Abrocitinib Provides Rapid and Sustained Improvement in Skin Pain and Is Associated with Improved Quality of Life Outcomes in Adult and Adolescent Patients with Moderate-to-Severe Atopic Dermatitis.

BACKGROUND: Skin pain in atopic dermatitis (AD) increases with disease severity and is associated with substantial quality of life (QoL) burden. OBJECTIVES: The aim of the study was to evaluate abrocitinib efficacy on skin pain and QoL in adults and adolescents with moderate-to-severe AD. METHODS: This post hoc analysis included data with abrocitinib administered as monotherapy (pooled phase 2b [NCT02780167] and phase 3 JADE MONO-1 [NCT03349060] and JADE MONO-2 [NCT03575871]) or in combination with topical therapy (phase 3 JADE COMPARE [NCT03720470] and JADE TEEN [NCT03796676]). Patients received oral, once-daily abrocitinib 200 mg, abrocitinib 100 mg, or placebo for 12 or 16 weeks (JADE COMPARE). Skin pain was rated using the Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) skin pain Numerical Rating Scale (NRS) item ("How painful was your skin over the past 24 h?") on a scale from 0 (not painful) to 10 (extremely painful). Itch (Peak Pruritus NRS) and QoL (Dermatology Life Quality Index or Children's Dermatology Life Quality Index) were assessed. Least squares mean (LSM) change from baseline was analyzed using mixed-effects repeated measures modeling. RESULTS: A total of 1,822 patients (monotherapy pool, n = 942; JADE COMPARE, n = 595; and JADE TEEN, n = 285) were analyzed. LSM change from baseline in PSAAD skin pain score was significantly greater with abrocitinib versus placebo from week 2 through week 12 or 16 across all 3 study populations and occurred in a dose-dependent manner. A greater proportion of patients achieved a ≥4-point improvement from baseline in PSAAD skin pain score with abrocitinib (200 mg and 100 mg) versus placebo in the monotherapy pool (56% and 38% vs. 12%; week 12), JADE COMPARE (72% and 52% vs. 26%; week 16), and JADE TEEN (51% and 60% vs. 31%; week 12). Additionally, a greater proportion of patients achieved a stringent threshold of skin pain improvement (PSAAD skin pain score <2) with abrocitinib versus placebo. Adults and adolescents who achieved a ≥4-point improvement in skin pain reported greater QoL improvement than those who did not achieve a ≥4-point improvement. A positive correlation (≥0.3) was observed between skin pain and QoL and separately between skin pain and itch across the 3 study populations. CONCLUSION: Abrocitinib as monotherapy or in combination with topical therapy improved skin pain and was associated with improved QoL in both adults and adolescents with moderate-to-severe AD across all evaluated studies.

Abrocitinib 100 mg Once Daily for Moderate-to-Severe Atopic Dermatitis: A Review of Efficacy and Safety, and Expert Opinion on Use in Clinical Practice.

Abrocitinib is a Janus kinase (JAK) 1-selective inhibitor approved for the treatment of moderate-to-severe atopic dermatitis (AD). Although specific dose recommendations for abrocitinib vary across regional product labels, abrocitinib 100 mg once daily is recommended as a starting and maintenance dose. This review summarizes the efficacy and safety of abrocitinib 100 mg once daily for patients with moderate-to-severe AD based on data from the pivotal phase 3 studies of the JAK1 Atopic Dermatitis Efficacy and Safety (JADE) clinical program, JADE MONO-1 (NCT03349060), JADE MONO-2 (NCT03575871), JADE COMPARE (NCT03720470), JADE TEEN (NCT03796676), and JADE REGIMEN (NCT03627767). Preliminary long-term efficacy and safety data are also summarized from the long-term extension study JADE EXTEND (NCT03422822). Expert opinion on use of abrocitinib 100 mg once daily in clinical practice is provided. In addition to efficacy, the decision to use abrocitinib for the treatment of AD should allow for individual patient factors such as age, comorbidities, previous therapy, quality of life, and treatment tolerability, and involve shared decision-making between the patient and clinician.

Medication management in primary and secondary schools: evaluation of mental health related in-service education in local schools.

An increasing number of students are taking medications while they are in school or are under the influence of medication during school hours. In a novel effort, clinical pharmacists and mental health therapists worked together to provide "mini-in-service" educational programs on psychological disorders and medications used to treat these disorders. The purpose of this study was to implement and evaluate the effectiveness of these educational programs presented to school nurses, teachers, school administrators, and other personnel. The study compared participant responses before and after attending a medication in-service session on a psychological disorder and its related medications. Results indicated that in-service education on attention deficit/hyperactivity disorder (ADHD) and depression improved the knowledge and confidence levels of school personnel regarding medications and symptoms. Feedback indicated school personnel wanted longer educational sessions and more information on these disorders and treatments. School nurses working with health professionals can improve education for staff, families, and students about mental health disorders and their treatment.

Medication management in primary and secondary schools.

OBJECTIVES: To identify whether and how pharmacy faculty members are addressing the issue of medication management in primary or secondary schools in their teaching, research, and service activities, and to ascertain the extent to which they think the issue is an important one. METHODS: Four hundred ninety-nine faculty members completed a questionnaire inquiring about the research, teaching, and service activities in which they participated that related to medication management in schools. RESULTS: Only 33 subjects (6.6%) addressed the topic of medication management in schools in their courses; only 13 (2.6%) conducted research on the topic; and only 30 (6%) were involved in service in this area. On the other hand, 432 respondents (86.6%) believed that the issue of medication management in schools was either somewhat or extremely important. CONCLUSIONS: There is a large gap between the number of subjects that think medication management in schools is an important topic and the number who actually include the topic in teaching, research, and or service.

The use of antidepressants in school-age children.

Approximately 5% of the pediatric population suffers from depression. Children suffering from depression should be treated first with some type of psychotherapy, cognitive therapy, and/or education. Pharmacotherapy (medications) should be used only as a last resort for those children suffering from severe, chronic, or recurring depression. The only antidepressant approved by the U.S. Food and Drug Administration for the treatment of depression in children is fluoxetine (Prozac), a selective serotonin reuptake inhibitor. In the school setting, children should be monitored closely upon the initiation of antidepressant therapy and changes in dosing or medication. They also should be monitored for side effects of the medication, response to therapy, and new signs of depression or worsening symptoms. After starting an antidepressant, children must be monitored closely for any changes in behavior, especially increased preoccupation with suicide. Any changes should be reported to the physician immediately for follow-up.