The recombinant zoster vaccine induced seroconversion in 83.3% of immunosuppressed IIM patients compared to 99.3% of healthy controls (p<0.001), without evidence of vaccine-related disease activation.
RCT (n=350)
Double-blind
1:1
Does the recombinant zoster vaccine induce seroconversion and maintain safety without worsening disease activity in immunocompromised patients with idiopathic inflammatory myopathies?
The recombinant zoster vaccine is safe and induces seroconversion in most immunosuppressed patients with idiopathic inflammatory myopathies, without exacerbating disease activity.
Absolute Event Rate: 83.3% vs 99.3%
p-value: p=<0.001
OBJECTIVES: To evaluate the immunogenicity and safety of the recombinant zoster vaccine (RZV) in immunosuppressed patients with idiopathic inflammatory myopathies (IIM), with particular focus on its impact on disease activity. METHODS: This sub-analysis of a randomized, double-blind, placebo-controlled study included 70 immunocompromised adult IIM patients(2017 ACR/EULAR criteria) and 280 healthy controls (CG), who received two RZV doses. Seroconversion was defined as a ≥4-fold increase in anti-gE antibodies. Geometric mean titers(GMT) and factor increase (FI) were assessed and multivariable regression analyses were performed to identify factors associated with seroconversion. Patients were randomized 1:1 to receive RZV or placebo during the blinded phase, and disease activity was evaluated using validated instruments: analogue visual scale(VAS), Myositis Disease Activity Assessment Visual Analogue(MYOACT), Manual Muscle Test-8(MMT-8), Health Assessment Questionnaire(HAQ), and Modified Medical Research Council(mMRC) dyspnea scale and serum muscle enzymes). RESULTS: IIM patients were younger (53 vs. 55 years, p=0.005) and had a higher prevalence of previous herpes zoster (36.7% vs. 13.3%, p0.05). CONCLUSION: RZV was safe and induced seroconversion in most immunosuppressed IIM patients, without evidence of vaccine-related disease activation. Attenuated antibody responses, particularly in patients receiving mycophenolate mofetil or with active cutaneous disease, support individualized vaccination strategies to optimize protection in this high-risk population(ClinicalTrials.gov NCT05879419).
Pasoto et al. (Mon,) conducted a rct in Idiopathic inflammatory myopathies (n=350). Recombinant zoster vaccine (RZV) vs. Placebo and healthy controls was evaluated on Seroconversion (≥4-fold increase in anti-gE antibodies) (p=<0.001). The recombinant zoster vaccine induced seroconversion in 83.3% of immunosuppressed IIM patients compared to 99.3% of healthy controls (p<0.001), without evidence of vaccine-related disease activation.
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