Winthrop KL, et al. – The safety and immunogenicity of live zoster vaccination (LZV) were explored in rheumatoid arthritis (RA) patients before starting tofacitinib. Similar varicella–zoster virus [VZV]–specific humoral and cell–mediated immune responses to LZV were observed in patients starting tofacitinib 2–3 weeks after LZV, compared with placebo–treated patients. In all patients, vaccination appeared safe but one lacking pre–existing VZV immunity.

Methods

• In this trial, patients aged ≥50 years with active RA on background methotrexate were given LZV and randomized to receive tofacitinib 5 mg twice daily or placebo, 2–3 weeks post–vaccination.
• At baseline, 2, 6, and 14 weeks post–vaccination, humoral (varicella–zoster virus [VZV]–specific IgG via gpELISA) and cell–mediated responses (VZV–specific T–cell enumeration via ELISPOT) were measured.
• Endpoints consisted of the geometric mean fold rise (GMFR) in VZV–specific IgG levels (primary endpoint) and T–cells (spot–forming cells/10⁶ PBMCs) at 6 weeks post–vaccination.

Results

• 112 patients were enrolled (tofacitinib, n=55; placebo, n=57).
• Six weeks post–vaccination, VZV–specific IgG GMFR was 2.11 for tofacitinib and 1.74 for placebo, and VZV–specific T–cell GMFR increased similarly for tofacitinib (1.50) and placebo (1.29).
• Serious adverse events occurred in 3 (5.5%) and 0 (0%) tofacitinib and placebo patients, respectively.
• One patient, lacking pre–existing VZV immunity, developed cutaneous vaccine dissemination 2 days after starting tofacitinib (16 days post–vaccination).
• This resolved after tofacitinib discontinuation and antiviral therapy.