AbbVie's Upadacitinib (ABT-494) Meets Primary Endpoint in Phase 2b Study in Atopic Dermatitis

北芝加哥，伊利诺伊州。，，，，Sept. 7, 2017/PRNewswire/ -- AbbVie (NYSE: ABBV), a global research and development based biopharmaceutical company, today announced positive top-line results from the Phase 2b randomized, placebo-controlled, dose-ranging study of upadacitinib (ABT-494), an investigational, once-daily oral JAK1-selective inhibitor, in adult patients with moderate to severe atopic dermatitis not adequately controlled by topical treatments, or for whom topical treatments were not medically advisable.¹In this study, all upadacitinib dose groups (30/15/7.5 mg once-daily) met the primary endpoint (mean percent change in EASI at week 16 versus placebo).¹Upadacitinib is not approved by regulatory authorities and safety and efficacy have not been established.

"We are excited by the results of this study, which show that upadacitinib has the potential to be an important treatment option for patients with atopic dermatitis," saidMichael Severino，，，，M.D., executive vice president, research and development and chief scientific officer, AbbVie. "We look forward to advancing upadacitinib to Phase 3 studies in 2018. AbbVie's continued progress across our upadacitinib clinical development program further demonstrates that selective inhibition of the JAK1 pathway may be a novel therapeutic approach across a broad range of immune-mediated diseases."

在第16周的结果表明，在所有剂量中，主要和所有皮肤和瘙痒特异性的次要终点，接受upadacitinib治疗的患者的改善与安慰剂相比具有统计学意义（p <0.05）。¹Additionally, reduction in itch was observed within the first week and improvement in skin within the first two weeks (p<0.001 across all doses).¹

“特应性皮炎是一种严重的慢性皮肤疾病，可能会对患者的生活产生负面影响。”Emma Guttman-Yassky，，，，M.D., Ph.D., Professor of Dermatology and Immunology, Icahn School of Medicine at Mount Sinai Medical Center and lead study investigator. "I am very encouraged that itch reduction was achieved within the first week and that up to half of patients achieved a 90 percent or more improvement in skin lesions (EASI 90) by week 16. These are both major concerns for patients with atopic dermatitis. With these results upadacitinib has the potential to be an important treatment option for patients."

The mean percent change from baseline in the EASI score, a measure of the extent and severity of atopic dermatitis and the primary endpoint in this study, was 74/62/39 percent for patients receiving the 30/15/7.5 mg doses of upadacitinib, respectively, compared to 23 percent for patients receiving placebo (p<0.001/0.001/0.05, respectively).¹69/52/29％的疾病改善（EAI 75）分别获得了30/15/7.5 mg剂量的upadacitinib，而接受安慰剂的患者为10​​％（P <0.001/0.001/0.0555）， 分别）。¹50/26/14％的疾病改善（EAI 90）分别获得了30/15/7.5 mg剂量的upadacitinib，而接受安慰剂的患者为2％（P <0.001/0.01）/0.05分别）。¹相应地，通过研究者的全球评估量表（IgA 0或1）衡量，接受30/15/7.5 mg剂量的upadacitinib的患者中，有50/31/14％的皮肤达到了透明或几乎清晰的皮肤，相比之下，有2％接受安慰剂的患者（分别为p <0.001/0.001/0.05）。¹

In addition, significant improvement was observed with respect to pruritus (itch). Patients treated with upadacitinib experienced 69/48/40 percent improvement in itch across the 30/15/7.5 mg upadacitinib doses, as measured by the pruritus numerical rating scale (NRS), compared to 10 percent for patients receiving placebo (p<0.001/0.001/0.01, respectively).¹

In this study, no new safety signals were detected.¹最常见的不良事件是上呼吸道感染，特应性皮炎和痤疮。¹Serious adverse events across treatment groups occurred in 2/1/0 patients in the 7.5/15/30 mg groups compared to 1 patient on placebo.¹No herpes zoster, malignancies, deaths or cases of pulmonary embolism (PE) or deep vein thrombosis (DVT) occurred in this Phase 2b study.¹在该患者人群中，将在第三阶段计划中进一步评估Upadacitib的安全性。

Additional data will be presented at an upcoming medical meeting and published in a peer-reviewed publication. Upadacitinib is an investigational oral agent and is not approved by regulatory authorities.

Abbvie正在继续评估在几种免疫介导的疾病中upadacitinib的潜力。在类风湿关节炎和银屑病关节炎中upadacitib的第3阶段试验正在进行中，还正在研究以治疗克罗恩病，溃疡性结肠炎和强直性脊柱炎。^4-9

关于2B期Upadacitinib研究¹
This study is an ongoing 88-week Phase 2b, randomized, double-blind, parallel-group, placebo-controlled multicenter study designed to evaluate the safety and efficacy of upadacitinib in adult patients with moderate to severe atopic dermatitis. In Period 1, subjects were randomized in a 1:1:1:1 ratio to one of four treatment groups (three dosing groups and one placebo group) for 16 weeks. The primary endpoint of the study was mean percentage change in Eczema Area and Severity Index (EASI) score at 16 weeks in comparison with placebo. Key secondary endpoints included proportion of patients achieving EASI 90, EASI 75, an Investigator Global Assessment (IGA) of 0 or 1 and percent change in pruritus/itch numerical rating scale from day 1 (baseline) to week 16 in comparison with placebo. More information on this trial can be found atwww.clinicaltrials.gov(NCT02925117).

关于upadacitinib
Discovered and developed by AbbVie, upadacitinib is an investigational oral agent engineered to selectively inhibit JAK1, which plays an important role in the pathophysiology of immune-mediated inflammatory disorders.^{2，，，，3}在类风湿关节炎和银屑病关节炎中upadacitib的第3阶段试验正在进行中，还正在研究以治疗克罗恩病，溃疡性结肠炎和强直性脊柱炎。^4-9

Upadacitinib是一名研究性口头代理商，未经监管机构批准。尚未确定安全性和功效。

关于Abbvie
AbbVie is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world's most complex and critical conditions. The company's mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us atwww.worldcupnut.com。Follow@abbvieon Twitter,FacebookorLinkedIn。

Forward-Looking Statements
Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry.

关于Abbvie 2016年2016年10-K表格年度报告，有关ABBVIE运营的经济，竞争，政府，技术和其他可能影响Abbvie行动的因素的其他信息，该信息已向证券和证券提交。交流委员会。Abbvie没有义务因随后的事件或发展而公开对前瞻性陈述进行公开修订，但法律要求除外。狗万正网地址

[1]文件中的abbvie数据。upadacitinib广告阶段2B新闻稿05Sept2017
[2] Voss，J等；大鼠关节炎和贫血模型以及健康的人类受试者中新型JAK1选择性抑制剂的药效学。[抽象的]。关节炎Rheum 2013; 65 Suppl 10：2374。doi：10.1002/art.2013.65.issue-s10
[3] O'Shea JJ, Plenge R. JAK and STAT signaling molecules in immunoregulation and immune-mediated disease. Immunity 2012;(36):542–550.
[4] A Study Comparing ABT-494 to Placebo and to Adalimumab in Subjects With Rheumatoid Arthritis Who Are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate (SELECT-COMPARE) - Full Text View - ClinicalTrials.gov. Clinicaltrialsgov. 2017. Available at:https://clinicaltrials.gov/ct2/show/NCT02629159?term=select+compare&rank=1。Accessed onAugust 11, 2017。
[5] A Study Comparing ABT-494 to Placebo and to Adalimumab in Participants With Psoriatic Arthritis Who Have an Inadequate Response to at Least One Non-Biologic Disease Modifying Anti-Rheumatic Drug (SELECT - PsA 1). Clinicaltrialsgov. 2017. Available at:https://clinicaltrials.gov/ct2/show/nct03104400?term=ABT-494&phase=2&rank=10。Accessed onAugust 11, 2017。
[6] A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Immunomodulators or Anti-TNF Therapy - Full Text View - ClinicalTrials.gov. Clinicaltrialsgov. 2017. Available at:https://clinicaltrials.gov/ct2/show/NCT02365649。Accessed onAugust 11, 2017。
[7]一项研究，评估ABT-494在中度至严重活跃的溃疡性结肠炎的受试者中对ABT-494的安全性和环境的诱导和维持治疗。临床研究。2017。可用：https://clinicaltrials.gov/ct2/show/NCT02819635。Accessed onAugust 11, 2017。
[8] A Study Evaluating the Safety and Ecacy of Upadacitinib in Subjects With Active Ankylosing Spondylitis (SELECT Axis 1). 2017. Available at:https://clinicaltrials.gov/ct2/show/study/NCT03178487?term=ABT-494&cond=ankylosing+spondylitis&rank=1。Accessed onAugust 11, 2017。
[9] A Study to Evaluate ABT-494 in Adult Subjects With Moderate to Severe Atopic Dermatitis. Clinicaltrialsgov. 2017. Available at:https://clinicaltrials.gov/ct2/show/nct02925117。Accessed onAugust 11, 2017。

来源Abbvie