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Table 3 Sensitivity analyses of disease activity at Week 48

From: Effect of peginterferon beta-1a on MRI measures and achieving no evidence of disease activity: results from a randomized controlled trial in relapsing-remitting multiple sclerosis

  Placebo Peginterferon beta-1a every 4 weeks Peginterferon beta-1a every 2 weeks
Sensitivity analysis 1 a
NEDA
 n/N (%) 89/500 (17.8) 132/500 (26.4) 204/512 (39.8)
 OR (95% CI) vs. placebo - 1.66 (1.22, 2.24) 3.06 (2.29, 4.09)
p = 0.0011 p < 0.0001
 OR (95% CI) vs. every 4 weeks - - 1.85 (1.42, 2.41)
p < 0.0001
MRI-NEDA only
 n/N (%) 91/477 (19.1) 116/463 (25.1) 187/457 (40.9)
 OR (95% CI) vs. placebo - 1.42 (1.04, 1.93) 2.94 (2.19, 3.95)
p = 0.0274 p < 0.0001
 OR (95% CI) vs. every 4 weeks - - 2.07 (1.56, 2.74)
p < 0.0001
Sensitivity analysis 2 b
No clinical activity + minimal MRI activity
 n/N (%) 129/483 (26.7) 160/469 (34.1) 251/466 (53.9)
 OR (95% CI) vs. placebo - 1.42 (1.08, 1.88) 3.20 (2.44, 4.20)
p = 0.0131 p < 0.0001
 OR (95% CI) vs. every 4 weeks - - 2.25 (1.73, 2.94)
p < 0.0001
Minimal MRI activity
 n/N (%) 161/476 (33.8) 194/462 (42.0) 295/457 (64.6)
 OR (95% CI) vs. placebo - 1.42 (1.09, 1.85) 3.56 (2.72, 4.67)
p = 0.0100 p < 0.0001
 OR (95% CI) vs. every 4 weeks - - 2.52 (1.93, 3.28)
p < 0.0001
Sensitivity analysis 3 c
No clinical activity + minimal MRI activity
 n/N (%) 104/484 (21.5) 135/469 (28.8) 214/466 (45.9)
 OR (95% CI) vs. placebo - 1.48 (1.10, 1.98) 3.10 (2.34, 4.12)
p = 0.0096 p < 0.0001
 OR (95% CI) vs. every 4 weeks - - 2.10 (1.60, 2.75)
p < 0.0001
Minimal MRI activity
 n/N (%) 129/477 (27.0) 158/462 (34.2) 251/457 (54.9)
 OR (95% CI) vs. placebo - 1.40 (1.06, 1.85) 3.29 (2.50, 4.32)
p = 0.0175 p < 0.0001
 OR (95% CI) vs. every 4 weeks - - 2.34 (1.80, 3.06)
p < 0.0001
  1. aLOCF (i.e. patients were not excluded from NEDA analyses if they had missing MRI scan data during Year 1, and were not excluded from MRI-NEDA only analyses if they had data from ≥1 MRI scan during Year 1); bDefined as the total number of new or newly-enlarging T2 lesions at Week 48 compared to baseline and the number of gadolinium-enhancing lesions at both Week 24 and Week 48 ≤2; cDefined as ≤1 new or newly-enlarging T2 lesion at Week 48 compared with baseline and no gadolinium-enhancing lesions at Weeks 24 and 48. CI = confidence interval; LOCF = last observation carried forward; n/N = patients free from disease activity/total number of patients analyzed; OR = odds ratio.