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Incidência Baseada em Idade (<65 vs ≥65 anos) de Infecções e Infecções Graves com Tofacitinib versus DMARDs biológicos nos Ensaios Clínicos em Artrite Reumatoide nos EUA e no Registro Corrona RA

Winthrop KL, Citera G, Gold D, Henrohn D, Connell CA, Shapiro AB, Shi H, Onofrei AM, Pappas DA, Schulze-Koops H. - Ann Rheum Dis 2020; DOI: 10.1136/annrheumdis-2020-218992

Reports from clinical trials and the US Corrona RA registry showed that serious infection event (SIE) incidence was higher in older versus younger patients with RA receiving 10 mg BID of TOF and ADA, however, SIE risk was similar between age groups with TOF 5 mg BID and ADA.

Data were collected from Phase II–IV tofacitinib studies, and the US Corrona RA registry. The clinical data set evaluated patients receiving TOF 5 and 10 mg BID versus TNFi (ADA/ETN) in RA patients aged ≥50 years. The EMA recommended that older patients should receive TOF when there is no suitable alternative treatment. Crude infection rate (IR) and hazard ratio (HR) were calculated for first infections and SIEs, overall and by age.

SIEs were higher in older versus younger patients for active treatments, and similar among younger patients for all treatments. HRs revealed similar SIE risk between older and younger patients for TOF 5 mg BID and ADA. The risk was significantly greater in older versus younger patients with TOF 10 mg BID. Age- and gender-standardised SIE IRs were higher in older versus younger patients, and similar between tofacitinib and bDMARD initiators for both age groups.

Results of this analysis are consistent with real-world data for >130 000 RA patients, which reported similar adjusted SIEs.

Keywords: JAK, Tofacitinib, Clinical, Safety

Access original article via Pubmed

Upload date: November 2020

Translated by: Igor Kos

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