medwireNews: Study findings suggest the herpes zoster recombinant adjuvanted vaccine is associated with a low risk for flare among patients with rheumatoid arthritis (RA) and other systemic rheumatic diseases taking immunosuppressants, indicating that these patients should not be exempt from receiving it.
Sonali Desai (Brigham & Women’s Hospital, Boston, Massachusetts, USA) and team explain that “[b]ecause of the potency of the adjuvant, there has been [a] question as to whether the vaccine could induce a clinical flare of underlying rheumatic disease.”
But based on their findings showing a 6.7% risk for flare and a 12.7% risk for side effects, they “encourage the use of the [zoster recombinant adjuvanted] vaccine in patients with RA and other [systemic rheumatic diseases] treated with immunosuppressive therapies.”
They add that “flares and side effects were mild and self-limited, and did not require a change in disease-modifying antirheumatic drug therapy.”
Of the 403 individuals (mean age 67.2 years, 75% female) included in this study, 27 had a flare within 12 weeks of receiving the vaccine. A flare was defined as having been documented as such in patients’ medical notes or a patient being given a new or increased corticosteroid dose.
The majority (78.4%) of patients included in the study were taking an immunosuppressant, the most common of which was methotrexate (35.5%), followed by prednisone (26.3%) and tumor necrosis factor inhibitors (26.1%).
Over half (n=239) of the patients had RA, 19 of whom experienced a flare, giving a 5.0% increased risk. The increased risk was slightly lower, at 3.6%, for the 164 patients with other systemic rheumatic diseases, of whom nine experienced flare.
Desai et al say that the full vaccine course requires two doses to be given 2 to 6 months apart and they elaborate that 23 of the 27 flares occurred after the first dose, while five occurred after the second, with one patient having a flare after each dose.
However, only 55.1% of the patients received both doses and not necessarily within the recommended 6 months, which the researchers attribute to “the national shortage of [the zoster recombinant adjuvanted vaccine] in the United States during the study period.”
Flares were commonly treated with and responded to a prednisone taper and no changes were required to the patients’ existing immunosuppressive treatments.
Side effects from the vaccine were experienced by 12.7% of patients; 10.7% of patients experienced side effects after the first dose and 5.4% after the second dose, with four patients experiencing side effects after both doses. The most common side effects were soreness at the injection site, rash, fever, stomach ache, nausea, and flu-like symptoms, which the investigators say “were similar to those reported in the nonimmunosuppressed patients studied in the pivotal trials of [zoster recombinant adjuvanted vaccine].”
Three patients developed herpes zoster, of whom two were taking tofacitinib and one was taking mycofenolate mofetil. This translated to an incidence rate of 0.7% in the study population, which Desai and team stress is no higher than that previously observed.
They conclude in ACR Open Rheumatology: “Larger studies of patients vaccinated with [the zoster recombinant adjuvanted vaccine] are required to confirm this observation in addition to confirming its efficacy and safety in this population.”
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