The need to vaccinate RA patients for herpes zoster (HZ) has been well established based on their increased risk of 1.5-2 times that of the general population.
A study led by Dr. Kevin Winthrop of the Oregon Health and Sciences University aimed to address the immune response to the HZ vaccine when given 2-3 weeks prior to the initiation of tofacitinib. 112 RA patients over age 50 with greater than 4 tender and 4 swollen joints and a CDAI score of at least 10 at baseline were enrolled. All patients had received at least 4 months of treatment with methotrexate at 15-25mg/wk, and use of oral prednisone ≤10mg/d was allowed during the study. The study excluded patients who had a history of infections or malignancy, or who had received the VZV (Varicella-Zoster vaccine) at any time, or any other vaccine in the prior 6 weeks.
Patients were administered the HZ vaccine and then randomized to receive either placebo or tofacitinib 5 mg b.i.d. starting 2-3 weeks post-vaccination with methotrexate continued throughout. Analysis of VZV-specific IgG levels and VZV-specific T-cell activity was carried out at baseline, week 2 (prior to treatment initiation), week 6 and week 14.
As expected, the VZV-specific IgG levels and T-cell activity in both the placebo and tofacitinib groups surged from baseline at week 2 and remained elevated at week 6, then subsequently fell to their anticipated maintenance level of protection by week 14. The surprising finding was that both the IgG and T-cell response to the vaccine was greater in the group treated with tofacitinib.
The vaccination appeared safe in all patients except one who lacked pre-existing VZVimmunity. This patient who had cutaneous dissemination of VZV recovered without sequelae after treatment with standard therapy. Post-vaccination, live HZ virus can circulate for 2-4 weeks. The affected patient who lacked VZV immunity started tofacitinib 16 days after administration of the vaccine and her cutaneous dissemination began immediately after.
Screening for VZV immunity is not common practice prior to administering HZ vaccine due to the widespread prevalence of this immunity. For this specific patient, waiting 4 weeks prior to starting tofacitinib would be expected to avoid this response. In many cases however, waiting more than 2 weeks to initiate advanced DMARD therapy is not acceptable.
Carolyn Whiskin, BSc. Phm is currently the director of pharmacy programs for the Charlton Centre for Specialized Treatments in Hamilton, Ontario. She also practices pharmacy at Brant Arts Dispensary in Burlington, Ontario and is the pharmacist representative to the Ontario Rheumatology Association’s Model of Care committee.View Full Bio