Inactivated flu vaccine is an option for patients with autoimmune inflammatory rheumatic diseases, but any vaccination for these patients should occur during periods of stable disease, according to new recommendations from the European League Against Rheumatism.

Patients with autoimmune inflammatory rheumatic diseases (AIIRDs) are at increased risk for infections, but vaccination can cause flares of the disease, wrote Dr. Sander van Assen of the University Medical Center Groningen (the Netherlands), and colleagues. To help rheumatologists make informed decisions about patient vaccinations, EULAR convened a task force that developed eight key questions and 13 evidence-based recommendations (Ann. Rheum. Dis. 2011;70:414-22).

"For the most part, such recommendations have been lacking and the field has been changing very quickly as new drugs are developed and roll into the marketplace," according to infectious disease specialist Dr. Kevin Winthrop of the Oregon Health and Science University in Portland. "New drugs and new vaccines make these recommendations a moving target, and it was extremely important for the expert group to sit down, review the latest data, and codify their thoughts. For the most part, there is a lack of data regarding the efficacy and utility of many of these vaccines in these patients, and it is often unclear how their immunosuppressive medications and underlying diseases affect vaccine responsiveness. With certain biologics, we know that some vaccines are diminished in their immunogenicity and it is important to clarify for physicians when these vaccines can and should be given," he said.

The following were the committee’s questions:

• Is the risk of infections for which vaccines are available increased in patients with AIIRD in general, and specifically in those with active disease and in those using immunomodulation agents?

• Do vaccines decrease the risk of infections in patients with AIIRD in general, and specifically in those with unstable disease and in those using immunomodulating agents?

• Do vaccines cause significant harm in patients with AIIRD in general, and specifically in those with unstable disease or in those using immunomodulating agents?

• Does the timing of vaccination in relation to disease activity and treatment with immunomodulating agents affect important harms of vaccination in patients with AIIRD?

• Does the timing of vaccination in relation to disease activity and treatment with immunomodulating agents affect the effectiveness of vaccination in patients with AIIRD?

• Does revaccination with any vaccines increase the effectiveness in patients with AIIRD?

• Does revaccination with any vaccine increase significant harms in patients with AIIRD?

• Is vaccination in patients with AIIRD cost effective?

The expert committee members represented 11 European countries. They reviewed studies from 1966 through October 2009, as well as abstracts presented at EULAR in 2008 and 2009 and at the American College of Rheumatology annual meeting in 2007 and 2008.

Their evidence-based recommendations for vaccination in patients with AIIRDs were the following:

• Assess vaccination status of an AIIRD patient at an initial work-up.

• Vaccinate patients during times of stable disease whenever possible.

• Avoid live, attenuated vaccines whenever possible in immunosuppressed patients.

• Vaccinate patients before starting B-cell–depleting biologic therapy if possible, but vaccines can be given during the use of disease-modifying antirheumatic drugs and tumor necrosis factor–alpha–blocking agents.

• Strongly consider inactivated flu vaccine for patients with AIIRD.

• Strongly consider PPV23 (23-valent pneumococcal polysaccharide vaccination) for AIIRD patients.

• Vaccinate AIIRD patients for tetanus toxoid in accordance with recommendations for the general population.

• Consider herpes zoster vaccination in AIIRD patients.

• Consider human papillomavirus vaccination for selected patients with AIIRD (young women with systemic lupus erythematosus up to age 25 years).

• Vaccinate hyposplenic or asplenic patients with AIIRD with vaccines for influenza, pneumococcal, Haemophilus influenzae type b, and meningococcal C.

• Vaccinate only at-risk AIIRD patients for hepatitis A and/or B.

• Vaccinate traveling AIIRD patients according to the general rules for travelers, but avoid live, attenuated vaccines whenever possible in immunosuppressed patients.

• Do not vaccinate AIIRD patients with the BCG vaccine for tuberculosis.

"The exact implementation of the current recommendations may need to take into account local differences in specific countries and settings," the researchers noted. They added that more research is needed to continue to assess the effects of vaccination in AIIRDs patients.

In an interview, Dr. Winthrop noted that the "EULAR statement includes a thoughtful discussion of needed research. Clearly, we need better information regarding the risk of vaccine-preventable diseases in this population, as well as the outcomes of such infections and how these outcomes are modulated by certain immunosuppressive therapies. Such research would help better clarify the potential benefits of vaccination. On the adverse event side, further research is certainly necessary to better understand the risk of such vaccines (particularly live vaccines) and how that risk is modulated by immunosuppressive therapies, most notably biologic therapies. Lastly, studies evaluating the safety and efficacy of new vaccines [such as zoster vaccine and the new conjugated pneumococcal vaccine PCV13] in the context of existing and new biologic therapies remains an important area of study."

The study was funded by the European League Against Rheumatism. The researchers had no financial conflicts to disclose. Dr. Winthrop said he had no disclosures.

EULAR Issues Vaccine Recommendations for Adults With AIIRD