Immunogenicity and safety of two doses of a non-adjuvanted influenza A H1N1/2009 vaccine in young autoimmune rheumatic diseases patients.

OBJECTIVES: The aim of this study was to evaluate the immunogenicity and safety of the influenza A H1N1/2009 vaccine in children under 9 years old with autoimmune rheumatic diseases (ARD). METHODS: Thirty-eight ARD patients and 11 healthy children received two doses of non-adjuvanted influenza A/California/7/2009 (H1N1) virus-like vaccine. Subjects were evaluated before and 21 days after vaccination. Seroprotection (SP) and seroconversion (SC) rates, geometric mean titers (GMT) and factor increases (FI) in GMT were calculated. RESULTS: Mean ages were comparable between patients and controls. Pre-vaccination SP and GMT were similar in patients and controls (p > 0.05). Three weeks after immunization, SP (81.6% vs. 81.8%, p = 1.0), SC (81.6% vs. 90.9%, p = 0.66), GMT (151.5 vs. 282.1, p = 0.26) and the FI in GMT (16.7 vs. 36.3, p = 0.23) were similar in patients and controls, with both groups achieving an adequate response, according to the European Medicines Agency and Food and Drug Administration standards. Analysis of the possible factors influencing SC showed no difference in demographic data, leukocyte/lymphocyte counts or immunosuppressant use between seroconverted and non-seroconverted patients (p > 0.05). The vaccine demonstrated a satisfactory safety profile in this population. CONCLUSIONS: Two doses of influenza A H1N1/2009 vaccination induced an effective antibody response and caused adverse events in rare instances, suggesting this vaccine is appropriate and can be recommended for this age group.

Cross-cultural adaptation of the Behçet's Disease Current Activity Form (BDCAF) to Brazilian Portuguese language.

The Behçet's Disease Current Activity Form (BDCAF) is a clinical instrument used to assess the activity of Behçet's disease (BD), which was originally developed in English. The aim of the present study was to perform a cross-cultural adaptation of the BDCAF to Brazilian Portuguese language and to evaluate its reliability in a population of Brazilian patients with BD. Brazilian Portuguese version of the BDCAF, named BR-BDCAF, was obtained according to established guidelines. Forty Brazilian patients with BD diagnosed according to the International Study Group for Behçet's Disease criteria were assessed by two rheumatologists in independent sessions and submitted to the BR-BDCAF. Inter- and intraobserver agreement were then evaluated by kappa scores (values higher than 0.6 indicated good agreement). Good inter- and intraobserver agreements were achieved for the most common manifestations of BD: kappa scores higher than 0.6 were obtained for oral and genital ulcerations, skin lesions, and articular and general complaints. Moderate interobserver agreement was obtained for ocular activity (kappa 0.483) and fair interobserver agreement was obtained for gastrointestinal (kappa 0.322), major vessel (kappa 0.281), and central nervous system activity (kappa 0.304). BR-BDCAF was found to be a reliable instrument for the classic mucocutaneous and articular manifestations of BD and for general complaints, but complementary assessment is needed to evaluate specific visceral involvement for disease activity.

LTBI screening in rheumatoid arthritis patients prior to anti-TNF treatment in an endemic area.

SETTING: Recommendations for screening for latent tuberculous infection (LTBI) in patients eligible for anti-tumour necrosis factor (TNF) agents remain unclear in endemic regions. OBJECTIVE: To evaluate the long-term efficacy of LTBI screening and treatment in patients with rheumatoid arthritis (RA) receiving TNF blockers. DESIGN: A total of 202 RA patients were screened for LTBI before receiving anti-TNF treatment using the tuberculin skin test (TST), chest X-ray (CXR) and history of exposure to tuberculosis (TB). All subjects were regularly followed at 1- to 3-month intervals. RESULTS: Eighty-five patients (42%) were treated with a single anti-TNF agent, while 117 patients (58%) changed anti-TNF agents once or twice. LTBI screening was positive in 66 patients, 44 were TST-positive, 23 had a history of TB exposure and 14 had an abnormal CXR. Exposure alone accounted for LTBI diagnosis in 14 patients with a negative TST. LTBI patients were treated with isoniazid (300 mg/day) for 6 months, and none developed TB. During follow-up, TST was repeated in 51 patients. Conversion was observed in 5; 3 were diagnosed with LTBI and 2 with active TB respectively 14 and 36 months after receiving anti-TNF treatment, suggesting new TB exposure. CONCLUSION: LTBI screening and treatment before anti-TNF treatment is effective in endemic areas and reinforces the importance of establishing contact history for diagnosing LTBI in RA patients.