Evidence map›Paper›PMID 31655974›Full record

Trial reportQuality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation2020

Ixekizumab treatment and the impact on SF-36: results from three pivotal phase III randomised controlled trials in patients with moderate-to-severe plaque psoriasis.

Richard G B Langley, Kristian Reich, Vibeke Strand, Steven R Feldman, Carle Paul, Kenneth Gordon, Richard B Warren, Darryl Toth, Enkeleida Nikaï, Baojin Zhu and 7 more

Abstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–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.

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

1 citing paper in PubMed.

  1. 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.

Richard G B LangleyDivision of Dermatology, Department of Medicine, Dalhousie University, 6054 Coburg Road, Halifax, NS, Canada. richardgblangley@gmail.com.
Kristian ReichTranslational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, and Skinflammation® Center, Hamburg, Germany.
Vibeke StrandBiopharmaceutical Consultant, Portola Valley, CA, USA.
Steven R FeldmanWake Forest University Health Sciences, Winston-Salem, NC, USA.
Carle PaulToulouse University, Toulouse, France.
Kenneth GordonMedical College of Wisconsin, Milwaukee, WI, USA.
Richard B WarrenThe Dermatology Centre, Salford Royal NHS Foundation Trust, The University of Manchester, Manchester Academic Health Science Centre, Manchester, UK.
Darryl TothProbity Medical Research, Windsor, ON, Canada.
Enkeleida NikaïEli Lilly Benelux S.A., Brussels, Belgium.
Baojin ZhuEli Lilly and Company, Indianapolis, IN, USA.
Orin GoldblumEli Lilly and Company, Indianapolis, IN, USA.
Emily Edson-HerediaEli Lilly and Company, Indianapolis, IN, USA.
Hilde CarlierEli Lilly Benelux S.A., Brussels, Belgium.
Russel BurgeEli Lilly and Company, Indianapolis, IN, USA.
Chen-Yen LinEli Lilly and Company, Indianapolis, IN, USA.
Kristin HollisterEli Lilly and Company, Indianapolis, IN, USA.
Matthias AugustinInstitute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg, Hamburg, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo assess improvements in health-related quality of life (HRQoL) with ixekizumab treatment in patients with moderate-to-severe psoriasis.

methodsAdults with plaque psoriasis were enrolled in phase III, double-blind, randomised, controlled trials (UNCOVER-1, UNCOVER-2, or UNCOVER-3). All 3 protocols included a 12-week, placebo-controlled induction period; UNCOVER-2 and UNCOVER-3 also had an active-control group (50 mg etanercept) during induction. After induction, patients in UNCOVER-1 and UNCOVER-2 entered a 48-week withdrawal (maintenance) period (Weeks 12-60), during which Week-12 sPGA (0,1) responders were rerandomized to receive placebo, or 80 mg ixekizumab every 4 weeks (Q4W) or 12 weeks. As a secondary objective, HRQoL was measured by the generic Medical Outcomes Survey Short Form-36 (SF-36) at baseline and Weeks 12 and 60. Changes in mean SF-36 Physical and Mental Component Summary (PCS and MCS) and domain scores and proportions of patients reporting improvements ≥ minimal important differences in SF-36 scores were compared between groups.

resultsAt Week 12, ixekizumab-treated patients (both dose groups in UNCOVER-1, -2, and -3) reported statistically significantly greater improvements in mean SF-36 PCS and MCS and all 8 SF-36 domain scores versus placebo. Further, more ixekizumab-treated patients than placebo-treated patients reported at least minimal treatment responses in SF-36 PCS and MCS scores and domain scores. Overall improvements in SF-36 PCS and MCS scores were maintained through Week 60.

conclusionsIxekizumab-treated patients reported statistically significant improvements in HRQoL at 12 weeks that persisted through 1 year.

Indexed as

Antibodies, Monoclonal, HumanizedDermatologic AgentsFemaleHumansInterleukin-17MaleMiddle AgedPsoriasisQuality of LifeTreatment OutcomeAntibodies, Monoclonal, HumanizedDermatologic AgentsInterleukin-17ixekizumabIxekizumabPsoriasisQuality of lifeSF-36

Identifiers

PMID31655974

What OpenQuestion holds

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Registered trials

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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.