Evidence map›Paper›PMID 30522501›Full record

Trial reportArthritis research & therapy2018

Improved patient-reported outcomes in patients with psoriatic arthritis treated with abatacept: results from a phase 3 trial.

Vibeke Strand, Evo Alemao, Thomas Lehman, Alyssa Johnsen, Subhashis Banerjee, Harris A Ahmad, Philip J Mease

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

Trial report in Arthritis research & therapy, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01860976 (A Phase 3 Randomized Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Subcutaneous Injection in Adults With Active Psoriatic Arthritis), which is not on this map. Cited by 10 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 3 pooled it
1.0field-weighted citation impact, top 23% 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.

NCT01860976 phase3completednot on this map

A Phase 3 Randomized Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Subcutaneous Injection in Adults With Active Psoriatic Arthritis

TypeinterventionalSponsorBristol-Myers SquibbRan2013 to 2020Enrolled489ConditionsPsoriatic ArthritisArmsAbatacept, Placebo
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 3 syntheses or guidelines pooled it, 13 citations in OpenAlex.

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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

7 authors at 3 institutions in 2 countries.

Vibeke StrandDivision of Immunology/Rheumatology, Stanford University School of Medicine, Palo Alto, CA, USA.
Evo AlemaoBristol-Myers Squibb, Princeton, NJ, USA. evo.alemao@bms.com.
Thomas LehmanBristol-Myers Squibb, Princeton, NJ, USA.
Alyssa JohnsenBristol-Myers Squibb, Princeton, NJ, USA.
Subhashis BanerjeeBristol-Myers Squibb, Princeton, NJ, USA.
Harris A AhmadBristol-Myers Squibb, Princeton, NJ, USA.
Philip J MeaseSwedish Medical Center and University of Washington, Seattle, WA, USA.
Bristol-Myers Squibb (United States) · USStanford University · USUniversity of Washington · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTo explore the effect of abatacept treatment on patient-reported outcomes (PROs) in psoriatic arthritis (PsA).

methodsPatients with PsA were randomised (1:1) to subcutaneous abatacept 125 mg weekly/placebo for 24 weeks with early escape (EE) to open-label abatacept (week 16). Adjusted mean changes from baseline to weeks 16 (all patients) and 24 (non-EE responders) in Health Assessment Questionnaire-Disability Index (HAQ-DI), Short Form-36 (SF-36; physical and mental component summary and domains), Dermatology Life Quality Index and Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) were evaluated. Subpopulations were analysed by baseline C-reactive protein (CRP) level (> vs ≤ upper limit of normal [ULN]) and prior tumour necrosis factor inhibitor (TNFi) exposure. Proportions of patients reporting improvements ≥ minimal clinically important differences (MCIDs) and ≥ normative values (NVs) in HAQ-DI, SF-36 and FACIT-F (week 16 before EE) were analysed.

resultsIn total population, numerically higher improvements in most PROs were reported with abatacept (n = 213) versus placebo (n = 211) at both time points (P > 0.05). Higher proportions of abatacept versus placebo patients reported PRO improvements ≥ MCID and ≥ NV at week 16. At week 16, all PRO improvements were numerically greater (P > 0.05) in patients with baseline CRP > ULN versus CRP ≤ ULN (all significant [95% confidence interval] for abatacept vs placebo); improvements in SF-36 component summaries and FACIT-F were greater in TNFi-naïve versus TNFi-exposed patients (abatacept > placebo). Week 24 subgroup data were difficult to interpret due to low patient numbers.

conclusionsAbatacept treatment improved PROs in patients with PsA versus placebo, with better results in elevated baseline CRP and TNFi-naïve subpopulations.

trial registrationClinicalTrials.gov number, NCT01860976 (funded by Bristol-Myers Squibb); date of registration: 23 May 2013.

Indexed as

Patient Reported Outcome MeasuresAbataceptAdultAntirheumatic AgentsArthritis, PsoriaticDouble-Blind MethodFemaleHumansMaleMethotrexateMiddle AgedQuality of LifeSeverity of Illness IndexTreatment OutcomeAbataceptAntirheumatic AgentsMethotrexateDMARDs (biologic)Outcomes researchPatient perspectivePsoriatic arthritis

Identifiers

PMID30522501
PMCPMC6282264
OpenAlexW2902429852

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.