Publications

生物学的抗リウマチ薬に抵抗性の活動性関節リウマチ患者におけるウパダシチニブの安全性と有効性 (SELECT-BEYOND): 二重盲検, 無作為化対照フェーズ 3 治験

Lancet 2018;391:2513–24

Genovese MC,

Fleischmann R,

Combe B,

Hall S,

Rubbert-Roth A,

Zhang Y,

Zhou Y,

Mohamed M-EF,

Meerwein S,

Pangan AL

Upadacitinib (UPA) extended release formulation was effective in treating patients with moderate-to-severe RA with an inadequate response to bDMARDs.Phase 2 study data has shown that UPA is an efficacious and safe treatment for active RA.1,2 SELECT-BEYOND was a double-blind, long-term extension, Phase 3 study to assess the efficacy of UPA in patients with RA who were bDMARD-IR. The first 12-weeks of SELECT-BEYOND were placebo-controlled, with a double-blind period followed by an ongoing double-b...

Keywords:

• JAK,
• Upadacitinib,
• Phase 3

患者特徴は関節リウマチにおける生物学的製剤選択に影響し, non-TNFi をTNFiよりも有害に見せてしまう

Ann Rheum Dis 2018; 77:650–57 DOI: 10.1136/annrheumdis-2017-212395

Frisell T,

Baecklund E,

Bengtsson K,

Giuseppe DD,

Forsblad-d’Elia H,

Askling J,

on behalf of the ARTIS Study Group

Analysis of patient characteristics revealed that older and less healthy patients with RA were more likely to receive non-TNFi bDMARDs as a first bDMARD compared to other treatments.This study aimed to describe patient characteristics at initiation of bDMARD treatment at two-time points: first bDMARD initiation and switch to second bDMARD after TNFi treatment. The second aim of the study was to estimate the potential of treatment channelling to confound results in comparative treatment studies i...

Keywords:

• Safety,
• Review

治療歴のある中等度または重症RAにおけるバリシチニブ: NICE Single Technology Appraisal における Evidence Review Groupの展望A

Pharmacoeconomics 2018 Jul; 36(7):769–78

Ren S,

Bermejo I,

Simpson E,

Wong R,

Scott DL,

Young A,

Stevenson M

In this National Institute for Health and Care (NICE) single technology appraisal of baricitinib (BARI) monotherapy and combination therapy with methotrexate (MTX), BARI efficacy was considered comparable to bDMARDs and a cost-effective use of National Health Service (NHS) resources.NICE is an independent organisation responsible for providing national guidance on health technologies in England. To be recommended by NICE, the company must provide evidence to prove BARI’s effectiveness, both clin...

Keywords:

• JAK,
• Baricitinib,
• Cost / Cost Effectiveness,
• Review

関節リウマチにおける抗リウマチ薬後のトファシチニブ: NICE Single Technology Appraisal における Evidence Review Groupの展望

Pharmacoeconomics 2018 Sep; 36(9): 1063–72

Uttley L,

Bermejo I,

Shijie R,

Martyn-St James M,

Wong R,

Scott DL,

Young A,

Stevenson M

In this National Institute for Health and Care (NICE) single technology appraisal of tofacitinib (TOF) plus methotrexate (MTX), TOF had similar efficacy and comparable costs to recommended bDMARDs plus MTX in patients with RA. NICE is an independent organisation responsible for providing national guidance on health technologies in England. To be recommended by NICE, the company must provide evidence to prove TOF’s effectiveness, both clinically and costly. This evidence based review, reports the...

Keywords:

• JAK,
• Tofacitinib,
• Cost / Cost Effectiveness,
• Review

Long-term Effectiveness of Tocilizumab in Patients with Rheumatoid Arthritis, Stratified by Number of Previous Treatment Failures with Biologic Agents: Results from the German RABBIT Cohort

Rheumatol Int 2018 Apr; 38(4):579-87

Baganz L,

Richter A,

Kekow J,

Bussmann A,

Krause A,

Stille C,

Listing J,

Zink A,

Strangfeld A.

In this observational study, the German RABBIT cohort was used to assess the long-term effectiveness and retention rates of tocilizumab (TCZ) in patients with prior bDMARD failures. Results of the study suggested that TCZ could be an effective treatment option for patients with difficult-to-treat RA. A total of 885 patients were involved in the study and these were categorised dependent on the number of bDMARD failures they had prior to TCZ treatment. Patient data recorded in the cohort included...

Tofacitinib Therapy for Rheumatoid Arthritis: A Direct Comparison Study between Biologic-naive and Experienced Patients

Intern Med. 2018 Mar 1;57(5):663-670. doi: 10.2169/internalmedicine.9341-17

Mori S,

Yoshitama T,

Ueki Y

This 6-month prospective direct comparison study analysed the effectiveness of tofacitinib (TOF) therapy on bDMARD-naïve and bDMARD-experienced patients. bDMARD-naïve patients were more responsive to TOF therapy than bDMARD-experienced patients.The study analysed the data of 113 patients diagnosed with high or moderate disease activity, defined using CDAI scores. All patients had failed to achieve CDAI low disease activity or remission with MTX therapy for ≥3 months. Patients were given 5 mg TOF...

Keywords:

• JAK,
• Tofacitinib,
• Phase 4

Patient-reported Outcomes of Baricitinib in Patients with Rheumatoid Arthritis and No or Limited Prior Disease-modifying Antirheumatic Drug Treatment

Arthritis Res Ther. 2017 Sep 18;19(1):208

Schiff M,

Takeuchi T,

Fleischmann R,

Gaich CL,

DeLozier AM,

Schlichting D,

Kuo W,

Won J,

Carmack T,

Rooney T,

Durez P,

Shaikh S,

Hidalgo RP,

van Vollenhoven R,

Zerbini C

RA-BEGIN was a Phase 3, double-blind randomised active comparator-controlled study to evaluate baricitinib as monotherapy or in combination with MTX in patients with active RA who were naïve to csDMARDS and bDMARDS. In this analysis of the RA-BEGIN study, baricitinib alone or with MTX when used as initial therapy resulted in significant improvements in most patient-reported outcome measures compared with MTX. At baseline, study participants had active RA, impaired physical function, moderate le...

Keywords:

• JAK,
• Baricitinib,
• PRO / QoL

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

Rheumatology. Doi 10.1093/rheumatology/kex068

Kubo S,

Yamaoka K,

Amano K,

Nagano S,

Tohma S,

Suematsu E,

Nagasawa H,

Iwata K and Tanaka Y

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...

Keywords:

• JAK,
• Tofacitinib,
• Real-World

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

EULAR RA Management Task Force Smolen J,

Landewé R,

Bijlsma J,

et al

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...

Keywords:

• EULAR

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