July 19, 2018
From the ALTC issue: Making the Case for Universal Herpes Zoster Vaccination in Older Adults
By Scott Baltic
NEW YORK (Reuters Health) - A recombinant zoster vaccine reduces the burden of herpes zoster (HZ) illness in older adults, mostly by preventing HZ outbreaks but also by reducing pain in "breakthrough" cases, according to a new study.
In two previous phase 3 trials of GlaxoSmithKline's Shingrix, "the recombinant zoster vaccine was shown to prevent cases of shingles," said Dr. Desmond Curran of GSK, in Wavre, Belgium. "Here we look at these same patients to determine any added benefits of vaccinating, including any impact on quality of life."
Vaccination "not only reduced the incidence of shingles, but reduced the shingles-related pain in the small number of subjects who developed herpes zoster following vaccination," he told Reuters Health by email.
Most HZ cases resolve completely within about one month. But 10% to 20% of patients develop postherpetic neuralgia, which may last months or even years and is difficult to treat, Dr. Curran and colleagues write in The Journals of Gerontology: Series A, online June 27.
For their study, the team used data from the ZOE-50 trial of Shingrix, which included participants 50 or older, and the ZOE-70, which included only participants 70 or older. A pre-specified pooled analysis was performed on data from all participants ages 70 or older from both cohorts.
Participants with suspected HZ were asked to complete the Zoster Brief Pain Inventory daily for 28 days from the onset of rash and then weekly for four weeks or until 90 days had elapsed from rash onset. Data were also collected on the burden of illness of HZ, its interference with the patients' activities of daily living (ADLs) and its impact on their quality of life (QoL).
In 7,340 patients in the ZOE-50 study who received the vaccine, there were nine cases of HZ, versus 254 cases among the 7,413 patients who received placebo. In the pooled ZOE-70 analysis, 25 HZ cases occurred among the 8,250 vaccinated subjects, versus 284 among the 8,346 who received placebo.
The vaccine's estimated overall efficacy in reducing the burden of illness was 98.4% in the ZOE-50 study and 92.1% in the pooled ZOE-70 analysis.
In cases of confirmed HZ, the vaccine significantly reduced the maximal worst-pain score on the Zoster Brief Pain Inventory in the pooled ZOE-70 analysis. It also significantly lowered the maximal average-pain scores in both the ZOE-50 and the pooled ZOE-70 analysis.
"In breakthrough HZ cases, trends for diminished loss of QoL compared to placebo-recipient HZ cases were observed, with differences up to 0.14 on the (EuroQol-5 Dimension) index at time points during the four weeks following HZ onset," the researchers write.
Dr. Kenneth Schmader, chief of the division of geriatrics at Duke University Medical Center, in Durham, North Carolina, told Reuters Health by email that "the quality of the research is very high."
"These findings reinforce the findings of the original efficacy trial, that the recombinant zoster vaccine will greatly reduce suffering from shingles in older adults," he continued. "Even among older individuals who develop 'breakthrough' shingles, there is less pain compared to placebo recipients."
"People tend to underestimate" the pain of postherpetic neuralgia, Dr. Greg Poland, director of the Vaccine Research Group at the Mayo Clinic, told Reuters Health by phone. He recalled that when he was a resident, 30-plus years ago, a patient of his killed herself because of unbearable pain from post-herpetic neuralgia.
He also noted that the risks of heart attack or stroke increase shortly after a shingles outbreak.
The key points from this study, Dr. Poland said, are that the vaccine's efficacy is well established and that it provides "significant benefits" with respect to ADL. "Even if there is breakthrough disease, it's mild."
He also cautioned that "We're going to have more and more shingles cases." Currently 30% of the U.S. population will experience shingles, possibly multiple outbreaks, but this will be increasing, for two reasons, Dr. Poland said.
The first is the aging of the U.S. population, because age is correlated with immunosenescence, and the second is the increase in individuals who are immunocompromised because of obesity or from taking immunosuppressive medications.
GlaxoSmithKline Biologicals SA, the maker of Shingrix, funded the study and employed several of the authors. Dr. Poland has consulted for the company on Shingrix.
J Gerontol A Biol Sci Med Sci 2018.
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