Comparison of the treatment status of patients with acute heart failure before and during the COVID-19 pandemic - Observational cohort study using Japanese administrative data.

BACKGROUND: There is a concern that the coronavirus disease 2019 (COVID-19) pandemic has led to underutilization of non-invasive positive pressure ventilation (NPPV) in patients with acute heart failure (HF). We investigated the alterations in clinical management of acute HF during the COVID-19 pandemic. METHODS AND RESULTS: This study was an observational study of patients treated in emergency care with acute HF, using a Japanese Administrative database for a period before and during the COVID-19 pandemic. Of the 9081 overall eligible patients, the ratio of patients receiving NPPV and tracheal intubation during to before the COVID-19 pandemic were 0.88 [95 % confidence interval (CI): 0.80, 0.96] and 1.38 (95 % CI: 1.11, 1.71), respectively. Propensity score matching in patients treated in COVID-19 receiving facilities and emergency declaration response areas showed that ratio of NPPV and tracheal intubation during to before the COVID-19 pandemic were 0.88 (95 % CI: 0.76, 1.03), and 1.65 (95 % CI: 1.19, 2.28), respectively. CONCLUSIONS: The implementation rate of NPPV decreased significantly in eligible patients, with a decreasing trend observed in patient populations in COVID-19 receiving facilities and emergency declaration response areas. Tracheal intubation increased in all populations.

Timing of Worsening Renal Function in Patients Hospitalized for Heart Failure Exacerbation Who Were Being Treated With Intravenous Diuretic Therapy.

BACKGROUND: This retrospective observational study investigated the incidence of worsening renal function (WRF) in patients hospitalized for heart failure (HF) and treated with intravenous diuretics in Japan.Methods and Results: Associations between WRF at any point and HF treatments, and the effects of WRF on outcomes were evaluated (Diagnosis Procedure Combination database). Of 1,788 patients analyzed (mean [±SD] age 80.5±10.2 years; 54.4% male), 641 (35.9%) had WRF during a course of hospitalization for worsening HF: 208 (32.4%) presented with WRF before admission (BA-WRF; estimated glomerular filtration rate decreased by ≥25% from baseline at least once between 30 days prior to admission and admission); 44 (6.9%) had WRF that persisted before and after admission (P-WRF); and 389 (60.7%) had WRF develop after admission (AA-WRF). Delayed initial diuretic administration, higher maximum doses of intravenous diuretics during hospitalization, and diuretic readministration during hospitalization were associated with a significantly higher incidence of AA-WRF. Patients with WRF at any time point were at higher risk of death during hospitalization compared with patients without WRF, with adjusted hazard ratios of 3.56 (95% confidence interval [CI] 2.23-5.69) for BA-WRF, 3.23 (95% CI 2.21-4.71) for AA-WRF, and 13.16 (95% CI 8.19-21.15) for P-WRF (all P<0.0001). CONCLUSIONS: Forty percent of WRF occurred before admission for acute HF; there was no difference in mortality between patients with BA-WRF and AA-WRF.

A retrospective study on tolvaptan prescription in clinical practice in patients with syndrome of inappropriate secretion of antidiuretic hormone (SIADH) using the Japanese claims database.

We aimed to survey the status of tolvaptan administration in routine clinical practice since the approval of a novel indication for treating syndrome of inappropriate secretion of antidiuretic hormone (SIADH) in Japan. Data from a population of 3,152 patients aged ≥18 years and diagnosed with SIADH between July 1, 2020 and June 30, 2021 were extracted from a Japanese database. Tolvaptan was administered to 586 patients while 2,566 patients were followed up without tolvaptan. In the tolvaptan-treated group, the standard initial doses were 3.75 mg and 7.5 mg in 290 (49.5%) and 250 (42.7%) patients, respectively. The dose was increased in 112 (38.6%) and 71 (28.4%) and decreased in 8 (2.8%) and 46 (18.4%) of patients with 3.75 and 7.5 mg initial doses, respectively. Of the total 586 SIADH patients treated with tolvaptan, serum sodium concentrations were analyzed in 60 patients. In both treatment groups of 3.75 and 7.5 mg initial doses, the serum sodium concentration was elevated from the second day of treatment and reached 135 mEq/L on the fourth day, which was maintained for 2 weeks. Rapid correction of hyponatremia (>10 mEq/L increase in serum sodium concentration over 1 day or >18 mEq/L increase over 2 days) occurred in 26.7% patients with a 7.5 mg initial dose (4 of 15 patients) but not in the patients with a 3.75 mg initial dose (n = 16), suggesting that an initial dose of 3.75 mg of tolvaptan may be a better choice for the safe and proper correction of hyponatremia.

Real-World Intravenous Diuretic Use to Treat Congestion in Patients With Heart Failure　- An Observational Study Using a Research Database.

Background: Intravenous (IV) diuretics are key in the treatment of acute heart failure, but the time of administration can affect outcomes. Using a medical database, we assessed the real-world usage and clinical impact of IV diuretics after admission. Methods and Results: This observational study included hospitalized patients with heart failure who received IV diuretics. Relationships between IV diuretic use and clinical outcomes (duration of hospitalization, in-hospital mortality, readmission) were evaluated using analysis of variance or logistic regression. Overall, 9,653 patients (51.1% male) were assessed (mean age 80.9 years). Most (89.1%) patients had IV loop diuretic treatment initiated on Day 1 of hospitalization and 68.0% achieved the maximum dose on that day. The median duration of hospitalization was 17.0 days. In-hospital mortality was 9.2%; 13.7% of patients were readmitted within 3 months after discharge. There were prognostic relationships between IV diuretic usage and both duration of hospitalization and in-hospital mortality. On multivariable analysis, the time of maximum dose had the biggest impact on outcomes. Duration of hospitalization was prolonged and in-hospital mortality rates increased when the time of maximum dose was delayed. There was little correlation between IV diuretic use and readmission following discharge. Conclusions: Short-term outcomes (duration of hospitalization, in-hospital mortality) correlated with the time of maximum IV diuretic dose; thus, early initiation and subsequent modification of appropriate congestion treatment is critical for prognostic improvement.

Impact of tolvaptan add-on treatment on patients with heart failure requiring long-term congestion management: A retrospective cohort study using a medical claim database in Japan.

BACKGROUND: The impact of tolvaptan on the long-term outcomes of patients with heart failure (HF) remains inconclusive. We evaluated patients requiring long-term congestion management for the time to rehospitalization for HF (HF rehospitalization), the time to in-hospital death and explored the factors that may influence the outcomes. METHODS: Using data (April 2008 to September 2019) from a medical claims database, patients with HF prescribed tolvaptan (tolvaptan cohort) and those prescribed loop diuretics before tolvaptan was introduced to the hospital (furosemide cohort) were compared. Patients with HF who experienced ≥2 HF hospitalizations and ≥1 tolvaptan or loop diuretic prescription during and after HF hospitalization were included. Data of patients with serum creatinine and estimated glomerular filtration rate were analyzed for time to HF rehospitalization and in-hospital death within 1 year after the second discharge and factors that may influence the outcomes. RESULTS: Among the 1931 and 631 tolvaptan and furosemide cohort patients, respectively, time to HF rehospitalization was not significantly different (p = 0.0921); time to in-hospital death was significantly longer in the tolvaptan cohort than in the furosemide cohort (p = 0.0005). Age, serum sodium, angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers were identified as factors for both outcomes (p < 0.05). CONCLUSIONS: Tolvaptan did not significantly affect time to HF rehospitalization. However, further worsening of the condition leading to death may be delayed, and time to in-hospital death may be prolonged in patients treated with tolvaptan, indicating its usefulness for long-term congestion management.

Treatment Discontinuation Among Patients with Schizophrenia Treated with Brexpiprazole and Other Oral Atypical Antipsychotics in Japan: A Retrospective Observational Study.

INTRODUCTION: Treatment continuation is essential for relapse prevention in patients with schizophrenia. The aim of this exploratory study was to compare the time to treatment discontinuation between patients with schizophrenia prescribed brexpiprazole (BRX group) and those prescribed other atypical antipsychotics (OAA group) in clinical settings in Japan using health insurance claims data. METHODS: De-identified data of working individuals with schizophrenia aged < 75 years and their dependents were assessed from April 2017 to May 2020 using a nationwide claims database. Cox proportional hazards models, adjusted for baseline patient variables, were used to compare the time to treatment discontinuation (primary outcome) for 180 days between BRX and OAA groups and to estimate the hazard ratio (HR) with 95% confidence interval (CI). The cumulative treatment continuation rates at 180 days were also estimated. Sensitivity and subgroup analyses were conducted for the primary outcome. RESULTS: The analysis included 978 and 4898 patients in the BRX and OAA groups, respectively. Patients in the BRX group were significantly less likely to discontinue treatment than those in the OAA group (HR 0.86, 95% CI 0.78-0.95; p = 0.0024). The cumulative treatment continuation rates were higher in the BRX group (45.9%, 95% CI 42.5-49.2]) than in the OAA group (39.5%, 95% CI 38.1-41.0; log-rank test, p < 0.0001). Based on patients matched by propensity score, the BRX group was significantly less likely to discontinue treatment than the OAA group (log-rank test, p = 0.0466). Similar results were obtained in sensitivity and subgroup analyses. CONCLUSION: This real-world study showed that patients in the BRX group were less likely to discontinue treatments than those in the OAA group. These findings suggest that BRX may contribute to treatment continuation among patients with schizophrenia. TRIAL REGISTRATION: University hospital Medical Information Network (UMIN) Clinical Trials Registry: UMIN000044682.

Real-world Safety and Effectiveness of Infliximab in Pediatric Patients With Acute Kawasaki Disease: A Postmarketing Surveillance in Japan (SAKURA Study).

BACKGROUND: In 2015, infliximab was approved for the treatment of patients with intravenous immunoglobulin-refractory Kawasaki disease (KD) in Japan. However, limited real-world data exist on the usefulness of infliximab for acute KD patients. We conducted a postmarketing surveillance study in patients with acute KD refractory to conventional therapies to evaluate the safety (including any live vaccine-related infections) and the effectiveness of infliximab. METHODS: This was a multicenter, prospective, open-label, single-cohort, observational study in patients with acute KD refractory to conventional therapy who were prescribed a single 5 mg/kg dose of infliximab. Safety and effectiveness of infliximab were evaluated at 1 month, and live vaccine-related infections were further observed until 6 months from KD onset. Effectiveness assessments included fever resolution rate, the incidence of coronary artery lesions and change in coronary diameter Z scores. RESULTS: A total of 291 patients were enrolled, and all patients completed the study. Adverse drug reactions and serious adverse drug reactions were reported in 12.4% and 3.1% of patients, respectively. Live vaccine-related infections were not observed. In the 208 patients with effectiveness assessments, the fever resolution rate within 48 hours after infliximab infusion was 77.4% (95% confidence interval: 71.1-82.9). Median time until fever resolution was 16.6 hours. After infliximab administration, the incidence (at baseline: 10.9%; at the final observation point: 12.0%; maximum value: 14.6%) and severity of coronary artery lesions did not change notably. CONCLUSIONS: In this study, Infliximab for patients with acute KD refractory to conventional therapies was well tolerated and effective.

Long-Term, Real-World Safety and Efficacy of Teneligliptin: A Post-Marketing Surveillance of More Than 10,000 Patients with Type 2 Diabetes in Japan.

INTRODUCTION: Teneligliptin is a dipeptidyl peptidase 4 inhibitor that was approved for the treatment of type 2 diabetes mellitus (T2DM) in Japan in 2012. We performed a long-term post-marketing surveillance (RUBY) to obtain real-world evidence regarding the safety and efficacy of teneligliptin in Japan. METHODS: This 3-year follow-up RUBY surveillance registered patients with T2DM who started treatment with teneligliptin between May 2013 and February 2015 in Japan. Collected data included demographics, treatments, adverse drug reactions (ADRs) and laboratory variables. Data were evaluated in all patients and in patients divided according to baseline renal function across categories of estimated glomerular filtration rate (G1-G5) and dialysis. Safety was assessed as the incidence of ADRs and efficacy was assessed in terms of glycaemic control, for up to 3 years. RESULTS: Of 11,677 patients registered, 10,696 and 10,249 were evaluable for safety and efficacy analyses, respectively. The median duration of exposure was 1096 days. ADRs occurred in 412 patients (3.85%) and were serious in 117 patients (1.09%). The most frequent ADR class was gastrointestinal disorders (0.68%), which included constipation. There were no new ADRs warranting attention beyond those already described in teneligliptin's package insert. ADRs and serious ADRs in renal function subgroups occurred in 3.24-7.14% and 0.65-5.36% in G1-G5, and 4.49% and 1.92% in patients on dialysis, respectively. Reduction in HbA1c was sustained for 3 years after starting teneligliptin (- 0.70% ± 1.36%, p < 0.001 at 3 years). The least-squares mean changes in HbA1c adjusted for baseline were - 0.76% to - 0.66% in G1-G5 at 3 years. Glycated albumin levels decreased in patients on dialysis (- 2.92% ± 4.78% at 3 years). CONCLUSION: There were no new safety or efficacy concerns about teneligliptin used in long-term, real-world, clinical settings in patients with T2DM with any stages of renal impairment. TRIAL REGISTRATION: Japan Pharmaceutical Information Center clinical trials database identifier: Japic CTI-153047. Plain language summary available for this article.

Safety and efficacy of infliximab in the treatment of refractory uveoretinitis in Behçet's disease: a large-scale, long-term postmarketing surveillance in Japan.

BACKGROUND: Infliximab, an anti-tumor necrosis factor-alpha antibody, has been reported to have excellent efficacy for refractory uveoretinitis in Behçet's disease (RUBD), and was approved for this indication in Japan. However, the long-term safety profile and efficacy in real-world clinical settings in patients with RUBD have not been fully clarified. The BRIGHT study, a prospective, large-scale, long-term postmarketing surveillance (PMS) study, was conducted to investigate the long-term safety and efficacy of infliximab in Japanese patients with RUBD. METHODS: All patients with RUBD who started infliximab treatment between January 2007 and January 2010 were enrolled. Safety was evaluated every 6 months for up to 24 months after initiation of therapy in 656 patients, and efficacy was evaluated in 650 patients. Patient characteristics were compared using the chi-square or Fisher's exact test. The frequency of ocular attacks before and after infliximab treatment was compared using the Wilcoxon signed-rank test. Independent associated factors for safety or efficacy were identified using multiple logistic regression analysis. A two-sided p value <0.05 was considered significant. RESULTS: Among the 656 patients evaluated for safety, 555 (84.6%) completed the 24-month study period. The incidence of adverse drug reactions (ADRs) and serious ADRs were 32.32% and 6.10%, respectively, and the safety profile was comparable to that of Japanese PMS of infliximab for other diseases. The most common ADRs and serious ADRs were infections (11.89% and 3.66%). Tuberculosis was reported in two patients, and Pneumocystis jirovecii in one. Identified independent associated factors for infections were comorbid respiratory disease, history of allergic disease, and concomitant use of glucocorticoids. Although infusion reactions were observed in 11.13% of patients, most were non-serious. The response rate at 24 months by physician global assessment was 80.7%. Median frequency of ocular attacks per 6 months significantly decreased compared with that before infliximab treatment (2.0 to 0.0), and corrected visual acuity was maintained during the study. CONCLUSIONS: Infliximab treatment had good tolerability and efficacy in Japanese patients with RUBD in this large-scale, long-term PMS. Infliximab treatment seemed to be a good treatment option for RUBD in real-world clinical settings. TRIAL REGISTRATION: UMIN Clinical Trials Registry, UMIN000027733 . Retrospectively registered on 6 June 2017.

Associations between eating habits and glycemic control and obesity in Japanese workers with type 2 diabetes mellitus.

PURPOSE: To investigate the impact of poor eating habits on glycemic and metabolic control, we analyzed the associations between eating behaviors and HbA1c and body mass index (BMI) in Japanese workers with type 2 diabetes mellitus (T2DM). SUBJECTS AND METHODS: The Japan Medical Data Center database of workers' medical health insurance claims was used to identify individuals with T2DM who were receiving antidiabetic medication between April 2012 and March 2015 (the primary analysis population). The database included routine medical check-up results and responses to questions on lifestyle and eating habits. Using these, we retrospectively analyzed the associations between the individuals' eating habits and their HbA1c levels and BMIs. RESULTS: In total, 31,722 individuals were included in the primary analysis. The mean values of HbA1c and BMI were 7.27% and 26.29 kg/m2, respectively; these tended to be higher among the younger population. Approximately 36% of the individuals regularly ate supper within 2 hours of bedtime, 14.5% regularly consumed late-night snacks, and 13.4% regularly skipped breakfast. Each of these eating habits correlated significantly with higher HbA1c and BMI. In addition, the population with two or all three of these poor dietary habits showed the highest association with HbA1c ≥7.0% and BMI ≥25 kg/m2. Approximately 38% of workers ate fast. Fast eating was significantly associated with BMI ≥25 kg/m2 but not with HbA1c ≥7.0%. CONCLUSION: Poor eating habits were significantly associated with poor glycemic and body weight control in Japanese workers with T2DM. Improved eating habits may help with glycemic and body weight management.

Relationship of Eating Patterns and Metabolic Parameters, and Teneligliptin Treatment: Interim Results from Post-marketing Surveillance in Japanese Type 2 Diabetes Patients.

INTRODUCTION: Healthy eating is a critical aspect of the prevention and management of type 2 diabetes (T2DM). Disrupted eating patterns can result in poor glucose control and increase the likelihood of diabetic complications. Teneligliptin inhibits dipeptidyl peptidase-4 activity for 24 h and suppresses postprandial hyperglycemia after all three daily meals. This interim analysis of data from the large-scale post-marketing surveillance of teneligliptin (RUBY) in Japan examined eating patterns and their relationship with metabolic parameters and diabetic complications. We also examined whether eating patterns affected safety and efficacy of teneligliptin. METHODS: We analyzed baseline data from survey forms collected in RUBY between May 2013 and June 2017, including patient characteristics, metabolic parameters, and eating patterns (eating three meals per day or not; timing of evening meal) before teneligliptin treatment was initiated. Safety and efficacy of 12 months' teneligliptin (20-40 mg/day) treatment was assessed. RESULTS: Data from 10,532 patients were available for analysis. Most patients who did not eat three meals per day (n =757) or who ate their evening meal after 10 PM (n =206) were 64 years old or younger. At baseline, glycated hemoglobin (HbA1c), fasting blood glucose, triglycerides, total and low-density lipoprotein cholesterol, body mass index, alanine aminotransferase, and aspartate aminotransferase levels were higher in those patients who did not eat three meals per day (p < 0.05) or who ate their evening meal late (p < 0.05). Diabetic complications were more common in patients who did not eat three meals per day. Treatment with teneligliptin reduced HbA1c over 6 or 12 months across all eating patterns, with a low incidence of adverse drug reactions. CONCLUSIONS: Eating patterns may be associated with altered metabolic parameters and diabetic complications among Japanese patients with T2DM. Teneligliptin may be well tolerated and improve hyperglycemia in patients with T2DM irrespective of eating patterns. FUNDING: Mitsubishi Tanabe Pharma Corporation and Daiichi Sankyo Co. Ltd. TRIAL REGISTRATION NUMBER: Japic CTI-153047.

Safety and Efficacy of Teneligliptin in Patients with Type 2 Diabetes Mellitus and Impaired Renal Function: Interim Report from Post-marketing Surveillance.

INTRODUCTION: Teneligliptin is a novel oral dipeptidyl peptidase-4 inhibitor for the treatment of type 2 diabetes mellitus (T2DM). Safety and efficacy of teneligliptin have been demonstrated in clinical studies; however, data supporting its use in patients with moderate or severe renal impairment are limited. This interim analysis of a post-marketing surveillance of teneligliptin, exploRing the long-term efficacy and safety included cardiovascUlar events in patients with type 2 diaBetes treated bY teneligliptin in the real-world (RUBY), aims to verify the long-term safety and efficacy of teneligliptin in Japanese patients with T2DM and impaired renal function. METHODS: For this analysis, we used the data from case report forms of the RUBY surveillance between May 2013 and June 2017. The patients were classified into G1-G5 stages of chronic kidney disease according to estimated glomerular filtration rate (eGFR) at initiation of teneligliptin treatment. Safety and efficacy were evaluated in these subgroups. Patients on dialysis were also assessed. Safety was assessed from adverse drug reactions (ADRs). Glycemic control was evaluated up to 2 years after teneligliptin initiation. RESULTS: A total of 11,677 patients were enrolled in the surveillance and 11,425 patient case-report forms were collected for the interim analysis. The incidence of ADRs in each subgroup was 2.98-6.98% of patients, with no differences in the ADR profile (including hypoglycemia and renal function ADRs) between subgroups. At 1 and 2 years after starting teneligliptin, the least-squares mean change in HbA1c adjusted to the baseline was - 0.68 to - 0.85% and - 0.71 to - 0.85% across the eGFR groups, respectively. Treatment with teneligliptin in patients on dialysis reduced or tended to reduce glycated albumin levels [- 2.29%, (p < 0.001) after 1 year; - 1.64%, (p = 0.064) after 2 years]. CONCLUSIONS: During long-term treatment, teneligliptin was generally well tolerated in patients with any stage of renal impairment from normal to end-stage renal disease, including those on dialysis, and improved glycemic control. TRIAL REGISTRATION NUMBER: Japic CTI-153047. FUNDING: Mitsubishi Tanabe Pharma Corporation and Daiichi Sankyo Co, Ltd.

Efficacy and Safety of Teneligliptin 40 mg in Type 2 Diabetes: A Pooled Analysis of Two Phase III Clinical Studies.

INTRODUCTION: Teneligliptin, an antihyperglycemic agent belonging to the dipeptidyl peptidase-4 inhibitor class, is usually prescribed at a dose of 20 mg/day. In Japan, the dose can be increased to 40 mg/day if needed. We examined the treatment response when the teneligliptin dose was increased from 20 to 40 mg in a post hoc pooled analysis of data from two 52-week, open-label, phase III clinical trials of teneligliptin 20-40 mg/day as monotherapy or combination treatment in Japanese patients with type 2 diabetes. METHODS: In both studies, patients received teneligliptin 20 mg for at least 28 weeks; thereafter the dose was increased if glycemic control was inadequate. The data set for this post hoc analysis comprised those patients whose teneligliptin dose was increased to 40 mg at week 28 (N = 204). We assessed (i) the proportion of patients achieving HbA1c reduction after teneligliptin dose increase [≤ - 0.1% change in HbA1c during weeks 28-52 (24 weeks); responders] and (ii) the response to teneligliptin 40 mg according to whether or not patients experienced HbA1c re-elevation (≥ 0.1% increase) during 28 weeks of teneligliptin 20 mg. RESULTS: Of 204 patients, 108 (52.9%) showed a response to teneligliptin 40 mg (HbA1c change ≤ - 0.1% during weeks 28-52) and had mean (± SD) HbA1c reduction of 0.50 ± 0.44%. Of patients showing re-elevation of HbA1c during treatment with teneligliptin 20 mg, 89/143 (62.2%) achieved HbA1c reduction after dose increase to 40 mg. Logistic regression analyses suggested that change in body weight is one of the parameters linked to HbA1c reduction after dose increase to teneligliptin 40 mg. The incidence of adverse events was not changed after teneligliptin dose increase. CONCLUSION: Increasing the dosage of teneligliptin from 20 to 40 mg/day has potential as a well-tolerated and effective option for treating type 2 diabetes. FUNDING: Mitsubishi Tanabe Pharma Corporation.

Safety and efficacy of long-term treatment with teneligliptin: Interim analysis of a post-marketing surveillance of more than 10,000 Japanese patients with type 2 diabetes mellitus.

BACKGROUND: This post-marketing surveillance examined the safety and efficacy of long-term teneligliptin therapy in Japanese patients. RESEARCH DESIGN AND METHODS: We report interim results (cut-off date: 28 June 2017) of a 3-year PMS undertaken in subjects with type 2 diabetes mellitus (T2DM). Survey items included demographics, treatments, adverse drug reactions (ADRs), and laboratory variables. A subgroup analysis was also performed across three age groups (<65 years; 65 to <75 years; ≥75 years). Main outcome measures were incidence of ADRs, laboratory variables, and change in glycated hemoglobin (HbA1c) from baseline over time. RESULTS: Of 11,677 patients registered, data from 10,532 patients (6,338 males/4,194 females) were analyzed for the safety analysis set; the median administration period was 731 days. Overall, ADRs and serious ADRs were reported in 364 (3.46%) and 91 patients (0.86%), respectively. The most common ADRs were all hypoglycemia (0.32%), constipation (0.27%), and hepatic function abnormal (0.24%). No change in mean body weight occurred, and a reduction in mean HbA1c was observed until 2 years. The safety and efficacy profiles did not differ markedly among the three age groups. CONCLUSIONS: These interim results show that teneligliptin was well tolerated and improved hyperglycemia in Japanese patients with T2DM in clinical practice.

Safety profiles and efficacy of infliximab therapy in Japanese patients with plaque psoriasis with or without psoriatic arthritis, pustular psoriasis or psoriatic erythroderma: Results from the prospective post-marketing surveillance.

A large-scale prospective post-marketing surveillance was conducted to evaluate the safety and efficacy of infliximab in Japanese patients with plaque psoriasis, psoriatic arthritis, pustular psoriasis and psoriatic erythroderma. This study was conducted in all psoriasis patients treated with infliximab after its Japanese regulatory approval. Infliximab was administrated at 5 mg/kg at weeks 0, 2 and 6, and every 8 weeks thereafter. Patients were serially enrolled and observed for 6 months to evaluate the safety and efficacy. The safety and efficacy were evaluated in 764 and 746 patients, respectively. Incidences of any and serious adverse drug reactions were 22.51% and 6.94%, respectively, and those of any and serious infusion reactions were 6.15% and 1.31%, respectively, which were comparable with the results in the post-marketing surveillance with 5000 rheumatoid arthritis patients in Japan. Major adverse drug reactions during the follow-up period were infections (5.10%) including pneumonia, cellulitis and herpes zoster, however, no tuberculosis was observed. The safety profiles were equivalent, regardless of the psoriasis types. No new safety problems were identified. The response rates on global improvement and median improvement rate of Psoriasis Area and Severity Index in all patients were 88.0% and 85.0%, respectively. Of note, the efficacy was equivalent for each psoriasis type as well as for each body region. Infliximab was also effective in pustular psoriasis symptoms, joint symptoms and nail psoriasis, as well as improvement of quality of life. Infliximab was confirmed to be highly effective and well tolerated in treating refractory psoriasis, including pustular psoriasis and psoriatic erythroderma.