CHICAGO—Patients with moderate to severe psoriasis who were administered the medication efalizumab experienced significant improvements, with a reduction in the frequency and severity of symptoms, according to an article in the December 17 issue of The Journal of the American Medical Association (JAMA).

According to background information in the article, psoriasis, a disease affecting millions of persons worldwide, is a chronic inflammatory disease that has a profound adverse effect on patients' physical, social, and mental well-being. The physical symptoms of psoriasis adversely affect daily functioning, with the most frequently reported symptoms including scaling, itching, and burning. With inadequate control of these symptoms, physical, social, and mental functioning and overall health-related quality of life (HRQL) are compromised. For example, the physical appearance of lesions can cause patients to experience stress and embarrassment and have adverse effects on emotional aspects and normal functioning.

Limitations of currently available psoriasis therapies highlight the need for effective and safe treatment options. Traditional systemic therapies are associated with cumulative toxic effects, potentially increasing the risk of end-organ damage or malignancy.

Kenneth B. Gordon, M.D., of Loyola University Medical Center, Maywood, Ill., and colleagues studied the effect of efalizumab on dermatology-related HRQL in patients with moderate to severe plaque psoriasis (the most common type of psoriasis), using a broad set of outcome measures including physicians' assessments and patients' perceptions.

This phase 3 randomized, double-blind, placebo-controlled trial involved 556 adult patients with stable, moderate to severe plaque psoriasis and was conducted at 30 study centers in the United States and Canada between January and July 2002. Patients were randomly assigned to receive 12 weekly doses of subcutaneous (by injection) efalizumab, 1 mg/kg (n = 369), or placebo equivalent (n = 187).

Patients were considered to have improvement with at least 75 percent improvement on the Psoriasis Area and Severity Index (PASI-75); improvement on the overall Dermatology Life Quality Index (DLQI), Itching Visual Analog Scale (VAS), and Psoriasis Symptom Assessment (PSA) at week 12 vs. baseline.

The researchers found that efalizumab-treated patients experienced significantly greater improvement on all end points than placebo-treated patients. "Twenty-seven percent of efalizumab-treated patients achieved PASI-75 vs. 4 percent of the placebo group. Efalizumab-treated patients exhibited significantly greater mean percentage improvement than placebo-treated patients on the overall DLQI (47 percent vs. 14 percent), Itching VAS (38 percent vs. ?- 0.2 percent), and PSA frequency and severity subscales (48 percent vs. 18 percent and 47 percent vs. 17 percent, respectively) at the first assessment point," the researchers write. They add that efalizumab was safe and well tolerated, with primarily mild to moderate adverse events.

"Efalizumab treatment reduced the frequency and severity of psoriasis symptoms, particularly in the severity of itching and scaling, the 2 most frequently reported subjective symptoms. The severity and frequency of other symptoms, including bleeding and burning or stinging, also were improved by efalizumab treatment," the authors write. "Efalizumab-treated patients reported greater improvement in their attitudes about their disease, their ability to participate in daily activities (including leisure and work), and their personal relationships, and they reported fewer treatment-related problems compared with placebo."

CHICAGO—A practice-based intervention enhanced the quality of care for families of young children and improved selected parenting practices, according to an article in the December 17 issue of The Journal of the American Medical Association (JAMA).

There is growing evidence of deficiencies in the quality of health care for children, including low rates of preventive services, persistent disparities in health status, and lack of a usual source of care among ethnic and racial minorities and children in low-income families, according to background information in the article.

The Healthy Steps for Young Children Program was designed to meet the needs of families regarding their young children's early development and behavior by enhancing relationships between parents and their children, between families and the pediatric practice, and among practice members.

Cynthia S. Minkovitz, M.D., M.P.P., of the Johns Hopkins Bloomberg School of Public Health, Baltimore, and colleagues conducted a study to determine whether the Healthy Steps program increased quality of care related to developmental and behavioral services and affected parenting practices regarding discipline, perceptions of their children's behavior, and promotion of development when children were ages 30 to 33 months.

The controlled clinical trial was conducted between September 1996 and November 1998 at 6 randomization and 9 quasi-experimental sites across the United States. The study included 5,565 children enrolled at birth and followed up through age 3 years. The Healthy Steps program included incorporation of developmental specialists and enhanced developmental services into pediatric care.

Intervention families received the Healthy Steps program components, including contact with the Healthy Steps specialist, who were nurses, nurse practitioners, early childhood educators, and social workers with training and experience in child development. The specialist's main focus was on developmental, behavioral, and psychosocial aspects of care. Healthy Steps provided 7 services to intervention families: enhanced well-child care (through visits with the physician and Healthy Steps specialist); 6 home visits in the first 3 years; Healthy Steps specialist-staffed child developmental telephone line to address parents' developmental concerns; developmental assessments; written materials emphasizing prevention and health promotion; parent groups offering support and learning opportunities; and linkages to community resources through targeted referrals.

Of the 5,565 enrolled families, 3,737 (67.2 percent) responded to an interview at 30 to 33 months. Families who participated in the Healthy Steps Program had a greater odds of receiving 4 or more Healthy Steps-related services; of discussing more than 6 anticipatory guidance topics; of being highly satisfied with care provided (e.g., someone in the practice went out of the way for them); of receiving timely well-child visits and vaccinations (e.g., age-appropriate 1-month visit) and of remaining at the practice for 20 months or longer. They also had a reduced odds of using severe discipline (e.g., slapping in face or spanking with object). Among mothers considered at risk for depression, those who participated in the Healthy Steps Program had greater odds of discussing their sadness with someone at the practice.

CHICAGO—Poor fitness in young adults is associated with the development of cardiovascular disease risk factors later in life, according to a study in the December 17 issue of The Journal of the American Medical Association (JAMA).

Cardiovascular diseases (CVDs) account for a large proportion of deaths in people over the age of 45 years, according to background information from the authors. "Numerous risk factors for CVD, including hypertension, diabetes, and hypercholesterolemia (high cholesterol), are suspected to be influenced by fitness, and these factors may mediate the association between low fitness and mortality [death]," the authors write.

Mercedes R. Carnethon, Ph.D., from Northwestern University's Feinberg School of Medicine, Chicago, and colleagues investigated whether low fitness, estimated by short duration on an exercise treadmill test, was associated with the development of CVD risk factors and whether improving fitness was associated with risk reduction.

The participants, men and women 18 to 30 years of age, were enrolled in the Coronary Artery Risk Development in Young Adults (CARDIA) study. The CARDIA study recruited 5,115 participants from four geographic areas (Birmingham, Ala., Chicago, Minneapolis, and Oakland, Calif.). Participants who completed the treadmill examination at baseline were followed up from 1985 - 1986 to 2000 - 2001. A subset of participants (n=2,478) repeated the exercise test in 1992 - 1993.

"After adjustment for age, race, sex, smoking, and family history of diabetes, hypertension or premature myocardial infarction [heart attack], participants with low fitness (less than 20th percentile) were 3- to 6- fold more likely to develop diabetes, hypertension, and the metabolic syndrome than participants with high fitness (at or above 60th percentile)," the authors write. "Improved fitness over 7 years was associated with a reduced risk of developing diabetes and the metabolic syndrome, but the strength and significance of these associations was reduced after accounting for changes in weight."

CHICAGO—In an effort to enhance the supply of necessary childhood vaccines without the shortages seen in recent years, the National Vaccine Advisory Committee (NVAC) has issued a list of recommendations that are published in a special communication in the December 17 issue of The Journal of the American Medical Association (JAMA).

The NVAC was chartered in 1988 to advise and make recommendations to the Director of the National Vaccine Program and the Assistant Secretary for Health at the Department of Health and Human Services on matters related to the prevention of infectious diseases through immunization and the prevention of adverse reactions to vaccines. The NVAC is composed of 15 members from public and private organizations representing vaccine manufacturers, physicians, parents, and state and local health agencies.

"Beginning in late 2000, significant unprecedented and unanticipated shortages of routinely administered vaccines against 8 of 11 vaccine-preventable childhood infectious diseases occurred in the United States," according to background information provided by the Committee's report. "Affected vaccines included diphtheria and tetanus toxoids and acellular pertussis [whooping cough] (DtaP), measles, mumps, and rubella (MMR), varicella [chicken pox], and pneumococcal conjugate [pneumonia] vaccines; combined tetanus and diphtheria toxoids (Td) was also in short supply. Vaccine supply disruptions affected private practices and public clinics because both sectors purchase vaccines from the same manufacturers."

The Committee's report states that some of the problems that contributed to the shortage of vaccine supplies between 2000 and 2003 included a relatively low value given to preventive measures such as vaccines compared with that of therapeutic medicines, reflected in what individuals and public and private payers are willing to pay for vaccines; the high cost and complexity of development, approval, manufacturing and distribution of vaccines; the lack of continued investment in some vaccine manufacturing facilities; the relatively small number of vaccine manufacturers; and communication barriers between stakeholder groups, including proprietary information and confidentiality requirements that inhibit the recognition of evolving problems and development of effective responses.

The Committee concludes that: "Disruptions to the supply of routinely administered vaccines are likely to continue to occur. Action to implement short- and long-term solutions should be considered and implemented now."

The Committee recommends several solutions that may be implemented in the immediate future, including: increase funds for vaccine stockpiles; increase support for regulatory agencies; maintain and strengthen liability protections; require manufacturers to provide advance notice regarding intent to withdraw from marketplace; improve communications among leaders and consumers - provide accurate information about vaccine supply; initiate a national campaign to emphasize the safety and benefits of recommended vaccines for the public good.

“NEW JAMA STUDY SHOWS POOR FITNESS IN YOUNG ADULTS LEADS TO GREATER RISK OF DEVELOPING HEART DISEASE AND RELATED CONDITIONS”