Publications

Relationship between lymphocyte count and risk of infection in Japanese rheumatoid arthritis patients treated with tofacitinib

Modern Rheumatology 2024;34:1115–24 doi: 10.1093/mr/roae030

Tanaka Y,

Takeuchi T,

Valdez H,

Collinge M,

Zwillich SH,

Toyoizumi S,

Kwok K,

Hirose T

Tanaka et al. observed that in Japanese patients with rheumatoid arthritis treated with tofacitinib, those with absolute lymphocyte counts (ALCs) <0.5x10³ cells/mm³ had a higher risk of serious infections and herpes zoster events compared to patients with higher ALC levels. This threshold may help identify increased infection risk in this population

Keywords:

• Efficacy,
• Infections,
• JAK,
• MTX,
• Tofacitinib

Tofacitinib in Rheumatoid Arthritis: Lack of Early Change in Disease Activity Predicts a Low Probability of Achieving Low Disease Activity at Month 6

Arthritis Care Res (Hoboken) 2019 Jan;71(1):71-79. DOI: 10.1002/acr.23585

Van Vollenhoven RF,

Lee EB,

Fallon L,

Zwillich SH,

Wilkinson B,

Chapman D,

Demasi R,

Keystone E

This post-hoc analysis of two, Phase 3 studies, ORAL Start and ORAL Standard shows that early treatment response can predict long-term disease activity outcomes. EULAR recommendations suggest that treat-to-target strategies require regular target assessments with treatment approaches changed if targets are not reached at 6 months. To optimize this strategy, therapy outcomes should be known, and the relationship between short and long-term outcomes defined. The current analysis focused on the dis...

Keywords:

• JAK,
• Tofacitinib,
• Phase 3

Tofacitinib Versus Biologic Treatments in Patients with Active Rheumatoid Arthritis who have had an Inadequate Response to Tumor Necrosis Factor Inhibitors: Results from a Network Meta-Analysis

Clin Ther 2016;38:2628–40.

Vieira M-C,

Zwillich SH,

Jansen JP,

Smiechowski B,

Spurden D and Wallenstein GV

This network meta-analysis, performed within a Bayesian framework, concluded that tofacitinib 5 mg BID has efficacy and AE rates comparable with currently available bDMARDs over a 24-week period in patients experiencing an inadequate response to TNF therapy. A systematic literature search identified five, Phase 2 or beyond, randomised controlled trials for inclusion in the analysis. Each trial had an adult population with moderate to severe RA, with inadequate response (IR) or failed treatment w...

Keywords:

• JAK,
• Tofacitinib,
• Meta analysis

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