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What Rheumatologists Need to Know in the Era of Herpes Zoster Prevention
Herpes zoster has become a topic of increasing interest and importance to our profession over the past number of years for several reasons, the most pressing of which is that our patients are 1.5 to 2 times more likely to develop herpes zoster (HZ) compared with healthy individuals, largely due to the effects of immunosuppressive drugs on the integrated immune response to varicella.
Coupled with our access to a new class of drugs — Janus kinase inhibitors — that appear to have a class effect of increasing the incidence of herpes zoster (HZ), we also have strong epidemiologic data demonstrating HZ is associated with an increased risk for stroke and possibly myocardial infarction in the early post-infectious phase of the illness; these compound the formidable burden of morbidity of acute HZ, especially among those unfortunate enough to develop postherpetic neuralgia.
Rheumatologists need to be more tuned in than ever to address our patients’ increasing questions and concerns regarding HZ — driven largely, I believe, by a highly effective disease awareness program that all of us have seen on TV, sponsored by the maker of the first-in-class vaccine for HZ, Zostavax (Merck). Adding to these questions, Shingrix (GlaxoSmithKline), the newly approved and endorsed subunit vaccine for HZ, has entered the arena.
With this background I would like to summarize the recommendations of the Advisory Committee on Immunization Practices (ACIP), which were published in the January 26, 2018, issue of the Morbidity and Mortality Weekly Report. However, I strongly urge all of you to read the MMWR article itself.
In addition to these new recommendations, let me now share with you my opinions on what we know — and what we don’t know — about the new vaccine as well as the implications for our practices. First, the new vaccine (Shingrix) is a recombinant (non-live) vaccine consisting of a glycoprotein component combined with a novel and potent adjuvant system (ASO1b). It is used in a two-dose regimen given 2 to 6 months apart. Unlike Zostavax, which is stored frozen and given subcutaneously, Shingrix is stored refrigerated and given intramuscularly.
As we all know there have always been concerns about giving Zostavax to individuals who were never exposed to varicella and most of us were uncertain whether such patients (especially immunosuppressed patients) should be screened for antibodies prior to administration. With Shingrix, however, this is no longer an issue, though it is not intended for use as a primary vaccine for varicella. The efficacy of the new vaccine is comparably dramatic, with about 97% protection from HZ even for individuals immunized at age 70 and over, and 90% protection from postherpetic neuralgia; such a protective effect seems to endure for a mean follow up of 3.7 years (length of longest study) and likely much longer.
Safety in these trials was acceptable but local and systemic adverse effects such as fever, chills, myalgia and fatigue were noted in 10.8% of the exposed population vs. 0.3% of placebo. Remember, readers, these data are derived from studies performed on non-immunosuppressed individuals who, though largely healthy, did include a fair number with a variety of chronic diseases.
Now you know about the vaccine and have seen the recommendations of the ACIP, but in the Oslerian tradition, let me raise a few questions. First and foremost, we have to at least wonder why the ACIP — while voting overwhelmingly to approve the vaccine — only supported making it the preferred vaccine by an 8 to 7 vote. I am told this came from an abundance of caution as we just don’t know what will happen when the vaccine receives widespread uptake in the general population, which is bound to include many immunosuppressed individuals.
I have informally polled a number of well-known fellow vaccine researchers working in our field and no one denies the need for a well-done safety trial in such a population of patients with various rheumatic and immunologic diseases, of varying disease activity and on varying immunosuppressive regimens.
In closing, while I do not want my HIPPA rights violated by divulging my age, I will tell you I am a Master of the ACR and am on Medicare (get it?) and had the live HZ vaccine over 5 years ago. Thus, I face a decision as to what I am going to do about getting the new vaccine. Answer: I am headed to get the recombinant HZ vaccine a soon as possible — those TV commercials are scary!
- References:
- Calabrese LH et al. Arthritis Rheumatol. 2017;doi: 10.1002/art.39855.
- Dooling KL et al. MMWR Morb Mortal Wkly Rep 2018; doi:10.15585/mmwr.mm6703a5.
- For more information:
- Leonard H. Calabrese, DO, is the Chief Medical Editor, Healio Rheumatology, and Professor of Medicine, Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, and RJ Fasenmyer Chair of Clinical Immunology at the Cleveland Clinic.
Disclosure: Calabrese reports serving as an investigator and a consultant to Horizon Pharmaceuticals.