Evidence map›Paper›PMID 25496464›Full record

Trial reportModern rheumatology2015

Efficacy and safety of tofacitinib as monotherapy in Japanese patients with active rheumatoid arthritis: a 12-week, randomized, phase 2 study.

Yoshiya Tanaka, Tsutomu Takeuchi, Hisashi Yamanaka, Hiroyuki Nakamura, Shigeyuki Toyoizumi, Samuel Zwillich

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Modern rheumatology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00687193 (A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Confirm Dose Responsiveness Following 12 Weeks Of The Administration Of CP-690,550), which is not on this map. Cited by 83 papers, 14 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
83citing papers in PubMed, 14 pooled it
–field-weighted citation impact
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.

NCT00687193 phase2completednot on this map

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Confirm Dose Responsiveness Following 12 Weeks Of The Administration Of CP-690,550 (5 Doses) Or Placebo In Subjects With Active Rheumatoid Arthritis Inadequately Responding To At Least 1 DMARD

TypeinterventionalSponsorPfizerRan2009 to 2010Enrolled318ConditionsArthritis, RheumatoidArmsPlacebo, CP-690,550
3 · Its place in the literature

Who cites it

83 citing papers in PubMed, 14 syntheses or guidelines pooled it.

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23 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

6 authors.

Yoshiya TanakaThe First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health , Kitakyushu, Fukuoka , Japan.
Tsutomu Takeuchi
Hisashi Yamanaka
Hiroyuki Nakamura
Shigeyuki Toyoizumi
Samuel Zwillich

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo evaluate oral tofacitinib versus placebo for treatment of active rheumatoid arthritis in Japanese patients with inadequate response to disease-modifying antirheumatic drugs.

methodsIn this double-blind, placebo-controlled, randomized, parallel-group, 12-week, phase 2 study (clinicaltrials.gov NCT00687193), 317 patients received tofacitinib: 1, 3, 5, 10, or 15 mg as monotherapy or placebo twice daily (BID). PRIMARY ENDPOINT: response rate by American College of Rheumatology (ACR) ≥ 20% improvement criteria (ACR20) at week 12.

resultsACR20 response rates: 37.7% (20/53), 67.9% (36/53), 73.1% (38/52), 84.9% (45/53), and 90.7% (49/54) with tofacitinib: 1, 3, 5, 10, and 15 mg BID, respectively, versus 15.4% (8/52) with placebo (p < 0.01; all doses). Dose-dependent ACR20 responses with tofacitinib versus placebo occurred from week 2 onward (p < 0.05). Changes from baseline in 28-joint disease activity score using erythrocyte sedimentation rate improved with tofacitinib versus placebo from week 4 (p < 0.01; all doses). Six tofacitinib patients experienced treatment-related serious adverse events (AEs). Most common treatment-emergent AEs: nasopharyngitis (10% vs 12%) and hyperlipidemia (5% vs 0%). Serum creatinine, hemoglobin, and total-, low-, and high-density lipoprotein-cholesterol levels increased with tofacitinib.

conclusionsTofacitinib produced dose-dependent ACR20 responses and reduced disease activity. The safety profile was consistent with that reported from global monotherapy trials.

Indexed as

AdultAgedAntirheumatic AgentsArthritis, RheumatoidDouble-Blind MethodFemaleFollow-Up StudiesHumansJanus Kinase 3JapanMaleMiddle AgedPiperidinesProtein Kinase InhibitorsPyrimidinesPyrrolesAntirheumatic AgentsJanus Kinase 3PiperidinesProtein Kinase InhibitorsPyrimidinesPyrrolestofacitinibJapanMonotherapyRandomized controlled trialRheumatoid arthritisTofacitinib

Identifiers

PMID25496464
PMCPMC4819568

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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.