Evidence map›Paper›PMID 21994233›Full record

Trial reportAnnals of the rheumatic diseases2012

Infliximab plus methotrexate is superior to methotrexate alone in the treatment of psoriatic arthritis in methotrexate-naive patients: the RESPOND study.

Asta Baranauskaite, Helena Raffayová, N V Kungurov, Anna Kubanova, Algirdas Venalis, Laszlo Helmle, Shankar Srinivasan, Evgeny Nasonov, Nathan Vastesaeger, RESPOND investigators

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

Trial report in Annals of the rheumatic diseases, 2012. 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 74 papers, 18 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
74citing papers in PubMed, 18 pooled it
10.1field-weighted citation impact, top 1% 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.

NCT00367237 phase3completednot on this map

A Randomized, Multicenter, International, Open-label Study of Infliximab Plus Methotrexate Versus Methotrexate (MTX) Alone for the Treatment of MTX naïve Subjects With Active Psoriatic Arthritis

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2006 to 2008Enrolled115ConditionsArthritis, PsoriaticArmsInfliximab + methotrexate (IFX + MTX), Methotrexate (MTX)
NCT03736161 phase3completednot on this mapstarted 2017, after this paper: background citation

Safety and Efficacy of Tofacitinib vs Methotrexate in the Treatment of Psoriatic Arthritis

TypeinterventionalSponsorGlobe Pharmaceuticals LimitedRan2017 to 2019Enrolled61ConditionsPsoriatic ArthritisArmsGroup A- Tofacitinib, Group B- Methotrexate
3 · Its place in the literature

Who cites it

74 citing papers in PubMed, 18 syntheses or guidelines pooled it, 201 citations in OpenAlex.

  1. Tumor necrosis factor (TNF) inhibitors for psoriatic arthritis.The Cochrane database of systematic reviews · 2025
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  10. Methotrexate for psoriatic arthritis.The Cochrane database of systematic reviews · 2019
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14 more citing papers are in PubMed but not listed here.

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 7 institutions in 5 countries.

Asta BaranauskaiteKaunas Medical University Hospital, Kaunas, Lithuania.
Helena Raffayová
N V Kungurov
Anna Kubanova
Algirdas Venalis
Laszlo Helmle
Shankar Srinivasan
Evgeny Nasonov
Nathan Vastesaeger
RESPOND investigators
Hospital of Lithuanian University of Health Sciences Kaunas Clinics · LTMerck & Co., Inc., Rahway, NJ, USA (United States) · USMSD (Belgium) · BENational Institute of Rheumatic Diseases · SKState Research Center for Dermatovenereology and Cosmetology · RUUral Scientific Research Institute of Dermatovenerology and Immunopathology · RUVilnius University · LT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo compare the efficacy and safety of treatment with infliximab plus methotrexate with methotrexate alone in methotrexate-naive patients with active psoriatic arthritis (PsA).

methodsIn this open-label study, patients 18 years and older with active PsA who were naive to methotrexate and not receiving disease-modifying therapy (N=115) were randomly assigned (1:1) to receive either infliximab (5 mg/kg) at weeks 0, 2, 6 and 14 plus methotrexate (15 mg/week); or methotrexate (15 mg/week) alone. The primary assessment was American College of Rheumatology (ACR) 20 response at week 16. Secondary outcome measures included psoriasis area and severity index (PASI), disease activity score in 28 joints (DAS28) and dactylitis and enthesitis assessments.

resultsAt week 16, 86.3% of patients receiving infliximab plus methotrexate and 66.7% of those receiving methotrexate alone achieved an ACR20 response (p<0.02). Of patients whose baseline PASI was 2.5 or greater, 97.1% receiving infliximab plus methotrexate compared with 54.3% receiving methotrexate alone experienced a 75% or greater improvement in PASI (p<0.0001). Improvements in C-reactive protein levels, DAS28 response and remission rates, dactylitis, fatigue and morning stiffness duration were also significantly greater in the group receiving infliximab. In the infliximab plus methotrexate group, 46% (26/57) had treatment-related adverse events (AE) and two patients had serious AE, compared with 24% with AE (13/54) and no serious AE in the methotrexate-alone group.

conclusionsTreatment with infliximab plus methotrexate in methotrexate-naive patients with active PsA demonstrated significantly greater ACR20 response rates and PASI75 improvement compared with methotrexate alone and was generally well tolerated. This trial is registered in the US National Institutes of Health clinicaltrials.gov database, identifier NCT00367237.

Indexed as

AdultAntibodies, MonoclonalAntirheumatic AgentsArthritis, PsoriaticDrug Therapy, CombinationFemaleHumansImmunosuppressive AgentsInfliximabMaleMethotrexateMiddle AgedSeverity of Illness IndexTreatment OutcomeAntibodies, MonoclonalAntirheumatic AgentsImmunosuppressive AgentsInfliximabMethotrexate

Identifiers

PMID21994233
PMCPMC3298666
OpenAlexW2115041506

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.