Age-based (<65 vs ≥65 years) incidence of infections and serious infections with tofacitinib versus biological DMARDs in rheumatoid arthritis clinical trials and the US Corrona RA registry
| Autor: | Hendrik Schulze-Koops, Andrea Shapiro, Dimitrios A. Pappas, Kevin L. Winthrop, Harry Shi, David Gold, D. Henrohn, Gustavo Citera, Alina Onofrei, Carol A. Connell |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
0301 basic medicine
Male Letter antirheumatic agents tumor necrosis factor inhibitors Etanercept Arthritis Rheumatoid 0302 clinical medicine Piperidines Risk Factors adalimumab Immunology and Allergy Registries Incidence (epidemiology) Incidence Age Factors Middle Aged arthritis biological therapy Rheumatoid arthritis Female medicine.drug medicine.medical_specialty rheumatoid Immunology Placebo Infections General Biochemistry Genetics and Molecular Biology 03 medical and health sciences Rheumatology Internal medicine medicine Adalimumab Humans Janus Kinase Inhibitors Risk factor Aged Proportional Hazards Models 030203 arthritis & rheumatology Biological Products Tofacitinib business.industry medicine.disease United States Clinical trial 030104 developmental biology Pyrimidines business |
| Zdroj: | Annals of the Rheumatic Diseases |
| ISSN: | 1468-2060 0003-4967 |
| Popis: | A randomised, open-label, blinded endpoint post-authorisation safety study (Study A3921133; NCT02092467; database not locked and subject to change) evaluated the safety of tofacitinib 5 mg and 10 mg twice daily (BID) versus tumour necrosis factor inhibitors (TNFi) (adalimumab/etanercept) in rheumatoid arthritis (RA) patients aged ≥50 years with ≥1 cardiovascular risk factor. An ad hoc interim safety analysis of Study A3921133 reported incidence rates (IRs) per 100 patient-years (95% CIs) for fatal infections (within 28 days of treatment) and non-fatal serious infection events (SIEs), respectively: tofacitinib 5 mg BID, 0.18 (0.07 to 0.39) and 3.35 (2.78 to 4.01); tofacitinib 10 mg BID, 0.22 (0.09 to 0.46) and 3.51 (2.93 to 4.16); TNFi, 0.06 (0.01 to 0.22) and 2.79 (2.28 to 3.39).1 SIEs risk (fatal/non-fatal) was further increased with tofacitinib in patients aged >65 years versus younger patients; therefore, the European Medicines Agency recommended that older patients should receive tofacitinib when there is no suitable alternative treatment.2 Further to these recommendations, we sought to assess age-based ( |
| Databáze: | OpenAIRE |
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