scholarly journals Effectiveness and safety of infliximab dose escalation in patients with refractory Takayasu arteritis: A real-life experience from a monocentric cohort

2021 ◽  
Author(s):  
Alessandro Tomelleri ◽  
Corrado Campochiaro ◽  
Silvia Sartorelli ◽  
Francesco Baldassi ◽  
Federico Fallanca ◽  
...  
Keyword(s):  
Takayasu Arteritis ◽  
Dose Escalation ◽  
Dose Group ◽  
Life Experience ◽  
Clinical Symptoms ◽  
Standard Dose ◽  
Univariate Analysis ◽  
Real Life ◽  
Factors Associated ◽  
Observational Cohort

ABSTRACT Objectives To evaluate effectiveness and safety of infliximab dose escalation in Takayasu arteritis (TAK) patients. To identify factors associated with refractoriness to standard-dose infliximab. Methods Medical records of infliximab-treated TAK patients from a large single-centre observational cohort were reviewed. Infliximab therapy duration, concomitant therapies, and reasons for dose escalation and therapy suspension were evaluated. Occurrence of adverse events was recorded. A comparison between patients who maintained infliximab standard-dose and those who needed dose-escalation was performed. Factors associated with refractoriness to standard dose were analysed. Results Forty-one patients were included. Starting infliximab dose was 5 mg/kg 6-weekly and 28 patients (68%) needed dose escalation. Persistence/recurrence of clinical symptoms was the most frequent reason for escalation. Median therapy duration was 39 (IQR, 26–61) months in the standard-dose group and 68 (38–87) months in the intensified-dose group. In the intensified-dose-group, infliximab was suspended in eight patients (29%) after a median of 38 (31–71) months, due to loss of response (n = 7) or patient’s request (n = 1). Patients in the intensified-dose group had a higher number of relapses (3.4 vs 0.8 events/patient) and received a higher cumulative steroid dose (1.7 [1.6–2.3] vs 1.3 [1–1.6] g/month of prednisone). Three patients from the intensified-dose group had serious infections; one patient from the standard-dose group developed paradoxical psoriasis. At univariate analysis, age at diagnosis and age at infliximab start were associated with infliximab escalation. Conclusion In TAK, dose escalation is safe and allows to optimise infliximab durability in refractory patients. Younger patients seem to be more refractory to standard dosages.

scholarly journals Clinical Factors Associated With Dose Escalation of Solifenacin for the Treatment of Overactive Bladder in Real Life Practice

2014 ◽  
Vol 18 (1) ◽  
pp. 23 ◽  
Author(s):  
Ji-Youn Chun ◽  
Miho Song ◽  
Ji-Yeon Han ◽  
Selee Na ◽  
Bumsik Hong ◽  
...  
Keyword(s):  
Overactive Bladder ◽  
Dose Escalation ◽  
Real Life ◽  
Clinical Factors ◽  
Factors Associated

scholarly journals P0052EMERGING CONCEPTS IN KIDNEY ATTR AMYLOIDOSIS: CHRONIC ADMINISTRATION OF TAFAMIDIS

2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Joana Tavares ◽  
Andreia Campos ◽  
Ana Rocha ◽  
Idalina Beirão ◽  
Isabel Fonseca ◽  
...  
Keyword(s):  
Symptom Onset ◽  
Combined Therapy ◽  
Univariate Analysis ◽  
Disease Onset ◽  
Real Life ◽  
Chronic Administration ◽  
Longitudinal Changes ◽  
Factors Associated ◽  
Attr Amyloidosis ◽  
Wide Range

Abstract Background and Aims Transthyretin (TTR) amyloidosis is a disease characterized by destabilization of the native TTR tetramer. It can be caused by aging or due to pathogenic mutations, and its diagnosis is often missed. Hereditary transthyretin amyloidosis (ATTRv), due to Val50Met mutation, is frequently linked with polyneuropathy but it can cause nephropathy too, causing wide range levels of albuminuria and renal dysfunction. Tafamidis, a TTR tetramer stabilizer, has been associated with significant decrease of albuminuria in ATTRv. However, TTR nephropathy is not an approved indication for its use. Plus, the renal effects of chronic oral administration of this TTR stabilizer are yet to be understood. This study evaluated longitudinal changes of eGFR-EPI within 72 months of therapy with tafamidis and identified factors associated with these changes. Method A retrospective cohort, single centre study was conducted. We have followed consecutive ATTRv Val50Met patients on tafamidis therapy from July 2012 to March 2019. Men and women aged 18-85 years were eligible if they had neuropathy stage I, were anti-amyloid treatment-naïve patients that accomplished at least 60 months of tafamidis therapy and had eGFR over 45 ml/min/1.73m2 with any grade of albuminuria. Exclusion criteria were: pregnancy, malignancies, diabetes and concurrent etiologies for nephropathy. Statistical analyses included Mann-Whitney test and linear mixed models to analyze the longitudinal changes in eGFR of the two groups of patients (albumunuric/ non-albuminuric at baseline), by controlling for variables that could be associated with eGFR EPI Cystatin C course. Results From 366 patients, biopsy-proven ATTR amyloidosis, treated with tafamidis, 122 patients met our criteria (56 males, 66 females) and had a median age of 36 (IQR: 32-46) years old. Twenty-eight had pathological urinary albumin-to-creatinine ratio (ACR), defined by ACR >30 mg/dL, and ACR >300 mg/dL was only found in females. In univariate analysis no significant differences were found between median eGFR decline in albuminuric versus non-albuminuric patients (p=0.330). At all time points, mean eGFR levels were significantly lower in baseline albuminuric patients. According to our estimation, eGFR at baseline was 11.2 mL/min/1.73 m2 lower in baseline albuminuric patients, adjusted for age at the disease onset and time between symptom onset and tafamidis initiation. Baseline albuminuria status (p=0,005), age at the disease onset (p<0,001) and time between initiation of symptoms and initiation of tafamidis (p=0,016) were the only independent factors associated with longitudinal changes of eGFR (higher age at the disease onset and higher time between symptom onset and tafamidis initiation were associated with lower levels of eGFR). Figure 1 shows the predicted eGFR EPI trajectories over time for baseline albuminuric/ non-albuminuric subjects. Conclusion This study represents a real-life experience of oral chronic administration of tafamidis and its effects on ATTR nephropathy, concerning albuminuria reduction and renal function decline. Our analysis had shown similar decline rates in eGFR, irrespectively the degree of albuminuria at baseline, differently from what would be expected, since higher grades of albuminuria are related with more rapidly kidney function deterioration. Besides its capacity of stabilizing TTR tetramers, tafamidis could have an enhancing role in the podocyte regeneration process through potential cofactors for amyloid fibrils toxic effect, that could be present in the glomerular basement membrane and mesangium. This nephroprotector effect should be considered when a switch of therapy is demanded by the neuropathy status and a second line treatment is considered. Presence of renal disease may be an indication for tafamidis maintenance and combined therapy.

scholarly journals Real-life experience with 4 years of golimumab persistence in ulcerative colitis patients

2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Marisa Iborra ◽  
Natalia García-Morales ◽  
Saoia Rubio ◽  
Federico Bertoletti ◽  
Marta Calvo ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Disease Duration ◽  
Life Experience ◽  
Real Life ◽  
Efficacy And Safety ◽  
Dose Intensification ◽  
Factors Associated ◽  
Mean Time

Abstract Golimumab has demonstrated its long-term efficacy and safety in ulcerative colitis in clinical trials, but no data of long-term persistence has been published from real world. To estimate long-term persistence of golimumab, as well as factors associated with longer persistence, in patients with ulcerative colitis in real life. Observational multicentre study including adult patients with ulcerative colitis treated with golimumab and with at least twelve months of follow-up. We included 190 patients, 105 (55.26%) naive to anti-TNF, with mean disease duration of 9.32 ± 8.09 years. Probability of persistence was 63%, 46%, 39% and 27% at 1, 2, 3 and 4 years, respectively. Persistence was lower in patients with primary failure to previous anti-TNF. Eighty-two (43.16%) patients needed dose intensification during follow-up, with a mean time until intensification of 8.03 ± 8.64 months. Dose intensification and lower disease duration predicted higher persistence with golimumab (p = 0.037 and p = 0.008, respectively). During a follow-up of 17.25 ± 15.83 months, 32 (16.5%) patients needed hospitalisation and 11 (6%) underwent colectomy. No unexpected adverse events were reported. Golimumab has demonstrated good persistence and safety profile for long treatment in ulcerative colitis patients.

scholarly journals Voluntary Testing Practice Among People with Clinical Symptoms of COVID-19 in Somalia: Using Andersen’s Behavioral model

2021 ◽  
Author(s):  
Mohamed Ali Magan ◽  
Duah Dwomoh
Keyword(s):  
Peer Influence ◽  
Clinical Symptoms ◽  
Statistical Significance ◽  
Univariate Analysis ◽  
Behavioral Model ◽  
Contact Tracing ◽  
Household Level ◽  
Factors Associated ◽  
Voluntary Testing ◽  
Study Participants

Abstract Background: COVID-19, is a respiratory disease caused by a novel coronavirus. The virus is a global pandemic which threatens children and their rights in countries around the world. Epidemiologists have advocated for a robust testing and contact tracing as a potential solution to balance public health and economic priorities. Using Anderson Behavioral Model, our study aimed to analyze predisposing, Enabling and Need factors associated with VT4C-19 practice in Somalia. Methods: A cross sectional community-based survey were conducted at household level among adults above the age 18 years living in Mogadishu and Garowe cities. The study used multi-stage stratified-cluster sampling method. Out of the Four main towns in Somalia with a designated free National laboratory for COVID-19 testing by the government, the study randomly selected two cities (Mogadishu & Garowe) using Simple Random Sampling (SRS) Method. The study used univariate analysis and Multivariable Binary Logistic Regression model to control other possible confounders and to give the Andersen Behavioral Modal that were independently associated with voluntary testing for COVID-19 in Somalia. The statistical significance tests were accepted at p < 0.05.Results: Only 113 (6.6%) out of (1,708) study participants who experienced clinical symptoms of COVID-19 (between 16 March – 31 December 2020) voluntarily tested their COVID-19 status. The study found Predisposing factors including gender (P<0.001), marital status (p<0.05), mass media availability (p<0.05), telephone ownership (p<0.05), peer influence (P<0.001) and stigma of COVID-19 positive individuals in the community (P<0.001), and Enabling factors including: place of residence (p<0.001), expense decision maker at household level (p<0.05), insurance status (p<0.001) and access to outreach and health education program (p<0.05), as well as the Need factors including: perceived importance of COVID-19 voluntary test (p<0.001) and chronic diseases status among the study participants (p<0.05) were among the factors associated with the practice of voluntary tests of COVID-19 among the clinically symptomatic individuals in Somalia.Conclusion: The uptake of Voluntary testing for COVID-19 is very low in Somalia. To promote this, health officials and policy makers need to focus on a consistent and culturally sensitive community sensitization programs and bringing the COVID-19 test closer to the communities including rural communities.

Factors associated with fingolimod rebound: A Single Center Real-life Experience

2021 ◽  
pp. 103278
Author(s):  
Cansu Goncuoglu ◽  
Dr. Asli Tunceri ◽  
Dr. Aygin Bayraktar-Ekincioglu ◽  
Dr. Cansu Ayvacioglu-Cagan ◽  
Dr. Pinar Acar-Ozen ◽  
...  
Keyword(s):  
Life Experience ◽  
Real Life ◽  
Single Center ◽  
Factors Associated

270 Real life experience of tocilizumab for Takayasu arteritis

Rheumatology ◽  
2019 ◽  
Vol 58 (Supplement_3) ◽  
Author(s):  
Kavina Shah ◽  
Justin C Mason
Keyword(s):  
Takayasu Arteritis ◽  
Life Experience ◽  
Real Life

scholarly journals AB0534 EFFICACY OF TOCILIZUMAB IN LARGE-VESSEL GIANT CELL ARTERITIS: A SINGLE-CENTER REAL-LIFE EXPERIENCE

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1563.1-1564
Author(s):  
A. Tomelleri ◽  
C. Campochiaro ◽  
S. Sartorelli ◽  
E. Baldissera ◽  
L. Dagna
Keyword(s):  
Giant Cell Arteritis ◽  
Giant Cell ◽  
Life Experience ◽  
Clinical Symptoms ◽  
Vascular Inflammation ◽  
Significant Proportion ◽  
Real Life ◽  
Pet Scan ◽  
Protein Levels ◽  
Daily Dose

Background:In a significant proportion of giant cell arteritis (GCA) patients, large vessels (LV) are affected1. GiACTA trial showed tocilizumab (TCZ) to be effective for the treatment of GCA2but did not differentiate between patients with and without LV involvement and did not evaluate LV-imaging response.Objectives:To assess efficacy of TCZ in LV-GCA, evaluating both clinical symptoms and vascular inflammation on PET scan.Methods:Data from GCA patients followed-up at our Institution between January 2003 and December 2019 were retrospectively collected. Only TCZ-treated patients, with evidence of LV 18F-FDG-uptake at baseline (T0) and who repeated a PET scan after at least 6 months of treatment (T1) were included. All patients received subcutaneous TCZ 162 mg weekly. PET scans were read by 2 physicians blinded with regard to clinical data and to each other’s assessment; vascular inflammation was quantified using the PETVAS score3. Clinical symptoms, prednisone (PDN) dosage, and PETVAS score between T0 and T1 were compared. Flares and adverse events were recorded. Non parametric tests were used.Results:61 TCZ-treated GCA patients were identified. Of these, 28 (45.9%) had evidence of vascular inflammation at T0, and 14 of them (10 female, mean age 66.2±7.4 years) repeated a PET scan during follow-up, after a median of 13 months (IQR, 9.5-17.5). 10 patients started TCZ upon GCA relapse, with a median delay from GCA diagnosis of 7.5 (3-15.8) months; 4 patients were newly diagnosed and started TCZ at diagnosis. At T0, 10 patients had systemic symptoms, 6 patients had cranial symptoms, and 7 had polymyalgia rheumatica (PMR). 12/14 patients were on concomitant steroids, with a median PDN daily dose of 15 (15-25) mg. Erythrocyte sedimentation rate and C-reactive protein levels were respectively 35 (21-39) mm/h and 7.8 (3.2-11) mg/L. Median PETVAS was 7 (3.3-11). At T1, 13/14 patients were asymptomatic; 1 patient had a PMR relapse. No GCA flare was recorded. Median PDN daily dose was 1.25 (0-2.5), p=0.002, and PDN suspension was achieved in 5 patients. Median PETVAS was 0 (0-0.8), p=0.003; only in 1 patient PETVAS increased between T0-T1 (from 2 to 5), in absence of clinical symptoms. This was the patient with the longest delay between diagnosis and TCZ start (124 months) and suspended TCZ for 3 months due to oral aphthosis. No patients had severe infections; 1 patient definitively suspended TCZ at T1 due to severe leukopenia.Conclusion:In LV-GCA patients, TCZ seems to be effective in obtaining clinical remission and in reducing vascular inflammation on PET scan.References:[1]Dejaco C, et al. Nature Reviews Rheumatology (2017)[2]Stone JH, et al. N Engl J Med (2017)[3]Grayson PC, et al. Arthritis Rheumatol (2018)Disclosure of Interests:Alessandro Tomelleri: None declared, Corrado Campochiaro Speakers bureau: Novartis, Pfizer, Roche, GSK, SOBI, Silvia Sartorelli: None declared, Elena Baldissera Speakers bureau: Novartis, Pfizer, Roche, Alpha Sigma, Sanofi, Lorenzo Dagna Grant/research support from: Abbvie, BMS, Celgene, Janssen, MSD, Mundipharma Pharmaceuticals, Novartis, Pfizer, Roche, SG, SOBI, Consultant of: Abbvie, Amgen, Biogen, BMS, Celltrion, Novartis, Pfizer, Roche, SG, and SOBI

scholarly journals High Toxicity and Poor Survival with Association CHOP Plus Etoposide Compared to CHOP Regimen in 124 Brazilian Patients with Nodal PTCL Lymphomas (nPTCL): A Real-Life Experience

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 1398-1398
Author(s):  
Luis Alberto de Padua Covas Lage ◽  
Claudio Vinicius Brito ◽  
Guilherme Carneiro Barreto ◽  
Cadiele Oliana Reichert ◽  
Débora Levy ◽  
...  
Keyword(s):  
Latin American ◽  
Clinical Laboratory ◽  
Univariate Analysis ◽  
Real Life ◽  
Prognostic Impact ◽  
First Line ◽  
Chop Regimen ◽  
Factors Associated ◽  
Epidemiological Characteristics

Abstract Introduction: Nodal PTCL constitute a heterogeneous group of rare malignancies derived from CD4+ T-helper, CD8+ T-cytotoxic or follicular T-helper lymphocytes. It presents aggressive clinical-biological behavior and distinct outcomes [1]. These tumors have significant geographic variation, making important studies of clinical and epidemiological characteristics and outcomes of patients in specific areas of the word. Latin American data on nPTCL are scarce in the literature [2] and its first-line treatment is still controversial and ineffective, due to high rates of primary chemo-resistance. Therefore, this study aims to describe clinical, laboratory and epidemiological characteristics, identify prognostic factors and analyze the outcomes of patients with nPTCL treated with CHOP/CHOP-like regimens as first-line therapy in Brazil. Methods: This is a retrospective, observational and unicentric study involving 124-Brazilian patients with nPTCL treated at HC/FMUSP from January 2000 to December 2017. All cases were submitted to centralized histopathological review and classified according to WHO-2016 criteria on PTCL/NOS, AITL, ALK+/ALCL or ALK-/ALCL. Clinical-laboratory and outcomes data were obtained from digital medical records. Descriptive variables were arranged in absolute numbers and relative frequencies. OS and PFS curves were estimated by the Kaplan-Meier method. Univariate Cox analysis was used to determine factors with prognostic impact through the association between categorical variables and survival curves. Variables that were significant in the univariate analysis were tested in a multivariate analysis to establish independent variables. Statistical analysis was performed using SPSS V.22 software and p-values ≤ 0.05 were considered statistically significant. Results: The clinical-laboratory characteristics of 124 nPTCL patients were summarized in Table 1. With a median age of 48.5 years (18-87 years) and 57.3% of male, about 81.5% had B-symptoms, 88.7% with CS III/IV and 58.1% had IPI ≥ 3. ORR to first-line treatment was 58.9%, 37.9% (47/124) were treated with CHOP regimen and 35.5% (44/124) with CHOEP, 30.1% (37/124) were submitted to radiotherapy and 32.3% (40/124) were consolidated with ASCT. We observed a higher 2-year OS for patients treated with CHOP versus CHOEP (78.7% vs. 61.4%; p=0.05), as well as a better 2-year PFS for the same regimen (69.7% vs. 25.0%; p&lt;0.0001) - Figure 1. CHOEP treatment was associated with higher rates of G3-4 neutropenia, febrile neutropenia and G3-4 thrombocytopenia (57% x 88% p=0.001, 38% x 70% p=0.003 and 27% x 63% p=0.0007, respectively). Overall mortality was 55.6% (69/124) during all follow-up, with disease progression being the major cause of death (29/69 - 42.0%). With a median follow-up of 23.7 months (0.10-278.6 months), medians of OS and PFS were 48.0 months (95% CI: 9.0-86.9) and 8.8 months (95% CI: 3.9-13.7), respectively. Estimative of 2-year OS and PFS for the global cohort were 61.3% and 41.5%, respectively. In the univariate analysis, factors with a favorable prognostic impact on OS were: IPI &lt; 3 (HR: 0.30; 95% CI: 0.15-0.58; p&lt;0.0001), absence of bone marrow infiltration (HR: 0.39; 95% CI: 0.20-0.75; p=0.005), LDH &lt; 480 U/L (HR: 0.36; 95% CI: 0.19-0.68; p=0.002), radiotherapy (HR: 0.23; 95% CI: 0.10-0.55; p=0.001) and ASCT (HR: 0.28; 95% CI: 0.004-0.30; p&lt;0.0001). Factors associated with better 2-year PFS were: IPI &lt; 3 (HR: 0.36; 95% CI: 0.18-0.71, p=0.004), absence of bone marrow infiltration (HR: 0.30; 95% CI: 0.26-0.55; p=0.03 ), LDH &lt; 480 U/L (HR: 0.36; 95% CI: 0.19-0.67; p=0.001), radiotherapy (HR: 0.17; 95% CI: 0.06-0.44; p&lt;0.0001) and ASCT (HR: 0.03 ; 95% CI: 0.004-0.23); p=0.001). In the multivariate analysis, factors associated with better 2-year OS were: LDH &lt; 480 U/L (HR: 0.40; 95% CI: 0.21-0.76); p=0.005) and ASCT (HR: 0.47; 95% CI: 0.006-0.34; p=0.003). LDH &lt; 480 U/L (HR: 0.45; 95% CI: 0.23-0.87; p=0.01) and ASCT (HR: 0.07; 95% CI: 0.01-0.54; p=0.01) were also associated with higher 2-year PFS. Conclusion: This is the largest real-life Latin American nPTCL cohort published to date. Patients with nPTCL have poor survival and high rate of chemo-resistance. In our cohort, adding etoposide to the CHOP regimen showed no survival benefit and was associated with high toxicity. Normal values of LDH and consolidation with ASCT were independent factors associated with better outcomes in Brazilian patients with nPTCL. Figure 1 Figure 1. Disclosures No relevant conflicts of interest to declare.

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