Evidence map›Paper›PMID 29945203›Full record

Trial reportRheumatology (Oxford, England)2018

Ixekizumab improves patient-reported outcomes up to 52 weeks in bDMARD-naïve patients with active psoriatic arthritis (SPIRIT-P1).

Alice B Gottlieb, Vibeke Strand, Mitsumasa Kishimoto, Philip Mease, Diamant Thaçi, Julie Birt, Chin H Lee, Catherine L Shuler, Chen-Yen Lin, Dafna D Gladman

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
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 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 17 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 5 pooled it
3.0field-weighted citation impact, top 9% 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

17 citing papers in PubMed, 5 syntheses or guidelines pooled it, 31 citations in OpenAlex.

  1. Tumor necrosis factor (TNF) inhibitors for psoriatic arthritis.The Cochrane database of systematic reviews · 2025
    Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Trial
  7. Observational
  8. Biologic and Small-Molecule Therapies for Moderate-to-Severe Psoriasis: Focus on Psoriasis Comorbidities.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2023
    Review
  9. Review
  10. Article
  11. Review
  12. Review
  13. Article
  14. Article
  15. Article
  16. Review
  17. 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

10 authors at 7 institutions in 4 countries.

Alice B GottliebDepartment of Dermatology, New York Medical College, Metropolitan Hospital, New York, NY.
Vibeke StrandDivision of Immunology/Rheumatology, Stanford University, Palo Alto, CA, USA.
Mitsumasa KishimotoSt Luke's International Hospital, Immuno-Rheumatology Centre, Tokyo, Japan.
Philip MeaseDepartment of Rheumatology, Swedish Medical Centre, Seattle, WA, USA.
Diamant ThaçiComprehensive Centre for Inflammation Medicine, University Hospital Schleswig-Holstein, Campus Lübeck, Lübeck, Germany.
Julie BirtEli Lilly and Company, Indianapolis, IN, USA.
Chin H LeeEli Lilly and Company, Indianapolis, IN, USA.
Catherine L ShulerEli Lilly and Company, Indianapolis, IN, USA.
Chen-Yen LinEli Lilly and Company, Indianapolis, IN, USA.
Dafna D GladmanDivision of Rheumatology, Department of Medicine, University of Toronto, Krembil Research Institute, Toronto Western Hospital, Toronto, Ontario, Canada.
Eli Lilly (United States) · USKrembil Research InstituteNew York Medical College · USStanford University · USSt. Luke's International Hospital · JPUniversity of Lübeck · DEUniversity of Washington · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Objective: To report patient-reported outcomes of patients with PsA treated with ixekizumab up to 52 weeks. Methods: In SPIRIT-P1, biologic-naïve patients with active PsA were randomized to ixekizumab 80 mg every 4 weeks (IXEQ4W; N = 107) or every 2 weeks (IXEQ2W; N = 103) following a 160 mg starting dose, adalimumab 40 mg every 2 weeks (ADA; N = 101) or placebo (PBO; N = 106) during the initial 24-week double-blind treatment period. At week 24 (week 16 for inadequate responders), ADA (8-week washout before starting ixekizumab) and PBO patients were re-randomized to IXEQ2W or IXEQ4W. Patients receiving ixekizumab at week 24 received the same dose during the extension period (EP) to week 52. Patients completed measures including the Dermatology Life Quality Index (DLQI), Itch Numeric Rating Scale, 36-Item Short Form Health Survey version 2, European Quality of Life 5 Dimensions Visual Analogue Scale and Work Productivity and Activity Impairment Questionnaire-Specific Health Problem. Results: The IXEQ4W, IXEQ2W and ADA groups reported significant improvements in DLQI at week 24; 22% (PBO), 53% (IXEQ4W), 63% (IXEQ2W) and 54% (ADA) of patients reported DLQI scores of 0/1. The IXEQ4W, IXEQ2W and ADA groups reported significant improvements in Itch Numeric Rating Scale, 36-Item Short Form Health Survey version 2 physical component summary and some domain scores, and European Quality of Life 5 Dimensions Visual Analogue Scale at weeks 12 and 24; and in three of four Work Productivity and Activity Impairment Questionnaire-Specific Health Problem domains at week 24. Results are also presented through week 52 for the EP. Conclusion: In biologic-naïve patients with active PsA, ixekizumab significantly improved skin symptoms, health-related quality of life and work productivity. Trial Registration: ClinicalTrials.gov, http://clinicaltrials.gov, NCT01695239; EU Clinical Trials Register, https://www.clinicaltrialsregister.eu, EudraCT2011-002326-49.

Indexed as

AdalimumabAdultAntibodies, Monoclonal, HumanizedAntirheumatic AgentsArthritis, PsoriaticDermatologic AgentsDouble-Blind MethodEfficiencyFemaleHumansMaleMiddle AgedPatient Reported Outcome MeasuresQuality of LifeSurveys and QuestionnairesTime FactorsAdalimumabAntibodies, Monoclonal, HumanizedAntirheumatic AgentsDermatologic Agentsixekizumab

Identifiers

PMID29945203
PMCPMC6152421
OpenAlexW2810908182

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.