Evidence map›Paper›PMID 30900375›Full record

ArticleInternational journal of rheumatic diseases2019

Efficacy and safety of tofacitinib for the treatment of rheumatoid arthritis in patients from the Asia-Pacific region: Post-hoc analyses of pooled clinical study data.

Eun Bong Lee, Hisashi Yamanaka, Yi Liu, Wen-Chan Tsai, Connie Chen, Kenneth Kwok, Hyun-Jeong Yoo, Lyndon J Llamado, Lisy Wang, Yingchun Luo and 2 more

Abstract read
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In one paragraph

Article in International journal of rheumatic diseases, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
–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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

12 citing papers in PubMed.

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  10. JAK inhibitors and infections risk: focus on herpes zoster.Therapeutic advances in musculoskeletal disease · 2020
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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

12 authors.

Eun Bong LeeSeoul National University College of Medicine, Seoul, Korea.ORCID https://orcid.org/0000-0003-0703-1208
Hisashi YamanakaTokyo Women's Medical University, Tokyo, Japan.
Yi LiuWest China Hospital of Sichuan University, Sichuan, China.
Wen-Chan TsaiKaohsiung Medical University, Kaohsiung, Taiwan.ORCID https://orcid.org/0000-0002-2777-4298
Connie ChenPfizer Inc, New York City, New York.
Kenneth KwokPfizer Inc, New York City, New York.
Hyun-Jeong YooPfizer Korea Inc, Seoul, Korea.
Lyndon J LlamadoPfizer Inc, Makati City, Philippines.
Lisy WangPfizer Inc, Groton, Connecticut.
Yingchun LuoEliassen Group, Reading, Massachusetts.
Naonobu SugiyamaPfizer Japan Inc, Tokyo, Japan.
Yoshiya TanakaUniversity of Occupational and Environmental Health Japan, Kitakyushu, Japan.

Funding

Pfizer Inc
6 · The paper itself

Abstract

aimWe report tofacitinib efficacy and safety in Asia-Pacific patients who participated in the rheumatoid arthritis (RA) clinical development program.

methodThis post-hoc analysis included pooled data from patients with RA in the Asia-Pacific region treated with tofacitinib with/without conventional synthetic disease-modifying antirheumatic drugs in Phase (P)1, 2, 3, and long-term extension (LTE) studies (one LTE ongoing; January 2016 data-cut). Efficacy was assessed over 24 months in patients who received tofacitinib 5 (N = 397) or 10 (N = 382) mg twice daily or placebo (N = 243) in three P2 and five P3 studies. Endpoints included American College of Rheumatology (ACR)20/50/70 responses, Disease Activity Score in 28 joints, erythrocyte sedimentation rate (DAS28-4[ESR]) and Clinical Disease Activity Index (CDAI) remission rates, and change from baseline in Health Assessment Questionnaire-Disability Index (∆HAQ-DI). Safety data pooled over 92 months from one P1, four P2, six P3, and two LTE studies for all tofacitinib doses (N = 1464) included incidence rates (IRs) (patients with events/100 patient-years) for adverse events (AEs) of special interest.

resultsAt month 3, patients receiving tofacitinib 5/10 mg twice daily improved vs placebo in ACR20 (69.2%/77.9% vs 27.5%), ACR50 (36.9%/44.4% vs 9.5%), and ACR70 (15.1%/22.4% vs 2.7%) responses, remission rates for DAS28-4(ESR) (8.5%/18.5% vs 2.6%) and CDAI (6.1%/12.3% vs 0.5%), and ∆HAQ-DI (-0.5/-0.6 vs -0.1); improvements were sustained through 24 months. IRs (95% CI) were 9.4 (8.5, 10.3) for serious AEs, 9.1 (8.3, 10.1) for discontinuations due to AEs, 3.7 (3.2, 4.3) for serious infections, 5.9 (5.2, 6.7) for herpes zoster, and 0.8 (0.6, 1.1) for malignancies (excluding non-melanoma skin cancer).

conclusionIn Asia-Pacific patients, tofacitinib improved signs/symptoms over 24 months. Safety over 92 months was generally consistent with global tofacitinib studies; however, infection IRs were higher in Asia-Pacific patients.

Indexed as

AdultArthritis, RheumatoidAsiaClinical Trials as TopicEvidence-Based MedicineFemaleHumansJanus Kinase InhibitorsMaleMiddle AgedNeoplasmsOpportunistic InfectionsPiperidinesPyrimidinesPyrrolesRecovery of FunctionJanus Kinase InhibitorsPiperidinesPyrimidinesPyrrolestofacitinibclinical aspectsdrug treatmentrheumatoid arthritis

Identifiers

PMID30900375
PMCPMC6617812

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Registered trials

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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.