1.
A dose comparison study of IVIG in postpartum relapsing-remitting multiple sclerosis
Haas J, Hommes OR
Multiple Sclerosis (Houndmills, Basingstoke, England). 2007;13((7):):900-8.
Abstract
Untreated patients with relapsing-remitting multiple sclerosis (RRMS) have an elevated risk of exacerbation in the first 3 months postpartum. Pregnant patients (n =173) with RRMS and with at least one relapse in the two years before pregnancy were enrolled in this multinational, multicentre, randomized double-blind clinical trial investigating different doses of intravenous immunoglobulin (IVIG) treatment in the 6 months postpartum. Group I (unloaded) received 150 mg/kg body weight (BW) IVIG on Day 1, then placebo infusions on Day 2 and Day 3. Group II (loaded) received 450, 300 and 150 mg/kg BW on Days 1, 2 and 3 respectively. Both groups then received 150 mg/kg BW five times in four-weekly intervals. The ratio of patients remaining relapse-free during the first 3 months postpartum did not differ significantly between both groups (81. 5% in Group II versus 75. 6% in Group I). The ratio of relapse-free patients was independent of dosage in the subgroup of patients breastfeeding for at least 3 months (89% in Group I versus 90% in Group II). The mean annualized relapse rate (ARR) after pregnancy did not show an increased risk for exacerbation, but returned to prepregnancy level within 3 months independent of dosage. The treatment was well tolerated.
2.
IV immunoglobulins as add-on treatment to methylprednisolone for acute relapses in MS
Sorensen PS, Haas J, Sellebjerg F, Olsson T, Ravnborg M, TARIMS Study Group
Neurology. 2004;63((11):):2028-33.
Abstract
OBJECTIVE To investigate if IV immunoglobulins (IVIg) in combination with methylprednisolone make recovery from a relapse faster and more complete than methylprednisolone alone. Design/METHODS The authors studied 76 patients with multiple sclerosis (MS) who had an acute relapse with involvement of visual function, upper limb motor function, or gait, and with onset of symptoms between 24 hours and 14 days before. Patients were treated with either IVIg 1 g/kg or placebo (0. 1% human albumin), given 24 hours before treatment with IV methylprednisolone 1 g on 3 consecutive days. RESULTS Both groups improved, but the authors observed no significant difference between IVIg and placebo patients regarding the primary endpoint, the mean change in the Z-score of the individually chosen targeted neurologic deficit (the most affected system) from baseline to 12 weeks (p = 0. 89). A slightly better, but not significant remission was seen in the IVIg group in global scores, i. e. , Expanded Disability Status Scale (p = 0. 23) and Multiple Sclerosis Impairment Scale (p = 0. 24), and in time to next relapse (p = 0. 22). CONCLUSIONS The results do not justify routine application of IV immunoglobulins as add-on therapy to IV methylprednisolone in the treatment of acute multiple sclerosis attacks.
3.
Intravenous immunoglobulin (IVIG) treatment for patients with primary or secondary progressive multiple sclerosis -- outline of a double-blind randomized, placebo-controlled trial
Poehlau D, Federlein J, Postert T, Sailer M, Bethke F, Kappos L, Haas J, Przuntek H
Multiple Sclerosis. 1997;3((2):):149-52.
Abstract
We present the design of a double-blind, randomised placebo-controlled phase III study to evaluate safety and efficacy of IVIG in the treatment of patients suffering from primary or secondary chronic progressive multiple sclerosis. The primary endpoint is disability. Two measures of disability were chosen in order to assess the primary end point (a) sustained improvement (assessed at month 6, confirmed at month 9) and (b) progression to increasing disability of the disease (sustained for 3 months) at any time during the course of this 2 years study. The disability is measured by the Extended Disability Status Scale (EDSS). Secondary end points include the assessment of visual function, functions of the upper extremity, cognitive functions, depression and quality of life.