Risk Of Relapse
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2021 ◽  
Vol 12 ◽  
Amber N. Edinoff ◽  
Prithvi K. Doppalapudi ◽  
Claudia Orellana ◽  
Caroline Ochoa ◽  
Shelby Patti ◽  

Given the typical age onset of schizophrenia, there are tremendous economic and social impacts that extend beyond the person and their families. One critical determinant of the diseases' impact is the patient's adherence to antipsychotic drug treatment. Approved in 2015 for the treatment of schizophrenia, paliperidone palmitate (Invega Trinza, a 3-month injection, noted as PP3M) is a second-generation long-acting injectable antipsychotic medication. Among the different formulations offered for palmitate paliperidone, including the 1 and 3-month formulations, the longer duration 3-month formulation was better at preventing relapse in schizophrenic patients. To date, different formulations of palmitate paliperidone that have been studied on relapse episodes of schizophrenia include once-daily extended-release oral paliperidone (ORAL paliperidone), once-monthly paliperidone palmitate (PP1M), and once-every-3-months paliperidone palmitate (PP3M). Post-hoc analyses show that patients who were withdrawn from PP1M paliperidone had the least risk of relapse, followed by patients withdrawn from PP3M and patients withdrawn from ORAL paliperidone. PP3M was better at preventing relapse compared to ORAL paliperidone. The results demonstrated that 50% of patients who were withdrawn from ORAL paliperidone, PP1M, or PP3M remained relapse-free for ~2, 6, and 13 months, respectively. Compared to PP1M, PP3M is just as safe and effective and has the added advantage of increased adherence related to a longer dose interval, decreasing the risk of relapse.

2021 ◽  
Vol 8 (1) ◽  
pp. 81-87
Gian Luca Breschi ◽  
Federica Demma ◽  
Paolo Morelli ◽  
Maria De Francesco

Abstract Introduction: In Hodgkin Lymphoma (HL), the early administration of brentuximab vedotin (BV) represents a highly effective treatment to consolidate patients after autologous stem cell transplantation (ASCT). For this indication, the Summary of Product Characteristics (SPC) reports a lower medical resource utilization in BV vs. placebo. This study aimed at assessing costs accrued by using BV in consolidation after ASCT and compare them with the resource consumption associated with the main options today used in Italy for HL. Methods and results: A cost-analysis based on patients at high risk of relapse (HL CD30+-HR) after ASCT was developed by collecting data about health care consumption (drugs and monitoring). The model is described by two arms, "A," where BV is used as consolidation therapy after ASCT, and "B", where patients are treated only at the time of relapse. A 3-year time horizon and the Italian National Health System perspective were adopted. All data inputs for the analysis were sourced from the available literature and official list prices. The simulation was integrated by sensitivity analysis. The introduction of BV as consolidation therapy would allow savings in terms of drug acquisition and resource consumption. Over a 3-year time frame, the Consolidation arm’s overall expenditure was 137,059€ vs. 225,418€ in the Non-consolidation arm. Early after the ASCT, BV administration guarantees a long period free from relapses (5-year PFS is not reached), thus reducing the clinical and economic burden of the subsequent therapies needed to treat further relapses. Conclusions: The present pharmacoeconomic analysis shows that the introduction of BV as consolidation therapy after ASCT represents a sustainable expenditure for the National Healthcare System (NHS) and a cost-saving paradigm when compared with the drug mainly used for treating the relapses.

2021 ◽  
Vol 30 (5) ◽  
pp. 453-460
Arild Opheim ◽  
Zhanna Gaulen ◽  
Kristin Klemmetsby Solli ◽  
Zill‐e‐Huma Latif ◽  
Lars T. Fadnes ◽  

Haematologica ◽  
2021 ◽  
Jun Zou ◽  
Piyanuch Kongtim ◽  
Betül Oran ◽  
Vasilis Kosmoliaptsis ◽  
Yudith Carmazzi ◽  

HLA-DPB1 mismatches between donor and recipient are commonly seen in allogeneic hematopoietic stem cell transplantation (HSCT) from an unrelated donor. HLA-DPB1 mismatch, conventionally determined by the similarity of the T-cell epitope (TCE), is associated with an increased risk of acute graft-versus-host disease (aGVHD) and a decreased risk of disease relapse. We investigated the clinical impact of HLA-DPB1 molecular mismatch quantified by mismatched eplets (ME) and Predicted Indirectly Recognizable HLA Epitopes score (PS) in a cohort of 1,514 patients receiving HSCT from unrelated donors matched at HLA-A, -B, -C, -DRB1/3/4/5, and -DQB1 loci. HLA-DPB1 alloimmunity in the GVH direction determined by high GVH ME/PS was associated with a reduced risk of relapse (HR 0.83, P= .05 for ME) and increased risk of grade 2-4 aGVHD (HR 1.44, P< .001 for ME), whereas high HVG ME/PS was only associated with an increased risk of grade 2-4 aGVHD (HR 1.26, P= .004 for ME). Notably, in the permissive mismatch subgroup classified by TCE grouping, high HVG ME/PS was associated with an increased risk of relapse (HR 1.36, P= .026 for ME) and grade 2-4 aGVHD (HR 1.43, P= .003 for PS-II). Decision curve analysis showed GVH ME outperformed other models and provided the best clinical net benefit for the modification of aGVHD prophylaxis regimen in patients with high risk of developing clinically significant aGVHD. In conclusion, molecular assessment of HLA-DPB1 mismatch enables separate prediction of HVG or GVH alloresponse quantitatively and allows further refinement of HLA-DPB1 permissiveness as defined by conventional TCE grouping.

2021 ◽  
Ignacio Ruz-Caracuel ◽  
Álvaro López-Janeiro ◽  
Victoria Heredia-Soto ◽  
Jorge L. Ramón-Patino ◽  
Laura Yébenes ◽  

AbstractLow-grade and early-stage endometrioid endometrial carcinomas (EECs) have an overall good prognosis but biomarkers identifying patients at risk of relapse are still lacking. Recently, CTNNB1 exon 3 mutation has been identified as a potential risk factor of recurrence in these patients. We evaluate the prognostic value of CTNNB1 mutation in a single-centre cohort of 218 low-grade, early-stage EECs, and the correlation with beta-catenin and LEF1 immunohistochemistry as candidate surrogate markers. CTNNB1 exon 3 hotspot mutations were evaluated by Sanger sequencing. Immunohistochemical staining of mismatch repair proteins (MLH1, PMS2, MSH2, and MSH6), p53, beta-catenin, and LEF1 was performed in representative tissue microarrays. Tumours were also reviewed for mucinous and squamous differentiation, and MELF pattern. Nineteen (8.7%) tumours harboured a mutation in CTNNB1 exon 3. Nuclear beta-catenin and LEF1 were significantly associated with CTNNB1 mutation, showing nuclear beta-catenin a better specificity and positive predictive value for CTNNB1 mutation. Tumours with CTNNB1 exon 3 mutation were associated with reduced disease-free survival (p = 0.010), but no impact on overall survival was found (p = 0.807). The risk of relapse in tumours with CTNNB1 exon 3 mutation was independent of FIGO stage, tumour grade, mismatch repair protein expression, or the presence of lymphovascular space invasion. CTNNB1 exon 3 mutation has a negative impact on disease-free survival in low-grade, early-stage EECs. Nuclear beta-catenin shows a higher positive predictive value than LEF1 for CTNNB1 exon 3 mutation in these tumours. Graphical abstract

Reumatismo ◽  
2021 ◽  
Vol 73 (2) ◽  
pp. 117-121
D. Soddu ◽  
D. Sola ◽  
M. Bellan ◽  
E. Boin ◽  
M.G. Cittone ◽  

Red blood cell distribution width (RDW) has been studied as a prognostic biomarker for different chronic inflammatory diseases. In this paper we aim to evaluate its potential role in the prediction of early relapse in patients affected by polymyalgia rheumatica (PMR). We revised retrospectively clinical records of patients who received a diagnosis of PMR, according to 2012 ACR/EULAR classification criteria, for whom baseline clinical and laboratory data were available. The baseline RDW variation coefficient was correlated to the risk of relapse, in the first 6 months of the disease. We identified 44 patients [females 15 (34.0%)/males 29 (66.0%); median age 80 (72-83)], 9 of whom had an early relapse. These patients showed a larger median RDW than patients who did not relapse [13.7 (13.5-14.9)% vs 13.5 (12.7-14.2)%; p=0.04). The two groups were comparable for all the other clinical and laboratory parameters considered. Interestingly, patients in the higher half of the RDW distribution showed a shorter relapse-free survival (p<0.03). In a stepwise logistic regression, RDW (p=0.01) predicted the risk of relapse at 6 months, while age, gender, CRP, ESR, Hb, MCV and prednisone dose did not fit the model. Our results show that RDW is an independent biomarker of early relapse, making this parameter a potentially promising predictive marker in PMR.

Addiction ◽  
2021 ◽  
Kara E. Rudolph ◽  
Matisyahu Shulman ◽  
Marc Fishman ◽  
Iván Díaz ◽  
John Rotrosen ◽  

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