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Impact in Clinical Practice of the European Medicines Agency Health Alert About the Restriction of the Use of JAK Inhibitors.
Pharmaceuticals (Basel)
December 2024
Department of Rheumatology, Hospital Universitario Infanta Sofía, FIIB HUIS HHEN, Universidad Europea, 28702 Madrid, Spain.
Janus kinase inhibitors (JAKi) have revolutionized the treatment of various inflammatory and immune disorders. Concerns about the potential increased risk of major adverse cardiovascular events (MACEs) associated with JAKi use led to a European Medicines Agency (EMA) health alert recommending restricting the use of JAKi in high-risk populations. This study aims to determine the proportion of patients who developed any cardiovascular, ischemic, neoplastic, or thrombotic adverse event in a cohort of patients receiving, or who have received, JAKi treatment between January 2017 and September 2023.
View Article and Find Full Text PDFIntegrated safety analysis of tofacitinib from Phase 2 and 3 trials of patients with ankylosing spondylitis.
Adv Rheumatol
December 2024
Amsterdam Rheumatology and Immunology Center, Amsterdam University Medical Centers, Amsterdam, The Netherlands.
Objectives: Describe tofacitinib safety from an integrated analysis of randomized controlled trials (RCTs) in patients with ankylosing spondylitis (AS).
Method: Pooled data from Phase 2 (NCT01786668; 04/2013-03/2015)/Phase 3 (NCT03502616; 06/2018-08/2020) RCTs in AS patients were analyzed (3 overlapping cohorts): 16-week placebo-controlled (tofacitinib 5 mg twice daily [BID] [n = 185]; placebo [n = 187]); 48-week only-tofacitinib 5 mg BID (n = 316); 48-week all-tofacitinib (≥ 1 dose of tofacitinib 2, 5, or 10 mg BID; n = 420). Baseline 10-year atherosclerotic cardiovascular disease (ASCVD) risk was determined in patients without history of ASCVD (48-week cohorts).
Risk of Malignancy Related to Ixekizumab in Patients in Patients With Psoriatic Arthritis or Axial Spondyloarthropathy: Systematic Review and Meta-analysis.
J Clin Rheumatol
December 2024
Department of Psychiatry, Radiology, Public Health, Nursing and Medicine, Medical School, Universidad de Santiago de Compostela.
Article Synopsis
- The study evaluated the malignancy risk linked to ixekizumab in patients with rheumatological conditions through a systematic review of randomized controlled trials (RCTs) and long-term extension studies (LTEs).
- Meta-analyses indicated a low overall risk of malignancy, with Peto odds ratios showing varied results when compared to placebo and another drug, adalimumab.
- The research concluded that while ixekizumab generally poses a low risk for malignancy, certain conditions, like nonmelanoma skin cancer, may be exceptions for patients with psoriatic arthritis and axial spondyloarthritis.
The risk of malignancy in patients with psoriasis treated with long-term tumor necrosis factor-α inhibitor: a systematic review and meta-analysis.
Clin Exp Dermatol
November 2024
Department of Dermatology, Wan Fang Hospital, Taipei Medical University, Taipei, Taiwan.
Article Synopsis
- The relationship between tumor necrosis factor-α inhibitors (TNFi) and cancer risk in psoriasis patients is complex, requiring a careful analysis to understand long-term implications for treatment.
- This systematic review and meta-analysis assessed the cancer risk associated with long-term TNFi therapy in psoriasis patients, analyzing data from multiple medical databases.
- The results indicated no significant increase in cancer risk for most types, but highlighted an elevated risk of non-melanoma skin cancer (NMSC) and squamous cell carcinoma (SCC) among those receiving TNFi treatment.
Post-Marketing Safety of Ustekinumab Based on 14-Year Follow-Up in Danish National Patient Data.
Pharmacoepidemiol Drug Saf
December 2024
Department of Pediatrics and Adolescent Medicine, Danish National University Hospital "Rigshospitalet", Copenhagen, Denmark.
Article Synopsis
- This 14-year cohort study investigated the long-term safety of ustekinumab, a biologic treatment for psoriasis, using data from Danish national registers.
- The study compared safety outcomes like cancers and serious infections in ustekinumab users against patients receiving other systemic treatments, including non-biologics and various biologic therapies.
- Results showed that ustekinumab is generally safe, with no major safety concerns identified, and users were younger and had different gender distributions compared to users of other treatments.
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