Evidence map›Paper›PMID 30886974›Full record

ArticleBMC rheumatology2018

Achieving minimal disease activity in psoriatic arthritis predicts meaningful improvements in patients' health-related quality of life and productivity.

Laura C Coates, Ana-Maria Orbai, Akimichi Morita, Olivier Benichou, Lisa Kerr, David H Adams, Catherine L Shuler, Julie Birt, Philip S Helliwell

2 registry-linked trialsAbstract read
In one paragraph

Article in BMC rheumatology, 2018. 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 22 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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

22 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. Article
  12. Article
  13. Article
  14. Observational
  15. Article
  16. Article
  17. Article
  18. Article
  19. Article
  20. Observational
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.

Laura C CoatesNuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, Windmill Road, Oxford, OX3 7LD UK.ORCID 0000-0002-4756-663X
Ana-Maria Orbai2Johns Hopkins University School of Medicine, Baltimore, MD USA.
Akimichi Morita3Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.
Olivier BenichouLaboratoires Lilly France, Neuilly, France.
Lisa Kerr5Eli Lilly and Company, Indianapolis, IN USA.
David H Adams5Eli Lilly and Company, Indianapolis, IN USA.
Catherine L Shuler5Eli Lilly and Company, Indianapolis, IN USA.
Julie Birt5Eli Lilly and Company, Indianapolis, IN USA.
Philip S Helliwell6University of Leeds School of Medicine, Leeds, UK.

Funding

Department of Health CS-2016-16-016
6 · The paper itself

Abstract

backgroundAlthough psoriatic arthritis is complex and involves multiple domains, recent advances in treatments have made remission or near-remission of most symptoms a potentially achievable goal for many patients. We sought to evaluate whether achieving minimal disease activity (MDA) criteria represented meaningful improvement from the patient perspective.

methodsData were combined from two randomized, multinational, 24 week clinical studies of ixekizumab, a high-affinity monoclonal antibody selectively targeting interleukin-17A, in biological drug-naïve or experienced adults. MDA required 5 of 7 of: tender joint count ≤1; swollen joint count ≤1; Psoriasis Area and Severity Index total score ≤ 1 or body surface area ≤ 3%; patient's assessment of pain visual analogue scale (VAS) ≤15; patient's global assessment of disease activity VAS ≤20; Health Assessment Questionnaire Disability Index ≤0.5; and tender entheseal points ≤ 1. MDA responders and non-responders were compared for mean change from baseline on the 36-Item Short Form Health Survey (SF-36), European Quality of Life 5 Dimension 5 Level Health Questionnaire (EQ-5D-5 L); EQ-5D-5 L VAS; and Work Productivity and Activity Impairment-Specific Health Problem (WPAI-SHP) questionnaire.

resultsMDA responders had significantly greater improvements versus non-responders in each SF-36 domain and in the SF-36 physical summary score; improvements were also greater in the EQ-5D-5 L and EQ-5D-5 L VAS, and in 3 of the 4 WPAI-SHP domains. MDA responders were more likely to achieve minimal clinically important differences than non-responders.

conclusionThese findings support MDA response as being strongly associated with achieving improved disease status based on measures of patient reported health-related quality of life and productivity.

trial registrationSPIRIT-P1, NCT01695239, First Posted: September 27, 2012; and SPIRIT-P2, NCT02349295, First Posted: January 28, 2015.

Indexed as

IxekizumabMinimal disease activityPsoriatic arthritis

Identifiers

PMID30886974
PMCPMC6390571

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.