Shingles Vaccine Immunogenic in Rheumatoid Arthritis Patients Starting Tofacitinib

Patients with rheumatoid arthritis (RA) have a higher risk of developing shingles than adults without the disease, and disease-modifying antirheumatic drugs are thought to further increase the risk.

In a 2-part study published in Arthritis & Rheumatology, investigators found that a varicella-zoster vaccine elicited a robust immune response in patients when administered several weeks prior to the start of tofacitinib.

The first study enrolled 112 patients with active RA who first received the vaccination and were then randomized to receive either tofacitinib or placebo, 2 to 3 weeks after the vaccination.

The findings showed patients developed a robust immune response to the vaccine. Furthermore, the initiation of tofacitinib post vaccination did not have any negative impact on the immune response.

Patients treated with tofacitinib had similar or higher immune responses to the vaccine compared with patients in the placebo arm.

“We showed that the vaccine was adequately immunogenic in patients whether they were starting tofacitinib or placebo in a few weeks, and the immunogenicity and the response to the vaccine were similar to what we’ve seen outside the rheumatoid arthritis setting in general population studies,” said investigator Kevin Winthrop, MD, MPH.

The authors noted that only 1 patient experienced disseminated varicella infection after beginning treatment with tofacitinib; however, the patient was the sole participant who never had chicken pox.

The findings highlight the importance of only giving patients the vaccine if they have had chicken pox prior to the emergence of shingles.

For the second study, the investigators sought to examine whether concomitant use of conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) or corticosteroids contributed to the increased risk of shingles associated with tofacitinib.

The investigators analyzed 19 clinical trials comprised of 6192 patients with RA, and found that shingles rates were lowest among patients administered tofacitinib without csDMARDs or corticosteroids.

Shingles rates were highest among patients administered tofacitinib with csDMARDs and corticosteroids.

Similar efficacy has been observed with tofacitinib in phase 3 clinical trials, regardless if it was administered as a monotherapy or in combination with csDMARDs and/or corticosteroids, the authors noted.

“If you want to lower shingles risk for rheumatoid arthritis patients, there are 2 strategies: 1 is vaccinating them and the other is getting them off steroids and methotrexate if you can,” Dr Winthrop concluded.