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BACKGROUND: Acute graft-versus-host disease (aGVHD), a potentially life-threatening complication of hematopoietic stem cell transplantation (HSCT), often occurs within 100 days of HSCT. While steroids are typically used as first-line treatment, there is no consensus on second-line steroid-refractory (SR) treatments. SR aGVHD is associated with significantly worse pediatric health outcomes, but less is known about its economic impact. OBJECTIVE: To evaluate the economic burden of SR pediatric aGVHD in a commercially insured US patient population. METHODS: Retrospective analyses were conducted using medical and pharmacy claims data from the HealthCore Integrated Research Database (study period January 1, 2006-May 31, 2019). Included patients had at least 1 claim for allogeneic HSCT (earliest HSCT claim set as index date), no claims for autologous HSCT, and no pre-index GVHD. Patients were aged less than 18 years with no minimum pre- or post-index continuous enrollment. The GVHD cohort included patients with at least 1 claim for aGVHD over 100 days from index with at least 1 claim for any steroid and at least 1 claim for second-line therapy, both on or after the date of the first aGVHD claim. Patients post-HSCT with no GVHD claims over follow-up formed the comparison cohort. Health care resource utilization and costs over 12 months from the index date were calculated and compared between cohorts using parametric testing. RESULTS: 38 patients with SR aGVHD and 184 controls were included. Mean age and sex were similar for aGVHD (8.6 years, 50% female) and control (8.2 years, 45% female). During the 12-month post-index follow-up, SR aGVHD patients had higher rates of complications vs controls (* for P < 0.05): anemia (79% vs 68%), drug-induced anemia* (53% vs 34%), neutropenia (63% vs 53%), thrombocytopenia (58% vs 42%), gastrointestinal complications* (95% vs 65%), and infections* (95% vs 79%). Mean inpatient length of stay was longer by 31.6 days ( P < 0.01) with a total average of 96.0 days for those with SR aGVHD vs 64.3 days for the controls. More SR aGVHD patients required inpatient total parenteral nutrition (71% vs 58%), readmission within 12 months of discharge from index hospitalization* (89% vs 60%), ER visits (34% vs 24%), and outpatient visits (100% vs 86%). Total 12-month mean medical costs were higher in aGVHD patients: $1,212,944 vs $673,491 ( P < 0.001), mostly because of complication-related costs: $868,966 vs $396,757 ( P < 0.001). Among patients with SR aGVHD, mean total costs were higher by about $1.8 million ($2,609,445 vs $812,385; P = 0.014) for those who died compared with those who were alive within 12 months. CONCLUSIONS: SR aGVHD in pediatric patients following HSCT is associated with incremental 12-month medical costs of greater than $500,000, driven largely by complications. DISCLOSURES: This research was sponsored by Mesoblast, Inc. Grabner is an employee of HealthCore, Inc., which acted as consultants to Mesoblast, Inc., during the conduct of this research. Strati is an employee of Mesoblast, Inc. Sandman and Forsythe are employees of Purple Squirrel Economics, which acted as consultants to Mesoblast, Inc., during the conduct of this research. This work was presented at the AMCP Annual Meeting online in April 2020 and was an encore presentation at AMCP Nexus 2020 Virtual in October 2020.

Background: Allogeneic hematopoietic stem cell transplantation (allo-HSCT) can be a lifesaving treatment for hematologic malignancies, but acute graft-versus-host-disease (aGVHD) is a potentially deadly adverse effect experienced by up to half of allo-HSCT recipients. Inadequate response to steroid therapy for aGVHD is associated with poor prognosis and high mortality, including among pediatric patients, who are the focus of this study. Ruxolitinib and remestemcel-L-rknd were evaluated for the treatment of steroid-refractory (SR) aGVHD in two separate single-arm trials. To effectively compare the safety and efficacy of these treatments without a head-to-head trial, a simulated treatment comparison (STC) was conducted. Methods: Regression techniques were used to adjust individual patient-level data from the remestemcel-L-rknd trial to mutually reported baseline characteristics from the ruxolitinib trial. Outcomes of interest included a 28-day overall response rate (ORR), a 28-day ORR in the grade III-IV aGVHD population, and adverse events (AEs). Results: In the full populations, the STC of risk ratios (RRs) found treatment with remestemcel-L-rknd to be associated with a numerical but not statistically significant improvement in the 28-day ORR versus ruxolitinib. In the grade III-IV aGVHD sub-group, the STC showed significantly improved 28-day ORR for remestemcel-L-rknd versus ruxolitinib ( P =0.04). Remestemcel-L-rknd was also associated with improved safety outcomes ( P <0.05) in 17 out of 30 AEs, including hematologic events, peripheral edema, muscular weakness, nausea, back pain, and fatigue. Conclusion: Remestemcel-L-rknd was associated with significant improvements in day 28 ORR compared with ruxolitinib in patients with severe (grade III-IV) SR aGVHD. Across all grades of SR aGVHD, remestemcel-L-rknd was associated with fewer all-grade treatment-emergent adverse events (TEAEs) (27/30) available for comparison, including the majority reaching statistical significance.

Phlebology is not a specialty for its own in Italy. Phlebological patients are treated by vascular and general surgeons, dermatologists, phlebologists, angiologists, internists and even general practitioners. Even tough guidelines present a series of recommendations based on evidence-based medicine, guidelines may also be a tool to unify the diagnostic and therapeutic approach in a vast medical field like phlebology. Since vascular surgeons and phlebologists are particularly involved in phlebology-related pathologies the scientific societies of the Italian Society of Phlebology (SIF) and the Italian Society for Vascular and Endovascular Surgery (SICVE) decided to cooperate for the preparation of phlebo-lymphological guidelines. These guidelines comprehend also an important chapter dealing with the lymphology of the lower extremities; phlebological active physicians are often faced with lymphatic pathologies and a good differential diagnosis can be sometimes very helpful. Sclerotherapy and Surgery as the major therapeutical alternatives are extensively analyzed, but also the compression therapy, the medical and physical therapy are presented under the critical view of evidence based analyses. Separate chapters deal with the treatment alternatives for superficial and deep venous thromboses and the recommendations for the treatment of venous ulcers. The current scientific evidences were confronted with the experiences of Italian specialists and the particular practice and reality in Italy. They represent therefore the actual valid positions and recommendations in Italy which shall be updated regularly.

This paper traces the unfolding of the therapeutic relationship in the analysis of a boy with marked presenting difficulties in Foster Care and attempts to address the technical issues regarding psychoanalytic work with looked-after children but also with children who have experienced early deprivation and neglect. The patient's disrupted attachment history of early loss called for a gradual building of interpretative work in the context of his growing trust and sense of safety within the therapeutic relation. It will be shown how the differential use of the therapist as a transference, developmental and contemporary object enabled him to resume his "arrested" development, as it helped him reconnect with disowned feelings of rage, helplessness, as well as despair and longing for his lost objects. Emphasis will be particularly placed on the use of Countertransference, as at times the only means to be in touch with the patient's predicament and affective experiences which have been preverbal and possibly unverbalizable.

160 newborns have been studied, some of them with APGAR index greater than 7 at a minute after birth and some others with a lower index, by continuous pressure monitoring for 60 minutes, with noninvasive automatic oscillometric technique. This continuous monitoring has pointed out systolic, mean and diastolic pressure values very useful for the knowledge of the pressure trend during the early days of life, so as for the suggestion of a considerable oscillation of blood pressure in the different times of day. Pressure changes, linked to the kind of delivery and/or to the APGAR index, appeared unsignificant.