PO:17:250 | Effectiveness and safety of the recombinant zoster vaccine in patients ≥18 years of age with systemic lupus

Giulia Boschi¹, Sheryl A. Kluberg², Sophie E. Mayer², O'Mareen Spence³, Driss Oraichi³, Harry Seifert³, Omar Ali³, Huifeng Yun³, Andrew L. Simon⁴, Jenice S. Ko⁴, Caroline Hugh⁴, Meg Her⁴, Kathleen Shattuck⁴, Richard Platt², Aziza Jamal-Allial⁵, Djeneba Audrey Djibo⁶, Kimberly Daniels⁵, Qianli Ma⁷, Cheryl N. Mcmahill-Walraven⁶, Rachel P. Ogilvie⁸, Kristin Palmsten⁹, Mano Selvan⁷, Najat Ziyadeh⁸, Alexis Ogdie¹⁰, Michael George¹⁰ | ¹GSK Verona Italy; ²Harvard Medical School and the Department of Population Medicine, Harvard Pilgrim Health Care Institute, Boston; ³GSK Rockville; ⁴Department of Population Medicine, Harvard Pilgrim Health Care Institute, Boston; ⁵Carelon Research, Wilmington; ⁶CVS Health, Blue Bell; ⁷Humana Healthcare Research, Louisville; ⁸OptumInsight Life Sciences, Boston; ⁹HealthPartners Institute, Bloomington; ¹⁰University of Pennsylvania, Philadelphia, USA

Background. The recombinant zoster vaccine (RZV) is FDA-approved for herpes zoster (HZ) prevention in adults ≥50, and immunocompromised adults ≥18 at increased HZ risk, which may include those with SLE or MS. This retrospective cohort study interim analysis assessed 2-dose RZV vaccine effectiveness (VE) in patients with SLE or MS, and severe SLE flare risk.

Materials and Methods. Adults aged 18+ years with MS or SLE were identified within 7 insurers databases between 2018 or 2021-2023. In the analyses for determining VE, adults completing the 2-dose RZV series were matched 1:4 against unvaccinated controls, and patients with HZ one year prior to vaccination were excluded. The parameter for determining VE was the first episode of HZ ≥31 days after the administration of the second dose of RZV. For safety analyses, adults with SLE receiving RZV dose 1 or 2 were separately matched 1:4 to unvaccinated patients, excluding those with severe SLE flare 90 days prior to index. Safety outcome was the presence or absence of flare ≤90 days after index. Adjusted hazard ratios (HR) and VE were estimated using weighted Cox models to balance confounders.

Results. Vaccinated patients had more immunosuppressive use and fewer comorbidities, emergency department visits and hospitalisations before weighting. VE cohorts included 1,308 and 6,025 commercially insured RZV-vaccinated patients with SLE and MS, respectively, and 2,284 and 8,705 Medicare patients. RZV 2-dose VE (95% confidence interval [CI]) in commercially insured patients was 54% (18-74) and 81% (70-88) in SLE and MS, respectively, and 70% (50-82) and 64% (51-74) in Medicare patients. SLE safety cohorts comprised 2,775 commercially insured patients receiving 4,196 RZV doses and 4,227 Medicare patients receiving 6,602 RZV doses. HR (95% CI) of severe SLE flare was 0.94 (0.72-1.24) in commercially insured patients, and 0.91 (0.75-1.11) in Medicare patients.

Conclusions. RZV 2-dose VE ranged from 54-81% and RZV was not associated with severe SLE flare. These data justify efforts to increase RZV vaccination among patients with SLE and MS.