Evidence map›Paper›PMID 30696483›Full record

Trial reportArthritis research & therapy2019

Ixekizumab and complete resolution of enthesitis and dactylitis: integrated analysis of two phase 3 randomized trials in psoriatic arthritis.

Dafna D Gladman, Ana-Maria Orbai, Uta Klitz, James Cheng-Chung Wei, Gaia Gallo, Julie Birt, Suchitrita Rathmann, David Shrom, Helena Marzo-Ortega

2 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Arthritis research & therapy, 2019. 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 24 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 1 pooled it
6.6field-weighted citation impact, top 3% 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

24 citing papers in PubMed, 1 synthesis or guideline pooled it, 52 citations in OpenAlex.

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  12. Consensus on targeted drug therapy for spondyloarthritis.Rheumatology and immunology research · 2023
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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 6 institutions in 5 countries.

Dafna D GladmanDivision of Rheumatology, Department of Medicine, Centre for Prognosis Studies in The Rheumatic Diseases, University of Toronto, Krembil Research Institute, Toronto Western Hospital, 399 Bathurst St. 1E-410B, Toronto, Ontario, M5T 2S8, Canada. dafna.gladman@utoronto.ca.
Ana-Maria OrbaiPsoriatic Arthritis Program, Division of Rheumatology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Uta KlitzRheumazentrum Ruhrgebiet, Claudiusstr 45, 44649, Herne, Germany.
James Cheng-Chung WeiInstitute of Medicine, Chinese Medicine Clinical Trial Center, Chung Shan Medical University Hospital, Taichung, Taiwan.
Gaia GalloEli Lilly and Company, Indianapolis, IN, USA.
Julie BirtEli Lilly and Company, Indianapolis, IN, USA.
Suchitrita RathmannEli Lilly and Company, Indianapolis, IN, USA.
David ShromEli Lilly and Company, Indianapolis, IN, USA.
Helena Marzo-OrtegaNIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust and Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.
Eli Lilly (United States) · USChung Shan Medical University Hospital · TWJohns Hopkins University · USKrembil Research InstituteLeeds Teaching Hospitals NHS Trust · GBRheumazentrum Ruhrgebiet · DE

Funding

Eli Lilly and Company n/a
6 · The paper itself

Abstract

backgroundIxekizumab improves signs/symptoms of psoriatic arthritis (PsA). We present an integrated analysis of baseline disease burden and post-baseline outcomes in ixekizumab-treated patients with enthesitis or dactylitis.

methodsData from SPIRIT-P1 and SPIRIT-P2 were integrated. Patients with PsA were randomized to 80-mg ixekizumab every 4 weeks (IXEQ4W) or 2 weeks (IXEQ2W), after a 160-mg starting dose, or to placebo. Inadequate responders at week 16 received rescue therapy. Among patients with baseline enthesitis (Leeds Enthesitis Index [LEI] > 0) or dactylitis (Leeds Dactylitis Index-Basic [LDI-B] > 0), baseline characteristics and disease burden were reported. At week 24, LEI and LDI-B (percentage of patients with resolution [LEI = 0, LDI-B = 0]) were assessed. In pooled treatment groups, the impact of enthesitis or dactylitis resolution on health-related quality of life (HRQoL) (EuroQol-5 Dimensions Visual Analogue Scale [EQ-5D VAS]), physical function (Health Assessment Questionnaire-Disability Index [HAQ-DI]), and pain was assessed.

resultsThe integrated analysis set comprised 679 patients; of these, 60% (n = 403 of 675) had baseline enthesitis (LEI > 0) and 23% (n = 155 of 676) had baseline dactylitis (LDI > 0). At week 24, ixekizumab-treated patients experienced significantly more resolution than placebo of enthesitis (39% IXEQ4W, 35% IXEQ2W, 21% placebo) and dactylitis (78% IXEQ4W, 65% IXEQ2W, 24% placebo). Furthermore, at entheseal points measured by the LEI, ixekizumab-treated patients had significantly higher resolution of enthesitis compared to placebo. At week 24, among all placebo- and ixekizumab-treated patients, resolution of enthesitis was associated with improvements in function and HRQoL whereas dactylitis resolution was associated with more limited improvements. The least squares mean HAQ-DI improvements from baseline were - 0.44 and - 0.25 for patients who did/did not resolve enthesitis, and - 0.41 and - 0.31 for patients who did/did not resolve dactylitis. EQ-5D VAS improvements were 12.3 and 5.8 for patients who did/did not resolve enthesitis, and 10.8 and 9.8 for patients who did/did not resolve dactylitis.

conclusionsAmong patients with pre-existing enthesitis or dactylitis, IXEQ2W- and IXEQ4W-treatment resulted in significant improvements in enthesitis and dactylitis. Enthesitis resolution was associated with improvements in patients' function, pain, and HRQoL.

trial registrationClinicalTrials.gov, NCT01695239 , registered on September 25, 2012, and NCT02349295 , registered on October 10, 2014.

Indexed as

AdultAntibodies, Monoclonal, HumanizedArthritis, PsoriaticClinical Trials, Phase III as TopicDermatologic AgentsDrug Administration ScheduleEnthesopathyFemaleFingersHumansInflammationMaleMiddle AgedQuality of LifeTreatment OutcomeAntibodies, Monoclonal, HumanizedDermatologic AgentsixekizumabDactylitisEnthesitisIxekizumabPsoriatic arthritis

Identifiers

PMID30696483
PMCPMC6350390
OpenAlexW2920733805

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.