Evidence map›Paper›PMID 27553214›Full record

Trial reportAnnals of the rheumatic diseases2017

Ixekizumab, an interleukin-17A specific monoclonal antibody, for the treatment of biologic-naive patients with active psoriatic arthritis: results from the 24-week randomised, double-blind, placebo-controlled and active (adalimumab)-controlled period of the phase III trial SPIRIT-P1.

Philip J Mease, Désirée van der Heijde, Christopher T Ritchlin, Masato Okada, Raquel S Cuchacovich, Catherine L Shuler, Chen-Yen Lin, Daniel K Braun, Chin H Lee, Dafna D Gladman and 1 more

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

Trial report in Annals of the rheumatic diseases, 2017. 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 280 papers, 32 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
280citing papers in PubMed, 32 pooled it
31.6field-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.

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

280 citing papers in PubMed, 32 syntheses or guidelines pooled it, 559 citations in OpenAlex.

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  6. Tumor necrosis factor (TNF) inhibitors for psoriatic arthritis.The Cochrane database of systematic reviews · 2025
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  19. Brazilian Society of Rheumatology 2020 guidelines for psoriatic arthritis.Advances in rheumatology (London, England) · 2021
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220 more citing papers are in PubMed but not listed here.

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

11 authors at 6 institutions in 4 countries.

Philip J MeaseDepartment of Rheumatology, Swedish Medical Center, and University of Washington, Seattle, Washington, USA.
Désirée van der HeijdeDepartment of Rheumatology, Leiden University Medical Centre, Leiden, The Netherlands.ORCID http://orcid.org/0000-0002-5781-158X
Christopher T RitchlinAllergy, Immunology, & Rheumatology Division, University of Rochester Medical Center, Rochester, New York, USA.
Masato OkadaImmuno-Rheumatology Center, St. Luke's International Hospital, Tokyo, Japan.
Raquel S CuchacovichEli Lilly and Company, Indianapolis, Indiana, USA.
Catherine L ShulerEli Lilly and Company, Indianapolis, Indiana, USA.
Chen-Yen LinEli Lilly and Company, Indianapolis, Indiana, USA.
Daniel K BraunEli Lilly and Company, Indianapolis, Indiana, USA.
Chin H LeeEli Lilly and Company, Indianapolis, Indiana, USA.
Dafna D GladmanDivision of Rheumatology, Department of Medicine, University of Toronto, Toronto, Ontario, Canada.
SPIRIT-P1 Study Group
Eli Lilly (United States) · USLeiden University Medical Center · NLSt. Luke's International Hospital · JPSwedish Medical Center · USUniversity of Rochester Medical Center · USUniversity of Toronto · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo assess the safety and efficacy of ixekizumab, a monoclonal antibody that inhibits interleukin-17A, in a double-blind phase III trial enrolling patients with active psoriatic arthritis (PsA).

methodsPatients naive to biologic therapy with active PsA were randomised to subcutaneous injections of placebo (N=106), adalimumab 40 mg once every 2 weeks (active reference; N=101), ixekizumab 80 mg once every 2 weeks (IXEQ2W) (N=103), or ixekizumab 80 mg once every 4 weeks (IXEQ4W) (N=107). Both ixekizumab regimens included a 160-mg starting dose. The primary objective was to assess the superiority of IXEQ2W or IXEQ4W versus placebo as measured by the proportion of patients achieving an American College of Rheumatology 20 (ACR20) response at week 24.

resultsSignificantly more patients treated with ixekizumab achieved an ACR20 response with IXEQ2W (62.1%) or IXEQ4W (57.9%) than placebo (30.2%) (p≤0.001; non-responder imputation method). Disease activity and functional disability were significantly improved with both ixekizumab doses versus placebo at weeks 12 and 24, and there was significantly less progression of structural damage at week 24 (p≤0.01). Clearance of plaque psoriasis was greater with ixekizumab than placebo (p≤0.001). Efficacy results with adalimumab, the active reference arm, showed significant improvements versus placebo. Treatment-emergent adverse events were more frequent with ixekizumab (65.7-66.4%) and adalimumab (64.4%) than placebo (47.2%) (p<0.05).

conclusionsIn biologic-naive patients with active PsA, ixekizumab treatment resulted in improvements in disease activity and physical function, as well as in the inhibition of structural damage progression. Overall, adverse events were more frequent in all active groups compared with placebo. TRIAL REGISTRATION NUMBER: NCT01695239; EudraCT2011-002326-49; Results.

Indexed as

AdalimumabAdultAntibodies, Monoclonal, HumanizedAntirheumatic AgentsArthritis, PsoriaticDouble-Blind MethodFemaleHumansInterleukin-17MaleMiddle AgedTreatment OutcomeAdalimumabAntibodies, Monoclonal, HumanizedAntirheumatic AgentsInterleukin-17ixekizumabDMARDs (biologic)Psoriatic ArthritisSpondyloarthritisTreatment

Identifiers

PMID27553214
PMCPMC5264219
OpenAlexW2512436288

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.