Evidence map›Paper›PMID 35397092›Full record

ArticleRheumatology and therapy2022

Responses to Ixekizumab in Male and Female Patients with Psoriatic Arthritis: Results from Two Randomized, Phase 3 Clinical Trials.

Lihi Eder, Hans-Peter Tony, Satish Odhav, Eva Galindez Agirregoikoa, Mariusz Korkosz, Sergio Schwartzman, Aubrey Trevelin Sprabery, Amanda M Gellett, So Young Park, Clinton C Bertram and 1 more

2 registry-linked trialsOpen access · goldAbstract read
In one paragraph

Article in Rheumatology and therapy, 2022. 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 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
2.4field-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.

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

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 16 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Observational
  5. Review
  6. Article
  7. Article
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 7 institutions in 5 countries.

Lihi EderDepartment of Medicine, Women's College Hospital, University of Toronto, 76 Grenville St, 6th Floor, Toronto, ON, Canada. Lihi.eder@wchospital.ca.
Hans-Peter TonyRheumatology/Clinical Immunology, University Hospital of Würzburg, Würzburg, Germany.
Satish OdhavArthritis Clinic, Jackson, TN, USA.
Eva Galindez AgirregoikoaRheumatology Department, University Hospital Basurto, Bilbao, Spain.
Mariusz KorkoszJagiellonian University Medical College, Kraków, Poland.
Sergio SchwartzmanThe Hospital for Special Surgery, New York, NY, USA.
Aubrey Trevelin SpraberyEli Lilly and Company, Indianapolis, IN, USA.
Amanda M GellettEli Lilly and Company, Indianapolis, IN, USA.
So Young ParkEli Lilly and Company, Indianapolis, IN, USA.
Clinton C BertramEli Lilly and Company, Indianapolis, IN, USA.
Alexis OgdiePenn Medicine, Philadelphia, PA, USA.
Eli Lilly (United States) · USHospital de Basurto · ESHospital for Special Surgery · USJagiellonian University · PLPenn Center for AIDS Research · USUniversitätsklinikum Würzburg · DEWomen's College Hospital · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionDifferences in psoriatic arthritis (PsA) treatment response between sexes for ixekizumab, an interleukin-17A antagonist, are largely unexplored. This analysis used data from randomized clinical trials (RCTs) evaluating ixekizumab to study differences in treatment response between male and female patients with PsA.

methodsWe used pooled data from patients enrolled in SPIRIT-P1 and SPIRIT-P2 (NCT01695239 and NCT02349295, respectively), phase 3 RCTs evaluating ixekizumab every 4 and 2 weeks in patients with active PsA. Subgroups of patients were defined by sex (male, female). Efficacy was measured by the proportion of male and female patients achieving American College of Rheumatology 20%/50%/70% improvement criteria (ACR20/50/70), minimal disease activity or very low disease activity (MDA/VLDA), and Disease Activity Index for Psoriatic Arthritis (DAPSA) scores representing low disease activity (LDA) or remission through week 156. Changes from baseline in components of the above measures were also assessed through week 156.

resultsCompared to male patients at baseline, female patients were older, had higher body mass index and lower C-reactive protein levels, and had worse tender joint count, Health Assessment Questionnaire Disability Index, and Leeds Enthesitis Index scores. Through week 156, female patients in all treatment arms had lower response rates than male patients in all analyzed composite measures (ACR20/50/70; MDA/VLDA; DAPSA LDA/remission), with significant differences observed at multiple timepoints in both ixekizumab treatment arms. Female patients also had smaller numeric changes from baseline in the composite measures' individual components.

conclusionCompared to female patients, male patients had greater response rates in ACR20/50/70, MDA/VLDA, and DAPSA LDA/remission and numerically larger improvements in these measures' individual components, although clinical significance is unclear. Continued efforts to understand sex differences in treatment response may provide insights that can help optimize clinical decision making.

trial registrationClinicalTrials.gov identifiers, NCT01695239 and NCT02349295.

Indexed as

IxekizumabOutcome measuresPsoriatic arthritisSex differencesWomen’s health

Identifiers

PMID35397092
PMCPMC9127019
OpenAlexW4223530465

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.