Abstract | BACKGROUND: METHODS: 318 patients with clinically definite secondary progressive multiple sclerosis (mean age 44 years [SD 7]) were randomly assigned IVIG 1 g/kg per month (n=159) or an equivalent volume of placebo ( albumin 0.1%; n=159) for 27 months. After baseline investigation, clinical assessments were made every 3 months and MRI was repeated after 12 months and 24 months. The primary outcome was confirmed worsening of disability as defined by the time to first confirmed progression on the expanded disability status scale (EDSS). Analyses were by intention to treat. FINDINGS: 19 patients in the IVIG group and 39 in the placebo group terminated study treatment prematurely but were included in the analyses. IVIG treatment had no beneficial effect on time to confirmed EDSS progression (hazard ratio 1.11 [95% CI 0.80-1.53] for IVIG versus placebo). The annual relapse rate was 0.46 in both groups. No significant differences between the treatment groups were found in any of the other clinical outcome measures or in the change of T2-lesion load over time. The treatment was generally well tolerated, although deep venous thrombosis, pulmonary embolism, or both occurred in seven patients with risk factors for thromboembolism ( IVIG six, placebo one). INTERPRETATION:
|
Authors | Otto R Hommes, Per S Sørensen, Franz Fazekas, Monika Maas Enriquez, Hans W Koelmel, Oscar Fernandez, Carlo Pozzilli, Paul O'Connor |
Journal | Lancet (London, England)
(Lancet)
2004 Sep 25-Oct 1
Vol. 364
Issue 9440
Pg. 1149-56
ISSN: 1474-547X [Electronic] England |
PMID | 15451222
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
|
Chemical References |
- Immunoglobulins, Intravenous
|
Topics |
- Adult
- Brain
(pathology)
- Disease Progression
- Double-Blind Method
- Female
- Humans
- Immunoglobulins, Intravenous
(therapeutic use)
- Magnetic Resonance Imaging
- Male
- Multiple Sclerosis, Chronic Progressive
(diagnosis, pathology, therapy)
|