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Title: Influenza Vaccination in Patients With Quiescent Wegener's Granulomatosis: Presented at EULAR

"Influenza Vaccination in Patients With Quiescent Wegener's Granulomatosis: Presented at EULAR"

By Chris Berrie BARCELONA, SPAIN -- June 18, 2007 -- Influenza vaccination is safe and provides an adequate humoral response in patients with Wegener's granulomatosis (WG) with quiescent disease, according to a randomized, prospective study presented here at the Annual European Congress of Rheumatology (EULAR). Wegener's granulomatosis is autoimmune-mediated systemic vasculitis that affects several organs, mostly the lungs, the upper respiratory tract, and the kidneys. It normally occurs at a later age, and it often leads to patients being treated with immunosuppressant medication. Principal investigator Bert Holvast, MD, PhD student, University Medical Center, Groningen, The Netherlands, discussed the study's findings in a presentation on June 15th. He is a PhD student under the supervision of Marc Bijl, MD, PhD, doctor of internal medicine, department of rheumatology, University Medical Center. Although patients with WG appear to represent a relevant group for routine influenza vaccination, there have been concerns that these vaccines might exacerbate the disease activity in patients with such autoimmune diseases. Indeed, there have been reports of patients with WG showing relapse following infections. Therefore, Dr. Holvast and colleagues conducted their study to assess the safety, humoral response, and immunogenicity of influenza vaccination in patients with quiescent WG. The study included 72 patients with quiescent WG, defined by a Birmingham Vasculitis Activity Score (BVAS) of <2. Of these, 23 were randomized to no vaccine WG and 48 received trivalent subunit influenza vaccine. Further, a group of 65 healthy controls was also vaccinated. Mean ages in these three groups were 62, 57, and 43 years, respectively (male, 61%, 47%, 32%, respectively). Patients were evaluated with BVAS and patient visual analogue scores (VAS) at 1 month and again at 3 to 4 months. Titers against influenza were measured using the hemagglutination inhibition test on serum samples. The baseline clinical characteristics across the nonvaccinated and vaccinated WG patient groups showed no significant differences with consideration of influenza vaccination in previous season, use of immunosuppressant, use of azathioprine, and other immunosuppressant use. At 1 month postvaccination, there were no significant differences in the occurrence of active disease between these two groups at 1 month ([P =.540), with a reverse tendency at the second assessment (P =.099).

For the patient VAS assessment, there were no significant changes within the groups or differences between groups in either of the assessments.

Before vaccination, the mean titers for influenza A/H1N1 and influenza B showed no significant differences between the (to-be) vaccinated WG group and healthy controls, while for influenza A/H3N2, the WG group showed a significantly higher titer (P =.033).

At both assessments following vaccination, both groups showed equivalent mean levels of influenza A/H3N2 and B titers.

For influenza A/H1N1, while both groups saw increases in the mean titers, those of the WG group were significantly lower than those for healthy controls (P =.007 at 1 month; P =.003 at 3-4 months).

Despite these significant differences, when examined according to the percentage of patients within each group that attained protective titers against each vaccine strain, the only significant difference between the patients with WG and healthy controls was the significantly better protection against influenza B in patients with WG (P =.034).

Therefore, Dr. Holvast said, "At least in quiescent disease, influenza vaccination is safe, it does not elicit increased disease activity, and it is also effective, and our conclusion is that it would be reasonable to routinely vaccinate this type of patient."

This study was sponsored by Solve Pharmaceuticals (vaccine supply only).

[Presentation title: Influenza Vaccination in Wegener's Granulomatosis Patients With Quiescent Disease. Abstract FRI0327]

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