Phase 2B randomized study of nemolizumab in adults with moderate-to-severe atopic dermatitis and severe pruritus.

BACKGROUND: Nemolizumab targets the IL-31 receptor α subunit involved in atopic dermatitis (AD) pathogenesis. OBJECTIVE: We sought to evaluate a new dosing strategy of nemolizumab in patients with AD. METHODS: We performed a 24-week, randomized, double-blind, multicenter study of nemolizumab (10, 30, and 90 mg) subcutaneous injections every 4 weeks versus placebo, with topical corticosteroids in adults with moderate-to-severe AD, severe pruritus, and inadequate control with topical treatment (n = 226). The Eczema Area and Severity Index (EASI), the peak pruritus (PP) numeric rating scale (NRS), and the Investigator's Global Assessment (IGA) were assessed. Standard safety assessments were performed. RESULTS: Nemolizumab improved EASI, IGA, and/or NRS-itch scores, with the 30-mg dose being most effective. Nemolizumab (30 mg) reduced EASI scores versus placebo at week 24 (-68.8% vs -52.1%, P = .016); significant differences were observed by week 8 (P ≤ .01). With significant improvement (P = .028) as early as week 4, IGA 0/1 rates were higher for 30 mg of nemolizumab versus placebo at week 16 (33.3% vs 12.3%, P = .008) but not week 24 because of an increased placebo/topical corticosteroid effect (36.8% vs 21.1%, P = .06). PP-NRS scores were improved for 30 mg of nemolizumab versus placebo at week 16 (-68.6% vs -34.3%, P < .0001) and week 24 (-67.3% vs -35.8%, P < .0001), with a difference by week 1 (P < .001). NRS response rates (≥4-point decrease) were greater for 30 mg of nemolizumab versus placebo at week 16 (P ≤ .001) and week 24 (P ≤ .01). Nemolizumab was safe and well tolerated. The most common adverse events were nasopharyngitis and upper respiratory tract infection. CONCLUSIONS: Nemolizumab resulted in rapid and sustained improvements in cutaneous signs of inflammation and pruritus in patients with AD, with maximal efficacy observed at 30 mg. Nemolizumab had an acceptable safety profile.

Use of the extended parallel processing model to evaluate culturally relevant kernicterus messages.

INTRODUCTION: Kernicterus is a serious but easily preventable disease in newborns that is not well-known even by some health care professionals. This study evaluated a parent guide and poster on kernicterus awareness and prevention generated by the Centers for Disease Control and Prevention. The extended parallel processing model was used as a framework for creating the interview protocol and analyzing the results. METHOD: In-depth interviews were conducted with four parents and six health care personnel of different ethnicities to evaluate the materials. Content for the parent guide and poster was held constant, but photos were varied according to the ethnicity of the baby (white, African American, or Hispanic) and the language in which the interviews were conducted (English and Spanish). RESULTS: The parent guide was evaluated positively, but reactions to the poster were varied. The consensus was that the poster drew more attention than the pocket guide but lacked sufficient information about what jaundice is or how to treat it, while the pocket guide provided information, especially with regard to efficacy. The extended parallel processing model claims that when efficacy is equal to or higher than perceived threat, respondents should engage in recommended responses, which was the general finding from these interviews. DISCUSSION: Recommendations for improvements of the materials are presented. The focus on different ethnicities in the materials was perceived as unnecessary and potentially counter-productive. Both parents and health care professionals mentioned the lack of information regarding treatment. Providing information on the length and effectiveness of treatment for jaundice and kernicterus might increase efficacy in averting the threat in both conditions.

Developing effective campaign messages to prevent neural tube defects: a qualitative assessment of women's reactions to advertising concepts.

The incidence of neural tube defects (NTDs), serious birth defects of the brain and spine that affect approximately 3,000 pregnancies in the United States each year, can be reduced by 50-70% with daily periconceptional consumption of the B vitamin folic acid. Two studies were designed to assess college women's reactions to and perceptions of potential campaign advertising concepts derived from preproduction formative research to increase folic acid consumption through the use of a daily multivitamin. Study one assessed draft advertising concepts in eight focus groups (N = 71) composed of college-enrolled women in four cities geographically dispersed across the United States. Based on study one results, the concepts were revised and reassessed in study two with a different sample (eight focus groups; N = 73) of college women in the same four cities. Results indicated that participants generally responded favorably to concepts in each of the two studies, and provided insight into individual concepts to increase their overall appeal and effectiveness. The specific findings and implications of these results are discussed.

Predictors of engaging in family discussion about organ donation and getting organ donor cards witnessed.

Family knowledge of organ donation intentions has been found to double rates of family consent regarding organ donation; therefore, it is an important communication process to study in the effort to persuade more people to become organ donors. This article reports the results of a study based on the heuristic-systematic model of persuasion designed to assess predictors of family discussion of organ donation and getting organ donor cards witnessed. Possible predictors of family discussion and getting organ donor cards witnessed included individual differences and cognitive, emotional, and behavioral factors. A path model of the process leading to family discussion and getting organ donor cards witnessed is presented and results are discussed for their practical importance.

Understanding optimal nutrition among women of childbearing age in the United States and Puerto Rico: employing formative research to lay the foundation for national birth defects prevention campaigns.

Neural tube defects (NTDs) are serious birth defects of the brain and spine that affect approximately 3,000 pregnancies in the United States each year and affected 404 pregnancies in Puerto Rico from 1996 to 2002. Consuming the B vitamin folic acid can reduce the incidence of NTDs 50%-70%, and recent efforts to reduce NTD rates have focused on increasing the number of childbearing-aged women who take a vitamin containing folic acid every day. As the first stage of formative research in campaign planning, two exploratory, qualitative studies were conducted in order to (a) understand the complexity of vitamin use among women in the United States and Puerto Rico and (b) serve as a foundation on which to develop national communication and education interventions. Also, this information shed light on theories that might be used to guide campaign development. Results indicated that campaign messages designed to increase folic acid use through multivitamin supplementation in the United States must address women's barriers to vitamin use (e.g., cost, time), increase women's perceived need for multivitamins (e.g., identify immediate, tangible results from taking a daily multivitamin), and address the relationship between daily food choices and the need for supplementation. Future campaign messages in Puerto Rico must focus on many of these same issues, in addition to increasing women's knowledge about when folic acid should be taken in relation to pregnancy and addressing women's perceptions that vitamins cause weight gain (an undesirable outcome for most participants). The practical and theoretical implications of these results are discussed in terms of their contribution to the development of a creative new approach to increase multivitamin consumption among women of childbearing age in the United States and Puerto Rico.

Encouraging family discussion on the decision to donate organs: the role of the willingness to communicate scale.

Family discussion of organ donation has been found to double rates of family consent regarding organ donation. Therefore, family discussion is an important communication process to study in the effort to get more people to become organ donors. This investigation concerns the willingness to communicate about organ donation and its relationship to other variables and processes related to family discussion of organ donation. Previous research on willingness to communicate examined the antecedent variables of knowledge, attitude toward organ donation, and altruism. This research found that being willing to communicate about organ donation with one's family is related to prior thought and intent to sign an organ donor card, to perceiving organ donation messages as credible, and to feeling relatively low anxiety after reading organ donation messages. One week after being presented with the messages, willingness to communicate was found to be positively associated with worrying about the lack of donors, engaging in family discussion about organ donation, and having an organ donor card witnessed. It was negatively related to feeling personally uneasy about organ donation during the past week.