RESUMO
This report describes the results of a clinic-based study conducted to verify a community-reported excess prevalence of systemic lupus erythematosus (SLE) and a possible connection between ethnicity and environmental factors in the reporting of SLE in the United States-Mexico border town of Nogales, Arizona. A community group in Nogales reported 37 cases of SLE in its community, suggesting a prevalence rate of 200 per 100,000. This report describes 19 definite and 7 probable cases of SLE using the 1982 American College of Rheumatology criteria. All definite and probable cases were self-identified, Mexican-American females. This yields a prevalence rate of 94 per 100,000, among the highest reported to date. The majority of cases resided within 3 miles of the United States-Mexico border and within 1 mile of the polluted Nogales Wash or ground wells with documented toxins. It remains to be determined whether this confirms that SLE is more common in Mexican-Americans or whether environmental factors, especially pollutants, are predominantly responsible. In addition to the need to be aware about the apparent increased risk of SLE in many Latin-Americans, clinicians should ask about possible environmental factors.
RESUMO
Considerations in designing clinical trials of novel molecules are not different from those that should be considered in every rheumatoid arthritis clinical trial. This article raises some critical issues that clinicians have to face in the planning and design of clinical trials for new molecules in rheumatoid arthritis. The most frequent problems are related to outcome measures (core set of endpoints, improvement and remission), patient populations, characteristics of the study design, and economic evaluation. Although some of these issues have been resolved by consensus, further research needs to be carried out to support the use of different measurement techniques. Because clinical trials remain the most powerful investigative instrument for deciding about the benefits of new advances in medical therapy, their design should be based on an appropriate methodology.