Evidence map›Paper›PMID 27334658›Full record

Trial reportArthritis research & therapy2016

Switching from adalimumab to tofacitinib in the treatment of patients with rheumatoid arthritis.

Mark C Genovese, Ronald F van Vollenhoven, Bethanie Wilkinson, Lisy Wang, Samuel H Zwillich, David Gruben, Pinaki Biswas, Richard Riese, Liza Takiya, Thomas V Jones

2 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Arthritis research & therapy, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
2.7field-weighted citation impact, top 11% 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
NCT00853385 phase3completednot on this map

Phase 3 Randomized, Double-Blind, Active Comparator, 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 2011Enrolled717ConditionsRheumatoid ArthritisArmsCP 690,550, CP-690,550, Placebo, Biologic TNFi
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 20 citations in OpenAlex.

  1. Pooled it
  2. Trial
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  4. Trial
  5. Review
  6. Article
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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

10 authors at 3 institutions in 2 countries.

Mark C GenoveseDivision of Rheumatology, Stanford University, Palo Alto, CA, USA.
Ronald F van VollenhovenUnit for Clinical Therapy Research, Inflammatory Diseases, Karolinska Institute, Stockholm, Sweden.
Bethanie WilkinsonPfizer Inc, Groton, CT, USA.
Lisy WangPfizer Inc, Groton, CT, USA.
Samuel H ZwillichPfizer Inc, Groton, CT, USA.
David GrubenPfizer Inc, Groton, CT, USA.
Pinaki BiswasPfizer Inc, 500 Arcola Drive, F5352, Collegeville, PA, 19426, USA.
Richard RiesePfizer Inc, Groton, CT, USA.
Liza TakiyaPfizer Inc, 500 Arcola Drive, F5352, Collegeville, PA, 19426, USA. Liza.Takiya@pfizer.com.
Thomas V JonesPfizer Inc, 500 Arcola Drive, F5352, Collegeville, PA, 19426, USA.
Pfizer (United States) · USKarolinska Institutet · SEStanford University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). The aim of this study was to explore the safety and efficacy of open-label tofacitinib following blinded treatment with adalimumab or tofacitinib for moderate to severe RA.

methodsAnalyses included patients treated with adalimumab 40 mg once every 2 weeks or tofacitinib 10 mg twice daily (BID) with background methotrexate (MTX) in a 12-month randomized study (NCT00853385), who subsequently received tofacitinib 10 mg BID (with/without background MTX) in an open-label extension (NCT00413699). Patients with treatment-related serious adverse events (AEs) and serious or recurrent infections in the index study were excluded from the extension study. Exposure-adjusted incidence rates of safety-related events were assessed in 3-month and 12-month periods in the year before and in the year after switching. Efficacy was assessed 3 months before, at the time of, and 3 months after switching.

resultsThere were 233 (107 adalimumab to tofacitinib 10 mg BID, 126 blinded to open-label tofacitinib 10 mg BID) patients included in these analyses. Patients in both treatment sequences had similar incidence rates (per 100 patient-years) of discontinuation due to AEs, serious AEs, and serious infections in the year before and in the year after switching. Incidence rates of AEs were increased in the first 3 months after switching compared with the last 3 months before switching in both treatment groups. Switching from either blinded adalimumab or tofacitinib to open-label tofacitinib resulted in numerically higher incidence of responders for signs and symptoms of disease and improved physical function.

conclusionsTreatment can be directly switched from adalimumab to tofacitinib. A similar safety and efficacy profile was seen when patients received open-label tofacitinib after receiving either blinded adalimumab or tofacitinib.

trial registrationClinicalTrials.gov Identifiers: NCT00853385 , registered 27 February 2009; NCT00413699 , registered 18 December 2006.

Indexed as

AdalimumabAdultAgedAntirheumatic AgentsArthritis, RheumatoidDouble-Blind MethodDrug SubstitutionFemaleHumansMaleMiddle AgedPiperidinesPyrimidinesPyrrolesTreatment OutcomeAdalimumabAntirheumatic AgentsPiperidinesPyrimidinesPyrrolestofacitinibAdalimumabDrug switchingEfficacyRheumatoid arthritisSafetyTofacitinib

Identifiers

PMID27334658
PMCPMC4918072
OpenAlexW2464702273

What OpenQuestion holds

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LicenceCC BY
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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.