Evidence map›Paper›PMID 32926247›Full record

Trial reportClinical rheumatology2021

The effect of intravenous golimumab on health-related quality of life and work productivity in adult patients with active ankylosing spondylitis: results of the phase 3 GO-ALIVE trial.

John D Reveille, Mark C Hwang, Abhijeet Danve, Shelly Kafka, Steven Peterson, Kim Hung Lo, Lilianne Kim, Elizabeth C Hsia, Eric K H Chan, Atul Deodhar

Registry-linked trialAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Clinical rheumatology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02186873 (A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, an Anti-TNFα Monoclonal Antibody, Administered Intravenously, in Subjects With Active Ankylosing Spondylitis), which is not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
1.8field-weighted citation impact, top 15% 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.

NCT02186873 phase3completednot on this map

A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, an Anti-TNFα Monoclonal Antibody, Administered Intravenously, in Subjects With Active Ankylosing Spondylitis

TypeinterventionalSponsorJanssen Research & Development, LLCRan2014 to 2016Enrolled208ConditionsAnkylosing SpondylitisArmsPlacebo, Golimumab
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 12 citations in OpenAlex.

  1. Health state utility values in patients with Ankylosing Spondylitis: a systematic review and meta-analysis.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2024
    Pooled it
  2. Efficacy and Safety of Intravenous Golimumab in Ankylosing Spondylitis Patients With Early and Late Disease Through One Year of the GO-ALIVE Study.Journal of clinical rheumatology : practical reports on rheumatic & musculoskeletal diseases · 2022
    Trial
  3. Review
  4. 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

10 authors at 5 institutions in 1 country.

John D ReveilleDepartment of Internal Medicine, Division of Rheumatology, The University of Texas McGovern Medical School, 6431 Fannin, MSB 5.270, Houston, TX, USA. Reveille@uth.tmc.edu.ORCID http://orcid.org/0000-0001-5950-0913
Mark C HwangDepartment of Internal Medicine, Division of Rheumatology, The University of Texas McGovern Medical School, 6431 Fannin, MSB 5.270, Houston, TX, USA.
Abhijeet DanveSection of Rheumatology, Yale School of Medicine, New Haven, CT, USA.
Shelly KafkaJanssen Scientific Affairs, LLC, Horsham, PA, USA.
Steven PetersonJanssen Global Services, LLC, Horsham, PA, USA.
Kim Hung LoJanssen Research & Development, LLC, Spring House, PA, USA.
Lilianne KimJanssen Research & Development, LLC, Spring House, PA, USA.
Elizabeth C HsiaJanssen Research & Development, LLC, Spring House, PA, USA.
Eric K H ChanPatient Reported Outcomes, Janssen Global Services, LLC, Raritan, NJ, USA.
Atul DeodharOregon Health & Science University, Portland, OR, USA.
Janssen (United States) · USOregon Health & Science University · USThe University of Texas Health Science Center · USThe University of Texas Health Science Center at Houston · USYale University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

INTRODUCTION/

objectivesThe effect of intravenous (IV) golimumab on health-related quality of life (HRQoL) and productivity in patients with ankylosing spondylitis (AS) was evaluated.

methodPatients were randomized to IV golimumab 2 mg/kg (n = 105) at weeks 0, 4, then every 8 weeks (q8w) through week 52 or placebo (n = 103) at weeks 0, 4, 12, with crossover to golimumab 2 mg/kg at weeks 16, 20, then q8w through week 52. Changes from baseline in EuroQol-5 dimension-5 level (EQ-5D-5L) index and visual analog scale (EQ-VAS), daily productivity VAS, Work Limitations Questionnaire (WLQ), and Ankylosing Spondylitis Quality of Life (ASQoL) were assessed. Correlations between these outcomes and disease activity and patient functioning outcomes were evaluated post hoc.

resultsAt week 16, changes from baseline (mean ± standard deviation) in EQ-5D-5L index (0.17 ± 0.16 vs 0.05 ± 0.14), EQ-VAS (20.3 ± 24.6 vs 4.8 ± 23.5), daily productivity VAS (- 2.9 ± - 2.9 vs - 1.1 ± - 2.5), WLQ productivity loss score (- 3.5 ± - 5.3 vs - 1.9 ± - 4.0), and ASQoL (- 5.4 ± - 5.0 vs - 1.8 ± - 4.5) were greater in the IV golimumab versus placebo group, respectively. At week 28, changes from baseline were similar between the IV golimumab and placebo-crossover groups (EQ-5D-5L index: 0.18 ± 0.17 and 0.16 ± 0.16, EQ-VAS: 20.5 ± 27.9 and 22.5 ± 23.1, daily productivity VAS: - 3.1 ± - 3.0 and - 3.1 ± - 2.8, WLQ productivity loss: - 3.9 ± - 5.5 and - 4.5 ± - 4.5, and ASQoL: - 5.3 ± - 5.2 and - 5.3 ± - 4.8, respectively); improvements were maintained through week 52. HRQoL and productivity outcomes were generally moderately correlated with disease activity and functioning outcomes.

conclusionsIn patients with AS, IV golimumab produced sustained improvements in HRQoL and productivity through 1 year, which correlated with improvements in disease activity and functioning. ClinicalTrials.gov registry number is NCT02186873. Key Points • Intravenous (IV) golimumab resulted in clinically important improvement in general and ankylosing spondylitis-specific health-related quality of life (HRQoL) and productivity outcomes in patients with ankylosing spondylitis (AS) as early as week 8 and maintained improvement through 1 year • Improvements in HRQoL and productivity outcomes in these patients with AS were correlated with improvements in measures of disease activity and patient functional capability • IV golimumab is an effective treatment option for AS that can help mitigate the negative effects of the disease on HRQoL and productivity.

Indexed as

Antirheumatic AgentsSpondylitis, AnkylosingAdultAntibodies, MonoclonalDouble-Blind MethodHumansQuality of LifeSeverity of Illness IndexTreatment OutcomeAntibodies, MonoclonalAntirheumatic AgentsgolimumabAnkylosing spondylitisHealth-related quality of lifeIntravenous golimumabWork productivity

Identifiers

PMID32926247
OpenAlexW3084937789

What OpenQuestion holds

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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.