According to a recent study, dupilumab demonstrated notable improvements in the quality of life of young children who suffer from severe atopic dermatitis (AD), while maintaining an acceptable level of safety. The study’s findings were published in the journal, Advances in therapy.

In this pre-specified subgroup analysis, data of 125 patients aged 6 months to 5 years with severe AD at baseline (Investigator's Global Assessment [IGA] = 4) from a randomized, double-blind, placebo-controlled, phase III trial of dupilumab was examined. Patients were assigned randomly to receive either subcutaneous dupilumab (200/300 mg) [n=63] or a placebo [n=62] every 4 weeks, in addition to low-potency topical corticosteroids for a duration of 16 weeks. The study’s co-primary endpoints at week 16 included the proportion of patients displaying a ≥ 75% improvement from the baseline in Eczema Area and Severity Index (EASI-75) and the proportion of patients achieving IGA ≤ 1 (representing clear or almost clear skin). Secondary endpoints at week 16 included pruritis, mean changes in EASI, sleep loss, skin pain, and quality of life.

At week 16, a significantly higher percentage of patients who were given dupilumab compared to those who were given a placebo had achieved IGA ≤ 1 (14.3% vs. 1.6%) and EASI-75 (46.0% vs. 6.6%). Notable enhancements with dupilumab were seen in all secondary endpoints measured, with a least squares mean reduction of 48.9% in pruritus. The overall occurrence of adverse events (AEs) was comparable in both the dupilumab group (66.7%) and the placebo group (73.8%). No AEs related to dupilumab were severe or led to treatment discontinuation.

Based on the above results, it can be concluded that dupilumab may lead to significant improvement in the signs, symptoms, and overall quality of life for children between the ages of 6 months and 5 years with severe AD. Furthermore, the dupilumab treatment exhibited an acceptable level of safety.

According to a recent study, alirocumab may reduce low-density lipoprotein cholesterol (LDL-C) and other lipid parameters in pediatric patients with heterozygous familial hypercholesterolemia (HeFH) who have not achieved sufficient control with statins. This study’s findings were published in the journal, JAMA pediatrics.

In this phase 3, randomized clinical trial, 153 pediatric patients aged 8-17 years with HeFH, LDL-C levels of 130 mg/dL or higher, and undergoing statin or other lipid-lowering therapy (LLT) were randomly assigned to receive subcutaneous alirocumab or a placebo and dosed every 2 weeks (Q2W) or every 4 weeks (Q4W). The dosage depended on weight (if <50 kg then 40 mg for Q2W or 150 mg for Q4W; if ≥50 kg then 75 mg for Q2W or 300 mg for Q4W) and was adjusted at week 12 if LDL-C was 110 mg/dL or higher at week 8. Following the 24-week double-blind phase, patients could continue alirocumab treatment in an 80-week open-label phase. The primary endpoint of the study was the percentage change in LDL-C from baseline to week 24 in each group.

Alirocumab demonstrated statistically significant decreases in LDL-C compared to the placebo in both groups at week 24. The least squares mean difference in percentage change from baseline was -43.3% for the Q2W group and -33.8% for the Q4W group. A hierarchical analysis of secondary efficacy endpoints revealed notable enhancements in other lipid parameters at weeks 12 and 24 with alirocumab. The findings from the open-label period were consistent with those from the double-blind period.

Based on the above results, it can be concluded that alirocumab dosed every two weeks or every four weeks may lower LDL-C levels and improve other lipid parameters in pediatric patients with HeFH who have not achieved adequate control with statins.

According to a recent study, quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT) booster dose was found to be immunogenic and well tolerated in participants aged ≥59 years, irrespective of previously received quadrivalent meningococcal vaccine. This study was published in the journal, Human vaccines & immunotherapeutics.

This 2-stage phase III randomized study included 401 older adults (≥59 years) who were primed with either MenACYW-TT or a quadrivalent meningococcal polysaccharide vaccine (MPSV4). During Stage I, the participants who had received either MPSV4 (n = 165) or MenACYW-TT (n = 236) 3 years before, were randomized in a 9:2 ratio to receive either the booster (MenACYW-TT) or to have blood drawn for persistence only. Those participants who were primed 6-7 years earlier with MPSV4 or MenACYW-TT, had blood drawn for antibody persistence only. Functional antibodies against each serogroup were measured at baseline and for those participants receiving a booster, it was measured 30 days post-vaccination (D30).

For all serogroups, the seroresponse rates at D30 ranged from 49.2% to 60.8% and 79.3 to 93.1% in the MPSV4-primed and MenACYW-TT-primed groups, respectively. It was found that MenACYW-TT induced adequate seroresponses in each primed group. After primary vaccination, geometric mean titers (GMTs) for serogroups C, W, and Y trended higher than pre-vaccination levels at both 3 and 6-7 years.

Based on the above results, it can be concluded that MenACYW-TT booster may be immunogenic and well tolerated in participants aged ≥59 years, who may elicit the greatest immune responses.

According to a recent study, respiratory syncytial virus prefusion F protein (RSVPreF3 OA) vaccine helps attenuate the severity of respiratory syncytial virus (RSV)-associated symptoms in acute respiratory infections (ARIs). This study was published in the journal, Influenza and Other Respiratory Viruses.

This phase 3 trial included adults aged ≥60 years who were randomized in a 1:1 ratio to receive either one dose of RSVPreF3 OA vaccine (N = 12,466) or placebo (N = 12,494). Patient-reported outcomes (PROs) were assessed using Short Form-12 (SF-12), InFLUenza Patient-Reported Outcome (FLU-PRO), and EuroQol-5 Dimension (EQ-5D) questionnaires. Wilcoxon test was used to compare the Peak FLU-PRO Chest/Respiratory scores during the first 7 days from ARI episode onset. Along with this, EQ-5D health utility scores and least squares mean (LSMean) of SF-12 physical functioning (PF) were estimated.

In the vaccine group, 27 first RSV-ARI episodes were observed, compared to 95 in the placebo group. For the RSVPreF3 OA group, median peak FLU-PRO Chest/Respiratory scores were lower (1.07) versus placebo group (1.86). The LSMean group differences for the EQ-5D health utility score and PF were 7.00.

From the above study, it can be concluded that RSVPreF3 OA vaccine may not only prevent infection but may also attenuate the severity of RSV-associated symptoms in breakthrough infections.