NEW YORK -- Vaccination against shingles may be safe for patients with mild, stable systemic lupus erythematosus, a researcher said here.
In a pilot study that included 10 lupus patients and 10 healthy controls all older than 50, there were no disease flares and safety was identical in the two groups, with three participants in each experiencing mild, transient erythema and tenderness at the injection site, according to Eliza F. Chakravarty, MD, of the Oklahoma Medical Research Foundation in Oklahoma City.
There also were no cases of vesicular or bullous lesions "or anything else that would be concerning," she said during an advanced rheumatology seminar at New York University Langone Medical Center.
"Patients with lupus have a dramatically increased risk of shingles even in their 20s and 30s, so that a 30-year-old woman with the disease has a risk of zoster that's about equivalent to a 60- or 65-year-old person with a healthy immune system," she said.
Reactivation of the varicella zoster virus occurs with senescence of cell-mediated immunity, as plasmacytoid dendritic cells produce large amounts of interferon-alpha through toll-like receptor-9 dependent and independent pathways that are also involved in the pathogenesis of lupus.
The zoster vaccine Zostavax has been available since 2006, but there are no data on either immunogenicity or safety for patients with autoimmune diseases.
Potential concerns have been whether the vaccine would result in exacerbations of lupus or more-difficult-to-manage disease, and if the vaccine itself could result in disease in these immunocompromised patients.
In addition, it's not always feasible in lupus for patients to have a drug holiday for immunizations because of the likelihood of flare.
The CDC has said that the vaccine is "probably okay" for immunosuppressed patients taking prednisone in doses below 20 mg per day, methotrexate in doses no higher than 0.4 mg/kg per week, and azathioprine in doses no higher than 3 mg/kg per day.
However, the recommendations didn't address other medications that are important in lupus, such as mycophenolate mofetil or cyclophosphamide. "So we're left in the dark," Chakravarty said.
To examine the possibility that the vaccine could be used safely in lupus patients and would generate an adequate cell-mediated immunogenic response, she and her colleagues conducted a small, open-label trial that included patients older than 50 who had IgG evidence of previous exposure and were taking medications considered acceptable in the CDC recommendations.
The participants were all women. Four of the patients and two controls had a history of shingles.
The primary safety endpoint was the appearance of any herpetiform or bullous lesions at the site of the injection.
"If we had seen any evidence of this we could have immediately instituted antiviral therapy," she said.
Only minor changes were seen on disease activity scores, primarily relating to fluctuations in complement levels.
Tests for immunogenicity had similar results in patients and controls, although zoster IgG concentrations were somewhat lower among patients than controls.
"We don't really know what that means. But patients don't care about their antibody levels -- they care about whether they're going to get shingles," she commented.
Further work will be needed to determine the safety and efficacy of the vaccine for patients younger than 50, who also have significant potential for benefit, and those who are receiving immunosuppressants not okayed by the CDC.
Chakravarty disclosed no relevant relationships with industry.
Primary source: NYU Advanced Rheumatology Seminar
Source reference: Chakravarty E "Vaccines in SLE: when are they appropriate?" NYU Advanced Rheumatology Seminar; March 20-21.
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