Efficacy and Safety of Intravenous Immunoglobulin and Eculizumab in the Treatment of Guillain-Barré Syndrome: A Systematic Review and Meta-Analysis

Abstract

Introduction:
Guillain-Barré Syndrome (GBS) is an acute autoimmune polyradiculoneuropathy that causes increasing deterioration and sudden paralysis. Current standard therapy includes intravenous immunoglobulin (IVIG) and plasma exchange, making partial recoveries in GBS patients, reflecting the need for advanced therapies. Eculizumab is a monoclonal antibody that targets complement component C5, though the safety and effectiveness of it in conjunction with IVIG remain unknown.
Objective:
The study’s objective is to evaluate the efficacy and safety of Eculizumab+IVIG with placebo+IVIG in GBS patients.
Methods:
Following PRISMA guidelines and registering with PROSPERO CRD420251073535
Databases including PubMed, Google Scholar, Scopus, and Cochrane Library were thoroughly searched from inception to May, 2025. Three RCTs comparing Eculizumab+IVIG against placebo+IVIG in GBS patients comprising 99 adult patients (≥18 years) with onset of GBS symptoms within 2 weeks were included. Non-RCTs, pediatric population, and trials using Eculizumab with other immunotherapies were excluded. RevMan software was used for data analysis. Pooled risk ratios with 95% confidence intervals were estimated using a random-effects model for the dichotomous outcomes. I 2 statistics assessed the heterogeneity. GRADEpro and Cochrane RoB 2.0 assessed the certainty of evidence and risk of bias, respectively.
Results:
At 4 and 24 weeks, Eculizumab in combination with IVIG did not significantly improve primary outcomes including GBS disability grade (RR = 0.99; 95% CI: 0.82-1.19) or walking ability (RR = 1.28; 95% CI: 0.88-1.85). Secondary outcomes including ventilation, headache, rash, and SAEs, showed no significant results, though trends toward increased adverse events were found. The study’s reliability is based on low heterogeneity (I 2 = 0%) in all the possible outcomes. Additionally, the inclusion of only three RCTs limits bias assessment. The GRADEpro evaluated a very low certainty in GBS grade and all secondary outcomes, and low certainty in walking ability.

Conclusion:
Eculizumab+IVIG compared to IVIG alone shows non-significant outcomes results in GBS patients, mainly GBS disability grade and walking ability, but might increase the adverse effects. Future trials should focus on large and biomarker-based RCTs to evaluate Eculizumab efficacy in GBS sub-phenotypes.
Keywords:
Eculizumab, Guillain-Barré Syndrome, Efficacy.