Evidence map›Paper›PMID 32166429›Full record

Trial reportClinical rheumatology2020

Effectiveness of maintenance therapy with methotrexate compared with leflunomide for patients with RA having achieved disease control with both these drugs: results of a predefined sub-analysis of CareRA, a pragmatic RCT.

Veerle Stouten, Stijn Michiels, René Westhovens, Diederik De Cock, Amy Belba, Sofia Pazmino, Kristien Van der Elst, Johan Joly, Patrick Verschueren

Registry-linked trialAbstract readRandomized Controlled TrialPragmatic Clinical Trial
PubMed Publisher
In one paragraph

Trial report in Clinical rheumatology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01172639 (A 2 Year Prospective Multicentre Randomised Controlled Trial Comparing Effectiveness in Daily Practice of Different Treatment Strategies for Early Rheumatoid Arthritis.), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.4field-weighted citation impact, top 40% 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.

NCT01172639 phase4completednot on this map

A 2 Year Prospective Multicentre Randomised Controlled Trial Comparing Effectiveness in Daily Practice of Different Treatment Strategies for Early Rheumatoid Arthritis.

TypeinterventionalSponsorP. VerschuerenRan2009 to 2015Enrolled400ConditionsRheumatoid ArthritisArmsMethotrexate, Sulfasalazine, Leflunomide, Prednisone
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 2 citations in OpenAlex.

  1. 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

9 authors at 1 institution in 1 country.

Veerle StoutenKU Leuven, Department of Development and Regeneration, Skeletal Biology and Engineering Research Centre, Herestraat 49, 3000, Leuven, Belgium. Veerle.stouten@kuleuven.be.
Stijn MichielsUniversity Hospitals Leuven, Division of Rheumatology, 3000, Leuven, Belgium.
René WesthovensKU Leuven, Department of Development and Regeneration, Skeletal Biology and Engineering Research Centre, Herestraat 49, 3000, Leuven, Belgium.
Diederik De CockKU Leuven, Department of Development and Regeneration, Skeletal Biology and Engineering Research Centre, Herestraat 49, 3000, Leuven, Belgium.
Amy BelbaKU Leuven, Department of Development and Regeneration, Skeletal Biology and Engineering Research Centre, Herestraat 49, 3000, Leuven, Belgium.
Sofia PazminoKU Leuven, Department of Development and Regeneration, Skeletal Biology and Engineering Research Centre, Herestraat 49, 3000, Leuven, Belgium.
Kristien Van der ElstUniversity Hospitals Leuven, Division of Rheumatology, 3000, Leuven, Belgium.
Johan JolyUniversity Hospitals Leuven, Division of Rheumatology, 3000, Leuven, Belgium.
Patrick VerschuerenKU Leuven, Department of Development and Regeneration, Skeletal Biology and Engineering Research Centre, Herestraat 49, 3000, Leuven, Belgium.
KU Leuven · BE

Funding

Vlaamse Instelling voor Technologisch Onderzoek NA
6 · The paper itself

Abstract

INTRODUCTION/

objectivesEvidence regarding the effectiveness of step-down strategies for patients with well-controlled early rheumatoid arthritis (RA) on a combination of methotrexate (MTX) and leflunomide (LEF) is currently lacking.

methodThe Care in early RA (CareRA) trial is a 2-year randomized pragmatic trial comparing different remission induction strategies in treatment-naïve patients with early RA. For this study, we included participants who achieved low disease activity (LDA) (DAS28-CRP ≤ 3.2) between 40 to 52 weeks after starting a combination of MTX, LEF, and a prednisone bridging scheme followed by a treat-to-target approach. Patients were re-randomized to a maintenance monotherapy of either MTX 15 mg weekly or LEF 20 mg daily. Remission rates (DAS28-CRP < 2.6) at week 65 counted from re-randomization, as well as drug retention rates and safety during the 65 weeks of follow-up, were compared.

resultsRemission rates at week 65 after re-randomization were numerically higher in patients assigned to MTX (29/32; 90.6%) compared with patients on LEF (20/27; 74.1%) (p = 0.091). Of patients assigned to MTX, 60% (19/32) maintained LDA while continuing their assigned monotherapy until week 65 after re-randomization versus 44% (12/27) in the LEF group (p = 0.25). Patients re-randomized to MTX were more frequently in LDA measured by Clinical Disease Activity Index (32/32; 100%) compared with patients on LEF (23/27; 85.2%) (p = 0.024) 65 weeks after re-randomization. According to survival analyses, the probability of maintaining MTX monotherapy was higher (81%) than maintaining LEF monotherapy (55%) for 65 weeks (p = 0.025) after re-randomization. Safety analysis after re-randomization showed a good safety profile in both groups.

conclusionMTX monotherapy seems not significantly more efficacious as maintenance treatment compared with LEF monotherapy but has a better retention rate and is well tolerated in early RA patients in LDA after combination therapy with both.

trial registrationClinical trials NCT01172639 Key points • Methotrexate should be preferred over leflunomide as maintenance therapy after an initial intensive combination of these two drugs. • Methotrexate shows a better retention rate to leflunomide as maintenance therapy in this context.

Indexed as

Antirheumatic AgentsPharmaceutical PreparationsDrug Therapy, CombinationHumansLeflunomideMethotrexateTreatment OutcomeAntirheumatic AgentsLeflunomideMethotrexatePharmaceutical PreparationsLeflunomideMaintenance therapyMethotrexateMonotherapyRheumatoid

Identifiers

PMID32166429
OpenAlexW3011006124

What OpenQuestion holds

Textmetadata
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.