Publications

The results of ORAL Sequel suggest that the live zoster vaccine (LZV) may not provide adequate long-term protection in patients with RA receiving TOF. This LTE study enrolled 100 patients with RA, 14 weeks post LZV vaccination. Patients received either TOF 5 mg BID, or TOF 10 mg BID in addition to any background csDMARDs. Incidence rates and 95% CIs for HZ post-vaccination were calculated based on time to first event. Short-term varicella zoster vaccine (VZV) specific immunity was evaluated at baseline and week 6 post-vaccination during the index study.1Five HZ cases occurred in the LTE study 218, 280, 748, 741 and 544 days post-vaccination respectively. All HZ events were mild/moderate in severity and resolved with antiviral treatment. Cases 1, 4 and 5 had undetectable VZV cell-mediated immunity, at baseline and week 6. Cases 2 and 3 responded adequately to vaccination by both IgG and ELISPOT measures but had lower than average VZV IgG levels at baseline and week 6.These results suggest that LZV may not provide adequate long-term protection. These findings highlight the importance of evaluating the newly approved subunit non-live vaccine in patients with RA receiving TOF. Limitations of the study included the small number of patients and wide 95% CI. 1.Wollenhaupt J, et al. Arthritis Res Ther. 2019 Apr 5;21(1):89.