ArticlesIntravenous immunoglobulin versus intravenous methylprednisolone for chronic inflammatory demyelinating polyradiculoneuropathy: a randomised controlled trial
Introduction
Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) is a chronic progressive or relapsing neuropathy,1, 2 with a prevalence ranging from 0·8 to 8·4 per 100 000 people.3, 4 CIDP is often disabling with over 50% of patients having temporary disability and about 10% eventually becoming persistently disabled or dying because of the disease.5
The cause of CIDP remains unknown, but there are data supporting an immune pathogenesis.6 These data have led to the use of immune therapies, the efficacy of which has reinforced the hypothesis of an autoimmune origin. A few randomised trials and several uncontrolled studies on a large series of patients have shown the efficacy of corticosteroids, plasma exchange, and intravenous immunoglobulin (IVIg) in CIDP.7, 8, 9 Two randomised trials on a small population of patients showed a comparable short-term efficacy of IVIg and oral corticosteroids10 and of IVIg and plasma exchange.11 Little is known about the efficacy of these therapies over the long term. In a large randomised trial, IVIg was more efficacious than placebo for 6 months and possibly up to 12 months,12, 13 whereas a similar chance of remission was seen over 12 months with the use of either daily oral corticosteroids or pulsed high-dose dexamethasone.14 The comparative efficacy and tolerance of IVIg or corticosteroids over this period remains unclear. We compared the efficacy and tolerability of 6-month therapy with IVIg or intravenous methylprednisolone in patients with CIDP.
Section snippets
Patients
In this multicentre, randomised, double-blind, placebo controlled, parallel-group study, patients with CIDP were enrolled from 14 Italian neurological centres. Patients were eligible if they were at least 18 years of age, had definite typical CIDP according to the European Federation of Neurological Societies (EFNS)/Peripheral Nerve Society (PNS) criteria,15 had some disability (scoring 2 or more on either the overall neuropathy limitation scale [ONLS]16 or the modified Rankin scale17), were in
Results
46 patients were enrolled between September, 2007, and December, 2009. A patient assigned to IVIg was later excluded since he had received high-dose intravenous corticosteroids 2 months before inclusion (figure 1). 21 patients were treated with intravenous methylprednisolone and 24 with IVIg. Compared with patients in the IVIg group, those in the methylprednisolone group tended to have a worse median Rankin scale score and ONLS score, to be older, to report less frequent use of IVIg, and to
Discussion
Treatment of CIDP with IVIg for 6 months was less frequently discontinued because of inefficacy, adverse events, or intolerance than was treatment with intravenous methylprednisolone. Assessment scores showed that responses tended to be more favourable in the IVIg group, possibly reflecting the different drop-out rate in the two groups; however, these data should be interpreted with caution because of the large number of comparisons for which no adjustment was made.
The small sample size
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