Publications

Tofacitinib safety and effectiveness in Canadian patients with rheumatoid arthritis by cardiovascular risk enrichment: Subanalysis of the CANTORAL study

Rheumatol Ther 2024;11:1629–48 doi: 10.1007/s40744-024-00719-5

Haraoui B,

Khraishi M,

Choquette D,

Fortin I,

Kinch CD,

Galos C,

Roy P,

Gruben D,

Vaillancourt J,

Sampalis JS,

Keystone EC

Haraoui et al. conducted a subgroup analysis of the CANTORAL study, showing that tofacitinib effectiveness was similar in patients with or without CV risk enrichment. However, AEs, particularly in older patients (≥65 years), were more frequent in the CV+ cohort. These findings highlight the need for tailored CV risk management when treating RA with tofacitinib.

Keywords:

• Cardiovascular,
• Efficacy,
• JAK,
• Safety

乾癬性関節炎患者におけるトファシチニブ治療の有効性、安全性、継続率の性差: フェーズ3および長期延長試験の事後解析

RMD Open 2023;9:e002718 doi 10.1136/rmdopen-2022-002718

Eder L,

Gladman DD,

Mease P,

Pollock RA,

Luna R,

Aydin SZ,

Ogdie A,

Polachek A,

Gruben D,

Cadatal MJ,

Kinch C,

Strand V

Evidence from two phase 3 RCTs and one LTE shows that while tofacitinib efficacy exceeds placebo in both sexes and is comparable between sexes, males are more likely to achieve minimal disease activity than females.

Keywords:

• JAK,
• Tofacitinib,
• Phase 3,
• LTE

関節リウマチ患者の倦怠感、睡眠、健康関連QOLに対するトファシチニブの効果: フェーズ３試験結果の事後解析

Arthritis Res Ther. 2022;24(1):83 doi:10.1186/s13075-022-02724-x

Bartlett SJ,

Bingham CO,

van Vollenhoven R,

Murray C,

Gruben D,

Gold DA,

Cella D.

This was an exploratory post hoc analysis of pooled data, from over 2000 patients in three Phase 3 studies of tofacitinib, which demonstrates an association between tofacitinib treatment and significantly greater improvements in fatigue, sleep, and health-related quality of life (HRQoL), compared with placebo.

Keywords:

• JAK,
• Tofacitinib,
• PRO / QoL,
• Phase 3

関節リウマチ患者におけるMTX併用Tofacitinib: 24か月間の フェーズ3 ORAL Scan試験からの患者報告アウトカム結果

Clin Exp Rheumatol . Sep-Oct 2020;38(5):848-857. Epub 2019 Dec 19.

Strand V,

van der Heijde D,

Tanaka Y,

Keystone E,

Kremer J,

Zerbini C A F,

Cardiel M H,

Cohen S,

Nash P,

Song Y-W,

Tegzová D,

Gruben D,

Wallenstein G,

Connell C A,

Fleischmann R

In the ORAL SCAN study, patients receiving TOF 5 mg or 10 mg BID reported significant improvements in patient-reported outcomes at month 3 compared with placebo, which were maintained through 24 months of treatment.RA causes a significant health and socioeconomic burden and affects all aspects of health related quality of life. ORAL Scan included patients with active RA and inadequate response to MTX who were randomised to receive TOF 5 mg or 10 mg BID plus MTX or PBO. This study evaluated the i...

Keywords:

• JAK,
• Tofacitinib,
• Phase 3,
• PRO / QoL

関節リウマチ患者におけるメトトレキサート併用トファシチニブ: 24ヶ月，フェーズ 3 ORAL Scan 試験からの臨床的有効性，　　画像的アウトカムおよび安全性

Arthritis Rheumatol. 2019 Jun;71(6):878-891

van der Heijde D,

Strand V,

Tanaka Y,

Keystone E,

Kremer J,

Zerbini CAF,

Cardiel MH,

Stanley Cohen S,

Nash P,

Song YW,

Tegzová D,

Gruben D,

Wallenstein G,

Connell CA,

Fleischmann R; ORAL Scan investigators

RA patients receiving TOF 5 or 10 mg BID plus MTX showed sustained clinical and radiographic treatment effects through months 12-24. The safety profile was consistent with previous TOF studies. The 12-month data from the ORAL Scan study have been previously reported. This report assesses durability of responses, including structural damage progression, and safety with TOF through 24 months. Patients were randomized 4:4:1:1 to receive TOF 5 or 10 mg BID, or PBO advanced to TOF with stable, backgr...

Keywords:

• JAK,
• Tofacitinib,
• Phase 3,
• Radiographic

Evaluation of Real-World Experience with Tofacitinib Compared with Adalimumab, Etanercept, and Abatacept in RA Patients with 1 Previous Biologic DMARD: Data from a U.S. Administrative Claims Database

J Manag Care Spec Pharm. 2016 Dec;22(12):1457-1471.

Harnett J,

Gerber R,

Gruben D,

Koenig AS and Chen C

Data were examined to compare patient characteristics, treatment patterns and costs in patients with RA receiving tofacitinib (TOF) or common bDMARDs (adalimumab [ADA], etanercept (ETN) or abatacept [ABA]) who had previously received a single bDMARD.This study analyses real-world data from two US claims databases between November 2012 and October 2014. Data were collected from a total of 1252 patients in the Truven Marketscan Commercial and Medicare Supplemental databases. Pre-index (12-months b...

Keywords:

• JAK,
• Tofacitinib,
• Real-World,
• Cost / Cost Effectiveness

Tofacitinib in Combination with Conventional DMARDs in Patients with Active Rheumatoid Arthritis: PROs from a Phase 3 Randomised Controlled Trial

Arthritis Care Res 2016; Accepted article. DOI 10.1002/acr.23004

Strand V,

Kremer JM,

Gruben D,

Krishnaswami S,

Zwillich SH,

Wallenstein GV

Further evidence is presented that treatment with tofacitinib improves patient-reported outcomes (PROs), in addition to improving underlying disease activity.Data were analysed from the Phase 3 ORAL Sync 12-month randomised controlled trial in adult patients with active RA and previous inadequate response to ≥1 conventional or biologic DMARD(s). Patients received (4:4:1:1) TOF 5mg or 10mg BID or Placebo advanced to 5 mg or10 mg BID plus conventional DMARD(s).PROs assessed at Month 3 were: Patien...

Keywords:

• JAK,
• Tofacitinib,
• Phase 3,
• PRO / QoL

Effects of tofacitinib monotherapy on patient-reported outcomes in a randomized phase 3 study of patients with active rheumatoid arthritis and inadequate responses to DMARDs

Arthritis Research & Therapy (2015) 17:307 DOI: 10.1186/s13075-015-0825-9 [Epub ahead of print]

Strand V,

Kremer J,

Wallenstein G,

Kanik KS,

Connell C,

Gruben D,

Zwillich SH,

Fleischmann R

RA presents a significant health and socioeconomic burden particularly in physical functioning, fatigue, and emotional roles. A phase III 6-month study of tofacitinib in patients with active RA, who had prior inadequate responses to cDMARDs or bDMARDs, uses patient-reported outcomes (PROs) to assess the impact on quality of life. Patients were randomized 4:4:1:1 to receive tofacitinib 5 or 10 mg BID, or placebo for 3 months followed by tofacitinib 5 or 10 mg BID. At month 3, tofacitinib 5 and 10...

Keywords:

• JAK,
• Tofacitinib,
• PRO / QoL,
• Phase 3

Tofacitinib with methotrexate in third-line treatment of patients with active rheumatoid arthritis: Patient-reported outcomes from a Phase 3 trial

Arthritis Care Res (Hoboken). 2014 Sep 3. doi: 10.1002/acr.22453. [Epub ahead of print]

Strand V,

Burmester GR,

Zerbini CA,

Mebus CA,

Zwillich SH,

Gruben D,

Wallenstein GV

For many patients with rheumatoid arthritis, improvements in pain, physical function, fatigue, and health-related quality of life (HRQoL) are more important and meaningful than improvements in joint swelling, tenderness, or inhibition of structural damage. These patient-perceived benefits of RA therapy contribute importantly to overall clinical efficacy.

This paper presents patient-reported outcomes (PROs) form the ORAL Step trail, which assessed tofacitinib 5 mg or 10 mg twice daily, or ...

Keywords:

• JAK,
• Tofacitinib,
• Phase 3