Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

Shingrix effective in older adults with preexisting immune-mediated disorders

Publish date:: October 19, 2020

Key clinical point: Shingrix appears to be safe and effective in preventing herpes zoster in older adults with preexisting immune-mediated disorders.

Major finding: The overall effectiveness of Shingrix in the study was 90.5% in patients with preexisting immune-mediated disorders, and there was a similar rate of serious adverse events between the vaccine and placebo groups.

Study details: A post hoc analysis of 983 patients who received Shingrix and 960 patients who received placebo in the phase 3 ZOE-50 and ZOE-70 clinical trials.

Disclosures: This study was funded by GlaxoSmithKline; the company helped with conducting and analyzing the study and also provided the costs associated with publishing it. Five authors reported being an employee of GlaxoSmithKline during the time the work was conducted, and four of the five own stock in the company. One author is now an employee of UCB. One author reported having served on the advisory boards for Merck Sharp & Dohme, GlaxoSmithKline, and Curevo.

Commentary

"Autoimmune conditions and several medications used in its management, including corticosteroids and JAK inhibitors, predispose patients to reactivation of herpes zoster. Effective vaccination for herpes zoster for patients with rheumatic disease would be ideal, but until 2018, the only available vaccine was a live attenuated virus, which is contraindicated in patients who are immunocompromised and/or taking immunosuppressive medication. With the availability of an adjuvant recombinant zoster vaccine (RZV), the question of its safety and efficacy in patients with rheumatic disease remains. This study presents a post hoc analysis of the large phase 3 placebo-controlled clinical trials of RZV in patients with inflammatory and autoimmune diseases, the most common of which were psoriasis, RA, and spondyloarthropathy.

There was no significant difference in side effects among vaccine or placebo recipients. Although the trials were not powered for this subset analysis, the lower number of herpes zoster episodes in vaccinated patients vs. placebo recipients suggests that RZV is effective in patients with autoimmune and inflammatory conditions. Since RZV was not tested in patients currently receiving immunosuppressive medications, its role in patients receiving active therapy is not clear and requires further investigation.”