“What we can see here is that disease activity in lupus patients may actually play a role in the ability of the body to respond adequately to vaccinations,” Dr. Melmed said.
Combination Therapy and Vaccines
A study at Dr. Melmed’s center found that, when they checked five of the 23 serotypes in the pneumococcal polysaccharide vaccine, those on combination therapy with methotrexate or azathioprine plus an antitumor necrosis factor (anti-TNF) agent had significantly blunted responses compared with those who were not.4
Studies have generally found that those on anti-TNF agents as monotherapy do not have an impaired response, while those on concomitant methotrexate tend to have blunted responses, he said. “It’s probably more the methotrexate or the azathioprine that’s influencing the vaccine response rather than anti-TNF drugs,” he said.
As tofacitinib is an oral drug, it opens the possibility of simply stopping the drug for a period of time when the vaccine is given. But one study—with the drug either continued or withheld for a week prior and a week after, with response measured 35 days later—found no significant differences in postvaccination responses between those groups.5 So, there may be no advantage to withholding the drug, Dr. Melmed said.
A recent study found that the human papillomavirus vaccine seems to bring no increased risk of developing rheumatoid arthritis, lupus, Guillain-Barre Syndrome, Hashimoto’s thyroiditis, and other autoimmune diseases.6 Because this non-live vaccine protects against cancer-causing serotypes of human papillomavirus, it is recommended in women and men up to the age of 26 regardless of immunosuppression status.
Hepatitis B Vaccine and Reactivation
A study out of Spain found that that there was a 39% reactivation of latent hepatitis B vaccine among recipients of anti-TNF therapy, including four with fulminant hepatic failure, in patients who were hepatitis B surface antigen-positive. But even among those in whom the infection seemingly cleared—those who were isolated hepatitis B virus (HBV) core antibody-positive—the reactivation rate was 5%—“a not insignificant” number, Dr. Melmed said.7 Therefore, these patients should be treated for HBV or followed very closely with HBV viral loads if initiating anti-TNF therapy.
Live vaccines are generally contraindicated for those on any kind of immunosuppressive therapies, including the live attenuated influenza virus, yellow fever, bacille Calmette-Guerin (given outside the U.S), measles/mumps, rubella, varicella, and herpes zoster vaccines, although U.S. Centers for Disease Control and Prevention (CDC) guidelines say the zoster vaccine can be administered to those on low-dose immunosuppression (not biologics)—prednisone less than 20 mg, 6MP less than 1.5 mg/kg, azathioprine less than 3 mg/kg, and methotrexate less than 0.4 mg/kg/week.