A Retrospective Review of Real-life Practice of Intravenous Immunoglobulin Usage in Autoimmune Neurological Disease
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Abstract
OBJECTIVES: To review the prescription of Intravenous immunoglobulin (IVIg) in neurological disease regarding its efficacy, prescription pattern, indication and treatment outcome.
MATERIALS AND METHODS: We studied IVIg usage and treatment outcomes by reviewing the prescription database and medical records from 2013 to 2019 at Thammasat University Hospital (TUH), which is the university hospital in the lower central region of Thailand, and records at Bangkok International Hospital (BIH), part of the largest private hospital network in Thailand.
RESULTS: IVIg was used in 28 patients in TUH and 86 patients in BIH. The diagnoses were Guillain-Barré syndrome (GBS) (50%), myasthenia gravis (MG) crisis (23%) and chronic inflammatory demyelinating polyneuropathy (CIDP) (6%). 39.5% of patients were prescribed IVIg apart from those prescribed in line with the Thailand national list of essential medicine (NLEM) indication. The major cause of NLEM deviation is usage beyond reimbursement guidelines, but the dose of IVIg administered is within standard guidelines. IVIg usage and treatment outcomes were similar in both hospitals in the case of GBS and MG. Both groups show beneficial outcomes from IVIg. BIH used IVIg often as first line treatment for CIDP, but TUH used IVIg as subsequent therapy after failure of corticosteroid administration. TUH preferred plasmapheresis combined with a high dose steroid for neuromyelitis optica spectrum disorder (NMOSD) and autoimmune encephalitis reflecting the cost of therapy and reimbursement guidelines.
CONCLUSION: IVIg is still the mainstay treatment of GBS and MG crisis in Thailand. The outcome of GBS and MG crisis is similar in both hospitals. Private hospitals seem to have more off label use and often used IVIg as a first line therapy in CIDP, NMOSD and autoimmune encephalitis. Reimbursement guidelines and NLEM have a major impact on prescription patterns.
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References
Lünemann JD, Quast I, Dalakas MC. Efficacy of intravenous immunoglobulin in neurological diseases. neurotherapeutics. Neurotherapeutics 2016;13(1):34-46. doi: 10.1007/s13311- 015-0391-5.
Lünemann JD, Nimmerjahn F, Dalakas MC. Intravenous immunoglobulin in neurology--mode of action and clinical efficacy. Nat Rev Neurol 2015;11(2):80-9. doi: 10.1038/nr neurol.2014.253.
Committee TNDSD. The national list of essential medicines (NLEM): Drug and medical supply information center, Ministry of Public Health; 2019 (Accessed at June 20, 2023, at http://dmsic.moph.go.th/index/download/831).
Kleyweg RP, van der Meché FG, Schmitz PI. A randomized trial comparing intravenous immunoglobulin and plasma exchange in Guillain-Barré syndrome. Transfus Sci 1994;15(4):389-92. doi: 10.1016/0955-3886(94)90171-6.
Hughes RA, Dalakas MC, Cornblath DR, et al. Clinical applications of intravenous immunoglobulins in neurology. Clin Exp Immunol 2009;158 Suppl 1(Suppl 1):34-42. doi: 10.1111/j.1365-2249.2009.04025.x.
Walgaard C, Lingsma HF, Ruts L, et al. Early recognition of poor prognosis in Guillain-Barré syndrome. Neurology 2011;76(11):968-75. doi: 10.1212/WNL.0b013e3182104407.
Yamagishi Y, Suzuki H, Sonoo M, et al. Markers for Guillain Barré syndrome with poor prognosis: a multi-center study. J Peripher Nerv Syst 2017;22(4):433-9. doi: 10.1111/ jns.12234.
van Lieverloo GGA, Peric S, Doneddu PE, et al. Corticoste roids in chronic inflammatory demyelinating polyneuropathy : A retrospective, multicentre study, comparing efficacy and safety of daily prednisolone, pulsed dexamethasone, and pulsed intravenous methylprednisolone. J Neurol 2018;265(9):2052-9. doi: 10.1007/s00415-018-8948-y.
Hughes R, Bensa S, Willison H, et al. Randomized controlled trial of intravenous immunoglobulin versus oral prednisolone in chronic inflammatory demyelinating polyradiculoneu ropathy. Ann Neurol 2001;50(2):195-201. doi: 10.1002/ ana.1088.
Dyck PJ, Litchy WJ, Kratz KM, et al. A plasma exchange versus immune globulin infusion trial in chronic inflamma tory demyelinating polyradiculoneuropathy. Ann Neurol 1994;36(6):838-45. doi: 10.1002/ana.410360607.
Oaklander AL, Lunn MP, Hughes RA, et al. Treatments for chronic inflammatory demyelinating polyradiculoneuropathy (CIDP): an overview of systematic reviews. Cochrane Database Syst Rev 2 0 1 7 ; 1 ( 1 ) : C d 0 1 0 3 6 9 . d o i : 10.1002/14651858.CD010369.pub2.
Hughes RA, Donofrio P, Bril V, et al. Intravenous immune globulin (10% caprylate-chromatography purified) for the treatment of chronic inflammatory demyelinating polyradiculoneuropathy (ICE study): a randomised placebo controlled trial. Lancet Neurol 2008;7(2):136-44. doi: 10.1016/S1474-4422(07)70329-0.
Merkies ISJ, van Schaik IN, Léger JM, et al. Efficacy and safety of IVIG in CIDP: Combined data of the PRIMA and PATH studies. J Peripher Nerv Syst 2019;24(1):48-55. doi: 10.1111/jns.12302.
Latov N, Deng C, Dalakas MC, et al. Timing and course of clinical response to intravenous immunoglobulin in chronic inflammatory demyelinating polyradiculoneuropathy. Arch Neurol 2010;67(7):802-7. doi: 10.1001/archneurol.2010.105.
Gilhus NE, Verschuuren JJ. Myasthenia gravis: subgroup classification and therapeutic strategies. The Lancet Neurol 2015;14(10):1023-36. doi: 10.1016/S1474-4422(15)00145-3.
Gajdos P, Chevret S, Clair B, et al. Clinical trial of plasma exchange and high-dose intravenous immunoglobulin in myasthenia gravis. Myasthenia Gravis Clinical Study Group. Ann Neurol 1997;41(6):789-96. doi: 10.1002/ana.410410615.
Zinman L, Ng E, Bril V. IV immunoglobulin in patients with myasthenia gravis: a randomized controlled trial. Neurology 2007;68(11):837-41. doi: 10.1212/01. wnl.0000256698.69121.45.
Gajdos P, Chevret S, Toyka KV. Intravenous immunoglobulin for myasthenia gravis. Cochrane Database Syst Rev 2012;12(12):Cd002277. doi: 10.1002/14651858.CD002277. pub4.
Sanders DB, Wolfe GI, Benatar M, et al. International con sensus guidance for management of myasthenia gravis: Ex ecutive summary. Neurology 2016;87(4):419-25. doi: 10.1212/ WNL.0000000000002790.
Goyal NA. Immune-Mediated Myopathies. Continuum (Minneapolis, Minn) 2019;25(6):1564-85. doi: 10.1212/ CON.0000000000000789.
Dalakas MC, Illa I, Dambrosia JM, et al. A controlled trial of high-dose intravenous immune globulin infusions as treatment for dermatomyositis. N Engl J Med 1993;329(27):1993-2000. doi: 10.1056/NEJM199312303292704.
Bamrungsawad N, Upakdee N, Pratoomsoot C, et al. Economic Evaluation of Intravenous Immunoglobulin plus Corticosteroids for the Treatment of Steroid-Resistant Chronic Inflammatory Demyelinating Polyradiculoneuropa thy in Thailand. Clin Drug Investig 2016;36(7):557-66. doi: 10.1007/s40261-016-0401-3.
Blackhouse G, Gaebel K, Xie F, et al. Cost-utility of Intravenous Immunoglobulin (IVIG) compared with corticosteroids for the treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) in Canada. Cost Eff Resour Alloc 2010;8:14. doi: 10.1186/1478-7547-8-14.
Sakpichaisakul K, Patibat L, Wechapinan T, et al. Heterogenous treatment for anti-NMDAR encephalitis in children leads to different outcomes 6-12 months after diagnosis. J Neuroimmunol 2018;324:119-25. doi: 10.1016/j.jneuro im.2018.09.007.
Beydoun HA, Beydoun MA, Hossain S, et al. Nationwide study of therapeutic plasma exchange vs intravenous immunoglobulin in Guillain-Barré syndrome. Muscle Nerve 2020;61(5):608-15. doi: 10.1002/mus.26831.
Kulkantrakorn K, Sukphulloprat P. Outcome of Guillain-Barré syndrome in tertiary care centers in Thailand. J Clin Neuromuscul Dis 2017;19(2):51-6. doi: 10.1097/ CND.0000000000000176.
Verboon C, van den Berg B, Cornblath DR, et al. Original research: Second IVIg course in Guillain-Barré syndrome with poor prognosis: the non-randomised ISID study. J Neu rol Neurosurg Psychiatry 2020;91(2):113-21. doi: 10.1136/ jnnp-2019-321496.
Silvestri NJ, Wolfe GI. Treatment-refractory myasthenia gravis. J Clin Neuromuscul Dis 2014;15(4):167-78. doi: 10.1097/CND.0000000000000034.
Hellmann MA, Mosberg-Galili R, Lotan I, et al. Maintenance IVIg therapy in myasthenia gravis does not affect disease activity. J Neurol Sci 2014;338(1-2):39-42. doi: 10.1016/j. jns.2013.10.043. 30. Gotterer L, Li Y. Maintenance immunosuppression in myasthenia gravis. J Neurol Sci 2016;369:294-302. doi: 10.1016/j.jns.2016.08.057.
Elsone L, Panicker J, Mutch K, et al. Role of intravenous immunoglobulin in the treatment of acute relapses of neuromyelitis optica: experience in 10 patients. Mult Scler 2014;20(4):501-4. doi: 10.1177/1352458513495938.
Magraner MJ, Coret F, Casanova B. The effect of intravenous immunoglobulin on neuromyelitis optica. Neurologia 2013;28(2):65-72. doi: 10.1016/j.nrl.2012.03.014.
Abboud H, Petrak A, Mealy M, et al. Treatment of acute relapses in neuromyelitis optica: Steroids alone versus steroids plus plasma exchange. Mul Scler 2016;22(2):185-92. doi: 10.1177/1352458515581438.
Yamasaki R, Matsushita T, Fukazawa T, et al. Efficacy of intravenous methylprednisolone pulse therapy in patients with multiple sclerosis and neuromyelitis optica. Mul Scler 2016;22(10):1337-48. doi: 10.1177/1352458515617248.
Li X, Tian DC, Fan M, et al. Intravenous immunoglobulin for acute attacks in neuromyelitis optica spectrum disorders (NMOSD). Mult Scler Relat Disord 2020;44:102325. doi: 10.1016/j.msard.2020.102325.
Zuliani L, Nosadini M, Gastaldi M, et al. Management of antibody-mediated autoimmune encephalitis in adults and children: literature review and consensus-based practical recommendations. Neurol Sci 2019;40(10):2017-30. doi: 10.1007/s10072-019-03930-3.
Koelman DL, Mateen FJ. Acute disseminated encephalomyelitis: current controversies in diagnosis and outcome. J Neurol 2015;262(9):2013-24. doi: 10.1007/s00415-015-7694-7.
Dubey D, Britton J, McKeon A, et al. Randomized placebo controlled trial of intravenous immunoglobulin in autoimmune LGI1/CASPR2 Epilepsy. Ann Neurol 2020;87(2):313-23. doi: 10.1002/ana.25655.
Pohl D, Tenembaum S. Treatment of acute disseminated encephalomyelitis. Curr Treat Options Neurol 2012;14(3):264- 75. doi: 10.1007/s11940-012-0170-0.
Goebel A, Netal S, Schedel R, et al. Human pooled immunoglobulin in the treatment of chronic pain syndromes. Pain Med 2 0 0 2 ; 3 ( 2 ) : 11 9 - 2 7 . d o i : 10.1046/j.1526-4637.2002.02018.x.
Chang MC, Park D. Effectiveness of Intravenous Immunoglobulin for Management of Neuropathic Pain: A Narrative Review. J Pain Res 2020;13:2879-84. doi: 10.2147/JPR.S273475.