Ogata A.,Osaka University |
Tanimura K.,Hokkaido Medical Center for Rheumatic Diseases |
Sugimoto T.,National Hospital Organization |
Inoue H.,Inoue Hospital |
And 9 more authors.
Arthritis Care and Research | Year: 2014
Objective To evaluate the efficacious noninferiority of subcutaneous tocilizumab injection (TCZ-SC) monotherapy to intravenous TCZ infusion (TCZ-IV) monotherapy in Japanese patients with rheumatoid arthritis (RA) with an inadequate response to synthetic and/or biologic disease-modifying antirheumatic drugs (DMARDs). Methods This study had a double-blind, parallel-group, double-dummy, comparative phase III design. Patients were randomized to receive TCZ-SC 162 mg every 2 weeks or TCZ-IV 8 mg/kg every 4 weeks; no DMARDs were allowed during the study. The primary end point was to evaluate the noninferiority of TCZ-SC to TCZ-IV regarding the American College of Rheumatology criteria for 20% improvement in disease activity (ACR20) response rates at week 24 using an 18% noninferiority margin. Additional efficacy, safety, pharmacokinetic, and immunogenicity parameters were assessed. Results At week 24, ACR20 response was achieved in 79.2% (95% confidence interval [95% CI] 72.9, 85.5) of the TCZ-SC group and in 88.5% (95% CI 83.4, 93.5) of the TCZ-IV group; the weighted difference was -9.4% (95% CI -17.6, -1.2), confirming the noninferiority of TCZ-SC to TCZ-IV. Remission rates of the Disease Activity Score in 28 joints using the erythrocyte sedimentation rate and the Clinical Disease Activity Index at week 24 were 49.7% and 16.4% in the TCZ-SC group and 62.2% and 23.1% in the TCZ-IV group, respectively. Serum trough TCZ concentrations were similar between the groups over time. Incidences of all adverse events and serious adverse events were 89.0% and 7.5% in the TCZ-SC group and 90.8% and 5.8% in the TCZ-IV group, respectively. Anti-TCZ antibodies were detected in 3.5% of the TCZ-SC group; no serious hypersensitivity was reported in these patients. Conclusion TCZ-SC monotherapy demonstrated comparable efficacy and safety to TCZ-IV monotherapy. TCZ-SC could provide additional treatment options for patients with RA. © 2014 The Authors. Arthritis Care & Research is published by Wiley Periodicals, Inc. on behalf of the American College of Rheumatology.
Takeuchi T.,Keio University |
Yamanaka H.,Tokyo Women's Medical University |
Tanaka Y.,University of Occupational and Environmental Health Japan |
Sakurai T.,Inoue Hospital |
And 4 more authors.
Modern Rheumatology | Year: 2015
Objectives. To demonstrate the pharmacokinetic equivalence of CT-P13 and its innovator infliximab (IFX) in Japanese patients with rheumatoid arthritis (RA), and to compare the efficacy and safety of these drugs, administered for 54 weeks. Methods. In a randomized, double-blind, parallel-group, multicenter study, 3 mg/kg of CT-P13 or IFX, in combination with methotrexate (MTX) (6-16 mg/week), was administered for 54 weeks to Japanese active RA patients with an inadequate response to MTX, to demonstrate the pharmacokinetic equivalence, based on the area under the curve (AUCτ) (weeks 6-14) and Cmax (week 6) of these drugs, and to compare their efficacy and safety. Results. The CT-P13-to-IFX ratios (90% confidence intervals) of the geometric mean AUCτ and Cmax values in patients negative for antibodies to infliximab at week 14 were 111.62% (100.24-124.29%) and 104.09% (92.12-117.61%), respectively, demonstrating the pharmacokinetic equivalence of these drugs. In the full analysis set, CT-P13 and IFX showed comparable therapeutic effectiveness, as measured by the American College of Rheumatology, Disease Activity Score in 28 joints, the European League Against Rheumatism, and other efficacy criteria, at weeks 14 and 30. The incidence of adverse events was similar for these drugs. Conclusion. CT-P13 and IFX, administered at a dose of 3 mg/kg in combination with MTX to active RA patients, were pharmacokinetically equivalent and comparable in efficacy and safety. © 2015 The Author(s). Published by Japan College of Rheumatology.
PubMed | Isesaki Fukushima Hospital, Takasaki University of Health and Welfare, Gunma University and Inoue Hospital
Type: Journal Article | Journal: Rheumatology international | Year: 2016
The present retrospective study investigated the relationship between [(18)F]fluorodeoxyglucose-positron emission tomography (FDG-PET) findings and subsequent progression of joint destruction on plain X-ray. Nineteen rheumatoid arthritis (RA) patients (59 joints) who underwent FDG-PET and whose joints could be evaluated on plain X-ray 5 years later were included in this retrospective investigation. The relationship between the standardized uptake value (SUV) on FDG-PET and Larsen grade progression on plain X-ray was investigated for each joint. Factors related to progression of joint destruction were also investigated. Joints with advanced joint destruction (Larsen grades IV and V) on X-ray imaging at the time of FDG-PET were excluded. On initial plain X-ray images taken at the time of FDG-PET, a significant correlation was observed between the initial SUV of each joint and the progression of joint destruction 5 years later (R = 0.47, P < 0.01). Significant correlations between the SUV and progression of joint destruction were observed in both load-bearing (R = 0.52, P < 0.01) and non-load-bearing joints (R = 0.52, P < 0.01). On logistic regression analysis, higher SUV and lower prednisolone dose were associated with greater risk of progressive joint destruction (P < 0.05). On receiver operating characteristics curve analysis, the optimum threshold for identifying preceding joint destruction was an SUVmean of 1.33. In RA joints, FDG uptake was seen mostly by inflammatory cells; therefore, FDG uptake reflected joint inflammation. Additionally, the activity seen on FDG-PET might be associated with future radiographic changes in RA patients.
Tsujimoto Y.,Inoue Hospital |
Tahara H.,Osaka City University |
Shoji T.,Osaka City University |
Emoto M.,Osaka City University |
And 5 more authors.
Clinical Journal of the American Society of Nephrology | Year: 2011
Background and objectives Vitamin D has gained attention for its pleiotropic effects in areas other than bone metabolism, and the effects of vitamin D in preventing respiratory infections have been reported as one of its immunomodulating properties. This study assessed the preventive effect of vitamin D receptor activator (VDRA) on respiratory infections in dialysis patients. Design, setting, participants, & measurements Maintained Japanese hemodialysis patients (n = 508) were observed for 5 years, and the incidence of hospitalization during this period because of acute respiratory infection (ARI) was recorded. Results: Of the 508 patients, 212 had taken oral VDRA at the start of the study, whereas 296 patients had not received it. During the 5-year follow-up period, 57 patients were hospitalized because of ARIs. Kaplan-Meier analysis revealed that the incidence of hospitalization because of respiratory infection was significantly lower in patients who had been treated with VDRA compared with patients who had not (log ranktest; P = 0.02). The multivariate Cox proportional hazards model demonstrated that the patients who had taken oral VDRA were at a significantly lower risk of hospitalization because of respiratory disease (hazardratio 0.47, 95% confidence interval 0.25 to 0.90).Conclusions: The findings of this study suggest that the administration of oral VDRA has a preventive effecton the incidence of ARIs in dialysis patients. © 2011 by the American Society of Nephrology.
Shoji T.,Osaka City University |
Kakiya R.,Osaka City University |
Kakiya R.,Inoue Hospital |
Hayashi T.,Osaka City University |
And 11 more authors.
American Journal of Kidney Diseases | Year: 2013
Background: Unlike the n-6 polyunsaturated fatty acid (PUFA) arachidonic acid (AA), n-3-PUFAs such as eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) appear to have beneficial effects on inflammation, thrombosis, and cardiovascular disease (CVD). We examined possible alterations in serum PUFA profiles in patients on maintenance hemodialysis therapy and its association with CVD risk. Study Design: An observational study including cross-sectional and longitudinal analyses. Setting & Participants: Single-center study of 517 maintenance hemodialysis patients in an urban area in Japan. Predictors: Serum EPA, DHA, and AA concentrations and EPA:AA, DHA:AA, and (EPA+DHA):AA ratios. Outcomes: CVD events, including ischemic heart disease, stroke, peripheral artery disease, pulmonary edema, and valve disease. Results: Hemodialysis patients showed lower (EPA+DHA):AA, EPA:AA, and DHA:AA ratios than 122 controls similar in age and sex. During follow-up, 190 CVD events were recorded. (EPA+DHA):AA ratio was not associated significantly with CVD in unadjusted analysis, but was associated significantly and inversely with CVD in Cox models adjusted for age and other confounding variables, with HRs in the range of 1.71-1.99 in the lowest versus highest quartile of (EPA+DHA):AA ratios. Similarly, EPA:AA and DHA:AA ratios showed inverse associations with CVD, whereas serum EPA, DHA, and AA concentrations were not predictive of CVD. Limitations: No information for dietary intake, use of dietary supplements, or cell membrane PUFA content. Conclusions: In hemodialysis patients, serum PUFA profile is unfavorably altered, and the low n-3-PUFA:AA ratios are independent predictors of CVD. © 2013 National Kidney Foundation, Inc.
Nishikawa T.,Inoue Hospital
Kyobu geka. The Japanese journal of thoracic surgery | Year: 2012
A 82-year-old man consulted for therapy for lung cancer in March 2010. Chest computed tomography (CT) showed a mass in right lower lobe of the lung. Fluorodeoxyglucose-positron emission tomography (FDG-PET) showed the accumulation in the mass. Lung cancer was strongly suspected and anticancer chemotherapy was started. The patient complained of difficulty in swallowing in August 2011. Gastroendoscopy revealed a submucosal mass in the gastric corpus. The specimen from the mass showed gastric metastasis from lung cancer on pathological study. The case of gastric metastasis from lung cancer is rare. When we concern the patient of lung cancer, it should be considered gastric metastasis.
Shiga Y.,Fukuoka University |
Miura S.-I.,Fukuoka University |
Mitsutake R.,Fukuoka University |
Uehara Y.,Fukuoka University |
And 2 more authors.
JRAAS - Journal of the Renin-Angiotensin-Aldosterone System | Year: 2012
Objective: Losartan/hydrochlorothiazide (HCTZ) (Preminent®) is a fixed-dose combination of angiotensin II receptor blocker (ARB) and the thiazide diuretic HCTZ that has consistently been shown to be more effective than either losartan or HCTZ. Little is known about the relationship between losartan/HCTZ and blood levels of brain natriuretic peptide (BNP).Methods and results: In this study, 44 patients with hypertension who were being treated with ARB were enrolled. The ARB was changed to losartan/HCTZ because of uncontrolled hypertension. Blood pressure (BP), pulse rate (PR), plasma levels of BNP and other biochemical parameters were analyzed at baseline and 6 and 12 months after the change from ARB. Of the total 44 patients, 33 (75%) achieved the target BP at 12 months. While there was no significant change in PR, systolic and diastolic BP were significantly reduced (-23 ± 3 mmHg and -10 ± 2 mmHg, respectively) during this period. Although there were no significant changes in biochemical parameters, plasma levels of BNP were significantly decreased, especially in patients who had higher levels of BNP at baseline, during this period.Conclusion: Losartan/HCTZ therapy significantly reduced not only BP but also plasma levels of BNP in patients with hypertension. These findings suggest that losartan/HCTZ might have cardioprotective effects in patients with higher levels of BNP. © The Author(s) 2011.
Suzuki M.,Nagasaki University |
Yoshimine H.,Inoue Hospital |
Harada Y.,Nagasaki University |
Harada Y.,Inoue Hospital |
And 4 more authors.
PLoS ONE | Year: 2013
Background: Influenza vaccine effectiveness (VE) studies are usually conducted by specialized agencies and require time and resources. The objective of this study was to estimate the influenza VE against medically attended influenza using a test-negative case-control design with rapid influenza diagnostic tests (RIDT) in a clinical setting. Methods: A prospective study was conducted at a community hospital in Nagasaki, western Japan during the 2010/11 influenza season. All outpatients aged 15 years and older with influenza-like illnesses (ILI) who had undergone RIDT were enrolled. A test-negative case-control design was applied to estimate the VEs: the cases were ILI patients with positive RIDT results and the controls were ILI patients with negative RIDT results. Information on patient characteristics, including vaccination histories, was collected using questionnaires and medical records. Results: Between December 2010 and April 2011, 526 ILI patients were tested with RIDT, and 476 were eligible for the analysis. The overall VE estimate against medically attended influenza was 47.6%, after adjusting for the patients' age groups, presence of chronic conditions, month of visit, and smoking and alcohol use. The seasonal influenza vaccine reduced the risk of medically attended influenza by 60.9% for patients less than 50 years of age, but a significant reduction was not observed for patients 50 years of age and older. A sensitivity analysis provided similar figures. Conclusion: The test-negative case-control study using RIDT provided moderate influenza VE consistent with other reports. Utilizing the commonly used RIDT to estimate VE provides rapid assessment of VE; however, it may require validation with more specific endpoint. © 2013 Suzuki et al.
Suzuki M.,Nagasaki University |
Minh L.N.,Nagasaki University |
Yoshimine H.,Inoue Hospital |
Inoue K.,Inoue Hospital |
And 3 more authors.
PLoS ONE | Year: 2014
The objective of this study was to estimate influenza vaccine effectiveness (VE) against medically attended, laboratoryconfirmed influenza during the 2011-2012 season in Japan using a test-negative case-control study design. The effect of cocirculating non-influenza respiratory viruses (NIRVs) on VE estimates was also explored. Nasopharyngeal swab samples were collected from outpatients with influenza-like illnesses (ILIs) in a community hospital in Nagasaki, Japan. Thirteen respiratory viruses (RVs), including influenza A and B, were identified from the samples using a multiplex polymerase chain reaction. The difference in VE point estimates was assessed using three different controls: ILI patients that tested negative for influenza, those that tested negative for all RVs, and those that tested positive for NIRVs. The adjusted VE against medically attended, laboratory-confirmed influenza using all influenza-negative controls was 5.3% (95% confidence interval [CI], -60.5 to 44.1). The adjusted VEs using RV-negative and NIRV-positive controls were -1.5% (95% CI, -74.7 to 41) and 50% (95% CI, -43.2 to 82.5), respectively. Influenza VE was limited in Japan during the 2011-2012 season. Although the evidence is not conclusive, co-circulating NIRVs may affect influenza VE estimates in test-negative case-control studies. Copyright: © 2014 Suzuki et al.
PubMed | Inoue Hospital and Nagasaki University
Type: Journal Article | Journal: Journal of oral rehabilitation | Year: 2016
Obstructive sleep apnoea-hypopnea (OSAH) is a common disorder characterised by repetitive complete or partial closure of the upper airway during sleep, which results in sleep fragmentation and oxygen desaturation. There is growing interest in the use of oral appliances (OAs) to treat OSAH. The purpose of this study was to clarify the cephalometric factors that are associated with OSAH severity and that predict the outcome of OA therapy. Two hundred nine patients with OSAH were recruited and analysed retrospectively. They had a polysomnographically documented apnoea-hypopnea index (AHI) of more than five respiratory events per hour. Lateral skull radiographs were used for cephalometric analysis. Only 67 of the 209 recruited patients underwent a second polysomnography (PSG) to evaluate the efficacy of OA therapy. In all recruited patients, the angle formed by the subspinal point (A) to the nasion (N) to the supramental point (B) (i.e. ANB angle) and the distance between the mandibular plane and hyoid bone (MP-H) were predictive factors of OSAH severity. In only 67 patients underwent PSG with an OA, the mean rate of decrease in the AHI was 478 291%. OA therapy effectively treated OSAH in some patients with a very severe form of OSAH. However, patients who had a high position of the hyoid bone had a poor response to OA therapy. This study suggested that cephalometric analysis is useful for predicting OSAH severity and OA therapy efficacy.