Rapid Improvement in Skin Pain Severity and Its Impact on Quality of Life in Adult Patients With Moderate-to-Severe Atopic Dermatitis From a Double-Blind, Placebo-Controlled Baricitinib Phase 3 Study.

BACKGROUND: Skin pain (discomfort/soreness) is a common symptom associated with atopic dermatitis (AD). OBJECTIVE: To evaluate rapid changes in skin pain severity with baricitinib, and its impact on patient quality of life (QoL) in adults with moderate-to-severe AD who were inadequate responders to topical therapy. METHODS: Adult patients with moderate-to-severe AD who were inadequate responders to topical therapies (N = 440, BREEZE-AD5 [NCT03435081]) were randomized to once-daily placebo, baricitinib 1 mg, or baricitinib 2 mg for 16 weeks. Change in Skin Pain Numeric Rating Scale (NRS) scores were assessed for the randomized population. Skin Pain NRS and Dermatology Life Quality Index (DLQI) scores were assessed for Skin Pain Response groups and patients with Body Surface Area (BSA) 10% to 50%. RESULTS: Skin Pain NRS improvement was significant versus placebo by day 1 baricitinib 2 mg (least squares mean [LSM] difference -4.4%, P = .048) and by day 2 for baricitinib 1 mg (-6.7%, P = .011). As measured weekly, improvement was significant starting at Week 1 and remained significant through Week 16 for both doses. At Week 16, 70.9% of Skin Pain NRS responders vs 10.4% of nonresponders had a clinically meaningful improvement in DLQI (P < .0001). At week 16, LSM DLQI change from baseline was -11.1 for all Skin Pain NRS responders versus -3.5 for nonresponders (P < .0001). Patients with BSA 10% to 50% showed similar trends. CONCLUSIONS: Patients with moderate-to-severe AD, treated with baricitinib, reported rapid improvements in skin pain severity by day 1 for baricitinib 2 mg and day 2 for baricitinib 1 mg and remained effective through 16 weeks of treatment, which positively impacted patient QoL.

Onset of Symptom Relief Reported in Daily Diaries of Patients With Atopic Dermatitis Treated With Baricitinib in a United States Clinical Trial (BREEZE-AD5).

BACKGROUND: Itch and sleep disturbance due to itch are burdensome symptoms associated with atopic dermatitis (AD). Rapid onset of action is important for AD treatments to improve quality of life and relieve suffering. OBJECTIVES: This subanalysis evaluated how quickly baricitinib 1-mg and 2-mg reduced itch and associated sleep disturbance during the first 7 days after treatment initiation in a phase 3, double-blind, placebo-controlled trial. METHODS: Adult patients with AD were randomized 1:1:1 to placebo (N = 147), baricitinib 1 mg (N = 147) or baricitinib 2 mg (N = 146). Patients kept daily diaries, completing the Itch Numeric Rating Scale (NRS) (itch severity from 0 = no itch to 10 = worst itch imaginable) and the Atopic Dermatitis Sleep Scale (ADSS) to measure sleep disturbance (number of nighttime awakenings because of itch). Mixed model repeated measures analysis was used to analyze change from day 1 to day 7 values. RESULTS: Patients receiving either dose of baricitinib had a 9.9% decrease in itch NRS scores from baseline to Day 2 vs 1.5% decrease for placebo (significant between-group least squares mean [LSM] difference: 8.3; 95% CI -12.66 to -3.89; P = .0002). Baricitinib 2 mg reduced nighttime awakenings due to itch (ADSS item 2) at day 2 by 25.2% vs 3.9% in the placebo group (between-group LSM difference: -21.4, P = .0025). Baricitinib 2 mg continued to demonstrate a statistically significant difference from placebo in sleep symptoms at day 7 (LSM difference -23.9; P = .001). CONCLUSIONS: Baricitinib 2-mg provided relief from itching and sleep disturbance in patients with AD, beginning the day after taking first dose.Clinical trials at www.clinicaltrials.gov: BREEZE-AD5 (NCT03435081).

Raloxifene: mechanism of action, effects on bone tissue, and applicability in clinical traumatology practice.

Raloxifene, a member of the class of selective estrogen receptor modulators (SERM), reproduces the beneficial effects of estrogens on the skeletal systems, without the negative effects estrogens on breast and endometrium. This is a review article summarizing its mechanism, effects on bone and its applicability in traumatology clinical practice. In postmenopausal osteoporosis, this drug has been proven to decrease accelerated bone turnover, increase bone mineral density (BMD), and to structurally recover bone, decreasing the risk of vertebral fractures and the risk of non-vertebral fractures in patients with previous, severe vertebral fractures. Moreover, raloxifene appears to lower the risk of invasive breast cancer. Raloxifene would be efficacious in the prevention and treatment of postmenopausal osteoporosis.We can therefore conclude that raloxifene would be efficacious in the prevention and treatment of postmenopausal osteoporosis, while reducing the risk of breast cancer when used at the indicated dose of 60 mg/day and with a low incidence of side effects.

Pemetrexed in first-line treatment of non-small cell lung cancer.

Pemetrexed is an antitumor agent traditionally used as monotherapy for the second-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) as well as in combination with cisplatin for the treatment of chemonaïve patients with unresectable malignant pleural mesothelioma. Recently, pemetrexed has been approved in combination with cisplatin for the first-line treatment of patients with locally advanced or metastatic NSCLC other than predominantly squamous cell histology. Studies that support the development of this indication are detailed in this review. We performed a PubMed/Medline database search to identify relevant literature from 1998 until August 2008. Bibliographies from identified references were searched, as well as were abstracts from the most relevant congresses in lung cancer area (American Society of Clinical Oncology Congress, World Conferences of Lung Cancer). We detailed pemetrexed studies in the first-line setting of NSCLC treatment, in monotherapy, in combination with platinum and also, with other agents. Data regarding efficacy differences related to different histologic types were also analyzed.

Risk factors for osteoporosis and fractures in postmenopausal women between 50 and 65 years of age in a primary care setting in Spain: a questionnaire.

INTRODUCTION: Osteoporosis (OP) is a major, highly prevalent health problem and osteoporosis-related fractures account for high morbidity and mortality. Therefore, prevention and early detection of osteoporosis should strive to substantially reduce this risk of fracture. OBJECTIVE: The present observational, descriptive, cross-sectional study sought to assess the prevalence of risk factors for osteoporosis and fractures in a large sample of postmenopausal women aged 50 to 65 years attending Primary Care facilities in Spain. METHODS: We recruited 4,960 women, at 96 Primary Care centers. Demographic and anthropometrical data, as well as information regarding risk factors for OP were collected using a questionnaire. RESULTS: the prevalence rates for the major osteoporosis risk factors in our population were: low calcium intake, 43%; benzodiazepine use, 35.1%, and height loss, 30.1%. Other relatively prevalent factors include: having suffered at least one fall during the preceding year; positive family history of falls (particularly on the mother's side), smoking, kyphosis, presence of any disease affecting bone metabolism, personal history of falls, and inability to rise from a chair without using one's arms. The least frequent factors were weight loss of greater than 10% over the preceding 10 years and problems in sensory perception that affect patient's ability to walk. CONCLUSIONS: The main risk factors for osteoporosis in women 50-65 years of age are low calcium intake, use of benzodiazepines, and observed loss of height. Our results may help physicians to identify groups at risk for OP and fractures at early stages and consequently, optimize prevention and early diagnosis of osteoporosis in postmenopausal women.