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  药店国别: 英国药房
产地国家: 英国
所属类别: 骨科药物->关节炎
处方药:处方药
包装规格: 27片/盒
计价单位:
   
生产厂家中文参考译名:
赛尔基因
生产厂家英文名:
Celgene UK
该药品相关信息网址1:
http://www.otezla.com/
该药品相关信息网址2:
https://en.wikipedia.org/wiki/Apremilast
原产地英文商品名:
OTEZLA TABLETS 10/20/30MG STARTER PACK, 27 tablets/pack
原产地英文药品名:
Apremilast
中文参考商品译名:
Otezla 10/20/30毫克/片 精简包裝, 27片/盒
中文参考药品译名:
阿普斯特
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
Active psoriatic arthritis
临床试验期:

中文适应病症参考翻译1:
活动性银屑病关节炎
药品信息:
OTEZLA组的疾病活动性指标在第16周的改善有临床意义,最长维持至治疗第52周 三项III期PALACE研究1,493例患者数据显示,52周疗程中,OTEZLA的安全性特征一致,实验室指标未见有临床意义的改变 PALACE 1研究16周单独分析显示,OTEZLA组的工作效率高于安慰剂组 瑞士布德利 -- (美国商业资讯) -- Celgene Corporation (NASDAQ:CELG)的全资子公司Celgene International Sàrl今天发布了该公司的磷酸二酯酶4 (PDE4)选择性抑制剂口服制剂OTEZLA的III期临床试验的追加分析结果。其中包括有关OTEZLA对银屑病关节炎疾病活动性、安全性和耐受性长期(52周)影响的PALACE 1、2、3试验结果分析,另外还包括PALACE 1研究的16周生产效率单独分析结果。这些结果在法国巴黎召开的欧洲抗风湿病联盟年会(EULAR 2014)上呈报。 德国Erlangen大学医院内科III部-风湿科和免疫科主任Georg Schett, M.D., Ph.D.说:“银屑病关节炎令人痛苦,患者会一直被该病的症状折磨。PALACE试验一年数据分析结果提示,根据我们迄今所见的有效性和安全性数据,OTEZLA有望在银屑病关节炎各类表现的长期处治中帮助患者。” PALACE 1、PALACE 2、PALACE 3研究:疾病活动性的衡量指标 三项研究的长期(52周)结果显示,第16周时,OTEZLA治疗组的银屑病关节炎疾病活动性指标改善优于安慰剂组,包括关节压痛和肿胀。疾病活动性的评估采用28个关节计数的疾病活动性评分(DAS-28)、C反应蛋白(CRP)的水平、银屑病关节炎缓解标准修订版(PsARC)缓解和欧洲抗风湿病联盟(EULAR)缓解优或良。疾病活动性的三种指标均显示,OTEZLA持续治疗的患者在第52周时仍维持改善。 PALACE 1、PALACE 2、PALACE 3研究:52周安全性数据汇总 PALACE 1、2、3试验(包含1,493例患者)长期安全性数据汇总分析结果显示,与既往报道的24周安全性结果相比,OTEZLA治疗的银屑病关节炎患者在最长达52周的疗程中未见新的安全性发现。24周疗程的不良事件(AEs)性质、发生率和严重程度接近52周疗程。 多数AE的严重程度属轻度或中度,AE所致停药率低(OTEZLA 20毫克每天2次组为7.5%,OTEZLA 30毫克每天2次组为8.3%),主要发生于治疗的最初24周。24周疗程的AE发生率和严重程度接近52周。最常报告的AE是恶心、腹泻、头痛、上呼吸道感染和鼻咽炎。严重AE发生率,OTEZLA 20毫克每天2次组为 6.8%,OTEZLA 30毫克每天2次组为7.2%。1例患者(OTEZLA 20毫克每天2次)因多器官衰竭死亡,未疑诊为治疗相关。 重大心脏事件、严重感染(包括机会性感染)或恶性肿瘤的每100例受试者年暴露量校正发生率接近安慰剂。 52周数据未显示OTEZLA治疗需要实验室监测,接近PALACE 1、2、3研究既往报道的24周数据。 PALACE 1研究:工作效率 PALACE 1研究261例患者的工作效率分析结果显示,第16周时,OTEZLA治疗组的工作效率和工作受限改善均优于安慰剂组。该研究中的患者在基线和第16周完成《工作受限问卷》,该问卷有25项条目,评估慢性健康状况对工作业绩和生产力的影响。WLQ指数的计算采用四大领域的工作受限:躯体需求、精神需求、时间管理需求和付出需求。 关于 PALACE 研究 PALACE 1、2、3是枢纽性III期多中心、双盲、安慰剂对照、平行组研究,有2个活性治疗组。这些研究中,约1,500例受试者按1:1:1随机接受OTEZLA 20毫克每天2次、OTEZLA 30毫克每天2次或外观相同的安慰剂,疗程为16周。第16周时,部分安慰剂组患者随机分配至2个OTEZLA组之一,其余仍然用安慰剂,直至第24周。第24周之后,患者开始一个后续的长期、开放、活性治疗期。PALACE 1、2、3研究纳入了谱系广泛的活动性银屑病关节炎患者,包括既往用过口服延缓病程的抗风湿药(DMARDs)和/或生物制剂的患者,这些患者中有一部分曾经用肿瘤坏死因子(TNF)阻断剂无效。 PALACE 1、2、3研究的主要终点是第16周的美国风湿科学会20%改善(ACR20)修订版标准,次要终点包括银屑病关节炎的体征和症状的其他衡量指标、躯体功能和患者自诉的转归指标。 汇总来看,PALACE研究是监管报批中迄今为止样本最大的银屑病关节炎研究。 2014年3月21日,美国食品药品管理局(FDA)核准OTEZLA用于治疗活动性银屑病关节炎成人患者。银屑病关节炎/银屑病的联合上市授权申请(MAA)于2013年第四季度向欧洲卫生管理部门递交。 有关OTEZLA的进一步信息,请访问www.otezla.com。 关于OTEZLA OTEZLA是磷酸二酯酶4 (PDE4)的小分子抑制剂口服制剂,特定作用于单磷酸环腺苷酸(cAMP)。PDE4抑制可导致细胞内cAMP水平升高。 重要安全性信息 适应证 OTEZLA® (apremilast)适用于治疗活动性银屑病关节炎成人患者。 重要安全性信息 禁忌症 OTEZLA禁用于已知对apremilast或其剂型中任何成分超敏的患者。 警示和注意事项 抑郁症:OTEZLA治疗与抑郁不良反应增加有关。临床试验期间,1.0% (10/998)的OTEZLA治疗患者报告抑郁症或抑郁心境,相比之下,安慰剂组为0.8% (4/495);0.3% (4/1441) 的OTEZLA治疗患者因抑郁症或抑郁心境而停药,相比之下,安慰剂组没有患者停药(0/495)。OTEZLA组报告严重抑郁的患者为0.2% (3/1441),相比之下,安慰剂组没有患者报告严重抑郁(0/495)。OTEZLA组的0.2% (3/1441)患者可见自杀意念和行为,相比之下,安慰剂组没有自杀意念和行为(0/495)。安慰剂组有2例患者自杀,OTEZLA组没有患者自杀。 对于有抑郁史和/或自杀意念/行为的患者、或OTEZLA用药期间发生此类症状的患者,须慎重权衡OTEZLA治疗的风险和收益。须告知患者、照料者和家属,必须警惕抑郁、自杀意念或其他心境变化的出现和恶化,如果发生这些变化,必须与医疗保健提供者联系。 体重减轻:OTEZLA用药患者中10%报告体重减轻5-10%,安慰剂组为3.3%。应定期监测体重;评估无法解释或有临床意义的体重减轻,并考虑停用OTEZLA。 药物相互作用:OTEZLA与利福平(一种CYP450酶强诱导剂)合用时会降低apremilast暴露量;OTEZLA可能失效。不推荐OTEZLA与CYP450酶诱导剂(例如利福平、苯巴比妥、卡马西平、苯妥英)合用。 不良反应 (在5天剂量递增后)服用OTEZLA最长达16周的患者中,报告率至少为2%、且发生率比安慰剂组高至少1% 的不良反应(OTEZLA%,安慰剂%)有:腹泻(7.7, 1.6)、恶心(8.9, 3.1)、头痛(5.9, 2.2)、上呼吸道感染(3.9, 1.8)、呕吐(3.2, 0.4)、鼻咽炎(2.6, 1.6)、上腹痛(2.0, 0.2)。 特殊人群用药 妊娠和哺乳母亲:OTEZLA属于妊娠C类;尚未在妊娠女性中研究过。仅在潜在收益大于对胎儿的潜在风险时,方可用于妊娠期。Apremilast或其代谢产物是否存在于人类乳汁尚属未知。OTEZLA应慎用于哺乳女性。 肾功能损害:重度肾功能损害(肌酐清除率小于30毫升/分钟)患者应降低OTEZLA剂量;详细情况,参见完整处方信息的第二节“剂量与用法”。 完整处方信息,请点击此处。 关于银屑病关节炎 银屑病关节炎是一种令人痛苦的慢性炎性疾病,特点是关节疼痛、僵硬、肿胀、特定韧带和肌腱的炎症、躯体功能减退。据估计,世界各地有近3800万人罹患银屑病关节炎。银屑病关节炎可影响日常活动,有报道称可加重工作残疾。银屑病关节炎常见体征和症状包括关节疼痛、僵硬、肿胀。 Disease activity index OTEZLA group in the first 16 weeks of improving clinical significance, the longest maintained until 52 weeks of treatment III PALACE study of three 1,493 patients data show that 52 weeks of treatment, the safety profile consistent OTEZLA, laboratory parameters and no clinically significant change PALACE 1 study 16 weeks a separate analysis showed that the efficiency of OTEZLA group than in the placebo group 瑞士布德利 - (BUSINESS WIRE) - Celgene Corporation (NASDAQ: CELG), a wholly owned subsidiary of Celgene International Sàrl today announced the company's phosphodiesterase 4 (PDE4) selective inhibitors of oral formulations OTEZLA additional analysis of the phase III clinical trial results. Including information on PALACE 1,2,3 OTEZLA results psoriatic arthritis disease activity, safety and tolerability of long-term (52 weeks) analysis of the impact, and also the production efficiency including 16 weeks study separately analyzed PALACE 1 the result. Held in Paris, France reported the European League Against Rheumatism Annual Meeting (EULAR 2014) on these results. Germany Erlangen University Hospital Department of Internal Medicine III - rheumatology and immunology department director Georg Schett, MD, Ph.D., said: "painful psoriatic arthritis, patients with symptoms of the disease may have been tortured .PALACE test year data the results suggest that we have ever seen based on efficacy and safety data, OTEZLA Treatment of psoriatic arthritis is expected in the long-term performance of various types to help patients. " PALACE 1, PALACE 2, PALACE 3 studies: a measure of disease activity Long-term (52 weeks) results of three studies showed that the first 16 weeks, the psoriatic arthritis disease activity index OTEZLA improve the treatment group than in the placebo group, including joint tenderness and swelling. Disease activity was assessed using 28 joint count disease activity score (DAS-28), C-reactive protein (CRP) levels, psoriatic arthritis remission criteria revision (PsARC) mitigation and the European League Against Rheumatism (EULAR) remission excellent or good. Three indicators of disease activity have shown that patients OTEZLA continued treatment in the first 52 weeks while still maintaining the improvements. PALACE 1, PALACE 2, PALACE 3 studies: 52 weeks Safety Data Summary PALACE 1,2,3 trials (including 1,493 patients) Long-term safety data meta-analysis showed that, compared with the previously reported results of the safety of 24 weeks, the treatment of patients with psoriatic arthritis OTEZLA at up to 52 weeks of course of treatment no new safety findings. 24 weeks of treatment adverse events (AEs) the nature, incidence and severity of near 52 weeks of treatment. Most of the severity of the case of mild or moderate AE, AE-induced withdrawal low (OTEZLA 20 mg twice daily group was 7.5%, OTEZLA 30 mg twice daily group, 8.3%), mainly in the treatment of the first 24 weeks. AE incidence of 24 weeks of treatment and severity of the approaching 52 weeks. The most commonly reported AE was nausea, diarrhea, headache, upper respiratory tract infection and nasopharyngitis. The incidence of serious AE, OTEZLA 20 mg twice daily group was 6.8%, OTEZLA 30 mg twice daily group was 7.2%. One patient (OTEZLA 20 mg twice a day) due to multiple organ failure and death, are not suspected treatment-related. Major cardiac events, serious infections (including opportunistic infections) or malignant tumors per 100 subjects in the incidence of exposure correction close to placebo. 52 weeks of treatment requires laboratory monitoring data OTEZLA close PALACE 1,2,3 Previous studies reported 24 weeks data not shown. PALACE 1 Study: Work Efficiency PALACE 1 study of 261 cases of patients with the efficiency analysis showed that during the first 16 weeks, OTEZLA treatment group restricted improve work efficiency and are superior to the placebo group. Patients in the study at baseline and 16 weeks to complete, "work is limited Questionnaire", there are 25 entries in the questionnaire to assess the impact of chronic health conditions on work performance and productivity. Work is limited to calculate WLQ index using four areas: physical needs, spiritual needs, time management needs and pay requirements. About PALACE Research PALACE 1,2,3 is a pivotal Phase III multi-center, double-blind, placebo-controlled, parallel-group study, there are two active treatment groups. These studies, approximately 1,500 subjects 1: 1: 1 randomized to receive OTEZLA 20 mg twice daily, OTEZLA 30 mg daily or placebo twice the same appearance, treatment for 16 weeks. The first 16 weeks, the part of the placebo patients were randomly assigned to one of two OTEZLA group, the other is still with placebo until the first 24 weeks. After the first 24 weeks, the patient began a long-term follow-up, open, active treatment period. PALACE 1,2,3 study included a broad spectrum of patients with active psoriatic arthritis, including the previously used oral anti-rheumatic drugs slow the course of the disease (DMARDs) and patient / or biological agents, some of these patients have used tumor necrosis factor (TNF) blockers invalid. The primary endpoint PALACE 1,2,3 study is the first 16 weeks of the American Society of Rheumatology 20% improvement (ACR20) revised version of the standard, secondary endpoints include other measures of psoriatic arthritis signs and symptoms, physical function and private prosecution patient outcome indicators. Summary view, PALACE study regulatory approval in the largest sample to date psoriatic arthritis research. March 21, 2014, the US Food and Drug Administration (FDA) approved OTEZLA for the treatment of adult patients with active psoriatic arthritis. Psoriatic arthritis / psoriasis joint marketing authorization application (MAA) submitted to the European health authorities in the fourth quarter of 2013. For further information on OTEZLA, visit www.otezla.com. About OTEZLA OTEZLA phosphodiesterase 4 (PDE4) small molecule inhibitors of the oral preparation, the specific role of cyclic adenosine monophosphate in (cAMP). PDE4 inhibition may lead to elevated intracellular cAMP levels. Important Safety Information Indications OTEZLA® (apremilast) indicated for the treatment of adult patients with active psoriatic arthritis. Important Safety Information Contraindications OTEZLA banned from the dosage form known to apremilast or hypersensitivity to any component of the patient. Warning and Precautions Depression: OTEZLA treatment of depression associated with increased adverse events. During a clinical trial, 1.0% (10/998) of the patients reported OTEZLA treating depression or depressive mood, compared to the placebo group was 0.8% (4/495); 0.3% (4/1441) patients in OTEZLA due to depression or depressed mood and withdrawal, by contrast, no patients discontinued the placebo group (0/495). OTEZLA group of severely depressed patients reported 0.2% (3/1441), compared with no patients in the placebo group reported severe depression (0/495). 0.2% OTEZLA Group (3/1441) seen in patients with suicidal ideation and behavior, compared with the placebo group did not suicidal ideation and behavior (0/495). There are two cases of patients in the placebo group suicide, OTEZLA group no patients commit suicide. For patients with such symptoms have a history of depression and / or suicidal ideation / behavior of the patient, or during the OTEZLA medication, must carefully weigh the risks and benefits of treatment OTEZLA. Must inform patients, caregivers and their families, must be vigilant depression, suicidal ideation, or other mood changes appear and worsen if these changes occur, you must contact your health care provider. Weight loss: OTEZLA medication in 10% of patients reported weight loss of 5-10% in the placebo group was 3.3%. Weight should be monitored regularly; the assessment can not be explained or clinically significant weight loss, and consider disabling OTEZLA. Drug Interactions: OTEZLA with rifampicin (a kind of strong inducers of CYP450 enzymes) will reduce exposure when combined apremilast; OTEZLA may fail. Not recommended OTEZLA and CYP450 enzyme inducers (eg, rifampicin, phenobarbital, carbamazepine, phenytoin) combined. Adverse reactions (5 days after dosing) taking OTEZLA most patients for up to 16 weeks, the reporting rate of at least 2%, and a high incidence of adverse reactions, at least 1% than the placebo group (OTEZLA%, placebo%) are: diarrhea (7.7, 1.6), nausea (8.9, 3.1), headache (5.9, 2.2), upper respiratory tract infection (3.9, 1.8), vomiting (3.2, 0.4), nasopharyngitis (2.6, 1.6), upper abdominal pain (2.0, 0.2). Special Populations medication Pregnancy and breast-feeding mothers: OTEZLA belong pregnancy category C; in pregnant women has not been studied. Only when the potential benefits outweigh the potential risk to the fetus, only for pregnancy. Are Apremilast or its metabolites present in human milk is unknown. OTEZLA should be used with caution in nursing women. Renal impairment: Severe renal impairment (creatinine clearance less than 30 ml / min) should be reduced in patients with OTEZLA dose; for details, see the full prescribing information in Section II, "Dosage and Administration." Full prescribing information, please click here. About Psoriatic Arthritis Psoriatic arthritis is a painful, chronic inflammatory disease characterized by joint pain, stiffness, swelling, inflammation of ligaments and tendons specific somatic dysfunction. It is estimated that there are nearly 38 million people around the world suffer from psoriatic arthritis. Psoriatic arthritis can affect daily activities, there were reports that can aggravate work disability. Common signs and symptoms of psoriatic arthritis include joint pain, stiffness and swelling.
更新日期: 2018-10-03
附件:
201810618294638.pdf    

 
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