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1.
Zhongguo Dang Dai Er Ke Za Zhi ; 23(4): 338-342, 2021 Apr.
Artículo en Chino | MEDLINE | ID: mdl-33840404

RESUMEN

OBJECTIVE: To study the efficacy and safety of mycophenolate mofetil (MMF) versus cyclophosphamide (CTX) in the treatment of children with Henoch-Schönlein purpura nephritis (HSPN) and nephrotic-range proteinuria. METHODS: A prospective clinical trial was conducted in 68 pediatric patients who were admitted to the Department of Nephrology, Children's Hospital Affiliated to Capital Institute of Pediatrics and who were diagnosed with HSPN and nephrotic-range proteinuria from August 2016 to November 2019. The patients were randomly divided into two groups:MMF treatment (n=33) and CTX treatment (n=35). The two groups were compared in terms of complete remission rate, response rate (complete remission + partial remission), urinary protein clearance time, and adverse events. RESULTS: At months 3, 6, and 12 of treatment, there was no significant difference in the complete remission rate and the response rate between the MMF treament and CTX treatment groups (P > 0.05). There was also no significant difference between the two groups in the urinary protein clearance time and the incidence rate of adverse events (P > 0.05). CONCLUSIONS: MMF and CTX have similar efficacy and safety in the treatment of HSPN children with nephrotic-range proteinuria.


Asunto(s)
Nefritis , Púrpura de Schoenlein-Henoch , Niño , Ciclofosfamida/efectos adversos , Humanos , Inmunosupresores/efectos adversos , Ácido Micofenólico/efectos adversos , Nefritis/tratamiento farmacológico , Estudios Prospectivos , Proteinuria/tratamiento farmacológico , Proteinuria/etiología , Púrpura de Schoenlein-Henoch/complicaciones , Púrpura de Schoenlein-Henoch/tratamiento farmacológico , Estudios Retrospectivos
2.
Nihon Shokakibyo Gakkai Zasshi ; 118(4): 318-326, 2021.
Artículo en Japonés | MEDLINE | ID: mdl-33840713

RESUMEN

Although standard treatment for autoimmune hepatitis (AIH) comprises prednisolone (PSL) and azathioprine (AZA), some patients are intolerant to or do not respond to PSL and/or AZA. The clinical practice guidelines of AIH in Europe and North America recommend mycophenolate mofetil (MMF) as second-line treatment in these patients. We administered MMF as second-line therapy to 7 patients with AIH (male/female 1/6, age range 27-79 years) who were intolerant to or failed to respond to standard treatment. At the commencement of MMF, the median ALT value was 84U/L (28-254U/L), and the PSL dose was 15.0mg/day (0-45mg/day). In terms of adverse effects of PSL, diabetes mellitus was observed in 4 patients (insulin injection in 2) and femoral head necrolysis in 2. Adverse effects of AZA were present in 2, and 5 patients were not treated with AZA. At 24 weeks of MMF treatment, the median ALT and daily PSL dose were decreased to 16U/L (6-41U/L) and 7.0mg, respectively. Blood sugar control improved, and insulin injection was discontinued in both the patients. While intractable diarrhea developed in 1 patient with cirrhosis, no adverse effect was observed in other 6 patients. In conclusion, MMF appeared effective and safe in at least non-cirrhotic patients with AIH who were intolerant or failed to respond to standard treatment with PSL and AZA in Japanese clinical practice.


Asunto(s)
Hepatitis Autoinmune , Ácido Micofenólico , Adulto , Anciano , Azatioprina , Europa (Continente) , Femenino , Hepatitis Autoinmune/tratamiento farmacológico , Humanos , Inmunosupresores/efectos adversos , Masculino , Persona de Mediana Edad , Ácido Micofenólico/efectos adversos , Estándares de Referencia , Resultado del Tratamiento
3.
BMC Infect Dis ; 21(1): 347, 2021 Apr 13.
Artículo en Inglés | MEDLINE | ID: mdl-33849463

RESUMEN

BACKGROUND: Recently developed immunosuppressive drugs, especially TNF antagonists, may enhance the risk of granulomatous infections, including leprosy. We aimed to evaluate the leprosy detection rate in patients under immunosuppression due to rheumatological, dermatological and gastroenterological diseases. METHODS: We performed a systematic review of the literature by searching the PubMed, EMBASE, LILACS, Web of Science and Scielo databases through 2018. No date or language restrictions were applied. We included all articles that reported the occurrence of leprosy in patients under medication-induced immunosuppression. RESULTS: The search strategy resulted in 15,103 articles; finally, 20 articles were included, with 4 reporting longitudinal designs. The detection rate of leprosy ranged from 0.13 to 116.18 per 100,000 patients/year in the USA and Brazil, respectively. In the meta-analysis, the detection rate of cases of leprosy per 100,000 immunosuppressed patients with rheumatic diseases was 84 (detection rate = 0.00084; 95% CI = 0.0000-0.00266; I2 = 0%, p = 0.55). CONCLUSION: Our analysis showed that leprosy was relatively frequently detected in medication-induced immunosuppressed patients suffering from rheumatological diseases, and further studies are needed. The lack of an active search for leprosy in the included articles precluded more precise conclusions. TRIAL REGISTRATION: This review is registered in PROSPERO with the registry number CRD42018116275 .


Asunto(s)
Enfermedades Gastrointestinales/tratamiento farmacológico , Inmunosupresores/uso terapéutico , Lepra/diagnóstico , Enfermedades Reumáticas/tratamiento farmacológico , Enfermedades de la Piel/tratamiento farmacológico , Enfermedades Gastrointestinales/patología , Humanos , Inmunosupresores/efectos adversos , Lepra/etiología , Estudios Longitudinales , Enfermedades Reumáticas/patología , Enfermedades de la Piel/patología , Factor de Necrosis Tumoral alfa/antagonistas & inhibidores , Factor de Necrosis Tumoral alfa/inmunología
4.
Arq Gastroenterol ; 58(1): 77-81, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-33909801

RESUMEN

BACKGROUND: The use of immunosuppressive drugs after liver transplantation (LT) is associated with the development of systemic arterial hypertension (SAH), in addition to other comorbidities of metabolic syndrome. OBJECTIVE: Therefore, the purpose of this study was to analyze the time after use immunosuppressive drugs the patient progresses to SAH, as well as to identify its prevalence and the factors that may be correlated to it. METHODS: A retrospective and longitudinal study was conducted, based on the analysis of medical records of 72 normotensive patients, attended in the transplant unit of a university hospital, between 2016 and 2019. RESULTS: It was observed, on average, 9±6.98 months after immunosuppressive use, the patients were diagnosed with hypertension, and the prevalence of transplanted patients who evolved to SAH in this study was 59.64% (41 patients). In addition, there was a correlation between serum dosage of tacrolimus and the development of SAH (P=0.0067), which shows that tacrolimus has a significant role in the development of SAH. Finally, it was noticed that the development of post-transplantation hypertension indicates a higher risk of the patient presenting the other parameters of metabolic syndrome, as well as a higher impairment in its renal function (P=0.0061). CONCLUSION: This study shows that the patients evolved to SAH in an average of 9±6.98 months after immunosuppressive drug use. We have also found high prevalence of systemic arterial hypertension (59.64%) in patients after liver transplantation, who used calcineurin inhibitors, especially when associated with the use of tacrolimus.


Asunto(s)
Hipertensión , Trasplante de Hígado , Humanos , Hipertensión/epidemiología , Hipertensión/etiología , Inmunosupresores/efectos adversos , Trasplante de Hígado/efectos adversos , Estudios Longitudinales , Prevalencia , Estudios Retrospectivos , Tacrolimus/efectos adversos
5.
Rev Neurol ; 72(7): 250-260, 2021 04 01.
Artículo en Español | MEDLINE | ID: mdl-33764494

RESUMEN

INTRODUCTION: The recent availability of SARS-CoV-2 vaccines has raised concerns in certain patient groups, such as those with multiple sclerosis. However, there are currently few publications that provide information on this issue. We pooled the information available on the safety and efficacy of vaccination against SARS-CoV-2 in patients with multiple sclerosis, with and without disease-modifying therapy. DEVELOPMENT: The study consisted in a literature search focused on the types of SARS-CoV-2 vaccines, the current status of their approval, and the data available on the safety and efficacy of vaccines in patients with multiple sclerosis, including the new COVID-19 vaccines. Based on this search, the document has been designed taking into account current evidence and expert recommendations. There are no data on the safety and efficacy of SARS-CoV-2 vaccines in patients with multiple sclerosis. However, evidence does exist to suggest that messenger RNA (mRNA) vaccines against SARS-CoV-2 are as safe in these patients as in other individuals. Some therapies with immunosuppressants might reduce the effectiveness of these vaccines and require the scheduling of their administration, preferably before the start of treatment if possible. CONCLUSION: The data available make it possible to recommend mRNA vaccines against SARS-CoV-2 in patients with multiple sclerosis. In patients on fingolimod, cladribine, alemtuzumab, ocrelizumab and rituximab, vaccination prior to the initiation of medication administration would be recommendable whenever possible.


Asunto(s)
/prevención & control , Inmunosupresores/efectos adversos , Esclerosis Múltiple/inmunología , Vacunación , Anticuerpos Antivirales/biosíntesis , Formación de Anticuerpos/efectos de los fármacos , /administración & dosificación , /inmunología , Control de Enfermedades Transmisibles/métodos , Humanos , Esquemas de Inmunización , Huésped Inmunocomprometido , Inmunogenicidad Vacunal , Inmunosupresores/farmacología , Inmunosupresores/uso terapéutico , Vacunas contra la Influenza/administración & dosificación , Máscaras , Esclerosis Múltiple/tratamiento farmacológico , Vacunación/efectos adversos
6.
Medicine (Baltimore) ; 100(8): e24541, 2021 Feb 26.
Artículo en Inglés | MEDLINE | ID: mdl-33663060

RESUMEN

BACKGROUND: IgA nephropathy (IgAN) is one of the significant contributing factors of end-stage renal disease (ESRD). It is reported that over half of patients with IgAN accompany multiple high-risk factors, which increase the risk of ESRD progression. Studies have shown that immunosuppressive agents were beneficial in high-risk IgAN, but the efficacy and safety have not been fully demonstrated yet. The present study aims to elucidate the efficacy of commonly used immunosuppressants in high-risk IgAN and their relative safety profiles via a network meta-analysis strategy. METHODS: Randomized controlled trials (RCTs) eligible for this network meta-analysis were included to evaluate the efficacy and safety of different immunosuppressants for high-risk IgAN. Main outcomes and measures include incidence of renal composite end point, the rate of total remission, adverse events, and proteinuria. Besides, subgroup analysis and cluster analysis were carried out. RESULTS: This network meta-analysis of 37 RCTs involving 3012 participants found that Mycophenolate mofetil (MMF) combined with corticosteroids (CS) was superior to other interventions in end point events and proteinuria. Cyclosporine A (CsA) plus CS was the best option for clinical remission rate, and supportive care (SC) was the safest treatment. Cluster analysis showed that MMF+CS and Leflunomide (LEF)+CS were best protocols in efficacy and safety. Subgroup analysis indicated the best benefits of MMF were presented among the Asian population, and the benefits increased with the increase of follow-up duration. The effect of Cyclophosphamide (CTX) +CS on crescent IgAN was better than that of other risk factors. Moreover, the increasing follow-up duration was negatively associated with the effect. CONCLUSIONS: MMF+CS and LEF+CS appear to serve as the best choice for treating high-risk IgAN than other immunosuppressive therapies.


Asunto(s)
Glomerulonefritis por IGA/tratamiento farmacológico , Inmunosupresores/uso terapéutico , Corticoesteroides/uso terapéutico , Ciclofosfamida/uso terapéutico , Ciclosporina/uso terapéutico , Quimioterapia Combinada , Tasa de Filtración Glomerular , Humanos , Inmunosupresores/administración & dosificación , Inmunosupresores/efectos adversos , Ácido Micofenólico/uso terapéutico , Metaanálisis en Red , Ensayos Clínicos Controlados Aleatorios como Asunto
7.
Medicine (Baltimore) ; 100(9): e24989, 2021 Mar 05.
Artículo en Inglés | MEDLINE | ID: mdl-33655969

RESUMEN

RATIONALE: Tacrolimus-associated neurologic disorders can be found in some cases, mainly in organ transplantation patients. However, epilepsy induced by tacrolimus in primary membranous nephropathy (PMN) patient is scare. PATIENT CONCERNS: A 63-year-old man experienced 1-year history of foamy urine, and edema of lower extremity. DIAGNOSIS: The patient had proteinuria, hypoalbuminemia, which indicated nephrotic syndrome. Further, we performed renal biopsy for this patient. Combined with the renal biopsy result, the diagnosis of primary membranous nephropathy was established. INTERVENTION: At first, irbesartan was administrated for 6 months. However, the proteinuria had no obvious improvement. Tacrolimus was administrated afterwards. OUTCOMES: Twenty-two days after tacrolimus treatment, epilepsy occurred. Sodium valproate and carbamazepine were successively given to control epilepsy. However, the epileptic symptoms were not effectively controlled. During the treatment, the concentration of tacrolimus fluctuated greatly. At last, levetiracetam was given to maintain the curative effect. Fortunately, the patient did not suffer from epilepsy again. The concentration of temporary tacrolimus was stable, whereas proteinuria gradually decreased. LESSONS: Tacrolimus-induced epilepsy should be considered in patients exhibiting acute neurological symptoms. Early diagnosis and effective treatment play a vital role for favorable prognosis.


Asunto(s)
Epilepsia/inducido químicamente , Glomerulonefritis Membranosa/tratamiento farmacológico , Tacrolimus/efectos adversos , Electroencefalografía , Epilepsia/diagnóstico , Humanos , Inmunosupresores/efectos adversos , Inmunosupresores/uso terapéutico , Masculino , Persona de Mediana Edad , Tacrolimus/uso terapéutico
8.
Aliment Pharmacol Ther ; 53(9): 1021-1029, 2021 05.
Artículo en Inglés | MEDLINE | ID: mdl-33715177

RESUMEN

BACKGROUND: Methotrexate can be used to maintain remission in Crohn's disease patients who are intolerant to thiopurines. Data on its use as monotherapy in other scenarios are limited. AIM: To assess the effectiveness of methotrexate monotherapy in Crohn's disease patients after previous failure to anti-tumour necrosis factor (anti-TNFα) drugs. METHODS: A retrospective, observational multicentre study of data from the Spanish ENEIDA registry. Participants were patients with active Crohn's disease and previous failure to anti-TNFα started on methotrexate monotherapy. Short-term effectiveness was assessed at 12-16 weeks based on Harvey-Bradshaw index (HBI): clinical remission as HBI ≤ 3 points and clinical response as HBI drop of ≥ 3 points over baseline. Long-term effectiveness was defined as steroid-free methotrexate persistence from 12 to 16 weeks until maximum follow up. Adverse events were recorded. RESULTS: Data were compiled for 110 patients treated with methotrexate after a failed response to one (39%) or two (55.6%) anti-TNFα agents. Short-term clinical response and remission rates were 60% and 30.9% respectively. Of 74 patients who continued after week 16, long-term effectiveness was achieved in 82% and 74% at 12 and 24 months respectively. In the multivariate analysis, non-remission at short term (vs remission) was associated with long-term failure (HR 2.58, 95%CI 1.95-3.68, P = 0.028). Adverse events (evaluated in 100 patients) were recorded in 44%, and in 30.4% of these patients, they led to methotrexate discontinuation. CONCLUSIONS: The benefits observed suggest methotrexate monotherapy could be a valid option in Crohn's disease patients with previous failure to anti-TNFα.


Asunto(s)
Enfermedad de Crohn , Metotrexato , Enfermedad de Crohn/tratamiento farmacológico , Humanos , Inmunosupresores/efectos adversos , Metotrexato/efectos adversos , Sistema de Registros , Inducción de Remisión , Estudios Retrospectivos , Resultado del Tratamiento , Factor de Necrosis Tumoral alfa
9.
Curr Opin Pulm Med ; 27(3): 176-183, 2021 05 01.
Artículo en Inglés | MEDLINE | ID: mdl-33779588

RESUMEN

PURPOSE OF REVIEW: Patients on chronic immunosuppressive treatments at baseline are at increased risk of opportunistic infections. These patients are at especially increased risk of morbidity and mortality during the coronavirus-19 (COVID-19) pandemic. This review will focus on patients with diseases in which immunosuppression is a vital part of the treatment regimen, including those with solid organ transplants, rheumatologic disorders, sarcoidosis, and inflammatory bowel disease (IBD). We will summarize the current knowledge of immunosuppression in these diseases and the risk of contracting COVID-19. Furthermore, we will discuss if immunosuppression increases severity of COVID-19 presentation. RECENT FINDINGS: Since the start of the COVID-19 pandemic, a large number patients receiving chronic immunosuppression have been infected with SARS-CoV-2. Moreover, our understanding of the immunology of SARS-CoV-2 is advancing at a rapid pace. Currently, a number of clinical trials are underway to investigate the role of immunosuppressive treatments in the management of this disease. SUMMARY: Currently, there is no conclusive evidence to suggest that solid organ transplant recipients on chronic immunosuppression are at increased risk of contracting COVID-19. Solid organ transplant recipients may be at increased risk for worse COVID-19 outcomes but the data are not consistent. There is evidence to suggest that patients with rheumatologic disorders or IBDs are not at increased risk of contracting COVID-19 and do not necessarily experience worse clinical outcomes. Patients with sarcoidosis are not necessarily at increased risk of COVID-19, although there is limited data available to determine if immunosuppression worsens outcomes in this population.


Asunto(s)
Inmunosupresores , /epidemiología , /terapia , Humanos , Huésped Inmunocomprometido , Inmunosupresión/métodos , Inmunosupresores/efectos adversos , Inmunosupresores/inmunología , Inmunosupresores/uso terapéutico , Medición de Riesgo , /aislamiento & purificación , Receptores de Trasplantes
10.
Clinics (Sao Paulo) ; 76: e2597, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-33681947

RESUMEN

A combination of immunosuppressants may improve outcomes due to the synergistic effect of their different action mechanisms. Currently, there is no consensus regarding the best immunosuppressive protocol after liver transplantation. This review aimed to evaluate the effectiveness and safety of tacrolimus associated with mycophenolate mofetil (MMF) in patients undergoing liver transplantation. We performed a systematic review and meta-analysis of randomized clinical trials. Eight randomized trials were included. The proportion of patients with at least one adverse event related to the immunosuppression scheme with tacrolimus associated with MMF was 39.9%. The tacrolimus with MMF immunosuppression regimen was superior in preventing acute cellular rejection compared with that of tacrolimus alone (risk difference [RD]=-0.11; p =0.001). The tacrolimus plus MMF regimen showed no difference in the risk of adverse events compared to that of tacrolimus alone (RD=0.7; p=0.66) and cyclosporine plus MMF (RD=-0.7; p=0.37). Patients undergoing liver transplantation who received tacrolimus plus MMF had similar adverse events when compared to patients receiving other evaluated immunosuppressive regimens and had a lower risk of acute rejection than those receiving in the monodrug tacrolimus regimen.


Asunto(s)
Trasplante de Riñón , Trasplante de Hígado , Quimioterapia Combinada , Rechazo de Injerto/prevención & control , Humanos , Inmunosupresión , Inmunosupresores/efectos adversos , Ácido Micofenólico/efectos adversos , Ensayos Clínicos Controlados Aleatorios como Asunto , Tacrolimus/efectos adversos
11.
Int. j. med. surg. sci. (Print) ; 8(1): 1-9, mar. 2021. ilus
Artículo en Español | LILACS | ID: biblio-1151628

RESUMEN

La terapia con fármacos antagonistas del factor de necrosis tumoral alfa ha sido beneficiosa en el tratamiento de varias enfermedades como las del tejido conectivo e inflamatorias del intestino, pero no está exenta de riesgos. Las principales complicaciones de estas drogas inmunosupresoras son las infecciones, y la tuberculosis pulmonar es una de las principales afecciones, que se pueden observar en los pacientes con este tipo de tratamiento.Se presentó una mujer de 31 años, atendida en el Hospital Clínico Quirúrgico Hermanos Ameijeiras, La Habana, Cuba, con antecedentes de colitis ulcerativa, que hace 3 meses recibe terapia con Infliximab. Acude al hospital por referir 4 días previos al ingreso, fiebre de 390 C dos veces al día, acompañándose de cefalea, pérdida del apetito y dolor en la región perineal. Se le realizó radiografía de tórax, donde se describe radiopacidad heterogénea que va desde el cuerno superior del hilio derecho hasta planos axilares, en la tomografía axial de tórax reportan consolidación en segmento anterior del lóbulo superior derecho con presencia de broncograma aéreo y en el lavado bronquial microbiológico para bacilos ácido-alcohol resistentes se informó codificación 8, positivo a Mycobacterium tuberculosis. El diagnóstico preciso de tuberculosis relacionada con el uso de fármacos antagonistas del factor de necrosis tumoral alfa requiere un alto índice de sospecha y una investigación detallada. Existe un alto grado de complejidad diagnóstica, por la existencia de un amplio espectro clínico y la necesidad de excluir otras enfermedades.


Tumor necrosis factor alpha antagonist drug therapy has been beneficial in the treatment of several diseases such as connective tissue and inflammatory bowel diseases, but it is not without risks. The main complications of these immunosuppressive drugs are infections, and pulmonary tuberculosis is one of the main conditions, which can be observed in patients with this type of treatment. A 31-year-old woman, treated at the Hermanos Ameijeiras Clinical Surgical Hospital, Havana, Cuba, with a history of ulcerative colitis, who has been receiving Infliximab therapy for 3 months, presented. He went to the hospital for referring 4 days prior to admission, a fever of 390 C twice a day, accompanied by headache, loss of appetite and pain in the perineal region. A chest X-ray was performed, which described heterogeneous radiopacity that goes from the upper horn of the right hilum to axillary planes, in the chest axial tomography they report consolidation in the anterior segment of the right upper lobe with the presence of air bronchogram and in the bronchial lavage microbiological for acid-fast bacilli coding 8, positive for mycobacterium tuberculosis was reported. Accurate diagnosis of tuberculosis related to the use of tumor necrosis factor alpha antagonist drugs requires a high index of suspicion and detailed investigation. There is a high degree of diagnostic complexity, due to the existence of a wide clinical spectrum and the need to exclude other diseases.


Asunto(s)
Humanos , Femenino , Adulto , Tuberculosis Pulmonar/diagnóstico por imagen , Infliximab/efectos adversos , Inmunosupresores/efectos adversos , Tuberculosis Pulmonar/etiología , Tomografía Computarizada por Rayos X , Infecciones/etiología
12.
Cochrane Database Syst Rev ; 2: CD010668, 2021 02 25.
Artículo en Inglés | MEDLINE | ID: mdl-33631841

RESUMEN

BACKGROUND: Belimumab, the first biologic approved for the treatment of systemic lupus erythematosus (SLE), has been shown to reduce autoantibody levels in people with SLE and help control disease activity. OBJECTIVES: To assess the benefits and harms of belimumab (alone or in combination) in systematic lupus erythematosus. SEARCH METHODS: An Information Specialist carried out the searches of CENTRAL, MEDLINE, Embase, CINAHL, Web of Science, the World Health Organization (WHO) International Clinical Trials Registry Platform, and clinicaltrials.gov from inception to 25 September 2019. There were no language or date restrictions. SELECTION CRITERIA: We included randomized controlled trials (RCTs) or controlled clinical trials (CCTs) of belimumab (alone or in combination) compared to placebo/control treatment (immunosuppressive drugs, such as azathioprine, cyclosporine, mycophenolate mofetil or another biologic), in adults with SLE. DATA COLLECTION AND ANALYSIS: We used standard methodologic procedures expected by Cochrane. MAIN RESULTS: Six RCTs (2917 participants) qualified for quantitative analyses. All included studies were multicenter, international or US-based. The age range of the included participants was 22 to 80 years; most were women; and study duration ranged from 84 days to 76 weeks. The risk of bias was generally low except for attrition bias, which was high in 67% of studies. Compared to placebo, more participants on belimumab 10 mg/kg (Food and Drug Administration (FDA)-approved dose) showed at least a 4-point improvement (reduction) in Safety of Estrogen in Lupus National Assessment (SELENA) - Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score, a validated SLE disease activity index: (risk ratio (RR) 1.33, 95% confidence interval (CI) 1.22 to 1.45; 829/1589 in belimumab group and 424/1077 in placebo; I2= 0%; 4 RCTs; high-certainty evidence). Change in health-related quality of life (HRQOL), assessed by Short Form-36 Physical Component Summary score improvement (range 0 to 100), showed there was probably little or no difference between groups (mean difference 1.6 points, 95% CI 0.30 to 2.90; 401 in belimumab group and 400 in placebo; I2= 0%; 2 RCTs; moderate-certainty evidence). The belimumab 10 mg/kg group showed greater improvement in glucocorticoid dose, with a higher proportion of participants reducing their dose by at least 50% compared to placebo (RR 1.59, 95% CI 1.17 to 2.15; 81/269 in belimumab group and 52/268 in placebo; I2= 0%; 2 RCTs; high-certainty evidence). The proportion of participants experiencing harm may not differ meaningfully between the belimumab 10 mg/kg and placebo groups: one or more serious adverse event (RR 0.87, 95% CI: 0.68 to 1.11; 238/1700 in belimumab group and 199/1190 in placebo; I2= 48%; 5 RCTs; low-certainty evidence; ); one or more serious infection (RR 1.01, 95% CI: 0.66 to 1.54; 44/1230 in belimumab group and 40/955 in placebo; I2= 0%; 4 RCTs; moderate-certainty evidence); and withdrawals due to adverse events (RR 0.82, 95% CI: 0.63 to 1.07; 113/1700 in belimumab group and 94/1190 in placebo; I2= 0%; 5 RCTs; moderate-certainty evidence). Mortality was rare, and may not differ between belimumab 10 mg/kg and placebo (Peto odds ratio 1.15, 95% CI 0.41 to 3.25; 9/1714 in belimumab group and 6/1203 in placebo; I2= 4%; 6 RCTs; low-certainty evidence). AUTHORS' CONCLUSIONS: The six studies that provided evidence for benefits and harms of belimumab were well-designed, high-quality RCTs. At the FDA-approved dose of 10 mg/kg, based on moderate to high-certainty data, belimumab was probably associated with a clinically meaningful efficacy benefit compared to placebo in participants with SLE at 52 weeks. Evidence related to harms is inconclusive and mostly of moderate to low-certainty evidence. More data are needed for the longer-term efficacy of belimumab.


Asunto(s)
Anticuerpos Monoclonales Humanizados/uso terapéutico , Inmunosupresores/uso terapéutico , Lupus Eritematoso Sistémico/tratamiento farmacológico , Adulto , Anciano , Anciano de 80 o más Años , Anticuerpos Monoclonales Humanizados/efectos adversos , Sesgo , Femenino , Glucocorticoides/uso terapéutico , Humanos , Inmunosupresores/efectos adversos , Lupus Eritematoso Sistémico/mortalidad , Masculino , Persona de Mediana Edad , Placebos/uso terapéutico , Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como Asunto , Resultado del Tratamiento , Adulto Joven
13.
Ann Hematol ; 100(4): 865-878, 2021 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-33547921

RESUMEN

Post-transplantation lymphoproliferative disorder (PTLD) is a severe complication of haematopoietic stem cell transplantation (HSCT), occurring in a setting of immune suppression and dysregulation. The disease is in most cases driven by the reactivation of the Epstein-Barr virus (EBV), which induces B cell proliferation through different pathomechanisms. Beyond EBV, many factors, variably dependent on HSCT-related immunosuppression, contribute to the disease development. PTLDs share several features with primary lymphomas, though clinical manifestations may be different, frequently depending on extranodal involvement. According to the WHO classification, histologic examination is required for diagnosis, allowing also to distinguish among PTLD subtypes. However, in cases of severe and abrupt presentation, a diagnosis based on a combination of imaging studies and EBV-load determination is accepted. Therapies include prophylactic and pre-emptive interventions, aimed at eradicating EBV proliferation before symptoms onset, and targeted treatments. Among them, rituximab has emerged as first-line option, possibly combined with a reduction of immunosuppression, while EBV-specific cytotoxic T lymphocytes are effective and safe alternatives. Though prognosis remains poor, survival has markedly improved following the adoption of the aforementioned treatments. The validation of innovative, combined approaches is the future challenge.


Asunto(s)
Trasplante de Células Madre Hematopoyéticas/efectos adversos , Trastornos Linfoproliferativos/etiología , Adulto , Anciano , Linfocitos B/patología , Linfocitos B/virología , Niño , Diagnóstico Diferencial , Infecciones por Virus de Epstein-Barr/complicaciones , Infecciones por Virus de Epstein-Barr/inmunología , Enfermedad Injerto contra Huésped/tratamiento farmacológico , Enfermedad Injerto contra Huésped/etiología , Enfermedad Injerto contra Huésped/prevención & control , Herpesvirus Humano 4/patogenicidad , Herpesvirus Humano 4/fisiología , Humanos , Huésped Inmunocomprometido , Inmunosupresores/efectos adversos , Inmunosupresores/uso terapéutico , Trastornos Linfoproliferativos/epidemiología , Trastornos Linfoproliferativos/terapia , Trastornos Linfoproliferativos/virología , MicroARNs/genética , Persona de Mediana Edad , Mutación , Pronóstico , Factores de Riesgo , Rituximab/uso terapéutico , Linfocitos T Citotóxicos/trasplante , Acondicionamiento Pretrasplante/efectos adversos , Trasplante Homólogo/efectos adversos , Activación Viral
18.
Ann Hematol ; 100(5): 1295-1301, 2021 May.
Artículo en Inglés | MEDLINE | ID: mdl-33580280

RESUMEN

Cytokine release syndrome (CRS), occurring in more than 70% of HLA-haploidentical hematopoietic stem-cell transplantations with post-transplant cyclophosphamide (PT/CY-haplo), can lead to hemodynamic instability and worsen clinical outcomes. A calcineurin inhibitor is initiated after cyclophosphamide administration in the commonly used PT/CY regimens. Here, we conducted a phase I/II, prospective, single-center trial of PT/CY-haplo to evaluate the safety and efficacy of cyclophosphamide on days 3 and 5 along with cyclosporin and mycophenolate mofetil started from day - 1. Thirty-five adults with hematologic malignancies were enrolled. Myeloablative and reduced-intensity conditioning were used in 25 and 10 patients, respectively. Graft sources were bone marrow in 11 patients and mobilized peripheral blood stem cells in 24 patients. Disease-free survival on day 100, the primary endpoint, was 86% (95% confidence interval (CI), 69-94), which was over the predefined threshold of 50%. Unexpectedly, only 20% (95% CI, 8.4-37) of patients developed fever of > 38 °C early after graft infusion, all CRS grade 1, and all of which resolved just after cyclophosphamide administration. The cumulative incidences of grades II-IV acute graft-versus-host disease (GVHD), III-IV acute GVHD, and moderate-severe chronic GVHD were 23% (95% CI, 11-38), 6% (95% CI, 1-17), and 11% (95% CI, 4-25), respectively. The 3-year overall survival rate was 49% (95% CI, 31-64). Our results suggest that administration of cyclosporine and mycophenolate mofetil prior to PT/CY can reduce the frequency and severity of CRS without increasing GVHD. UMIN Clinical Trial Registry numbers: 000006631 and 000015694.


Asunto(s)
Ciclofosfamida/uso terapéutico , Ciclosporina/uso terapéutico , Síndrome de Liberación de Citoquinas/prevención & control , Trasplante de Células Madre Hematopoyéticas/efectos adversos , Inmunosupresores/uso terapéutico , Ácido Micofenólico/uso terapéutico , Adolescente , Adulto , Anciano , Ciclofosfamida/administración & dosificación , Ciclofosfamida/efectos adversos , Ciclosporina/administración & dosificación , Ciclosporina/efectos adversos , Síndrome de Liberación de Citoquinas/etiología , Supervivencia sin Enfermedad , Femenino , Enfermedad Injerto contra Huésped/etiología , Enfermedad Injerto contra Huésped/prevención & control , Humanos , Inmunosupresores/administración & dosificación , Inmunosupresores/efectos adversos , Incidencia , Masculino , Persona de Mediana Edad , Ácido Micofenólico/administración & dosificación , Ácido Micofenólico/efectos adversos , Estudios Prospectivos , Trasplante Haploidéntico/efectos adversos , Adulto Joven
19.
Eur J Gastroenterol Hepatol ; 33(3): 443-447, 2021 03 01.
Artículo en Inglés | MEDLINE | ID: mdl-33522752

RESUMEN

The course of coronavirus 19 (COVID-19) might be determined by certain comorbidities (e.g. diabetes, hypertension and other cardiovascular diseases) and advanced age. Because the impact of immunosuppression on disease severity is not entirely clear, management of patients under immunosuppressive treatment remains controversial. Six cases of inflammatory bowel disease (IBD) patients with COVID-19 on immunosuppressive medication are presented. The aim of this study was to describe patients' clinical manifestation and chronologic development of virus-specific antibodies of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection before and after restart with immunosuppressive/biological therapy as an indicator for a specific immune response. All patients were tested for the presence of SARS-CoV-2-RNA with PCR, were in clinical remission prior to COVID-19 and only one patient continued his immunosuppressive treatment during the COVID-19 infection. Initial symptoms of COVID-19 were pyrexia, diarrhea, cephalea, and dysgeusia and anosmia. No patient needed admission to hospital or ICU. The SARS-CoV-2 antibody development was described to be late in three of the six patients. Late antibody development seems to be more frequent in older patients and in patients with combined immunosuppressive treatment. In this scenario, SARS-CoV-2 antibody testing could be useful prior to restarting immunosuppressive therapy.


Asunto(s)
Anticuerpos Antivirales/sangre , Colitis Ulcerosa/tratamiento farmacológico , Enfermedad de Crohn/tratamiento farmacológico , Inmunidad Humoral , Huésped Inmunocomprometido , Inmunosupresores/administración & dosificación , /inmunología , Adulto , Anciano , Biomarcadores/sangre , /diagnóstico , Colitis Ulcerosa/diagnóstico , Colitis Ulcerosa/inmunología , Enfermedad de Crohn/diagnóstico , Enfermedad de Crohn/inmunología , Esquema de Medicación , Femenino , Interacciones Huésped-Patógeno , Humanos , Inmunosupresores/efectos adversos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Factores de Tiempo , Adulto Joven
20.
BMJ ; 372: m4979, 2021 02 03.
Artículo en Inglés | MEDLINE | ID: mdl-33536186

RESUMEN

The uveitides are a heterogeneous group of diseases characterized by inflammation inside the eye. The uveitides are classified as infectious or non-infectious. The non-infectious uveitides, which are presumed to be immune mediated, can be further divided into those that are associated with a known systemic disease and those that are eye limited,-ie, not associated with a systemic disease. The ophthalmologist identifies the specific uveitic entity by medical history, clinical examination, and ocular imaging, as well as supplemental laboratory testing, if indicated. Treatment of the infectious uveitides is tailored to the particular infectious organism and may include regional and/or systemic medication. First line treatment for non-infectious uveitides is corticosteroids that can be administered topically, as regional injections or surgical implants, or systemically. Systemic immunosuppressive therapy is used in patients with severe disease who cannot tolerate corticosteroids, require chronic corticosteroids at >7.5 mg/day prednisone, or in whom the disease is known to respond better to immunosuppression. Management of many of these diseases is optimized by coordination between the ophthalmologist and rheumatologist or internist.


Asunto(s)
Oftalmología/métodos , Uveítis/diagnóstico , Corticoesteroides/administración & dosificación , Corticoesteroides/efectos adversos , Corticoesteroides/uso terapéutico , Técnicas de Diagnóstico Oftalmológico , Humanos , Inmunosupresores/administración & dosificación , Inmunosupresores/efectos adversos , Inmunosupresores/uso terapéutico , Uveítis/clasificación , Uveítis/tratamiento farmacológico , Uveítis/fisiopatología
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