Evidence map›Paper›PMID 33682378›Full record

ArticleArthritis & rheumatology (Hoboken, N.J.)2021

Withdrawing Ixekizumab in Patients With Psoriatic Arthritis Who Achieved Minimal Disease Activity: Results From a Randomized, Double-Blind Withdrawal Study.

Laura C Coates, Sreekumar G Pillai, Hasan Tahir, Ivo Valter, Vinod Chandran, Hideto Kameda, Masato Okada, Lisa Kerr, Denise Alves, So Young Park and 7 more

Open access · hybridAbstract read
In one paragraph

Article in Arthritis & rheumatology (Hoboken, N.J.), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 2 pooled it
3.7field-weighted citation impact, top 6% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 2 syntheses or guidelines pooled it, 31 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Trial
  4. Observational
  5. Article
  6. Review
  7. Article
  8. Article
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  11. Article
  12. 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

17 authors at 9 institutions in 5 countries.

Laura C CoatesUniversity of Oxford, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences and Oxford University Hospitals NHS Foundation Trust, NIHR Oxford Biomedical Research Centre, Oxford, UK.ORCID 0000-0002-4756-663X
Sreekumar G PillaiEli Lilly and Company, Indianapolis, Indiana.
Hasan TahirRoyal Free London NHS Trust and University College London, Division of Medicine, London, UK.
Ivo ValterCenter for Clinical and Basic Research, Tallinn, Estonia.
Vinod ChandranUniversity of Toronto and Krembil Research Institute, University Health Network, Toronto, Ontario, Canada, and Memorial University of Newfoundland, St. John's, Newfoundland, Canada.
Hideto KamedaToho University, Tokyo, Japan.ORCID 0000-0002-4330-5782
Masato OkadaImmuno-Rheumatology Center, St. Luke's International Hospital, Tokyo.
Lisa KerrEli Lilly and Company, Indianapolis, Indiana.
Denise AlvesEli Lilly and Company, Indianapolis, Indiana.
So Young ParkEli Lilly and Company, Indianapolis, Indiana.
David H AdamsEli Lilly and Company, Indianapolis, Indiana.
Gaia GalloEli Lilly and Company, Indianapolis, Indiana.
Matthew M HuffordEli Lilly and Company, Indianapolis, Indiana.
Maja HojnikEli Lilly and Company, Indianapolis, Indiana.
Philip J MeaseSwedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle.
Arthur KavanaughUniversity of California San Diego.
SPIRIT-P3 Study Group
Eli Lilly (United States) · USEast Tallinn Central Hospital · EEMemorial University of Newfoundland · CANuffield Orthopaedic Centre · GBRoyal Free London NHS Foundation Trust · GBSt. Luke's International Hospital · JPSwedish Medical Center · USToho University · JPUniversity of California San Diego · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate the effect of withdrawing ixekizumab in patients with psoriatic arthritis (PsA) in whom minimal disease activity (MDA) has been achieved after open-label ixekizumab treatment.

methodsSPIRIT-P3 was a multicenter, randomized, double-blind withdrawal study of biologic treatment-naive adult patients with PsA who were treated with open-label ixekizumab for 36 weeks (160 mg at week 0, then 80 mg every 2 weeks). Patients in whom MDA was sustained for >3 consecutive months were randomized 1:1, between weeks 36 and 64, to undergo blinded withdrawal of ixekizumab treatment (placebo) or to continue ixekizumab treatment every 2 weeks up to week 104. The primary efficacy end point was time to relapse (loss of MDA) for randomized patients. Patients who experienced a relapse were re-treated with ixekizumab every 2 weeks up to week 104.

resultsA total of 394 patients were enrolled and received open-label ixekizumab every 2 weeks. Of those patients, 158 (40%) achieved sustained MDA and were randomized to undergo withdrawal of ixekizumab treatment (placebo every 2 weeks; n = 79) or to continue ixekizumab treatment every 2 weeks (n = 79). Disease relapse occurred more rapidly with treatment withdrawal (median 22.3 weeks [95% confidence interval (95% CI) 16.1-28.3]) compared to those who continued treatment with ixekizumab (median not estimable; P < 0.0001). Sixty-seven patients (85%) compared to 30 patients (38%) experienced relapse in the placebo group and the continued treatment group, respectively. Median time to achieving MDA again with re-treatment was 4.1 weeks (95% CI 4.1-4.3); in 64 of 67 patients (96%) who experienced relapse with treatment withdrawal, MDA was achieved again with re-treatment. Safety was consistent with the known safety profile for ixekizumab.

conclusionContinued ixekizumab therapy is superior to ixekizumab withdrawal in maintaining low disease activity in biologic treatment-naive patients with PsA. Re-treatment with ixekizumab following a relapse may restore disease control in cases of treatment interruption.

Indexed as

AdultAntibodies, Monoclonal, HumanizedAntirheumatic AgentsArthritis, PsoriaticDermatologic AgentsDouble-Blind MethodFemaleHumansMaleMiddle AgedRemission InductionTreatment OutcomeWithholding TreatmentAntibodies, Monoclonal, HumanizedAntirheumatic AgentsDermatologic Agentsixekizumab

Identifiers

PMID33682378
PMCPMC8457232
OpenAlexW3132803064

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.