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 Novel Pandemic Influenza A (H1N1) 2009 Vaccine: Low Rate of Seroconversion after Vaccination in Systemic Lupus Erythematosus.
Borba4, Eduardo F., Saad5, Carla G. S., Calich5, Ana Luisa G., Pasoto5, Sandra G., Viana5, Vilma S. T., Timenetsky2, Maria do Carmo S. T., Precioso3, Alexander R.
Faculdade de Medicina da Universidade de São Paulo, Sao Paulo, Brazil
Instituto Adolpho Lutz, Brazil
Instituto Butantan, Brazil
Rheumatology Division, Faculdade de Medicina da Universidade de São Paulo, Sao Paulo, Brazil
Rheumatology Division, Faculdade de Medicina da Universidade de São Paulo, Brazil
To evaluate efficacy and safety of a single vaccination with a novel split virion, inactivated, non-adjuvanted pandemic H1N1 influenza vaccine (A/California/7/2009/Instituto Butantan/Sanofi Pasteur S.A.) in systemic lupus erythematosus (SLE) patients.
173 SLE patients (ACR criteria) of a single tertiary center and 159 healthy age-matched subjects were immunized with H1N1 influenza vaccine. Exclusion criteria were: fever, egg allergy, and autoimmune neurological diseases. At entry SLE patients and controls received a single dose of influenza vaccine containing A/California/7/2009 H1N1 strain. Patients and controls were evaluated at baseline (immunization day) and 21 days post-vaccination. Disease safety was monitored by SLEDAI. Antibody titers were evaluated by hemagglutination inhibition (HAI) assay. Seroconversion to vaccination was defined by either an antibody titer of 1:10 or less before and of at least 1:40 after or at least 1:10 before and at least four-fold increase in antibody titer 21 days after single vaccination. Vaccine adverse effects were also analyzed.
Before vaccination, 8 (4.6%) patients and 20 (11.1%) controls (p=0.01) had a HAI titer of >=1:40 and 21 days after vaccination 115 (66.4%) patients and 136 (85.5%) controls (p=0.0001) had a HAI titer of >=1:40. Seroconversion rate for H1N1 was significantly lower in SLE patients compared to controls [108 (62.4%) vs. 123 (77.35%), p=0.0041]. Vaccine-related side-effects were only mild and transient with a similar frequency in both groups (p>0.05).The comparison of the 108 seroconverters patients with 65 nonresponders revealed a similar mean age, female predominance, mean disease duration, mean number of SLE criteria and mean SLEDAI score (p>0.05). In contrast, nonresponders were more often under mycophenolate mofetil than seroconverters (27.7 vs. 12.9%, p=0.02) with a tendency of higher frequency of immunomodulators (78.5 vs. 64.8%, p=0.062) and prednisone (64.6 vs. 50%, p=0.082) therapies. Regarding lupus safety at the time of immunization the mean SLEDAI was 3.5 ± 4.2 (024) and only 12 patients had an increased in SLEDAI scores (6.9%) whereas 133 remained stable (76.8%) and 28 had decreased (16.2%). Forty patients (23.1%) had SLEDAI >= 6 at baseline and none, except one, had an increase in SLEDAI.
The pandemic vaccine is safe in SLE patients regardless of disease activity but seroconversion is lower than in healthy subjects, particularly in patients under MMF therapy. Further studies are necessary to determine if a second dose will increase the seroconversion rate. ClinicalTrials.gov Identifier: NCT01151644
To cite this abstract, please use the following information:
Borba, Eduardo F., Saad, Carla G. S., Calich, Ana Luisa G., Pasoto, Sandra G., Viana, Vilma S. T., Timenetsky, Maria do Carmo S. T., et al; The Novel Pandemic Influenza A (H1N1) 2009 Vaccine: Low Rate of Seroconversion after Vaccination in Systemic Lupus Erythematosus. [abstract]. Arthritis Rheum 2010;62 Suppl 10 :481