Evidence map›Paper›PMID 35139908›Full record

ArticleArthritis research & therapy2022

Time to response for clinical and patient-reported outcomes in patients with psoriatic arthritis treated with tofacitinib, adalimumab, or placebo.

Dafna D Gladman, Laura C Coates, Joseph Wu, Lara Fallon, Elizabeth D Bacci, Joseph C Cappelleri, Andrew G Bushmakin, Philip S Helliwell

2 registry-linked trialsOpen access · goldAbstract read
In one paragraph

Article in Arthritis research & therapy, 2022. 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 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.2field-weighted citation impact, top 22% 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.

NCT01877668 phase3completednot on this map

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Of The Efficacy And Safety Of 2 Doses Of Tofacitinib (CP-690,550) Or Adalimumab In Subjects With Active Psoriatic Arthritis

TypeinterventionalSponsorPfizerRan2014 to 2015Enrolled422ConditionsPsoriatic ArthritisArmsTofacitinib 5 mg BID, Tofacitinib 10 mg BID, Adalimumab, Placebo
NCT01882439 phase3completednot on this map

A Phase 3, Randomized, Double-blind, Placebo-controlled Study Of The Efficacy And Safety Of 2 Doses Of Tofacitinib (Cp-690,550) In Subjects With Active Psoriatic Arthritis And An Inadequate Response To At Least One Tnf Inhibitor

TypeinterventionalSponsorPfizerRan2013 to 2016Enrolled395ConditionsPsoriatic ArthritisArmsTofacitinib, Placebo
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 8 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. 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 6 institutions in 3 countries.

Dafna D GladmanDepartment of Medicine, University of Toronto, Schroeder Arthritis Institute, Krembil Research Institute, Toronto Western Hospital, Toronto, ON, Canada. dafna.gladman@utoronto.ca.ORCID 0000-0002-9074-0592
Laura C CoatesUniversity of Oxford, Oxford, UK.
Joseph WuPfizer Inc, Groton, CT, USA.
Lara FallonPfizer Inc, Kirkland, QC, Canada.
Elizabeth D BacciEvidera, Seattle, WA, USA.
Joseph C CappelleriPfizer Inc, Groton, CT, USA.
Andrew G BushmakinPfizer Inc, Groton, CT, USA.
Philip S HelliwellLeeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.
Pfizer (United States) · USIthaka Harbors · USPfizer (Canada) · CAUniversity of Leeds · GBUniversity of Oxford · GBUniversity of Toronto · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis study examined the time to clinically meaningful response in patients with active psoriatic arthritis treated with tofacitinib, adalimumab, or placebo switching to tofacitinib.

methodsData were from two phase 3 studies, OPAL Broaden (12 months) and OPAL Beyond (6 months). Patients received tofacitinib 5 or 10 mg twice daily (BID), adalimumab 40 mg once every 2 weeks (OPAL Broaden only), or placebo switching to tofacitinib 5 or 10 mg BID at month 3. Baseline to initial response time was according to pre-defined clinically meaningful criteria on Health Assessment Questionnaire-Disability Index (HAQ-DI; ≥ 0.35-point improvement), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F; ≥ 4-point improvement), Psoriatic Arthritis Disease Activity Score (PASDAS; post-baseline score ≤ 3.2 and > 1.6-point improvement from baseline), and minimal disease activity (MDA; meeting at least 5 of 7 criteria) composite.

resultsIn OPAL Broaden, median time to initial HAQ-DI score response was 29, 53, and 30 days in patients treated with tofacitinib 5 mg BID, tofacitinib 10 mg BID, or adalimumab, compared with 162 and 112 days in patients treated with placebo switching to tofacitinib 5 or 10 mg BID at month 3, respectively. Across studies, median time to initial FACIT-F total score response was shorter in patients receiving tofacitinib 5 mg BID (31 days) vs other groups (84-92 days). Median time to initial response was approximately 11 (MDA)/6-9 months (PASDAS) in tofacitinib/adalimumab groups in OPAL Broaden.

conclusionThis analysis demonstrates tofacitinib's efficacy on most patient-reported and clinical endpoints over time and shows a shorter time to initial, clinically meaningful response in patients receiving tofacitinib vs patients switching from placebo to tofacitinib.

trial registrationClinicalTrials.gov , NCT01877668. Registered June 12, 2013. ClinicalTrials.gov , NCT01882439. Registered June 18, 2013.

Indexed as

Antirheumatic AgentsArthritis, PsoriaticAdalimumabHumansPatient Reported Outcome MeasuresPiperidinesPyrimidinesPyrrolesTreatment OutcomeAdalimumabAntirheumatic AgentsPiperidinesPyrimidinesPyrrolestofacitinibAnti-rheumatic agentsArthritisPsoriatic

Identifiers

PMID35139908
PMCPMC8826651
OpenAlexW4211075151

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.