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[PMID]:28749092
[Au] Autor:Andrade C
[Ad] Endereço:Department of Psychopharmacology, National Institute of Mental Health and Neurosciences, Bangalore, India. candrade@psychiatrist.com.
[Ti] Título:Ketamine for Depression, 4: In What Dose, at What Rate, by What Route, for How Long, and at What Frequency?
[So] Source:J Clin Psychiatry;78(7):e852-e857, 2017 Jul.
[Is] ISSN:1555-2101
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Ketamine, administered in subanesthetic doses, is an effective off-label treatment for severe and even treatment-refractory depression; however, despite dozens of studies across nearly 2 decades of research, there is no definitive guidance on matters related to core practice issues. METHODS: This article presents a qualitative review and summary about what is known about ketamine dosing, rate of administration, route of administration, duration of treatment, and frequency of sessions. RESULTS: Ketamine is most commonly administered in the dose of 0.5 mg/kg, but some patients may respond to doses as low as 0.1 mg/kg, and others may require up to 0.75 mg/kg. The ketamine dose is conventionally administered across 40 minutes; however, safety and efficacy have been demonstrated in sessions ranging between 2 and 100 minutes in duration. Bolus administration is safe and effective when the drug is administered intramuscularly or subcutaneously. Whereas the intravenous route is the most commonly employed, safety and efficacy have been described with other routes of administration, as well; these include oral, sublingual, transmucosal, intranasal, intramuscular, and subcutaneous routes. Patients may receive a single session of treatment or a course of treatment during the acute phase, and treatment may rarely be continued for weeks to years to extend and maintain treatment gains in refractory cases. When so extended, the ideal frequency is perhaps best individualized wherein ketamine is dosed a little before the effect of the previous session is expected to wear off. CONCLUSIONS: There is likely to be a complex interaction between ketamine dose, session duration, route of administration, frequency of administration, and related practice. Until definitive studies comparing different doses, rates of administration, routes of administration, and other considerations are conducted, firm recommendations are not possible. From the point of view of clinical practicability, subcutaneous, intranasal, and oral ketamine warrant further study. If domiciliary treatment is considered, the risk of abuse must be kept in mind.
[Mh] Termos MeSH primário: Antidepressivos/administração & dosagem
Transtorno Depressivo Maior/tratamento farmacológico
Ketamina/administração & dosagem
[Mh] Termos MeSH secundário: Antidepressivos/efeitos adversos
Relação Dose-Resposta a Droga
Esquema de Medicação
Seres Humanos
Infusões Intravenosas
Injeções Intramusculares
Injeções Subcutâneas
Ketamina/efeitos adversos
Resultado do Tratamento
[Pt] Tipo de publicação:COMPARATIVE STUDY; JOURNAL ARTICLE; REVIEW
[Nm] Nome de substância:
0 (Antidepressive Agents); 690G0D6V8H (Ketamine)
[Em] Mês de entrada:1709
[Cu] Atualização por classe:180308
[Lr] Data última revisão:
180308
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170728
[St] Status:MEDLINE


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[PMID]:29220564
[Au] Autor:Benhaberou-Brun D
[Ti] Título:Cancer de la prostate. Les précautions liées à l'injection du dégarélix..
[So] Source:Perspect Infirm;14(3):52, 2017 May-Jun.
[Is] ISSN:1708-1890
[Cp] País de publicação:Canada
[La] Idioma:fre
[Mh] Termos MeSH primário: Oligopeptídeos/administração & dosagem
Neoplasias da Próstata/tratamento farmacológico
[Mh] Termos MeSH secundário: Seres Humanos
Injeções Subcutâneas/efeitos adversos
Injeções Subcutâneas/métodos
Masculino
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Oligopeptides); 0 (acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide)
[Em] Mês de entrada:1803
[Cu] Atualização por classe:180306
[Lr] Data última revisão:
180306
[Sb] Subgrupo de revista:N
[Da] Data de entrada para processamento:171209
[St] Status:MEDLINE


  3 / 30212 MEDLINE  
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[PMID]:29419393
[Au] Autor:Ford TJ; Rocchiccioli P
[Ad] Endereço:British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.
[Ti] Título:A keen eye for risk.
[So] Source:BMJ;360:j5884, 2018 02 01.
[Is] ISSN:1756-1833
[Cp] País de publicação:England
[La] Idioma:eng
[Mh] Termos MeSH primário: Arco Senil/diagnóstico
Doenças da Córnea/diagnóstico
Doença da Artéria Coronariana/diagnóstico
Hiperlipoproteinemia Tipo II/diagnóstico
Receptores de LDL/genética
[Mh] Termos MeSH secundário: Anticorpos Monoclonais/administração & dosagem
Anticorpos Monoclonais/uso terapêutico
Anticolesterolemiantes/administração & dosagem
Anticolesterolemiantes/uso terapêutico
Arco Senil/etiologia
Colesterol/sangue
Doenças da Córnea/etiologia
Doença da Artéria Coronariana/complicações
Doença da Artéria Coronariana/etiologia
Feminino
Seres Humanos
Inibidores de Hidroximetilglutaril-CoA Redutases/uso terapêutico
Hiperlipoproteinemia Tipo II/sangue
Hiperlipoproteinemia Tipo II/tratamento farmacológico
Hiperlipoproteinemia Tipo II/genética
Injeções Subcutâneas
Meia-Idade
Mutação
Pró-Proteína Convertase 9/antagonistas & inibidores
Xantomatose/diagnóstico
Xantomatose/etiologia
[Pt] Tipo de publicação:CASE REPORTS; JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Antibodies, Monoclonal); 0 (Anticholesteremic Agents); 0 (Hydroxymethylglutaryl-CoA Reductase Inhibitors); 0 (Receptors, LDL); 97C5T2UQ7J (Cholesterol); EC 3.4.21.- (PCSK9 protein, human); EC 3.4.21.- (Proprotein Convertase 9); LKC0U3A8NJ (evolocumab)
[Em] Mês de entrada:1803
[Cu] Atualização por classe:180305
[Lr] Data última revisão:
180305
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:180209
[St] Status:MEDLINE
[do] DOI:10.1136/bmj.j5884


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[PMID]:29191846
[Au] Autor:David M; Rangaraju M; Raine A
[Ad] Endereço:The Royal Orthopaedic Hospital, Birmingham, UK michaeldavid@nhs.net.
[Ti] Título:Acquired triggering of the fingers and thumb in adults.
[So] Source:BMJ;359:j5285, 2017 11 30.
[Is] ISSN:1756-1833
[Cp] País de publicação:England
[La] Idioma:eng
[Mh] Termos MeSH primário: Deformidades Adquiridas da Mão/patologia
Deformidades Articulares Adquiridas/patologia
Tenossinovite/patologia
Polegar/patologia
Dedo em Gatilho/patologia
[Mh] Termos MeSH secundário: Adulto
Idoso
Inglaterra/epidemiologia
Feminino
Deformidades Adquiridas da Mão/etiologia
Deformidades Adquiridas da Mão/cirurgia
Seres Humanos
Injeções Subcutâneas
Liberação da Cápsula Articular/métodos
Deformidades Articulares Adquiridas/etiologia
Deformidades Articulares Adquiridas/cirurgia
Masculino
Meia-Idade
Estudos Observacionais como Assunto
Prevalência
Atenção Primária à Saúde/estatística & dados numéricos
Esteroides/administração & dosagem
Esteroides/uso terapêutico
Tenossinovite/etiologia
Polegar/cirurgia
Dedo em Gatilho/tratamento farmacológico
Dedo em Gatilho/etiologia
Dedo em Gatilho/cirurgia
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Steroids)
[Em] Mês de entrada:1803
[Cu] Atualização por classe:180305
[Lr] Data última revisão:
180305
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:171202
[St] Status:MEDLINE
[do] DOI:10.1136/bmj.j5285


  5 / 30212 MEDLINE  
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[PMID]:28468639
[Au] Autor:Sasajima H; Yagi S; Osada H; Zako M
[Ad] Endereço:Department of Ophthalmology, Aichi Medical University, Nagakute, Aichi, Japan.
[Ti] Título:Botulinum toxin-induced acute anterior uveitis in a patient with Behçet's disease under infliximab treatment: a case report.
[So] Source:J Med Case Rep;11(1):124, 2017 May 04.
[Is] ISSN:1752-1947
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Injections of lipopolysaccharide in animal models generate acute anterior uveitis (also known as endotoxin-induced uveitis), but the effects of lipopolysaccharide injection are unknown in humans. We describe an unusual case in which acute anterior uveitis was dramatically activated subsequent to botulinum toxin injection in a patient with Behçet's disease but the acute anterior uveitis was satisfactorily attenuated by infliximab. CASE PRESENTATION: A 53-year-old Japanese man had normal ocular findings at his regularly scheduled appointment. He had been diagnosed as having incomplete-type Behçet's disease 11 years before. Three years after the diagnosis he was given systemic infusions of 5 mg/kg infliximab every 8 weeks and he had not experienced a uveitis attack for 8 years with no treatment other than infliximab. Two days after the eye examination, he received intracutaneous botulinum toxin injections to treat axillary hyperhidrosis on both sides. Three hours after the injections, he noted rapidly increasing floaters in his right eye. Four days after the injections, his right eye showed severe acute anterior uveitis with deteriorated aqueous flare and anterior vitreous opacity. He received his scheduled infliximab injection, and the right acute anterior uveitis immediately attenuated. CONCLUSIONS: Botulinum toxin may have clinical effects similar to those of lipopolysaccharide in endotoxin-induced uveitis models. To the best of our knowledge, this is the first report to suggest that botulinum toxin may trigger acute anterior uveitis, although the precise mechanism is still unclear.
[Mh] Termos MeSH primário: Síndrome de Behçet/tratamento farmacológico
Toxinas Botulínicas/efeitos adversos
Hiperidrose/tratamento farmacológico
Infliximab/administração & dosagem
Neurotoxinas/administração & dosagem
Uveíte/induzido quimicamente
[Mh] Termos MeSH secundário: Seres Humanos
Injeções Subcutâneas
Masculino
Meia-Idade
Tomografia de Coerência Óptica
Uveíte/diagnóstico por imagem
Uveíte/tratamento farmacológico
[Pt] Tipo de publicação:CASE REPORTS; JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Neurotoxins); B72HH48FLU (Infliximab); EC 3.4.24.69 (Botulinum Toxins)
[Em] Mês de entrada:1803
[Cu] Atualização por classe:180305
[Lr] Data última revisão:
180305
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170505
[St] Status:MEDLINE
[do] DOI:10.1186/s13256-017-1288-1


  6 / 30212 MEDLINE  
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[PMID]:29260924
[Au] Autor:Molina Vega M; Muñoz-Garach A; Tinahones FJ
[Ad] Endereço:a Department of Endocrinology and Nutrition , Virgen de la Victoria Hospital, Málaga University (IBIMA). , Málaga , Spain.
[Ti] Título:Pharmacokinetic drug evaluation of exenatide for the treatment of type 2 diabetes.
[So] Source:Expert Opin Drug Metab Toxicol;14(2):207-217, 2018 02.
[Is] ISSN:1744-7607
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:INTRODUCTION: Glucagon-like peptide-1 (GLP-1) receptor analogs are a group of therapeutic agents which mimic endogenous GLP-1, exerting their effect by the stimulation of the GLP-1 receptor with a wide distribution. Its activation increases insulin releasing dependent on blood glucose levels, suppression of glucagon secretion and a reduction of hepatic glucose output. It delays gastric emptying and increases satiety. Exenatide is the synthetic version of exendin-4, a natural peptide with similar properties to human GLP-1. There are two pharmaceutical forms, for subcutaneous injection: twice daily and once weekly. Clinical practice guidelines recommend them because of a high efficacy reducing hyperglycemia, low risk of hypoglycemia and a significative weight loss effect. Gastrointestinal adverse events are the most common beside injection site-related. Their cost is the main limitation to use. Areas covered: We review the recent literature investigating the pharmacokinetics and pharmacodynamics and efficacy-safety studies of exenatide twice daily and once weekly in type 2 diabetes Expert opinion: GLP-1 receptor analogs are now positioned as an effective and safe drug for the treatment of type 2 diabetes. Exenatide significally reduces HbA1c and fasting plasma glucose. Additionally, it produces moderate weight loss and decreases blood pressure. One weekly formulation may improve compliance while cost is still a limitation. EXSCEL trial has shown that, despite cardiovascular safety, exenatide do not exhibits cardiovascular benefits.
[Mh] Termos MeSH primário: Diabetes Mellitus Tipo 2/tratamento farmacológico
Hipoglicemiantes/administração & dosagem
Peptídeos/administração & dosagem
Peçonhas/administração & dosagem
[Mh] Termos MeSH secundário: Animais
Glicemia/efeitos dos fármacos
Esquema de Medicação
Receptor do Peptídeo Semelhante ao Glucagon 1/agonistas
Seres Humanos
Hipoglicemia/induzido quimicamente
Hipoglicemiantes/farmacocinética
Hipoglicemiantes/farmacologia
Injeções Subcutâneas
Insulina/metabolismo
Peptídeos/farmacocinética
Peptídeos/farmacologia
Peçonhas/farmacocinética
Peçonhas/farmacologia
Perda de Peso/efeitos dos fármacos
[Pt] Tipo de publicação:JOURNAL ARTICLE; REVIEW
[Nm] Nome de substância:
0 (Blood Glucose); 0 (Glucagon-Like Peptide-1 Receptor); 0 (Hypoglycemic Agents); 0 (Insulin); 0 (Peptides); 0 (Venoms); 9P1872D4OL (exenatide)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180222
[Lr] Data última revisão:
180222
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:171221
[St] Status:MEDLINE
[do] DOI:10.1080/17425255.2018.1420160


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[PMID]:29173359
[Au] Autor:Al-Bayati I; Saadi M; Elhanafi S; McCallum RW
[Ad] Endereço:Department of Internal Medicine, Texas Tech University Health Sciences Center Paul L. Foster School of Medicine, El Paso, Texas.
[Ti] Título:Effectiveness of Bulking Agent (Solesta) Therapy in Fecal Incontinence in Patients Refractory to Conventional Therapies.
[So] Source:Am J Med Sci;354(5):476-479, 2017 11.
[Is] ISSN:1538-2990
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Fecal incontinence is a problem that imposes considerable socioeconomic consequences. Despite many medical therapies, unmet needs remain. A new treatment option is a biocompatible bulking agent (Solesta) administered by submucosal injection in the distal rectum. The aims of this study are as follows: (1) To evaluate the efficacy and safety of this bulking agent in decreasing the severity of fecal incontinence (FI) and improving quality of life. (2) To obtain objective evidence of changes in anorectal physiology by high-resolution anorectal manometry pretreatment and posttreatment. MATERIALS AND METHODS: From January 2014 to June 2015, 17 patients who had failed medical therapy for FI received stabilized hyaluronate injected submucosally into the rectum under direct anoscopic visualization. The treatment was considered successful if patients achieved >50% reduction in FI events during monitoring for up to 12 months. RESULTS: After the first treatment session, 14 patients (82.3%) had a successful outcome. The remaining 3 patients received a second therapy 3 months later to achieve this result. At last follow-up, 7 of the 17 patients (41%) were having no FI events. The remaining patients had reduction in fecal accidents from a mean of 6.4/week baseline to 2.8/week during follow-up. CONCLUSIONS: Intrarectal injection of stabilized hyaluronate is effective for treating FI in patients who had failed standard medical treatments and is technically easy and safely performed as an outpatient procedure.
[Mh] Termos MeSH primário: Dextranos/administração & dosagem
Incontinência Fecal/tratamento farmacológico
Fármacos Gastrointestinais/administração & dosagem
Ácido Hialurônico/administração & dosagem
[Mh] Termos MeSH secundário: Adulto
Idoso
Idoso de 80 Anos ou mais
Feminino
Seres Humanos
Injeções Subcutâneas
Masculino
Meia-Idade
Reto
Resultado do Tratamento
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Dextrans); 0 (Gastrointestinal Agents); 0 (dextranomer-hyaluronic acid copolymer); 9004-61-9 (Hyaluronic Acid)
[Em] Mês de entrada:1711
[Cu] Atualização por classe:180223
[Lr] Data última revisão:
180223
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:171128
[St] Status:MEDLINE


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[PMID]:29238761
[Au] Autor:Paton DM
[Ad] Endereço:Emeritus Professor of Pharmacology, University of Auckland, Auckland, New Zealand. dmpaton38@yahoo.ca.
[Ti] Título:Dupilumab: human monoclonal antibody against IL-4Rα for moderate to severe atopic dermatitis.
[So] Source:Drugs Today (Barc);53(9):477-487, 2017 Sep.
[Is] ISSN:1699-3993
[Cp] País de publicação:Spain
[La] Idioma:eng
[Ab] Resumo:Atopic dermatitis (AD) is one of the most common skin disorders with a prevalence of about 20% in children and affecting adults in significant numbers. Moderate to severe AD significantly impairs a patient's quality of life with severe pruritus as a major issue that impairs sleep and contributes to major psychological disturbances. Detailed studies of its pathogenesis have revealed that immune mechanisms are involved including activation of T helper type 2 cells (Th2). Dupilumab is a fully human Ig4 monoclonal antibody directed against the interleukin-4 receptor subunit α (IL-4Rα) of IL-4 and IL-13 receptors. In clinical studies it has been demonstrated to significantly reduce the molecular signature in the skin of patients with AD and to significantly reduce the clinical manifestations of moderate to severe AD. It also very importantly significantly reduces the pruritus of moderate to severe AD thus improving the patients' quality of life. Dupilumab is administered by subcutaneous injection every other week. It was approved by the FDA in March 2017 for the treatment of moderate to severe AD.
[Mh] Termos MeSH primário: Anticorpos Monoclonais/administração & dosagem
Dermatite Atópica/tratamento farmacológico
Subunidade alfa de Receptor de Interleucina-4/imunologia
[Mh] Termos MeSH secundário: Adulto
Anticorpos Monoclonais/farmacologia
Criança
Dermatite Atópica/patologia
Seres Humanos
Injeções Subcutâneas
Prurido/tratamento farmacológico
Prurido/etiologia
Qualidade de Vida
Índice de Gravidade de Doença
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Antibodies, Monoclonal); 0 (IL4R protein, human); 0 (Interleukin-4 Receptor alpha Subunit); 0 (SAR231893)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180206
[Lr] Data última revisão:
180206
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:171215
[St] Status:MEDLINE
[do] DOI:10.1358/dot.2017.53.9.2693150


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[PMID]:29264900
[Au] Autor:Sahan A; Tamer F
[Ad] Endereço:Doctor Al-Sa Aesthetic & Cosmetic Dermatology Clinic, Ankara, Turkey.
[Ti] Título:Non-surgical minimally invasive rhinoplasty: tips and tricks from the perspective of a dermatologist.
[So] Source:Acta Dermatovenerol Alp Pannonica Adriat;26(4):101-103, 2017 Dec.
[Is] ISSN:1581-2979
[Cp] País de publicação:Slovenia
[La] Idioma:eng
[Ab] Resumo:INTRODUCTION: Rhinoplasty is one of the most common aesthetic procedures performed by plastic surgeons all over the world. In recent years, a non-surgical nose job has become the preferred option for most patients and specialists. Minimally invasive techniques already result in high satisfaction rates. Moreover, patients do not need anesthesia and there is no post-operative recovery period. METHODS: Between January 2016 and January 2017, 35 patients (33 female, 2 male) that had undergone nonsurgical rhinoplasty with dermal fillers were included in the study. Clinical and demographic features of the patients, our technique, satisfaction rates, and complications were discussed. RESULTS: We recorded an extremely high satisfaction rate and did not observe any complications. All of the patients returned to their normal daily activities immediately after the procedure. CONCLUSIONS: Non-surgical nose augmentation with dermal fillers is an easy, safe, and comfortable technique. It appears that dermatologists need to assume a more active role in rhinoplasty.
[Mh] Termos MeSH primário: Preenchedores Dérmicos/administração & dosagem
Satisfação do Paciente
Rinoplastia/métodos
[Mh] Termos MeSH secundário: Adulto
Feminino
Seres Humanos
Injeções Subcutâneas
Masculino
Resultado do Tratamento
Adulto Jovem
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Dermal Fillers)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180201
[Lr] Data última revisão:
180201
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:171222
[St] Status:MEDLINE


  10 / 30212 MEDLINE  
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Registro de Ensaios Clínicos
Registro de Ensaios Clínicos
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[PMID]:28745999
[Au] Autor:Stone JH; Tuckwell K; Dimonaco S; Klearman M; Aringer M; Blockmans D; Brouwer E; Cid MC; Dasgupta B; Rech J; Salvarani C; Schett G; Schulze-Koops H; Spiera R; Unizony SH; Collinson N
[Ad] Endereço:From the Massachusetts General Hospital Rheumatology Unit, Harvard Medical School, Boston (J.H.S., S.H.U.); Roche Products, Welwyn Garden City (K.T., S.D., N.C.), and Southend University Hospital NHS Foundation Trust, Westcliff-on-Sea (B.D.) - both in the United Kingdom; Genentech, South San Francis
[Ti] Título:Trial of Tocilizumab in Giant-Cell Arteritis.
[So] Source:N Engl J Med;377(4):317-328, 2017 07 27.
[Is] ISSN:1533-4406
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Giant-cell arteritis commonly relapses when glucocorticoids are tapered, and the prolonged use of glucocorticoids is associated with side effects. The effect of the interleukin-6 receptor alpha inhibitor tocilizumab on the rates of relapse during glucocorticoid tapering was studied in patients with giant-cell arteritis. METHODS: In this 1-year trial, we randomly assigned 251 patients, in a 2:1:1:1 ratio, to receive subcutaneous tocilizumab (at a dose of 162 mg) weekly or every other week, combined with a 26-week prednisone taper, or placebo combined with a prednisone taper over a period of either 26 weeks or 52 weeks. The primary outcome was the rate of sustained glucocorticoid-free remission at week 52 in each tocilizumab group as compared with the rate in the placebo group that underwent the 26-week prednisone taper. The key secondary outcome was the rate of remission in each tocilizumab group as compared with the placebo group that underwent the 52-week prednisone taper. Dosing of prednisone and safety were also assessed. RESULTS: Sustained remission at week 52 occurred in 56% of the patients treated with tocilizumab weekly and in 53% of those treated with tocilizumab every other week, as compared with 14% of those in the placebo group that underwent the 26-week prednisone taper and 18% of those in the placebo group that underwent the 52-week prednisone taper (P<0.001 for the comparisons of either active treatment with placebo). The cumulative median prednisone dose over the 52-week period was 1862 mg in each tocilizumab group, as compared with 3296 mg in the placebo group that underwent the 26-week taper (P<0.001 for both comparisons) and 3818 mg in the placebo group that underwent the 52-week taper (P<0.001 for both comparisons). Serious adverse events occurred in 15% of the patients in the group that received tocilizumab weekly, 14% of those in the group that received tocilizumab every other week, 22% of those in the placebo group that underwent the 26-week taper, and 25% of those in the placebo group that underwent the 52-week taper. Anterior ischemic optic neuropathy developed in one patient in the group that received tocilizumab every other week. CONCLUSIONS: Tocilizumab, received weekly or every other week, combined with a 26-week prednisone taper was superior to either 26-week or 52-week prednisone tapering plus placebo with regard to sustained glucocorticoid-free remission in patients with giant-cell arteritis. Longer follow-up is necessary to determine the durability of remission and safety of tocilizumab. (Funded by F. Hoffmann-La Roche; ClinicalTrials.gov number, NCT01791153 .).
[Mh] Termos MeSH primário: Anticorpos Monoclonais Humanizados/uso terapêutico
Arterite de Células Gigantes/tratamento farmacológico
Glucocorticoides/administração & dosagem
Prednisona/administração & dosagem
Receptores de Interleucina-6/antagonistas & inibidores
[Mh] Termos MeSH secundário: Idoso
Anticorpos Monoclonais Humanizados/efeitos adversos
Método Duplo-Cego
Esquema de Medicação
Quimioterapia Combinada
Feminino
Glucocorticoides/efeitos adversos
Seres Humanos
Injeções Subcutâneas
Masculino
Meia-Idade
Prednisona/efeitos adversos
Indução de Remissão
[Pt] Tipo de publicação:CLINICAL TRIAL, PHASE III; COMPARATIVE STUDY; JOURNAL ARTICLE; MULTICENTER STUDY; RANDOMIZED CONTROLLED TRIAL
[Nm] Nome de substância:
0 (Antibodies, Monoclonal, Humanized); 0 (Glucocorticoids); 0 (Receptors, Interleukin-6); 0 (interleukin-6 receptor alpha); I031V2H011 (tocilizumab); VB0R961HZT (Prednisone)
[Em] Mês de entrada:1708
[Cu] Atualização por classe:180124
[Lr] Data última revisão:
180124
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:170727
[Cl] Clinical Trial:ClinicalTrial
[St] Status:MEDLINE
[do] DOI:10.1056/NEJMoa1613849



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