Efecto de Glucocorticoides en la eficacia Clínica y Radiográfica de Tofacitinib en Pacientes con Artritis Reumatoide: Un análisis Posthoc de datos desde 6 estudios fase III
In this post hoc analysis, six Phase 3 studies were used to analyse the effect of glucocorticoids (GC) on the efficacy of tofacitinib (TOF) in patients with RA. Concomitant use of GC did not affect the clinical or radiographic outcomes of patients treated with TOF.
Data from all six clinical trials were evaluated, with four studies (ORAL Scan, ORAL Standard, ORAL Sync and ORAL Step) being pooled for analysis. In these studies, MTX was used as a comparison and patients were required to maintain a stable dose of GC throughout. Clinical endpoints were: ACR response rates, CDAI scores, change in DAS28-4-ESR, HAQ-DI scores, pain VAS and change in mTSS.
Rates of ACR20/50/70 responses, CDAI low disease activity and remission were similar across all treatment groups. Radiographic progression was similar between TOF groups; however, a trend was seen for greater radiographic inhibition in patients given MTX combined with GC compared to MTX alone. For all endpoints, patients given MTX had significantly lower results (P<0.05, P<0.001 and P<0.0001) than those given TOF.
Results indicate that TOF efficacy is unaffected by GC use. However, further research is needed in the form of a clinical trial to characterize the efficacy and safety profile of TOF in combination with GCs.