Intravenous methylprednisolone versus intravenous immunoglobulin in chronic inflammatory demyelinating polyradiculoneuropathy: a randomized trial
Abstract
Introduction: Corticosteroids and Intravenous immunoglobulin (IVIg) are effective as initial treatment in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), but their long-term use is less defined. We compared the efficacy and tolerability of 6-month therapy of intravenous methylprednisolone (IV MP) versus IVIg.
Methods: This trial compared efficacy and tolerability of IVIg (0·5g/kg per day for 4 consecutive days) and IV MP (0·5 g in 250 ml sodium chloride solution per day for 4 consecutive days) given every month for 6 months were assessed. After therapy discontinuation, patients were followed up for 6 months to assess relapses.
Results: 40 patients (20 IV MP, 20 IVIg) completed the study. More patients stopped MP (12 [60%] of 20) than IVIg (8 [40%] of 20; relative risk 0·54, 95% CI 0·34–0·87; p=0·0085). When adjusted for sex, age, disease duration, comorbidity, modified Rankin scale (mRS) at enrolment, and previous treatment with IVIg and steroids, the difference between the two groups remained significant (odds ratio 7·6, 95% CI 1·7–33·8; p=0·0070). Reasons for discontinuation were lack of efficacy (twelve in the IV MP group vs. 8 in the IVIg group), adverse events (one in the IV MP group), or voluntary withdrawal (2 in IV MP group). The proportion of patients with adverse events did not differ between IV MP group (14 [67%] of 20) and IVIg group (11 [46%] of 20; p=0·1606). After discontinuation, more patients on IVIg worsened and required further therapy (eight [38%] of 20, p=0·0316).
Conclusion: Treatment of CIDP with IVIg for 6 months was less frequently discontinued than with IV MP.
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References
Hahn AF, Hartung HP, Dyck PJ. Chronic inflammatory demyelinating polyradiculoneuropathy. In: Dyck PJ, Thomas PK, eds. Peripheral Neuropathy, 4th edn. Philadelphia: Elsevier; 2005.2221–53.
Vallat JM, Sommer C, Magy L. Chronic inflammatory demyelinating polyradiculoneuropathy: diagnostic and therapeutic challenges for a treatable condition. Lancet Neurol. 2010 Apr;9(4):402-12. doi: https://doi.org/10.1016/S1474-4422(10)70041-7.
Lunn MP, Manji H, Choudhary PP, Hughes RA, Thomas PK. Chronic inflammatory demyelinating polyradiculoneuropathy: a prevalence study in south east England. J Neurol Neurosurg Psychiatry. 1999 May;66(5):677-80.doi: https://doi.org/10.1136/jnnp.66.5.677.
Kusumi M, Nakashima K, Nakayama H, Takahashi K. Epidemiology of inflammatory neurological and inflammatory neuromuscular diseases in Tottori Prefecture, Japan. Psychiatry Clin Neurosci. 1995 Jun;49(3):169-74.doi: https://doi.org/10.1111/j.1440-1819.1995.tb02223.x.
Laughlin RS, Dyck PJ, Melton LJ 3rd, Leibson C, Ransom J, Dyck PJ. Incidence and prevalence of CIDP and the association of diabetes mellitus. Neurology. 2009 Jul 7;73(1):39-45. doi: https://doi.org/10.1212/WNL.0b013e3181aaea47.
Hughes RA, Allen D, Makowska A, Gregson NA. Pathogenesis of chronic inflammatory demyelinating polyradiculoneuropathy. J Peripher Nerv Syst. 2006 Mar;11(1):30-46.doi: https://doi.org/10.1111/j.1085-9489.2006.00061.x.
Mehndiratta MM, Hughes RA, Agarwal P. Plasma exchange for chronic inflammatory demyelinating polyradiculoneuropathy. Cochrane Database Syst Rev. 2004;(3):CD003906.doi: https://doi.org/10.1002/14651858.cd003906.pub2.
Eftimov F, Winer JB, Vermeulen M, de Haan R, van Schaik IN. Intravenous immunoglobulin for chronic inflammatory demyelinating polyradiculoneuropathy. Cochrane Database Syst Rev 2009; 1: CD001797.doi: https://doi.org/10.1002/14651858.cd001797.pub2.
Mehndiratta MM, Hughes RAC. Corticosteroids for chronic inflammatory demyelinating polyradiculoneuropathy. Cochrane Database Syst Rev 2002; 1: CD002062.doi: https://doi.org/10.1002/14651858.cd002062.pub4.
Hughes R, Bensa S, Willison H, Van den Bergh P, Comi G, Illa I, Nobile-Orazio E, van Doorn P, Dalakas M, Bojar M, Swan A; Inflammatory Neuropathy Cause and Treatment (INCAT) Group. Randomized controlled trial of intravenous immunoglobulin versus oral prednisolone in chronic inflammatory demyelinating polyradiculoneuropathy. Ann Neurol. 2001 Aug;50(2):195-201.doi: https://doi.org/10.1002/ana.1088.
Dyck PJ, Litchy WJ, Kratz KM, Suarez GA, Low PA, Pineda AA, Windebank AJ, Karnes JL, O'Brien PC. A plasma exchange versus immune globulin infusion trial in chronic inflammatory demyelinating polyradiculoneuropathy. Ann Neurol. 1994 Dec;36(6):838-45.doi: https://doi.org/10.1002/ana.410360607.
Hughes RA, Donofrio P, Bril V, Dalakas MC, Deng C, Hanna K et al. Intravenous immune globulin (10% caprylate-chromatography purified) for the treatment of chronic inflammatory demyelinating polyradiculoneuropathy (ICE study): a randomized placebo-controlled trial. Lancet Neurol 2008; 7: 136–44.doi: https://doi.org/10.1016/s1474-4422(07)70329-0.
Merkies IS, Bril V, Dalakas MC, Deng C, Donofrio P, Hanna K, Hartung HP, Hughes RA, Latov N, van Doorn PA; ICE Study Group. Health-related quality-of-life improvements in CIDP with immune globulin IV 10%: the ICE Study. Neurology. 2009 Apr 14;72(15):1337-44. doi: https://doi.org/10.1212/WNL.0b013e3181a0fd80.
van Schaik IN, Eftimov F, van Doorn PA, Brusse E, van den Berg LH, van der Pol WL, Faber CG, van Oostrom JC, Vogels OJ, Hadden RD, Kleine BU, van Norden AG, Verschuuren JJ, Dijkgraaf MG, Vermeulen M. Pulsed high-dose dexamethasone versus standard prednisolone treatment for chronic inflammatory demyelinating polyradiculoneuropathy (PREDICT study): a double-blind, randomised, controlled trial. Lancet Neurol. 2010 Mar;9(3):245-53. doi: https://doi.org/10.1016/S1474-4422(10)70021-1. Epub 2010 Feb 2.
Joint Task Force of the EFNS and the PNS. European Federation of Neurological Societies/Peripheral Nerve Society Guideline on management of chronic inflammatory demyelinating polyradiculoneuropathy: report of a joint task force of the European Federation of Neurological Societies and the Peripheral Nerve Society--First Revision. J Peripher Nerv Syst. 2010 Mar;15(1):1-9. doi: https://doi.org/10.1111/j.1529-8027.2010.00245.x.
Graham RC, Hughes RA. A modified peripheral neuropathy scale: the Overall Neuropathy Limitations Scale. J Neurol Neurosurg Psychiatry. 2006 Aug;77(8):973-6. Epub 2006 Mar 30.doi: https://doi.org/10.1136/jnnp.2005.081547.
Bamford JM, Sandercock PA, Warlow CP, Slattery J. Interobserver agreement for the assessment of handicap in stroke patients. Stroke. 1989 Jun;20(6):828.doi: https://doi.org/10.1161/01.str.20.6.828.
Joint Task Force of the EFNS and the PNS. European Federation of Neurological Societies/Peripheral Nerve Society guideline on management of multifocal motor neuropathy. Report of a joint task force of the European Federation of Neurological Societies and the Peripheral Nerve Society--first revision. J Peripher Nerv Syst. 2010 Dec;15(4):295-301. doi: https://doi.org/10.1111/j.1529-8027.2010.00290.x.
RMC Trial Group. Randomised controlled trial of methotrexate for chronic inflammatory demyelinating polyradiculoneuropathy (RMC trial): a pilot, multicentre study. Lancet Neurol. 2009 Feb;8(2):158-64. doi: https://doi.org/10.1016/S1474-4422(08)70299-0. Epub 2009 Jan 10.
Kleyweg RP, van der Meché FG, Schmitz PI. Interobserver agreement in the assessment of muscle strength and functional abilities in Guillain-Barré syndrome. Muscle Nerve. 1991 Nov;14(11):1103-9.doi: https://doi.org/10.1002/mus.880141111.
Merkies IS, Schmitz PI, van der Meché FG, van Doorn PA. Psychometric evaluation of a new sensory scale in immune-mediated polyneuropathies. Inflammatory Neuropathy Cause and Treatment (INCAT) Group. Neurology. 2000 Feb 22;54(4):943-9.doi: https://doi.org/10.1212/wnl.54.4.943.
Dyck PJ, O'Brien PC, Oviatt KF, Dinapoli RP, Daube JR, Bartleson JD, Mokri B, Swift T, Low PA, Windebank AJ. Prednisone improves chronic inflammatory demyelinating polyradiculoneuropathy more than no treatment. Ann Neurol. 1982 Feb;11(2):136-41.doi: https://doi.org/10.1002/ana.410110205.
van Koningsveld R, Schmitz PI, Meché FG, Visser LH, Meulstee J, van Doorn PA; Dutch GBS study group. Effect of methylprednisolone when added to standard treatment with intravenous immunoglobulin for Guillain-Barré syndrome: randomised trial. Lancet. 2004 Jan 17;363(9404):192-6.doi: https://doi.org/10.1016/s0140-6736(03)15324-x.
Lopate G, Pestronk A, Al-Lozi M. Treatment of chronic inflammatory demyelinating polyneuropathy with high-dose intermittent intravenous methylprednisolone. Arch Neurol. 2005 Feb;62(2):249-54.doi: https://doi.org/10.1001/archneur.62.2.249.
Muley SA, Kelkar P, Parry GJ. Treatment of chronic inflammatory demyelinating polyneuropathy with pulsed oral steroids. Arch Neurol. 2008 Nov;65(11):1460-4. doi: https://doi.org/10.1001/archneur.65.11.1460.
Molenaar DS, van Doorn PA, Vermeulen M. Pulsed high dose dexamethasone treatment in chronic inflammatory demyelinating polyneuropathy: a pilot study. J Neurol Neurosurg Psychiatry. 1997 Apr;62(4):388-90.doi: https://doi.org/10.1136/jnnp.62.4.388.
Eftimov F, Vermeulen M, van Doorn PA, Brusse E, van Schaik IN; PREDICT. Long-term remission of CIDP after pulsed dexamethasone or short-term prednisolone treatment. Neurology. 2012 Apr 3;78(14):1079-84. doi: https://doi.org/10.1212/WNL.0b013e31824e8f84. Epub 2012 Mar 21.
Dukes MN. Meyler’s side effects of drugs. New York: Elsevier, 1996: 1193–209.
Mahdi-Rogers M1, Swan AV, van Doorn PA, Hughes RA. Immunomodulatory treatment other than corticosteroids, immunoglobulin and plasma exchange for chronic inflammatory demyelinating polyradiculoneuropathy. Cochrane Database Syst Rev. 2010 Nov 10;(11):CD003280. doi: https://doi.org/10.1002/14651858.CD003280.pub5.
Dyck PJ, O'Brien P, Swanson C, Low P, Daube J. Combined azathioprine and prednisone in chronic inflammatory-demyelinating polyneuropathy. Neurology. 1985 Aug;35(8):1173-6.doi: https://doi.org/10.1212/wnl.35.8.1173.
Hadden RDM, Sharrack B, Bensa S. Randomized trial of interferon beta-1a in chronic inflammatory demyelinating polyradiculoneuropathy. Neurology 1999; 53: 57–61.doi: https://doi.org/10.1212/wnl.53.1.57.
Hughes RAC, Gorson KC, Cros D, A Sandrock. Intramuscular interferon beta-1a in chronic inflammatory demyelinating polyradiculoneuropathy. Neurology 2010; 74: 651–57.doi: https://doi.org/10.1212/wnl.0b013e3181d1a862.
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