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

Faber, Catharina G.; Oosten, Bob W. van; Walgaard, Christa; Jacobs, Bart C.; Lingsma, Hester F.; Steyerberg, Ewout W.; Berg, B. van den; Doets, A.Y.; Leonhard, Sonja E.; Verboon, Christine; Huizinga, Ruth; Drenthen, Judith; Arends, Samuel; Budde, Ilona Kleine; Kleyweg, R. P.; Kuitwaard, Krista; Meulen, M. F. G. van der; Samijn, Johnny P.A.; Vermeij, Frédérique H; Kuks, Jan B. M.; Dijk, Gert W van; Wirtz, Paul W.; Eftimov, Filip; Kooi, Anneke J. van der; Garssen, Marcel P J; Gijsbers, Cees J; Rijk, Maarten C. de; Visser, Leo H.; Blom, R. J.; Linssen, W.H.J.P.; Kooi, E.L. van der; Verschuuren, Jan; Koningsveld, Rinske van; Dieks, Rita J.G.; Gilhuis, H.J.; Jellema, Korné; Ree, Taco C van der; Bienfait, H.M.E.; Faber, Karin G.; Lovenich, Harry; Engelen, B.G.M. van; Groen, R.; Merkies, Ingemar S. J.; Oosten, B.W. van; Pol, W. Ludo van der; Meulen, Willem D.M. Van der; Badrising, Umesh A.; Stevens, Martijn; Breukelman, A.J.; Zwetsloot, Casper P.; Graaff, M.M. van der; Wohlgemuth, M.; Hughes, Richard; Cornblath, David R.; Doorn, Pieter A. van; Geusau, R.B. Althingh van; Boheemen, Caroline J. M. van; Bronner, I. M.; Feenstra, B. W. A.; Fokke, C.; Hoogendoorn, T.A.; Houten, Rachel; Hovestad, A.; Jansen, P.J.H.W.; Keuter, E. J. W.; Krudde, J.; Linn, FH; Lion, John R.; Manschot, S.M.; Mellema, S.J.; Molenaar, D.S.M.; Nieuwkamp, Dennis J.; Oenema, D.G.; Oostrom, Joost C. H. van; Orshoven, Narender P. van; Ploeg, R J; Polman, Susanne KL; Ruitenberg, Annemieke; Ruts, Liselotte; Schyns-Soeterboek, Angelique; Trip, R.

doi:10.1016/s1474-4422(20)30494-4

Cited by 52 publications

(26 citation statements)

References 33 publications

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“…41,42 This was indicated by a recent 2021 randomized controlled trial, which reported a second IVIG dose was not significantly associated with any significant improvements in patients with severe GBS and it can negatively impact the prognosis by inducing some adverse events. 43 The same results were also previously reported by an observational study by Verboon et al which showed that second IVIG doses could not significantly enhance the prognosis of poor GBS. 44 Although previous investigations have approached the efficacy of some other management modalities, none of these approaches have been proven to be significantly efficacious as compared to plasma exchange and IVIG.…”

Section: Managementsupporting

confidence: 82%

Guillain–Barré syndrome: pathophysiology, etiology, causes, and treatment

Rahman¹,

Bauthman

Alanazi

et al. 2021

Int J Community Med Public Health

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Guillain–Barré syndrome (GBS) is a polyradiculoneuropathy autoimmune disease that is characterized by significant inflammation that affects the peripheral nervous system in a rapidly progressive pattern that is mainly clinically presented by muscle weakness. The present literature review aims to broadly discuss GBS: etiology, pathophysiology and management in order to gain an understading of the existing studies that are relevant to this literature review. Among the reported antibodies, anti-GM1 and anti-GQ1B have been reported to be responsible for attacking and damaging either the neuromuscular junctions or peripheral nerves. Moreover, it has been found that the anti-GD1a antibodies in patients bind to the neuromuscular junction and also bind to the nodes of Ranvier of the peripheral nerves and the paranodal myelin of the affected nerves. Reports have shown that this disease is identified as special forms of neuropathies that develop in immune-mediated, post-infection sequelae. Furthermore, in another study it was reported that Molecular mimicry has been previously reported to significantly correlate with the development of the disease as it was investigated in animal models. In addition, Campylobacter jejuni, a pathogen that causes gastrointestinal infections has been previously reported to predispose to the development of GBS in humans. However, scientists have found that plasma exchange and intravenous immunoglobulins (IVIG) remain the most significant and efficacious factors in managing the disease. Nevertheless, recent trials have investigated other approaches that are less efficacious and can lead to serious adverse events and complications.

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Section: Managementsupporting

confidence: 82%

Guillain–Barré syndrome: pathophysiology, etiology, causes, and treatment

Rahman¹,

Bauthman

Alanazi

et al. 2021

Int J Community Med Public Health

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“…Nevertheless, our data argue against a strong effect of multiple treatments on short-term outcome. To investigate whether repeated treatments had negative effects due to adverse events—as suggested by the recent randomized study for IVIg 8 —was beyond the scope of our study. However, given the comparable rate of side effects of IVIg and PE it is currently hard to justify any sequential treatment in patients with GBS, regardless of clinical severity or assumed prognosis.…”

Section: Discussionmentioning

confidence: 99%

“…A second IVIg course after PE or IVIg has not been associated with an additional benefit regarding outcome in non-randomized studies 6 , 7 . Recently, a placebo-controlled, randomized trial in patients with poor prognosis also failed to show a treatment effect of a second IVIg course and led to a higher number of adverse events 8 .…”

Section: Introductionmentioning

confidence: 99%

Real-world treatment of adult patients with Guillain-Barré syndrome over the last two decades

Rath

Zulehner

Schober

et al. 2021

Sci Rep

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This study investigated treatment characteristics of Guillain-Barré syndrome (GBS) in a real-world setting between 2000 and 2019. We analyzed clinical improvement between nadir and last follow-up in patients with severe GBS (defined as having a GBS disability scale > 2 at nadir) and aimed to detect clinical factors associated with multiple treatments. We included 121 patients (74 male; median age 48 [IQR 35–60]) with sensorimotor (63%), pure motor (15%), pure sensory (10%) and localized GBS (6%) as well as Miller Fisher syndrome (6%). 44% of patients were severely affected. All but one patient received at least one immunomodulatory treatment with initially either intravenous immunoglobulins (88%), plasma exchange (10%) or corticosteroids (1%), and 25% of patients received more than one treatment. Severe GBS but not age, sex, GBS subtype or date of diagnosis was associated with higher odds to receive more than one treatment (OR 4.22; 95%CI 1.36–13.10; p = 0.01). Receiving multiple treatments had no adjusted effect (OR 1.30, 95%CI 0.31–5.40, p = 0.72) on clinical improvement between nadir and last follow-up in patients with severe GBS. This treatment practice did not change over the last 20 years.

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“…Moreover, the recently published SID-GBS study, a randomized, double-blind, placebo-controlled trial, did not provide evidence that GBS patients with a poor prognosis benefit from a second IVIg course and showed that patients given a second IVIg course had more serious adverse effects. Second IVIg courses should not be administered in GBS patients with poor prognosis [ 138 ].…”

Section: Guillain-barré Syndromementioning

confidence: 99%

Novel Immunological and Therapeutic Insights in Guillain-Barré Syndrome and CIDP

Querol

Lleixà

2021

Neurotherapeutics

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Inflammatory neuropathies are a heterogeneous group of rare diseases of the peripheral nervous system that include acute and chronic diseases, such as Guillain-Barré syndrome (GBS) and chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). The etiology and pathophysiological mechanisms of inflammatory neuropathies are only partly known, but are considered autoimmune disorders in which an aberrant immune response, including cellular and humoral components, is directed towards components of the peripheral nerve causing demyelination and axonal damage. Therapy of these disorders includes broad-spectrum immunomodulatory and immunosuppressive treatments, such as intravenous immunoglobulin, corticosteroids, or plasma exchange. However, a significant proportion of patients do not respond to any of these therapies, and treatment selection is not optimized according to disease pathophysiology. Therefore, research on disease pathophysiology aiming to reveal clinically and functionally relevant disease mechanisms and the development of new treatment approaches are needed to optimize disease outcomes in CIDP and GBS. This topical review describes immunological progress that may help guide therapeutic strategies in the future in these two disorders. Supplementary Information The online version contains supplementary material available at 10.1007/s13311-021-01117-3.

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

Abstract: Second intravenous immunoglobulin dose in patients with Guillain-Barre syndrome with poor prognosis (SID-GBS): a double-blind, randomised, placebo-controlled trial. Lancet Neurology, 20(4), 275-283.

Cited by 52 publications

References 33 publications

Guillain–Barré syndrome: pathophysiology, etiology, causes, and treatment

Guillain–Barré syndrome: pathophysiology, etiology, causes, and treatment

Real-world treatment of adult patients with Guillain-Barré syndrome over the last two decades

Novel Immunological and Therapeutic Insights in Guillain-Barré Syndrome and CIDP

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