Background/Purpose

Herpes Zoster (HZ) occurs in 1 in 3 people in the U.S. during their lifetime.  The greatest risk factor is age.  Immune suppression from illness or medications is also a strong risk factor.  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.  Zoster vaccine 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 HZ vaccine in patients on biologic therapies.  However, recent large data-base studies have not found an increase in zoster complications in patients inadvertently given the vaccine while on biologics.  These data encouraged our group to evaluate the safety of this vaccine in current biologic users.   

Methods

Since July 2012, all 160 patients with RA, PSA & AS receiving IV biologics in our infusion center have been prospectively assessed for HZ vaccine 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, vaccine 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 week of vaccine and restarted 1 week post vaccine.  Biologic restarted 2 weeks after vaccine. In 17 Rituxan patients vaccine was given 2-4 weeks pre Rituxan or >  than 6 months post Rituxan.  No other vaccines were given the week of the HZ vaccine.   

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 years, 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 HZ vaccine  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 HZ vaccine.  

Conclusion

HZ 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.   

---

« Back to 2014 ACR/ARHP Annual Meeting

ACR Meeting Abstracts - https://acrabstracts.org/abstract/safety-of-zoster-vaccination-administration-in-rheumatic-patients-on-current-biologic-therapy/