Evidence map›Paper›PMID 27734232›Full record

Trial reportClinical rheumatology2017

Efficacy of tofacitinib in patients with rheumatoid arthritis stratified by background methotrexate dose group.

R Fleischmann, P J Mease, S Schwartzman, L-J Hwang, K Soma, C A Connell, L Takiya, E Bananis

Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Clinical rheumatology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00847613 (Phase 3 Randomized, Double Blind, Placebo Controlled Study Of The Efficacy And Safety Of 2 Doses Of CP-690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate), which is not on this map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed
–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.

NCT00847613 phase3completednot on this map

Phase 3 Randomized, Double Blind, Placebo Controlled Study Of The Efficacy And Safety Of 2 Doses Of CP-690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate

TypeinterventionalSponsorPfizerRan2009 to 2012Enrolled800ConditionsArthritis, RheumatoidArmsCP-690,550, Placebo
3 · Its place in the literature

Who cites it

19 citing papers in PubMed.

  1. Trial
  2. Article
  3. Review
  4. Article
  5. Article
  6. Article
  7. Article
  8. Review
  9. Efficacy of Janus kinase inhibitors in rheumatoid arthritis.Inflammation research : official journal of the European Histamine Research Society ... [et al.] · 2023
    Review
  10. Review
  11. Review
  12. Review
  13. Review
  14. Methotrexate remediates spinal cord injuryExperimental and therapeutic medicine · 2018
    Article
  15. Article
  16. Review
  17. Review
  18. Article
  19. 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

8 authors.

R FleischmannMetroplex Clinical Research Center and University of Texas Southwestern Medical Center, Dallas, TX, USA.
P J MeaseSwedish Medical Center and University of Washington School of Medicine, Seattle, WA, USA.
S SchwartzmanHospital for Special Surgery, New York, NY, USA.
L-J HwangPfizer Inc, New York, NY, USA.
K SomaPfizer Inc, Groton, CT, USA.
C A ConnellPfizer Inc, Groton, CT, USA.
L TakiyaPfizer Inc, Collegeville, PA, USA.
E BananisPfizer Inc, Collegeville, PA, USA. stratis.bananis@pfizer.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). This post hoc analysis investigated the effect of methotrexate (MTX) dose on the efficacy of tofacitinib in patients with RA. ORAL Scan (NCT00847613) was a 2-year, randomized, Phase 3 trial evaluating tofacitinib in MTX-inadequate responder (IR) patients with RA. Patients received tofacitinib 5 or 10 mg twice daily (BID), or placebo, with low (≤12.5 mg/week), moderate (>12.5 to <17.5 mg/week), or high (≥17.5 mg/week) stable background MTX. Efficacy endpoints (at months 3 and 6) included American College of Rheumatology (ACR) 20/50/70 response rates, and mean change from baseline in Clinical Disease Activity Index (CDAI), Disease Activity Score in 28 joints (DAS28)-4(erythrocyte sedimentation rate [ESR]), Health Assessment Questionnaire-Disability Index (HAQ-DI), and modified Total Sharp score. 797 patients were treated with tofacitinib 5 mg BID (N = 321), tofacitinib 10 mg BID (N = 316), or placebo (N = 160); 242, 333, and 222 patients received low, moderate, and high MTX doses, respectively. At months 3 and 6, ACR20/50/70 response rates were greater for both tofacitinib doses vs placebo across all MTX doses. At month 3, mean changes from baseline in CDAI and HAQ-DI were significantly greater for both tofacitinib doses vs placebo, irrespective of MTX category; improvements were maintained at month 6. Both tofacitinib doses demonstrated improvements in DAS28-4(ESR), and less structural progression vs placebo, across MTX doses at month 6. Tofacitinib plus MTX showed greater clinical and radiographic efficacy than placebo in MTX-IR patients with RA, regardless of MTX dose.

Indexed as

AdultAgedAntirheumatic AgentsArthritis, RheumatoidBlood SedimentationDisease ProgressionDouble-Blind MethodDrug Therapy, CombinationFemaleHumansJanus KinasesMaleMethotrexateMiddle AgedPiperidinesPyrimidinesAntirheumatic AgentsJanus KinasesMethotrexatePiperidinesPyrimidinesPyrrolestofacitinibDisease activityJanus kinaseMethotrexateRadiographic progressionRheumatoid arthritisTofacitinib

Identifiers

PMID27734232
PMCPMC5216063

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.