Objective The Systemic Lupus Collaborating Clinics (SLICC) revised and validated the American College of Rheumatology (ACR) SLE classification criteria in order to improve clinical relevance, meet stringent methodology requirements and incorporate new knowledge in SLE immunology. Methods The classification criteria were derived from a set of 702 expert-rated patient scenarios. Recursive partitioning was used to derive an initial rule that was simplified and refined based on SLICC physician consensus. SLICC validated the classification criteria in a new validation sample of 690 SLE patients and controls. Results Seventeen criteria were identified. The SLICC criteria for SLE classification requires: 1) Fulfillment of at least four criteria, with at least one clinical criterion AND one immunologic criterion OR 2) Lupus nephritis as the sole clinical criterion in the presence of ANA or anti-dsDNA antibodies. In the derivation set, the SLICC classification criteria resulted in fewer misclassifications than the current ACR classification criteria (49 versus 70, p=0.0082), had greater sensitivity (94% versus 86%, p<0.0001) and equal specificity (92% versus 93%, p=0.39). In the validation set, the SLICC Classification criteria resulted in fewer misclassifications (62 versus 74, p=0.24), had greater sensitivity (97% versus 83%, p<0.0001) but less specificity (84% versus 96%, p<0.0001). Conclusions The new SLICC classification criteria performed well on a large set of patient scenarios rated by experts. They require that at least one clinical criterion and one immunologic criterion be present for a classification of SLE. Biopsy confirmed nephritis compatible with lupus (in the presence of SLE autoantibodies) is sufficient for classification.

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Objective. Hydroxychloroquine (HCQ) is often needed to manage disease activity in systemic lupus erythematosus (SLE) during pregnancy. The purpose of this study was to examine lupus activity and pregnancy outcomes in women with SLE treated or not treated with HCQ during pregnancy.Methods. This was a prospective study of pregnancies in women with SLE who were evaluated between 1987 and 2002. The pregnancies were divided into 3 groups: no HCQ exposure during pregnancy (163 pregnancies), continuous use of HCQ during pregnancy (56 pregnancies), or cessation of HCQ treatment either in the 3 months prior to or during the first trimester of pregnancy (38 pregnancies). The pregnancy outcomes, fetal outcomes, and lupus activity during pregnancy were compared among these groups.Results. The rates of miscarriage, stillbirth, pregnancy loss, and congenital abnormality were not statistically different among the 3 groups. The degree of lupus activity during pregnancy, however, was significantly higher in women who stopped taking HCQ. These women had a higher degree of lupus activity, as measured by the physician's estimate of lupus activity and the SLE Disease Activity Index, as well as an increased rate of flare, during pregnancy. More serious lupus complications, such as proteinuria and thrombocytopenia, were not significantly higher in women who stopped taking HCQ. Women who continued taking HCQ were maintained on a lower average dose of prednisone during pregnancy.Conclusion. We recommend the continuation of HCQ treatment during pregnancy. Our findings are consistent with prior reports of the absence of fetal toxicity. Similar to studies of nonpregnant women, the cessation of HCQ treatment during pregnancy increases the degree of lupus activity.Many women with systemic lupus erythematosus (SLE) take hydroxychloroquine (HCQ) to control disease activity. Studies have shown that HCQ can prevent renal and central nervous system lupus and lessen the effects of SLE (1,2). It has also been demonstrated that cessation of HCQ treatment places a woman at more than twice the risk of a lupus flare in the subsequent 6 months (3,4). Women with SLE maintain fertility, and most can have a successful pregnancy (5-7). Experts in the care of SLE during pregnancy generally recommend continuing HCQ treatment during pregnancy (8). At the Fourth International Conference on Sex Hormones, Pregnancy, and the Rheumatic Diseases in 2004, the working group on medications during pregnancy recommended continuing HCQ treatment (9). The data to support this recommendation are limited to reports of Ͻ300 pregnancies, however. A significant minority of rheumatologists, particularly those who see few lupus pregnancies per year, do not routinely continue HCQ treatment during pregnancy (8).Early reports of in utero chloroquine toxicity have led to some trepidation about the use of HCQ during pregnancy (10,11). However, more recent systematic studies of HCQ use during pregnancy have suggested its safety (12-16). There have been no reported cases of fetal malfor...

Objective. Systemic lupus erythematosus is associated with multiple adverse pregnancy outcomes. We examined the impact of disease activity on spontaneous abortions, perinatal mortality, preterm delivery, and birth weight.Methods. The study was designed to assess all pregnancies in a cohort of lupus patients who were observed prospectively from 1987 to 2002. At each visit, the physician's estimate of lupus activity was determined on a visual analog scale (high-activity lupus defined as a score of >2). Disease activity in each trimester was compared. We assessed the impact of high-activity lupus during pregnancy on gestational age, live birth rate, and small for gestational age babies. Potential confounders, including demographics of the women as well as maternal history of lupus, renal lupus, and antiphosphoplipid antibody syndrome, were analyzed through multivariate analysis.Results. Two hundred sixty-seven pregnancies were observed. Of these, 229 (85.8%) resulted in a live birth. High-activity lupus occurred in 57 pregnancies (21%). Fewer pregnancies among women with highactivity lupus ended with live births (77% versus 88% of those with low-activity lupus; P ‫؍‬ 0.063). Full-term delivery was achieved in 15 pregnancies (26%) among women with high-activity lupus, compared with 127 pregnancies (61%) achieving full-term in those with no or mild lupus activity (P < 0.001). High-activity lupus in the first and second trimesters led to a 3-fold increase in pregnancy loss (miscarriages and perinatal mortality).Conclusion. High-activity lupus during pregnancy leads to increased premature birth and a decrease in live births, with almost one-quarter of these pregnancies resulting in fetal loss. Pregnancies in lupus patients must be closely watched and treated during all trimesters to improve pregnancy outcomes.Systemic lupus erythematosus (SLE) is a disease that affects primarily women of reproductive age. The peak incidence of SLE occurs between the ages of 15 and 40 years, with an estimated female-to-male SLE incidence of 9:1. Previous studies have demonstrated that women with SLE maintain fertility, leading to the potential for a large number of pregnancies in this population (1). Pregnancies in women with lupus, however, have poorer obstetric outcomes than pregnancies in healthy women. These pregnancies have higher rates of preterm delivery and fetal loss, and the mothers and newborns have longer hospital stays than that experienced by women without lupus (2-4).The impact of increased lupus activity on pregnancy outcomes is a subject of debate in the literature. Some reports indicate that lupus activity, particularly lupus nephritis, increases the risk of fetal loss (3,(5)(6)(7). Other studies show no statistically significant difference between pregnancies in women with active lupus and those in women with inactive lupus (8-10). The first 74 pregnancies in the Hopkins Lupus Cohort were previously analyzed in a report published in 1992 (11). This analysis found that the occurrence of a lupus flare during pregnancy d...

Youth psychotropic treatment utilization during the 1990s nearly reached adult utilization rates. Youth findings can be used to accurately assess the duration of treatment and unforeseen practice pattern changes, and to identify safety concerns.

Objective. To evaluate the association between corticosteroid use and organ damage in patients with systemic lupus erythematosus (SLE).Methods. The occurrence and date of organ damage, as measured by the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index, were determined for 539 patients enrolled in the Hopkins Lupus Cohort Study. The risk of damage associated with the cumulative prednisone dose, high-dose prednisone (>60 mg/day for >2 months), and pulse methylprednisolone (1,000 mg intravenously for 1-3 days) was estimated using Cox proportional hazards regression analyses, controlling for age, race, and sex. Risk estimates for the cumulative prednisone dose were based on a reference dose of 36.5 gm (e.g., 10 mg of prednisone daily for 10 years [or equivalent]).Results. The cumulative prednisone dose was significantly associated with the development of osteoporotic fractures (relative risk [RR] 2.5, 95% confidence interval [95% CI] 1.7, 3.7), symptomatic coronary artery disease (RR 1.7, 95% CI 1.1, 2.5), and cataracts (RR 1.9, 95% CI 1.4, 2.5). Each intravenous pulse was associated with a small increase in the risk of osteoporotic fractures (RR 1.3, 95% CI 1.0, 1.8); however, this result failed to reach statistical significance (P ‫؍‬ 0.07). Each 2-month exposure to high-dose prednisone was associated with a 1.2-fold increase in the risk of both avascular necrosis (95% CI 1.1, 1.4) and stroke (95% CI 1.0, 1.5).Conclusion. SLE patients receiving long-term prednisone therapy were at significant risk of morbidity due to permanent organ damage. Additional research is required to determine the relative contributions of SLE disease activity and corticosteroids to the pathogenesis of specific types of organ damage. Furthermore, new steroid-sparing therapies are needed in order to treat disease activity and minimize cumulative and high-dose prednisone exposure.

The purpose of this study was to identify risk factors for hepatitis C virus (HCV) infection in a rural village in the Nile Delta with a high prevalence of antibodies to HCV (anti-HCV). One half of the village households were systematically selected, tested for anti-HCV, and interviewed: 973 of 3,999 (24.3%) subjects were anti-HCV-positive (reflecting prior HCV infection but not necessarily current liver disease), with nearly equal prevalence among males and females. Anti-HCV prevalence increased sharply with age among both males and females, from 9.3% in those 20 years of age and younger to >50% in those older than 35, suggesting a cohort effect with reduced transmission in recent years. Multivariate regression was used to estimate independent effects of risk factors on seropositivity. Among those over 20 years of age, the following risk factors were significantly associated with seropositivity: age (P < . Previous studies of hepatitis C viral (HCV) infection in Egypt have shown a high prevalence of antibody to HCV (anti-HCV) among blood donors 1-4 and residents of rural areas endemic for schistosomiasis. 5 Anti-HCV was found in 12.1% of primary schoolchildren, 18.1% of residents of rural villages, and 22.1% of army recruits, 6 as well as in 31% of Egyptians applying to work abroad. 7,8 It is widely believed that parenteral exposure to the virus is the most important route for acquiring infection in Egypt. 7,9 We have recently reported data that suggest the very high prevalence of HCV infection in the adult population of rural areas of Egypt, particularly in men living in villages where schistosomiasis is endemic, is at least partially the result of extensive mass-control campaigns using parenteral tartar emetic conducted from the 1950s up until 1982. 10 Although the prevalence of infection among those too young to be exposed to these mass antischistosomiasis injection campaigns is lower than among the older population, infection in this younger cohort indicates that other modes of transmission have perpetuated the infection in the community. Uncertainty remains regarding the relative importance of various types of parenteral exposures and widely practiced community activities, e.g., circumcisions, goza smoking in a group, or being shaved at a community barber.To resolve this uncertainty, we conducted a large serologic survey in a rural Egyptian community. The purpose of this article is to report the observed associations of HCV infection with both the acknowledged parenteral exposures (e.g., blood transfusions, injections, invasive hospital procedures, dental treatment) and widely practiced community activities that are usually not considered to be determinants of HCV transmission. PATIENTS AND METHODSStudy Population. In 1997, one half of the households of a village in the Nile Delta, Aghour El Soughra, were systematically selected and interviewed with a structured questionnaire to identify potential exposures that might be related to HCV acquisition. Adults and children older than 10 years of age were interv...

There was no increase in the risk of vaccine-associated Guillain-Barré syndrome from 1992-1993 to 1993-1994. For the two seasons combined, the adjusted relative risk of 1.7 suggests slightly more than one additional case of Guillain-Barré syndrome per million persons vaccinated against influenza.