Table 1

Endpoints

Cohort 1, MTX-IRCohort 2, TNF-IR
FEN-5050 mgQD(n=40)FEN-150150 mgQD(n=109)FEN-200200 mg BID(n=110)PBO(n=110)ADA40 mg Q2W(n=111)FEN-200200 mgBID(n=48)PBO(n=50)
ACR50 responders at W12 7 (18%)30 (28%)38 (35%)16 (15%)40 (36%)12 (25%)6 (12%)
95% confidence interval (CI)(6%, 29%)(19%, 36%)(26%, 43%)(8%, 21%)(27%, 45%)(13%, 37%)(3%, 21%)
Weighted difference vs. PBO8.0%12.9%20.0%-21.6%13.9%-
95% CI of weighted difference*(-6%, 22%)(2%, 23%)(9%, 31%)-(11%, 33%)(-1%, 29%)-
P-value**0.25030.01640.0003-0.00010.0650-
Weighted difference vs. ADA-17.8%-8.6%-1.5%-21.6%---
95% CI of weighted difference*(-34%, -2%)(-21%, 4%)(-14%, 11%)(-33%, -11%)---
P-value**0.02680.16940.81320.0001---
DAS28-CRP at W12Change from baseline
Pts (n) completing W12369595991044744
Adjusted mean*-1.74-1.96-1.96-1.33-2.11-1.96-1.20
95% CI of weighted difference*(-0.93, -0.11)(-1.00, -0.25)(-1.00, -0.24)-(-1.15, -0.41)(-1.14, -0.37)-
P-value vs. PBO**0.16740.00020.0002-<0.00010.0002-
Safety
AEsPts with ≥1 event, n (%)15 (37.5)45 (41.3)56 (50.9)50 (45.5)50 (45.0)11 (22.4)^22 (44.9)^
Serious AEs:Pts with ≥1 event, n (%)-1 (0.9)3 (2.7)1 (0.9)2 (1.8)--
Deaths, n (%)--1 (0.9)***----

*Adjusted for geographic region (Eastern Europe, Latin America, and USA) for Cohort 1, and geographic region and prior exposure to a non-TNF biologic for Cohort 2

**Not adjusted for multiplicity

***Death was due to myocardial infarction

^One PBO pt was treated with FEN-200 in error