Evidence map›Paper›PMID 33906853›Full record

Trial reportAnnals of the rheumatic diseases2021

Tofacitinib for the treatment of ankylosing spondylitis: a phase III, randomised, double-blind, placebo-controlled study.

Atul Deodhar, Paula Sliwinska-Stanczyk, Huji Xu, Xenofon Baraliakos, Lianne S Gensler, Dona Fleishaker, Lisy Wang, Joseph Wu, Sujatha Menon, Cunshan Wang and 4 more

2 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of the rheumatic diseases, 2021. 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 131 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
131citing papers in PubMed, 9 pooled it
31.5field-weighted citation impact, top 1% 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.

NCT03502616 phase3completednot on this map

A phase 3, randomized, double-blind, placebo-controlled, study of the efficacy and safety of tofacitinib in subjects with active ankylosing spondylitis (as)

TypeinterventionalSponsorPfizerRan2018 to 2020Enrolled270ConditionsAnkylosing SpondylitisArmsTofacitinib
NCT06114407 phase2unknown statusnot on this mapstarted 2023, after this paper: background citation

Baricitinib in the Treatment of Refractory Axial Spondyloarthritis Patients: A Comparison With Tofacitinib

TypeinterventionalSponsorBangabandhu Sheikh Mujib Medical University, Dhaka, BangladeshRan2023 to 2024Enrolled184ConditionsSpondyloarthritis, AxialArmsBaricitinib 2mg, Tofacitinib 5 mg
3 · Its place in the literature

Who cites it

131 citing papers in PubMed, 9 syntheses or guidelines pooled it, 239 citations in OpenAlex.

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71 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

14 authors at 6 institutions in 5 countries.

Atul DeodharDivision of Arthritis and Rheumatic Diseases, Oregon Health & Science University, Portland, Oregon, USA deodhara@ohsu.edu.ORCID 0000-0002-2130-1246
Paula Sliwinska-StanczykDepartment of Rheumatology, Reumatika Centrum Reumatologii, Warsaw, Poland.
Huji XuDepartment of Rheumatology and Immunology, Shanghai Changzheng Hospital, Shanghai, China.ORCID 0000-0002-8588-118X
Xenofon BaraliakosRheumazentrum Ruhrgebiet, Ruhr-University Bochum, Herne, Germany.ORCID 0000-0002-9475-9362
Lianne S GenslerDepartment of Medicine/Rheumatology, University of California San Francisco, San Francisco, California, USA.
Dona FleishakerGlobal Product Development, Pfizer Inc, Groton, Connecticut, USA.
Lisy WangGlobal Product Development, Pfizer Inc, Groton, Connecticut, USA.
Joseph WuGlobal Product Development, Pfizer Inc, Groton, Connecticut, USA.
Sujatha MenonGlobal Product Development, Pfizer Inc, Groton, Connecticut, USA.
Cunshan WangGlobal Product Development, Pfizer Inc, Groton, Connecticut, USA.
Oluwaseyi DinaHealth Economics and Outcomes Research, Pfizer Inc, New York, New York, USA.
Lara FallonInflammation and Immunology - Global Medical Affairs, Pfizer Inc, Montreal, Québec, Canada.
Keith S KanikGlobal Product Development, Pfizer Inc, Groton, Connecticut, USA.
Désirée van der HeijdeDepartment of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands.ORCID 0000-0002-5781-158X
Pfizer (United States) · USLeiden University Medical Center · NLOregon Health & Science University · USRheumazentrum Ruhrgebiet · DEShanghai Changzheng Hospital · CNUniversity of California, San Francisco · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo assess the efficacy/safety of tofacitinib in adult patients with active ankylosing spondylitis (AS).

methodsThis phase III, randomised, double-blind, placebo-controlled study enrolled patients aged ≥18 years diagnosed with active AS, meeting the modified New York criteria, with centrally read radiographs, and an inadequate response or intolerance to ≥2 non-steroidal anti-inflammatory drugs. Patients were randomised 1:1 to receive tofacitinib 5 mg two times per day or placebo for 16 weeks. After week 16, all patients received open-label tofacitinib until week 48. The primary and key secondary endpoints were Assessment of SpondyloArthritis international Society ≥20% improvement (ASAS20) and ≥40% improvement (ASAS40) responses, respectively, at week 16. Safety was assessed throughout.

results269 patients were randomised and treated: tofacitinib, n=133; placebo, n=136. At week 16, the ASAS20 response rate was significantly (p<0.0001) greater with tofacitinib (56.4%, 75 of 133) versus placebo (29.4%, 40 of 136), and the ASAS40 response rate was significantly (p<0.0001) greater with tofacitinib (40.6%, 54 of 133) versus placebo (12.5%, 17 of 136). Up to week 16, with tofacitinib and placebo, respectively, 73 of 133 (54.9%) and 70 of 136 (51.5%) patients had adverse events; 2 of 133 (1.5%) and 1 of 136 (0.7%) had serious adverse events. Up to week 48, with tofacitinib, 3 of 133 (2.3%) patients had adjudicated hepatic events, 3 of 133 (2.3%) had non-serious herpes zoster, and 1 of 133 (0.8%) had a serious infection; with placebo→tofacitinib, 2 (1.5%) patients had non-serious herpes zoster. There were no deaths, malignancies, major adverse cardiovascular events, thromboembolic events or opportunistic infections.

conclusionsIn adults with active AS, tofacitinib demonstrated significantly greater efficacy versus placebo. No new potential safety risks were identified. TRIAL REGISTRATION NUMBER: NCT03502616.

Indexed as

Antirheumatic AgentsHerpes ZosterSpondylitis, AnkylosingAdolescentAdultAntibodies, Monoclonal, HumanizedDouble-Blind MethodHumansPiperidinesPyrimidinesTreatment OutcomeAntibodies, Monoclonal, HumanizedAntirheumatic AgentsPiperidinesPyrimidinestofacitinibankylosingantirheumatic agentsspondylitistherapeutics

Identifiers

PMID33906853
PMCPMC8292568
OpenAlexW3157994245

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.