OMERACT-OARSI and MCII
CS n=199 | Celecoxib n=199 | Placebo n=205 | CS vs placebo χ2 p Value | Celecoxib vs placebo χ2 p Value | |
VAS–MCII 20 mm, n (%) | |||||
Day 30—Yes (%) | 94 (47) | 99 (50) | 93 (45) | 0.706 | 0.378 |
Day 91—Yes (%) | 126 (63) | 128 (64) | 125 (61) | 0.628 | 0.487 |
Day 182—Yes (%) | 136 (68) | 137 (69) | 125 (61) | 0.122 | 0.098 |
PASS, n (%) | |||||
Day 30—Yes (%) | 62 (31) | 80 (40) | 65 (32) | 0.905 | 0.075 |
Day 91—Yes (%) | 93 (47) | 108 (54) | 91 (44) | 0.636 | 0.047 |
Day 182—Yes (%) | 113 (57) | 118 (59) | 101 (49) | 0.130 | 0.043 |
VAS–MCII 40%, n (%) | |||||
Day 30—Yes (%) | 59 (30) | 78 (39) | 64 (31) | 0.731 | 0.093 |
Day 91—Yes (%) | 105 (53) | 103 (52) | 102 (50) | 0.545 | 0.687 |
Day 182—Yes (%) | 127 (64) | 116 (58) | 106 (52) | 0.014 | 0.184 |
VAS–MCII 50%, n (%) | |||||
Day 30—Yes (%) | 43 (22) | 50 (25) | 49 (24) | 0.582 | 0.775 |
Day 91—Yes (%) | 86 (43) | 83 (42) | 77 (38) | 0.247 | 0.394 |
Day 182—Yes (%) | 115 (58) | 103 (52) | 83 (40) | 0.005 | 0.023 |
LI–MCII 40%, n (%) | |||||
Day 30—Yes (%) | 34 (17) | 45 (23) | 27 (13) | 0.272 | 0.013 |
Day 91—Yes (%) | 71 (36) | 67 (34) | 56 (27) | 0.070 | 0.165 |
Day 182—Yes (%) | 94 (47) | 90 (45) | 72 (35) | 0.013 | 0.038 |
LI–MCII 50%, n (%) | |||||
Day 30—Yes (%) | 18 (9) | 27 (14) | 13 (6) | 0.307 | 0.015 |
Day 91—Yes (%) | 52 (26) | 44 (22) | 34 (17) | 0.019 | 0.159 |
Day 182—Yes (%) | 74 (37) | 70 (35) | 56 (27) | 0.034 | 0.088 |
OMERACT-OARSI—scenario F, n (%) | |||||
Day 30—Yes (%) | 82 (41) | 89 (45) | 82 (40) | 0.805 | 0.337 |
Day 91—Yes (%) | 118 (59) | 119 (60) | 110 (54) | 0.253 | 0.213 |
Day 182—Yes (%) | 132 (66) | 133 (67) | 113 (55) | 0.021 | 0.016 |
If we use the ITT2 population the results for MCII (20 mm) reported in the text of the publication are not correct (the comparisons vs placebo are not statistically significant, see table above).
ITT, intention-to-treat; LI, Lequesne Index; MCII, Minimal-Clinically Important Improvement; PASS, Patient-Acceptable Symptoms State; VAS, Visual Analogue Scale.