Evidence map›Paper›PMID 32031665›Full record

Trial reportRheumatology (Oxford, England)2020

Ixekizumab treatment of biologic-naïve patients with active psoriatic arthritis: 3-year results from a phase III clinical trial (SPIRIT-P1).

Vinod Chandran, Désirée van der Heijde, Roy M Fleischmann, Eric Lespessailles, Philip S Helliwell, Hideto Kameda, Ruben Burgos-Vargas, Janelle S Erickson, Suchitrita S Rathmann, Aubrey Trevelin Sprabery and 3 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Rheumatology (Oxford, England), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01695239 (A Multicenter, Randomized, Double-Blind, Active and Placebo-Controlled 24-Week Study Followed by Long Term Evaluation of Efficacy and Safety of Ixekizumab), which is not on this map. Cited by 36 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
36citing papers in PubMed, 4 pooled it
2.4field-weighted citation impact, top 10% 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.

NCT01695239 phase3completednot on this map

A Multicenter, Randomized, Double-Blind, Active and Placebo-Controlled 24-Week Study Followed by Long Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in Biologic Disease-Modifying Antirheumatic Drug-Naive Patients With Active Psoriatic Arthritis

TypeinterventionalSponsorEli Lilly and CompanyRan2012 to 2017Enrolled417ConditionsPsoriasis, ArthriticArmsIxekizumab, Placebo, Adalimumab
3 · Its place in the literature

Who cites it

36 citing papers in PubMed, 4 syntheses or guidelines pooled it, 53 citations in OpenAlex.

  1. Pooled it
  2. Tumor necrosis factor (TNF) inhibitors for psoriatic arthritis.The Cochrane database of systematic reviews · 2025
    Pooled it
  3. Pooled it
  4. Pooled it
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Review
  10. Article
  11. Article
  12. Psoriatic Arthritis: From Diagnosis to Treatment.Journal of clinical medicine · 2025
    Review
  13. Article
  14. Article
  15. Article
  16. Article
  17. Article
  18. Observational
  19. Article
  20. 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

13 authors at 8 institutions in 7 countries.

Vinod ChandranDivision of Rheumatology, Department of Medicine, University of Toronto, ON, Canada.
Désirée van der HeijdeDepartment of Rheumatology, Leiden University Medical Centre, Leiden, The Netherlands.
Roy M FleischmannMetroplex Clinical Research Center, University of Texas Southwestern Medical Center, Dallas, TX, USA.
Eric LespessaillesDepartment of Rheumatology CHR Orléans, University of Orléans, Orléans, France.
Philip S HelliwellUniversity of Leeds, Leeds, UK.
Hideto KamedaDepartment of Internal Medicine, Toho University, Tokyo, Japan.
Ruben Burgos-VargasDepartment of Rheumatology, Hospital General de Mexico, Mexico City, Mexico.
Janelle S EricksonEli Lilly and Company, Indianapolis, IN, USA.
Suchitrita S RathmannEli Lilly and Company, Indianapolis, IN, USA.
Aubrey Trevelin SpraberyEli Lilly and Company, Indianapolis, IN, USA.
Julie A BirtEli Lilly and Company, Indianapolis, IN, USA.
Catherine L ShulerEli Lilly and Company, Indianapolis, IN, USA.
Gaia GalloEli Lilly and Company, Indianapolis, IN, USA.
Eli Lilly (United States) · USHospital General de México · MXLeiden University Medical Center · NLMetroplex Clinical Research Center · USToho University · JPUniversité d'Orléans · FRUniversity Health Network · CAUniversity of Leeds · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThe aim was to assess the safety and efficacy of up to 156 weeks of ixekizumab (an IL-17A antagonist) treatment in PsA patients.

methodsIn a phase III study, patients naïve to biologic treatment were randomized to placebo, adalimumab 40 mg every 2 weeks (ADA; active reference) or ixekizumab 80 mg every 2 weeks (IXEQ2W) or every 4 weeks (IXEQ4W) after an initial dose of 160 mg. At week 24 (week 16 for inadequate responders), ADA (after 8-week washout) and placebo patients were re-randomized to IXEQ2W or IXEQ4W. Outcomes were evaluated using a modified non-responder imputation [linear extrapolation for radiographic progression (modified total Sharp score = 0)] during extended treatment until week 156.

resultsOf 417 patients, 381 entered the extension, and 243 of 381 (63.8%) completed the 156-week study. Incidence rates of treatment-emergent and serious adverse events, respectively, were 38.0 and 5.2 with IXEQ2W (n = 189) and 38.1 and 8.0 with IXEQ4W (n = 197). One death occurred (IXEQ4W). With IXEQ2W and IXEQ4W, respectively, the response rates persisted to week 156 as measured by the ACR response ≥20% (62.5 and 69.8%), ≥50% (56.1 and 51.8%) and ≥70% (43.8 and 33.4%), psoriasis area and severity index (PASI) 75 (69.1 and 63.5%), PASI 90 (64.5 and 51.2%) and PASI 100 (60.5 and 43.6%). Inhibition of radiographic progression also persisted to week 156 in 61% of IXEQ2W and 71% of IXEQ4W patients.

conclusionIn this 156-week study of ixekizumab, the safety profile remained consistent with previous reports, and improvements in signs and symptoms of PsA were observed, including persistent low rates of radiographic progression.

trial registrationClinicalTrials.gov, http://clinicaltrials.gov, NCT01695239, EudraCT 2011-002326-49.

Indexed as

Antibodies, Monoclonal, HumanizedAntirheumatic AgentsArthritis, PsoriaticFemaleHumansIntention to Treat AnalysisInterleukin-17MaleMiddle AgedPsoriasisQuality of LifeSafetySeverity of Illness IndexTreatment OutcomeAntibodies, Monoclonal, HumanizedAntirheumatic AgentsInterleukin-17ixekizumabDMARDs (biologic)ixekizumabpsoriasispsoriatic arthritisspondyloarthritis

Identifiers

PMID32031665
PMCPMC7516094
OpenAlexW3004681236

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.