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1.
Isr Med Assoc J ; 22(3): 154-159, 2020 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-32147979

RESUMO

BACKGROUND: Guidelines recommend initiation of parenteral biologic or oral target-specific disease-modifying anti-rheumatic drugs (bDMARDs/tsDMARDs) in rheumatoid arthritis (RA) patients who do not adequately respond to conventional DMARDs. OBJECTIVES: To compare the preferred route of administration of bDMARDs or tsDMARDs in RA patients who were previously treated with at least one type. METHODS: A cross-sectional survey was conducted of consecutive RA patients previously prescribed bDMARDs or tsDMARDs. We analyzed the factors associated with patients' preferred route of administration. RESULTS: The cohort included 95 patients, mostly female (72.6%), seropositive (81.05%), mean age 63.4 ± 11.9 years. The oral route was preferred by 39 patients (41%) and 56 (59%) preferred the parenteral route. Most patients (65.9%) preferred to continue with their current route (P < 0.001). Switching from a current route was less common with patients who were currently using the oral route (13.3% vs. 38.2%, P = 0.04). Many patients (53.8%) who preferred the oral route had never experienced it before, while this was rare (3.6%) regarding the parenteral route (P = 0.0001). Employment status was associated with preference of the subcutaneous route over the intravenous route of bDMARDs (P = 0.01). Of the 21 patients who had previously experienced both parenteral and oral treatment, 16 (76.2%) preferred the oral route. CONCLUSIONS: RA patients preferred to continue treatment with an administration route they have already experienced. However, when choosing an unexperienced route, significantly more patients preferred the oral route. Our results strengthen the understanding of patient preferences, which could improve drug adherence, compliance, and disease outcome.


Assuntos
Antirreumáticos/administração & dosagem , Artrite Reumatoide/tratamento farmacológico , Produtos Biológicos/administração & dosagem , Nutrição Parenteral/estatística & dados numéricos , Preferência do Paciente/estatística & dados numéricos , Administração Oral , Adulto , Idoso , Idoso de 80 Anos ou mais , Antirreumáticos/uso terapêutico , Produtos Biológicos/uso terapêutico , Estudos de Coortes , Estudos Transversais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Inquéritos e Questionários
3.
Cancer Immunol Immunother ; 69(5): 759-769, 2020 May.
Artigo em Inglês | MEDLINE | ID: mdl-32052079

RESUMO

BACKGROUND: Resistance to immune checkpoint blockade and targeted therapy in melanoma patients is currently one of the major clinical challenges. With the approval of talimogene laherparepvec (T-VEC), oncolytic viruses are now in clinical practice for locally advanced or non-resectable melanoma. Here, we describe the usage of T-VEC in stage IVM1b-M1c melanoma patients, who achieved complete remission or stable disease upon systemic treatment but suffered from a loco-regional recurrence. To our knowledge, there are no case reports so far describing T-VEC as a means to overcome acquired resistance to immune checkpoint blockade or targeted therapy. METHODS: All melanoma patients in our department treated with T-VEC in the period of 2016-2018 were evaluated retrospectively. Data on clinicopathological characteristics, treatment response, and toxicity were analyzed. RESULTS: Fourteen melanoma patients were treated with T-VEC in our center. Six patients (43%) received T-VEC first-line. In eight patients (57%), T-VEC followed a prior systemic therapy. Three patients with M1b stage and one patient with M1c stage melanoma were treated with T-VEC. These patients suffered from loco-regional progress, whilst distant metastases had regressed during prior systemic treatment. 64% of patients showed a benefit from therapy with T-VEC. The durable response rate was 36%. CONCLUSION: T-VEC represents an effective and tolerable treatment option. This is true not only for loco-regionally advanced melanoma patients, but also for patients with stable or regressive systemic metastases who develop loco-regionally acquired resistance upon treatment with immune checkpoint blockade or targeted therapy. A sensible selection of suitable patients seems to be crucial.


Assuntos
Antineoplásicos Imunológicos/farmacologia , Produtos Biológicos/administração & dosagem , Imunoterapia/métodos , Melanoma/terapia , Terapia Viral Oncolítica/métodos , Neoplasias Cutâneas/terapia , Adulto , Idoso , Idoso de 80 Anos ou mais , Antineoplásicos Imunológicos/uso terapêutico , Receptores Coestimuladores e Inibidores de Linfócitos T/antagonistas & inibidores , Receptores Coestimuladores e Inibidores de Linfócitos T/imunologia , Progressão da Doença , Resistencia a Medicamentos Antineoplásicos/efeitos dos fármacos , Resistencia a Medicamentos Antineoplásicos/imunologia , Feminino , Seguimentos , Herpesvirus Humano 1 , Humanos , Masculino , Melanoma/imunologia , Melanoma/mortalidade , Melanoma/patologia , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Intervalo Livre de Progressão , Estudos Retrospectivos , Neoplasias Cutâneas/imunologia , Neoplasias Cutâneas/mortalidade , Neoplasias Cutâneas/patologia
4.
Pneumologie ; 74(2): 103-111, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-31935761

RESUMO

In the EU, five biologics have been approved as add-on therapy for patients with severe asthma. Until recently, none of the biologics was approved for home use and had to be administered under medical supervision, a time-consuming schedule for both patients and physicians, accompanied by greater expenditure. However, over the last year, four out of the five biologics have been granted approval for patient self-administration at home. The objective of this multiple-choice survey was to understand how patients with severe asthma treated with omalizumab and their treating physicians view the potential home use of biologics exemplified by omalizumab. The questionnaires were answered by 120 physicians and 432 patients (response rate: 51.7 % and 20.6 %, respectively). Overall, 44.7 % of patients were in favour of self-administration at home while 30.6 % opposed this method of administration and 23.8 % of patients were neutral. Especially teenagers and young adults had a positive attitude towards self-administration. 76.7 % of the questioned physicians were in favour of home use for certain patients. Time saving was the main advantage for self-administration mentioned by patients (53.2 %) as well as by physicians (72.5 %). The main concern for patients was 'making a mistake while injecting' (43.8 %) while 'forgetting to inject omalizumab' (73.3 %) was the main concern for physicians. 44.4 % of patients expressed a wish for individual training and 70.8 % of physicians agreed with this statement. The latter group also considered a starter kit including several information materials (54.2 %) as well as an electronic reminder system (50.8 %) as useful. In conclusion, self-administration of biologics has the potential to be timesaving for both patients and physicians.


Assuntos
Antialérgicos/administração & dosagem , Antiasmáticos/administração & dosagem , Anticorpos Monoclonais Humanizados/uso terapêutico , Asma/tratamento farmacológico , Produtos Biológicos/administração & dosagem , Omalizumab/administração & dosagem , Autoadministração , Adolescente , Adulto , Antialérgicos/uso terapêutico , Antiasmáticos/uso terapêutico , Anticorpos Monoclonais Humanizados/administração & dosagem , Produtos Biológicos/uso terapêutico , Pesquisas sobre Serviços de Saúde , Conhecimentos, Atitudes e Prática em Saúde , Humanos , Inquéritos e Questionários , Adulto Jovem
5.
Gut ; 69(1): 32-41, 2020 01.
Artigo em Inglês | MEDLINE | ID: mdl-30979718

RESUMO

INTRODUCTION: The optimal trial design for assessing novel therapies in paediatric IBD (PIBD) is a subject of intense ongoing global discussions and debate among the different stakeholders. However, there is a consensus that the current situation in which most medications used in children with IBD are prescribed as off-label without sufficient paediatric data is unacceptable. Shortening the time lag between adult and paediatric approval of drugs is of the upmost importance. In this position paper we aimed to provide guidance from the global clinical research network (Pediatric Inflammatory Bowel Disease Network, PIBDnet) for designing clinical trials in PIBD in order to facilitate drug approval for children. METHODS: A writing group has been established by PIBDnet and topics were assigned to different members. After an iterative process of revisions among the writing group and one face-to-face meeting, all statements have reached consensus of >80% as defined a priori. Next, all core members of PIBDnet voted on the statements, reaching consensus of >80% on all statements. Comments from the members were incorporated in the text. RESULTS: The commentary includes 18 statements for guiding data extrapolation from adults, eligibility criteria to PIBD trials, use of placebo, dosing, endpoints and recommendations for feasible trials. Controversial issues have been highlighted in the text. CONCLUSION: The viewpoints expressed in this paper could assist planning clinical trials in PIBD which are both of high quality and ethical, while remaining pragmatic.


Assuntos
Ensaios Clínicos como Assunto/métodos , Fármacos Gastrointestinais/uso terapêutico , Doenças Inflamatórias Intestinais/tratamento farmacológico , Fatores Etários , Produtos Biológicos/administração & dosagem , Produtos Biológicos/uso terapêutico , Criança , Ensaios Clínicos como Assunto/normas , Relação Dose-Resposta a Droga , Aprovação de Drogas/métodos , Fármacos Gastrointestinais/administração & dosagem , Humanos , Seleção de Pacientes , Projetos de Pesquisa , Índice de Gravidade de Doença , Resultado do Tratamento
7.
J Ethnopharmacol ; 246: 112230, 2020 Jan 10.
Artigo em Inglês | MEDLINE | ID: mdl-31526860

RESUMO

BACKGROUND: The pharmacology, toxicology and pharmacokinetics of bioactive preparations derived from natural sources has become a flourishing field of research. However, researching complex extracts and natural products faces numerous challenges. More broadly in recent years the critique of pharmacological research, and specifically its design, the methods used and reporting has intensified. AIMS: This consensus document provides a perspective on what constitutes best practice in pharmacological research on bioactive preparations derived from natural sources, providing a perspective of what the leading specialist journals in the field consider as the core characteristics of good research. APPROACH ('METHODS'): The editors-in-chief of seven journals developed this best practice statement in an iterative process. A first draft of the guidelines (prepared by MH) was then discussed and amended by the other editors. OUTCOMES: Core to this contribution is a table which provides detailed advice including simple points like a use of appropriate controls and the full taxonomic validity of the material under investigation (see also below), to the relevance of the model for the question being researched (e.g., can specific in silico or in vitro models really address the species anti-inflammatory activity?). Therefore, obviously, researchers must pay detailed attention to reporting and discussing such studies. This information must be discussed critically (as much as it is possible based on the published papers) in terms of their scientific quality and validity. While these points are obvious, as editors, we are aware that they are often not properly implemented. CONCLUSION: We call for an approach which incorporates a careful design, meticulous execution and a detailed reporting of studies focusing on the pharmacology/bioactivity of bioactive preparations. Clearly testable research questions must be developed and investigated experimentally. As the founder of pharmacology Claude Bernard put it already in 1865: '…. either the experimenter's hypothesis will be disproved or it will be proved by experiment. When experiment disproves its preconceived ideas, the experimenter must discard or modify it.'


Assuntos
Produtos Biológicos/uso terapêutico , Pesquisa Biomédica/métodos , Pesquisa Biomédica/normas , Produtos Biológicos/administração & dosagem , Humanos , Plantas Medicinais
8.
Surg Clin North Am ; 99(6): 1223-1235, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31676060

RESUMO

Inflammatory bowel disease has become a growing concern worldwide. The chronic and progressive nature of inflammatory bowel disease poses significant challenges to the treatment and management of affected patients, straining health care resources. Therapeutic options and optimal management strategies have evolved dramatically. The treat-to-target strategy has shifted focus toward identifiable and attainable treatment targets and with the ability to optimize tight control. Advancements in our understanding of the pathophysiology led to therapeutic mechanisms that have a more narrowed focus toward gut-specific targets, improving safety profiles.


Assuntos
Produtos Biológicos/administração & dosagem , Tratamento Conservador/métodos , Imunossupressores/administração & dosagem , Doenças Inflamatórias Intestinais/terapia , Produtos Biológicos/farmacologia , Gerenciamento Clínico , Feminino , Seguimentos , Humanos , Doenças Inflamatórias Intestinais/diagnóstico , Masculino , Seleção de Pacientes , Recidiva , Retratamento , Medição de Risco , Fatores de Tempo , Resultado do Tratamento
9.
Expert Opin Drug Saf ; 18(12): 1161-1170, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31594389

RESUMO

Introduction: The last two decades have seen significant progress in the treatment of severe asthma especially the severe eosinophilic phenotype. This review article serves to update the reader on the known safety profiles of these medications. It does not serve as a review of their clinical efficacies.Areas covered: All four of the currently approved monoclonal antibodies (biologics) used in the treatment of severe asthma are discussed with reference to the known safety data garnered from clinical trials and real world evidence. A fifth, approved by The European Commission and FDA, but not yet by NICE or Health Canada, is also discussed.Expert opinion: For each of the five biologics the authors shall summarize the known safety profiles and also the potential adverse effects as their usage is extended long term with suggestions for real world studies to help us develop our knowledge base.


Assuntos
Antiasmáticos/administração & dosagem , Anticorpos Monoclonais/administração & dosagem , Asma/tratamento farmacológico , Antiasmáticos/efeitos adversos , Anticorpos Monoclonais/efeitos adversos , Asma/fisiopatologia , Produtos Biológicos/administração & dosagem , Produtos Biológicos/efeitos adversos , Eosinófilos/metabolismo , Humanos , Índice de Gravidade de Doença
11.
Expert Opin Drug Saf ; 18(11): 1031-1041, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31479282

RESUMO

Introduction: Psoriasis is a chronic inflammatory disease and affects about 10% of the world's population. Psoriasis is associated with a number of comorbidities. Biologic therapies for the treatment of moderate-severe plaque psoriasis include tumor necrosis factor α inhibitors (TNFi), and newer molecules targeting IL-12 and 23, blocking p40 subunit, or targeting subunit p19 of IL-23 and other molecules blocking IL-17A, or directed against the IL-17 receptor. Areas covered: Anti-interleukin drugs show great improvement in disease control and on the other hand are not affected by important adverse reactions of older compounds. Approach to chronic disease affected patients, in particular, and to patients with multiple comorbidities is revolutionized by novel molecules that are safer and more manageable. Expert opinion: A recent work suggests that pro-fibrogenic cytokines, IL-17, might be important player of liver damage and even in regulation of obesity, diabetes, and non-alcoholic fatty liver disease (NAFLD) pathogenesis. Choosing to interfere with IL-23/Il-17 axis, definitely, is like acting against psoriatic march and in a parallel way against its comorbidities.


Assuntos
Anticorpos Monoclonais/administração & dosagem , Fármacos Dermatológicos/administração & dosagem , Psoríase/tratamento farmacológico , Animais , Anticorpos Monoclonais/efeitos adversos , Anticorpos Monoclonais/imunologia , Produtos Biológicos/administração & dosagem , Produtos Biológicos/efeitos adversos , Produtos Biológicos/imunologia , Fármacos Dermatológicos/efeitos adversos , Fármacos Dermatológicos/imunologia , Humanos , Interleucina-12/imunologia , Interleucina-17/imunologia , Interleucina-23/imunologia , Psoríase/imunologia , Psoríase/patologia , Índice de Gravidade de Doença
12.
Ars pharm ; 60(3): 185-192, jul.-sept. 2019. tab, ilus
Artigo em Inglês | IBECS | ID: ibc-186764

RESUMO

Objective: Carry out a bibliographical survey about the use of nanoparticles in the delivery of natural products for the treatment of lung cancer. Methods: A bibliographic review was made using the descriptors "Nanoparticles", "Biological Products" and "Lung Neoplasms", through the databases ScienceDirect, PubMed and SciELO, in the period from 2009 to 2018. Results: After analyzing the articles according to the inclusion criteria, we obtained 31 articles, of which 25.81% refer to natural products in the treatment of lung cancer, 29.03% to nanoparticles in the treatment of lung cancer and 45.16 % to nanoparticles as carriers of natural products for the treatment of lung cancer. Conclusion: The use of nanoparticles allows the delivery of natural products, increasing their therapeutic properties against lung cancer cells, and decreasing the side effects of these highly toxic agents


Objetivo: Realizar un estudio bibliográfico sobre el uso de nanopartículas en el transporte de productos naturales para el tratamiento del cáncer de pulmón. Métodos: Se realizó una revisión bibliográfica utilizando los descriptores "Nanoparticles", "Biological Products" y "Lung Neoplasms", a través de las bases de datos ScienceDirect, PubMed y SciELO, en el período comprendido entre 2009 y 2018. Resultados: Después del análisis de los artículos de acuerdo con los criterios de inclusión, obtuvimos 31 artículos, de los cuales 25.81% hacían referencia a productos naturales en el tratamiento del cáncer de pulmón, el 29.03% a nanopartículas en el tratamiento del cáncer de pulmón y un 45.16 % a nanopartículas como agentes transportadores de productos naturales para el tratamiento del cáncer de pulmón. Conclusión: El uso de nanopartículas permite el transporte de productos naturales, aumentando sus propiedades terapéuticas contra las células de cáncer de pulmón, además de disminuir los efectos secundarios de estos agentes altamente tóxicos


Assuntos
Humanos , Nanopartículas/administração & dosagem , Neoplasias Pulmonares/tratamento farmacológico , Produtos Biológicos/administração & dosagem , Antineoplásicos Fitogênicos/administração & dosagem
13.
Am J Health Syst Pharm ; 76(17): 1296-1304, 2019 Sep 01.
Artigo em Inglês | MEDLINE | ID: mdl-31418790

RESUMO

PURPOSE: The development of a tool to measure medication safety, therapeutic efficacy, and other quality outcomes in patients receiving self-injectable biologic therapy for the management of inflammatory bowel disease (IBD) at a health-system specialty pharmacy is described. SUMMARY: Through a collaborative initiative by pharmacists, gastro-enterologists, and representatives of a pharmacy benefit manager and a pharmaceutical company, a set of clinical and specialty pharmacy quality measures was developed. The clinical measures are intended for use in assessing patient safety, disease status, treatment efficacy, and healthcare resource utilization during 3 assessments (pre-treatment, on-treatment, and longitudinal). The specialty pharmacy measures can be used to assess medication adherence, medication persistence, specialty pharmacy accreditation, and patient satisfaction. The proposed quality measures provide a foundation for evaluating the quality of IBD care and improving patient outcomes within a health-system specialty pharmacy. Future efforts to validate and implement the tool in clinical practice are planned. CONCLUSION: The proposed quality measures provide a foundation for future inquiry regarding the appropriateness and feasibility of integrating the measures into clinical care. Further work is needed to implement and validate these quality measures and determine their impact in optimizing health outcomes.


Assuntos
Produtos Biológicos/administração & dosagem , Doenças Inflamatórias Intestinais/tratamento farmacológico , Serviço de Farmácia Hospitalar/organização & administração , Autoadministração/normas , Terapia Biológica/métodos , Terapia Biológica/normas , Comportamento Cooperativo , Indústria Farmacêutica/organização & administração , Gastroenterologistas/organização & administração , Humanos , Farmacêuticos/organização & administração
14.
EBioMedicine ; 47: 89-97, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31409575

RESUMO

BACKGROUND: Talimogene laherparepvec (T-VEC) is an intralesionally delivered, modified herpes simplex virus type-1 oncolytic immunotherapy. The biodistribution, shedding, and potential transmission of T-VEC was systematically evaluated during and after completion of therapy in adults with advanced melanoma. METHODS: In this phase 2, single-arm, open-label study, T-VEC was administered into injectable lesions initially at 106 plaque-forming units (PFU)/mL, 108 PFU/mL 21 days later, and 108 PFU/mL every 14 (±3) days thereafter. Injected lesions were covered with occlusive dressings for ≥1 week. Blood, urine, and swabs from exterior of occlusive dressings, surface of injected lesions, oral mucosa, anogenital area, and suspected herpetic lesions were collected throughout the study. Detectable T-VEC DNA was determined for each sample type; infectivity was determined for all swabs with detectable T-VEC DNA. FINDINGS: Sixty patients received ≥1 dose of T-VEC. During cycles 1-4, T-VEC DNA was detected in blood (98·3% of patients, 36·7% of samples), urine (31·7% of patients, 3·0% of samples) and swabs from injected lesions (100% of patients, 57·6% of samples), exterior of dressings (80% of patients,19·5% of samples), oral mucosa (8·3% of patients, 2·5% of samples), and anogenital area (8·0% of patients, 1·1% of samples). During the safety follow-up period, T-VEC DNA was only detected on swabs from injected lesions (14% of patients, 5.8% of samples). T-VEC DNA was detected in 4/37 swabs (3/19 patients) of suspected herpetic lesions. Among all samples, only those from the surface of injected lesions tested positive for infectivity (8/740 [1·1%]). Three close contacts reported signs and symptoms of suspected herpetic origin; however, no lesions had detectable T-VEC DNA. INTERPRETATION: Using current guidelines, T-VEC can be administered safely to patients with advanced melanoma and is unlikely to be transmitted to close contacts with appropriate use of occlusive dressings. FUND: This study was funded by Amgen Inc.: ClinicalTrials.gov, NCT02014441.


Assuntos
Produtos Biológicos/uso terapêutico , Melanoma/terapia , Terapia Viral Oncolítica , Vírus Oncolíticos , Adulto , Idoso , Idoso de 80 Anos ou mais , Produtos Biológicos/administração & dosagem , Produtos Biológicos/efeitos adversos , Produtos Biológicos/farmacocinética , DNA Viral , Esquema de Medicação , Herpesvirus Humano 1 , Humanos , Melanoma/diagnóstico , Melanoma/etiologia , Pessoa de Meia-Idade , Imagem Multimodal/métodos , Estadiamento de Neoplasias , Terapia Viral Oncolítica/efeitos adversos , Terapia Viral Oncolítica/métodos , Vírus Oncolíticos/genética , Distribuição Tecidual , Resultado do Tratamento , Adulto Jovem
15.
World J Gastroenterol ; 25(30): 4158-4171, 2019 Aug 14.
Artigo em Inglês | MEDLINE | ID: mdl-31435170

RESUMO

High-quality data remains scarce in terms of optimal management strategies in the elderly inflammatory bowel disease (IBD) population. Indeed, available trials have been mostly retrospective, of small sample size, likely owing to under-representation of such a population in the major randomized controlled trials. However, in the last five years, there has been a steady increase in the number of published trials, helping clarify the estimated benefits and toxicity of the existing IBD armamentarium. In the Everhov trial, prescription strategies were recorded over an average follow-up of 4.2 years. A minority of elderly IBD patients (1%-3%) were treated with biologics within the five years following diagnosis, whilst almost a quarter of these patients were receiving corticosteroid therapy at year five of follow-up, despite its multiple toxicities. The low use of biologic agents in real-life settings likely stems from limited data suggesting lower efficacy and higher toxicity. This minireview will aim to highlight current outcome measurements as it portends the elderly IBD patient, as well as summarize the available therapeutic strategies in view of a growing body of evidence.


Assuntos
Anti-Inflamatórios/administração & dosagem , Colite Ulcerativa/terapia , Doença de Crohn/terapia , Proctocolectomia Restauradora/normas , Fatores Etários , Idoso , Anti-Inflamatórios/efeitos adversos , Produtos Biológicos/administração & dosagem , Produtos Biológicos/efeitos adversos , Ensaios Clínicos como Assunto , Colite Ulcerativa/epidemiologia , Comorbidade , Doença de Crohn/epidemiologia , Uso de Medicamentos/estatística & dados numéricos , Medicina Baseada em Evidências/métodos , Medicina Baseada em Evidências/normas , Medicina Baseada em Evidências/estatística & dados numéricos , Gastroenterologia/métodos , Gastroenterologia/normas , Gastroenterologia/estatística & dados numéricos , Glucocorticoides/administração & dosagem , Glucocorticoides/efeitos adversos , Humanos , Seleção de Pacientes , Guias de Prática Clínica como Assunto , Prevalência , Proctocolectomia Restauradora/efeitos adversos , Proctocolectomia Restauradora/estatística & dados numéricos , Resultado do Tratamento
16.
Br J Hosp Med (Lond) ; 80(8): 448-455, 2019 Aug 02.
Artigo em Inglês | MEDLINE | ID: mdl-31437052

RESUMO

Giant cell arteritis has been widely studied throughout the world. Involvement of cranial vessels can lead to visual loss and strokes. This review primarily focusses on the presentation, diagnosis and treatment. The last 10 years have brought dramatic improvements in the imaging and medical therapies for this condition. After the American College of Rheumatology suggested criteria for the diagnosis of giant cell arteritis, many studies have been performed to find alternatives to a temporal artery biopsy. There is growing evidence that a biopsy may not be needed when one can make a convincing clinical and radiological diagnosis. Although glucocorticoids are the mainstay of treatment and their role has not changed, various biological and non-biological therapies are being used to reduce relapses and prolong remission of symptoms.


Assuntos
Produtos Biológicos/administração & dosagem , Arterite de Células Gigantes/diagnóstico por imagem , Arterite de Células Gigantes/tratamento farmacológico , Glucocorticoides/administração & dosagem , Angiografia por Ressonância Magnética/métodos , Idoso , Biópsia por Agulha , Gerenciamento Clínico , Feminino , Previsões , Arterite de Células Gigantes/patologia , Humanos , Imuno-Histoquímica , Masculino , Pessoa de Meia-Idade , Índice de Gravidade de Doença
17.
Lancet ; 394(10201): 831-839, 2019 09 07.
Artigo em Inglês | MEDLINE | ID: mdl-31402114

RESUMO

BACKGROUND: Antibodies targeting interleukin (IL)-23 and IL-17A effectively treat moderate-to-severe psoriasis. ECLIPSE is the first comparator study of an IL-23p19 inhibitor, guselkumab, versus an IL-17A inhibitor, secukinumab. The primary objective of this study was to show superiority of clinical response at week 48 for guselkumab versus secukinumab. METHODS: In this phase 3, multicentre, double-blind, randomised, comparator-controlled trial at 142 outpatient clinical sites in nine countries (Australia, Canada, Czech Republic, France, Germany, Hungary, Poland, Spain, and the USA), eligible patients were aged 18 years or older, had moderate-to-severe plaque-type psoriasis, and were candidates for phototherapy or systemic therapy. Eligible patients were randomly assigned with permuted block randomisation using an interactive web response system to receive either guselkumab (100 mg at weeks 0 and 4 then every 8 weeks) or secukinumab (300 mg at weeks 0, 1, 2, 3, and 4, and then every 4 weeks). The primary endpoint, the proportion of patients in the intention-to-treat population who achieved 90% reduction or more from baseline of Psoriasis Area and Severity Index (PASI 90 response) at week 48, and major secondary endpoints (the proportions of patients in the guselkumab group and in the secukinumab group who achieved a PASI 75 response at both weeks 12 and 48, a PASI 90 response at week 12, a PASI 75 response at week 12, a PASI 100 response at week 48, an Investigator's Global Assessment [IGA] score of 0 [cleared] at week 48, and an IGA score of 0 or 1 [minimal] at week 48) were to be tested in a fixed sequence to control type I error rate. Safety was evaluated in patients who received one or more doses of study drug from week 0 to 56. The study is registered with ClinicalTrials.gov, NCT03090100. FINDINGS: This study was done between April 27, 2017, and Sept 20, 2018. 1048 eligible patients were enrolled and, of these, 534 were assigned to receive guselkumab and 514 to receive secukinumab. The proportion of patients with a PASI 90 response at week 48 was greater in the guselkumab group (451 [84%]) than in the secukinumab group (360 [70%]; p<0·0001). Although non-inferiority (margin of 10 percentage points) was established for the first major secondary endpoint (452 [85%] of patients in the guselkumab group vs 412 [80%] of patients in the secukinumab group achieving a PASI 75 response at both weeks 12 and 48), superiority was not established (p=0·0616). Consequently, formal statistical testing was not done for subsequent major secondary endpoints. Proportions of patients with adverse events, infections, and serious adverse events were similar between the two treatments and, in general, safety findings were consistent with registrational trial observations. INTERPRETATION: Guselkumab showed superior long-term efficacy based on PASI 90 at week 48 when compared with secukinumab for treating moderate-to-severe psoriasis. This finding could assist health-care providers in their decision making process when selecting a biologic for treating moderate-to-severe psoriasis. FUNDING: This study was funded by Janssen Research & Development.


Assuntos
Anticorpos Monoclonais/uso terapêutico , Produtos Biológicos/uso terapêutico , Psoríase/tratamento farmacológico , Adulto , Anticorpos Monoclonais/administração & dosagem , Anticorpos Monoclonais Humanizados , Produtos Biológicos/administração & dosagem , Método Duplo-Cego , Feminino , Humanos , Interleucina-17/antagonistas & inibidores , Subunidade p19 da Interleucina-23/antagonistas & inibidores , Masculino , Pessoa de Meia-Idade , Índice de Gravidade de Doença , Resultado do Tratamento
18.
Biologicals ; 61: 52-54, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31327630

RESUMO

The aim of this study was to determine the proportion of biological prescriptions over time. This study is based on data from IMS® Diagnosis Monitor and included patients who had received a biological drug in dermatology practices due to psoriasis (PSO), gastroenterology practices due to Crohn's disease (CD) or ulcerative colitis (UC), or rheumatology practices due to rheumatoid arthritis (RA) between April 2015 and December 2018. We analyzed 1,748,948 CD/UC-related prescriptions, 3,968,879 RA-related prescriptions, and 7,321,496 PSO-related prescriptions. Of these, 343,263 (19.6%) prescriptions for IBD, 92,343 (16.2%) prescriptions for RA, and 169,573 (6.9%) prescriptions for PSO were for biologicals. The proportion of biologicals has increased continuously over 4 years, namely from 16.3% to 21.3% (p < 0.01) for CD/UC treatment prescribed by gastroenterologists, from 12.4% to 16.0% (p < 0.01) for RA treatment prescribed by rheumatologists, and from 3.2% to 7.7% (p < 0.01) for PSO treatment prescribed by dermatologists. The proportions of biological therapies and their increase over time were age- and sex-dependent. In summary, we were able to show a significant increase in the proportion of biologicals used to treat CD/UC, RA, and PSO over the last four years.


Assuntos
Artrite Reumatoide , Produtos Biológicos/administração & dosagem , Colite Ulcerativa , Doença de Crohn , Bases de Dados Factuais , Prescrições , Psoríase , Adulto , Artrite Reumatoide/tratamento farmacológico , Artrite Reumatoide/epidemiologia , Colite Ulcerativa/tratamento farmacológico , Colite Ulcerativa/epidemiologia , Doença de Crohn/tratamento farmacológico , Doença de Crohn/epidemiologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Prevalência , Psoríase/tratamento farmacológico , Psoríase/epidemiologia
19.
Surg Today ; 49(12): 1066-1073, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31309329

RESUMO

PURPOSE: We evaluated the recent incidence of surgery and the changing surgery trends for ulcerative colitis (UC) in Japan due to the increasing use of anti-tumor necrosis factor (TNF) agents. METHODS: A questionnaire survey was performed to assess the number of surgeries, surgical indications, surgical timing, and immunosuppressive treatments before surgery between 2007 and 2017. RESULTS: A total of 3801 surgical cases were reported over 11 years. The prevalence of UC surgery decreased over the period studied. The rate of prednisolone (PSL) use did not change. The prevalence of both calcineurin inhibitors (CNIs) and anti-TNF agents increased during the period studied (p < 0.01). The prevalence of urgent/emergent surgery did not change. The most distinctive change in surgical indications was the increase in cancer/dysplasia (CAC), the prevalence of which increased from 20.2% in 2007 to 34.8%. CONCLUSION: The prevalence of UC surgery seems to be decreasing according to the increasing rate of anti-TNF agent and CNI administration. However, the indication of CAC significantly increased. Further research should evaluate whether or not long-term remission maintained with several agents can lead to increasing CAC.


Assuntos
Produtos Biológicos/administração & dosagem , Inibidores de Calcineurina/administração & dosagem , Colectomia/estatística & dados numéricos , Colectomia/tendências , Colite Ulcerativa/cirurgia , Uso de Medicamentos/estatística & dados numéricos , Fator de Necrose Tumoral alfa/antagonistas & inibidores , Estudos de Coortes , Colite Ulcerativa/epidemiologia , Humanos , Japão/epidemiologia , Prevalência , Indução de Remissão , Inquéritos e Questionários , Fatores de Tempo
20.
Immunol Med ; 42(2): 84-93, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31318324

RESUMO

Atopic dermatitis (AD) is the most common inflammatory skin disease driven by both terminal keratinocyte differentiation defects and type 2 immune responses, and this condition causes psychological and social morbidity. Although patients with severe AD require systemic immunotherapy, conventional agents including ciclosporin could not be used for several years due to side effects such as nephrotoxicity, hypertension and long-term risks of malignancy. It is well known that dupilumab, which blocks receptor binding of both IL-4 and IL-13, is remarkably efficacious in the treatment of AD. We have entered a new era when many novel topical and systemic agents that may have great potential in AD treatment are emerging through clinical trials. The purpose of this article is to summarize the efficacy and safety of the current topical and systemic therapies in AD by reviewing recently published papers regarding phase II/III clinical trials. It is revealed that topical phosphodiesterase 4 inhibitors and Janus kinase (JAK) inhibitors are promising treatments for AD. Moreover, systemic therapies such as biologics targeting IL-13 and oral JAK inhibitors show strong efficacy in AD.


Assuntos
Dermatite Atópica/tratamento farmacológico , Inibidores de Janus Quinases/administração & dosagem , Inibidores da Fosfodiesterase 4/administração & dosagem , Acrilamidas/administração & dosagem , Administração Tópica , Anticorpos Monoclonais Humanizados/administração & dosagem , Produtos Biológicos/administração & dosagem , Compostos de Boro/administração & dosagem , Compostos Bicíclicos Heterocíclicos com Pontes/administração & dosagem , Dermatite Atópica/etiologia , Dermatite Atópica/imunologia , Humanos , Imunoterapia , Interleucina-13 , Terapia de Alvo Molecular , Piperidinas/administração & dosagem , Piridinas/administração & dosagem , Pirimidinas/administração & dosagem , Pirróis/administração & dosagem , Resorcinóis/administração & dosagem , Estilbenos/administração & dosagem , Canais de Cátion TRPV/antagonistas & inibidores
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