Arthritis & Rheumatism, Volume 62,
November 2010 Abstract Supplement

Abstracts of the American College of
Rheumatology/Association of Rheumatology Health Professionals
Annual Scientific Meeting
Atlanta, Georgia November 6-11, 2010.


The Influence of Immunosuppressive Therapy and Underlying Diseases on Vaccine Responses to Influenza A H1N1/09 Vaccines in Inflammatory Rheumatic Diseases.

Gabay,  Cem, Meier,  Sara, Gascon,  Danielle, Posfay-Barbe,  Karin, Combesure,  Christophe, Bel,  M., Kaiser,  Laurent

Background:

Influenza A H1N1 is a new virus that emerged in spring 2009 and rapidly spread around the world causing a pandemic. As patients with inflammatory rheumatic diseases (IRD) exhibit some form of immunodeficiency related to their diseases and the use of immunosuppressive drugs, the Swiss Society of Rheumatology recommended the vaccination of all IRD patients under immunosuppressive agents. However, two important questions remain unresolved: 1) are immunocompromised hosts able to raise successful vaccine responses, 2) is the use of adjuvanted vaccines safe in patients with autoimmune diseases.

Objectives:

To determine the efficacy and safety of influenza A H1N1/09 vaccine formulated in a lipid adjuvant (squalene) in patients with IRD.

Patients and Methods:

173 patients with IRD and 138 healthy controls were included from November 2009 to January 2010 in this prospective, open-labeled, single center, parallel-cohorts study. Among IRD patients, there were 82 cases of rheumatoid arthritis (RA), 45 cases of spondylarthropathies (SpA), and 46 cases of connective tissue diseases (18 systemic lupus erythematosus (SLE)) or vasculitis. All received a first vaccine dose and 154 (89%), the second prescheduled vaccine dose. Safety after vaccination was assessed, respectively, in 173 and 149 patients using medical history and clinical indices of disease activity (DAS28, RADAI, and HAQ for RA, BASDAI for axial SpA, SLEDAI for SLE, and BVAS for vasculitis). The kinetic of the vaccine response and antibody titers (using a standardized in-house hemagglutination inhibition assay) were assessed after the first and the second dose and compared to titers obtained in a control group of healthy individuals vaccinated once. Cellular immune responses to influenza H1N1/09 vaccine will be also determined in a subset of patients and controls.

Results:

Disease modifying antirheumatic drugs were used in 85% of RA, 63% of SpA, 94% of SLE patients; oral corticosteroids in 31% of RA, 11% of SpA, and 70 of SLE patients; anti-TNF in 43% of RA and 71% of SpA; and rituximab in 21% of RA and 11% of SLE patients. The different indices of disease activity were not significantly different at baseline and after vaccination. Despite immunosuppression, injection-site tolerability and systemic inflammatory reactions were similar in patients with IRD than in healthy controls. Seroprotection rates (defined by IHA titer >= 1/40) after dose 1 were 129/146 (88.4%) in controls and 103/138 (74.6%) in patients (P<0.001). This rate increased to 128/148 (86.5%) after 2 doses. The analysis of the pattern of vaccine immune responses in the different IRD patient groups is in progress and will be presented.

Conclusions:

The adjuvanted vaccine against influenza A H1N1/09 is well tolerated and does not induce short-term exacerbation in patients with IRD treated with immunosuppressive agents.

To cite this abstract, please use the following information:
Gabay, Cem, Meier, Sara, Gascon, Danielle, Posfay-Barbe, Karin, Combesure, Christophe, Bel, M., et al; The Influence of Immunosuppressive Therapy and Underlying Diseases on Vaccine Responses to Influenza A H1N1/09 Vaccines in Inflammatory Rheumatic Diseases. [abstract]. Arthritis Rheum 2010;62 Suppl 10 :792
DOI: 10.1002/art.28560

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