Table 1

Baseline and on-randomised control trial clinical characteristics of the patients included (and those not included) in the detailed long term follow-up evaluation after 16 years*

Patients included in LTF populationPatients not included in LTF populationp Value
No of patients260112
% Women69%71%0.7125
Age at disease onset (years)27.3 (6.8)27.7 (7.3)0.5361
Age at start of RCT (years)35.4 (7.4)35.8 (6.7)0.5220
Baseline EDSS2.9 (1.3)2.9 (1.3)0.8373
Baseline EDSS ≥3 (% of population)138 (53)62 (55)0.7343
Disease duration (years)8.0 (6.2)8.1 (6.3)0.9950
Baseline MSSS4.3 (2.3)4.4 (2.2)0.7118
Baseline MRI T2 BOD (cm2)19.6 (20.1)23.1 (23.8)0.0699
Baseline third ventricular width (mm)4.86 (2.28)5.19 (2.42)0.1893
Annualised relapse rate (2 years prior to RCT)1.68 (0.77)1.67 (0.85)0.5964
Annualised relapse rate (on-RCT)1.2 (1.2)1.6 (2)0.0849
EDSS change (on-RCT)0.05 (1.3)0.3 (1.6)0.2415
No of T2 CAL (on-RCT)2.4 (3.3)3.0 (4.0)0.1613
MRI T2 BOD change (on-RCT) (cm2)1.3 (6.1)2.2 (10.2)0.0729
Change, third ventricular width (on-RCT) (mm)0.62 (0.97)0.63 (1.14)0.7321
On IFNβ-1b (250 μg) during RCT (%)37250.0178
  • * Values are means (SDs) or number.

  • p Value derived from Fisher's exact test for rates, z score for percentages and Wilcoxon's rank sum test for all others.

  • Seven deceased patients included in the LTF population; 28 deceased patients not included in LTF population.

  • BOD, burden of disease; CAL, combined active lesions; EDSS, Expanded Disability Status Scale score; IFNβ, interferon β; LTF, long term follow-up; MSSS, Multiple Sclerosis Severity Score; RCT, randomised controlled trial.