NEW YORK (Reuters Health)—Tofacitinib begun two to three weeks after live zoster vaccination does not impair immunogenicity, and vaccination appears to be safe in patients with pre-existing varicella zoster virus (VZV) immunity, researchers report.
Patients with rheumatoid arthritis (RA) are about twice as likely as healthy adults to develop herpes zoster, or shingles, and the risk is even higher with some disease-modifying antirheumatic drugs, including tofacitinib.
Dr. Kevin L. Winthrop from Oregon Health and Science University, in Portland, and colleagues investigated the safety and immunogenicity of live zoster vaccination in their Phase 2 study of 112 patients with active RA on stable background methotrexate therapy.
Patients were randomized to receive 5 mg tofacitinib twice daily or placebo beginning two to three weeks after receiving live zoster vaccine.
Among the 107 patients evaluable for immune response endpoints, the geometric mean fold rise (GMFR) in VZV-specific immunoglobulin G (IgG) six weeks post-vaccination (the primary endpoint) did not differ significantly between the tofacitinib (2.11) and placebo (1.74) groups, according to the Aug. 24 Arthritis & Rheumatology online report.1
At all post-vaccination time points, GMFR in VZV-specific IgG tended to be numerically higher in tofacitinib recipients, but the differences were small and not statistically significant.
VZV-specific interferon-gamma-secreting T-cell counts and GMFR also were similar between the tofacitinib and placebo groups.
One patient in the tofacitinib group developed disseminated primary varicella with the vaccine strain of VZV, and subsequent analysis of her baseline blood specimens showed that she lacked pre-existing immunity to VZV. She subsequently developed robust immunity to VZV.
“We observed that patients with active RA developed robust immune responses to this vaccine, and that the start of tofacitinib two to three weeks after vaccination had no negative impact on the established immune response,” the researchers note.
“Importantly,” they add,” while our results suggest that the vaccine is safe for patients with RA with prior VZV exposure, they also indicate the potential need to either screen for prior exposure before giving this vaccine or waiting longer than two to three weeks before starting immunosuppression with tofacitinib.”
Pfizer Inc. sponsored the study, employed 8 of the 11 authors, and had various relationships with the other three.
Dr. Winthrop did not respond to a request for comment.
- Winthrop KL, Wouters A, Choy E, et al. The safety and immunogenicity of live zoster vaccination in rheumatoid arthritis patients before starting tofacitinib: A randomized phase 2 trial. Arthritis Rheumatol. 2017 Aug 28. doi: 10.1002/art.40187. [Epub ahead of print]