This post-marketing study confirmed the clinically meaningful benefits of omalizumab in a majority of patients from Japan, and showed safety and efficacy in a real-life clinical setting to be consistent with previous reports.

Although the global economic burden of asthma is well described, detailed data regarding Asia, particularly for Japan, are relatively scarce. This retrospective study aims to fill this evidence gap by evaluating asthma-associated healthcare resource utilization (HCRU) and economic burden in Japanese patients aged ≥16 years, identified using anonymized patient data from the Japan Medical Data Center (JMDC) database from April 2009 to March 2015. Asthma severity was classified according to asthma treatment guidelines from the Japanese Society of Allergology. HCRU was calculated based on hospitalizations, emergency room visits, outpatient visits, and prescriptions. Incidence rate ratios (IRRs) for HCRU and per-patient-per-year direct costs were reported. In addition, differences across HCRU and cost variables for severe versus non-severe asthma patients were also compared. Of 541,434 asthma cases identified from the JMDC database during the study period, 54,433 patients who met the inclusion criteria were included in this analysis. HCRU and costs were heavily concentrated within severe asthma, a subgroup comprising 12.7% of total study population. Moreover, patients with severe asthma had significantly higher all-cause hospitalizations, outpatient visits, outpatient prescriptions (IRR [95% CI], 1.60 [1.46–1.76]; 1.43 [1.41–1.45]; 1.24 [1.22–1.25], respectively), and total medical costs (mean ± SD costs, US$ 4345 ± 11,104 versus US$ 1528 ± 3989, P < 0.001 ( t -test); US$ 1 = 110 JPY) compared with those with non-severe asthma. The burden of asthma is significantly and disproportionately concentrated in Japanese severe asthma patients, suggesting clinical failure to achieve adequate disease control. This study highlights the unmet needs for severe asthma in Japan and provides a catalyst for important dialogues in advancing public health.

Childhood asthma is one condition within a family of allergic diseases, which includes allergic rhinitis, atopic dermatitis, and food allergy, among others. Omalizumab is an anti-IgE antibody therapy that was approved in Japan for children with asthma and added to the Japanese pediatric asthma guidelines in 2017. This review highlights the Japanese clinical perspectives in pediatric allergic asthma, and consideration for allergic comorbidities, and reflects on omalizumab clinical trials in progress to present comprehensive future opportunities.

ObjectiveWe report the 2-year visual and psychological outcomes of the MERCURY study, examining the long-term effectiveness and safety of ranibizumab and subsequent therapy in Japanese patients with diabetic macular oedema with impaired visual acuity (VA) in the real-world setting.Methods and analysisThis was a 24-month, phase 4, open-label, single-arm, multicentre, prospective, observational study. Following an initial dose of ranibizumab (0.5 mg) by intravitreal injection (0.05 mL), treatment was administered as needed after month 1. The primary treated eye (PTE) was the first eye that received a ranibizumab injection.ResultsIn total, 209 patients were enrolled; 192 (91.9%) and 174 (83.3%) completed months 12 and 24, respectively. In the PTE set, mean±SD changes in best-corrected VA (BCVA) from baseline to months 12 (primary endpoint) and 24 were −0.08±0.35 (p=0.015) and −0.13±0.30 (p<0.001) logarithmic minimum angle of resolution, respectively. Mean±SD central subfoveal thickness (CSFT) changes from baseline to months 12 and 24 were −102.3±146.1 µm (p<0.001) and −103.6±157.2 µm (p<0.001), respectively. Patients receiving three injections during the first 2 months had greater BCVA improvements throughout the study than those receiving 1–2 consecutive injections. Overall, 91 (43.5%) and 130 (62.2%) patients had ocular and non-ocular adverse events, respectively. At month 24, the mean±SD Hospital Anxiety and Depression Scale (HADS)-Anxiety and HADS-Depression scores decreased by 0.44±3.75 (p=0.196) and 0.19±3.38 (p=0.541), respectively.ConclusionsAt 24 months after initiation of ranibizumab and subsequent treatment, patients showed significant BCVA and CSFT improvements. Long-term treatment was considered safe and tolerable and did not lead to worsened psychological status.

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