Second intravenous immunoglobulin dose in patients with Guillain-Barré syndrome with poor prognosis (SID-GBS): a double-blind, randomised, placebo-controlled trial
| العنوان: | Second intravenous immunoglobulin dose in patients with Guillain-Barré syndrome with poor prognosis (SID-GBS): a double-blind, randomised, placebo-controlled trial |
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| المؤلفون: | Christa Walgaard, Bart C Jacobs, Hester F Lingsma, Ewout W Steyerberg, Bianca van den Berg, Alexandra Y Doets, Sonja E Leonhard, Christine Verboon, Ruth Huizinga, Judith Drenthen, Samuel Arends, Ilona Kleine Budde, Ruud P Kleyweg, Krista Kuitwaard, Marjon F G van der Meulen, Johnny P A Samijn, Frederique H Vermeij, Jan B M Kuks, Gert W van Dijk, Paul W Wirtz, Filip Eftimov, Anneke J van der Kooi, Marcel P J Garssen, Cees J Gijsbers, Maarten C de Rijk, Leo H Visser, Roderik J Blom, Wim H J P Linssen, Elly L van der Kooi, Jan J G M Verschuuren, Rinske van Koningsveld, Rita J G Dieks, H Job Gilhuis, Korné Jellema, Taco C van der Ree, Henriette M E Bienfait, Catharina G Faber, Harry Lovenich, Baziel G M van Engelen, Rutger J Groen, Ingemar S J Merkies, Bob W van Oosten, W Ludo van der Pol, Willem D M van der Meulen, Umesh A Badrising, Martijn Stevens, Albert-Jan J Breukelman, Casper P Zwetsloot, Maaike M van der Graaff, Marielle Wohlgemuth, Richard A C Hughes, David R Cornblath, Pieter A van Doorn, Bart C. Jacobs, Hester F. Lingsma, Ewout W. Steyerberg, Bianca Van den Berg, Alexandra Y. Doets, Sonja E. Leonhard, Ruud P. Kleyweg, Marjon F.G. Van der Meulen, Johnny P.A. Samijn, Frederique H. Vermeij, Jan B.M. Kuks, Gert W. Van Dijk, Paul W. Wirtz, Anneke J. Van der Kooi, Marcel P.J. Garssen, Cees J. Gijsbers, Maarten C. De Rijk, Leo H. Visser, Roderik J. Blom, Wim H.J.P. Linssen, Elly L. Van der Kooi, Jan J.G.M. Verschuuren, Rinske Van Koningsveld, Rita J.G. Dieks, H. Job Gilhuis, Taco C. Van der Ree, Henriette M.E. Bienfait, Karin G. Faber, Baziel G.M. Van Engelen, Rutger J. Groen, Ingemar S.J. Merkies, Bob W. Van Oosten, W. Ludo Van der Pol, Willem D.M. Van der Meulen, Umesh A. Badrising, Albert-Jan J. Breukelman, Casper P. Zwetsloot, Maaike M. Van der Graaff, Richard A.C. Hughes, David R. Cornblath, Pieter A. Van Doorn, R.B. Althingh van Geusau, C.J.M. Van Boheemen, I.M. Bronner, B. Feenstra, C. Fokke, T.A. Hoogendoorn, R. Van Houten, A. Hovestad, P.J.H.W. Jansen, E. Keuter, J. Krudde, F.H.H. Linn, J. Lion, S.M. Manschot, S.J. Mellema, D.S.M. Molenaar, D.J. Nieuwkamp, D.G. Oenema, J.C.H. Van Oostrom, N.P. Van Orshoven, R.J.O. Van der Ploeg, S. Polman, A. Ruitenberg, L. Ruts, A.J.G.M. Schyns-Soeterboek, R. Trip |
| المساهمون: | Neurology, Amsterdam Neuroscience - Neuroinfection & -inflammation, Immunology, Public Health, RS: MHeNs - R1 - Cognitive Neuropsychiatry and Clinical Neuroscience, Klinische Neurowetenschappen, MUMC+: MA Med Staf Spec Neurologie (9), ANS - Neuroinfection & -inflammation, EURO-NMD |
| المصدر: | The Lancet Neurology, 20(4), 275-283. Lancet Publishing Group Walgaard, C, Jacobs, B C, Lingsma, H F, Steyerberg, E W, van den Berg, B, Doets, A Y, Leonhard, S E, Verboon, C, Huizinga, R, Drenthen, J, Arends, S, Budde, I K, Kleyweg, R P, Kuitwaard, K, van der Meulen, M F G, Samijn, J P A, Vermeij, F H, Kuks, J B M, van Dijk, G W, Wirtz, P W, Eftimov, F, van der Kooi, A J, Garssen, M P J, Gijsbers, C J, de Rijk, M C, Visser, L H, Blom, R J, Linssen, W H J P, van der Kooi, E L, Verschuuren, J J G M, van Koningsveld, R, Dieks, R J G, Gilhuis, H J, Jellema, K, van der Ree, T C, Bienfait, H M E, Faber, C G, Lovenich, H, van Engelen, B G M, Groen, R J, Merkies, I S J, van Oosten, B W, van der Pol, W L, van der Meulen, W D M, Badrising, U A, Stevens, M, Breukelman, A-J J, Zwetsloot, C P, van der Graaff, M M, Wohlgemuth, M, Hughes, R A C, Cornblath, D R, van Doorn, P A, Jacobs, B C, Lingsma, H F, Steyerberg, E W, Doets, A Y, Leonhard, S E, Kleine Budde, I, Kleyweg, R P, van der Meulen, M F G, Samijn, J P A, Vermeij, F H, Kuks, J B M, van Dijk, G W, Wirtz, P W, van der Kooi, A J, Garssen, M P J, Gijsbers, C J, de Rijk, M C, Visser, L H, Blom, R J, Linssen, W H J P, van der Kooi, E L, Verschuuren, J J G M, Dieks, R J G, Gilhuis, H J, van der Ree, T C, Bienfait, H M E, Faber, K G, van Engelen, B G M, Groen, R J, Merkies, I S J, van Oosten, B W, van der Pol, W L, van der Meulen, W D M, Badrising, U A, Breukelman, A-J J, Zwetsloot, C P, van der Graaff, M M, Hughes, R A C, Cornblath, D R, van Doorn, P A, Althingh van Geusau, R B, van Boheemen, C J M, Bronner, I M, Feenstra, B, Fokke, C, Hoogendoorn, T A, van Houten, R, Hovestad, A, Jansen, P J H W, Keuter, E, Krudde, J, Linn, F H H, Lion, J, Manschot, S M, Mellema, S J, Molenaar, D S M, Nieuwkamp, D J, Oenema, D G, van Oostrom, J C H, van Orshoven, N P, van der Ploeg, R J O, Polman, S, Ruitenberg, A, Ruts, L, Schyns-Soeterboek, A J G M, Trip, R & Dutch GBS Study Group 2021, ' Second intravenous immunoglobulin dose in patients with Guillain-Barré syndrome with poor prognosis (SID-GBS): a double-blind, randomised, placebo-controlled trial ', The Lancet Neurology, vol. 20, no. 4, pp. 275-283 . https://doi.org/10.1016/S1474-4422Test(20)30494-4 The Lancet Neurology, 20(4), 275-283. ELSEVIER SCIENCE INC Lancet Neurology, 20(4), 275-283. ELSEVIER SCIENCE INC Lancet Neurology, 20(4), 275-283. Elsevier Science Lancet Neurology, 20, 275-283 Lancet neurology, 20(4), 275-283. Lancet Publishing Group Lancet Neurology, 20, 4, pp. 275-283 |
| سنة النشر: | 2021 |
| مصطلحات موضوعية: | Adult, Male, medicine.medical_specialty, Placebo-controlled study, Placebo, Guillain-Barre Syndrome, law.invention, 03 medical and health sciences, All institutes and research themes of the Radboud University Medical Center, 0302 clinical medicine, Randomized controlled trial, Double-Blind Method, law, Internal medicine, Medicine, Humans, In patient, 030212 general & internal medicine, Adverse effect, Aged, Netherlands, biology, Guillain-Barre syndrome, business.industry, Immunoglobulins, Intravenous, Odds ratio, Middle Aged, Disorders of movement Donders Center for Medical Neuroscience [Radboudumc 3], medicine.disease, Prognosis, Treatment Outcome, biology.protein, Female, Neurology (clinical), Antibody, business, 030217 neurology & neurosurgery |
| الوصف: | Summary Background Treatment with one standard dose (2 g/kg) of intravenous immunoglobulin is insufficient in a proportion of patients with severe Guillain-Barre syndrome. Worldwide, around 25% of patients severely affected with the syndrome are given a second intravenous immunoglobulin dose (SID), although it has not been proven effective. We aimed to investigate whether a SID is effective in patients with Guillain-Barre syndrome with a predicted poor outcome. Methods In this randomised, double-blind, placebo-controlled trial (SID-GBS), we included patients (≥12 years) with Guillain-Barre syndrome admitted to one of 59 participating hospitals in the Netherlands. Patients were included on the first day of standard intravenous immunoglobulin treatment (2 g/kg over 5 days). Only patients with a poor prognosis (score of ≥6) according to the modified Erasmus Guillain-Barre syndrome Outcome Score were randomly assigned, via block randomisation stratified by centre, to SID (2 g/kg over 5 days) or to placebo, 7–9 days after inclusion. Patients, outcome adjudicators, monitors, and the steering committee were masked to treatment allocation. The primary outcome measure was the Guillain-Barre syndrome disability score 4 weeks after inclusion. All patients in whom allocated trial medication was started were included in the modified intention-to-treat analysis. This study is registered with the Netherlands Trial Register, NTR 2224/NL2107. Findings Between Feb 16, 2010, and June 5, 2018, 327 of 339 patients assessed for eligibility were included. 112 had a poor prognosis. Of those, 93 patients with a poor prognosis were included in the modified intention-to-treat analysis: 49 (53%) received SID and 44 (47%) received placebo. The adjusted common odds ratio for improvement on the Guillain-Barre syndrome disability score at 4 weeks was 1·4 (95% CI 0·6–3·3; p=0·45). Patients given SID had more serious adverse events (35% vs 16% in the first 30 days), including thromboembolic events, than those in the placebo group. Four patients died in the intervention group (13–24 weeks after randomisation). Interpretation Our study does not provide evidence that patients with Guillain-Barre syndrome with a poor prognosis benefit from a second intravenous immunoglobulin course; moreover, it entails a risk of serious adverse events. Therefore, a second intravenous immunoglobulin course should not be considered for treatment of Guillain-Barre syndrome because of a poor prognosis. The results indicate the need for treatment trials with other immune modulators in patients severely affected by Guillain-Barre syndrome. Funding Prinses Beatrix Spierfonds and Sanquin Plasma Products. |
| وصف الملف: | application/pdf |
| اللغة: | English |
| تدمد: | 1474-4422 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::fac234079bfe0a75e9f04cbd3f24fe28Test https://research.vumc.nl/en/publications/ed0fb2cb-ebfd-4d51-a9f8-133541aa7cfaTest |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....fac234079bfe0a75e9f04cbd3f24fe28 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 14744422 |
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