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Showing 30 results for “Winthrop KL”.

March 2023

Safety Profile of Upadacitinib over 15 000 Patient-years Across Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis and Atopic Dermatitis

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

Influenza Adverse Events in Patients with Rheumatoid Arthritis, Ulcerative Colitis, or Psoriatic Arthritis in the Tofacitinib Clinical Development Programs

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

Safety of synthetic and biological DMARDs: a systematic literature review informing the 2022 update of the EULAR recommendations for the management of rheumatoid arthritis

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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Efficacy of synthetic and biological DMARDs: a systematic literature review informing the 2022 update of the EULAR recommendations for the management of rheumatoid arthritis

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

Consensus statement on blocking interleukin-6 receptor and interleukin-6 in inflammatory conditions: an update

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

Oral surveillance and JAK inhibitor safety: the theory of relativity

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

Clinical Management of Herpes Zoster in Patients With Rheumatoid Arthritis or Psoriatic Arthritis Receiving Tofacitinib Treatment

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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December 2021

Highlights of 2021

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

I’m sure we’d all hoped that this year would be a return to normal but, in the midst of the challenges we’ve faced with COVID-19, the rheumatology community has continued to deliver excellent publications, and we’ve covered many of these on the CSF. Here are my highlights from 2021's publications: Points to Consider for the Treatment of Immune-Mediated Inflammatory Diseases With Janus Kinase Inhibitors: A Co...

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Integrated safety analysis of filgotinib in patients with moderately to severely active rheumatoid arthritis receiving treatment over a median of 1.6 years

Ann Rheum Dis. 2021. Epub ahead of print. doi: 10.1136/annrheumdis-2021-221051

Integrated analysis evaluates the safety of filgotinib among patients with RA treated for a median of 1.6 years.Winthrop, et al. analysed data from seven trials, including long-term extension studies, and found that rates of TEAEs, grade ≥3 TEAEs, serious TEAEs and TEAEs leading to study drug discontinuation were comparable for filgotinib and placebo. In addition, analysis of AEs of special interest showed a generally similar incidence for filgotinib 200 mg and 100 mg....

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