Long-Term Safety and Efficacy of Epratuzumab in the Treatment of Moderate-to- Severe Systemic Lupus Erythematosus: Results From an Open-Label Extension Study.

OBJECTIVE: The primary objective was to assess the long-term safety of repeated courses of epratuzumab therapy in patients with moderate-to-severe systemic lupus erythematosus. Secondary objectives were to assess long-term efficacy and health-related quality of life (HRQOL). METHODS: Eligible patients from the 12-week, phase IIb, randomized, placebo-controlled EMBLEM study enrolled into the open-label extension (OLE) study, SL0008. In the SL0008 study, patients received 1,200 mg epratuzumab infusions at weeks 0 and 2 of repeating 12-week cycles, plus standard of care. Safety measures included treatment-emergent adverse events (TEAEs) and serious TEAEs. Efficacy measures included combined treatment response, the British Isles Lupus Assessment Group score, the Systemic Lupus Erythematosus Disease Activity Index score, and the physician's and patient's global assessment of disease activity. Total daily corticosteroid dose and HRQOL (by the Short Form 36 health survey) were also assessed. RESULTS: A total of 113 of the 203 patients (55.7%) who entered the SL0008 study continued epratuzumab therapy until study closure (total cumulative exposure: 381.3 patient-years, median exposure: 845 days, and maximum exposure: 1,185 days/approximately 3.2 years). TEAEs were reported in 192 patients (94.6%); most common were infections and infestations (68.0%, 138 patients). Serious TEAEs were reported in 51 patients (25.1%), and 14 patients (6.9%) had serious infections. In patients treated for 108 weeks (n = 116), the median corticosteroid dose was reduced from 10.0 mg/day at OLE screening to 5.0 mg/day at week 108. Improvements in efficacy and HRQOL measures in EMBLEM were maintained in the OLE, while placebo patients exhibited similar improvements in disease activity upon a switch to epratuzumab. CONCLUSION: Open-label epratuzumab treatment was well tolerated for up to 3.2 years, and associated with sustained improvements in disease activity and HRQOL, while steroids were reduced.

Sexual behaviors and reproductive health outcomes: associations with wife abuse in India.

CONTEXT: Wife abuse has been associated with a variety of health concerns. Associations between abuse and reproductive health in India are not well known. OBJECTIVE: To examine relationships between men's reports of wife abuse and reproductive health issues in northern India. DESIGN: Structured face-to-face interviews were conducted as part of the male reproductive health supplement of the PERFORM System of Indicators Survey, a systematic multistage survey conducted in 1995-1996. SETTING: The northern state of Uttar Pradesh, one of the least developed states in India. PARTICIPANTS: A total of 6632 married men aged 15 to 65 years who lived with their wives and completed all survey questions for the study variables reported here. MAIN MEASURES: Physically and sexually abusive behaviors toward wives, sexual activities outside marriage, sexually transmitted disease (STD) symptoms, contraception use, unplanned pregnancies, and sociodemographic characteristics. RESULTS: Fifty-four percent of men reported not abusing their wives, while 17% reported physically but not sexually abusing their wives, 22% reported sexual abuse without physical force, and 7% reported sexual abuse with physical force. Abuse was more common among men who had extramarital sex (for sexual abuse using force: odds ratio [OR], 6.22; 95% confidence interval [CI], 3.98-9.72). Similarly, men who had STD symptoms were more likely to abuse their wives (with current symptoms: OR, 2.43; 95% CI, 1.73-3.42). Unplanned pregnancies were significantly more common among wives of abusive men, especially sexually abusive men who used force (OR, 2.62; 95% CI, 1.91-3.60). CONCLUSIONS: Wife abuse appears to be fairly common in northern India. Our findings that abusive men were more likely to engage in extramarital sex and have STD symptoms suggest that these men may be acquiring STDs from their extramarital relationships, thereby placing their wives at risk for STD acquisition, sometimes via sexual abuse. These abusive sexual behaviors also may result in an elevated rate of unplanned pregnancies.

Women in a prenatal care/substance abuse treatment program: links between domestic violence and mental health.

OBJECTIVES: This study examines the prevalence of violence experienced by patients enrolled in the Step by Step program, a combined prenatal care/substance abuse treatment program at the Wake County Health Department in North Carolina. In addition, potential associations between violence and sociodemographic characteristics, substance use, and mental health are investigated. METHOD: All prenatal care/substance abuse treatment patients who met study eligibility criteria (N = 84) were assessed by health care providers. Descriptive statistics and bivariate analyses were used to compare victims of violence and nonvictims on a wide range of variables. Multiple linear regression analysis estimated the impact of the women's experiences of violence on their levels of mental health symptoms while controlling for confounding factors. RESULTS: Forty-two percent of patients had been victims of both sexual and physical violence, and 30% had been victims of physical violence alone. The combination of sexual and physical violence was significantly less common among African-American women compared with other women. No other significant differences were found between victims and nonvictims in terms of sociodemographics or substance use. Compared with nonvictims, victims of the combination of sexual and physical violence had significantly elevated levels of general psychological distress as well as elevated levels of hostility, depression, anxiety, interpersonal sensitivity, and somatization. However, no significant differences in levels of mental health symptoms were observed among women who had experienced physical violence in the absence of sexual violence. CONCLUSIONS: Questions concerning experiences of violence, including sexual victimization, should be incorporated into the clinical history-taking procedures of professionals working within prenatal care/substance abuse treatment programs so that effective interventions that take experiences of violence into account can be put into place for these high-risk women.