Table 10.
Study/N/Age/Location | Intervention and treatment duration | Summary of efficacy results |
---|---|---|
TARIMS Study (2004)41 N=76 Mean age, years: IVIG, 35.3; placebo, 35.2 (P=0.99) Germany, Denmark, Sweden |
Intervention IVIG followed by IVMP 24 hrs later (n=36) vs placebo followed by IVMP 24 hrs later (n=40) Treatment duration NR Assessments Baseline, 4 days after treatment onset, and 3, 12, and 26 weeks after treatment onset |
Baseline EDSS: IVIG followed by IVMP: 4.4±1.3; placebo followed by IVMP: 4.2±1.3 Improvement from baseline in EDSS scores: Day 4: IVIG followed by IVMP, 0.63; placebo followed by IVMP, 0.69 Week 3: IVIG followed by IVMP, 1.28; placebo followed by IVMP, 0.96 |
Visser et al (2004)42 N=19 Mean age, years: IVMP followed by IVIG, 37.5; IVMP, 38.1 The Netherlands |
Intervention IVMP followed by IVIG (n=10) vs IVMP followed by placebo (n=9) Treatment duration 5 days Assessments Upon entry, after 1, 2, 4, 8, and 12 weeks, after 6 months, and during relapse occurrence |
Baseline median (range) EDSS: IVMP followed by IVIG, 3.75 (3–6.5); IVMP followed by placebo, 3.5 (2, 5–7) Median change in EDSS from baseline to: Week 1: not reported Week 2: not reported Week 4: IVMP followed by IVIG, 1.0 (95% CI, 0–3); IVMP followed by placebo, 1.0 (95% CI, 0.28–1.94); P=0.81 Percentage of patients achieving a 1-point EDSS score improvement at week 4: IVMP followed by IVIG, 60%; IVMP followed by placebo, 67%; P=0.76 |
Abbreviations: AE, adverse event; EDSS, Expanded Disability Status Scale; IVIG, intravenous immunoglobulin; IVMP, intravenous methylprednisolone; NR, not reported.