June 2024

Integrated safety analysis of filgotinib in patients with moderate-to-severe rheumatoid arthritis over a treatment duration of up to 8.3 years

Ann Rheum Dis 2024;0:1–8 doi: 10.1136/ard-2024-225759 Epub ahead of print

Burmester, et al. found that long-term filgotinib exposure was well tolerated in patients with moderate-to-severe active RA, with a stable rate of TEAEs over time. However, potential dose-dependent relationships for herpes zoster infections, malignancies and all-cause mortality were observed in patients aged ≥65 years, indicating the potential impact of age on the safety profile of Filgotinib. Therefore, some patients aged ≥65 years may benefit from the filgotinib 100 mg dose option.

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April 2024

EULAR recommendations for the management of psoriatic arthritis with pharmacological therapies: 2023 update

Ann Rheum Dis 2024 doi: 10.1136/ard-2024-225531 Epub ahead of print

The 2023 EULAR recommendations provided an updated consensus on the pharmacological management of PsA with a new overarching principle and recommendation for 2023. Recent MOA safety data emphasised the importance of patient-specific benefit-risk profiling in JAKi therapy, and extra-musculoskeletal (MSK) manifestations related to PsA should be considered during drug selection.

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March 2023

関節リウマチ、乾癬性関節炎、強直性脊椎炎を対象とした１５０００人年におよぶウパダシチニブの安全性

RMD Open. 2023;9(1):e002735 doi: 10.1136/rmdopen-2022-002735

Integrated analysis of the safety profile of upadacitinib demonstrates that it was generally well-tolerated in RA, PsA, AS and AD, with no new safety risks identified, compared with previous reports.

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January 2023

トファシチニブ開発プログラムにおける関節リウマチ, 潰 瘍性大腸炎, 乾癬性関節炎患者のインフルエンザ

Rheumatol Ther. 2022. Epub ahead of print doi: 10.1007/s40744-022-00507-z

This post-hoc analysis of 31 clinical trials in ulcerative colitis, rheumatoid arthritis and psoriatic arthritis concludes that combined influenza adverse event incidence rates were highest in ulcerative colitis, while in each indication they were generally similar across tofacitinib, placebo, and comparator groups.

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December 2022

合成および生物学的抗リウマチ薬によるRAマネジメントに関する 2022 EULAR リコメンデーション

Ann Rheum Dis. 2022. Epub ahead of print [05/12/2022] doi: 10.1136/ard-2022-223356

Smolen, et al. provide a 2022 update of the EULAR recommendations for the management of RA with synthetic and biological DMARDs.

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合成および生物学的抗リウマチ薬の安全性: 2022 EULAR リコメンデーションのためのシステマティックレビュー

Ann Rheum Dis. 2022. Epub ahead of print doi: 10.1136/ard-2022-223357

Sepriano, et al. provide results of a systematic literature review (SLR) on the safety of synthetic and biological DMARDs, to inform the 2022 update of the EULAR recommendations for the management of rheumatoid arthritis.

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合成および生物学的抗リウマチ薬の有効性: 2022 EULAR リコメンデーションのためのシステマティックレビュー

Ann Rheum Dis. 2022. Epub ahead of print. doi: 10.1136/ard-2022-223365

Kerschbaumer, et al. provide results of a systematic literature review (SLR) on efficacy of synthetic and biological DMARDs, to inform the 2022 update of the EULAR recommendations for the management of rheumatoid arthritis.

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September 2022

炎症疾患におけるインターロイキン-6およびインターロイキン-6受容体阻害に関するとコンセンサス: アップデート

doi: 10.1136/ard-2022-222784.

Blocking the IL-6R is a major therapeutic advance for many diseases in adults and children. Updated consensus statement provides guidance to rheumatologists and other experts, as well as patients and administrators, on managing patients with the use of drugs blocking the IL-6 pathway.

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April 2022

オーラルサーベイランス試験とJAK阻害薬の安全性: 相対的な評価

Nat Rev Rheumatol. 2022. Epub ahead of print doi: 10.1038/s41584-022-00767-7

Putting the data into context, Winthrop, et al. conclude that the ORAL Surveillance data are not dissimilar to those from the original developmental programme, which suggested additional safety concerns at the 10 mg dosage and that resulted in the 5 mg twice daily dosage as the approved dose for RA.Following the recent results of the ORAL Surveillance (ORALSURV) study, and the consequent changes to the utilisation of JAKinibs, made by the regulatory authorities, Winthrop, et al. aim to put the O...

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January 2022

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

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...

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