Q12W; or placebo Q4W. Patients receiving tildrakizumab 20 mg or placebo switched to tildrakizumab 200 mg Q12W at W24; treatment continued to W52. The primary efficacy endpoint was proportion of patients with ACR20 response (≥20% improvement by American College of Rheumatology criteria) at W24. Secondary efficacy endpoints were assessed without adjustment for multiplicity. Safety was evaluated from treatment-emergent adverse events (TEAEs).

results391/500 patients screened were randomised and treated. At W24, 71.4%-79.5% of tildrakizumab-treated versus 50.6% of placebo-treated patients achieved ACR20 (all p<0.01). Patients receiving tildrakizumab versus placebo generally achieved higher rates of ACR50, Disease Activity Score in 28 joints with C reactive protein <3.2, minimal disease activity and 75%/90%/100% improvement from baseline Psoriasis Area and Severity Index responses at W24 and through W52. Improvement in dactylitis and enthesitis was not observed; results were mixed for other outcomes. Responses in patients switched to tildrakizumab 200 mg at W24 were consistent with treatment from baseline. TEAEs and serious TEAEs occurred in 64.5% and 3.3%, respectively, of all patients through W52 and were comparable among treatment arms.

conclusionsTildrakizumab treatment significantly improved joint and skin manifestations of PsA other than dactylitis and enthesitis. Treatment was generally well tolerated through W52. Clinicaltrials.gov NCT02980692.

Indexed as

AdultAntibodies, Monoclonal, HumanizedAntirheumatic AgentsArthritis, PsoriaticDouble-Blind MethodDrug Therapy, CombinationFemaleGlucocorticoidsHumansLeflunomideMaleMethotrexateMiddle AgedSulfasalazineAntibodies, Monoclonal, HumanizedAntirheumatic AgentsGlucocorticoidsLeflunomideMethotrexateSulfasalazinetildrakizumabarthritisbiological therapycytokinespsoriatic

Identifiers

PMID33985942
PMCPMC8372392
OpenAlexW3162222593

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.