relapse rates
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Author(s):  
Tjalf Ziemssen ◽  
Michael Lang ◽  
Stephan Schmidt ◽  
Holger Albrecht ◽  
Luisa Klotz ◽  
...  

Abstract Objective To evaluate the 5-year real-world benefit–risk profile of fingolimod in patients with relapsing–remitting MS (RRMS) in Germany. Methods Post-Authorization Non-interventional German sAfety study of GilEnyA (PANGAEA) is a non-interventional real-world study to prospectively assess the effectiveness and safety of fingolimod in routine clinical practice in Germany. The follow-up period comprised 5 years. Patients were included if they had been diagnosed with RRMS and had been prescribed fingolimod as part of clinical routine. There were no exclusion criteria except the contraindications for fingolimod as defined in the European label. The effectiveness and safety analysis set comprised 4032 and 4067 RRMS patients, respectively. Results At the time of the 5-year follow-up of PANGAEA, 66.57% of patients still continued fingolimod therapy. Annualized relapse rates decreased from baseline 1.5 ± 1.15 to 0.42 ± 0.734 at year 1 and 0.21 ± 0.483 at year 5, and the disability status remained stable, as demonstrated by the Expanded Disability Status Scale mean change from baseline (0.1 ± 2.51), the decrease of the Multiple Sclerosis Severity Score from 5.1 ± 2.59 at baseline to 3.9 ± 2.31 at the 60-months follow-up, and the percentage of patients with ‘no change’ in the Clinical Global Impression scale at the 60-months follow-up (78.11%). Adverse events (AE) occurring in 75.04% of patients were in line with the known safety profile of fingolimod and were mostly non-serious AE (33.62%) and non-serious adverse drug reactions (50.59%; serious AE 4.98%; serious ADR 10.82%). Conclusions PANGAEA demonstrated the sustained beneficial effectiveness and safety of fingolimod in the long-term real-world treatment of patients with RRMS.


2021 ◽  
Vol 18 (4) ◽  
pp. 74-82
Author(s):  
A. V. Kovaleva ◽  
E. V. Kovalev ◽  
I. M. Arestova

Objective. To develop a diagnostic algorithm, a rational method of treatment, and principles of preconception care in women with herpes-associated recurrent vulvovaginal candidiasis (RVVC).Materials and methods. We examined 68 patients with herpes-associated RVVC and 20 gynecologically healthy women.Results. It has been found that in RVVC it is necessary to study vaginal swab culture with the determination of the microorganism and its biofilm-forming ability in combination with viral DNA detection by the polymerase chain reaction (PCR) in vaginal secretion, determination of the IgG titer to the herpes simplex virus (HSV), the avidity index to HSV I and II. In the presence of laboratory-confirmed RVVC and HSV infection, it is necessary to assume the presence of an atypical course of HSV infection followed by complex antiviral and antimycotic therapy.Conclusion. The use of the developed algorithm of diagnostic and treatment interventions as preconception care makes it possible to address symptoms, reduce relapse rates and extend a non-relapse interval, prepare women with the mixed-infection for favorable pregnancy outcomes.  


2021 ◽  
pp. 025371762110563
Author(s):  
Raakhi Tripathi ◽  
Sharmila Jalgaonkar ◽  
Snehalata Gajbhiye ◽  
Nishtha Khatri ◽  
Mohsin Sayyed ◽  
...  

Background: Schizophrenia is associated with high relapse rates, and medication nonadherence is a major factor contributing toward relapse. Since medication adherence and treatment awareness are linked, an alarming need was felt to evaluate the level of drug treatment awareness in patients who have schizophrenia. Besides, patients who have schizophrenia are often dependent on their caregivers for medications. Hence, the current study was also designed to look into drug treatment awareness among caregivers. Methods: This was a cross-sectional, questionnaire-based study. Patients diagnosed with schizophrenia as per The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition were included, provided they had good insight and had been prescribed medications at the study center for at least three months. Caregivers were included using the Pollak and Perlick criteria. The sociodemographic profile of the patients and caregivers was recorded, and further assessment for treatment awareness was done using the prevalidated Drug Treatment Awareness Questionnaire (DTAQ). Results: A total of 166 patients and 157 caregivers were enrolled. Mean drug awareness scores among patients and caregivers did not show statistically significant differences (P= 0.22). Mean ± SD DTAQ awareness scores in patients and caregivers were 12.57 ± 1.81 and 12.84 ± 1.91, respectively. The majority of patients and caregivers (> 90%) possessed awareness in domains related to past medication records and in that of re-visit/re-contact instructions. Awareness was least commonly seen in relation to side effects of medications and details of the prescribed medications, where only about 50% of patients and caregivers possessed awareness. No clinically significant correlation was found between sociodemographic factors and drug treatment awareness scores. Conclusion: Drug treatment awareness in patients and caregivers was comparable and was not reliant on the sociodemographic factors. Special interventions should be conducted to raise drug treatment awareness among patients having insight and their caregivers.


Author(s):  
Tetsuya Akaishi ◽  
Tatsuro Misu ◽  
Kazuo Fujihara ◽  
Toshiyuki Takahashi ◽  
Yoshiki Takai ◽  
...  

Abstract Objective The patterns of relapse and relapse-prevention strategies for anti-myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD) are not completely investigated. We compared the patterns of relapse in later stages of MOGAD with those of anti-aquaporin-4 antibody (AQP4-Ab)-positive neuromyelitis optica spectrum disorder (NMOSD). Methods In this observational, comparative cohort study, 66 patients with MOGAD and 90 with AQP4-Ab-positive NMOSD were enrolled. We compared the patterns of relapse and annualized relapse rates (ARRs) in the first 10 years from disease onset, stratified by relapse-prevention treatments. Results Approximately 50% of the patients with MOGAD experienced relapses in the first 10 years. Among those not undergoing relapse-prevention treatments, ARRs in the first 5 years were slightly lower in MOGAD patients than in AQP4-Ab-positive NMOSD patients (MOGAD vs. AQP4-Ab NMOSD: 0.19 vs. 0.30; p = 0.0753). After 5 years, the ARR decreased in MOGAD patients (MOGAD vs. AQP4-Ab NMOSD: 0.05 vs. 0.34; p = 0.0001), with a 72% reduction from the first 5 years (p = 0.0090). Eight (61.5%) of the 13 MOGAD patients with more than 10-year follow-up from disease onset showed relapse 10 years after onset. Clustering in the timing and phenotype of attacks was observed in both disease patients. The effectiveness of long-term low-dose oral PSL for relapse prevention in patients with MOGAD has not been determined. Conclusions The relapse risk in patients with MOGAD is generally lower than that in patients with AQP4-Ab-positive NMOSD, especially 5 years after onset. Meanwhile, relapses later than 10 years from onset are not rare in both diseases.


Healthcare ◽  
2021 ◽  
Vol 9 (12) ◽  
pp. 1613
Author(s):  
Alan B. McGuire ◽  
Mindy E. Flanagan ◽  
Marina Kukla ◽  
Angela L. Rollins ◽  
Laura J. Myers ◽  
...  

Prior studies have demonstrated disruption to outpatient mental health services after the onset of the COVID-19 pandemic. Inpatient mental health services have received less attention. The current study utilized an existing cohort of 33 Veterans Health Affairs (VHA) acute inpatient mental health units to examine disruptions to inpatient services. It further explored the association between patient demographic, clinical, and services variables on relapse rates. Inpatient admissions and therapeutic services (group and individual therapy and peer support) were lower amongst the COVID-19 sample than prior to the onset of COVID-19 while lengths of stay were longer. Relapse rates did not differ between cohorts. Patients with prior emergent services use as well as substance abuse or personality disorder diagnoses were at higher risk for relapse. Receiving group therapy while admitted was associated with lower risk of relapse. Inpatient mental health services saw substantial disruptions across the cohort. Inpatient mental health services, including group therapy, may be an important tool to prevent subsequent relapse.


Author(s):  
Vanessa A Fabrizio ◽  
Christine L. Phillips ◽  
Adam Lane ◽  
Christina Baggott ◽  
Snehit Prabhu ◽  
...  

Chimeric antigen receptor (CAR) T-cells have transformed the therapeutic options for relapsed/refractory (R/R) B-cell ALL. Data for CAR therapy in extramedullary (EM) involvement is limited. Retrospective data was abstracted from the Pediatric Real World CAR Consortium (PRWCC) of 184 infused patients from 15 US institutions. Response (CR) rate, overall survival (OS), relapse-free survival (RFS), and duration of B-cell aplasia (BCA) in patients referred for tisagenlecleucel with EM disease (both CNS3 and non-CNS EM) were compared to bone marrow (BM) only. Patients with CNS disease were further stratified for comparison. Outcomes are reported on 55 patients with EM disease prior to CAR (n=40 CNS3; n=15 non-CNS EM). The median age at infusion in CNS cohort was 10 years (range <1-25) and the non-CNS EM cohort was 13 years (2-26). In patients with CNS disease, 88% (35/40) achieved a CR, versus only 66% (10/15) with non-CNS EM disease. Patients with CNS disease (both with and without marrow involvement) had comparable 24-month OS outcomes to non-CNS EM or BM only (p=0.41). There was no difference in 12-month RFS between CNS, non-CNS EM, or BM only patients (p=0.92). No increased toxicity was seen with CNS or non-CNS EM disease (p=0.3). Active CNS disease at time of infusion did not impact outcomes. Isolated (iCNS) disease trended towards improved OS when compared to combined CNS and BM (p=0.12). R/R EM disease can be effectively treated with tisagenlecleucel with toxicity, relapse rates and survival rates comparable to patients with BM only. Outcomes for iCNS relapse are encouraging.


2021 ◽  
pp. ijgc-2021-002699
Author(s):  
Jennifer Chae-Kim ◽  
Gunjal Garg ◽  
Larisa Gavrilova-Jordan ◽  
Lindsay E Blake ◽  
Tongil "TI" Kim ◽  
...  

ObjectiveProgestin therapy is the recommended fertility-sparing management of atypical endometrial hyperplasia or early-stage endometrial cancer in reproductive-aged women. Our objective was to evaluate disease relapse after progestin and metformin versus progestin therapy alone in patients with endometrial hyperplasia or cancer. Our secondary outcomes were disease remission, clinical pregnancy and live birth rate.MethodsA systematic review of the literature was conducted (MEDLINE, Web of Science, Cochrane Library, CINAHL, LILACS, clinicaltrials.gov) from inception to April 2021. Studies of reproductive-aged women with atypical endometrial hyperplasia or early endometrial cancer who received progestin and metformin or progestin alone for fertility-sparing management, were included in the review. Early endometrial cancer was defined as grade 1, stage 1 disease. Exclusion criteria included women with higher grade endometrial cancer and when conservative management was not for fertility-sparing purposes. Data are presented as odds ratios (ORs) and 95% confidence intervals (CIs) with fixed or random effects meta-analysis. Quality scoring was based on the Newcastle-Ottawa and Jadad scales.ResultsIn total, 271 reports were identified and six studies met the inclusion criteria. These studies included 621 women; 241 (38.8%) patients received combined therapy and 380 (61.2%) received progestin therapy alone. Relapse rates were lower for progestin and metformin than for progestin therapy alone (pooled OR 0.46, 95% CI 0.24 to 0.91, p=0.03). The remission rates were not different (pooled OR 1.35, 95% CI 0.91 to 2.00, p=0.14). Women who received progestin and metformin achieved pregnancy and live birth rates similar to those who received progestin therapy only (pooled OR 1.01, 95% CI 0.44 to 2.35, p=0.98; pooled OR 0.46, 95% CI 0.21 to 1.03, p=0.06).ConclusionFor reproductive-aged women with atypical endometrial hyperplasia or early endometrial cancer, progestin and metformin therapy compared with progestin therapy alone is associated with lower relapse rates, and similar remission, clinical pregnancy and live birth rates.PROSPERO registration numberCRD42020179069.disease remission,


2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Aricia Leone Evangelista Monteiro de Assis ◽  
Anderson Barros Archanjo ◽  
Raul C. Maranhão ◽  
Suzanny O. Mendes ◽  
Rafael P. de Souza ◽  
...  

AbstractThe comparison of chemical and histopathological data obtained from the analysis of excised tumor fragments oral squamous cell carcinoma (OSCC) with the demographic and clinical evolution data is an effective strategy scarcely explored in OSCC studies. The aim was to analyze OSCC tissues for protein expression of enzymes related to oxidative stress and DNA repair and trace elements as candidates as markers of tumor aggressiveness and prognosis. Tumor fragments from 78 OSCC patients that had undergone ablative surgery were qualitatively analyzed by synchrotron micro-X-ray fluorescence for trace elements. Protein expression of SOD-1, Trx, Ref-1 and OGG1/2 was performed by immunohistochemistry. Sociodemographic, clinical, and histopathological data were obtained from 4-year follow-up records. Disease relapse was highest in patients with the presence of chlorine and chromium and lowest in those with tumors with high OGG1/2 expression. High expression of SOD-1, Trx, and Ref-1 was determinant of the larger tumor. Presence of trace elements can be markers of disease prognosis. High expression of enzymes related to oxidative stress or to DNA repair can be either harmful by stimulating tumor growth or beneficial by diminishing relapse rates. Interference on these players may bring novel strategies for the therapeutic management of OSCC patients.


Author(s):  
María Barroso-Hurtado ◽  
Daniel Suárez-Castro ◽  
Carmela Martínez-Vispo ◽  
Elisardo Becoña ◽  
Ana López-Durán

Smoking cessation interventions are effective, but they are not easily accessible for all treatment-seeking smokers. Mobile health (mHealth) apps have been used in recent years to overcome some of these limitations. Smoking cessation apps can be used in combination with a face-to-face intervention (FFSC-Apps), or alone as general apps (GSC-Apps). The aims of this review were (1) to examine the effects of FFSC-Apps and GSC-Apps on abstinence, tobacco use, and relapse rates; and (2) to describe their features. A systematic review was conducted following the internationally Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. Of the total 6016 studies screened, 24 were included, of which nine used GSC-Apps and 15 FFSC-Apps. Eight studies reported significant differences between conditions in smoking cessation outcomes, with three of them being in favor of the use of apps, and two between different point-assessments. Concerning Apps features, most GSC-Apps included self-tracking and setting a quit plan, whereas most of the FFSC-Apps included self-tracking and carbon monoxide (CO) measures. Smartphone apps for smoking cessation could be promising tools. However, more research with an adequate methodological quality is needed to determine its effect. Nevertheless, smartphone apps’ high availability and attractiveness represent a great opportunity to reach large populations.


Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 2760-2760
Author(s):  
Paola Andrea Charry ◽  
Maria Queralt Salas ◽  
Alexandra Pedraza ◽  
María Suárez-Lledó ◽  
Nuria Martínez-Cibrian ◽  
...  

Abstract INTRODUCTION The continuous refinement of transplant techniques has lead to a reduction of transplant-related toxicity resulting on an increasing number of allogeneic hematopoietic cell transplantation (alloHCT) performed in older patients. Since 2014, post-transplant cyclophosphamide (PTCy) with tacrolimus (PTCy-TK), alone, has been progressively implemented at our Institution as GvHD prophylaxis for related, matched and mismatched unrelated donor transplantation (MRD, MUD, MMUD). The experience has proved that the use of this prophylaxis induces effective GvHD prevention without increased relapsed rates (Pedraza et al, 2021). Secondary to the encouraging results obtained from the use of PTCy-TK at our Institution, and considering that older patients with hematological disorders are a group of patients with higher risk to develop transplant-related toxicity, this study compares, as far as we know, the results provided by the use of PTCy-TK with conventional GVHD prophylaxis in a consecutive cohort of patients older than 50 years. METHODS Between January 2014 and June 2020, 147 adults with hematological malignancies and > 50 years underwent alloHCT either from MRD or UD at our Institution. Seventy-two (48.9%) patients received PTCy 50 mg/kg/day IV on day +3 and +4, followed by TK, initiated at a dose of 0.03/kg/24h IV on day +5 and titrated to achieve a therapeutic level of 5-15mg/mL. Other GvHD prophylaxes combined calcineurine inhibitors combined with methotrexate, mycophenolate mofetil, or sirolimus, and anti-thymocyte globulin was added especially when MMUD were selected. Data were collected retrospectively and updated in June 2021. Overall survival (OS) and GvHD-Free/Relapsed free survival (GRFS) were considered the main outcome variables, and the cumulative incidence of GvHD was calculated accounting relapse and dead as competing events. In order to analyze the independent impact of PTCy-TK prophylaxis on OS and GRFS, a multivariate Cox regression analysis was performed including GvHD prophylaxis, Disease Risk Index, and transplant year (dichotomized with a cut-off in 2017, given the marked increase of PTCy-TK after this year) as explanatory variables together with other variables with prognostic value in the univariate analysis. RESULTS Baseline characteristics of patients classified according to the GvHD prophylaxis are reported in Figure 1. The two cohorts of patients according to GvHD prophylaxis are well balanced. Peripheral blood was the predominant stem cell source in the vast majority (97%). Of note, 53 out of 72 patients receiving PTCy-TK were transplanted between July 2017 and December 2020. And UD was used in more than 90% of PTCy-TK alloHCT, compared to 44% of alloHCT with other prophylaxes. The median of days for neutrophil (20 vs 16, p<0.01) and platelet (19 vs 11, p<0.01) engraftment were higher for patients receiving PTCy-TK, while the differences between the incidences of viral reactivations and infections were not statistically significant between the two groups. The cumulative incidence of grade II-IV aGvHD (day +100: 21.9% vs 21.5%, p=0.88) and grade III-IV aGvHD (day +100: 9.2% vs 9.3%, p=0.88) were comparable between both cohorts, but the use of PTCY-TK resulted on a significant reduction on the incidence of moderate/severe cGvHD (1-y: 9% vs 31.5%, p<0.01) (Figure 1). OS (1-y: 72.1% vs 66.7%, HR 0.98; p=0.91), NRM (1-y: 18.1% vs 13.3%, HR 1.20; p=0.63), and relapse rates (1-y: 18.1% vs 22.9%, HR 0.86, P=0.65) were similar in both groups (PTCy-TK and other GvHD prophylaxis, respectively). However, PTCy-TK significantly resulted into an improved GRFS (1-y: 52.6% vs 30.7%, HR 1.68, p=0.01). A multivariate analysis confirmed the independent favorable impact of PTCy-TK prophylaxis on GRFS (HR 0.58, p=0.01), but not on OS (Figure 1). CONCLUSIONS PTCy-TK, alone, is an effective GVHD prophylaxis for alloHCT when related and UD are selected. The use of this innovative combination provides superior GRFS than the use of conventional GvHD prophylaxis in older adults undergoing alloHCT, with comparable transplant-related mortality and relapse rates. GRFS is a composite endpoint considered a surrogate outcome of health-related quality of life, and the improvement of this parameter is remarkable in PTCy-TK alloHCT, especially for older patients. Figure 1 Figure 1. Disclosures Lozano: Grifols: Honoraria; Terumo BCT: Honoraria, Research Funding; Macopharma: Research Funding. Rosinol: Janssen, Celgene, Amgen and Takeda: Honoraria. Esteve: Novartis: Consultancy, Research Funding; Abbvie: Consultancy; Astellas: Consultancy; Jazz: Consultancy; Novartis: Research Funding; Pfizer: Consultancy; Bristol Myers Squibb/Celgene: Consultancy.


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