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.
Safety and Efficacy of a Pandemic 2009 Influenza A (H1N1) Monovalent, Unadjuvanted Vaccine in Systemic Lupus Erythematosus Patients.
Mathian3, Alexis, Devilliers2, Herve, Krivine1, Anne, Costedoat-Chalumeau3, Nathalie, Haroche3, Julien, Thi Huong3, Du Boutin-Le, Wechsler3, Bertrand
to assess the safety and efficacy of pandemic 2009 influenza A (H1N1) vaccination in patients with Systemic Lupus Erythematosus (SLE), and to evaluate factors influencing the immune response.
A hundred and eleven SLE patients were vaccinated with a pandemic 2009 influenza A (H1N1), monovalent, inactivated, unadjuvanted, split-virus vaccine in December 2009-January 2010 and received a second dose of vaccination three weeks after. Sera were obtained before each injection and three weeks after the last injection. Adverse events and SLE activity were recorded at each visit. The haemagglutination inhibition test was used to measure antibody titers. The antibody response was evaluated in three ways: the proportion of subjects with antibody titers >= 1:40 (seroprotection), the proportion of subjects with either a prevaccination HI titer < 1:10 and a post-vaccination titer >= 40 or a prevaccination titer >= 10 and an increase in the titer by a factor of four or more (seroconversion) and the factor increase in the geometric mean antibody titers (GMTs) after vaccination (Geometric Mean Ratio (GMR)).
According to international guidelines used to evaluate influenza vaccines, immunogenicity criteria were met, but not for all criteria, at day 21: seroprotection rate was 66.7% (95% CI 57.975.4) (below the required level of 70%), seroconversion rates was 60.4% (95% CI 51.369.5) (above the required level of 40%) and GMR was 8.5 (95% CI 3.2 12.0) (above the required level of 2.5). The second vaccine administration did result in additional increased in humoral response. Indeed, immunogenicity criteria were fully met at day 42: seroprotection rate was 80.0% (95% CI 72.587.5) (p = 0.0002 versus day 21), seroconversion rate was 71.8% (95% CI 63.480.2) (p = 0.003 versus day 21) and GMR was 10.3 (95% CI 2.914.2) (p < 0.0001 versus day 21). None of SLE patients developed symptoms suggestive of influenza infection. Vaccine was well tolerated and did not increase disease activity. At day 21 and day 42, in the multivariate analysis, failure to obtain seroconversion was statistically associated with the use of an immunosuppressive treatment and lymphocytes count < 1000/mm3. Failure to obtain seroprotection was statistically associated with the same parameters and a total serum IgM level <1 g/l at day 21. As expected, GMR values were significantly lower in SLE patients treated with an immunosuppressive drug. Vaccine was fully effective after one injection in patients with lymphocyte > 1000/mm3 and not treated with immunosuppressive drugs.
pandemic 2009 influenza A (H1N1) unadjuvanted vaccination is safe and effective in SLE patients. Our study shows that SLE patients with normal lymphocyte count and not treated with immunosuppressive have a normal vaccine response.
To cite this abstract, please use the following information:
Mathian, Alexis, Devilliers, Herve, Krivine, Anne, Costedoat-Chalumeau, Nathalie, Haroche, Julien, Thi Huong, Du Boutin-Le, et al; Safety and Efficacy of a Pandemic 2009 Influenza A (H1N1) Monovalent, Unadjuvanted Vaccine in Systemic Lupus Erythematosus Patients. [abstract]. Arthritis Rheum 2010;62 Suppl 10 :478