Evidence map›Paper›PMID 30053162›Full record

Trial reportRheumatology (Oxford, England)2018

Safety and efficacy of ixekizumab in patients with PsA and previous inadequate response to TNF inhibitors: week 52 results from SPIRIT-P2.

Mark C Genovese, Benard Combe, Joel M Kremer, Tsen-Fang Tsai, Frank Behrens, David H Adams, Chin Lee, Lisa Kerr, Peter Nash

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Rheumatology (Oxford, England), 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02349295 (A Multicenter, Randomized, Double-Blind, Placebo Controlled 24-Week Study Followed by Long Term Evaluation of Efficacy and Safety of Ixekizumab), which is not on this map. Cited by 21 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 6 pooled it
2.3field-weighted citation impact, top 11% 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.

NCT02349295 phase3completednot on this map

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

TypeinterventionalSponsorEli Lilly and CompanyRan2014 to 2019Enrolled363ConditionsPsoriatic ArthritisArmsPlacebo, Ixekizumab 80 mg Q4W, Ixekizumab 80 mg Q2W
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 6 syntheses or guidelines pooled it, 45 citations in OpenAlex.

  1. Pooled it
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  6. Pooled it
  7. Trial
  8. Review
  9. Article
  10. Sequencing of Targeted Therapy in Psoriasis: Does it Matter?American journal of clinical dermatology · 2024
    Review
  11. Article
  12. Article
  13. Review
  14. Consensus on targeted drug therapy for spondyloarthritis.Rheumatology and immunology research · 2023
    Article
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  17. 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

9 authors at 7 institutions in 5 countries.

Mark C GenoveseDivision of Immunology and Rheumatology, Stanford University, Palo Alto, CA, USA.
Benard CombeDepartement de Rhumatologie, CHU Montpellier, Montpellier University, Montpellier, France.
Joel M KremerAlbany Medical College and The Center for Rheumatology, Albany, NY, USA.
Tsen-Fang TsaiNational Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan, Republic of China.
Frank BehrensDepartment of Rheumatology and Fraunhofer Institute IME, Translational Medicine and Pharmacology, Goethe University, Frankfurt am Main, Germany.
David H AdamsEli Lilly and Company, Indianapolis, IN, USA.
Chin LeeEli Lilly and Company, Indianapolis, IN, USA.
Lisa KerrEli Lilly and Company, Indianapolis, IN, USA.
Peter NashDepartment of Medicine, University of Queensland, Rheumatology Research Unit Sunshine Coast, Queensland, Australia.
Eli Lilly (United States) · USAlbany Medical Center Hospital · USFraunhofer Institute for Translational Medicine and Pharmacology · DENational Taiwan University Hospital · TWStanford University · USThe University of Queensland · AUUniversité de Montpellier · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Objectives: To assess the long-term safety and efficacy of ixekizumab, an IL-17A antagonist, in patients with active PsA. Methods: In SPIRIT-P2 (NCT02349295), patients (n = 363) with previous inadequate response to TNF inhibitors entered the double-blind period (weeks 0-24) and received placebo or ixekizumab 80 mg every 4 weeks (IXEQ4W) or every 2 weeks (IXEQ2W) following a 160-mg starting dose at week 0. During the extension period (weeks 24-156), patients maintained their original ixekizumab dose, and placebo patients received IXEQ4W or IXEQ2W (1:1). We present the accumulated safety findings (week 24 up to 156) at the time of this analysis for patients who entered the extension period (n = 310). Exposure-adjusted incidence rates (IRs) per 100 patient years are presented. ACR responses are presented on an intent-to-treat basis using non-responder imputation up to week 52. Results: From week 24 up to 156 (with 228 patient years of ixekizumab exposure), 140 [61.3 IR] and 15 (6.6 IR) patients reported infections and serious adverse events, respectively. Serious adverse events included one death and four serious infections. In all patients initially treated with IXEQ4W and IXEQ2W at week 0 (non-responder imputation), ACR20 (61 and 51%), ACR50 (42 and 33%) and ACR70 (26 and 18%) responses persisted out to week 52. Placebo patients re-randomized to ixekizumab demonstrated efficacy as measured by ACR responses at week 52. Conclusion: During the extension period, the overall safety profile of ixekizumab remained consistent with that observed with the double-blind period, and clinical improvements persisted up to 1 year.

Indexed as

AdultAgedAntibodies, Monoclonal, HumanizedAntirheumatic AgentsArthritis, PsoriaticDouble-Blind MethodFemaleHumansMaleMiddle AgedRetreatmentTherapeuticsTreatment OutcomeTumor Necrosis Factor-alphaAntibodies, Monoclonal, HumanizedAntirheumatic AgentsixekizumabTumor Necrosis Factor-alpha

Identifiers

PMID30053162
PMCPMC6199530
OpenAlexW2883072230

What OpenQuestion holds

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LicenceCC BY-NC
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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.