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[PMID]:29465579
[Au] Autor:Wang L; Qi CH; Zhong R; Yuan C; Zhong QY
[Ad] Endereço:Department of Pharmacy, Jining No.1 People's Hospital, Jining.
[Ti] Título:Efficacy of alemtuzumab and natalizumab in the treatment of different stages of multiple sclerosis patients.
[So] Source:Medicine (Baltimore);97(8):e9908, 2018 Feb.
[Is] ISSN:1536-5964
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Multiple sclerosis (MS) is an autoimmune disease, in which the insulating covers of nerve cells in the brain and spinal cord are demyelinated. This study was conducted to compare the efficacy of alemtuzumab and natalizumab in the treatment of different stages of MS patients. METHODS: A total of 585 patients diagnosed with MS and hospitalized were included and analyzed after which they were divided into the primary progressive MS A and B groups, the relapsing-remitting MS (RRMS) C and D groups, and the secondary progressive MS E and F groups. Patients in A, C, and E groups were administered alemtuzumab while those in B, D, and F groups were administered natalizumab for the treatment. The expanded disability status scale (EDSS) scores and the EDSS difference were calculated before and after treatment. The number of head magnetic resonance imaging enhanced lesions in the patients, recurrence time and recurrence rate were measured before and after treatment. RESULTS: The EDSS score of the RRMS group was significantly lower than that of the primary progressive MS group and the secondary progressive MS group. After 12 months of treatment, the EDSS score of RRMS patients treated with natalizumab was significantly lower compared with the patients with alemtuzumab, and the difference before and after treatment was significantly higher than alemtuzumab. The recurrence rate of the RRMS-D group was significantly lower than the RRMS-C group. After 12 months of treatment, compared with the RRMS-C group, a significant reduction was observed in the number of head magnetic resonance imaging enhanced lesions and longer recurrence time in the RRMS-D group. CONCLUSION: The efficacy of natalizumab was better than alemtuzumab in the treatment of patients in the RRMS group, while there was no significant difference among other stages of MS patients, which provided the theoretical basis and clinical guidance for the treatment of different stages of MS.
[Mh] Termos MeSH primário: Alemtuzumab/uso terapêutico
Fatores Imunológicos/uso terapêutico
Esclerose Múltipla Crônica Progressiva/tratamento farmacológico
Esclerose Múltipla Recidivante-Remitente/tratamento farmacológico
Natalizumab/uso terapêutico
[Mh] Termos MeSH secundário: Adulto
Feminino
Seres Humanos
Imagem por Ressonância Magnética
Masculino
Esclerose Múltipla Crônica Progressiva/diagnóstico por imagem
Esclerose Múltipla Recidivante-Remitente/diagnóstico por imagem
Resultado do Tratamento
Adulto Jovem
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Immunologic Factors); 0 (Natalizumab); 3A189DH42V (Alemtuzumab)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180227
[Lr] Data última revisão:
180227
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:180222
[St] Status:MEDLINE
[do] DOI:10.1097/MD.0000000000009908


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[PMID]:28461106
[Au] Autor:Staun-Ram E; Miller A
[Ad] Endereço:Rappaport Faculty of Medicine, Technion-Israel Institute of Technology, Haifa, Israel.
[Ti] Título:Effector and regulatory B cells in Multiple Sclerosis.
[So] Source:Clin Immunol;184:11-25, 2017 11.
[Is] ISSN:1521-7035
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:The role of B cells in the pathogenesis of Multiple Sclerosis (MS), an autoimmune neurodegenerative disease, is becoming eminent in recent years, but the specific contribution of the distinct B cell subsets remains to be elucidated. Several B cell subsets have shown regulatory, anti-inflammatory capacities in response to stimuli in vitro, as well as in the animal model of MS: Experimental Autoimmune Encephalomyelitis (EAE). However, the functional role of the B regulatory cells (Bregs) in vivo and specifically in the human disease is yet to be clarified. In the present review, we have summarized the updated information on the roles of effector and regulatory B cells in MS and the immune-modulatory effects of MS therapeutic agents on their phenotype and function.
[Mh] Termos MeSH primário: Subpopulações de Linfócitos B/imunologia
Linfócitos B Reguladores/imunologia
Encefalomielite Autoimune Experimental/imunologia
Esclerose Múltipla/imunologia
[Mh] Termos MeSH secundário: Alemtuzumab/uso terapêutico
Animais
Crotonatos/uso terapêutico
Fumarato de Dimetilo/uso terapêutico
Cloridrato de Fingolimode/uso terapêutico
Acetato de Glatiramer/uso terapêutico
Seres Humanos
Fatores Imunológicos/uso terapêutico
Imunossupressores/uso terapêutico
Interferon beta/uso terapêutico
Esclerose Múltipla/tratamento farmacológico
Natalizumab/uso terapêutico
Rituximab/uso terapêutico
Toluidinas/uso terapêutico
[Pt] Tipo de publicação:JOURNAL ARTICLE; REVIEW
[Nm] Nome de substância:
0 (Crotonates); 0 (Immunologic Factors); 0 (Immunosuppressive Agents); 0 (Natalizumab); 0 (Toluidines); 1C058IKG3B (teriflunomide); 3A189DH42V (Alemtuzumab); 4F4X42SYQ6 (Rituximab); 5M691HL4BO (Glatiramer Acetate); 77238-31-4 (Interferon-beta); FO2303MNI2 (Dimethyl Fumarate); G926EC510T (Fingolimod Hydrochloride)
[Em] Mês de entrada:1711
[Cu] Atualização por classe:180206
[Lr] Data última revisão:
180206
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170503
[St] Status:MEDLINE


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[PMID]:29178444
[Au] Autor:Zhang J; Shi S; Zhang Y; Luo J; Xiao Y; Meng L; Yang X
[Ad] Endereço:Department of Neurology, The Second Affiliated Hospital, Guangxi Medical University, No. 166, Daxuedong Road, Nanning, Guangxi, China, 530007.
[Ti] Título:Alemtuzumab versus interferon beta 1a for relapsing-remitting multiple sclerosis.
[So] Source:Cochrane Database Syst Rev;11:CD010968, 2017 11 27.
[Is] ISSN:1469-493X
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Alemtuzumab is a humanised monoclonal antibody that alters the circulating lymphocyte pool, causing prolonged lymphopenia, thus remoulding the immune repertoire that accompanies homeostatic lymphocyte reconstitution. It has been proved more effective than interferon (IFN) 1a for the treatment of relapsing-remitting multiple sclerosis (RRMS). OBJECTIVES: To compare the efficacy, tolerability and safety of alemtuzumab versus interferon beta 1a in the treatment of people with RRMS to prevent disease activity. SEARCH METHODS: We searched the Cochrane Multiple Sclerosis and Rare Diseases of the CNS Group Trials Register (1 February 2017) which, among other sources, contains records from CENTRAL, MEDLINE, Embase, CINAHL, LILACS, PEDRO and the trial registry databases Clinical Trials.gov and WHO International Clinical Trials Registry Platform for all prospectively registered and ongoing trials. SELECTION CRITERIA: All double-blind, randomised, controlled trials comparing intravenous alemtuzumab (12 mg per day or 24 mg per day on five consecutive days during the first month and on three consecutive days at months 12 and 24) versus subcutaneous IFN beta 1a (22 µg or 44 µg three times per week (Rebif) or intramuscular injection 30 µg once a week (Avonex)) in people of any gender and age with RRMS. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. MAIN RESULTS: We included three trials involving 1694 participants. All trials compared alemtuzumab 12 mg per day or 24 mg per day versus IFN beta 1a for treating RRMS. In CAMMS223, participants received either subcutaneous IFN beta 1a 44 µg three times per week or annual intravenous cycles of alemtuzumab (at a dose of 12 mg per day or 24 mg per day) for 36 months. In CARE-MS I and CARE-MS II, participants received subcutaneous IFN beta 1a 44 µg three times per week or annual intravenous cycles of alemtuzumab 12 mg per day for 24 months. The methodological quality was good for all three studies.In the alemtuzumab 12 mg per day group, the results showed statistically significant difference in reducing relapses (risk ratio (RR) 0.60, 95% confidence interval (CI) 0.52 to 0.70), preventing disease progression (RR 0.60, 95% CI 0.45 to 0.79) and developing new T2 lesions on magnetic resonance imaging (RR 0.75, 95% CI 0.61 to 0.93) after 24 and 36 months' follow-up, but found no statistically significant difference in the changes of Expanded Disability Status Scale (EDSS) score (mean difference (MD) -0.35, 95% CI -0.73 to 0.03). In the alemtuzumab 24 mg per day group, the results showed statistically significant differences in reducing relapses (RR 0.38, 95% CI 0.23 to 0.62), preventing disease progression (RR 0.42, 95% CI 0.21 to 0.84) and the changes of EDSS score (MD -0.83, 95% CI -1.17 to -0.49) after 36 months' follow-up.All three trials reported adverse events and serious adverse events. There was no statistically significant difference in the number of participants with at least one adverse event (RR 1.03, 95% CI 0.97 to 1.08) and the number of participants who experienced serious adverse events (RR 1.03, 95% CI 0.83 to 4.54). AUTHORS' CONCLUSIONS: There is low- to moderate-quality evidence that annual intravenous cycles of alemtuzumab at a dose of 12 mg per day or 24 mg per day reduces the proportion of participants with relapses, disease progression, change of EDSS score and developing new T2 lesions on MRI over 24 to 36 months in comparison with subcutaneous IFN beta-1a 44 µg three times per week.Alemtuzumab appeared to be relatively well tolerated. The most frequently reported adverse events were infusion-associated reactions, infections and autoimmune events. The use of alemtuzumab requires careful monitoring so that potentially serious adverse effects can be treated early and effectively.
[Mh] Termos MeSH primário: Adjuvantes Imunológicos/administração & dosagem
Alemtuzumab/administração & dosagem
Interferon beta-1a/administração & dosagem
Esclerose Múltipla Recidivante-Remitente/tratamento farmacológico
[Mh] Termos MeSH secundário: Adjuvantes Imunológicos/efeitos adversos
Alemtuzumab/efeitos adversos
Progressão da Doença
Esquema de Medicação
Seres Humanos
Interferon beta-1a/efeitos adversos
Ensaios Clínicos Controlados Aleatórios como Assunto
Recidiva
[Pt] Tipo de publicação:JOURNAL ARTICLE; META-ANALYSIS; RESEARCH SUPPORT, NON-U.S. GOV'T; REVIEW
[Nm] Nome de substância:
0 (Adjuvants, Immunologic); 3A189DH42V (Alemtuzumab); XRO4566Q4R (Interferon beta-1a)
[Em] Mês de entrada:1801
[Cu] Atualização por classe:180111
[Lr] Data última revisão:
180111
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:171128
[St] Status:MEDLINE
[do] DOI:10.1002/14651858.CD010968.pub2


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[PMID]:28901730
[Au] Autor:Rastogi N; Katewa S; Thakkar D; Kohli S; Nivargi S; Yadav SP
[Ad] Endereço:Pediatric Hematology Oncology Unit, Department of Pediatrics, Fortis Memorial Research Institute, Gurgaon, Haryana, India.
[Ti] Título:Reduced-toxicity alternate-donor stem cell transplantation with posttransplant cyclophosphamide for primary immunodeficiency disorders.
[So] Source:Pediatr Blood Cancer;65(1), 2018 Jan.
[Is] ISSN:1545-5017
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:We describe here the outcomes of reduced-toxicity alternate-donor stem cell transplant (SCT) with posttransplant cyclophosphamide (PTCy) for primary immunodeficiency disorders (PIDs) in eight children (haploidentical-seven and matched unrelated donor-one). The conditioning was with serotherapy (alemtuzumab-3/rabbit-anti-thymoglobulin-5); fludarabine, cyclophosphamide, and total body irradiation-5 (additional thiotepa-3); fludarabine and treosulfan-2; and fludarabine and busulfan-1. All received PTCy 50 mg/kg on days 3 and 4 as graft versus host disease prophylaxis along with tacrolimus and mycophenolate. Mean CD34 dose was 13.8 × 10 /kg. Two children died because of PIDs. Acute graft versus host disease up to grades I and II was seen in three children. All six survivors are fully donor and disease free at median follow-up of 753 days. Alternate donor SCT with PTCy is feasible in PID and has good outcomes.
[Mh] Termos MeSH primário: Ciclofosfamida/administração & dosagem
Síndromes de Imunodeficiência/terapia
Transplante de Células-Tronco de Sangue Periférico
Condicionamento Pré-Transplante
Doadores não Relacionados
[Mh] Termos MeSH secundário: Alemtuzumab/administração & dosagem
Aloenxertos
Soro Antilinfocitário/administração & dosagem
Criança
Pré-Escolar
Intervalo Livre de Doença
Seguimentos
Seres Humanos
Síndromes de Imunodeficiência/mortalidade
Lactente
Masculino
Taxa de Sobrevida
Tiotepa/administração & dosagem
Irradiação Corporal Total
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Antilymphocyte Serum); 3A189DH42V (Alemtuzumab); 8N3DW7272P (Cyclophosphamide); 905Z5W3GKH (Thiotepa); D7RD81HE4W (thymoglobulin)
[Em] Mês de entrada:1711
[Cu] Atualização por classe:171129
[Lr] Data última revisão:
171129
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170914
[St] Status:MEDLINE
[do] DOI:10.1002/pbc.26783


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[PMID]:28835403
[Au] Autor:Coles AJ; Cohen JA; Fox EJ; Giovannoni G; Hartung HP; Havrdova E; Schippling S; Selmaj KW; Traboulsee A; Compston DAS; Margolin DH; Thangavelu K; Chirieac MC; Jody D; Xenopoulos P; Hogan RJ; Panzara MA; Arnold DL; CARE-MS II and CAMMS03409 Investigators
[Ad] Endereço:From the Department of Clinical Neurosciences (A.J.C., D.A.S.C.), University of Cambridge, UK; Mellen Center (J.A.C.), Cleveland Clinic, OH; MS Clinic of Central Texas (E.J.F.), Central Texas Neurology Consultants, Round Rock; Queen Mary University of London (G.G.), Barts and the London School of Me
[Ti] Título:Alemtuzumab CARE-MS II 5-year follow-up: Efficacy and safety findings.
[So] Source:Neurology;89(11):1117-1126, 2017 Sep 12.
[Is] ISSN:1526-632X
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:OBJECTIVE: To evaluate 5-year efficacy and safety of alemtuzumab in patients with active relapsing-remitting multiple sclerosis and inadequate response to prior therapy. METHODS: In the 2-year Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis (CARE-MS) II study (NCT00548405), alemtuzumab-treated patients received 2 courses (baseline and 12 months later). Patients could enter an extension (NCT00930553), with as-needed alemtuzumab retreatment for relapse or MRI activity. Annualized relapse rate (ARR), 6-month confirmed disability worsening (CDW; ≥1-point Expanded Disability Status Scale [EDSS] score increase [≥1.5 if baseline EDSS = 0]), 6-month confirmed disability improvement (CDI; ≥1-point EDSS decrease [baseline score ≥2.0]), no evidence of disease activity (NEDA), brain volume loss (BVL), and adverse events (AEs) were assessed. RESULTS: Most alemtuzumab-treated patients (92.9%) who completed CARE-MS II entered the extension; 59.8% received no alemtuzumab retreatment. ARR was low in each extension year (years 3-5: 0.22, 0.23, 0.18). Through 5 years, 75.1% of patients were free of 6-month CDW; 42.9% achieved 6-month CDI. In years 3, 4, and 5, proportions with NEDA were 52.9%, 54.2%, and 58.2%, respectively. Median yearly BVL remained low in the extension (years 1-5: -0.48%, -0.22%, -0.10%, -0.19%, -0.07%). AE exposure-adjusted incidence rates in the extension were lower than in the core study. Thyroid disorders peaked at year 3, declining thereafter. CONCLUSIONS: Alemtuzumab provides durable efficacy through 5 years in patients with an inadequate response to prior therapy in the absence of continuous treatment. CLASSIFICATION OF EVIDENCE: This study provides Class III evidence that alemtuzumab provides efficacy and slowing of brain atrophy through 5 years.
[Mh] Termos MeSH primário: Anticorpos Monoclonais Humanizados/uso terapêutico
Fatores Imunológicos/uso terapêutico
Esclerose Múltipla Recidivante-Remitente/tratamento farmacológico
[Mh] Termos MeSH secundário: Alemtuzumab
Anticorpos Monoclonais Humanizados/efeitos adversos
Atrofia/diagnóstico por imagem
Atrofia/prevenção & controle
Encéfalo/diagnóstico por imagem
Encéfalo/efeitos dos fármacos
Avaliação da Deficiência
Seguimentos
Seres Humanos
Fatores Imunológicos/efeitos adversos
Estimativa de Kaplan-Meier
Esclerose Múltipla Recidivante-Remitente/diagnóstico por imagem
Tamanho do Órgão
Fatores de Tempo
Resultado do Tratamento
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Antibodies, Monoclonal, Humanized); 0 (Immunologic Factors); 3A189DH42V (Alemtuzumab)
[Em] Mês de entrada:1709
[Cu] Atualização por classe:171116
[Lr] Data última revisão:
171116
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:170825
[St] Status:MEDLINE
[do] DOI:10.1212/WNL.0000000000004354


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[PMID]:28835401
[Au] Autor:Havrdova E; Arnold DL; Cohen JA; Hartung HP; Fox EJ; Giovannoni G; Schippling S; Selmaj KW; Traboulsee A; Compston DAS; Margolin DH; Thangavelu K; Rodriguez CE; Jody D; Hogan RJ; Xenopoulos P; Panzara MA; Coles AJ; CARE-MS I and CAMMS03409 Investigators
[Ad] Endereço:From the Department of Neurology and Center for Clinical Neuroscience (E.H.), First Faculty of Medicine, Charles University and General University Hospital in Prague, Czech Republic; NeuroRx Research (D.L.A.), Montréal; Department of Neurology and Neurosurgery (D.L.A.), Montréal Neurological Institu
[Ti] Título:Alemtuzumab CARE-MS I 5-year follow-up: Durable efficacy in the absence of continuous MS therapy.
[So] Source:Neurology;89(11):1107-1116, 2017 Sep 12.
[Is] ISSN:1526-632X
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:OBJECTIVE: To evaluate 5-year efficacy and safety of alemtuzumab in treatment-naive patients with active relapsing-remitting MS (RRMS) (CARE-MS I; NCT00530348). METHODS: Alemtuzumab-treated patients received treatment courses at baseline and 12 months later; after the core study, they could enter an extension (NCT00930553) with as-needed alemtuzumab retreatment for relapse or MRI activity. Assessments included annualized relapse rate (ARR), 6-month confirmed disability worsening (CDW; ≥1-point Expanded Disability Status Scale [EDSS] score increase [≥1.5 if baseline EDSS = 0]), 6-month confirmed disability improvement (CDI; ≥1-point EDSS decrease [baseline score ≥2.0]), no evidence of disease activity (NEDA), brain volume loss (BVL), and adverse events (AEs). RESULTS: Most alemtuzumab-treated patients (95.1%) completing CARE-MS I enrolled in the extension; 68.5% received no additional alemtuzumab treatment. ARR remained low in years 3, 4, and 5 (0.19, 0.14, and 0.15). Over years 0-5, 79.7% were free of 6-month CDW; 33.4% achieved 6-month CDI. Most patients (61.7%, 60.2%, and 62.4%) had NEDA in years 3, 4, and 5. Median yearly BVL improved over years 2-4, remaining low in year 5 (years 1-5: -0.59%, -0.25%, -0.19%, -0.15%, and -0.20%). Exposure-adjusted incidence rates of most AEs declined in the extension relative to the core study. Thyroid disorder incidences peaked at year 3 and subsequently declined. CONCLUSIONS: Based on these data, alemtuzumab provides durable efficacy through 5 years in the absence of continuous treatment, with most patients not receiving additional courses. CLINICALTRIALSGOV IDENTIFIER: NCT00530348; NCT00930553. CLASSIFICATION OF EVIDENCE: This study provides Class III evidence that alemtuzumab durably improves efficacy outcomes and slows BVL in patients with RRMS.
[Mh] Termos MeSH primário: Anticorpos Monoclonais Humanizados/uso terapêutico
Fatores Imunológicos/uso terapêutico
Esclerose Múltipla Recidivante-Remitente/tratamento farmacológico
[Mh] Termos MeSH secundário: Alemtuzumab
Anticorpos Monoclonais Humanizados/efeitos adversos
Encéfalo/diagnóstico por imagem
Encéfalo/efeitos dos fármacos
Avaliação da Deficiência
Seguimentos
Seres Humanos
Fatores Imunológicos/efeitos adversos
Esclerose Múltipla Recidivante-Remitente/diagnóstico por imagem
Tamanho do Órgão
Fatores de Tempo
Resultado do Tratamento
[Pt] Tipo de publicação:JOURNAL ARTICLE; RANDOMIZED CONTROLLED TRIAL
[Nm] Nome de substância:
0 (Antibodies, Monoclonal, Humanized); 0 (Immunologic Factors); 3A189DH42V (Alemtuzumab)
[Em] Mês de entrada:1709
[Cu] Atualização por classe:171116
[Lr] Data última revisão:
171116
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:170825
[St] Status:MEDLINE
[do] DOI:10.1212/WNL.0000000000004313


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[PMID]:28700465
[Au] Autor:Zheng J; Song W
[Ad] Endereço:Department of Transplant Surgeons, Tianjin First Center Hospital, Tianjin, China.
[Ti] Título:Alemtuzumab versus antithymocyte globulin induction therapies in kidney transplantation patients: A systematic review and meta-analysis of randomized controlled trials.
[So] Source:Medicine (Baltimore);96(28):e7151, 2017 Jul.
[Is] ISSN:1536-5964
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Alemtuzumab (ALEM) is widely used as an induction therapy for organ transplantation, and numerous randomized controlled trials (RCTs) have been published to evaluate its efficacy and safety in kidney transplantation as compared with antithymocyte globulin (ATG). The purpose of this study was to compare the benefits and safety of ALEM with those of ATG for induction therapy.A systematic literature search in three electronic databases, including PubMed, EmBase, and Cochrane Library, since inception through October 2016, was conducted to identify potential RCTs for inclusion. Trials that investigated the risk of biopsy-proven acute rejection (BPAR), mortality, graft failure, delayed graft function (DGF), chronic allograft nephropathy (CAN), infections, cytomegalovirus (CMV) infections, new-onset diabetes mellitus after transplant (NODAT), and granulocyte colony stimulation factor (GCSF) use in kidney transplant recipients who received ALEM or ATG as an induction therapy were included. Relative risk (RR) and 95% confidence intervals (CIs) were calculated using a random-effects model.Six RCTs involving 446 kidney transplantation patients were included in this meta-analysis. The effects of ALEM therapy were not significantly different from those of ATG therapy, including the incidence of BPAR (RR: 0.77; 95% CI: 0.51-1.18; P = .229), mortality (RR: 0.64; 95% CI: 0.30-1.39; P = .263), graft failure (RR: 0.81; 95% CI: 0.49-1.33; P = .411), DGF (RR: 1.00; 95% CI: 0.60-1.67; P = .999), CAN (RR: 1.42; 95% CI: 0.44-4.57; P = .556), infections (RR: 1.00; 95% CI: 0.74-1.35; P = .989), CMV infections (RR: 0.70; 95% CI: 0.38-1.30; P = .263), NODAT (RR: 0.50; 95% CI: 0.18-1.36; P = .174), and GCSF use (RR: 1.16; 95% CI: 0.81-1.66; P = .413). Sensitivity analyses were consistent with the overall analysis for all effects except CAN, suggesting that the risk of CAN might be higher with ALEM therapy than ATG therapy (RR: 2.45; 95% CI: 1.02-5.94; P = .046).The findings of this study suggest that the beneficial effects of ALEM therapy are greater than those of ATG therapy in kidney transplantation patients; however, the effects were not statistically significant because of the limited number of trials. Further large-scale RCTs are needed to verify the treatment effects of ALEM.
[Mh] Termos MeSH primário: Anticorpos Monoclonais Humanizados/uso terapêutico
Soro Antilinfocitário/uso terapêutico
Imunossupressores/uso terapêutico
Transplante de Rim
[Mh] Termos MeSH secundário: Alemtuzumab
Seres Humanos
Quimioterapia de Indução
Ensaios Clínicos Controlados Aleatórios como Assunto
[Pt] Tipo de publicação:COMPARATIVE STUDY; JOURNAL ARTICLE; META-ANALYSIS; REVIEW
[Nm] Nome de substância:
0 (Antibodies, Monoclonal, Humanized); 0 (Antilymphocyte Serum); 0 (Immunosuppressive Agents); 3A189DH42V (Alemtuzumab)
[Em] Mês de entrada:1707
[Cu] Atualização por classe:171116
[Lr] Data última revisão:
171116
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:170713
[St] Status:MEDLINE
[do] DOI:10.1097/MD.0000000000007151


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[PMID]:28654544
[Au] Autor:Taber DJ; McGillicuddy JW; Bratton CF; Rohan VS; Nadig S; Dubay D; Baliga PK
[Ad] Endereço:*Division of Transplant Surgery, Medical University of South Carolina, Charleston, SC †Department of Pharmacy Services, Ralph H Johnson VAMC, Charleston, SC ‡Department of Surgery, Medical University of South Carolina, Charleston, SC.
[Ti] Título:Cytolytic Induction Therapy Improves Clinical Outcomes in African-American Kidney Transplant Recipients.
[So] Source:Ann Surg;266(3):450-456, 2017 Sep.
[Is] ISSN:1528-1140
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:OBJECTIVE: Determine the impact of cytolytic versus IL-2 receptor antibody (IL-2RA) induction on acute rejection, graft loss and death in African-American (AA) kidney transplant (KTX) recipients. BACKGROUND: AAs are underrepresented in clinical trials in transplantation; thus, there is controversy regarding the optimal choice of perioperative antibody induction in KTX to improve outcomes. METHODS: National cohort study using US transplant registry data from January 1, 2000 to December 31, 2009 in adult solitary AA KTX recipients, with at least 5 years of follow-up. Multivariable logistic and Cox regression were utilized to assess the outcomes of acute rejection, graft loss, and mortality, with interaction terms to assess effect modification. RESULTS: Twenty-five thousand eighty-four adult AAs receiving solitary KTX were included, 16,927 (67.5%) received cytolytic induction and 8157 (32.5%) received IL-2RA induction. After adjustment for recipient sociodemographics, donor, and transplant characteristics, the use of cytolytic induction therapy reduced the risk of acute rejection by 32% (OR 0.68, 0.62-0.75), graft loss by 9% (HR 0.91, 0.86-0.97), and death by 12% (HR 0.88, 0.83-0.94). There were a number of significant effect modifiers, including public insurance, panel reactive antibody, delayed graft function, and steroid withdrawal; in these groups, cytolytic induction substantially improved clinical outcomes. CONCLUSIONS: These data demonstrate that cytolytic induction therapy, as compared with IL-2RA, reduces the risk of rejection, graft loss, and death in adult AA KTX recipients, particularly in those who are sensitized, receive public insurance, develop delayed graft function, or undergo steroid withdrawal.
[Mh] Termos MeSH primário: Afroamericanos
Rejeição de Enxerto/prevenção & controle
Imunossupressores/uso terapêutico
Quimioterapia de Indução/métodos
Transplante de Rim/mortalidade
[Mh] Termos MeSH secundário: Adolescente
Adulto
Idoso
Idoso de 80 Anos ou mais
Alemtuzumab
Anticorpos Monoclonais/uso terapêutico
Anticorpos Monoclonais Humanizados/uso terapêutico
Soro Antilinfocitário/uso terapêutico
Feminino
Seguimentos
Rejeição de Enxerto/etnologia
Rejeição de Enxerto/mortalidade
Seres Humanos
Imunoglobulina G/uso terapêutico
Modelos Logísticos
Masculino
Meia-Idade
Muromonab-CD3/uso terapêutico
Modelos de Riscos Proporcionais
Proteínas Recombinantes de Fusão/uso terapêutico
Sistema de Registros
Estudos Retrospectivos
Resultado do Tratamento
Estados Unidos
Adulto Jovem
[Pt] Tipo de publicação:COMPARATIVE STUDY; JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Antibodies, Monoclonal); 0 (Antibodies, Monoclonal, Humanized); 0 (Antilymphocyte Serum); 0 (Immunoglobulin G); 0 (Immunosuppressive Agents); 0 (Muromonab-CD3); 0 (Recombinant Fusion Proteins); 3A189DH42V (Alemtuzumab); 9927MT646M (basiliximab); CUJ2MVI71Y (daclizumab)
[Em] Mês de entrada:1709
[Cu] Atualização por classe:171116
[Lr] Data última revisão:
171116
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:170628
[St] Status:MEDLINE
[do] DOI:10.1097/SLA.0000000000002366


  9 / 1678 MEDLINE  
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[PMID]:28621800
[Au] Autor:Daver N; McClain K; Allen CE; Parikh SA; Otrock Z; Rojas-Hernandez C; Blechacz B; Wang S; Minkov M; Jordan MB; La Rosée P; Kantarjian HM
[Ad] Endereço:Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.
[Ti] Título:A consensus review on malignancy-associated hemophagocytic lymphohistiocytosis in adults.
[So] Source:Cancer;123(17):3229-3240, 2017 Sep 01.
[Is] ISSN:1097-0142
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Hemophagocytic lymphohistiocytosis (HLH) is a syndrome of severe immune activation and dysregulation resulting in extreme and often life-threatening inflammation. HLH has been well recognized in pediatric populations, and most current diagnostic and therapeutic guidelines are based on pediatric HLH. Recently there has been recognition of HLH in adults, especially secondary to immune deregulation by an underlying rheumatologic, infectious, or malignant condition. This review is focused on malignancy-associated HLH (M-HLH), in which possible mechanisms of pathogenesis include severe inflammation, persistent antigen stimulation by the tumor cells, and loss of immune homeostasis because of chemotherapy, hematopoietic stem cell transplantation, or infection. Previously considered rare, M-HLH may occur in up to 1% of patients with hematologic malignancies. M-HLH is often missed or diagnosed late in most published studies, and it has been associated with a poor median survival of less than 2 months. Identification of the clinical and laboratory features specific to M-HLH in adults may allow early detection, consultation with HLH experts, and intervention. Improved management of adult M-HLH with optimal combinations of T-lympholytic and immunosuppressive agents and the incorporation of novel agents based on the pediatric experience hopefully will improve outcomes in adults with M-HLH. Cancer 2017;123:3229-40. © 2017 American Cancer Society.
[Mh] Termos MeSH primário: Anticorpos Monoclonais Humanizados/uso terapêutico
Detecção Precoce de Câncer/métodos
Neoplasias Hematológicas/patologia
Linfo-Histiocitose Hemofagocítica/patologia
[Mh] Termos MeSH secundário: Adulto
Alemtuzumab
Consenso
Feminino
Neoplasias Hematológicas/tratamento farmacológico
Neoplasias Hematológicas/imunologia
Seres Humanos
Imunossupressores/uso terapêutico
Linfo-Histiocitose Hemofagocítica/tratamento farmacológico
Linfo-Histiocitose Hemofagocítica/imunologia
Linfo-Histiocitose Hemofagocítica/mortalidade
Masculino
Prognóstico
Medição de Risco
Taxa de Sobrevida
Resultado do Tratamento
[Pt] Tipo de publicação:JOURNAL ARTICLE; REVIEW
[Nm] Nome de substância:
0 (Antibodies, Monoclonal, Humanized); 0 (Immunosuppressive Agents); 3A189DH42V (Alemtuzumab)
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171116
[Lr] Data última revisão:
171116
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:170617
[St] Status:MEDLINE
[do] DOI:10.1002/cncr.30826


  10 / 1678 MEDLINE  
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[PMID]:28604916
[Au] Autor:Baker D; Herrod SS; Alvarez-Gonzalez C; Giovannoni G; Schmierer K
[Ad] Endereço:Centre for Neuroscience and Trauma, Blizard Institute, Queen Mary University of London, England.
[Ti] Título:Interpreting Lymphocyte Reconstitution Data From the Pivotal Phase 3 Trials of Alemtuzumab.
[So] Source:JAMA Neurol;74(8):961-969, 2017 Aug 01.
[Is] ISSN:2168-6157
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Importance: Alemtuzumab, a CD52-depleting monoclonal antibody, effectively inhibits relapsing multiple sclerosis (MS) but is associated with a high incidence of secondary B-cell autoimmunities that limit use. These effects may be avoided through control of B-cell hyperproliferation. Objective: To investigate whether the data describing the effect of alemtuzumab on lymphocyte subsets collected during the phase 3 trial program reveal mechanisms explaining efficacy and the risk for secondary autoimmunity with treatment of MS. Design, Setting, and Participants: Lymphocyte reconstitution data from regulatory submissions of the pivotal Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis I and II (CARE-MS I and II) trials were obtained from the European Medicines Agency via Freedom of Information requests. Data used in this study were reported from June 22 to October 12, 2016. Main Outcomes and Measures: Tabulated data from T- and B-lymphocyte subset analysis and antidrug antibody responses were extracted from the supplied documents. Results: Alemtuzumab depleted CD4+ T cells by more than 95%, including regulatory cells (-80%) and CD8+ T cells (>80% depletion), which remained well below reference levels throughout the trials. However, although CD19+ B cells were initially also depleted (>85%), marked (180% increase) hyperrepopulation of immature B cells occurred with conversion to mature B cells over time. These lymphocyte kinetics were associated with rapid development of alemtuzumab-binding and -neutralizing antibodies and subsequent occurrence of secondary B-cell autoimmunity. Hyperrepopulation of B cells masked a marked, long-term depletion of CD19+ memory B cells that may underpin efficacy in MS. Conclusions and Relevance: Although blockade of memory T and B cells may limit MS, rapid CD19+ B-cell subset repopulation in the absence of effective T-cell regulation has implications for the safety and efficacy of alemtuzumab. Controlling B-cell proliferation until T-cell regulation recovers may limit secondary autoimmunity, which does not occur with other B-cell-depleting agents.
[Mh] Termos MeSH primário: Anticorpos Monoclonais Humanizados/uso terapêutico
Antineoplásicos/uso terapêutico
Linfócitos B/efeitos dos fármacos
Linfócitos/efeitos dos fármacos
Linfopenia/induzido quimicamente
Esclerose Múltipla/tratamento farmacológico
[Mh] Termos MeSH secundário: Alemtuzumab
Antígenos CD/metabolismo
Autoimunidade/efeitos dos fármacos
Linfócitos B/metabolismo
Feminino
Seguimentos
Seres Humanos
Células Matadoras Naturais/efeitos dos fármacos
Contagem de Linfócitos
Linfócitos/metabolismo
Masculino
Esclerose Múltipla/patologia
[Pt] Tipo de publicação:CLINICAL TRIAL, PHASE III; JOURNAL ARTICLE; MULTICENTER STUDY
[Nm] Nome de substância:
0 (Antibodies, Monoclonal, Humanized); 0 (Antigens, CD); 0 (Antineoplastic Agents); 3A189DH42V (Alemtuzumab)
[Em] Mês de entrada:1708
[Cu] Atualização por classe:171116
[Lr] Data última revisão:
171116
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:170613
[St] Status:MEDLINE
[do] DOI:10.1001/jamaneurol.2017.0676



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