High Proportion of Zilucoplan Responders Identified in Secondary Analysis of RAISE Trial
After 12 weeks of treatment with zilucoplan 0.3 mg/kg, almost three-fourths of patients demonstrated at least a 3-point reduction in Myasthenia Gravis Activities of Daily Living scores.
Using self-controlled and case centered analysis, the reported rate of GBS after COVID-19 vaccination between the risk and control periods was significantly different (90.32% vs 9.7%, respectively; P <.0001). The findings remained similar when all patients, regardless of Brighton criteria, were included.
COVID-19 has been shown to be associated with several of neurological complications, including GBS, which has been more prominently throughout the pandemic. Recent work by Kayla E. Hanson, MPH, et al further suggested an increased risk of GBS following COVID-19 vaccination with Ad.26.COV2.S (Janssen). The analysis comprised of 15,120,073 doses of COVID-19 vaccines from December 2020 to November 2021, including 483,053 Ad.26.COV2.S doses; 8,806,595 BNY162b2 doses; and 5,830,425 mRNA-1273 doses.
In total, 11 cases of GBS were reported in those vaccinated with Ad.26.COV2.S, resulting in an unadjusted incidence rate of 32.4 (95% CI, 14.8-61.5) per 100,000 person-years in the 1 to 21 days following vaccination that was significantly higher than the background rate. Overall, the adjusted risk ratio (RR) in the 1 to 21 vs 22 to 42 days following Ad.26.COV2.S vaccination was 6.03 (95% CI, 0.79-147.79). The unadjusted incidence rate of GBS after mRNA vaccines was 1.3 (95% CI, 0.7-2.4), and when compared with Ad.26.COV2.S vaccines, the adjusted RR was 20.56 (95% CI, 6.94-64.66).2
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REFERENCES
1. Ors M, Jaffry M, Jaffry K, et al. Association of Guillain-Barré syndrome after Pzifer-BioNTech COVID-19 vaccination in pediatric patients: a vaccine adverse event reporting system study. Presented at: 2022 AANEM Annual Meeting; September 15-18; Nashville, TN. Abstract 19
2. Hanson KE, Goddard K, Lewis N, et al. Incidence of Guillain-Barré syndrome after COVID-19 vaccination in the vaccine safety datalink. JAMA Netw Open. 2022;5(4):e228879. doi:10.1001/jamanetworkopen.2022.8879