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Showing 63 results for “Safety”.

May 2023
April 2023

Identification of Two Tofacitinib Subpopulations with Different Relative Risk Versus TNF Inhibitors: An Analysis of the Open Label, Randomised Controlled Study ORAL Surveillance

Ann Rheum Dis. 2023 doi: 10.1136/ard-2022-223715 Epub ahead of print

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’.

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Sex Differences in the Efficacy, Safety and Persistence of Patients with Psoriatic Arthritis Treated with Tofacitinib: A Post Hoc Analysis of Phase 3 Trials and Long-Term Extension

RMD Open 2023;9:e002718 doi 10.1136/rmdopen-2022-002718

Evidence from two phase 3 RCTs and one LTE shows that while tofacitinib efficacy exceeds placebo in both sexes and is comparable between sexes, males are more likely to achieve minimal disease activity than females.

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Multidomain Efficacy and Safety of Guselkumab Through 1 Year in Patients with Active Psoriatic Arthritis with and Without Prior Tumor Necrosis Factor Inhibitor Experience: Analysis of the Phase 3, Randomized, Placebo-Controlled DISCOVER-1 Study

ACR Open Rheumatol. 2023 doi: 10.1002/acr2.11523

TNF inhibitors (TNFi) are one main mode of therapy in patients with PsA who fail to respond to csDMARDs. However, they have a primary treatment failure rate of 40% and only a modest target of ≥20% ACR20 response. The objective of this study was to evaluate efficacy and safety of guselkumab, interleukin-23 inhibitor in the DISCOVER-1 study with active PsA patients by prior use of TNFi.

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Efficacy and Safety of Golimumab in Patients with Non-radiographic Axial Spondyloarthritis: A Withdrawal and Retreatment Study (GO-BACK)

Rheumatology (Oxford). 2023 doi: 10.1093/rheumatology/kead112 Epub Ahead of Print

This study highlighted that continued treatment with Golimumab (GLM) QMT or GLM Q2MT was superior to placebo. The GO-BACK study was designed to evaluate the efficacy and safety of golimumab treatment withdrawal in adults with nr-axSpA who demonstrate inactive disease during a 10-month open label GLM run-in.

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May 2023

Efficacy and Safety of Upadacitinib in Patients with Active Psoriatic Arthritis and Axial Involvement: Results From Two Phase 3 Studies

Arthritis Res Ther. 2023;25(1):56 doi 10.1186/s13075-023-03027-5

Evidence from two phase 3 RCTs showed that patients with PsA and axial involvement had greater responses when treated with a once-daily oral dose of 15 mg upadacitinib versus placebo, and a similar or greater response versus adalimumab. Safety results were comparable between patients with or without axial involvement.

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A Patient with Adalimumab-induced Refractory Paradoxical Palmoplantar Pustulosis was Successfully Treated by Ixekizumab: A Case Report

Clin Cosmet Investig Dermatol. 2023;16:879–881 doi 10.2147/CCID.S406164

Ixekizumab, has been shown to be efficacious against paradoxical palmoplantar pustulosis which has been reported following the administration of therapeutic TNFi. Following the increased use of biologic therapies that improve patients’ quality of life are causing paradoxical adverse effects

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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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Baricitinib Safety for Events of Special Interest in Populations at Risk: Analysis from Randomised Trial Data Across Rheumatologic and Dermatologic Indications

Adv Ther. 2023:1–17 doi: 10.1007/s12325-023-02445-w Epub ahead of print

Analysis of pooled data from the baricitinib clinical development programmes finds a low incidence rate of MACE, myocardial infarction, lung cancer, VTE, and overall mortality in patients <65 years without risk factors.

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