adalimumab

阿达木单抗
  • 文章类型: Journal Article
    背景:对于需要接受非活疫苗或活疫苗的银屑病患者,对于是否暂停或继续进行银屑病和/或银屑病关节炎的全身治疗,我们需要提供循证建议.
    目的:评估有关疫苗效力和安全性的文献,并为接受非活疫苗或活疫苗的银屑病和/或银屑病关节炎全身治疗的成人提供基于共识的建议。
    方法:使用修改后的Delphi过程,国家银屑病基金会医学委员会和COVID-19工作组制定了22项共识声明,和传染病专家。
    结果:主要建议包括对接受非活疫苗的患者继续进行大多数口服和生物治疗而不进行修改;考虑对非活疫苗停止甲氨蝶呤治疗。对于接受活疫苗的患者,在活疫苗给药之前和之后停止大多数口服和生物药物治疗.具体建议包括停止大多数生物疗法,除了Abatacept,活疫苗给药前2-3个半衰期,并在活疫苗接种后2-4周推迟下一剂量。
    结论:缺乏关于疫苗接种后感染率的研究。
    结论:接受非活疫苗的患者通常不需要中断抗银屑病口服和生物治疗。在大多数情况下,建议在施用活疫苗之前和之后暂时中断口服和生物治疗。
    BACKGROUND: For psoriatic patients who need to receive nonlive or live vaccines, evidence-based recommendations are needed regarding whether to pause or continue systemic therapies for psoriasis and/or psoriatic arthritis.
    OBJECTIVE: To evaluate literature regarding vaccine efficacy and safety and to generate consensus-based recommendations for adults receiving systemic therapies for psoriasis and/or psoriatic arthritis receiving nonlive or live vaccines.
    METHODS: Using a modified Delphi process, 22 consensus statements were developed by the National Psoriasis Foundation Medical Board and COVID-19 Task Force, and infectious disease experts.
    RESULTS: Key recommendations include continuing most oral and biologic therapies without modification for patients receiving nonlive vaccines; consider interruption of methotrexate for nonlive vaccines. For patients receiving live vaccines, discontinue most oral and biologic medications before and after administration of live vaccine. Specific recommendations include discontinuing most biologic therapies, except for abatacept, for 2-3 half-lives before live vaccine administration and deferring next dose 2-4 weeks after live vaccination.
    CONCLUSIONS: Studies regarding infection rates after vaccination are lacking.
    CONCLUSIONS: Interruption of antipsoriatic oral and biologic therapies is generally not necessary for patients receiving nonlive vaccines. Temporary interruption of oral and biologic therapies before and after administration of live vaccines is recommended in most cases.
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  • 文章类型: Systematic Review
    为了促进将眼部护理纳入全民健康覆盖,世卫组织正在制定一套眼部护理干预措施(PECI)。PECI的开发涉及从相关的葡萄膜炎临床实践指南(CPG)中确定基于证据的干预措施。对2010年至2020年3月期间发表的葡萄膜炎的CPGs进行了系统评价。通过标题和摘要以及全文筛选的CPG使用评估指南II(AGREEII)工具进行评估,并使用标准数据提取表提取有关推荐干预措施的数据。在从系统文献检索中确定为潜在相关的56个CPG中,在筛选阶段和使用AGREEII工具进行评估之后,对3个CPG进行了数据提取。这些CPG涵盖了筛查,监测和治疗幼年特发性关节炎(JIA)相关葡萄膜炎,使用阿达木单抗和地塞米松治疗非感染性葡萄膜炎,和最高水平的评估总结,葡萄膜炎的鉴别诊断和转诊建议,针对初级保健医生。许多建议是根据专家意见提出的,尽管一些纳入临床研究和随机对照试验数据。目前,CPG中葡萄膜炎引起的疾病谱覆盖很少。这可能部分是由于广泛的病因和临床表现涵盖了广泛的葡萄膜炎,这使得许多准则是必要的。可供选择的CPG有限,这对临床医生寻求葡萄膜炎临床护理策略的指导具有重要意义。
    To facilitate the integration of eye care into universal health coverage, the WHO is developing a Package of Eye Care Interventions (PECI). Development of the PECI involves the identification of evidence-based interventions from relevant clinical practice guidelines (CPGs) for uveitis.A systematic review of CPGs published on uveitis between 2010 and March 2020 was conducted. CPGs passing title and abstract and full-text screening were evaluated using the Appraisal of Guidelines for Research and Evaluation II (AGREE II) tool and data on recommended interventions extracted using a standard data extraction sheet.Of 56 CPGs identified as potentially relevant from the systematic literature search, 3 CPGs underwent data extraction following the screening stages and appraisal with the AGREE II tool. These CPGs covered screening for, monitoring and treating juvenile idiopathic arthritis (JIA)-associated uveitis, the use of adalimumab and dexamethasone in treating non-infectious uveitis, and a top-level summary of assessment, differential diagnosis and referral recommendations for uveitis, aimed at primary care practitioners. Many of the recommendations were based on expert opinion, though some incorporated clinical study and randomised controlled trial data.There is currently sparse coverage of the spectrum of disease caused by uveitis within CPGs. This may partially be due to the large number of conditions with diverse causes and clinical presentations covered by the umbrella term uveitis, which makes numerous sets of guidelines necessary. The limited pool of CPGs to select from has implications for clinicians seeking guidance on clinical care strategies for uveitis.
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  • 文章类型: Journal Article
    背景:自从我们上一次发表克罗恩病患者肛周瘘的治疗算法以来,研究人员提出了一种针对肛门病变的靶向策略系统组合疗法,和干细胞注射的适应症。在没有强大出版物的情况下,法国国家学会(法国国家学会[SNFCP])希望使用Delphi方法建立小组共识。
    方法:从2020年10月到2021年1月,一个科学委员会和胃肠病学家和外科医生小组建立了答案,并在2020年11月的一次全国会议上提交给SNFCP成员。对三个问题进行了澄清和重新表述,然后在SNFCP成员的第三轮也是最后一轮磋商中提交。
    结果:目标定义为在每个领域获得的反应(症状,物理和放射学评估)可以被认为是令人满意的,不需要加强治疗管理。通过协商一致,临床评价治疗疗效所需的时间为6个月.对磁共振成像(MRI)的反应应包括在6个月时没有10毫米或更大尺寸的集合,在12个月时,主束的T1和T2序列中的高强度明显减少或完全消失。免疫抑制剂与肿瘤坏死因子抑制剂的系统关联未达到阿达木单抗的共识水平(50%),但只是英夫利昔单抗(70%)。大多数受访者认为一个人失败了,甚至两行不同的生物疗法是注射干细胞的潜在适应症。
    结论:这些发现加强了包括MRI评估在内的复合目标的重要性,并强调需要精确的评估时间。仅建议使用英夫利昔单抗进行联合治疗。注射干细胞是二线或三线选择。
    BACKGROUND: Since our last publication of algorithms for the management of perianal fistulas in patients with Crohn\'s disease, researchers have proposed a treat to target strategy systematic combotherapy for anal lesions, and indications for stem cell injection. In the absence robust publications, the Société Nationale Française de Coloproctologie (French National Society of Coloproctology [SNFCP]) wished to establish a group consensus using the Delphi method.
    METHODS: From October 2020 to January 2021, a scientific committee and panel of gastroenterologists and surgeons established answers which were submitted to the members of the SNFCP during a national conference in November 2020. Three questions were clarified and reformulated, and then submitted during a third and final round of consultation of members of the SNFCP.
    RESULTS: The target was defined as being the response obtained in every domain (symptoms, physical and radiological evaluation) which could be considered satisfactory, without the need to intensify therapeutic management. By consensus, the time required for clinical evaluation of the efficacy of treatment was 6 months. A response on magnetic resonance imaging (MRI) should include the absence of a collection of 10 mm or more in size at 6 months, and a frank decrease or complete disappearance of hyperintensity in T1 and T2 sequences of the main tract at 12 months. Systematic association of an immunosuppressant with tumor necrosis factor inhibitors did not reach the consensus level for adalimumab (50%), but just did for infliximab (70%). The majority of the respondents considered failure of one, or even two lines of different biotherapies to be potential indications for injection of stem cells.
    CONCLUSIONS: These findings reinforce the importance of composite targets including MRI evaluation, and underscore the need for precise timing of evaluation. Combotherapy is only recommended with infliximab. Injection of stem cells is a second- or third-line option.
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  • 文章类型: Journal Article
    溃疡性结肠炎(US)是一种病因不明的慢性疾病。它是无法治愈的,它的临床过程是间歇性的,以缓解和复发为特征。该疾病的患病率和发病率在世界范围内一直在增加。本文提供的更新包括医疗保健专业人员的参与,决策者,和患者的代表,所有这些人都宣布了他们的利益冲突。制定了可回答的临床问题,并对结果进行分级。信息搜索是在Medline/PubMed上进行的,Embase,认识论,和LILACS数据库,并涵盖了灰色文献来源,也是。该搜索于2020年11月30日更新,没有日期或语言限制。建议评估的分级,实施了开发和评估(GRADE)分类系统,以建立推荐强度和证据质量。达成了正式共识,基于兰德/加州大学洛杉矶分校的方法,该文件经过同行评审。本文介绍了成人人群溃疡性结肠炎治疗临床实践指南的简短版本,以及支持证据和各自的建议。在轻度至中度UC中,当5-ASA治疗失败时,布地奈德MMX是一种选择,在使用全身性类固醇之前。在中度至重度UC中,英夫利昔单抗,阿达木单抗,维多珠单抗,ustekinumab,托法替尼可以作为一线治疗。如果抗TNF治疗失败,ustekinumab和tofacitinib提供了最好的结果。在抗生素难治性囊炎患者中,抗TNF是首选的治疗方法。
    Ulcerative colitis (US) is a chronic disease of unknown etiology. It is incurable and its clinical course is intermittent, characterized by periods of remission and relapse. The prevalence and incidence of the disease has been increasing worldwide. The update presented herein includes the participation of healthcare professionals, decision-makers, and a representative of the patients, all of whom declared their conflicts of interest. Answerable clinical questions were formulated, and the outcomes were graded. The information search was conducted on the Medline/PubMed, Embase, Epistemonikos, and LILACS databases, and covered grey literature sources, as well. The search was updated on November 30, 2020, with no restrictions regarding date or language. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) classification system was implemented to establish the strength of the recommendation and quality of evidence. A formal consensus was developed, based on the RAND/UCLA methodology and the document was peer reviewed. The short version of the Clinical Practice Guidelines for the Treatment of Ulcerative Colitis in the Adult Population is presented herein, together with the supporting evidence and respective recommendations. In mild-to-moderate UC, budesonide MMX is an option when treatment with 5-ASA fails, and before using systemic steroids. In moderate-to-severe UC, infliximab, adalimumab, vedolizumab, ustekinumab, and tofacitinib can be used as first-line therapy. If there is anti-TNF therapy failure, ustekinumab and tofacitinib provide the best results. In patients with antibiotic-refractory pouchitis, anti-TNFs are the treatment of choice.
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  • 文章类型: Practice Guideline
    在过去的15年中,由于监管机构批准了几种新药,中度至重度溃疡性结肠炎的管理发生了重大变化。特别是,在第一个生物批准后,即英夫利昔单抗,一些进一步的生物药物,比如阿达木单抗,戈利木单抗,维多珠单抗和ustekinumab,和小分子,如托法替尼,已被批准,从而丰富了溃疡性结肠炎的治疗性医疗设备。治疗的选择必须考虑到不仅需要诱导和维持疾病缓解根据患者的概况,还有年龄,合并症,和先前的治疗。为了指导这些决定,意大利炎症性肠病研究小组制定了临床指南,取代了2011年之前的文件.这些新的指南是根据GRADE方法制定的,用于对证据质量进行评级并确定建议的强度。本文介绍了方法和结果,以20份声明的形式,对使用五种生物制剂和托法替尼治疗活动性溃疡性结肠炎的肠道表现和维持缓解进行了评论。单独的技术审查报告了对本建议所依据的证据的分析。
    The management of moderate to severe ulcerative colitis has undergone significant changes over the past 15 years due to the regulatory approval of several new drugs. In particular, following the approval of the first biological, i.e. infliximab, a number of further biological drugs, such as adalimumab, golimumab, vedolizumab and ustekinumab, and small molecules, such as tofacitinib, have been approved, thus enriching the therapeutic armamentarium for ulcerative colitis. Choice of therapy must take into consideration not only the need to induce and maintain disease remission according to the patient\'s profile, but also age, co-morbidities, and prior treatments. To guide these decisions, the Italian Group for the Study of Inflammatory Bowel Disease has developed clinical guidelines that supersede its earlier document from 2011. These new guidelines were developed following the GRADE methodology for rating the quality of the evidence and for determining the strength of the recommendations. This article presents the methodology and results, in the form of 20 statements with commentary on the use of the five biologics and tofacitinib for managing the intestinal manifestations of active ulcerative colitis and for maintaining remission. A separate technical review reports the analyses of the evidence upon which the present recommendations are based.
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  • 文章类型: Journal Article
    This evidence- and consensus-based guideline on the treatment of psoriasis vulgaris was developed following the EuroGuiDerm Guideline and Consensus Statement Development Manual. The first part of the guideline includes general information on the scope and purpose, health questions covered, target users and strength/limitations of the guideline. Suggestions for disease severity grading and treatment goals are provided. It presents the general treatment recommendations as well as detailed management and monitoring recommendations for the individual drugs. The treatment options discussed in this guideline are as follows: acitretin, ciclosporin, fumarates, methotrexate, adalimumab, apremilast, brodalumab, certolizumab pegol, etanercept, guselkumab, infliximab, ixekizumab, risankizumab, secukinumab, tildrakizumab and ustekinumab.
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  • 文章类型: Journal Article
    溃疡性结肠炎和克罗恩病是以胃肠道慢性缓解性炎症为特征的炎症性肠病的主要实体。发病率和患病率在全球范围内呈上升趋势,随着时间的推移,患者之间和个体内部的异质性是惊人的。我们对病因认识的进步以及治疗选择的空前增加,已经改变了临床医生对患者进行循证干预的管理。本指南受到阿联酋胃肠病学和肝病学会的鼓励和支持,经过系统评价和Delphi共识过程,提供了基于证据和专家意见的建议。提供有关诊断的全面最新指导,疾病严重程度的评估,适当和及时地使用不同的调查,根据疾病严重程度选择适当的诱导和缓解期治疗,以及主要并发症的处理。
    Ulcerative colitis and Crohn\'s disease are the main entities of inflammatory bowel disease characterized by chronic remittent inflammation of the gastrointestinal tract. The incidence and prevalence are on the rise worldwide, and the heterogeneity between patients and within individuals over time is striking. The progressive advance in our understanding of the etiopathogenesis coupled with an unprecedented increase in therapeutic options have changed the management towards evidence-based interventions by clinicians with patients. This guideline was stimulated and supported by the Emirates Gastroenterology and Hepatology Society following a systematic review and a Delphi consensus process that provided evidence- and expert opinion-based recommendations. Comprehensive up-to-date guidance is provided regarding diagnosis, evaluation of disease severity, appropriate and timely use of different investigations, choice of appropriate therapy for induction and remission phase according to disease severity, and management of main complications.
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  • 文章类型: Journal Article
    治疗药物监测(TDM)是测量个体中的药物和抗药物抗体浓度以指导治疗决策。在克罗恩病(CD)患者中,TDM,反应性或主动使用,正在成为优化肿瘤坏死因子(TNF)拮抗剂治疗的有价值的工具。反应性TDM是针对治疗失败而进行的,而主动TDM涉及对TNF拮抗剂治疗的患者的定期监测,以优化治疗.在CD患者中,TDM的大多数可用数据与首次上市的TNF拮抗剂英夫利昔单抗有关,在较小程度上,阿达木单抗和塞妥珠单抗。几个胃肠病学协会,包括美国胃肠病学协会,已批准在活动性CD患者中使用反应性TDM。然而,目前使用主动TDM的建议较少,尽管已经发表了几项新的评估前瞻性TDM策略的前瞻性随机对照试验.在这次审查中,讨论了反应性和主动性TDM的当前证据,并提出了一种基于先前发表的阈值浓度的塞托珠单抗pegol的主动治疗算法。
    Therapeutic drug monitoring (TDM) is the measurement of drug and antidrug antibody concentrations in individuals to guide treatment decisions. In patients with Crohn disease (CD), TDM, used either reactively or proactively, is emerging as a valuable tool for optimization of tumor necrosis factor (TNF) antagonist therapy. Reactive TDM is carried out in response to treatment failure, whereas proactive TDM involves the periodic monitoring of patients responding to TNF antagonist therapy to allow treatment optimization. In patients with CD, most of the available data for TDM relate to the first-to-market TNF antagonist infliximab and, to a lesser extent, to adalimumab and certolizumab pegol. Several gastroenterology associations, including the American Gastroenterology Association, have endorsed the use of reactive TDM in patients with active CD. However, fewer recommendations currently exist for the use of proactive TDM, although several new prospective randomized controlled trials evaluating proactive TDM strategies have been published. In this review, the current evidence for reactive and proactive TDM is discussed, and a proactive treatment algorithm for certolizumab pegol based on previously published threshold concentrations is proposed.
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  • 文章类型: Journal Article
    背景:化脓性汗腺炎(HS)是一种慢性疼痛性皮肤病,严重损害患者的生活质量。虽然HS疗法的高质量试验仍然有限,最佳治疗实践的医学知识正在迅速发展,导致最近发布了多项国际HS治疗指南。
    结论:本综述比较了国际HS治疗指南,描述了常见和新兴HS疗法有效性的证据,并为将循证HS护理纳入实践提供指导。尽管国际HS指南中提到了50多种医疗和程序治疗,在所有主要指南中,只有阿达木单抗和英夫利昔单抗具有B级/弱推荐或更高.这篇综述描述了最常用的HS医学和程序治疗的适当患者选择和有效性。它还包括咨询建议,给药,和医学治疗的持续时间以及执业皮肤科医生的程序视频。
    BACKGROUND: Hidradenitis suppurativa (HS) is a chronic painful skin disease that severely impairs patients\' quality of life. While high-quality trials of HS therapies remain limited, medical knowledge of best treatment practices is rapidly evolving, leading to the recent publication of multiple international treatment guidelines for HS.
    CONCLUSIONS: This review compares international HS treatment guidelines, describes evidence for effectiveness of common and emerging HS therapies, and provides guidance for integrating evidence-based HS care into practice. Although over 50 medical and procedural treatments are mentioned across international HS guidelines, only adalimumab and infliximab have grade B/weak recommendation or higher across all major guidelines. This review describes the appropriate patient selection and effectiveness of the most commonly used medical and procedural treatments for HS. It also includes recommendations for counseling, dosing, and duration of medical therapies as well as procedure videos for the practicing dermatologist.
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  • 文章类型: Journal Article
    溃疡性结肠炎和克罗恩病是炎症性肠病的主要形式。两者都代表胃肠道的慢性炎症,随着时间的推移,患者之间和个体内部的炎症和症状负担表现出异质性。最佳管理依赖于临床医生与患者合作理解和定制基于证据的干预措施。此16岁以上成人炎症性肠病管理指南由代表英国医生(英国胃肠病学会)的利益相关者制定,外科医生(大不列颠和爱尔兰结肠病学协会),专科护士(皇家护理学院),儿科医生(英国儿科胃肠病学会,肝病学和营养学),营养师(英国饮食协会),放射科医师(英国胃肠道和腹部放射学学会),全科医生(胃肠病学初级保健协会)和患者(克罗恩病和结肠炎英国)。对88247份出版物进行了系统审查,并进行了涉及81名多学科临床医生和患者的Delphi共识程序,以制定168项基于证据和专家意见的药理学建议。非药物和手术干预,以及在溃疡性结肠炎和克罗恩病的管理中提供最佳服务。提供了关于适应症的全面最新指导,开始和监测免疫抑制疗法,营养干预,pre,围手术期及术后管理,以及多学科团队的结构和功能以及初级和二级保健之间的整合。提出了20项研究重点,以告知未来的临床管理,在客观衡量优先重要性的同时,由2379名来自溃疡性结肠炎和克罗恩病患者的电子调查回复确定,包括患者,他们的家人和朋友。
    Ulcerative colitis and Crohn\'s disease are the principal forms of inflammatory bowel disease. Both represent chronic inflammation of the gastrointestinal tract, which displays heterogeneity in inflammatory and symptomatic burden between patients and within individuals over time. Optimal management relies on understanding and tailoring evidence-based interventions by clinicians in partnership with patients. This guideline for management of inflammatory bowel disease in adults over 16 years of age was developed by Stakeholders representing UK physicians (British Society of Gastroenterology), surgeons (Association of Coloproctology of Great Britain and Ireland), specialist nurses (Royal College of Nursing), paediatricians (British Society of Paediatric Gastroenterology, Hepatology and Nutrition), dietitians (British Dietetic Association), radiologists (British Society of Gastrointestinal and Abdominal Radiology), general practitioners (Primary Care Society for Gastroenterology) and patients (Crohn\'s and Colitis UK). A systematic review of 88 247 publications and a Delphi consensus process involving 81 multidisciplinary clinicians and patients was undertaken to develop 168 evidence- and expert opinion-based recommendations for pharmacological, non-pharmacological and surgical interventions, as well as optimal service delivery in the management of both ulcerative colitis and Crohn\'s disease. Comprehensive up-to-date guidance is provided regarding indications for, initiation and monitoring of immunosuppressive therapies, nutrition interventions, pre-, peri- and postoperative management, as well as structure and function of the multidisciplinary team and integration between primary and secondary care. Twenty research priorities to inform future clinical management are presented, alongside objective measurement of priority importance, determined by 2379 electronic survey responses from individuals living with ulcerative colitis and Crohn\'s disease, including patients, their families and friends.
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