Herpes zoster vaccine safe for use in rheumatoid arthritis patients on biologics

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."