scholarly journals Gamunex® in Guillain-Barré Syndrome: A Postmarketing, Retrospective, Observational Study

Author(s):  
Zaeem A. Siddiqi ◽  
Kecia Courtney ◽  
Kim Hanna ◽  
Elsa Mondou ◽  
Vera Bril

AbstractBackground: The objective of this retrospective study was to evaluate the effectiveness and safety of Gamunex® (immune globulin [human] 10%; hereinafter “Gamunex”) when administered intravenously in the initial treatment of Guillain-Barré syndrome (GBS). The study was conducted as a postapproval commitment for Health Canada. Methods: A medical chart review for hospitalized patients diagnosed with GBS and treated with Gamunex (Gamunex 10% and IGIVnex® 10%; N=109; n=69 evaluable) was conducted at seven Canadian study centers in reverse chronological order. The primary endpoint for assessing effectiveness was the proportion of patients with treatment success compared with a prospectively defined historical effectiveness threshold for plasma exchange (PE) treatment (55.05%). Treatment success was assessed as ≥1 point improvement from baseline on the GBS Disability Scale or abbreviated GBS Disability Scale. Cases were not evaluable if treatment success, relapse, or treatment failure could not be determined by the available chart data. Results: Applying a conservative estimate with all nonevaluable patients (n= 40) classified as treatment failures, Gamunex treatment success was estimated at 57.8% (63 of 109 patients), which exceeded the predefined historical PE effectiveness threshold. In the evaluable population of this study, Gamunex treatment was successful in 91.3% of patients (63/69). Some 23 (21.1%) of 109 Gamunex-treated patients experienced ≥1 adverse event; the profile and frequency were consistent with the adverse events reported for Gamunex in the product’s labeling and with the natural clinical course of GBS. Conclusions: The effectiveness of Gamunex for treatment of GBS was comparable to PE therapy. Gamunex was observed to have an acceptable safety profile in this study population.

2021 ◽  
pp. 1-9
Author(s):  
Moshe Bondi ◽  
Einat Engel-Haber ◽  
Julie Wolff ◽  
Liza Grosman-Rimon ◽  
Ayala Bloch ◽  
...  

BACKGROUND: Treatment with either Intravenous immunoglobulin (IVIg) or plasma exchange (PE) in patients with Guillain-Barré Syndrome (GBS) showed equivalent efficacy as attested by a commonly used disability scale. However, it has been suggested that this scale may not be sensitive enough to detect subtle functional changes between the two treatments since it mainly focuses on walking capability and respiratory function. OBJECTIVE: To evaluate functional outcomes following treatment with IVIg or PE using comprehensive scales that incorporate parameters of basic activities of daily living. METHODS: A retrospective cohort study was conducted between 2007 and 2013 in an inpatient neurologic rehabilitation department. The study group included 70 individuals with GBS: 39 were treated with PE and 31 with IVIg. A comparison of functional outcomes was performed using Functional Independence Measure (FIM), rehabilitation efficiency (REy), rehabilitation effectiveness (REs), and the GBS disability scale (GDS). RESULTS: Both treatments had a comparable effect on the various functional outcomes. Patients showed a significant increase in total FIM scores (30 points on average) during rehabilitation mainly as a result of an increase in motor sub-scores. A mean improvement of 1.23 (SD 0.9) in GDS was also observed. On average, individuals with GBS spent 20 days combined in the acute departments and 61 days in the rehabilitation department, with length of stay being similar for both treatments. CONCLUSIONS: IVIg and PE treatments have similar basic activities of daily living (ADL) functional outcomes. Nevertheless, due to the different mechanism of actions of these treatments and the multitude of GBS variants, it is possible that further comprehensive assessment tools may demonstrate differences in activity and participation of individuals with GBS.


2011 ◽  
Vol 02 (02) ◽  
pp. 168-170 ◽  
Author(s):  
Thirunavukkarasu Thivakaran ◽  
Ranjanie Gamage ◽  
Inuka Kishara Gooneratne

ABSTRACTGuillain-Barre syndrome (GBS) is usually a monophasic illness but relapses occur. A 55-year-old female with hypertension and vitiligo presented with acute inflammatory demyelinating polyradiculoneuropathy. She improved with immunoglobulin treatment started on day 6 of illness, but relapsed on day 14 warranting repeat immunoglobulin therapy. Thereafter recovery was complete. Her relapse was due to treatment-related fluctuation (TRF). TRF is improvement in the GBS disability scale of at least one grade after completion of immunotherapy followed by worsening of the disability scale of at least one grade within the first 2 months after disease onset. Recurrent GBS and chronic inflammatory demyelinating polyradiculoneuropathy were excluded. During the peak of the illness ANA titres were transiently high. The presence of other medical conditions, predominant proximal weakness and the absence of preceding diarrhea are predictors for TRF seen in this patient. Early treatment and evidence of ongoing immune activation have contributed toward TRF.


Author(s):  
Geneviève Deceuninck ◽  
Renée-Myriam Boucher ◽  
Philippe De Wals ◽  
Manale Ouakki

Background:In the province of Quebec, a population-based study of Guillain-Barré syndrome (GBS) was conducted at the time of a mass immunization campaign against meningococcal disease, in 2001.Methods:The study population included residents aged 2 months to 20 years observed from November 1st, 2000 to December 31, 2002, representing 4 075 465 person-years of observation. GBS cases were identified in the provincial hospital database Med-Echo and medical records were reviewed.Results:Thirty-three incident GBS cases were identified, including 27 cases of acute inflammatory demyelinating polyradiculopathy. The overall GBS incidence rate was 0.8/100 000 person-years, higher in persons aged 1 to 4 years (2.1/100 000) than in those 5 years or more (0.6/100 000). There was a female preponderance and no significant seasonal variation. All patients survived.Conclusion:Results could be used to interpret reports of adverse events associated with the introduction of new vaccines in this age-group in Canada.


2012 ◽  
Vol 2012 ◽  
pp. 1-7 ◽  
Author(s):  
Shujuan Li ◽  
Ming Yu ◽  
Haifeng Li ◽  
Hongliang Zhang ◽  
Yanfang Jiang

Guillain-Barré syndrome (GBS) is an acute autoimmune-mediated inflammatory demyelinating disease that causes rapidly progressing paralysis and occasionally respiratory failure. We hypothesized that interleukin (IL)-17 and IL-22 are elevated in GBS and participate in the autoimmune inflammatory response of GBS. We used sandwich enzyme-linked immunosorbent assay (ELISA) to measure the IL-17 and IL-22 levels in the CSF, and plasma from 22 GBS patients at the acute phase and 18 healthy controls (HC). The results show that CSF and plasma levels of IL-17 and IL-22 are elevated in GBS patients compared with HC. IL-17 and IL-22 levels in CSF, respectively, are correlated with GBS disability scale scores (GDSs). Meanwhile, IL-17 and IL-22 levels in CSF, IL-22 in CSF, and plasma of GBS patients have positive correlation, respectively. The increased levels of IL-17 and IL-22 in CSF may be explained by the disruption of blood-brain barrier (BBB) and peripheral nervous system (PNS) local inflammation in GBS. Meanwhile, the elevated levels of these two cytokines in plasma suggest the activation of Th17 and Th22 cells in the systemic immune response of GBS. Our data provide preliminary evidence that GBS is associated with high levels of IL-17 and IL-22 in CSF and plasma. These cytokines display pathogenic potential and may serve as useful biomarkers for GBS.


2013 ◽  
Vol 2013 ◽  
pp. 1-9 ◽  
Author(s):  
Cong Li ◽  
Pingwei Zhao ◽  
Xiguang Sun ◽  
Yuanyuan Che ◽  
Yanfang Jiang

Aims. Interleukin-37 (IL-37) is an anti-inflammatory cytokine. This study aims to investigate the concentrations of plasma and cerebrospinal fluid (CSF) IL-37 in patients with Guillain-Barré Syndrome (GBS).Methods. The levels of plasma and CSF IL-37, IL-17A, IFN-γ, and TNF-αin 25 GBS patients and 20 healthy controls (HC) were determined by enzyme-linked immunoabsorbent assay and flow cytometric bead array assay, respectively. The values of clinical parameters in the patients were also measured.Results. The concentrations of plasma IL-37, IL-17A, IFN-γ, and TNF-αand CSF IL-37 and IL-17A in patients at the acute phase of GBS were significantly higher than those in the HC. The levels of plasma IL-37, IL-17A, IFN-γ, and TNF-αwere positively correlated in those patients, and the levels of CSF IL-37 and IL-17A as well as the levels of plasma TNF-αwere correlated positively with the GBS disability scale scores (GDSs) in those patients. Treatment with intravenous immunoglobulin significantly reduced the levels of plasma IL-37, IL-17A, IFN-γ, and TNF-αin the drug-responding patients.Conclusions. Our findings indicate higher levels of plasma and CSF IL-37 and IL-17A and other proinflammatory cytokines in patients with GBS.


2019 ◽  
Vol 2019 ◽  
pp. 1-5 ◽  
Author(s):  
Saroj Kumar Bhagat ◽  
Shrey Sidhant ◽  
Mukesh Bhatta ◽  
Ashish Ghimire ◽  
Bhupendra Shah

Introduction. Guillain-Barre syndrome is the most common cause of acute flaccid paralysis in the adult population. It occurs at the rate of 0.34 to 4 per 100000 individuals. This study was conducted to determine the clinicoepidemiological profile and outcome of the patients with Guillain-Barre syndrome. Materials and Methods. We conducted a retrospective study of patients with Guillain-Barre syndrome, presented at B.P. Koirala Institute of Health Sciences, a tertiary care centre in eastern Nepal, from January 2013 to December 2017. All patients diagnosed with Guillain-Barre syndrome were included in this study. The handwritten case record files of the study population were retrieved from medical record section of the institute. Results. Of 31 patients with Guillain-Barre syndrome, the mean age of patients was 17±12 years. The most common presenting symptom of study population was ascending paralysis (93.5%). Respiratory failure requiring mechanical ventilation occurred in 16.1%. The common variants are AIDP and AMAN. Respiratory tract infection (29%) was the most common antecedent event. The in-hospital mortality of Guillain-Barre syndrome was 6.45%. Conclusion. Guillain-Barre syndrome is commonly seen in the young population. The most common symptom of Guillain-Barre syndrome was ascending paralysis. The in-hospital mortality rate of patients with GBS was 6.45%.


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