Rheumatoid arthritis is a chronic disease that causes pain, stiffness, swelling and limitation in the motion and function of multiple joints. Though joints are the principal body parts affected by RA, inflammation can develop in other organs as well. An estimated 1.3 million Americans have RA, and the disease typically affects women twice as often as men.
Herpes zoster occurs in one out of three U.S. adults during their lifetimes. A primary risk factor is age. People with RA are at as much as twofold increased risk of developing HZ due to their suppressed immune systems or taking medications like prednisone. Research has been mixed on the increased risk of HZ while taking methotrexate or anti-TNF biologic drugs.
While the HZ vaccine is approved by the U.S. Food and Drug Administration for use in patients over 50, HZ vaccination is not recommended for RA patients on biologic therapy. Rheumatologists at Ochsner Clinic and Ochsner Health Systems in Baton Rouge, La., studied the safety and efficacy of HZ vaccination on 176 RA patients on either infused or subcutaneous biologics.
“Every month, I see patients with RA who have had shingles. Despite having an effective vaccine since 2006, our CDC and ACR guidelines do not recommend using it in rheumatic patients on biologics,” said Stephen Lindsey, MD of Ochsner Health System and a lead author of the study. “Studies in 2011 and 2012 suggested no increase in zoster complications inadvertently receiving HZ vaccine. We decided to develop and test a protocol to safely vaccinate high-risk patients and help prevent zoster and its complications.”
The study protocol required that patients be 50 or older, give consent, and have moderate or lower disease activity which was stable. In July 2012, RA patients at the clinic were assessed for HZ vaccination. This study is ongoing. Patients are continually analyzed at each office visit to ensure that they still fulfill the study protocol criteria.
Since the study began, 162 patients with RA, psoriatic arthritis and spondyloarthropathies who are on infused biologics have been screened for HZ vaccination. Of these, 119 have 194 patients on subcutaneous biologics, 57 have been vaccinated for HZ. Overall, 81 percent of eligible patients on infused biologics and 50 percent of patients on subcutaneous biologics have been vaccinated to date in the study. Patients in both groups who were not vaccinated included those who were under 50 years of age, those with RA disease activity issues, those with recent HZ infection or with other HZ vaccine concerns. No patients in either group developed HZ in the six weeks after vaccination. Three patients vaccinated since 2012 in the infusion group and one in the subcutaneous group have developed HZ at 10 to 20 months. None have had complications.
The study’s authors concluded that following this protocol, HZ vaccination is safe for patients with RA, psoriatic arthritis and ankylosing spondylitis who are currently taking biologics.
“Using this protocol, there have been no occurrences of herpes zoster post-vaccination,” said Dr. Lindsey. “I feel we can begin to safely vaccinate the thousands of patients who have been on biologics for years and are presently unvaccinated and at high risk.”
This study was self-funded by Ochsner Health System as part of a quality improvement project.
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The American College of Rheumatology is an international professional medical society that represents more than 9,500 rheumatologists and rheumatology health professionals around the world. Its mission is to Advance Rheumatology! The ACR/ARHP Annual Meeting is the premier meeting in rheumatology. For more information about the meeting, visit http://www.acrannualmeeting.org/ or join the conversation on Twitter by using the official #ACR14 hashtag. Paper Number: 1836
Safety of Zoster Vaccination Administration in Rheumatic Patients on Current Biologic Therapy
Stephen Lindsey, Brandi Oufnac and Holly Walker, Ochsner Clinic Baton Rouge, Baton Rouge, LA, Ochsner Health Systems, Baton Rouge, LA
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.
Disclosure: S. Lindsey, None; B. Oufnac, None; H. Walker, None.
Meeting Link: American College of Rheumatology Annual Meeting
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