Background: Individuals with autoimmune diseases (AIDs) are particularly vulnerable to herpes zoster (HZ) and its related complications. Although the live attenuated HZ vaccine is contraindicated in many of these individuals, the two-dose non-live recombinant zoster vaccine (RZV) can be used in immunosuppressed individuals. Based on accumulating data from RZV studies within specific immunosuppressive conditions, recently updated guidelines recommend RZV not only in immunocompetent adults aged ≥50 years, but also in adults aged ≥18 years (EU)/≥19 years (USA) at risk of HZ due to immunodeficiency or immunosuppression. ^1–3

Objectives: To evaluate the burden of HZ in individuals with AIDs and the use of RZV as a preventative strategy.

Methods: We reviewed PubMed for available data on HZ incidence, summarised RZV data (effectiveness and safety) and the current recommendations for RZV in individuals with AIDs. The latest search was conducted in September 2021.

Results: HZ incidence in the general population is 4–7/1000 person-years (increases with age) and 8–15/1000 person-years in individuals with AIDs. Common immunosuppressive and immunomodulatory therapies can predispose individuals to HZ, as shown by large meta-analyses of interventional and observational studies. No published randomised controlled trial data of RZV in AID populations were found in our search. In two retrospective cohort studies in patients with inflammatory bowel disease (IBD), ^4,5 RZV demonstrated high vaccine effectiveness (OR 0.64; 95% CI 0.44, 0.77). ⁴ In a real-world observational study investigating RZV in beneficiaries of the Medicare national health insurance program in the USA, individuals with AIDs achieved vaccine effectiveness of 68.0% (95% CI 62.3%, 72.8%), which was similar to the overall population (70.1% [95% CI 68.6%, 71.5%]). ⁶ In two single-centre, retrospective studies of RZV in individuals with AIDs, including rheumatoid arthritis (RA), adverse events after the first RZV dose were mild ^7,8 . Disease flares were uncommon, mild and self-limiting, although a flare at the first RZV dose was significantly associated with an increased risk of a flare at the second dose (hazard ratio 3.9; P=0.0015) ⁷ . In addition, glucocorticoid use during vaccination was significantly associated with flares (odds ratio [OR] 2.31; P=0.004; Lenfant, 2021) ⁷ . In a study of individuals with IBD, receiving ≥1 RZV dose was associated with a low flare rate ⁹ . Current RZV guidelines vary by country and will be revised as new data emerge. Ongoing studies include phase 4 studies of individuals with RA and IBD receiving immunotherapies, and a study investigating the immunogenicity and safety of RZV in individuals with stable systemic lupus erythematosus.

Conclusion: Individuals with AIDs are at increased risk of HZ and its related complications, which may be due to either or both of their underlying condition and the treatment(s) they are receiving. The developing collective scientific evidence from the published literature on RZV in individuals with AIDs demonstrates a favourable benefit:risk profile for RZV in this population which contributed to the recent USA ACIP recommendation. Further studies are warranted to evaluate potential effects of individual conditions and immunotherapies on vaccine efficacy and methods to optimise vaccine use.

REFERENCES:

[1]Dooling KL, et al. MMWR Morb Mortal Wkly Rep , 2018

[2]GlaxoSmithKline, Press Release, 2021

[3]GlaxoSmithKline, RZV EU SmPC, 2021

[4]Kochhar GS, et al. Vaccine , 2021

[5]Khan N, et al. Clin Gastroenterol Hepatol , 2021

[6]Izurieta HS, et al. Clin Infect Dis , 2021

[7]Lenfant T, et al. Rheumatology , 2021

[8]Stevens E, et al. ACR Open Rheumatol , 2020

[9]Satyam VR, et al. Dig Dis Sci , 2020

Acknowledgements: This abstract was funded by GlaxoSmithKline Biologicals SA. Medical writing support in the preparation of this abstract was provided by Silvia Pregnolato of OPEN Health Communications, London, UK, with financial support from GlaxoSmithKline Biologicals SA.

Disclosure of Interests: Kevin Winthrop Consultant of: KLW has received consultancy fees from GlaxoSmithKline, Bristol Myers Squibb, Pfizer, AbbVie, Union Chimique Belge, Eli Lilly, Galapagos, Roche, Gilead, Sanofi, Regeneron, AstraZeneca and Novartis., Grant/research support from: KLW has received research grants from Bristol Myers Squibb and Pfizer., Francis A Farraye Consultant of: KMS has received consultancy fees from and been part of publication committees for GlaxoSmithKline., Keith M Sullivan Shareholder of: FAF is a stockholder in Innovation Pharmaceuticals., Paid instructor for: FAF sits on the data safety monitoring board for Eli Lilly and Theravance., Consultant of: FAF has received consultancy fees from Arena, Bristol Myers Squibb, Braintree Labs, GI reviewers, GlaxoSmithKline, Iterative Scopes, Janssen, Pfizer and Sebela., David O Willer Shareholder of: DOW holds restricted share stock ownership for GlaxoSmithKline., Employee of: DOW is employed by GlaxoSmithKline., Peter Vink Employee of: PV was an employee at GSK at the time this work was completed., Fernanda Tavares-Da-Silva Shareholder of: FTDS holds restricted share stock ownership for GlaxoSmithKline., Employee of: FTDS is employed by GlaxoSmithKline.