Arthritis & Rheumatism, Volume 63,
November 2011 Abstract Supplement

Abstracts of the American College of
Rheumatology/Association of Rheumatology Health Professionals
Annual Scientific Meeting
Chicago, Illinois November 4-9, 2011.


Influenza A H1N1/2009 Vaccine in Juvenile Dermatomyositis: Reduced Response in Patients Under Immunosuppressive Agents.

Guissa1,  Vanessa R., Aikawa2,  Nadia E., Sallum1,  Adriana M., Campos3,  Lucia M.A., Pereira4,  Rosa M.R., Bonfa5,  Eloisa, Silva1,  Clovis A.

Faculdade de Medicina da Universidade de São Paulo, São Paulo-SP, Brazil
Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil
Faculdade de Medicina da Universidade de São Paulo (FMUSP), São Paulo, Brazil
Disciplina de Reumatologia da FMUSP, Sao Paulo, Brazil
University of Sao Paulo, São Paulo, Brazil

Background/Purpose:

We recently evaluated in adults the immunogenicity and safety of the 2009 non-adjuvanted influenza A/H1N1 vaccine in a large cohort of autoimmune rheumatic diseases, including those with dermatomyositis (Ann Rheum Dis 2011;70:1068–73). However, there are no data regarding immunogenicity and the safety of this immunization in juvenile dermatomyositis (JDM). We therefore, evaluated in these patients vaccine immunogenicity and adverse events, as well as, disease safety and the possible influence therapy in antibody response.

Methods:

30 JDM patients and 81 healthy controls were vaccinated with non-adjuvanted influenza A/California/7/2009 (H1N1) virus-like vaccine. All participants were evaluated pre- and 21 days post-vaccination and serology for anti-H1N1 was performed by hemagglutination inhibition (HI) assay. Seroprotection (percentage of subjects with HI antibody titer >= 1:40), seroconversion (percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post vaccination HI titer >= 1:40 or a pre-vaccination HI titer >= 1:10 and a minimum four-fold rise in post-vaccination HI antibody titer) rates, geometric mean titres (GMTs) and factor increase (FI) in GMT (ratio of the GMT after vaccination to the GMT before vaccination) were analyzed. Muscle enzymes levels and JDM scores [disease activity score (DAS), Manual Muscle Test (MMT-8) and Childhood Myositis Assessment Scale (CMAS)] were evaluated before and after vaccination. Adverse events were also reported.

Results:

JDM patients and healthy controls were comparable regarding median current age and female gender [15.5 (9–21) vs. 15 (9–21) years, p=0.511; 63 vs. 51%, p=0.286]. After immunization, seroconversion rates were significantly lower in JDM patients compared to controls (86.7 vs. 97.5%, p=0.045), whereas seroprotection (p=0.121), GMT (p=0.992) and FI in GMT (p=0.827) were similar in both groups. Clinical and laboratorial evaluations revealed that DAS [0 (0–11) vs. 0 (0–14), p=0.993)], CMAS [52 (45–52) vs. 52 (41–52), p=0.804], MMT [80 (74–80) vs. 80 (79–80), p=0.986], CPK [124 (49–533) vs. 102.5 (33–481), p=0.339], AST [20 (10–45) vs. 23 (11–36)UI/L, p=0.246], ALT [32.5 (12–72) vs. 31 (11–63)UI/L, p=0.826] and LDH [187 (93–469) vs. 179 (83–446)UI/L, p=0.907] remained stable throughout the study. Regarding therapy, seroconversion rates among JDM patients under current prednisone (p=0.005), methotrexate (MTX) (p=0.004), MTX and cyclosporine (p=0.005) and immunosuppressants other than MTX (p=0.039) were significantly lower compared to healthy controls. Local and systemic vaccine adverse events were uniformly mild and with similar frequency in patients and controls (p>0.05).

Conclusion:

This first study of non-adjuvanted influenza A/H1N1 2009 virus immunization in JDM patients revealed a reduced immunoresponse particularly associated with immunosuppressive agents. The observed overall vaccine and disease safety supports its recommendation and suggest that a booster may be appropriate to improve antibody response. (ClinicalTrials.gov, #NCT01151644)

To cite this abstract, please use the following information:
Guissa, Vanessa R., Aikawa, Nadia E., Sallum, Adriana M., Campos, Lucia M.A., Pereira, Rosa M.R., Bonfa, Eloisa, et al; Influenza A H1N1/2009 Vaccine in Juvenile Dermatomyositis: Reduced Response in Patients Under Immunosuppressive Agents. [abstract]. Arthritis Rheum 2011;63 Suppl 10 :2020
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