Search

Tozorakimab is a high‐affinity human immunoglobulin G1 monoclonal antibody that neutralizes interleukin (IL)‐33, an IL‐1 family cytokine. This phase 1, single‐center, randomized, double‐blind, placebo‐controlled, single ascending dose study (NCT05070312) evaluated tozorakimab in a healthy Chinese population. Outcomes included the characterization of the pharmacokinetic (PK) profile and immunogenicity of tozorakimab. Safety outcomes included treatment‐emergent adverse events (TEAEs) and clinical laboratory, electrocardiogram, and vital sign parameters. Healthy, non‐smoking, male, and female Chinese participants aged 18‐45 years with a body mass index 19‐24 kg/m2 were enrolled. In total, 36 participants across 2 cohorts of 18 participants were randomized 2:1 to receive a single subcutaneous dose of tozorakimab (300 mg [2 mL] or 600 mg [4 mL]) or matching placebo (2 or 4 mL). Tozorakimab showed dose‐dependent serum PK concentrations with an approximate monophasic distribution in serum over time and a maximum observed peak concentration of 20.1 and 33.7 μg/mL in the 300‐ and 600‐mg cohorts, respectively. No treatment‐emergent anti‐drug antibodies for tozorakimab were observed in any of the participants. There were no clinically relevant trends in the occurrence of TEAEs across the treatment groups. There were no clinically relevant trends over time in clinical laboratory (hematology, clinical chemistry, and urinalysis), electrocardiogram, or vital sign parameters in any treatment group. Overall, tozorakimab demonstrated dose‐dependent systemic exposure in healthy Chinese participants and was well tolerated, with no safety concerns identified in this study. [ABSTRACT FROM AUTHOR]

This article presents data from a phase 1 study on the safety, pharmacokinetics, and efficacy of selumetinib in Chinese pediatric and adult patients with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas (PN). The study found that selumetinib was well-tolerated, with most adverse events being mild. No unexpected trends or serious adverse events were observed, and no patients stopped treatment due to adverse events. The document also provides information on the adverse events experienced by patients receiving selumetinib, as well as the pharmacokinetics of the medication. Additionally, the document summarizes a study on the efficacy and safety of selumetinib in adults with NF1-PN in China. The study found promising efficacy and improvements in quality of life, but caution should be exercised when interpreting the efficacy data as it was a secondary endpoint. The study concluded that selumetinib has an acceptable benefit-risk profile and may address the medical needs of patients with NF1-PN in China. The study was funded by AstraZeneca and Merck Sharp & Dohme LLC. [Extracted from the article]

Objectives: China has implemented universal hepatitis B vaccination since 2002 and provided charge-free hepatitis B immunoglobulin (HBIG) to infants of HBV-infected mothers since July 2011. We aimed to compare mother-to-child transmission (MTCT) in children born before and since July 2011. Methods: In total, 5,149 children of HBV-infected mothers were tested for HBV markers. Group one contained 1,160 children born during August 2002–June 2011 and group two contained 3,989 children born during July 2011–June 2016. Results: In total, 92 (1.8%, 95% confidence interval [95%CI] 1.4–2.2) children were infected with HBV. None (0%, 95%CI 0.0–0.1) of 3,716 children of mothers with negative hepatitis B e antigen (HBeAg) was infected, whereas 92 (6.4%, 95%CI 5.2–7.8) of 1,433 children of HBeAg-positive mothers were infected (p < 0.0001). Among children of HBeAg-positive mothers, MTCT occurred in 10.3% (19/185) (95%CI 6.3–15.6) in group one and 5.8% (73/1,248) (95%CI 4.6–7.3) in group two (p = 0.02). Conclusions: Implementing charge-free active-passive immunoprophylaxis greatly reduces MTCT of HBV in children of HBeAg-positive mothers, highlighting the importance of timely administration of both hepatitis B vaccine and HBIG to prevent MTCT. The still remaining MTCT suggests that reducing maternal virus load before delivery is an additional important measure. [ABSTRACT FROM AUTHOR]

Objectives. To investigate the association of folic acid (FA) supplementation with hypertensive disorder complicating pregnancy (HDCP) and preeclampsia in Jiangsu Province, China. Materials and Methods. In this cross-sectional study, a total of 10,662 women with infants born between January 2017 and December 2018 were enrolled in Jiangsu Province, China. Maternal women with and without FA supplement intake were compared in this study. FA supplementation included 0.4 mg FA (0.4 FA), multivitamins with 0.4 mg FA (multivitamin (MV)+0.4 FA), and multivitamins with 0.8 mg FA (MV + 0.8 FA). Associations between FA intake, FA supplement dose or duration, (MV + FA) dosage per weight, and HDCP were analysed using ANOVA, the chi-square test, and logistic regression analysis. Results. Over the study follow-up period, the incidences of HDCP and preeclampsia were 3.5%, 1.4%, and 2.2%, 0.6% in the non-FA supplementation and FA supplementation groups, but only 1.5% and 0.1% in the MV + 0.8 FA group in early pregnancy. Compared with the non-FA group, HDCP and preeclampsia had the lowest risk in the MV + 0.8 FA group among the seven FA supplementation groups (HDCP: RR = 0.42, 95% CI = 0.27-0.68, P = 0.001 ; preeclampsia: RR = 0.09, 95% CI = 0.03–0.33, P = 0.001) in early pregnancy. Compared with the 0.4 FA alone group, the risk of HDCP and preeclampsia in women taking MV + 0.8 FA was significantly reduced (RR = 0.60, 95% CI = 0.41–0.87, P = 0.008 ; preeclampsia: RR = 0.18, 95% CI = 0.06–0.60, P = 0.005) in early pregnancy. (MV + FA)/BMI supplementation was associated with the risk of HDCP in early pregnancy (P trend = 0.002). Conclusions. MV supplement with 0.8 mg FA during early pregnancy may be effective in reducing HDCP and preeclampsia risk. The study provided the viewpoint that (MV + FA)/BMI could be used as a reference for FA intake in pregnant women of different weights. [ABSTRACT FROM AUTHOR]