Romatoid Artrit Hastalarında Tofasitinib Monoterapisinin, Metotreksat ile Tofasitinibin ve Metotreksat ile Adalimumab Kombinasyonunun Etkinliği ve Güvenliği (ORAL Strategy): Faz 3b/4, Çift Kör, Kafa-kafaya, Randomize Kontrollü Bir Çalışma
Lancet. 2017 Jul 29;390(10093):457-468. doi: 10.1016/S0140-6736(17)31618-5
In this first head-to-head non-inferiority trial assessing a JAKi ± MTX directly compared with a TNFi + MTX in patients with RA, tofacitinib (TOF) + MTX showed non-inferiority to adalimumab (ADA) + MTX. Non-inferiority was not shown for TOF monotherapy versus TOF + MTX, or versus ADA + MTX.In this 52-week study, MTX-inadequate responder (IR) patients were randomised 1:1:1 to receive TOF 5 mg BID monotherapy, TOF 5 mg BID + MTX or ADA 40 mg every other week + MTX. The primary endpoint, ACR50 resp...