February 2017

Analysis of Haematological Changes in Tofacitinib-treated Patients with Rheumatoid Arthritis across Phase 3 and Long-term Extension Studies

Rheumatology 2017;56:46–57.

In this analysis examining haematological changes after tofacitinib (TOF) treatment in patients with RA from pooled Phase 3 and LTE studies, TOF decreased mean lymphocyte counts and slightly increased mean haemoglobin (Hb) levels. The Phase 3 population included patients from six trials (n=4271) of TOF 5- or 10 mg BID, placebo or active comparator up to 24 months. The LTE population (n=4858) included patients from two studies (of up to 84 months), who had participated in Phase 1, 2 or 3 TOF stud...

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January 2017

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.

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...

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December 2016

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.

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...

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Biologic or Tofacitinib Monotherapy for Rheumatoid Arthritis in People with Traditional Disease-modifying Anti-rheumatic Drug (DMARD) Failure: a Cochrane Systematic Review and Network meta-analysis (NMA)

Cochrane Database Syst Rev 2016;11:CD012437.

Treatment options for RA patients who are MTX/DMARD incomplete responders (IR) include other DMARDs, biologics or tofacitinib (TOF). However, there is a lack of direct head-to-head comparator trials of biologics in people with RA. This review provides an update of the 2009 Cochrane overview, ‘Biologics for rheumatoid arthritis’,1 and provides comparisons and estimates for biologic or TOF monotherapy in MTX/DMARD-IR people with RA.The benefits and harms of biologic monotherapy (TNFis: adalimumab,...

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October 2016

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

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...

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July 2016

Pregnancy Outcomes in the Tofacitinib Safety Databases for Rheumatoid Arthritis and Psoriasis

Drug Saf. 2016 June 9; 39:755–762; DOI 10.1007/s40264-016-0431-z [Epub ahead of print]

RA and psoriasis may present in women of child-bearing potential, however there are currently no adequate or well-controlled studies of tofacitinib (TOF) or any DMARD in pregnant women. Pregnancy was an exclusion criterion of TOF randomized clinical trials because of the unknown effects of TOF on mother and child; TOF is a small molecule with the potential to cross the placenta. The current analysis looked at reported pregnancies and their outcomes from TOF RA and psoriasis clinical safety datab...

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Switching from Adalimumab to Tofacitinib in the Treatment of Patients with Rheumatoid Arthritis

Arthritis Research & Therapy. 2016. DOI 10.1186/s13075-016-1049-3 [Epub ahead of print]

Results are reported from an analysis exploring the safety and efficacy of open-label tofacitinib (TOF) following blinded treatment with TOF or adalimumab (ADA) in patients with moderate to severe RA. The analysis included patients from ORAL Sequel, an open-label long-term extension study, which all patients entered following ORAL Standard (one of the studies in the TOF phase 3 program). Only those patients who had been randomized to ADA 40 mg Q2W + MTX or 10 mg TOF + MTX in ORAL Standard were i...

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Biologics or Tofacitinib for Rheumatoid Arthritis in Incomplete Responders to Methotrexate or Other Traditional Disease-Modifying Anti-Rheumatic Drugs: A Systematic Review and Network Meta-Analysis

Cochrane Database of Systematic Reviews 2016 Issue 5. Art. No.: CD012183 [DOI: 10.1002/14651858.CD012183].

Treatment options for RA patients who are MTX/DMARD incomplete responders (IR) include other DMARDs, biologics or tofacitinib (TOF). However, there is a lack of head-to-head studies to show any important differences between these options in terms of benefits and harms. This review provides an update of the 2009 Cochrane overview and network meta-analysis (NMA) of biologics for RA.1Nine biologics (abatacept, adalimumab, anakinra, certolizumab pegol, etanercept, golimumab, infliximab, rituximab, a...

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Risk for Gastrointestinal Perforation Among Rheumatoid Arthritis Patients Receiving Tofacitinib, Tocilizumab, or Other Biologics

Arthritis Rheumatol. 2016 May 17. DOI 10.1002/art.39761 [Epub ahead of print]

Historically, patients with RA have suffered with upper tract gastrointestinal perforation (GIPs), associated with NSAID use. More recently, the IL-6 receptor antagonist tocilizumab (TCZ) has been associated with lower tract GIPs. Janus kinase (JAK) inhibitors, including tofacitinib (TOF), with some downstream effects on IL-6 signalling, also have potential for an increased risk of GIPs.There is limited real-world evidence and almost no comparative evidence on the risk for GIP associated with TC...

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May 2016

Initial Experience with Tofacitinib in Clinical Practice: Treatment Patterns and Costs of Tofacitinib Administered as Monotherapy or in Combination with Conventional Synthetic DMARDs in 2 US Health Care Claims Databases

Clin Ther. 2016 Mar 28. doi: 10.1116/j.clinthera. 2016.03.038 [Epub ahead of print]

This study analyzes data from two US claims databases between November 2012 and June 2014. It was designed to build upon knowledge from tofacitinib Phase 3 clinical trials providing clinical insights from independent sources on treatment patterns and costs for tofacitinib. Data were collected from 337 patients in the Truven Marketscan (TM) and 118 patients in the Optum Clinformatics (OC) databases. In this early experience cohort for tofacitinib, approximately 75% of patients had previously rece...

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