Herpes Vaccine Safe in Patients With Arthritis on Biologics

Alice Goodman

November 28, 2014

BOSTON — The herpes zoster vaccine can be safely used in patients with rheumatoid arthritis, psoriatic arthritis, and spondyloarthropathies who are being treated with biologic agents, according to the results of a new study.

This is particularly good news in light of a related study that showed that the rate of herpes zoster infection is almost twice as high in patients with autoimmune and inflammatory diseases as in the general population, and that the infection can be more severe and can occur at younger ages.

Both studies were presented here at the American College of Rheumatology (ACR) 2014 Annual Meeting.

"After childhood chicken pox, herpes zoster remains latent in the dorsal root of the spinal cord, waiting to pounce when people get older or have immunosuppressive conditions," said Jeffrey Curtis, MD, from the University of Alabama at Birmingham.

"It then manifests as a painful rash. About 15% of people develop serious postherpetic neuralgia at the rash site, and about one in six will need lifelong medication," Dr Curtis explained. In addition, "herpes zoster reactivation can be disseminated and threaten vision."

Dr Curtis and his team used data from the Multi-Payer Claims Database to assess the influence of herpes zoster in a non-Medicare younger population.

They identified a cohort of patients with autoimmune inflammatory diseases that consisted of 50,646 patients with rheumatoid arthritis, 8935 with systemic lupus erythematosus, 7916 with inflammatory bowel disease, 5893 with gout, 4299 with psoriasis, 2629 with psoriatic arthritis, and 1019 with ankylosing spondylitis. They also evaluated 224,631 patients with diabetes and 330,727 healthy control patients.

Herpes in Patients With Arthritis

The incidence of herpes zoster infection was higher in people of any age with rheumatoid arthritis, systemic lupus erythematosus, and inflammatory bowel disease than in healthy control patients who were 60 years of age.

"If you are 40 years old and have rheumatoid arthritis, your rate of herpes is much higher than a healthy 60-year-old. If you have systemic lupus erythematosus, your rate is significantly higher in your 20s, 30s, and 40s," Dr Curtis told reporters attending a news conference. "Lupus patients have an elevated risk of herpes zoster even at age 20."

These people could benefit from the herpes zoster vaccine, said Dr Curtis.

Results from the vaccine study were presented by Stephen Lindsey, MD, from the Ochsner Clinic in Baton Rouge, Louisiana.

Every rheumatoid arthritis patient should talk to their doctor about getting the vaccine.

Current recommendations from the ACR, the European League Against Rheumatism, and the Centers for Disease Control and Prevention suggest that the herpes zoster vaccine should not be given to patients receiving biologic therapy. However, a previous study demonstrated that the vaccine was safe and did not increase the risk for disseminated herpes infection in 633 patients taking biologic agents (JAMA. 2012;308:43-49).

"In my rheumatology practice, I frequently had rheumatoid arthritis patients on biologics with herpes zoster horrible pain and rash, so I decided to study the safety of this vaccine," said Dr Lindsey.

The study involved 110 patients receiving infusional biologics and 42 receiving subcutaneous biologics.

The patients were carefully selected and included those with rheumatoid arthritis, psoriatic arthritis, and spondyloarthritis who were stable on biologics.

Informed consent was obtained from all patients. At their next scheduled visit, the herpes zoster vaccine was administered instead of the biologic. On subsequent visits, the normal biologics schedule was resumed.

No cases of herpes zoster infection were reported 6 weeks after vaccination, and no cases of disseminated herpes zoster infection have occurred.

"Teamwork with the nurses was very important. Also, getting the buy-in from the team and from the patients was important," Dr Lindsey explained.

Since the study, more patients in his practice have been safely vaccinated with the herpes zoster vaccine. "You know it is safe within 6 weeks," Dr Lindsey said.

"Not one of the 176 patients who have been vaccinated developed local or disseminated herpes zoster infection," he reported. "I am continuing to vaccinate patients in my practice as part of this study."

"Every rheumatoid arthritis patient should talk to their doctor about getting the vaccine," Dr Lindsey said. "From what we showed, if you are careful and take precautions, it is safe in patients on biologics."

New National Institutes of Health Trial

On the basis of these two studies, the National Institutes of Health (NIH) has funded a pilot trial that will be followed by a large phase 3 controlled trial to determine the safety of the herpes zoster vaccine in patients with arthritis receiving biologic therapy. In the controlled trial, there will be no gaps in biologic therapy, Dr Curtis reported.

"These studies on herpes zoster infection add to the body of evidence that patients with autoimmune disease have an increased risk of infection," said news conference moderator Karen Costenbader, MD, from Brigham & Women's Hospital and Harvard Medical School in Boston.

"It is alarming that lupus patients are at increased risk so young. The next step is to study the safety of the vaccine in this larger trial."

"It is exciting to know that some patients have been vaccinated safely. We are looking forward to the stronger evidence from the NIH-sponsored trial. Maybe patients won't need to stop their biologics to get the vaccine," Dr Costenbader said.

Dr Curtis receives financial support from Roche, Genentech, UCB, Janssen, CORRONA, Pfizer, BMS, and Crescendo AbbVie. Dr Lindsey and Dr Costenbader have disclosed no relevant financial relationships.

American College of Rheumatology (ACR) 2014 Annual Meeting: Abstract 820, presented November 16, 2014; abstract 1836, presented November 17, 2014.


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