トファシチニブ治療による関節リウマチ患者の長期的画像および患者立脚型評価: ORAL Start および ORAL Scan 事後解析

Rheumatol Ther. 2018 Dec;5(2):341-353. doi: 10.1007/s40744-018-0113-7

Strand V,

Kavanaugh A,

Kivitz AJ,

van der Heijde D,

Kwok K,

Akylbekova E,

Soonasra A,

Snyder M,

Connell C,

Bananis E,

Smolen JS

Tofacitinib (TOF) therapy reduced the progression of structural joint damage at 2 years, in patients of all disease states, compared with patients given methotrexate (MTX). Early intervention with DMARDs aim to prevent the development of future RA symptoms and inhibit the progression of structural damage to the joints. This post-hoc analysis uses data from two Phase 3 TOF studies, to examine the efficacy of early intervention with TOF on long-term radiographic outcomes and disease activity state...

Keywords:

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

トシリズマブまたはメトトレキサートを用いたT2T戦略における新規診断早期関節リウマチ患者の患者立脚型評価

Rheumatology (Oxford) 2017 Dec 1;56(12):2179-2189 doi: 10.1093/rheumatology/kex319

Teitsma XM,

Jacobs JWG,

Welsing PMJ,

Pethö-Schramm A,

Borm MEA,

Hendriks L,

Denissen NHAM,

van Laar JM,

Lafeber FPJG,

Bijlsma JWJ

Patient-reported outcomes (PROs) vastly improved in the first 24 weeks post-initiation of tocilizumab (TCZ) therapies compared to methotrexate (MTX) monotherapy in the U-Act-Early trial.U-Act-Early was a two-year, treat-to-target study that compared the safety and efficacy of TCZ and MTX treatment strategies in DMARD-naïve patients with early RA. Sustained remission was classed as more effective in patients given TCZ monotherapy or combination therapy with MTX compared to MTX alone. TCZ therapie...

Patient-reported Outcomes from a Phase 3 Study of Baricitinib versus Placebo or Adalimumab in Rheumatoid Arthritis: Secondary Analyses from the RA-BEAM Study

Ann Rheum Dis 2017;76(11):1853-1861. doi: 10.1136/annrheumdis-2017-211259

Keystone EC,

Taylor PC,

Tanaka Y,

Gaich C,

DeLozier AM,

Dudek A,

Velasco Zamora J,

Covarrubias Cobos JA,

Rooney T,

de Bono S,

Arora V,

Linetzky B,

Weinblatt ME

This paper describes the patient-reported outcome (PRO) data collected in RA-BEAM, a Phase 3 study of baricitinib compared with both placebo and adalimumab in patients with RA and an inadequate response to MTX.PRO measures evaluated include health-related quality of life (HRQOL), physical function, disability, fatigue, sleep, mental health status, work productivity and work activity impairment. The RA-BEAM study demonstrated that patients treated with baricitinib experienced a greater improveme...

Keywords:

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

Sarilumab improves Patient-reported Outcomes in Rheumatoid Arthritis Patients with Inadequate Response/Intolerance to Tumour Necrosis Factor Inhibitors

RMD Open 2017;3:e000416. DOI:10.1136/rmdopen-2016-000416

Strand V,

Reaney M,

Chen C-I,

Proudfoot CWJ,

Guillonneau S,

Bauer D,

Mangan E,

Graham NMH,

van Hoogstraten H,

Lin Y,

Pacheco-Tena C,

Fleischmann R

Evidence is presented that treatment with sarilumab demonstrates patient-reported benefits in TNF-IR patients with moderate to severe RA. These improvements complement the clinical efficacy previously reported for sarilumab, and are consistent with those seen in the MOBILITY trial (MTX-IR patients)1, yet in a more difficult-to-treat population.Data were analysed from the 24-week Phase 3 TARGET randomised controlled trial in adult patients with active RA and previous inadequate response or intole...

Keywords:

• IL-6,
• Sarilumab,
• PRO / QoL

fficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the continuous treatment of patients with moderate to severe psoriasis: Results from the Phase III, double-blinded, placebo- and active comparator-controlled VOYAGE 1 trial

J Am Acad Dermatol 2017;76:405–17. doi: 10.1016/j.jaad.2016.11.041

Blauvelt A,

Papp KA,

Griffiths CE,

Randazzo B,

Wasfi Y,

Shen YK,

Li S,

Kimball AB

Guselkumab demonstrated superiority to adalimumab and placebo in treating PsO in this Phase 3 study. Improvements in IGA and PASI scores were observed as early as Week 16 and were maintained up to Week 48. Incidence of adverse events was similar across both treatment groups.

Keywords:

• Efficacy,
• Guselkumab,
• Phase 3,
• Safety,
• Skin

Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the treatment of patients with moderate to severe psoriasis with randomized withdrawal and retreatment: results from the Phase III, double-blind, placebo- and active comparator-controlled VOYAGE 2 trial

J Am Acad Dermatol 2017;76:418–31. doi: 10.1016/j.jaad.2016.11.042

Reich K,

Armstrong AW,

Foley P,

Song M,

Wasfi Y,

Randazzo B,

Li S,

Shen YK,

Gordon KB

Patients treated with guselkumab showed an improved and sustained clinical response compared to both adalimumab and placebo, without compromising safety profile. The Phase 3 VOYAGE 2 trial by Reich et al focused on treatment interruption and withdrawal, as well as treatment switching from adalimumab to guselkumab.

Keywords:

• Efficacy,
• Guselkumab,
• IL-23,
• Phase 3,
• Safety,
• Switching

Tofacitinib or adalimumab versus placebo: patient-reported outcomes from a phase 3 study of active rheumatoid arthritis

Strand et al. Rheumatology (Oxford). 2016 Feb 29. doi:pii: kev442. [Epub ahead of print]

Strand V,

van Vollenhoven R,

Bong Lee E et al.

RA not only affects the physical aspects of a patient’s health but also has an impact on the psychological well-being causing a significant disease burden. This paper reports on the patient-reported outcomes (PROs) from the ORAL Standard study. This study investigated tofacitinib 5mg BID, 10mg BID, adalimumab vs. placebo over 12 months with a primary endpoint at month 3. All treatment groups showed significant improvements over placebo in HAQ-DI, PtGA and Pain with LSM changes in baseline sustai...

Keywords:

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