Evidence map›Paper›PMID 39060905›Full record

ArticleRheumatology and therapy2024

Geographical Differences in the Safety and Efficacy of Tofacitinib Versus TNFi: A Post Hoc Analysis of ORAL Surveillance.

Bogdan Batko, Slawomir Jeka, Piotr Wiland, Agnieszka Zielińska, Maria Stopińska-Polaszewska, Marcin Stajszczyk, Magdalena Kosydar-Piechna, Mary Jane Cadatal, Jose L Rivas

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Rheumatology and therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02092467 (PHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR), which is not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
–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.

NCT02092467 phase4completednot on this map

Phase 3b/4 randomized safety endpoint study of 2 doses of tofacitinib in comparison to a tumor necrosis factor (tnf) inhibitor in subjects with rheumatoid arthritis

TypeinterventionalSponsorPfizerRan2014 to 2020Enrolled4,372ConditionsArthritis, RheumatoidArmstofacitinib, adalimumab, etanercept
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors.

Bogdan BatkoDepartment of Rheumatology and Immunology, Faculty of Medicine and Health Sciences, Andrzej Frycz Modrzewski University, Gustawa Herlinga-Grudzińskiego 1, 30-705, Kraków, Poland. bpbatko@gmail.com.ORCID http://orcid.org/0000-0003-3999-8093
Slawomir JekaClinic and Department of Rheumatology and Connective Tissue Diseases, University Hospital No. 2, Collegium Medicum, Nicolaus Copernicus University in Toruń, Toruń, Poland.
Piotr WilandDepartment of Rheumatology and Internal Medicine, Wroclaw Medical University, Wroclaw, Poland.ORCID http://orcid.org/0000-0001-9999-0267
Agnieszka ZielińskaMedycyna Kliniczna Marzena Waszczak-Jeka, Warsaw, Poland.
Maria Stopińska-PolaszewskaNasz Lekarz Ośrodek Badań Klinicznych, Toruń, Poland.
Marcin StajszczykDepartment of Rheumatology and Autoimmune Disease, Silesian Center for Rheumatology, Orthopedics and Rehabilitation, Ustroń, Poland.ORCID http://orcid.org/0000-0002-3939-7194
Magdalena Kosydar-PiechnaPfizer Inc, Warsaw, Poland.
Mary Jane CadatalPfizer Inc, Manila, Philippines.
Jose L RivasPfizer SLU, Madrid, Spain.ORCID http://orcid.org/0009-0004-6736-3962

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionIn ORAL Surveillance, incidence rates (IRs) of major adverse cardiovascular events (MACE) and malignancies (excluding non-melanoma skin cancer [NMSC]) in cardiovascular (CV)-risk-enriched patients with rheumatoid arthritis (RA) were numerically greater with tofacitinib in North America versus the rest of the world, due to underlying risk factors. Here, we evaluated the safety and efficacy of tofacitinib versus tumor necrosis factor inhibitors (TNFi) among patients with RA across geographical regions.

methodsPatients with RA in ORAL Surveillance (NCT02092467), who were aged ≥ 50 years with ≥ 1 additional CV risk factor, received tofacitinib 5 or 10 mg twice daily or TNFi; 45.9% were from either Poland or North America. This post hoc analysis stratified patients by region (Poland, North America, Other countries). Efficacy endpoints included Clinical Disease Activity Index, Disease Activity Score in 28 joints, with C-reactive protein (DAS28-4[CRP]), and Health Assessment Questionnaire-Disability Index (HAQ-DI). IRs and hazard ratios for adverse events were reported.

resultsOf 4362 patients (Poland, N = 759; North America, N = 1243; Other countries, N = 2360), more patients from North America versus Poland/Other countries had CV risk factors such as body mass index ≥ 30 kg/m

conclusionsDifferences in safety outcomes were driven by the presence of baseline risk factors; North America and Poland demonstrated a higher proportion of patients with some baseline CV risk factors/comorbidities versus Other countries.

trial registrationNCT02092467 (ClinicalTrials.gov).

Indexed as

Antirheumatic agentsCardiovascular diseasesEfficacyNorth AmericaPolandRheumatoid arthritisSafetyTofacitinibTumor necrosis factor inhibitors

Identifiers

PMID39060905
PMCPMC11422304

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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.