Shingles Vaccine Prior to Biologic Therapy Initiation Passes Phase 2 Trial for Patients With RA
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Administration of the shingles vaccine prior to biologic therapy in patients with rheumatoid arthritis was safe and efficacious, according to a results of a phase 2 trial.
“We showed that the vaccine was adequately immunogenic in patients whether they were starting tofacitinib or placebo in a few weeks, and the immunogenicity and the response to the vaccine were similar to what we have seen outside the rheumatoid arthritis setting in general population studies,” Kevin L. Winthrop, MD, MPH, from Oregon Health and Science University, said in a press release.
Researchers performed a phase 2, 14-week placebo-controlled trial of 112 patients who were randomized to receive either 5-mg tofacitinib twice daily or placebo 2 weeks to 3 weeks after shingles vaccination. The investigators found varicella-zoster virus (VZV)-specific IgG geometric mean fold rise (GMFR) was 2.11 for tofacitinib and 1.74 for placebo 6 weeks after vaccination. In addition, VZV-specific T-cell GMFR was 1.5 for tofacitinib and 1.29 for placebo.
Serious adverse events occurred in 5.5% of tofacitinib patients and 0% of placebo patients. One patient who lacked pre-existing VZV immunity developed cutaneous vaccine dissemination 2 days after tofacitinib initiation.
Reference:
www.eurekalert.org/emb_releases/2017-08/w-srh082417.php