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Table 2 Summary of primary and secondary efficacy endpoints during part I (6 weeks of treatment)

From: Evaluation of two doses of etoricoxib, a COX-2 selective non-steroidal anti-inflammatory drug (NSAID), in the treatment of Rheumatoid Arthritis in a double-blind, randomized controlled trial

  Placebo Etoricoxib 60 mg LS Mean Difference vs. Placebo; p-valuea,b Etoricoxib 90 mg LS Mean Difference vs. Placebo; p-value LS Mean Difference Between 60 mg and 90 mg; p-valuea,b
Co-Primary Endpointsa       
LS mean change from baseline DAS28-CRP (95 % CI) - 1.10 (-1.29, -0.90) - 1.39(-1.48, -1.30) -0.29 (-0.49, -0.09); p = 0.004 - 1.37 (-1.48, -1.26) -0.27 (-0.48, -0.06); p = 0.034 0.02 (-0.10, 0.14); p = 0.730
LS mean change from baseline in Pain - PGAP (95 % CI) - 20.26 (-24.04, -16.48) - 28 .25 (-30.05, -26.44) -7.99 (-11.85, -4.13); p < 0.001 - 30.96 (-33.13, -28.79) -10.70 (-14.74, -6.66); p < 0.001 -2.71 (-4.98, -0.45); p = 0.019
Secondary Endpointsb       
Proportions of Patients Who Met ACR20 (%) 41/111 (36.94) 377/769 (49.02) 12.09 (2.52, 21.66); p = 0.017 242/440 (55.00) 18.19 (8.17, 28.22); p < 0.001 6.03 (0.22, 11.85); p = 0.043
Time-weighted Average (LS Mean) Response over 6 Weeks in PGART (95 % CI) 2.00 (1.83, 2.18) 2.46 (2.38, 2.55) 0.46 (0.28, 0.64); p < 0.001 2.48 (2.38, 2.58) 0.47 (0.29, 0.66); p < 0.001 0.01 (-0.09, 0.12); p = 0.815
Proportion of Patients Who Discontinued due to Lack of Efficacy (%) 15/111 (13.51) 29/769 (3.77) -9.74 (-16.24, -3.24); p < 0.001 10/440 (2.27) -11.24 (-17.75, -4.73); p < 0.001 -1.50 (-3.44, 0.44); p = 0.178
  1. ap-values for primary endpoints were adjusted for multiplicity; statistical significance is achieved if p ≤ 0.05
  2. bp-values for secondary endpoints were not adjusted for multiplicity and are therefore nominal; statistical significance cannot be inferred from p-values for these endpoints