Efficacy and safety of tofacitinib in patients with active rheumatoid arthritis: review of key Phase 2 studies.

Abstract:

: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.

journal_name

Int J Rheum Dis

authors

Fleischmann R,Kremer J,Tanaka Y,Gruben D,Kanik K,Koncz T,Krishnaswami S,Wallenstein G,Wilkinson B,Zwillich SH,Keystone E

doi

10.1111/1756-185X.12901

subject

Has Abstract

pub_date

2016-12-01 00:00:00

pages

1216-1225

issue

12

eissn

1756-1841

issn

1756-185X

journal_volume

19

pub_type

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