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Showing 33 results for “Winthrop K”.

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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Safety Profile of Upadacitinib up to 3 Years in Psoriatic Arthritis: An Integrated Analysis of Two Pivotal Phase 3 Trials

Rheumatol Ther. 2022 doi: 10.1007/s40744-021-00410-z

Upadacitinib 15 mg once daily demonstrated a similar safety profile to adalimumab 40 mg every other week, except for higher rates of HZ and opportunistic infections with upadacitinib treatment in patients treated for PsA

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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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Evaluation of response to 13-valent conjugated pneumococcal vaccination in patients with rheumatoid arthritis receiving upadacitinib: results from a phase 2 open-label extension study

RMD Open. 2022;8(1):e002110 doi: 10.1136/rmdopen-2021-002110

Vaccine sub-study of the BALANCE-EXTEND upadacitinib trial finds that approximately two-thirds of patients receiving upadacitinib 15 mg once-daily achieve a satisfactory humoral response to pneumococcal 13-valent conjugate (PCV-13) vaccine, despite receiving concomitant methotrexate (MTX).It is well known that a weakened immune response, comorbidities and immunosuppressant drug therapy all contribute to an increased susceptibility to infections in patients with RA. Likewise, the morbidity and mo...

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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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Cytokine Signalling Forum: Single slide summaries – January 2022

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Upadacitinib as monotherapy or in combination with background MTX was effective in inhibiting the progression of structural joint damage through Week 48 in MTX-naïve and MTX‐inadequate responder patients with RA.Recently approved in many countries for the treatment of RA, upadacitinib has been shown to significantly reduce the progression of structural joint damage in two Phase 3 studies (SELECT-EARLY and SELECT-COMPARE). In this analysis, Peterfy, et al. evaluated the progression of structural ...

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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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Incidence and risk factors for herpes zoster in patients with rheumatoid arthritis receiving upadacitinib: a pooled analysis of six phase III clinical trials

Ann Rheum Dis. 2021. Epub ahead of print. doi: 10.1136/annrheumdis-2021-220822.

JAKinibs have been linked with an increased risk of HZ in patients with RA. To this end, Winthrop, et al. evaluated data from six Phase III clinical trials to determine the incidence of HZ in the upadacitinib (UPA)-treated patients with RA and identify potential risk factors for the development of HZ in these patients.Analysis of data provides further support for the need for continued vigilance and monitoring for signs of herpes zoster (HZ) in patients receiving UPA, particularly in Asian popul...

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Safety of baricitinib for the treatment of rheumatoid arthritis over a median of 4.6 and up to 9.3 years of treatment: final results from long-term extension study and integrated database

Ann Rheum Dis. 2021. Epub ahead of print. doi: 10.1136/annrheumdis-2021-221276.

Analysis of data from the highest level of patient exposure to baricitinib across the spectrum of the RA population demonstrates that baricitinib maintained a similar safety profile to earlier analyses, with no new safety signals identified.Using integrated data from nine randomised controlled trials, Taylor, et al. assessed the safety of baricitinib 2 mg and 4 mg once-daily. Analysis of data from 3770 patients (median 4.6 years, up to 9.3 years) with active RA showed that baricitinib maintained...

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