May 2017

Estimated Medical Expenditure and Risk of Job Loss among Rheumatoid Arthritis Patients undergoing Tofacitinib Treatment: Post Hoc Analyses of Two Randomized Clinical Trials

Rheumatology doi: 10.1093/rheumatology/kex087

The results of this post hoc analysis of two Phase 3 studies of tofacitinib (TOF) show that improvements in health-related quality of life related to TOF treatment are likely to translate into significant reductions in estimated medical expenditure and likelihood of current and future job loss. Data from 399 MTX inadequate responder (IR) patients from ORAL Step, and 716 TNF inhibitor (TNFi)-IR patients from ORAL Standard were included in this analysis. Patients were receiving 5 mg or 10 mg TOF B...

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Discontinuation of Tofacitinib after achieving Low Disease Activity in Patients with Rheumatoid Arthritis: a Multicentere, Observational Study

Rheumatology. Doi 10.1093/rheumatology/kex068

This study showed that in patients who achieved low disease activity (LDA), it is possible to discontinue tofacitinib without flare in approximately one-third of patients. Patients from the tofacitinib Phase 3 programme and long-term extension study were enroled. Discontinuation was based on physician-patient decision making with informed consent. The primary endpoint was the proportion of patients who remained tofacitinib free at post-treatment Week 52. Of 64 patients treated with tofacitinib w...

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Tofacitinib as induction and maintenance therapy for ulcerative colitis

N Engl J Med. 2017 May 4;376(18):1723-1736. DOI 10.1056/NEJMoa1606910

Tofacitinib, at a dose of 10 mg twice daily, was more effective than placebo for induction of remission and mucosal healing in patients with moderately to severely active ulcerative colitis. Furthermore, maintenance therapy with tofacitinib, at a dose of either 5 mg or 10 mg twice daily, was more effective than placebo in sustaining remission and mucosal healing.

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April 2017

EULAR Recommendations for the Management of Rheumatoid Arthritis with Synthetic and Biological Disease-modifying Antirheumatic Drugs: 2016 Update

Ann Rheum Dis Published Online First: 06March2017. doi:10.1136/annrheumdis-2016-210715

The EULAR 2016 recommendations update, based on three systematic literature reviews (SLRs) and expert opinion, comprises four overarching principles and 12 recommendations compared with 14, respectively, in 2013. These recommendations intend to inform regarding EULAR’s most recent consensus on the management of RA, with the aim of attaining the best outcomes with current therapies.All DMARD types: csDMARDs, bDMARDs, tsDMARD and bsDMARD are addressed, and cost aspects are taken into consideration...

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The Emerging Safety Profile of JAK Inhibitors in Rheumatic Disease

Nature Reviews Rheumatology 2017;13:234–43

This review discusses the current understanding of the safety of JAK inhibitors, including providing an overview of the changes in laboratory parameters, infection and malignancy risks associated with each JAK inhibitor compound.The review discusses the adverse event profiles and cellular changes characteristically seen with each JAK inhibitor, as well as the overlap or differences between the various compounds. The relative specificities for different JAKs between each compound do not always p...

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March 2017

Cardiovascular Safety of Tocilizumab versus Tumor Necrosis Factor Inhibitors in Patients with Rheumatoid Arthritis – a Multi-database Cohort Study

Arthritis Rheumatol 2017 Feb 28. doi: 10.1002/art.40084

This multi-database population-based US cohort study found no evidence of an increased cardiovascular (CV) risk among RA patients who switched from a different biologic drug or tofacitinib to tocilizumab (TCZ) versus to a TNF inhibitor (TNFi).The study used claims data in patients with RA newly starting treatment with TCZ or a TNFi from three large databases: Medicare (n=7397), PharMetrics (n=8119) and MarketScan (n=12512). Included within the analysis were 9218 TCZ initiators propensity-score m...

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Efficacy and Safety of Tofacitinib in Older and Younger Patients with Rheumatoid Arthritis

Clin Exp Rheumatol 2017 Jan 4

In this analysis of patients with moderate to severe RA treated with tofacitinib (TOF) in Phase 3 and long-term extension (LTE) studies, patients aged 65 years had similar efficacy and a numerically higher risk of SAEs and discontinuations due to AEs compared with younger patients.The Phase 3 population included patients from five trials (n=3111) of TOF 5 mg or 10 mg BID or placebo. The LTE population (n=4102) included patients from two studies who had participated in Phase 1, 2 or 3 TOF studie...

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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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