January 2020

関節リウマチ患者におけるMTX併用Tofacitinib: 24か月間の フェーズ3 ORAL Scan試験からの患者報告アウトカム結果

Clin Exp Rheumatol . Sep-Oct 2020;38(5):848-857. Epub 2019 Dec 19.

In the ORAL SCAN study, patients receiving TOF 5 mg or 10 mg BID reported significant improvements in patient-reported outcomes at month 3 compared with placebo, which were maintained through 24 months of treatment.RA causes a significant health and socioeconomic burden and affects all aspects of health related quality of life. ORAL Scan included patients with active RA and inadequate response to MTX who were randomised to receive TOF 5 mg or 10 mg BID plus MTX or PBO. This study evaluated the i...

Keywords:

患者報告アウトカムに対するUpadacitinibの効果: SELECT-BEYOND, 生物学的製剤に効果不十分な関節リウマ チ患者を対象とした無作為化フェーズ3試験, からの結果

Arthritis Res Ther . 2019 Dec 2;21(1):263. doi: 10.1186/s13075-019-2059-8.

In SELECT-BEYOND, UPA demonstrated clinically meaningful improvements in patient reported outcomes compared to PBO in patients with RA who had an inadequate response to bDMARDs. In this post-hoc analysis of the SELECT-BEYOND study, the effect of UPA 15 or 30 mg on patient reported outcomes were assessed and compared to PBO.Eligible patients (498) with an inadequate response to bDMARDs were randomly assigned 1:1:1 to receive UPA 15 mg, UPA 30 mg or PBO. PROs collected at Wk1, Wk4, and Wk12 includ...

Keywords:

Upadacitinib は従来型抗リウマチ薬が効果不十分な関節 リウマチ患者の患者報告アウトカムを改善する: SELECT-NEXT 試験結果

Arthritis Res Ther . 2019 Dec 9;21(1):272.

In SELECT-NEXT, UPA demonstrated clinically meaningful improvements in patient reported outcomes compared to PBO in patients with RA who had an inadequate response to csDMARDs. In this post hoc analysis, the effect of UPA 15 or 30 mg on patient reported outcomes were assessed and compared to PBO.Eligible patients (661) with an inadequate response to csDMARDs were randomly assigned 2:2:1:1 to receive background csDMARD therapy with either UPA 15 mg, UPA 30 mg or PBO. PROs collected at Wk4 and Wk1...

Keywords:

December 2019

Highlights of 2019

Please click the links below to go to the CSF review of each paper

2019 was another remarkable year in cytokine signalling. We can be optimistic that clinical practice for inflammatory arthritis will continue to improve, with promising long-term safety data supporting the use of established JAK inhibitors; tofacitinib and baricitinib, in addition to exciting phase III clinical data for filgotinib and newly approved upadacitinib. You can find the most notable papers, as selected by CSF Steering Committee Chair Professor Iain McInnes, with links to their respecti...

Keywords:

November 2019

フェーズ2と3試験におけるウパダシチニブの曝露と反応性に 関する有効性安全性解析 関節リウマチにおけるベネフィットリスク

Clin Pharmacol Ther . 2020 Apr;107(4):994-1003. doi: 10.1002/cpt.1671.

UPA 15 mg provided the optimal benefit-risk in RA through maximizing efficacy with only small incremental benefit with 30 mg, and with consistency across RA subpopulations and with UPA monotherapy or combination with csDMARDs. Exposure-response analyses were conducted using combined data from two Phase 2b and five Phase 3 studies in order to characterise the relationship between plasma exposure and efficacy, as well as to select safety parameters using the totality of the data in subjects with R...

Keywords:

October 2019

関節リウマチ患者におけるトファシチニブのフェーズIIIと長期 試験での, 主要な心血管有害事象のリスク因子

Arthritis Rheumatol .2019 Sep;71(9):1450-1459. doi: 10.1002/art.40911. Epub 2019 Aug 6.

Post hoc analyses of the six ORAL studies and two LTE’s suggested that after 24 weeks of TOF treatment, increases in HDL-c and decreases in the TC/HDL-c ratio appeared to be associated with reduced future MACE risk in RA patients. 52 MACE occurred in 4076 patients over 12873 patient-years of exposure. Separate Cox regression models were used to evaluate traditional CV risk factors’ association with time to first MACE at baseline and changes in lipid levels with time to future MACE after 24 weeks...

Keywords:

トファシチニブで治療された乾癬性関節炎患者の脂質変化と心血 管イベント発生率: フェーズ3と長期試験のプール解析

Arthritis Care Res (Hoboken) 2019;71(10):1387–95

Serum lipid level increases at month 3 following TOF treatment in PsA were consistent with observation in RA and psoriasis. The risk of CV disease is higher in people with PsA versus the general population – comparable with the well-documented rates seen in RA and diabetes. The reasons for this are not fully elucidated, but it has been suggested that there is an association between peripheral joint inflammation and lipid dysregulation in PsA. This post hoc analysis of pooled data from OPAL Broad...

Keywords:

低疾患活動性のRA患者における疼痛緩和と機能改善に対するバ リシチニブとアダリムマブの効果: RA-BEAMからの探索的解析

J Clin Med. 2019 Sep 5;8(9). pii: E1394

Post hoc analyses from RA-BEAM concluded that BARI 4 mg QD or ADA 40 mg Q2W resulted in improvements in pain, physical function, fatigue and work productivity in patients with RA, independent of the treatment’s impact on inflammation. Among patients achieving remission or LDA, greater improvements in pain and physical function were seen with BARI than with ADA or PBO.Of 1010 patients included in the analysis at Week 24, 168 were in remission, 310 were in remission/LDA and 700 were not in remissi...

Keywords:

August 2019

メソトレキセートに効果不十分の関節リウマチ患者におけるPeficitinib (ASP015K) の有効性と安全性: 日本で実施された Phase III 無作 為化二重盲検プラセボ対照臨床試験結果 (RAJ4)

Ann Rheum Dis 2019 DOI: 10.1136/annrheumdis-2019-215164

Peficitinib (PEF) 100 and 150 mg demonstrated robust clinical and structural efficacy in patients with RA who have an inadequate response to MTX. In Japan, two JAK inhibitors, TOF and BARI are currently available for RA patients with an inadequate response to conventional therapies. This randomized phase 3 study (RAJ4), assessed the efficacy and safety of two PEF doses in combination with MTX compared to PBO, in Japanese MTX-IR. Patients were randomized 1:1:1 to PBO, PEF 100 mg and 150 mg with M...

Keywords:

抗リウマチ薬に抵抗性の中等度から重度関節リウマチ患者に おける臨床的反応性に対する Filgotinib の Placebo対照とした 効果 : FINCH 2 無作為化試験

JAMA 2019 322(4):315-325

Among RA patients with an inadequate response or intolerance to bDMARDs, filgotinib (FIL) doses, compared to PBO resulted in significantly greater proportions achieving a clinical response at Wk12.Patients with active RA despite treatment with bDMARD therapy need treatment options. The FINCH 2 Phase 3 study compared the effects of FIL vs PBO for the treatment of RA patients with inadequate response or intolerance to ≥1 prior bDMARDs. Patients were randomized in a 1:1:1 ratio, receiving FIL 200 m...

Keywords: