We conducted a phase 2 study in which patients undergoing allogeneic hematopoietic stem cell transplantation received tocilizumab in addition to standard immune suppression with tacrolimus and methotrexate for graft-versus-host disease prophylaxis. Thirty-five patients were enrolled between January 2015 and June 2016. The median age of the cohort was 66 (range: 22-76). All patients received busulfan-based conditioning, and were transplanted with human leukocyte antigen-matched related or matched unrelated bone marrow or peripheral stem cell grafts. The cumulative incidences of grades II-IV and III-IV acute graft-versus-host disease were 14% (95% CI 5-30) and 3% (95% CI 0-11) at day 100, and 17% (95% CI 7-31) and 6% (95% CI 1-16) at day 180, respectively. Notably, there were no cases of graft-versus-host disease of the lower gastrointestinal tract within the first 100 days. A comparison to 130 matched controls who only received tacrolimus and methotrexate demonstrated a lower cumulative incidence of grades II-IV acute graft-versus-host disease (17% versus 45%, P=0.003) and a significant increase in grades II-IV acute graft-versus-host disease-free survival at six months (69% versus 42%, P=0.001) with tocilizumab, tacrolimus and methotrexate, which was the primary endpoint of the study. Immune reconstitution was preserved in patients treated with tocilizumab, tacrolimus and methotrexate, as T-cell and B-cell subsets recovered to near normal levels by 6-12 months post-transplantation. We conclude that tocilizumab has promising activity in preventing acute graft-versus-host disease, particularly in the lower gastrointestinal tract, and warrants examination in a randomized setting.
A simple tool can be administered in the clinic by radiation oncologists to screen for depression. The frequency of depression in our patients was 15%. Somatic symptoms alone were insufficient to score as depressed.
During the past 15 years, federal regulations, survey and inspection programs, and payment policies have presented conflicting incentives and disincentives for the provision of mental health services in nursing homes in the United States. Policies and regulatory measures have reflected the concern that many patients in nursing homes are not receiving the mental health care they need, and, more prominently, the concern that some of the services that are provided seem to be inappropriate or medically unnecessary. Despite evidence that payment policy and regulatory oversight can be used effectively to promote quality improvement, the need for improved access and quality of mental health services in long-term care remains substantial. Recent reports issued by the Surgeon General and by the Institute of Medicine identify a need for refinements in the assessment process, the use of outcomes-based quality measures, and payment policies designed to improve access and quality. These elements must be coordinated to promote humane treatment in nursing homes, including access to medically necessary psychiatric care.
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