Evidence map›Paper›PMID 32660977›Full record

Trial reportAnnals of the rheumatic diseases2020

Multicentre, randomised, open-label, parallel-group study evaluating the efficacy and safety of ixekizumab versus adalimumab in patients with psoriatic arthritis naïve to biological disease-modifying antirheumatic drug: final results by week 52.

Josef S Smolen, Philip Mease, Hasan Tahir, Hendrik Schulze-Koops, Inmaculada de la Torre, Lingnan Li, Maja Hojnik, Christophe Sapin, Masato Okada, Roberto Caporali and 5 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIClinical Trial, Phase IVMulticenter Study
In one paragraph

Trial report in Annals of the rheumatic diseases, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03151551 (A 52-Week Multicenter, Randomized, Open-Label, Parallel- Group Study Evaluating the Efficacy and Safety of Ixekizumab Versus Adalimumab in Patients With Psoriatic Arthritis Who Are Biologic Disease-Modifying Anti-Rheumatic Drug Naive), which is not on this map. Cited by 42 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
42citing papers in PubMed, 4 pooled it
9.8field-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.

NCT03151551 phase4completednot on this map

A 52-Week Multicenter, Randomized, Open-Label, Parallel- Group Study Evaluating the Efficacy and Safety of Ixekizumab Versus Adalimumab in Patients With Psoriatic Arthritis Who Are Biologic Disease-Modifying Anti-Rheumatic Drug Naive

TypeinterventionalSponsorEli Lilly and CompanyRan2017 to 2019Enrolled566ConditionsPsoriatic ArthritisArmsIxekizumab, Adalimumab
3 · Its place in the literature

Who cites it

42 citing papers in PubMed, 4 syntheses or guidelines pooled it, 83 citations in OpenAlex.

  1. Pooled it
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  5. Trial
  6. Trial
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  9. Observational
  10. Observational
  11. Article
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  13. Precision medicine using molecular-target drugs in psoriatic arthritis.Therapeutic advances in musculoskeletal disease · 2025
    Review
  14. Observational
  15. Article
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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

15 authors at 9 institutions in 9 countries.

Josef S SmolenDivision of Rheumatology, Department of Medicine 3, Medical University of Vienna, Vienna, Austria josef.smolen@meduniwien.ac.at.
Philip MeaseProvidence St Joseph Health, Rentton, Washington, USA.
Hasan TahirRoyal Free London NHS Foundation Trust, London, UK.
Hendrik Schulze-KoopsDivision of Rheumatology and Clinical Immunology, Department of Internal Medicine IV, Ludwig Maximilians University Munich, Munich, Germany.ORCID 0000-0002-1681-491X
Inmaculada de la TorreEli Lilly and Company, Indianapolis, Indiana, USA.
Lingnan LiEli Lilly and Company, Indianapolis, Indiana, USA.
Maja HojnikEli Lilly and Company, Indianapolis, Indiana, USA.
Christophe SapinEli Lilly and Company, Indianapolis, Indiana, USA.
Masato OkadaImmuno-Rheumatology Center, St. Luke's International Hospital, Tokyo, Japan.
Roberto CaporaliDepartment of Clinical Sciences and Community Health, University of Milan, G. Pini Hospital, Milan, Lombardia, Italy.
Jordi GratacósRheumatology Department, Hospital Universitario Parc Taulí, Barcelona, Spain.
Philippe GoupilleDepartment of Rheumatology, Regional University Hospital Centre Tours, Tours, Centre, France.
Soyi Liu LeageEli Lilly and Company, Indianapolis, Indiana, USA.
Sreekumar PillaiEli Lilly and Company, Indianapolis, Indiana, USA.
Peter NashGriffith University School of Medicine, Gold Coast, Queensland, Australia.ORCID 0000-0002-2571-788X
Eli Lilly (United States) · USCenter for Rheumatology · USCentre Hospitalier Universitaire de Tours · FRCorporació Sanitària Parc Taulí · ESGriffith University · AUProvidence College · USRoyal Free London NHS Foundation Trust · GBSt. Luke's International Hospital · JPUniversity of Milan · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesSPIRIT head-to-head (H2H) is a 52-week (Wk) trial comparing ixekizumab (IXE) with adalimumab (ADA) for simultaneous American College of Rheumatology (ACR)50 and Psoriasis Area and Severity Index (PASI)100 responses in 566 patients (distributed evenly across both groups) with psoriatic arthritis (PsA). IXE was superior to ADA for this primary end point at Wk24. We aimed to determine the final efficacy and safety results through Wk52 including a prespecified subgroup analysis of concomitant conventional synthetic disease-modifying anti-rheumatic drugs (csDMARD) use.

methodsSPIRIT-H2H is a Wk52 multicentre, open-label, blinded-assessor study comparing IXE and ADA in bionaïve patients with PsA. Patients were randomised 1:1 to IXE or ADA with stratification by concomitant csDMARD use and presence of moderate-to-severe plaque psoriasis. Prespecified end points at Wk24 and Wk52 included musculoskeletal, psoriasis, quality-of life outcomes, subgroup analyses and safety.

resultsA significantly higher proportion of patients treated with IXE versus ADA simultaneously achieved ACR50 and PASI100 (39% vs 26%, p<0.001), PASI100 (64% vs 41%, p<0.001) at Wk52. Efficacy of IXE and ADA was similar at Wk52 for ACR50 (49.8% vs 49.8%, p=0.924), treat-to-target outcomes, enthesitis and dactylitis resolution. Responses to IXE were consistent irrespective of concomitant csDMARD use. Significantly more patients on IXE monotherapy versus ADA monotherapy had simultaneous ACR50 and PASI100 (38% vs 19%, p=0.007), and PASI100 responses (66% vs 35%, p<0.001) at Wk52. There were no new safety findings for IXE or ADA.

conclusionsIXE provided significantly greater simultaneous joint and skin improvement than ADA through Wk52 in bionaïve patients with PsA. IXE showed better efficacy on psoriasis and performed at least as well as ADA on musculoskeletal manifestations. IXE efficacy was consistent irrespective of concomitant csDMARD use. TRIAL REGISTRATION NUMBER: NCT03151551.

Indexed as

AdalimumabAdultAntibodies, Monoclonal, HumanizedAntirheumatic AgentsArthritis, PsoriaticFemaleHumansMaleMiddle AgedTreatment OutcomeAdalimumabAntibodies, Monoclonal, HumanizedAntirheumatic Agentsixekizumabadalimumabarthritis, psoriaticinflammation

Identifiers

PMID32660977
PMCPMC7509529
OpenAlexW3041299022

What OpenQuestion holds

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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.