Evidence map›Paper›PMID 33499913›Full record

Trial reportArthritis research & therapy2021

Ixekizumab, with or without concomitant methotrexate, improves signs and symptoms of PsA: week 52 results from Spirit-P1 and Spirit-P2 studies.

Bernard Combe, Tsen-Fang Tsai, J Eugene Huffstutter, Aubrey Trevelin Sprabery, Chen-Yen Lin, So Young Park, Andris Kronbergs, Matthew M Hufford, Peter Nash

2 registry-linked trialsOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Arthritis research & therapy, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
2.5field-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
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

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 18 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Article
  6. Monotherapy or combination therapy in PsA: current aspects.Therapeutic advances in musculoskeletal disease · 2024
    Review
  7. Article
  8. Article
  9. Is there still a place for methotrexate in severe psoriatic arthritis?Therapeutic advances in musculoskeletal disease · 2022
    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

9 authors at 5 institutions in 4 countries.

Bernard CombeDepartment of Rheumatology, CHU Montpellier, Montpellier University, 34090, Montpellier, France. b-combe@chu-montpellier.fr.ORCID 0000-0003-4002-1861
Tsen-Fang TsaiNational Taiwan University, Taipei, Taiwan.
J Eugene HuffstutterArthritis Associates, Hixson, TN, USA.
Aubrey Trevelin SpraberyEli Lilly and Company, Indianapolis, IN, USA.
Chen-Yen LinEli Lilly and Company, Indianapolis, IN, USA.
So Young ParkEli Lilly and Company, Indianapolis, IN, USA.
Andris KronbergsEli Lilly and Company, Indianapolis, IN, USA.
Matthew M HuffordEli Lilly and Company, Indianapolis, IN, USA.
Peter NashSchool of Medicine, Griffith University, Brisbane, Australia.
Eli Lilly (United States) · USCarolina Arthritis Associates · USGriffith University · AUNational Taiwan University · TWUniversité de Montpellier · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe efficacy and safety of ixekizumab (IXE) with and without continuous concomitant methotrexate (MTX), for up to 52 weeks of treatment, were evaluated in patients with active psoriatic arthritis (PsA).

methodsPatients with active PsA who were biologic-naive (SPIRIT-P1) or had prior inadequate response to tumor necrosis factor inhibitors (SPIRIT-P2) were randomized to 80 mg IXE every 4 (IXE Q4W) or 2 weeks (IXE Q2W), after a 160-mg initial dose. In this post hoc analysis, efficacy and safety were assessed up to week 52 in the subgroups of patients who received (i) IXE as monotherapy and (ii) IXE along with a stable dose of MTX (no dose tapering or increase). Efficacy outcomes included, but were not limited to, the percentage of patients achieving the American College of Rheumatology (ACR) responses.

resultsOut of 455 patients initially randomized to IXE, 177 (38.9%) received monotherapy, 230 (50.5%) had concomitant MTX use, and 48 (10.5%) had other concomitant medication. Overall, 183 (40.2%) received IXE with a stable dose of concomitant MTX for 1 year. At week 52, the percentage of patients achieving ACR20/50/70 responses in IXE Q4W monotherapy versus concomitant MTX groups were 66.3% versus 55.3%, 48.4% versus 38.8%, and 35.8% versus 27.1%, respectively; these responses were generally similar with IXE Q2W. The safety profiles were similar between patients receiving IXE with or without concomitant MTX.

conclusionsIn this post hoc analysis, treatment with IXE demonstrated sustained efficacy in patients with PsA up to 1 year of treatment, with or without concomitant MTX therapy.

trial registrationClinicalTrials.gov NCT01695239 and NCT02349295 .

Indexed as

Antirheumatic AgentsArthritis, PsoriaticAntibodies, Monoclonal, HumanizedDouble-Blind MethodDrug Therapy, CombinationHumansMethotrexateTreatment OutcomeAntibodies, Monoclonal, HumanizedAntirheumatic AgentsixekizumabMethotrexatecDMARDsIxekizumabMethotrexatePsoriatic arthritis

Identifiers

PMID33499913
PMCPMC7839215
OpenAlexW3106628985

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.