Impact of Immunoablation and Autologous Hematopoietic Stem Cell Transplantation on Treatment Cost of Multiple Sclerosis: Real-World Nationwide Study.

OBJECTIVES: To provide real-world data on the impact of autologous hematopoietic stem cell transplantation (AHSCT) on treatment costs of patients with multiple sclerosis (MS) in Poland. METHODS: Medical data of 105 patients who underwent AHSCT in the years 2011 to 2016 were obtained from the National Health Fund (NHF) database. Treatment costs were calculated from the public payer's perspective per patient-year for the total available period as well as 12 months before and after AHSCT. The statistical analysis was performed using MATLAB 2016b. RESULTS: Mean treatment-related costs covered by the NHF per patient-year before and after the transplantation were €4314.9 and €1188.8 , respectively. The average cost of disease-modifying drugs per patient was reduced from €2497.9/year before to €65.3/year after AHSCT. CONCLUSIONS: Although the initial cost of AHSCT is high, the costs involving AHSCT and post-AHSCT treatment could, according to our analysis, pay off in 3.9 years, when compared to the costs of disease-modifying drug therapy in aggressive MS. The study provides evidence that the AHSCT can lead to significant savings in treatment costs of aggressive MS from the public payer's perspective.

Prevalence of alcohol use disorder among individuals who binge eat: a systematic review and meta-analysis.

BACKGROUND AND AIMS: Binge eating disorder (BED) is correlated with substance use. This study aimed to estimate the life-time prevalence of alcohol use disorder (AUD) among individuals with non-compensatory binge eating and determine whether their life-time prevalence of AUD is higher than in non-bingeing controls. DESIGN: A systematic search of databases (PubMed, Embase and Web of Science) for studies of adults diagnosed with BED or a related behavior that also reported the life-time prevalence of AUD was conducted. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) protocol was followed. The protocol was registered on the International Prospective Register of Systematic Reviews (PROSPERO). SETTING: Studies originating in Canada, Sweden, the United Kingdom and the United States. PARTICIPANTS: Eighteen studies meeting the inclusion criteria were found, representing 69 233 individuals. MEASUREMENTS: Life-time prevalence of AUD among individuals with binge eating disorder and their life-time relative risk of AUD compared with individuals without this disorder. RESULTS: The pooled life-time prevalence of AUD in individuals with binge eating disorder was 19.9% [95% confidence interval (CI) = 13.7-27.9]. The risk of life-time AUD incidence among individuals with binge eating disorder was more than 1.5 times higher than controls (relative risk = 1.59, 95% CI = 1.41-1.79). Life-time AUD prevalence was higher in community samples than in clinical samples (27.45 versus 14.45%, P = 0.041) and in studies with a lower proportion of women (ß = -2.2773, P = 0.044). CONCLUSIONS: Life-time alcohol use disorder appears to be more prevalent with binge eating disorder than among those without.

Emotion regulation in binge eating disorder. / Regulacja emocji w zaburzeniu z napadami objadania sie.

A review of the literature on emotion regulation in binge eating disorder (BED) published both in English and Polish between 1990 and 2020. BED might be considered as an impulsive and compulsive disorder associated with altered reward sensitivity and food-related attentional bias. The growing body of research indicated that there were corticostriatal circuitry alterations in BED, comparable to those observed in substance abuse, including altered function of orbitofrontal, prefrontal and insular cortices with the striatum included. Negative emotions and deficits in their regulation play a significant role in BED. Processing of anger, anxiety and sadness appear to be particularly important in this disorder. Research results identified an increase in negative emotions preceding episodes of binge eating. However, there is still inconsistency when it comes to whether these episodes alleviate negative affect. Individuals with BED more often use non-adaptive emotion regulation strategies, such as rumination and suppression of negative sensations. Whereas adaptive ones, for instance, cognitive reappraisal, are used less often. Clinical implications, besides pharmacology, highlight the high effectiveness of enhanced cognitive behavioral therapy (CBT-E), dialectic-behavioral therapy (DBT) and psychodynamic therapy in the treatment of emotional dysregulation in BED. Further studies, including ecological momentary assessment (EMA), should focus on emotional changes related to the binge cycle and the identification of reinforcing factors of BED.

Prior blood donations do not affect efficacy of G-CSF mobilization nor outcomes of haematopoietic stem cell collection in healthy donors.

BACKGROUND AND OBJECTIVES: Many consider volunteer blood donors as ideal candidates for unrelated haematopoietic progenitor cell (HPC) donation. However, frequent blood donations could influence the results of HPC mobilization. To our best knowledge, there are no data on the possible impact of repeated blood donation on efficiency of subsequent HPC mobilization by granulocyte colony-stimulating factor (G-CSF). MATERIALS AND METHODS: We compared outcomes of HPC mobilization in unrelated donors with and without a history of blood donation. We conducted a prospective study on 287 consecutive donors admitted to the Department of Hematology since January 2016. The final analysis included 153 donors who agreed to take part in the study and had undergone stem cell mobilization with G-CSF. RESULTS: History of blood donations prior to haematopoietic stem cell mobilization with G-CSF does not have a significant impact on the number of collected CD34+ cells in the first leucocytapheresis (516.2 x 106 (170-1148) in blood donors vs 490.5 x 106 (101-1154) in non-donors) (P = 0.32). In all donors, in this study mobilization of HPC was successful: 87.5% of blood donors and 85.6% of non-donors collected the required cell number in a single apheresis. In blood donors, a higher number of blood donations within 2 and 5 years prior to HPC mobilization correlated significantly with successful donation within one leucocytapheresis (P = 0.014 and P = 0.024, respectively). CONCLUSION: Multiple blood donations do not significantly influence the outcome of HPC collection in unrelated donors. Blood donors and non-donors have similar results of HPC collection, so there is no reason to favour either group.

Biosimilar G-CSF versus filgrastim and lenograstim in healthy unrelated volunteer hematopoietic stem cell donors.

The World Marrow Donor Organization recommends original granulocyte-colony stimulating factor (G-CSF) for the mobilization of stem cells in healthy unrelated hematopoietic stem cell donors. We report the comparison of a biosimilar G-CSF (Zarzio) with two original G-CSFs (filgrastim and lenograstim) in mobilization in unrelated donors. We included data of 313 consecutive donors who were mobilized during the period from October 2014 to March 2016 at the Medical University of Warsaw. The primary endpoints of this study were the efficiency of CD34+ cell mobilization to the circulation and results of the first apheresis. The mean daily dose of G-CSF was 9.1 µg/kg for lenograstim, 9.8 µg/kg for biosimilar filgrastim, and 9.3 µg/kg for filgrastim (p < 0.001). The mean CD34+ cell number per microliter in the blood before the first apheresis was 111 for lenograstim, 119 for biosimilar filgrastim, and 124 for filgrastim (p = 0.354); the mean difference was even less significant when comparing CD34+ number per dose of G-CSF per kilogram (p = 0.787). Target doses of CD34+ cells were reached with one apheresis in 87% donors mobilized with lenograstim and in 93% donors mobilized with original and biosimilar filgrastim (p = 0.005). The mobilized apheresis outcomes (mean number of CD34+ cells/kg of donor collected during the first apheresis) was similar with lenograstim, biosimilar filgrastim, and filgrastim: 6.2 × 106, 7.6 × 106, and 7.3 × 106, respectively, p = 0.06. There was no mobilization failure in any of the donors. Biosimilar G-CSF is as effective in the mobilization of hematopoietic stem cells in unrelated donors as original G-CSFs. Small and clinically irrelevant differences seen in the study can be attributed to differences in G-CSF dose and collection-related factors. Active safety surveillance concurrent to clinical use and reporting to donor outcome registry (e.g., EBMT donor outcome registry or WMDA SEAR/SPEAR) might help to evaluate the possible short- and long-term complications of biosimilar G-CSF.

Long-term response to sunitinib: everolimus treatment in metastatic clear cell renal cell carcinoma.

AIM: The study aim was to evaluate progression-free survival (PFS) and overall survival (OS) in patients with metastatic clear cell renal cell carcinoma on sunitinib (SU) and SU-everolimus treatment. PATIENTS & METHODS: After 7 years of enrollment and 9 years of follow-up, 193 consecutively presenting patients (151 men and 42 women) were treated. RESULTS: A total of 157 patients (81.3%) died and 36 patients (18.7%) survived. Median PFS in 193 SU-treated patients was 14.7 months and OS was 28.8 months. Median PFS was 13.98 months and median OS was 26.67 months in 175 patients treated with SU only or on SU-everolimus. CONCLUSION: The development of SU-induced hypothyroidism, hypertension, neutropenia and edema was a significant predictive and prognostic factor.