Hepatitis B virus (HBV) vaccination has been implicated as a potential trigger for autoimmune diseases but there are no prospective studies in lupus. We therefore assessed prospectively the safety and efficacy of immunization with recombinant DNA HBV vaccine (Euvax B; LG Life Sciences) in systemic lupus erythematosus (SLE) patients. Twenty-eight consecutive inactive SLE patients [Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) <4], age between 18 and 50 years and negative serology for HBV, were selected. Exclusion criteria were prednisone >/=20 mg/day and immunosuppressive drugs. Clinical and laboratorial assessments were obtained at study entry and one month after the three doses. In addition, a previous one year evaluation was performed using a standard electronic protocol. The mean age was 34 +/- 7.7 years and disease duration was 10.4 +/- 6.7 years. An adequate seroconversion was achieved at the end of the study (93%), although a lower frequency after the first (4%) and second dose (54%) was observed. No significant change in mean SLEDAI score was detected after each dose throughout the study (0.14 +/- 0.52 versus 0 versus 0.61 +/- 1.66 versus 0.36 +/- 1.34, P = 0.11). Reinforcing these findings, the 11% flares during vaccination was similar to the 21% observed in the previous year (P = 0.46). Furthermore, the mean prednisone dose at study entry was comparable to the end of the study (2.86 +/- 3.06 versus 4.64 +/- 8.25 mg/day, P = 0.32). In addition, the frequency of immunosuppressive therapy during the vaccination period (11%) was alike to the 14% observed in the previous year before entry (P = 0.66). Hepatitis B vaccination was safe in inactive SLE patients with an adequate vaccine response rate.

The objective of this study was to assess child chloroquine ototoxicity after its use during the gestational period in systemic lupus erythematosus (SLE). Nineteen children over four years old were evaluated: nine were exposed to chloroquine diphosphate (CDP) during gestation and 10 were born from mothers that did not take this drug before conception or anytime during pregnancy (CONTROL). Pure tone audiometry was performed in all children and high and low frequency threshold means were compared to evaluate the hearing status. All nine mothers taking CDP were exposed to this drug at least during the first trimester of pregnancy (56% during the whole gestational period) and the mean time of CDP use was 6.1 +/- 2.9 months. No significant difference was found in children of CDP and CONTROL groups regarding age (7.6 +/- 4.4 versus 12.3 +/- 7.2 years; P = 0.10, respectively) and gender (P = 0.65). Pure tone high frequency thresholds, which are the first to be affected by ototoxic drugs, presented within normal limits in children exposed or not to CDP (8.5 +/- 5.0 versus 7.4 +/- 3.6 dBHL; P = 0.55, respectively). Likewise, the mean hearing thresholds at low frequencies were also similar in both groups (11.4 +/- 4.5 versus 11.9 +/- 3.0 dBHL; P = 0.66). In conclusion, child in utero exposure to chloroquine diphosphate does not seem to induce hearing impairment as measured by pure tone audiometry, reinforcing its safe use during pregnancy of lupus patients.

Systemic sclerosis (SSc) is a disorder characterized by skin thickness and vasculopathy. The objective of the study was to evaluate the therapeutic effect and safety of the association of pentoxyphylline and vitamin E in SSc patients. Twelve SSc patients (American College of Rheumatology criteria) enrolled this 24-week open-label study. Patients received daily 800 mg of pentoxyphylline and 800 UI of vitamin E and were evaluated at 4-week interval. The primary efficacy endpoint was the change in Modified Rodnan Skin Score (MRSS) at week 24. Nine diffuse SSc patients treated 6 months with cyclophosphamide were used as a historical control group. The mean age of the treated group was 43.6 years, and ten of 12 (84%) patients were women. Their mean MRSS reduced from 25.7 to 18.7 (p = 0.03) at 16th week and remained significantly reduced throughout the study. In contrast, only a trend of MRSS reduction was observed in the historical control group (p = 0.06). Two patients started the study with active ischemic ulcers and ended with a complete healing of them. No serious side effects were reported. Pentoxyphylline and vitamin E might be an alternative therapeutic approach in SSc patients.

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