Publications

2つの異なるトファシチニブ治療グループのTNF阻害薬に対する相対リスク: オープンラベル無作為化試験のORAL Surveillance

Ann Rheum Dis. 2023;82(7):901-910 doi: 10.1136/ard-2022-223715

Kristensen LE,

Danese S,

Yndestad A,

Wang C,

Nagy E,

Modesto I,

Rivas J,

Benda B

Findings from a post hoc analysis of ORAL Surveillance can help guide individualised benefit/risk assessment and clinical decision-making on treatment with tofacitinib, based on identification of subpopulations ‘at risk’.

Keywords:

• JAK,
• Tofacitinib,
• Safety

関節リウマチtofacitinib臨床試験における心血管イベントリスク多寡の心血管イベント発生率への影響

Ann Rheum Dis. 2023;82(4):575–577 doi: 10.1136/ard-2022-223406

Dougados M,

Charles-Schoeman C,

Szekanecz Z,

Giles JT,

Ytterberg SR,

Bhatt DL,

Koch GG,

Vranic I,

Wu J,

Wang C,

Kwok K,

Menon S,

Connell CA,

Yndestad A,

Rivas JL,

Buch MH

Data suggest that an important difference between P123LTE and ORAL Surveillance was the proportion of patients with a history of atherosclerotic CV disease (ASCVD).

Keywords:

• JAK,
• Tofacitinib,
• Safety,
• Cardiovascular

関節リウマチ患者における動脈硬化の有無によるトファシチニブ対TNF阻害薬の心血管イベントのリスク: ORAL Surveillance 事後解析

Ann Rheum Dis. 2022. doi: 10.1136/ard-2022-222259

Charles-Schoeman C,

Buch MH,

Dougados M,

Bhatt DL,

Giles JT,

Ytterberg SR,

Koch GG,

Vranic I,

Wu J,

Wang C,

Kwok K,

Menon S,

Rivas JL,

Yndestad A,

Connell CA,

Szekanecz Z.

Post hoc analysis from ORAL Surveillance observes higher major adverse cardiovascular events (MACE) risk with tofacitinib vs TNFi in patients with RA and history of atherosclerotic cardiovascular disease (ASCVD).

Keywords:

• JAK,
• Tildrakizumab,
• Safety,
• Cardiovascular

Cardiovascular and Cancer Risk With Tofacitinib in Rheumatoid Arthritis

N Engl J Med 2022;386:316–26. doi: 10.1056/NEJMc2202778

Ytterberg SR,

Bhatt DL,

Mikuls TR,

Koch GG,

Fleischmann R,

Rivas JL,

Germino R,

Menon S,

Sun Y,

Wang C,

Shapiro AB,

Kanik KS,

Connell CA

In this paper, Ytterberg et al. compare incidence of MACE and cancers (excluding NMSC) with tofacitinib 5 mg BID, tofacitinib 10 mg BID and TNFi. They found that risk of MACE and cancer were higher with tofacitinib versus TNFi, and did not meet noninferiority criteria.This prospective head-to-head safety trial compared tofacitinib to TNFi, and was required by the FDA after increases in lipid levels and cancers were observed during tofacitinib drug development. ...

Keywords:

• JAK,
• Tofacitinib,
• Safety,
• Malignancy,
• Cardiovascular

トファシチニブ治療中の関節リウマチまたは乾癬性関節炎患者における帯状疱疹のマネジメント

Rheumatol Ther. 2021. Epub ahead of print. doi: 10.1007/s40744-021-00390-0

Winthrop KL,

Curtis JR,

Yamaoka K,

Lee EB,

Hirose T,

Rivas JL,

Kwok K,

Burmester GR

This post hoc analysis provides the first detailed description of the management and outcomes of HZ events in tofacitinib RA and PsA clinical studies.While prior studies have characterised the increased HZ risk with JAKinibs, the clinical management of these events has not been detailed.To this end, Winthrop, et al. analysed data from 21 RA and 3 PsA clinical studies to evaluate how HZ events and their sequelae were clinically managed during the RA and PsA tofacitinib clinical development progra...

Keywords:

• JAK,
• Tildrakizumab,
• Safety,
• Infections

トファシチニブ治療中関節リウマチ患者の間質性肺疾患発生率

J Clin Rheumatol. 2021;27(8):e482–e490

Citera G,

Mysler E,

Madariaga H,

Cardiel MH,

Castañeda O,

Fischer A,

Richette P,

Chartrand S,

Park JK,

Strengholt S,

Rivas JL,

Thorat AV,

Girard T,

Kwok K,

Wang L,

Ponce de Leon D

This post hoc analysis of pooled data from 21 clinical trials in the tofacitinib clinical trial programme highlights the importance of identifying known risk factors of RA-interstitial lung disease (ILD) in clinical practice.Citera, et al. investigated incidence rates of ILD – an extra-articular manifestation of RA – in patients with RA, receiving tofacitinib 5 or 10 mg BID and sort to identify potential risk factors for ILD in these patients....

Keywords:

• JAK,
• Tofacitinib,
• Safety,
• Lung / ILD

トファシチニブと生物学的製剤の承認後比較試験: アメ リカを中心としたリウマチ性疾患レジストリの5年結果

ACR Open Rheumatol. 2021 Feb 11.

Kremer JM,

Bingham CO 3rd,

Cappelli LC,

Greenberg JD,

Madsen AM,

Geier J,

Rivas JL,

Onofrei AM,

Barr CJ,

Pappas DA,

Litman HJ,

Dandreo KJ,

Shapiro AB,

Connell CA,

Kavanaugh A

Analysis from the US Corrona RA registry has provided the longest-term real-world safety data for a JAK inhibitor to date. The analysis showed that the cohorts had similar adverse events, except for higher herpes zoster rates for tofacitinib initiators vs bDMARDs.Kremer JM, et al. analysed adult patients with RA newly initiating tofacitinib, or a bDMARD, to compare incidence rates of MACE, SIEs, HZ, malignancies and death. VTE data were also collected prospectively and assessed descriptively thr...

Keywords:

• JAK,
• Tildrakizumab,
• Real-World

トファシチニブで治療された関節リウマチ患者における 間質性肺炎の頻度

Journal of Clinical Rheumatology, Aug 2020 doi: 10.1097/RHU.0000000000001552.

Citera G,

Mysler E,

Madariaga H,

Cardiel M H,

Castaneda O,

Fischer A,

Richette P,

Chartrand S,

Park J K,

Strengholt S,

Rivas J L,

Thorat A V,

Girard T,

Kwok K,

Wang L

This study highlights the importance of accounting for known risk factors of RA-ILD in clinical practice. Interstitial lung disease (ILD) is an extra-articular manifestation of RA. The post-hoc investigated incidence rates of ILD in patients with RA, receiving tofacitinib 5 or 10 mg twice daily, and identified potential risk factors for ILD. This post-hoc analysis comprised a pooled analysis of patients receiving tofacitinib 5 or 10 mg twice daily or placebo from 21 Phase 1-4, and 2 long-term ex...

Keywords:

• JAK,
• Tofacitinib,
• Safety,
• Lung / ILD