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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.
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BMC Neurology

ISSN: 1471-2377

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