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Ohta S.,Taga General Hospital | Tsuru T.,Medical Co. LTA | Shono E.,Shono Rheumatology Clinic
Japanese Pharmacology and Therapeutics | Year: 2013

Objective: The objective of this study is to assess pain during the subcutaneous injection of tocilizumab (TCZ-SC) using physiological saline as the control in patients with rheumatoid arthritis. Method: Either TCZ-SC (81 mg or 162 mg/2 weeks) or saline at corresponding volumes was injected at a 5-min interval to the right or left abdominal part of total 20 patients with rheumatoid arthritis. Immediately after each injection, the pain at the injection sites was assessed by order and using Wong-Baker Face Pain Rating Scale (FS) and visual analog scale (VAS). Results: Twenty patients (8 in 81 mg dose group and 12 in 162 mg dose group) were included in this study. No difference was observed in pains at the injection sites of TCZ-SC and saline expressed by injection order, FS scores and VAS ; thus in the analysis of injection order, patients who felt pain more in TCZ-SC were 50% in the 81 mg dose group and 58.3% in 162 mg dose group. In the analysis of variance of FS scores, the average values (95% CI) of the difference between TCZ-SC and saline were 0.00 ( -1.60 to 1.60) in the 81 mg dose group and 0.33 (-0.49 to 1.16) in the 162 mg dose group. In the analysis of variance of VAS, the average values (95% CI) of the difference between TCZ-SC and saline were -12.4 mm (-40.5 to 15.8 mm) in the 81 mg dose group and 7.9 mm ( -13.2 to 29.1 mm) in the 162 mg dose group. Conclusion: Since there was not observed significant difference in pain at the injection sites between TCZ-SC groups and saline group, high adherence of injection can be expected for the present TCZ-SC.

Hara M.,Saga University | Fukuoka M.,Saga Ken Medical Center Koseikan | Tashiro K.,Saga University | Ozaki I.,Saga University | And 6 more authors.
BMC Infectious Diseases | Year: 2015

Background: Recent studies worldwide have reported increasing numbers of adults diagnosed with Bordetella pertussis despite receiving childhood vaccinations. This study describes a pertussis outbreak at a university medical faculty campus and examines the effectiveness of diphtheria, tetanus, and pertussis (DTaP) vaccination completed during infancy in Japan. Methods: After the outbreak, self-administered questionnaires and serum samples were collected from students on campus to determine the incidence of pertussis and underlying diseases. Pertussis was diagnosed on the basis of clinical criteria and serum anti-pertussis toxin antibody levels. Using data collected from 248 first and second grade students who had submitted copies of their vaccination records, we evaluated the effectiveness of DTaP vaccination in infancy against adult pertussis. Results: Questionnaire responses were obtained from 636 students (of 671 registered students; 95% response rate). Of 245 students who reported a continuous cough during the outbreak period, 84 (attack rate: 13.2%) were considered "probable" pertussis cases that met clinical criteria. The outbreak occurred mainly in first and second grade students in the Faculty of Medicine. Of 248 students who provided vaccination records, 225 had received 4 DTaP doses (coverage: 90.7%); the relative risk of the complete vaccination series compared to those with fewer than 4 doses or no doses for probable cases was 0.48 (95% confidence interval: 0.24-0.97). Conclusions: Waning protection was suspected due to over time. Booster vaccination for teenagers and development of highly efficacious pertussis vaccines are needed. © 2015 Hara et al.; licensee BioMed Central.

Ohfuji S.,Osaka City University | Okada K.,Fukuoka Dental College | Nakano T.,Kawasaki Medical School | Ito H.,Japan National Institute of Infectious Diseases | And 4 more authors.
Vaccine | Year: 2015

In 2008, the number of pertussis cases increased substantially among Japanese adolescents, despite high coverage with acellular pertussis vaccine (DTaP). This study examined the effectiveness of DTaP vaccine in the routine immunization program in Japan. Between April 2009 and October 2012, we conducted a multicenter, case-control study, and compared the history of DTaP vaccination between 55 newly diagnosed pertussis cases and 90 age- and sex-matched controls. DTaP vaccine history was obtained by a self-administered questionnaire completed by their parents or guardians. Logistic regression models were used to calculate odds ratios (ORs) and 95% confidence intervals (CIs) of vaccination for development of pertussis. DTaP vaccination of ≥1 dose revealed a significantly lower OR for pertussis (OR = 0.20, 95%CI, 0.04-0.97), and the OR of complete vaccination (4 doses) was 0.22 (0.04-1.05). Even after limiting subjects to those whose vaccination status could be confirmed by the immunization records, the negative associations were observed. The decreasing ORs of 4-dose vaccinees remained, even among subjects who had received the fourth dose ≥9.2 years earlier (OR = 0.11, 95%CI, 0.01-1.02). In conclusion, DTaP vaccination had a preventive effect for pertussis. Effectiveness was observed even 9 or more years after the final dose. © 2015 Elsevier Ltd.

Iitsuka H.,Astellas Pharma Inc. | Tokuno T.,Astellas Pharma Inc. | Amada Y.,Astellas Pharma Inc. | Matsushima H.,Astellas Pharma Inc. | And 6 more authors.
Clinical Drug Investigation | Year: 2014

Background: Mirabegron is a human β3-adrenoceptor agonist for the treatment of overactive bladder. The pharmacokinetic profile of mirabegron has been extensively characterized in healthy Caucasian subjects. Objective: The objective of this study was to evaluate the pharmacokinetics, dose-proportionality, and tolerability of mirabegron following single and multiple oral doses in healthy Japanese male subjects. The results were compared with those reported in non-Japanese (primarily Caucasian) subjects. Methods: Two studies were conducted. In a single-blind, randomized, placebo-controlled, parallel-group, single- and multiple-ascending dose study (Study 1), mirabegron oral controlled absorption system (OCAS) tablets were administered at single doses of 50, 100, 200, 300, and 400 mg, with eight subjects (six active, two placebo) per dose group (Part I), and once daily for 7 days at 100 and 200 mg with 12 subjects (eight active, four placebo) per group (Part II). In an open-label, three-period, single-ascending dose study (Study 2), mirabegron OCAS was administered to 12 subjects at 25, 50, and 100 mg in an intra-subject dose-escalation design. Plasma and/or urine samples were collected up to 72 h after the first and last dose and analyzed for mirabegron. Pharmacokinetic parameters were determined using non-compartmental methods. Tolerability assessments included physical examinations, vital signs, 12-lead electrocardiogram, clinical laboratory tests (biochemistry, hematology, and urinalysis), and adverse event (AE) monitoring. Results: Forty and 24 young male subjects completed Part I and II, respectively, of Study 1. Twelve young males completed Study 2. After single oral doses (25-400 mg), maximum plasma concentrations (C max) were reached at approximately 2.8-4.0 h postdose. Plasma exposure (C max and area under the plasma concentration-time curve) of mirabegron increased more than dose proportionally at single doses of 25-100 mg and approximately dose proportionally at high doses of 300 and 400 mg. A more than dose proportional increase in plasma exposure was noted in the body of the same individual. Mirabegron accumulated twofold upon once-daily dosing relative to single-dose data. Steady state was reached within 7 days. Mirabegron was generally well-tolerated at single doses up to 400 mg and multiple doses up to 200 mg. The AE with the highest incidence was increased pulse rate at 400 mg in Study 1. Conclusions: Mirabegron OCAS exhibits similar single- and multiple-dose pharmacokinetic characteristics and deviations from dose proportionality in healthy Japanese male subjects compared with those observed in non-Japanese (primarily Caucasian) subjects in previous studies. © 2013 The Author(s).

Hiroi S.,Osaka Prefectural Institute of Public Health | Morikawa S.,Osaka Prefectural Institute of Public Health | Nakata K.,Osaka Prefectural Institute of Public Health | Maeda A.,Osaka City University | And 5 more authors.
Human Vaccines and Immunotherapeutics | Year: 2015

To evaluate antibody response induced by trivalent inactivated influenza vaccine (TIV) against circulating influenza A(H3N2) strains in healthy adults during the 2010/11 and 2011/12 seasons, a hemagglutination-inhibition (HI) assay wasutilized to calculate geometric mean antibody titer (GMT), seroprotection rate (post vaccination HI titers of ≥ 1 :40), andseroresponse rate (4-fold increase in antibody level). In the 2010/11 season, GMT increased 1.8- to 2.0-fold following thefirst dose of TIV against 3 circulating strains and 2.2-fold following the second compared to before vaccination. Theseroresponse rate ranged from 22% to 26% following the first dose of TIV and from 31% to 33% following the second(n = 54). The seroprotection rate increased from a range of 6% to 13% to a range of 26% to 33% following the firstdose of TIV and to a range of 37% to 42% following the second (n = 54). In the 2011/12 season, GMT increased 1.4-foldagainst A/Osaka/110/2011 and 1.8-fold against A/Osaka/5/2012. For A/Osaka/110/2011, the seroresponse rate was 29%,and the seroprotection rate increased from 26% to 55% following vaccination (n = 31). For A/Osaka/5/2012, theseroresponse rate was 26%, and the seroprotection rate increased from 68% to 84% following vaccination (n = 31). HIassays with reference antisera demonstrated that the strains in the 2011/12 season were antigenically distinct fromvaccine strain (A/Victoria/210/2009). In conclusion, the vaccination increased the seroprotection rate against circulatingH3N2 strains in the 2010/11 and 2011/12 seasons. Vaccination of TIV might have potential to induce reactive antibodiesagainst antigenically distinct circulating H3N2 viruses. © 2015 Taylor & Francis Group, LLC.

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