The safety and efficacy of live viral vaccines, such as the varicella-zoster vaccine, in patients with inflammatory diseases receiving immunomodulatory
therapy, such as tumor necrosis factor inhibitors (TNFis), are unknown .
A study published in Ann Intern Med evaluated the safety and immunogenicity of live attenuated varicella vaccine (ZVL) in patients treated with TNFis
Using a randomized, blinded, placebo-controlled design, adults 50 years of age and older receiving TNFis were randomized to ZVL versus placebo
Glycoproteinase-linked immunosorbent assay (gpELISA) and enzyme-linked immunosorbent assay (ELISpot) of serum and peripheral blood mononuclear cells were measured at baseline and 6 weeks after vaccination
Suspected varicella or herpes zoster infection
was assessed by digital photographs and polymerase chain reaction of vesicular fluid .
RESULTS: From March 2015 to December 2018, a total of 617 participants were included in the study, randomized 1:1 to receive ZVL (n = 310) or placebo (n = 307) at 33 centers
Mean age was 62.
7 years (SD, 7.
1% of participants were female, 90% white, 8.
2% black, and 5.
The most common TNFi indications were rheumatoid arthritis (57.
6%) and psoriatic arthritis (24.
1%); TNFi drugs were adalimumab (32.
7%), infliximab (31.
3%), enamel chypre (21.
2%), golimumab (9.
1%), and cetocilizumab (5.
Concurrent treatments included methotrexate (48.
0%) and oral corticosteroids (10.
By week 6, no confirmed cases of varicella infection were identified; the cumulative incidence of varicella infection or shingles was 0.
0% (95% CI, 0.
At 6 weeks, the mean of the geometric mean fold rise measured by gpELISA and ELISpot was 1.
33 percentage points (CI, 1.
51%) and 1.
39 percentage points (CI, 1.
82%), respectively, from baseline
Taken together, the findings provide evidence for the safety of live virus vaccines in patients receiving biologics
A limitation of the study is that generalizability to patients receiving other types of immunomodulators may be limited
Jeffrey R Curtis, et al.
, The Safety and Immunologic Effectiveness of the Live Varicella-Zoster Vaccine in Patients Receiving Tumor Necrosis Factor Inhibitor Therapy : A Randomized Controlled Trial .
Ann Intern Med.
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