Safety of Brodalumab in Plaque Psoriasis: Integrated Pooled Data from Five Clinical Trials.

Brodalumab is approved for treatment of moderate-to-severe plaque psoriasis. Here, we assess the safety profile of brodalumab using pooled safety data from 5 phase II/III trials of brodalumab 140 mg or 210 mg. In total, 4,464 patients received brodalumab, representing 8,891.

Development of Insulin Detemir/Insulin Aspart Cross-Reacting Antibodies Following Treatment with Insulin Detemir: 104-week Study in Children and Adolescents with Type 1 Diabetes Aged 2-16 Years.

Background: To study the long-term development (104 weeks) of insulin antibodies during treatment with insulin detemir (IDet) and insulin aspart (IAsp) in children with type 1 diabetes aged 2-16 years.

Methods: A 52-week, two-arm, randomized trial comparing IDet and neutral protamine Hagedorn insulin, both in combination with IAsp, was followed by a one-arm, 52-week extension trial of the IDet + IAsp arm. The present analysis was conducted in children who completed the randomized trial and entered into the extension trial.

The study of once- and twice-daily biphasic insulin aspart 30 (BIAsp 30) with sitagliptin, and twice-daily BIAsp 30 without sitagliptin, in patients with type 2 diabetes uncontrolled on sitagliptin and metformin-The Sit2Mix trial.

Aims: Investigate efficacy and tolerability of intensifying diabetes treatment with once- or twice-daily biphasic insulin aspart 30 (BIAsp 30) added to sitagliptin, and twice-daily BIAsp 30 without sitagliptin in patients with type 2 diabetes (T2D) inadequately controlled on sitagliptin.

Methods: Open-label, three-arm, 24-week trial; 582 insulin-naïve patients were randomized to twice-daily BIAsp 30+sitagliptin (BIAsp BID+Sit), once-daily BIAsp 30+sitagliptin (BIAsp QD+Sit) or twice-daily BIAsp 30 without sitagliptin (BIAsp BID), all with metformin.

Results: After 24 weeks, HbA1c reduction (%) was superior with BIAsp BID+Sit vs.

Treatment intensification with stepwise addition of prandial insulin aspart boluses compared with full basal-bolus therapy (FullSTEP Study): a randomised, treat-to-target clinical trial.

Background: We compared stepwise addition of bolus insulin with a full basal-bolus regimen in patients with type 2 diabetes inadequately controlled on basal insulin plus oral antidiabetic drugs.

Methods: The FullSTEP study was a phase 4, 32-week, randomised, open-label, two-arm, parallel-group, multinational, treat-to-target, non-inferiority trial done at 150 sites across seven countries to assess the effectiveness of a stepwise dosing approach versus a basal-bolus regimen. In this trial, 401 patients (mean age 59·8 years [SD 9·3]; HbA1c 7·9% [63 mmol/mol]; mean diabetes duration 12·6 years [SD 8·0]) were block randomised (ratio 1:1) to receive either stepwise treatment or full basal-bolus treatment.

Treatment with insulin detemir or NPH insulin in children aged 2-5 yr with type 1 diabetes mellitus.

This randomised (1:1), multinational, open-labelled, parallel group trial compared insulin detemir (IDet) with neutral protamine Hagedorn (NPH) insulin, in combination with mealtime insulin aspart, over 1 yr in subjects aged 2-16 yr with type 1 diabetes mellitus. Of 348 randomised subjects, 82 (23.6%) were 2-5 yr (IDet: 42, NPH: 40).

The impact of changes in self-rated general health on 28-year mortality among middle-aged Danes.

Objective: Self-rated general health (SRH) predicts future mortality. SRH may change, and these changes may alter the mortality risk. All-cause mortality until the age of 68 and its association with changes in SRH from the age of 40-45, 45-51, and 51-60 years was examined in a cohort of Danes.

Self-rated general health among 40-year-old Danes and its association with all-cause mortality at 10-, 20-, and 29 years' follow-up.

Aims: Self-rated general health (SRH) predicts future mortality. We examined all-cause mortality at 10, 20, and 29 years' follow-up and its association with SRH measured at the age of 40 years in a cohort of 1,198 healthy Danes born in 1936 and who were residents in suburban Copenhagen.

Methods: The association between SRH (dichotomized into good versus poor) and all-cause mortality was estimated in standard time-homogenous Cox regression models adjusting for covariates related to mortality, and in time-heterogeneous Cox regression models without covariate adjustment, where time-heterogeneity features as a separate risk assessment for each of the three follow-up periods defined by the follow-up examinations.