Session Title: 4M090: Infection-Related Rheumatic Disease (1800–1805)
Session Type: ACR Abstract Session
Session Time: 2:30PM-4:00PM
Background/Purpose: To evaluate the safety and humoral immunogenicity of a live attenuated herpes zoster (HZ) vaccine in patients with rheumatoid arthritis (RA) compared with healthy controls (HC).
Methods: This is a prospective multicenter study of a live attenuated HZ vaccine in 132 patients with RA receiving conventional disease-modifying anti rheumatic drugs (cDMARD) and/or low-dose glucocorticoids (GC), candidates to receive biologics or tofacitinib. The control groups was composed of 35 HC. All the subjects, above the age of 50 years. Clinical and laboratory assessments were performed at baseline and after 6 weeks. Each assessment included RA disease activity score (DAS-28) for RA patients, recording of side effects and blood samples for the evaluation of immunogenicity for each subject. At week 2 and 4 after vaccination, patients were contacted by phone and asked for adverse events. The immunogenicity was assessed using varicella zoster virus (VZV)-specific ELISA (Serion)
Results: 132 RA patients (median age 66, range 50-89, 81% women) and 35 HC (median age 67, range 51-100, 69 % women) were vaccinated with the Zostavax (MSD) vaccine. Safety: 67 (52%) of the RA patients and 12 (32%) of the HC developed vaccine related side effects. In the HC, all were local reactions to the vaccine which resolved after a few days. In the RA group, the adverse events included: 56 local reactions, 11 systemic reactions such as fever, 2 mild rash, and 1 event of herpes zoster. Seven RA patients reported worsening of the RA Effect on disease activity :No change in disease activity was observed . DAS28-ESR at baseline was (median [min, max], n (out of 132)) (4 [2,8], n=126/132) and (4, [1,9], n=121/132) after 6 weeks. Immunogenicity: The number of patients with non-protective titer at baseline was 1 (RA=0, and controls=1). The titer increased from (median [min, max], n) (877 [101, 3153], n=129/132) to (1327 [99, 4836], n=126) for RA and from (962 [54, 1650], n=35) to (1533 [222, 3564]) in the control group. The increase in each group was statistically significant (pv< 0.0001 for both groups, Wilcoxon signed-rank test, n.RA=124, n.Control=35). The degree of humoral response was similar in the 2 groups (p=0.238, Mann-Whitney Test, n.RA=124, n.Control=35)
Conclusion: In RA patients treated with cDMARDs, vaccination with a live attenuated vaccine against herpes zoster was safe and induced an adequate booster response
To cite this abstract in AMA style:Elkayam O, Rosner I, Zisman D, Lidar M, Mader R, Bieber A, Balbir-Gurman A, Amit M, Gertel S, Furer V. Safety and Humoral Immunogenicity to Herpes Zoster Vaccine in Patients with Rheumatoid Arthritis (interim Analysis) [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). https://acrabstracts.org/abstract/safety-and-humoral-immunogenicity-to-herpes-zoster-vaccine-in-patients-with-rheumatoid-arthritis-interim-analysis/. Accessed November 24, 2020.
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ACR Meeting Abstracts - https://acrabstracts.org/abstract/safety-and-humoral-immunogenicity-to-herpes-zoster-vaccine-in-patients-with-rheumatoid-arthritis-interim-analysis/