Second IVIg course in Guillain‐Barré syndrome patients with poor prognosis (SID‐GBS trial): Protocol for a double‐blind randomized, placebo‐controlled clinical trial

Steyerberg, Ewout W.; Wit, Marie Claire Y. de; Cornblath, David R.; Berg, B. van den; Doets, A.Y.; Doorn, Pieter A. van; Jacobs, Bart C.; Leonhard, Sonja E.; Verboon, J C; Walgaard, Christa; Woerkom, Marieke van; Tio‐Gillen, Anne P.; Rijs, Wouter van; Huizinga, H.; Badrising, Umesh A.; Bienfait, H.M.E.; Blom, R. J.; Boheemen, Caroline J. M. van; Breukelman, A.J.; Bronner, I. M.; Dieks, H.J.G.; Dijk, Gert W van; Engelen, B.G.M. van; Faber, Catharina G.; Feenstra, B. W. A.; Fokke, C.; Garssen, Marcel P J; Gijsbers, Cees J; Gilhuis, H. Jacobus; Graaff, M.M. van der; Groen, R.; Hoogendoorn, T.A.; Hovestad, A.; Jansen, P.J.H.W.; Jellema, Korné; Keuter, E. J. W.; Kleyweg, R. P.; Koningsveld, Rinske van; Kooi, Anneke J. van der; Kooi, E.L. van der; Krudde, J.; Kuks, Jan B. M.; Kuitwaard, Krista; Linssen, W.H.J.P.; Lion, John R.; Lovenich, Harry; Manschot, S.M.; Mellema, S.J.; Merkies, Ingemar S.J.; Meulen, M. F. G. van der; Meulen, Willem D.M. Van der; Molenaar, D.S.M.; Oenema, D.G.; Oosten, B.W. van; Oostrom, Joost C. H. van; Orshoven, Narender P. van; Ploeg, R J; Pol, W. Ludo van der; Polman, Susanne KL; Ree, Taco C van der; Rijk, Maarten C. de; Ruitenberg, Annemieke; Ruts, Liselotte; Samijn, Johnny P.A.; Schyns-Soeterboek, Angelique; Stevens, Martijn; Vermeij, Frédérique H; Verschuuren, Jan; Visser, L. H.; Wirtz, Paul W.; Wohlgemuth, M.; Zwetsloot, Casper P.; Lingsma, Hester F.; Steyerberg, Ewout W.; Dippel, Diederik W.J.; Hintzen, Rogier Q.

doi:10.1111/jns.12286

Cited by 44 publications

(40 citation statements)

References 30 publications

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“…The second IVIg course was often started late, and this was likely because of severe neurological impairment after a standard IVIg course. A positive effect of a second IVIg course cannot be ruled out but needs to be investigated further as is being done in the SID-GBS RCT 14 15…”

Section: Discussionmentioning

confidence: 99%

“…We excluded patients who had died or were lost to follow-up in the first 7 days from study entry, or who received a second IVIg course because of a reported treatment related fluctuation (TRF) observed by the local physician 13. We also excluded patients who participated in a randomised controlled study (Second Immunoglobulin Dose in GBS patients (SID-GBS) trial14 15 or Inhibition of Complement Activation in GBS (ICA-GBS) trial) 16…”

Section: Methodsmentioning

confidence: 99%

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Original research: Second IVIg course in Guillain-Barré syndrome with poor prognosis: the non-randomised ISID study

Verboon

Berg

Cornblath

et al. 2019

J Neurol Neurosurg Psychiatry

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ObjectiveTo compare disease course in patients with Guillain-Barré syndrome (GBS) with a poor prognosis who were treated with one or with two intravenous immunoglobulin (IVIg) courses.MethodsFrom the International GBS Outcome Study, we selected patients whose modified Erasmus GBS Outcome Score at week 1 predicted a poor prognosis. We compared those treated with one IVIg course to those treated with two IVIg courses. The primary endpoint, the GBS disability scale at 4 weeks, was assessed with multivariable ordinal regression.ResultsOf 237 eligible patients, 199 patients received a single IVIg course. Twenty patients received an ‘early’ second IVIg course (1–2 weeks after start of the first IVIg course) and 18 patients a ‘late’ second IVIg course (2–4 weeks after start of IVIg). At baseline and 1 week, those receiving two IVIg courses were more disabled than those receiving one course. Compared with the one course group, the adjusted OR for a better GBS disability score at 4 weeks was 0.70 (95%CI 0.16 to 3.04) for the early group and 0.66 (95%CI 0.18 to 2.50) for the late group. The secondary endpoints were not in favour of a second IVIg course.ConclusionsThis observational study did not show better outcomes after a second IVIg course in GBS with poor prognosis. The study was limited by small numbers and baseline imbalances. Lack of improvement was likely an incentive to start a second IVIg course. A prospective randomised trial is needed to evaluate whether a second IVIg course improves outcome in GBS.

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Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Original research: Second IVIg course in Guillain-Barré syndrome with poor prognosis: the non-randomised ISID study

Verboon

Berg

Cornblath

et al. 2019

J Neurol Neurosurg Psychiatry

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“…14 The disability caused by GBS was defined by the highest GBS disability score in the first 4 weeks after study entry (nadir), ranging from 0 (healthy) to 6 (dead). 15 When assessing treatment practice in patients without clinical recovery or with GBS-TRF, second-line treatment that was provided as part of a clinical trial (e.g., Second Immunoglobulin Dose in GBS trial [SID-GBS] 16 and Inhibition of Complement Activation in GBS trial [ICA-GBS] 17 ) was not taken into account. Disease severity during a TRF was defined by the GBS disability score and MRC sum score.…”

Section: Data Collectionmentioning

confidence: 99%

Current treatment practice of Guillain-Barré syndrome

Verboon¹,

Doets

Galassi³

et al. 2019

Neurology

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ObjectiveTo define the current treatment practice of Guillain-Barré syndrome (GBS).MethodsThe study was based on prospective observational data from the first 1,300 patients included in the International GBS Outcome Study. We described the treatment practice of GBS in general, and for (1) severe forms (unable to walk independently), (2) no recovery after initial treatment, (3) treatment-related fluctuations, (4) mild forms (able to walk independently), and (5) variant forms including Miller Fisher syndrome, taking patient characteristics and hospital type into account.ResultsWe excluded 88 (7%) patients because of missing data, protocol violation, or alternative diagnosis. Patients from Bangladesh (n = 189, 15%) were described separately because 83% were not treated. IV immunoglobulin (IVIg), plasma exchange (PE), or other immunotherapy was provided in 941 (92%) of the remaining 1,023 patients, including patients with severe GBS (724/743, 97%), mild GBS (126/168, 75%), Miller Fisher syndrome (53/70, 76%), and other variants (33/40, 83%). Of 235 (32%) patients who did not improve after their initial treatment, 82 (35%) received a second immune modulatory treatment. A treatment-related fluctuation was observed in 53 (5%) of 1,023 patients, of whom 36 (68%) were re-treated with IVIg or PE.ConclusionsIn current practice, patients with mild and variant forms of GBS, or with treatment-related fluctuations and treatment failures, are frequently treated, even in absence of trial data to support this choice. The variability in treatment practice can be explained in part by the lack of evidence and guidelines for effective treatment in these situations.

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“…76 A study regarding a second trial of IVIg in GBS patients with poor prognosis is currently ongoing, with results expected in 2019. 77…”

Section: Managementmentioning

confidence: 99%

Guillain–Barre Syndrome

Malek

Salameh

2019

Semin Neurol

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Guillain–Barre syndrome (GBS) is the leading cause of acute paralysis that can potentially affect all of the human population. GBS is believed to be an immune-mediated disease, possibly triggered by a recent infection, and driven by an immune attack targeting the peripheral nervous system. GBS can be divided into several subtypes depending on the phenotype, pathophysiology, and neurophysiological features. Unfortunately, morbidity and mortality rates are still high despite the current understanding of the pathophysiology and available treatment options. Additional research is still needed to shed more light into the pathogenesis for a better understanding and treatment of this condition.

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Second IVIg course in Guillain‐Barré syndrome patients with poor prognosis (SID‐GBS trial): Protocol for a double‐blind randomized, placebo‐controlled clinical trial

Cited by 44 publications

References 30 publications

Original research: Second IVIg course in Guillain-Barré syndrome with poor prognosis: the non-randomised ISID study

Original research: Second IVIg course in Guillain-Barré syndrome with poor prognosis: the non-randomised ISID study

Current treatment practice of Guillain-Barré syndrome

Guillain–Barre Syndrome

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