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Showing 84 results for “safety profile”.

November 2023

Long-term Safety of Guselkumab in Patients with Psoriatic Disease: An Integrated Analysis of Eleven Phase II/III Clinical Studies in Psoriasis and Psoriatic Arthritis

Drug Saf. 2023 doi:10.1007/s40264-023-01361-w. Epub ahead of print

Data gathered from 11 phase 2 and phase 3 trials have shown that guselkumab has a favourable safety profile in treating psoriatic disease. The data were gathered from 4399 patients over 10787 patient years. In the placebo-controlled periods, guselkumab showed a similar safety profile to placebo, and this remained consistent and stable in the non-placebo controlled preiods.

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October 2023

Bimekizumab Treatment in Biologic DMARD-Naïve Patients with Active Psoriatic Arthritis: 52-Week Efficacy and Safety Results from the Phase III, Randomised, Placebo-Controlled, Active Reference BE OPTIMAL Study

Ann Rheum Dis. 2023 doi: 10.1136/ard-2023-224431. Epub ahead of print

Data from this phase 3 RCT demonstrated that the efficacy of bimekizumab observed at 16 weeks remained consistent through to 52 weeks in the treatment of bDMARD-naïve patients with PsA. Patients who started the trial on placebo and switched to bimekizumab at week 16 showed similar improvements to those patients who were randomised to receive bimekizumab at the start of the trail. No new safety signals were identified.

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Treatment with Upadacitinib in Active Psoriatic Arthritis: Efficacy and Safety Data of the First 192 Patients from the UPJOINT Study, a Multicentre, Observational Study in Clinical Practice

Rheumatol Ther. 2023 doi: 10.1007/s40744-023-00589-3. Epub ahead of print

In the UPJOINT open label study, the proportion of patients with PsA, and an inadequate response to csDMARDs or bDMARDs, who achieved minimal disease activity with upadacitinib was in line with the results of previous studies at 24 weeks. No new safety signals were identified.

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September 2023

Long-Term Safety and Efficacy of Ixekizumab in Patients with Axial Spondyloarthritis: 3-year Data from the COAST Program

J Rheumatol. 2023;50(8):1020–1028 doi: 10.3899/jrheum.221022

Three-year data from the ixekizumab (IXE) COAST programme provide additional evidence that patients with axSpA receiving IXE experience long-term safety, and sustained improvements in efficacy outcomes, at 3 years.

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August 2023

Post-Marketing Safety Surveillance of Tofacitinib over 9 Years in Patients with Psoriatic Arthritis and Rheumatoid Arthritis

Rheumatol Ther. 2023 doi: 10.1007/s40744-023-00576-8 Epub ahead of print

The data gathered in this post-marketing surveillance study aligned with the previously established safety profile of tofacitinib, and reports were found to have consistent safety profiles in the treatment of both patient with PsA and RA. However, the results of this study should be interpreted considering the limitations of post-marketing surveillance studies.

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Upadacitinib in Patients with Psoriatic Arthritis and Inadequate Response to Biologics: 3-year Results from the Open-Label Extension of the Randomised Controlled Phase 3 SELECT-PsA 2 Study

Clin Exp Rheumatol. 2023 doi: 10.55563/clinexprheumatol/8l7bbk. Epub ahead of print

Data from this open-label extension showed the efficacy of upadacitinib observed at 56 weeks was maintained through to 152 weeks in the treatment of patients with PsA. No cumulative adverse effects were observed, and no new safety signals were identified.

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July 2023

Baricitinib in Juvenile Idiopathic Arthritis: An International, Phase 3, Randomised, Double-blind, Placebo-controlled, Withdrawal, Efficacy, and Safety Trial

Lancet. 2023 S0140-6736(23)00921-2 doi 10.1016/S0140-6736(23)00921-2 Epub ahead of print

Phase 3 trial of baricitinib demonstrates efficacy with acceptable safety profile in polyarticular and extended oligoarticular juvenile idiopathic arthritis, juvenile psoriatic arthritis and enthesitis-related arthritis.

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Safety profile of upadacitinib in patients at risk of cardiovascular disease: integrated post hoc analysis of the SELECT phase III rheumatoid arthritis clinical programme

Ann Rheum Dis. 2023 doi: 10.1136/ard-2023-223916

Pots hoc analysis of safety data in patients with RA at increased risk of CV events from the upadacitinib SELECT phase III RA clinical programme helps to contextualise the overall risk profile of upadacitinib.

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April 2023

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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