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2016 ; 19
(12
): 1216-1225
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gab.com Text
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English Wikipedia
Efficacy and safety of tofacitinib in patients with active rheumatoid arthritis:
review of key Phase 2 studies
#MMPMID27451980
Fleischmann R
; Kremer J
; Tanaka Y
; Gruben D
; Kanik K
; Koncz T
; Krishnaswami S
; Wallenstein G
; Wilkinson B
; Zwillich SH
; Keystone E
Int J Rheum Dis
2016[Dec]; 19
(12
): 1216-1225
PMID27451980
show ga
Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid
arthritis (RA). Here, the safety and efficacy data from five Phase 2 studies of
tofacitinib in patients with RA are summarized. Tofacitinib 1-30 mg twice daily
was investigated, as monotherapy and in combination with methotrexate, in
patients with RA. Tofacitinib 20 mg once daily was investigated in one study.
Tofacitinib 5 and 10 mg twice daily were selected for investigation in Phase 3
studies; therefore, the efficacy and safety of tofacitinib 5 and 10 mg twice
daily in Phase 2 studies are the focus of this review. Tofacitinib ? 5 mg twice
daily was efficacious in a dose-dependent manner, with statistically significant
and clinically meaningful reductions in the signs and symptoms of RA and
patient-reported outcomes. The safety profile was consistent across studies. The
efficacy and safety profile of tofacitinib in Phase 2 studies supported its
further investigation and the selection of tofacitinib 5 mg twice daily and
tofacitinib 10 mg twice daily for evaluation in Phase 3 studies.