Table 1. Patient characteristics: demographic data, clinical data, and adverse events
Adverse events during baseline
Adverse events during therapy
Patient code Sex/race/age MS type* IFN-β formulation/neutral. Ab MS duration, y End-baseline EDSS§ End-therapy EDSS§ Baseline NRS (mean) Therapy NRS (mean) Baseline exac. rate No./mo Therapy exac. rate No./mo I** L** O** I** L** O**
MS-Z1 F/W/38 SP A/- 8.0 4.5 5.0 68.3 63.6 0/4 0/6.5 1 1
MS-Z2 F/W/27 SP A/- 3.3 2.5 2.0 81.5 84.9 1/5 0/6.5
MS-Z3 M/W/36 SP B/- 9.3 6.0 6.0 60.0 81.8 2/6 0/6.5 1
MS-Z4 F/W/49 RR B/+ 24.0 3.5 3.0 66.3 78.3 2/6 1/7.5 1 1 1
MS-Z5 F/B/51 SP B/- 10.3 6.0 6.0 56.5 59.0 0/4 1/7.5 1
MS-Z6 F/W/42 RR B/- 7.9 3.0 3.0 83.5 86.6 2/6 0/6.5 1
MS-Z7 M/W/33 RR B/- 1.9 2.5 0.0 85.0 97.0 0/4 0/6.5 1 1 1
MS-Z8†† F/W/48 SP B/- 6.0 3.5 3.5 69.7 72.4 0/4 1/7.5
MS-Z9 M/W/23 RR B/- 1.0 2.0 2.0 94.8 89.6 2/6 0/6.5 1 1
MS-Z10 F/W/29 RR A/- 5.5 3.0 1.5 62.7 89.9 1/5 0/6.5 1
MS-Z11 F/W/40 RR B/+ 6.7 1.5 1.0 93.3 98.0 0/4 0/6.5 2
Group medians or cumulative values 7.6 3.0 2.5 74.9 85.8 10/50 2/67 1 2 2 5 2 4
  • * RR, relapsing-remitting MS; SP, secondary progressive MS.

  • A, Avonex; B, Betaserone; neutral. Ab, neutralizing antibodies; -, negative; +, positive.

  • Disease duration in years was calculated from the first symptom attributable to MS.

  • § EDSS at the end of baseline or treatment period that was sustained > 3 months = measure of sustained disability.

  • Average Scripps NRS score from baseline and treatment periods = clinical measure that includes monthly variations in clinical status.

  • Exacerbation rate (exac. rate) is displayed as number of exacerbations per number of months during baseline or treatment periods. Note that, when exacerbation occurred, the baseline or treatment period was extended by 1 month per 1 exacerbation because the MRI and clinical values within 28 days of IVMP therapy were excluded from the analysis and were replaced by the next month's values.

  • ** I, infections (four urinary tract infections, two upper respiratory tract infections); L, abnormal laboratory values (transient elevation of LFTs); O, others (transient headache, constipation, breast tenderness, iron-deficiency anemia, exacerbation of ongoing depression, surgery for kidney stones).

  • †† Patient MS-Z8 received higher dose of daclizumab (2mg/kg i.v. q 2w) and was excluded from final analysis.