A Randomized, Double Blind, Controlled Trial of Intravenous Immunoglobulins Versus Intravenous Methylprednisolone in Chronic Inflammatory Demyelinating Polyradiculoneuropathy (IMC Study) (S07.001)

Abstract

Objective: To compare the efficacy and safety of six-month therapy with intravenous immunoglobulin (IVIg) or methylprednisolone (IVMP) in chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). Background IVIg and steroid are similarly effective as initial treatment in CIDP but little is known on their relative risk-benefit profile over the long period. Design/Methods: Forty-six patients fulfilling EFNS/PNS criteria for definite CIDP were randomly allocated in a 1:1 proportion to receive IVIg (IgVena, Kedrion SpA) (2g/kg) + IVMP-placebo or IVMP (2 g) + IVIg-placebo over four days, monthly for six months. Patients were then followed for six months to assess relapses. The primary endpoint was the difference in the number of patients suspending IVIg or IVMP for intolerance or inefficacy. Secondary end-points included the difference in the improvement in assessment scales after 15 days, 2 months and 6 months of therapy, and the difference in the proportion of patients worsening after therapy discontinuation. Results: Forty-five patients (24 on IVIg and 21 on IVMP) were evaluated. One was excluded for inappropriate inclusion. More patients suspended IVMP (10/21, 52.5%) than IVIg (3/24, 12.5%) (p= 0,0085) for unresponsiveness or intolerance to therapy. At the end of the 6-month therapy, both groups had similarly improved in the Rankin, ONLS, Rotterdam and SF-36 quality of life scale and the IVIg group also in the MRC and sensory score and time to walk 10 meters. After therapy discontinuation more patients on IVIg (8/21, 38.1%) than IVMP (0/10) worsened and required further therapy. By 12 months, a similar proportion of patients remained improved without therapy in the IVIg (13/24, 54.1%) and IVMP (10/21, 47.6%) group. Conclusions: More patients on IVMP than on IVIg suspended therapy during the six months of therapy because of inefficacy or adverse events. After therapy discontinuation, more patients treated with IVIg than with IVMP worsened and had to resume therapy. Supported by: Kedrion SpA, Italy. Disclosure: Dr. Nobile-Orazio has received personal compensation for activities with CSL Behring. Dr. Cocito has nothing to disclose. Dr. Jann has nothing to disclose. Dr. Uncini has nothing to disclose. Dr. Beghi has received personal compensation for activities with UCB Pharma as a speaker. Dr. Beghi has received personal compensation in an editorial capacity for Epilepsia. Dr. Antonini has nothing to disclose. Dr. Fazio has nothing to disclose. Dr. Gallia has nothing to disclose. Dr. Schenone has nothing to disclose. Dr. Francia has nothing to disclose. Dr. Pareyson has nothing to disclose. Dr. Santoro has nothing to disclose. Dr. Tamburin has nothing to disclose. Dr. Macchia has received personal compensation for activities with Kedrion as an employee. Dr. Guarneri has received personal compensation for activities with Kedrion Biopharmaceutical an employee. Dr. Cavaletti has nothing to disclose. Dr. Giannini has nothing to disclose. Dr. Sabatelli has nothing to disclose.