Background Baloxavir marboxil (baloxavir), an anti-influenza drug with a novel mechanism of action, is expected to reduce influenza transmission by rapid reduction of viral load. The incidence of household transmission was compared between index patients (IPs) treated with baloxavir and those with neuraminidase inhibitors. Methods Using a Japanese claims database provided by JMDC Inc., the first family members with influenza diagnosis during 2018/2019 influenza season were identified as IPs, and the diagnosis date was designated Day 1. According to the anti-influenza drug dispensed to the IP, their families were classified into oral baloxavir group and three controls; oral oseltamivir group (a primary control), inhaled zanamivir group, and inhaled laninamivir group. A household transmission was defined as influenza diagnosed for any non-IP family members during Days 3−8. The incidence of household transmission was compared between groups using a logistic regression model adjusting backgrounds of IPs. Results The proportion of families with household transmission was 17.98% (15,226/84,672) in the baloxavir group and 24.16% (14,983/62,004) in the oseltamivir group. The covariate-adjusted odds ratio (oseltamivir/baloxavir) was 1.09 [95% confidence interval, 1.05–1.12], which indicated significantly lower incidence in the baloxavir group. Adjusted odds ratios (controls/baloxavir) against zanamivir and laninamivir were 0.93 [0.89–0.97] and 0.99 [0.96–1.02], respectively. Conclusions Baloxavir may contribute to reduce the incidence of household transmission compared with oseltamivir, which is widely used for oral influenza treatment. In comparison between baloxavir and inhalants, a similar reduction was not shown and it might be due to unmeasured confounding by administration route differences.

Background Baloxavir marboxil (baloxavir) is a single-dose, oral anti-influenza drug with a novel mechanism of action. We compared the incidence of hospitalization in patients treated with baloxavir versus neuraminidase inhibitors. Methods This was a retrospective observational cohort study using real-world patient data extracted from a Japanese health insurance claims database. The enrollment period was October 1, 2018 to April 17, 2019. On day 1, eligible patients (N = 339 007) received baloxavir, oseltamivir, zanamivir, or laninamivir. Baseline characteristics were standardized using the inverse probability of treatment weighting method. Primary end point was the incidence of hospitalization (days 2–14). Secondary end points included antibacterial use, secondary pneumonia, and additional anti-influenza drug use. Results Compared with the baloxavir group, the incidence of hospitalization was greater in the oseltamivir group (risk ratio [RR] and 95% confidence interval [CI], 1.41 [1.00–2.00]; risk difference [RD] and 95% CI, 0.06 [0.01–0.12]) and zanamivir group (RR, 1.85 [1.23–2.78]; RD, 0.11 [0.02–0.20]). Oseltamivir-treated patients were less likely to require antibacterials than baloxavir-treated patients (RR, 0.87 [0.82–0.91]). However, oseltamivir-treated patients were more likely to be hospitalized with antibacterials (RR, 1.70 [1.21–2.38]) or antibacterial injection (RR, 1.67 [1.17–2.38]) than baloxavir-treated patients (post hoc analysis). Compared with baloxavir-treated patients, additional anti-influenza drug use was greater in oseltamivir-, zanamivir-, and laninamivir-treated patients (RR, 1.51 [1.05–2.18], 2.84 [2.04–3.96], and 1.68 [1.35–2.10], respectively). Conclusions Baloxavir is an efficacious anti-influenza treatment that may reduce hospitalization compared with oseltamivir and zanamivir.

Purpose The objective of this post hoc analysis was to explore the relationship, including changes over time, between baseline clinical symptom characteristics and working ability, judged by investigators, after 12 weeks of antidepressant monotherapy in Japanese patients with major depressive disorder (MDD) and painful physical symptoms (PPS) in a real-world clinical setting. Patients and Methods This prospective, observational study in patients treated with duloxetine or selective serotonin reuptake inhibitors was conducted from 2014 to 2016. Both treatment groups were pooled and divided into 2 groups, “working ability recovered” or “working ability not recovered,” based on working ability at the end of the study. Patients were also divided into 4 subgroups by the presence or absence of previous depressive episodes and working ability. Main outcome measures included baseline demographics and clinical characteristics, and the 17-item Hamilton Rating Scale for Depression (HAM-D17). Results Comparison between “working ability recovered” (n=122) and “working ability not recovered” (n=91) showed that the percentage of patients with complications and psychotherapy at baseline, and baseline HAM-D17 total, insomnia, somatic, and anxiety scores, were significantly different. The results of subgroup analyses were mostly the same as the results analyzed by working ability alone. Although statistical differences were observed for some outcome measures, the differences at baseline, except use of psychotherapy, may not be applicable clinically, and there were no specific trends observed that could predict working ability. Conclusion This post hoc analysis suggested that most baseline clinical characteristics, including the presence or absence of previous depressive episodes, were not predictive of working ability recovery. However, the use of psychotherapy in parallel with antidepressant monotherapy may be positively associated with working ability recovery. All outcome measures improved over time, reinforcing the importance of continuous treatment and observation to improve and accurately judge working ability in patients with MDD and PPS.

No abstract