Evidence map›Paper›PMID 24441150›Full record

Trial reportRheumatology (Oxford, England)2014

Recovery of clinical but not radiographic outcomes by the delayed addition of adalimumab to methotrexate-treated Japanese patients with early rheumatoid arthritis: 52-week results of the HOPEFUL-1 trial.

Hisashi Yamanaka, Naoki Ishiguro, Tsutomu Takeuchi, Nobuyuki Miyasaka, Masaya Mukai, Tsukasa Matsubara, Shoji Uchida, Hideto Akama, Hartmut Kupper, Vipin Arora and 1 more

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

Trial report in Rheumatology (Oxford, England), 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00870467 (A Phase 3 Multi-Center, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study Comparing Adalimumab and Placebo in Adult Japanese Subjects With Rheumatoid Arthritis), which is not on this map. Cited by 17 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 6 pooled it
3.8field-weighted citation impact, top 7% 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.

NCT00870467 phase3completednot on this map

A Phase 3 Multi-Center, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study Comparing Adalimumab and Placebo in Adult Japanese Subjects With Rheumatoid Arthritis

TypeinterventionalSponsorAbbottRan2009 to 2011Enrolled334ConditionsRheumatoid ArthritisArmsDouble-blind adalimumab, Double-blind Placebo, Open-label Adalimumab, Open-labelAdalimumabRescue
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 6 syntheses or guidelines pooled it, 27 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

11 authors at 1 institution in 1 country.

Hisashi YamanakaInstitute of Rheumatology, Tokyo Women's Medical University, 10-22 Kawado-cho, Shinjuko-ku, Tokyo 162-0054, Japan. yamanaka@ior.twmu.ac.jp.
Naoki Ishiguro
Tsutomu Takeuchi
Nobuyuki Miyasaka
Masaya Mukai
Tsukasa Matsubara
Shoji Uchida
Hideto Akama
Hartmut Kupper
Vipin Arora
Yoshiya Tanaka
Tokyo Women's Medical University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThe aim of this study was to compare efficacy outcomes of initial treatment with adalimumab + MTX vs adalimumab addition following 26 weeks of MTX monotherapy in Japanese early RA patients naive to MTX with high disease activity.

methodsPatients completing the 26-week, randomized, placebo-controlled trial of adalimumab + MTX were eligible to receive 26 weeks of open-label adalimumab + MTX. Patients were assessed for mean change from baseline in the 28-joint DAS with ESR (DAS28-ESR) and modified total Sharp score (mTSS), and for the proportions of patients achieving clinical, functional or radiographic remission.

resultsOf 333 patients assessed, 278 (137 from the initial adalimumab + MTX and 141 from the initial placebo + MTX groups) completed the 52-week study. Significant differences in clinical and functional parameters observed during the 26-week blinded period were not apparent following the addition of open-label adalimumab to MTX. Open-label adalimumab + MTX slowed radiographic progression through week 52 in both groups, but patients who received adalimumab + MTX throughout the study exhibited less radiographic progression than those who received placebo + MTX during the first 26 weeks (mean ΔmTSS at week 52 = 2.56 vs 3.30, P < 0.001).

conclusionDelayed addition of adalimumab in Japanese MTX-naive early RA patients did not impact clinical and functional outcomes at week 52 compared with the earlier addition of adalimumab. However, the accrual of significant structural damage during blinded placebo + MTX therapy contributed to the persistence of differences between the treatment strategies, suggesting that Japanese patients at risk for aggressive disease should benefit from the early inclusion of adalimumab + MTX combination therapy. Trial registration. ClinicalTrials.gov (http://clinicaltrials.gov/), NCT00870467.

Indexed as

Asian PeopleAdalimumabAdultAgedAntibodies, Monoclonal, HumanizedAntirheumatic AgentsArthritis, RheumatoidDisease ProgressionDrug Therapy, CombinationFemaleHumansJapanLongitudinal StudiesMaleMethotrexateMiddle AgedAdalimumabAntibodies, Monoclonal, HumanizedAntirheumatic AgentsMethotrexateadalimumabJapanese patientsMTX naiverheumatoid arthritissafety

Identifiers

PMID24441150
PMCPMC3988871
OpenAlexW2159269317

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.