Hepatitis B Vaccine Ineffective in Most Patients With RA

Pam Harrison

July 02, 2015

ROME — A high proportion of patients with rheumatoid arthritis do not achieve protective antibody levels after vaccination with HBVAXPRO-10 (Sanofi Pasteur MSD), one of the vaccines used to prevent hepatitis B infection, new research suggests.

"People with rheumatoid arthritis have an increased risk of morbidity and mortality from infections, and to discover that immunization might not confer protection is a real concern," Misha Tilanus, a medical student at Radboud University Nijmegen Medical Centre in the Netherlands, told reporters.

"It's crucial that patients and healthcare practitioners are aware of this lack of efficacy and do all they can to minimize patients' risk of infection," she added.

The study was presented here at theEuropean League Against Rheumatism Congress 2015.

The HBVAXPRO-10 regimen — with vaccination at 0, 1, and 6 months — was completed by 47 patients with rheumatoid arthritis and 156 healthy control subjects.

Investigators assessed hepatitis B surface antibody titers 28 weeks after the last of the three doses was administered.

Patients whose titer levels were above 10 IU/L at 28 weeks were considered to be responders and were deemed to be protected against hepatitis B infection. Patients whose titer levels were below 10 IU/L were considered to be nonresponders and to be unprotected against hepatitis B infection.

We really did not expect such a high proportion of nonresponders.

Only 11% of the rheumatoid arthritis group — five of the 47 patients — achieved an adequate response to the vaccination at 28 weeks, Tilanus reported. In contrast, 83% of the control group — 129 of the 156 subjects — achieved a response that was protective against hepatitis B infection.

In the rheumatoid arthritis group, response to the vaccine was not affected by tumor necrosis factor inhibitors, disease-modifying antirheumatic drugs, or different combinations of antirheumatic drugs.

"In the literature, we did see that this vaccine would be a little bit less effective in rheumatoid arthritis patients, but we really did not expect such a high proportion of nonresponders," said Tilanus.

Paradox of Vaccination

The paradox of vaccination in immunocompromised patients is that they are most in need of protection against infection because of their immunocompromised status, but they are least likely to respond to vaccination because they can't mount an adequate immune response to many vaccines, said Sander van Assen, MD, PhD, from University Medical Center Groningen in the Netherlands.

However, "some vaccines are more immunogenic than others," Dr van Assen told Medscape Medical News. For example, the tetanus vaccine is highly immunogenic and even immunocompromised patients respond well to it, despite having suboptimal immune function.

In contrast, polysaccharide vaccines are not highly immunogenic and lead to much lower response rates, especially in rheumatoid arthritis patients on methotrexate, he added.

Live attenuated vaccines, although often effectively immunogenic in immunocompromised patients, are generally contraindicated in such patients, because even an attenuated microorganism is capable of producing infections and complications in the setting of a poorly functioning immune system.

Dr van Assen suggested that physicians try another hepatitis B vaccine, such as Engerix-B (GlaxoSmithKline), because previous studies have shown that immune responses in patients with rheumatoid arthritis are better with Engerix-B than with HBVAXPRO-10.

"In most immunocompromised patients, a booster dose won't do the trick," he pointed out.

"But we could increase the dose of the vaccine or use the combined hepatitis B and hepatitis A vaccine. The hepatitis A antigens in the vaccine lead to a better response to hepatitis B, so there may be an immune-stimulating effect in the combination vaccine that increases response to hepatitis B," Dr van Assen explained.

Ms Tilanus and Dr van Assen have disclosed no relevant financial relationships.

European League Against Rheumatism (EULAR) Congress 2015: Abstract OP0167. Presented June 12, 2015.


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