Shorter infusion time of ocrelizumab: Results from the randomized, double-blind ENSEMBLE PLUS substudy in patients with relapsing-remitting multiple sclerosis.

BACKGROUND: Ocrelizumab is an approved intravenously administered anti-CD20 antibody for multiple sclerosis (MS). Shortening the 600 mg infusion to 2 hours reduces the total site stay from 5.5-6 hours (approved infusion duration including mandatory pre-medication and post-infusion observation) to 4 hours. The safety profile of shorter-duration ocrelizumab infusions was investigated using results from ENSEMBLE PLUS. METHODS: ENSEMBLE PLUS is a randomized, double-blind substudy to the single-arm ENSEMBLE study (NCT03085810). In ENSEMBLE, patients with early-stage relapsing-remitting MS received ocrelizumab 600 mg infusions every 24 weeks for 192 weeks. In ENSEMBLE PLUS, ocrelizumab 600 mg administered over the approved 3.5-hour infusion time (conventional duration) is compared with a 2-hour infusion (shorter duration); the durations of the initial infusions (2×300 mg, 14 days apart) were unaffected. The primary endpoint was the proportion of patients with infusion-related reactions (IRRs) following the first Randomized Dose. RESULTS: From November 1, 2018, to December 13, 2019, 745 patients were randomized 1:1 to the conventional or shorter infusion group. At the first Randomized Dose, 99/373 patients (26.5%) in the conventional and 107/372 patients (28.8%) in the shorter infusion group experienced IRRs. The majority of IRRs were mild or moderate; >99% of all IRRs resolved without sequelae in both groups (conventional infusion group, 99/99; shorter infusion group, 106/107). No IRRs were serious, life-threatening, or fatal. No IRR-related discontinuations occurred. During the first Randomized Dose, 22/373 (5.9%) and 39/372 (10.5%) patients in the conventional and shorter infusion groups, respectively, had IRRs leading to infusion slowing/interruption. Adverse events were consistent with the known safety profile of ocrelizumab. CONCLUSION: The rates and severity of IRRs were similar between conventional and shorter infusions. No new safety signals were detected. Shortening the infusion time to 2 hours reduces the total site stay time (including mandatory pre-medication/infusion/observation) from 5.5-6 hours to 4 hours, and may reduce patient and site staff burden. A short video summarizing the key results is provided in supplemental material.

Experience in long-term neutron dose equivalent measurements using etched track detectors with (n,alpha) converters in moderators.

Etched track Makrofol detectors combined with Kodak BN-1 boron (n,alpha) converters were used inside a 30 cm diameter polyethylene (PE) sphere for the measurement of the neutron ambient dose equivalent. We found unexpectedly high values for the neutron dose equivalent of about 250 microSv instead of 25 microSv for 3 months' exposure in the natural environment. Results from such detectors etched in the authors' labortories revealed that the tracks could only be induced by spontaneous particle emission from the converter. This was confirmed by track diameter analysis and additional special etching of deeper detector layers. Eight surface barrier detectors were used simultaneosly for several days to measure the alpha spectra of the converters. The overall count rate in the energy range 2.5-7.5 MeV was 10 alpha particles d(-1) x cm(-2) for most of the converters and about 10 times less than this for some of them. To identify the nuclides responsible for alpha emission within the converters, gamma spectra of converters were measured for 8 days using a highly sensitive low-background gamma spectrometry system The spectra clearly indicated a small contamination (10 +/- 3 mBq) of the converter foils with 225Ra (T(1/2) = 5.7 y) typically originating from 232Th.

Therapeutic intimacy in nursing.

Capturing essential elements of the client-nurse relationship is an ongoing quest for nursing theorists and practitioners. The concepts which can describe this relationship may in fact have a long history of study in nursing and related disciplines. The concept of intimacy does have a trail of previous study. Giving credence to this work, in preference to developing a new lexicon, enables nurses to see interpersonal relationships with clients in the context of interdisciplinary, indeed human endeavour. In this article, the concept of intimacy is reviewed as it has been studied from a variety of perspectives. Selected aspects of intimacy in client-nurse relationships are also explored.

Homeward bound. Broadening student experience with home visits.

1. Because of patients are rapidly discharged after medication stabilization or crisis resolution, tertiary care in the home is emerging as an integral part of current psychiatric care. Students miss a valuable opportunity to participate in psychosocial rehabilitation if the clinical rotation is limited to an inpatient setting. 2. Guiding the client toward mental stabilization is the process of psychiatric care; outcomes are most apparent in the home. 3. Nursing is moving into psychiatric case management and continues to provide home care as a traditional role. Student home visits promote awareness of nursing responsibilities to families beyond the institution.