Evidence map›Paper›PMID 33057725›Full record

SynthesisRheumatology (Oxford, England)2021

Assessment of radiographic progression in patients with rheumatoid arthritis treated with tofacitinib in long-term studies.

Désirée van der Heijde, Robert B M Landewé, Jürgen Wollenhaupt, Sander Strengholt, Ketti Terry, Kenneth Kwok, Lisy Wang, Stanley Cohen

5 registry-linked trialsOpen access · hybridAbstract readMeta-Analysis
In one paragraph

Synthesis in Rheumatology (Oxford, England), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 5 registered trials, which are not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.9field-weighted citation impact, top 24% 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.

NCT00413699 phase3completednot on this map

A Long-term, Open-label Follow-up Study Of Tofacitinib (Cp-690,550) For Treatment Of Rheumatoid Arthritis

TypeinterventionalSponsorPfizerRan2007 to 2017Enrolled4,488ConditionsArthritis, RheumatoidArmsCP-690,550
NCT00661661 phase3completednot on this map

A Long-term, Open-label Study Of Cp-690,550 to Confirm The Safety Following Long Term Administration Of Cp-690,550 In The Treatment Of Rheumatoid Arthritis

TypeinterventionalSponsorPfizerRan2008 to 2013Enrolled487ConditionsRheumatoid ArthritisArmsCP-690,550
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
NCT01039688 phase3completednot on this map

Phase 3 Randomized, Double-blind Study Of The Efficacy And Safety Of 2 Doses Of Cp-690,550 Compared To Methotrexate In Methotrexate Navie Patients With Rheumatoid Arthritis

TypeinterventionalSponsorPfizerRan2010 to 2013Enrolled956ConditionsArthritis, RheumatoidArmsCP-690,550, Disease-modifying antirheumatic drug
NCT01164579 phase2completednot on this map

An Exploratory Phase 2, Randomized, Double-blind, Multicenter Study To Assess The Effects Of Tofacitinib (Cp-690,550) On Magnetic Resonance Imaging Endpoints, In Methotrexate Naive Subjects With Early Active Rheumatoid Arthritis

TypeinterventionalSponsorPfizerRan2010 to 2013Enrolled109ConditionsRheumatoid ArthritisArmsTasocitinib plus Methotrexate, Tofacitinib plus placebo methotrexate, Placebo tofacitinib plus Methotrexate
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 11 citations in OpenAlex.

  1. Review
  2. Review
  3. Article
  4. Article
  5. 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 at 5 institutions in 2 countries.

Désirée van der HeijdeDepartment of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands.
Robert B M LandewéAmsterdam Rheumatology & Immunology Center, Amsterdam University Medical Centers, Amsterdam, The Netherlands.
Jürgen WollenhauptRheumatologie im Struenseehaus, Hamburg, Germany.
Sander StrengholtPfizer Inc, Capelle aan den IJssel, The Netherlands.
Ketti TerryPfizer Inc, Groton, CT, USA.
Kenneth KwokPfizer Inc, New York, NY, USA.
Lisy WangPfizer Inc, Groton, CT, USA.
Stanley CohenDepartment of Rheumatology, Metroplex Clinical Research Center, Dallas, TX, USA.
Pfizer (United States) · USLeiden University Medical Center · NLMetroplex Clinical Research Center · USPfizer (Netherlands) · NLZuyderland Medisch Centrum · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTofacitinib is an oral Janus kinase inhibitor for the treatment of RA. We evaluated radiographic progression in tofacitinib-treated patients with RA for up to 3 years in two pooled long-term extension (LTE) studies (ORAL Sequel; A3921041) (primary analysis), and for up to 5 years using data integrated from one phase (P)2 (A3921068), two P3 (ORAL Start; ORAL Scan) and two LTE studies (exploratory analysis).

methodsIn LTE studies, patients received tofacitinib 5 mg twice daily (BID) or 10 mg BID as monotherapy or with conventional synthetic (cs)DMARDs. Radiographic outcomes up to 3 years: least squares mean (LSM) change from baseline in van der Heijde modified Total Sharp Score (ΔmTSS), erosion score (ΔES) and joint space narrowing (ΔJSN) score; proportion of patients with no radiographic progression (ΔmTSS ≤0.5); proportion of patients with no new erosions (ΔES ≤0.5). ΔmTSS was evaluated for up to 5 years in an exploratory analysis.

resultsFor all tofacitinib-treated patients with radiographic data available at LTE month 36 (n = 414), LSM ΔmTSS was 1.14, LSM ΔES was 0.66, LSM ΔJSN was 0.74, and 74.3% and 86.2% of patients showed no radiographic progression and no new erosions, respectively. Similar values were observed regardless of tofacitinib dose, or whether patients received tofacitinib as monotherapy or with csDMARDs. In an exploratory analysis of integrated P2/P3/LTE studies, LSM ΔmTSS was 3.34 at month 60 (n = 269).

conclusionLimited progression of structural damage was observed in tofacitinib-treated patients up to 5 years, with similar results for tofacitinib used as monotherapy or combination therapy up to 3 years.

trial registrationClinicalTrials.gov (http://clinicaltrials.gov): NCT01164579; NCT01039688; NCT00847613; NCT00413699; NCT00661661.

Indexed as

Disease ProgressionAdultAgedAged, 80 and overArthritis, RheumatoidClinical Trials as TopicFemaleHumansJanus Kinase InhibitorsLongitudinal StudiesMaleMiddle AgedPiperidinesPyrimidinesRadiographyYoung AdultJanus Kinase InhibitorsPiperidinesPyrimidinestofacitiniberosionjoint space narrowingmodified Total Sharp ScoreprogressionRAradiographtofacitinib

Identifiers

PMID33057725
PMCPMC8023998
OpenAlexW3093452063

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.