Efficacy and safety of a new vedolizumab subcutaneous formulation in Japanese patients with moderately to severely active ulcerative colitis

Background/Aims@#A subgroup analysis was conducted in Japanese patients with moderate to severe ulcerative colitis (UC) enrolled in the phase 3 VISIBLE 1 study, which evaluated the safety and efficacy of a new vedolizumab subcutaneous (SC) formulation. @*Methods@#Eligible patients received open-label infusions of vedolizumab 300 mg intravenous (IV) at weeks 0 and 2 in the induction phase. Patients with clinical response by complete Mayo score at week 6 entered the double-blind maintenance phase and were randomized to vedolizumab 108 mg SC every 2 weeks, placebo, or vedolizumab 300 mg IV every 8 weeks. The primary endpoint was clinical remission (complete Mayo score ≤ 2 points; no individual subscore > 1 point) at week 52. @*Results@#Of 49 patients who entered the induction phase, 22 out of 49 patients (45%) had clinical response at week 6 and were randomized to vedolizumab 108 mg SC (n = 10), placebo (n = 10), or vedolizumab 300 mg IV (n = 2). At week 52, 4 out of 10 patients (40%) who received vedolizumab SC had clinical remission versus 2 out of 10 patients (20%) who received placebo (difference: 20% [95% confidence interval, –27.9 to 61.8]). Two patients (2/10, 20%) who received vedolizumab SC experienced an injection-site reaction versus none who received placebo. @*Conclusions@#Our results indicate that the efficacy of vedolizumab SC in a subgroup of Japanese patients with UC are similar with those in the overall VISIBLE 1 study population, and with those established with vedolizumab IV. The safety and tolerability of vedolizumab SC were generally similar to that established for vedolizumab IV. (ClinicalTrials.gov ID NCT02611830; EudraCT 2015-000480-14)

Opioids for Secondary Generalized Hyperhidrosis Associated with Renal Cell Carcinoma

We encountered a case where opioids were effective for excessive sweating caused by secondary generalized hyperhidrosis associated with cancer. ​​A 64-year-old woman diagnosed with metastatic renal cell carcinoma was admitted to the palliative care unit with right hip pain caused by bone metastasis and sudden excessive sweating. An increased dose of fentanyl transdermal patch provided pain relief. Excessive sweating seemed to have occurred due to neoplastic fever initially, but antipyretic analgesics and steroids were ineffective. Prophylactic use of immediate-release oxycodone provided excessive sweating relief. Finally, we consider that hypothalamus and fentanyl transdermal patch were involved in excessive sweating. Opioids may suppress sweating by acting on the hypothalamus.

A Case with Pneumatosis Cystoides Intestinalis with Intra-abdominal Free Air following Steroid Therapy for End-stage Brain Tumor

<p>Introduction: We experienced a case of pneumatosis cystoides intestinalis with intra-abdominal free air following steroid therapy for an end-stage brain tumor. Case: The patient was a 67-year-old man. He had received surgery and chemotherapy for the brain tumor, but the disease progressed and his consciousness deteriorated. Eventually, he developed aspiration pneumonia and was hospitalized. His consciousness level remained poor even after the pneumonia improved. His survival prognosis was considered to be approximately 1 month, and he was transferred to a palliative care ward. After the transfer, administration of betamethasone 8 mg/day was started for the purpose of improving his level of consciousness. Temporary improvement was observed, and administration of this drug was continued with dose adjustments, as appropriate. Six weeks after the start of betamethasone administration, when his consciousness level again deteriorated, aspiration began to recur. Chest X-rays, obtained to assess pneumonia, showed intra-abdominal free air. Pneumatosis cystoides intestinalis was confirmed by computed tomography. He had few abdominal symptoms, and was managed conservatively. He died of respiratory failure. Conclusion: Pneumatosis cystoides intestinalis is mostly secondary, and steroid therapy is considered to be one of the causes. But follow-up observation is often conservative, and judgment of discontinuation of steroid needs to be made in consideration of its effect and prognosis is there.</p>

Efficacy and safety of two pH-dependent-release mesalamine doses in moderately active ulcerative colitis: a multicenter, randomized, double-blind, parallel-group study

BACKGROUND/AIMS: The therapeutic effect of mesalamine is considered to be dose-dependent; however, no consensus has been reached regarding the optimal doses for individual patients. This study aimed to provide new insight for dose optimization using two doses of pH-dependent release mesalamine for induction of remission of moderately active ulcerative colitis (UC). METHODS: In a multicenter, double-blind, randomized study, 110 patients with moderately active UC were assigned to two groups after treatment with a constant dose of mesalamine. Fifty-five patients were treated with a pH-dependent release formulation of 3.6 or 4.8 g/day for 8 weeks. The primary endpoint was a decrease in the UC disease activity index (UCDAI) adjusted by covariates. RESULTS: In the full analysis set (n=110), the mean decrease in UCDAI was 3.1 in the 3.6 g/day group and 3.4 in the 4.8 g/day group (P>0.05). In a subgroup analysis, the effectiveness of the 4.8 g/day dose was greater in particular populations, such as those who had been previously treated with a lower dose of mesalamine and those with more severe disease. The safety was comparable between the two groups. CONCLUSIONS: The results suggest that treatment with pH-dependent release mesalamine at either 3.6 or 4.8 g/day was effective and safe for the induction of remission in patients with moderately active UC. However, the patients receiving mesalamine at 2.4 g/day but in whom the therapeutic effect is not sufficient and having more severe symptoms (UCDAI 9-10), benefit from higher doses of mesalamine compared to others.

Rotavirus vaccine and health-care utilization for rotavirus gastroenteritis in Tsu City, Japan

Background: Rotavirus vaccines were introduced in Japan in November 2011. We evaluated the subsequent reduction of the health-care burden of rotavirus gastroenteritis. Methods: We conducted active surveillance for rotavirus gastroenteritis among children under 5 years old before and after the vaccine introduction. We surveyed hospitalization rates for rotavirus gastroenteritis in children in Tsu City, Mie Prefecture, Japan, from 2007 to 2015 and surveyed the number of outpatient visits at a Tsu City clinic from 2010 to 2015. Stool samples were obtained for rotavirus testing and genotype investigation. We assessed rotavirus vaccine coverage for infants living in Tsu City. Results: In the pre-vaccine years (2007-2011), hospitalization rates for rotavirus gastroenteritis in children under 5 years old were 5.5, 4.3, 3.1 and 3.9 cases per 1000 person-years, respectively. In the post-vaccine years (2011-2015), the rates were 3.0, 3.5, 0.8 and 0.6 cases per 1000 person-years, respectively. The hospitalization rate decreased significantly in the 2013-2014 and 2014-2015 seasons compared to the average of the seasons before vaccine introduction (p < 0.0001). In one pre-vaccine year (2010-2011), the number of outpatient visits due to the rotavirus infection was 66. In the post-vaccine years (2011-2015), the numbers for each season was 23, 23, 7 and 5, respectively. The most dominant rotavirus genotype shifted from G3P[8] to G1P[8] and to G2P[4]. The coverage of one dose of rotavirus vaccine in Tsu City was 56.5% in 2014. Conclusion: After the vaccine introduction, the hospitalization rates and outpatient visits for rotavirus gastroenteritis greatly decreased.

Implementation manual created for carrying out the Animal-Assisted Therapy in the Palliative Care Unit of a general hospital

<b>Introduction：</b>There are various problems in order to perform the Animal-Assisted Therapy（AAT）in the Palliative Care Unit（PCU）of a general hospital, a manual for carrying out is required.<b> Methods：</b>In our hospital PCU, implementation manual has been created by the cooperation of university of research institutes, health center of administrative agency, and the infection control team of our hospital.<b> Results：</b>1st AAT was held in February 2011. Then, at a pace of once a month, AAT was held a total of 35 times until March 2013. During the AAT, therapy dog, handler, doctor, nurses, ward volunteers, health center veterinarian played the role of each as a team. The evaluation meeting held after, in addition to the evaluation and reaction of participants, evaluation of environmental health and compliance with procedure were also performed, implementation report has been submitted to the health center.<b> Discussion：</b>In order to perform the AAT in PCU in general hospital, there are problems such as infection, environment and health. In the practice, by obtaining cooperation experts each, it was possible to create an implementation manual by perspective multicenter multiple sectors. This manual would be helpful to perform the AAT in each facility.

Seek to “acute palliative care unit with a hospice function”─Activity report of three years palliative care unit opened

<b>【Background】</b>From the time of establishment, management system of palliative care unit of cancer cooperation hospital in this community was created by consultation with regional home care agency. At the time of the current three－year establishment, its role is regarded as “acute palliative care unit with a hospice function”. In addition to the hospice function to perform hospice care for terminal cancer patients, with the aim of palliative care from early stage, it is an emphasis on functionality of acute palliative care unit (1.Symptom relief, 2.Decision support to patients and their families, 3.Adjustment and movement of the location of the medical treatment, 4.Adjustment of the support system at home care is difficult.) as a “second home” in the region for the “community hospice”. <b>【Result】</b>As a result, over three years, hospitalized patient number, home transition number of patients, home transition rate, number of patients dying at home and home mortality were increased, but the average length of stay, readmission rates were reduced. <b>【Conclusion】</b>In OPTIM－study, it is said that the ability to medical and welfare professionals involved in palliative care in the region is "meet" the opportunity, to be able to maximize the ability of the community, our palliative care unit establishment has become the opportunities in this community, cooperation with home care agencies deepened.

Ongoing increase in measles cases following importations, Japan, March 2014: times of challenge and opportunity

Since late 2013 through March 2014, Japan experienced a rapid rise in measles cases. Here, we briefly report on the ongoing situation and share preliminarily findings, concerns and challenges and the public health actions needed over the coming months and years. Measles is a notifiable disease in Japan based on nationwide case-based surveillance legally requiring physicians to report all clinically diagnosed and laboratory-confirmed cases within seven days, but preferably within 24 hours. After a large outbreak in 2007–2008 (more than 11 000 cases reported in 2008 alone) and a goal of elimination by April 2015, a catch-up programme using the bivalent measles-rubella (MR) vaccine was offered for grades seven and 12 (ages 12–13 and 17–18 years) from April 2008 through March 2013. During this period, there was an estimated 97% decline in measles notifications, and the cumulative number of reported cases has been steadily declining over the last five years (732 cases in 2009, 447 cases in 2010, 439 cases in 2011, 293 cases in 2012 and 232 cases in 2013). However, since late 2013 through March 2014, the country experienced a resurgence only a year after a large rubella outbreak.