Objectives: Approximately 17% of Japanese women have hemoglobin concentrations less than 12 g/dL. Therefore, anemia prevention and early intervention are crucial public health issues in Japan. This study aimed to identify the symptoms and characteristics of anemic individuals in the general adult population by comparing survey responses of individuals with anemia and without anemia visiting blood donation centers.Materials and Methods: This cross-sectional study used self-administered questionnaires. Individuals who visited two Japanese Red Cross Society blood donation centers in Fukushima Prefecture, Japan were included. Hemoglobin levels were measured at blood donation, and the levels of 13 g/dL for men and 12 g/dL for women were defined as anemia.Results: Of the 857 individuals analyzed, 530 were men and 327 were women, of whom 19 (3.6%) and 12 (3.7%) had low hemoglobin levels, respectively. Logistic regression analysis was performed in men, and the results showed that “lightheadedness” (odds ratio [OR]=8.4) and “depressive symptoms” (OR=3.6) were significantly associated with hemoglobin levels. None of the evaluated items were significantly associated with hemoglobin levels in women.Conclusion: Among healthy Japanese men, those who exhibit lightheadedness and depressive symptoms have an increased risk of anemia. Lightheadedness and depressive symptoms may be indicative of undiagnosed anemia in men, which necessitates greater clinical attention.

Background/Aims: PF-00547659 is a monoclonal antibody against human mucosal addressin cell adhesion molecule-1 (MAdCAM-1) that prevents the binding of α4β7+ lymphocytes to MAdCAM-expressing sites in the gastrointestinal tract with high affinity and selectivity, and is being developed for the treatment of Crohn’s disease (CD). Methods: OPERA is a randomized, multicenter, double-blind, placebo-controlled study to investigate the efficacy, safety, and pharmacokinetics of PF-00547659 following subcutaneous administration in subjects with active CD, a history of failure or intolerance to anti-tumor necrosis factor and/or immunosuppressants, high-sensitivity C-reactive protein > 3.0 mg/L, and ulcers on colonoscopy. The primary endpoint was Crohn’s Disease Activity Index-70 response at week 8 or 12. Subpopulation analyses for Asian subjects were performed as some differences are observed in genetics and clinical phenotypes in Asian CD patients compared with Western patients. Results: In this study, 265 CD subjects were randomized, with a subpopulation of 21 subjects (8 Japanese and 13 Korean) defined as the Asian population. In the overall and Asian populations; PF-00547659 was pharmacologically active as evidenced by soluble MAdCAM and circulating β7+ central memory CD4+ T-lymphocytes, although no clear evidence of efficacy was observed in any clinical endpoints; pharmacokinetics of PF-00547659 in the Asian subpopulation was generally comparable to the overall population; and the safety profile of PF-00547659 appeared acceptable up to 12 weeks of treatment. Conclusions In the overall and Asian populations, efficacy of PF-00547659 could not be demonstrated using any clinical endpoints compared with placebo. Pharmacokinetics and safety of PF-00547659 were generally comparable. Further studies with larger numbers of patients are required to confirm our results. (Trial Registration Number: NCT01276509)