Second intravenous immunoglobulin dose in patients with Guillain-Barré syndrome with poor prognosis (SID-GBS): a double-blind, randomised, placebo-controlled trial

Willison, 2016, Guillain-Barré syndrome, Lancet, 388, 717, 10.1016/S0140-6736(16)00339-1 Asbury, 1990, Assessment of current diagnostic criteria for Guillain-Barré syndrome, Ann Neurol, 27, S21, 10.1002/ana.410270707 Chevret, 2017, Plasma exchange for Guillain-Barré syndrome, Cochrane Database Syst Rev, 2 Hughes, 2014, Intravenous immunoglobulin for Guillain-Barré syndrome, Cochrane Database Syst Rev, 9 van den Berg, 2014, Guillain-Barré syndrome: pathogenesis, diagnosis, treatment and prognosis, Nat Rev Neurol, 10, 469, 10.1038/nrneurol.2014.121 Walgaard, 2011, Early recognition of poor prognosis in Guillain-Barre syndrome, Neurology, 76, 968, 10.1212/WNL.0b013e3182104407 Verboon, 2019, Current treatment practice of Guillain-Barré syndrome, Neurology, 93, e59, 10.1212/WNL.0000000000007719 Farcas, 1997, Efficacy of repeated intravenous immunoglobulin in severe unresponsive Guillain-Barré syndrome, Lancet, 350, 10.1016/S0140-6736(97)24050-X Godoy, 2015, Is a second cycle of immunoglobulin justified in axonal forms of Guillain-Barré syndrome?, Arq Neuropsiquiatr, 73, 848, 10.1590/0004-282X20150136 Raphael, 2001, Intravenous immune globulins in patients with Guillain-Barré syndrome and contraindications to plasma exchange: 3 days versus 6 days, J Neurol Neurosurg Psychiatry, 71, 235, 10.1136/jnnp.71.2.235 Ruts, 2010, Distinguishing acute-onset CIDP from fluctuating Guillain-Barre syndrome: a prospective study, Neurology, 74, 1680, 10.1212/WNL.0b013e3181e07d14 Kuitwaard, 2009, Pharmacokinetics of intravenous immunoglobulin and outcome in Guillain-Barré syndrome, Ann Neurol, 66, 597, 10.1002/ana.21737 Walgaard, 2018, Second IVIg course in Guillain-Barré syndrome patients with poor prognosis (SID-GBS trial): protocol for a double-blind randomized, placebo-controlled clinical trial, J Peripher Nerv Syst, 23, 210, 10.1111/jns.12286 Kleyweg, 1991, Interobserver agreement in the assessment of muscle strength and functional abilities in Guillain-Barré syndrome, Muscle Nerve, 14, 1103, 10.1002/mus.880141111 Ang, 2007, Validation of an ELISA for the diagnosis of recent Campylobacter infections in Guillain-Barré and reactive arthritis patients, Clin Microbiol Infect, 13, 915, 10.1111/j.1469-0691.2007.01765.x Jacobs, 1996, Campylobacter jejuni infections and anti-GM1 antibodies in Guillain-Barré syndrome, Ann Neurol, 40, 181, 10.1002/ana.410400209 Kuijf, 2005, Diagnostic value of anti-GM1 ganglioside serology and validation of the INCAT-ELISA, J Neurol Sci, 239, 37, 10.1016/j.jns.2005.07.009 van den Berg, 2014, Guillain-Barré syndrome associated with preceding hepatitis E virus infection, Neurology, 82, 491, 10.1212/WNL.0000000000000111 Hadden, 1998, Electrophysiological classification of Guillain-Barré syndrome: clinical associations and outcome, Ann Neurol, 44, 780, 10.1002/ana.410440512 Leonhard, 2019, Diagnosis and management of Guillain-Barré syndrome in ten steps, Nat Rev Neurol, 15, 671, 10.1038/s41582-019-0250-9 Hughes, 1978, Controlled trial prednisolone in acute polyneuropathy, Lancet, 2, 750, 10.1016/S0140-6736(78)92644-2 Graham, 2006, A modified peripheral neuropathy scale: the Overall Neuropathy Limitations Scale, J Neurol Neurosurg Psychiatry, 77, 973, 10.1136/jnnp.2005.081547 Maas, 2013, Advancing care for traumatic brain injury: findings from the IMPACT studies and perspectives on future research, Lancet Neurol, 12, 1200, 10.1016/S1474-4422(13)70234-5 Scott, 1997, Statistical assessment of ordinal outcomes in comparative studies, J Clin Epidemiol, 50, 45, 10.1016/S0895-4356(96)00312-5 van Leeuwen, 2019, Efficient design and analysis of randomized controlled trials in rare neurological diseases: an example in Guillain-Barré syndrome, PLoS One, 14, 10.1371/journal.pone.0211404 Roozenbeek, 2009, Baseline characteristics and statistical power in randomized controlled trials: selection, prognostic targeting, or covariate adjustment?, Crit Care Med, 37, 2683, 10.1097/CCM.0b013e3181ab85ec Nguyen, 2014, Occurrence of hemolytic anemia in patients with GBS treated with high-dose IVIg, Neurol Neuroimmunol Neuroinflamm, 1, e50, 10.1212/NXI.0000000000000050 1997, Randomised trial of plasma exchange, intravenous immunoglobulin, and combined treatments in Guillain-Barré syndrome, Lancet, 349, 225, 10.1016/S0140-6736(96)09095-2 Verboon, 2020, Original research: second IVIg course in Guillain-Barré syndrome with poor prognosis: the non-randomised ISID study, J Neurol Neurosurg Psychiatry, 91, 113, 10.1136/jnnp-2019-321496 van Koningsveld, 2004, Effect of methylprednisolone when added to standard treatment with intravenous immunoglobulin for Guillain-Barré syndrome: randomised trial, Lancet, 363, 192, 10.1016/S0140-6736(03)15324-X 1997, Appropriate number of plasma exchanges in Guillain-Barré syndrome, Ann Neurol, 41, 298, 10.1002/ana.410410304 Kapoor, 2020, Thromboembolic risk with IVIg: Incidence and risk factors in patients with inflammatory neuropathy, Neurology, 94, e635, 10.1212/WNL.0000000000008742