Flight Attendant Medical Research Institute

<h3>Objectives</h3> SB4 (Benepali, Brenzys) is a biosimilar of reference etanercept (ETN). In a randomised, double-blind, 52-week study, SB4 demonstrated comparable efficacy and safety to ETN in patients with rheumatoid arthritis (RA). The open-label extension period evaluated long-term efficacy, safety and immunogenicity when continuing SB4 versus switching from ETN to SB4. <h3>Methods</h3> In the randomised, double-blind phase, patients received weekly subcutaneous administration of 50 mg SB4 or ETN with background methotrexate for up to 52 weeks. Patients in the Czech Republic and Poland who completed the 52-week visit were enrolled in the open-label extension period and received SB4 for 48 additional weeks. Efficacy, safety and immunogenicity were assessed up to week 100. <h3>Results</h3> Of 245 patients entering the extension period, 126 continued to receive SB4 (SB4/SB4) and 119 switched to SB4 (ETN/SB4). American College of Rheumatology (ACR) response rates were sustained and comparable between SB4/SB4 and ETN/SB4 with ACR20 response rates at week 100 of 77.9% and 79.1%, respectively. Other efficacy results, including radiographic progression, were also comparable between the groups. After week 52, rates of treatment-emergent adverse events were 47.6% (SB4/SB4) and 48.7% (ETN/SB4); one patient/group developed non-neutralising antidrug antibodies. No cases of active tuberculosis or injection-site reactions were reported during the extension period. One patient (SB4/SB4) died of hepatic cancer. <h3>Conclusions</h3> SB4 was effective and well tolerated over 2 years in patients with RA. Efficacy, safety and immunogenicity were comparable between the SB4/SB4 and ETN/SB4 groups, showing no risk associated with switching patients from ETN to SB4. <h3>Trial registration number</h3> NCT01895309; 2012-005026-30

To determine whether early vascular aging may be present in flight attendants with remote in-cabin secondhand smoke (SHS) exposure. Twenty-six flight attendants with a history of in-cabin SHS exposure prior to the airline smoking bans were recruited. Pulse wave analysis, peripheral arterial tonometry, and brachial artery reactivity testing evaluated their arterial compliance and endothelial function. Flight attendants with remote in-cabin SHS exposure have normal blood pressure, pulse wave velocity, and reactive hyperemia index, but abnormal pulse pressure, augmentation index, flow-mediated dilation, and hyperemic mean flow ratio. These preliminary findings suggest that flight attendants with remote in-cabin SHS exposure have preclinical signs of accelerated vascular aging and raise new questions about the relationship between remote SHS exposure and vascular health.

To evaluate the impact of number of anomalous fetuses on the prevalence of very preterm births (< 32 weeks), very low birth weight (< 1,500 g), and small for gestational age (SGA) infants among their normal cotriplets. Cross-sectional study of United States triplet births from 1995 to 2000 using Matched Multiple Birth Files, comparing outcomes for triplet sets with no anomalous, 1 anomalous, and 2 anomalous fetuses. Chi-square test for trend and multiple logistic regression analyses, applying generalized estimating equations to account for correlation among cotriplets, were implemented. Of 34,881 matched triplets, 34,104 (97.8%) were nonanomalous (2.2% prevalence of fetal anomaly). Prevalence of very preterm birth (P < .001) and very low birth weight (P < .001), but not SGA (P = .52), among nonanomalous births increased significantly with number of anomalous cotriplets. The prevalence of very preterm birth was 44.1%, 54.8%, and 68.8%, respectively, as number of anomalous triplets per set increased from none to two. The prevalence of very low birth weight was 32.3%, 39.6%, and 62.0%, respectively. These trends remained unchanged after adjustment for correlation and potential confounding. Prevalence of triplet births with gestation less than 32 weeks and birth weight less than 1,500 g, but not SGA, among nonanomalous triplets increase linearly with number of anomalous members within triplet sets. III.