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Showing 263 results for “safety”.

September 2023

Cardiovascular Safety of Janus Kinase Inhibitors in Patients with Rheumatoid Arthritis: Systematic Review and Network Meta-analysis

Front Pharmacol. 2023; 8(14):1237234 doi 10.3389/fphar.2023.1237234

This meta-analysis by Wei, et al. found that JAKi therapy was not associated with a higher risk of MACE than treatment with adalimumab, abatacept, or placebo. However, a higher incidence of all-cause mortality was observed with tofacitinib treatment than with adalimumab treatment.

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A Randomized, Double-Blind, Placebo-Controlled Phase 2a Study of Tildrakizumab Efficacy and Safety in Patients with Active Ankylosing Spondylitis

J Clin Rheumatol. 2023;29(5):223–229 doi: 10.1097/RHU.0000000000001973

Phase 2a study assessing the efficacy and safety of tildrakizumab in patients with active AS fails to meet the primary endpoint.

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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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Efficacy and Safety of the TYK2/JAK1 Inhibitor Brepocitinib for Active Psoriatic Arthritis: A Phase IIb Randomized Controlled Trial

Arthritis Rheumatol. 2023;75(8):1370–1380 doi: 10.1002/art.42519

Phase IIb study of brepocitinib in patients with PsA concludes that treatment with brepocitinib 30 mg and 60 mg QD, was superior to placebo at reducing signs and symptoms of PsA and was well-tolerated over 52 weeks.

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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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A JAK Inhibitor for Treatment of Rheumatoid Arthritis: The Baricitinib Experience

J. Clin. Med. 2023;12(13):4527 doi 10.3390/jcm12134527

This review by Taylor, et al. reviews the long-term safety and efficacy data for baricitinib. Results from several studies showed that baricitinib has greater efficacy and survival compared to TNF inhibitors, and that the rate of CDAI <10 for baricitinib-treated RA patients increased over the course of seven years. Data also showed that remission rates were higher in real-world evidence than in RCTs.

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July 2023

Apremilast Long‑Term Safety Up to 5 Years from 15 Pooled Randomized, placebo‑Controlled Studies of Psoriasis, Psoriatic Arthritis, and Behçet’s Syndrome

Am J Clin Dermatol. 2023 Jun 14:1–12 doi: 10.1007/s40257-023-00783-7 Epub ahead of print

This study confirms the safety of long-term apremilast use in patients with plaque PsO, active PsA, or oral ulcers associated with Behçet’s syndrome. In coming to this conclusion, investigators conducted a pooled analysis of apremilast data from 15 clinical studies with open-label extension phases, focusing on long-term safety.

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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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Post Hoc Analysis of Patients with Rheumatoid Arthritis Under Clinical Remission in Two Japanese Phase 3 Trials of Peficitinib Treatment (RAJ3 and RAJ4)

Mod Rheumatol. 2023 doi: 10.1093/mr/road059 Epub ahead of print

Pots hoc analysis of peficitinib phase 3 trials shows that continued treatment with peficitinib up to Week 52 is linked to improved remission rates in Asian patients with RA.

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