Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Information has been received from the authors in a literature article as stated above concerning one adult patient older than 50 years old who was vaccinated with herpes zoster vaccine (manufacturer unknown) and developed significant swelling and tenderness at the injection site. Background/Purpose: Herpes Zoster (HZ) occurs in 1 in 3 people in the USA during their lifetime. The greatest risk factor is age. Immune suppression from illness or medications is also a strong risk factors. RA increases zoster rates 1.5-2 times normal as does > 10mg prednisone per day. Studies are mixed on the role of Mtx and antiTNF's on HZ. herpes zoster vaccine (manufacturer unknown) has been shown to lower risk and is approved for all patients over 50 by the FDA and recommended for patients over 60 by the Advisory Committee on Immunization Practices (ACIP). Guidelines from the ACIP and ACR do not recommend herpes zoster vaccine (manufacturer unknown) in patients on biologic therapies. However, recent large data-base studies have not found an increase in zoster complications in patients inadvertently given the herpes zoster vaccine (manufacturer unknown) while on biologics. These data encouraged our group to evaluate the safety of this herpes zoster vaccine (manufacturer unknown) in current biologic users. Methods: Since July 2012, all 160 patients with RA, PSA and AS receiving IV biologics in our infusion center have been prospectively assessed for Herpes zoster vaccine (manufacturer unknown) as well as 142 patients on subq biologics for the same indications. RA accounts for 93% of infusion and 66% of subq patients. All biologics were represented. REMICADE was the most common infusion followed by ORENCIA. ENBREL was the most common subq followed by HUMIRA. Inclusion/exclusion criteria for vaccination included: age > 50, no hx anaphylaxis to neomycin or gelatin, no episodes of HZ in last 4 years, pregnancy, patient consent, and disease activity stable- moderate or less on consecutive visits. No patients had an active infection or malignancy. If patient meets criteria, herpes zoster vaccine (manufacturer unknown) given at next interval scheduled dose of biologic, which is held. Example-hold ENBREL 1 week, HUMIRA 2 weeks, ORENCIA 4 weeks, REMICADE 8 weeks. Mtx was held weeks of vaccine and restarted 1 week post vaccine. Biologic restarted 2 weeks after vaccine. In 17 RITUXAN patients herpes zoster vaccine (manufacturer unknown) was given 2-4 weeks pre RITUXAN or > than 6 months post RITUXAN. No other vaccines were given the week of the herpes zoster vaccine (manufacturer unknown). Results: Of 160 infusion patients 110 (68%) have been vaccinated; over 60% had been on biologic > 5 years, 5% < 1 year. No patient developed disseminated HZ. One patient had significant swelling and tenderness at the injection site. Most common reasons not to vaccinate: 11 with recent HZ, 14 <age 50, and 17 with disease activity issues. Of 142 subq patients, 42 (32%) have been vaccinated; over 50% had been on biologic> 5 eyars, 10% < 1 year. No patients developed disseminated HZ or had a significant local reaction. Most common reasons not to vaccinate: 74 patients <50, 12 with disease activity issues, 5 with herpes zoster vaccine (manufacturer unknown) concerns and 5 with recent HZ. No patients in either group developed HZ within the six weeks post vaccination. Two patients vaccinated since 2012 in our infusion cohort have developed HZ at 16 and 20 months and none in the subq patients. Prior to 2012, only 7 and 8% of the cohorts had received herpes zoster vaccine (manufactuer unknown). Conclusion: herpes zoster vaccine (manufacturer unknown) vaccination in chronic RA, PSA or AS patients on current IV or subq biologic therapies appears safe using this protocol. No occurrence of disseminated HZ occurred. There was no increased incidence of HZ in the early post vaccination period. A copy of the published article is attached as further documentation of the patient's experience. This is one of several reports from the same literature (1502USA010440 and 1502USA005555). Additional information has been requested.