Phase 2 data in adults with hidradenitis suppurativa (HS) who had previously failed anti-TNF therapy who received lutikizumab (ABT-981) 300 mg weekly or 300 mg every other week showed higher response rates in HiSCR 50 at week 16 than those treated with placebo1,2

先前抗TNF治疗失败的化脓性汗腺炎（HS）成人的2期数据显示，每周接受300 mg或每隔一周300 mg的lutikizumab（ABT-981）治疗的患者在第16周的HiSCR 50反应率高于安慰剂治疗的患者1,2

Higher response rates were also observed in patients receiving lutikizumab 300 mg weekly or 300 mg every other week than those treated with placebo in the secondary endpoint of skin pain NRS30 at week 16 among patients with baseline NRS≥31,2

在基线NRS≥31,2的患者中，在第16周皮肤疼痛NRS30的次要终点中，每周接受300 mg鲁替珠单抗或每隔一周接受300 mg鲁替珠单抗治疗的患者的缓解率也高于安慰剂治疗的患者

HS is a chronic, often debilitating inflammatory skin disease that can form lumps, abscesses and scars under the arms, in the groin and other areas3,4,5,6,7

HS是一种慢性的，通常会使人衰弱的炎症性皮肤病，可在手臂下，腹股沟和其他区域形成肿块，脓肿和疤痕3,4,5,6,7

Program reflects AbbVie's leadership in immunology and history of investigating new options for patients with HS, where there remains a significant unmet medical need

该计划反映了AbbVie在免疫学方面的领导地位，以及研究HS患者新选择的历史，HS患者的医疗需求仍然没有得到满足

NORTH CHICAGO, Ill., Jan. 8, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced Phase 2 results showing adults with moderate to severe hidradenitis suppurativa (HS) who had previously failed anti-TNF therapy who received lutikizumab (ABT-981) 300 mg every other week or 300 mg weekly achieved higher response rates (59.5 percent, nominal p=0.027 and 48.7 percent, nominal p=0.197, respectively) than placebo (35.0 percent) in the primary endpoint of achieving HS Clinical Response (HiSCR 50) at week 16.

伊利诺伊州北芝加哥，1月8日，2024/PRNewswire/-AbbVie（纽约证交所：ABBV）今天宣布了第二阶段的结果，显示患有中度至重度化脓性汗腺炎（HS）的成年人，以前抗肿瘤坏死因子治疗失败，每隔一周服用300毫克或每周服用300毫克的lutikizumab（ABT-981）比安慰剂（35.0%）的有效率更高（分别为59.5%，标称p=0.027和48.7%，标称p=0.197）在第16周达到HS临床反应（HiSCR 50）的主要终点。

Based on these data, AbbVie will advance its clinical program of lutikizumab in HS to Phase 3.1,2.

基于这些数据，AbbVie将其在HS中的lutikizumab临床计划推进到3.1,2期。

Lutikizumab is AbbVie's investigational, dual-variable-domain interleukin (IL) 1α/1β antagonist. Studies have shown IL 1α and 1β are elevated in HS lesions.8

Lutikizumab是AbbVie的研究性双可变结构域白细胞介素（IL）1α/1β拮抗剂。研究表明，HS病变中IL 1α和1β升高

'AbbVie continues to pioneer research in the pursuit of new treatment options for patients with hidradenitis suppurativa, a frequently overlooked, underserved, and often suffering patient population,' said Roopal Thakkar, M.D., senior vice president, chief medical officer, global therapeutics, AbbVie. 'These results help us further understand the use of lutikizumab in adults with moderate to severe hidradenitis suppurativa, and we will continue to apply our more than 25 years of expertise in immune-mediated diseases in advancing our clinical program for lutikizumab in HS to Phase 3.'.

AbbVie全球治疗高级副总裁兼首席医疗官Roopal Thakkar医学博士说：“AbbVie继续开拓研究，为化脓性汗腺炎患者寻求新的治疗选择，化脓性汗腺炎是一种经常被忽视、服务不足且经常遭受痛苦的患者群体。”。“这些结果有助于我们进一步了解lutikizumab在成人中度至重度化脓性汗腺炎中的应用，我们将继续应用我们在免疫介导疾病方面超过25年的专业知识，将我们在HS中的lutikizumab临床计划推进到3期。”。

This study was a 16-week, Phase 2, randomized, double-blind, parallel group, placebo controlled, dose-ranging, multicenter study that evaluated the safety and efficacy of lutikizumab in 153 adult patients with moderate to severe HS who had previously failed anti-TNF therapy. Most patients (70.6 percent) had severe baseline Hurley Stage 3 disease – the most extensive form of HS – characterized by scarring, lesions and sinus tracts.

这项研究是一项为期16周的2期随机、双盲、平行组、安慰剂对照、剂量范围的多中心研究，评估了153名先前抗TNF治疗失败的中重度HS成年患者使用鲁替珠单抗的安全性和有效性。大多数患者（70.6%）患有严重的基线Hurley 3期疾病，这是HS最广泛的形式，其特征是疤痕，病变和窦道。

Patients were randomized at baseline to receive one of three subcutaneous doses of lutikizumab (100 mg every other week, 300 mg every other week, or 300 mg every week) or placebo. The study's primary endpoint was an achievement of HiSCR 50 at week 16, and the secondary endpoint was skin pain NRS30 at week 16 among subjects with baseline NRS≥3.1  .

患者在基线时随机接受三种皮下剂量的lutikizumab（每隔一周100 mg，每隔一周300 mg或每周300 mg）或安慰剂中的一种。该研究的主要终点是在第16周达到HiSCR 50，次要终点是基线NRS≥3.1的受试者在第16周的皮肤疼痛NRS30。

In addition to achieving higher response rates in the primary endpoint and despite most patients having severe disease, the trial also showed patients receiving lutikizumab 300 mg weekly and 300 mg every other week achieved higher rates of improved skin pain via NRS30 and HiSCR75, a higher threshold of HS clinical response, compared to placebo.

除了在主要终点获得更高的缓解率外，尽管大多数患者患有严重疾病，但该试验还显示，与安慰剂相比，每周接受lutikizumab 300 mg和每隔一周300 mg的患者通过NRS30和HiSCR75（HS临床反应的更高阈值）获得了更高的皮肤疼痛改善率。

Lutikizumab 100 mg every other week did not show greater efficacy compared to placebo.1.

与安慰剂相比，每隔一周服用100毫克的Lutikizumab没有显示出更大的疗效。

Results from select endpoints are as follows:

选定端点的结果如下：

Endpoints (All at Week 16)

终点（全部在第16周）

Response (%)

响应（%）

Response (%); Treatment Diff vs. PBO#  P-value+1

响应（%）；治疗差异与PBO#P值+1

PBO (N=40)

PBO（N=40）

Luti 100 mg EOW (N=37)

Luti 100 mg EOW（N=37）

Luti 300mg EOW (N=37)

鲁蒂300mg口服液（N=37）

Luti 300mg EW (N=39)

Luti 300 mg EW（N=39）

Primary

主要

HiSCR 50

HiSCR 50

35.0

35.0

27.0 ∆: -9.7 p=0.345

27.0∆：-9.7 p=0.345

59.5 ∆: 24.1 p=0.027

59.5Δ：24.1 p=0.027

48.7 ∆: 13.8 p=0.197

48.7Δ：13.8 p=0.197

Secondary

次要

Skin Pain NRS30*

皮肤疼痛NRS30*

N=31 12.9

N=31 12.9

N=27 22.2 ∆: 9.4 p=0.330

N=27 22.2Δ：9.4 p=0.330

N=29 34.5 ∆: 21.8 p=0.039

N=29 34.5Δ：21.8 p=0.039

N=23 34.8 ∆: 19.8 p=0.066

N=23 34.8Δ：19.8 p=0.066

Additional

其他

HiSCR 75

HiSCR 75

17.5

17.5

16.2 ∆: -2.2 p=0.795

16.2Δ：-2.2 p=0.795

45.9 ∆: 28.2 p=0.005

45.9Δ：28.2 p=0.005

38.5 ∆: 21.0 p=0.031

38.5Δ：21.0 p=0.031

#Cochran-Mantel-Haenszel test adjusted for the stratification factor (Baseline Hurley Stage <3 and 3)+All p values are nominal*Analyzed among patients with baseline Skin Pain NRS≥3

#Cochran-Mantel-Haenszel检验调整了分层因素（基线Hurley分期<3和3）+所有p值均为标称值*在基线皮肤疼痛NRS≥3的患者中进行分析

All doses were generally well-tolerated. The percentage of subjects with treatment-emergent adverse events (TEAE) were generally similar across combined lutikizumab treatment arms (70.8 percent) and placebo (75.0 percent) with the most common being HS (10.6 percent), diarrhea (8.8 percent), headache (8.8 percent), pruritus (6.2 percent), contact dermatitis (5.3 percent), eczema (5.3 percent), and nasopharyngitis (5.3 percent) in the combined lutikizumab treatment group.

所有剂量通常耐受性良好。联合治疗组（70.8%）和安慰剂组（75.0%）出现治疗紧急不良事件（TEAE）的受试者百分比大致相似，最常见的是HS（10.6%）、腹泻（8.8%）、头痛（8.8%）、瘙痒（6.2%）、接触性皮炎（5.3%）、湿疹（5.3%），联合lutikizumab治疗组的鼻咽炎（5.3%）。

Serious adverse events (SAEs) occurred in 5.3 percent of the combined lutikizumab treatment group and in 2.5 percent in the placebo group. There were no deaths, no events of neutropenia reported, and no Grade 3 or 4 laboratory evaluations of neutropenia observed. Throughout the study, one event of serious infection (infected stoma) was reported in lutikizumab 300 mg every other week, with no associated neutropenia, deemed by the investigator as having no reasonable possibility of being related to study drug.

严重不良事件（SAE）发生率为5.3%的联合鲁替珠单抗治疗组和2.5%的安慰剂组。没有死亡，没有中性粒细胞减少事件的报告，也没有观察到中性粒细胞减少的3级或4级实验室评估。在整个研究过程中，每隔一周服用300 mg lutikizumab报告一次严重感染事件（感染造口），没有相关的中性粒细胞减少症，研究者认为与研究药物无关。

There was one instance of T-cell lymphoma (lutikizumab 300 mg every week) reported in a patient with pre-existing risk factors, including HS9 and ongoing cigarette smoking. There were no dose-dependent trends in any TEAEs, SAEs, infections, or serious infections..

据报道，一名患有预先存在的危险因素（包括HS9和持续吸烟）的患者发生了一例T细胞淋巴瘤（每周服用300 mg lutikizumab）。任何TEAE，SAE，感染或严重感染均无剂量依赖性趋势。。

'The burdens of HS are high and include long times to diagnosis, significant pain, disability, isolation, and reduced quality of life,' said Alexa B. Kimball, M.D., MPH, a study investigator from Beth Israel Deaconess Medical Center in Boston and Professor of Dermatology, Harvard Medical School.10,11,12 'These results are encouraging and help us further understand the use of lutikizumab in patients with HS as we work to address the need for additional treatment options for patients living with this disease.'.

波士顿贝斯以色列女执事医学中心的研究调查员兼皮肤病学教授Alexa B.Kimball医学博士说：“HS的负担很重，包括诊断时间长，严重疼痛，残疾，孤立和生活质量下降。”，哈佛医学院[10,11,12]。这些结果令人鼓舞，并有助于我们进一步了解在HS患者中使用lutikizumab，因为我们致力于解决患有这种疾病的患者对额外治疗选择的需求。

HiSCR 50 at week 16, the primary endpoint of this study, is a measure that represents patients who achieve at least a 50 percent reduction at week 16 in the total abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count relative to baseline.

本研究的主要终点是第16周的HiSCR 50，它代表了在第16周总脓肿和炎性结节（AN）计数至少减少50%的患者，脓肿计数没有增加，引流瘘管计数相对于基线没有增加。

Similarly, HiSCR 75 represents the achievement of at least a 75 percent reduction in AN count at week 16 with no increase in draining fistula count relative to baseline. The secondary endpoint, NRS30 at week 16, defines the achievement of at least a 30 percent reduction and at least 1-unit reduction from baseline in NRS (Numeric Rating Scale) at week 16 as assessed by patient global assessment for skin pain, among subjects with baseline NRS≥3.13.

类似地，HiSCR 75代表在第16周时计数至少减少75%，而引流瘘管计数相对于基线没有增加。次要终点，第16周的NRS30，定义了在基线NRS≥3.13的受试者中，通过患者皮肤疼痛全球评估评估，在第16周NRS（数字评定量表）从基线至少减少30%和至少减少1个单位。

These data will be presented at a future medical congress. Additional information about the program can be found on clinicaltrials.gov under the identifier NCT05139602.2

这些数据将在未来的医学大会上公布。有关该计划的其他信息，请访问clinicaltrials.gov，标识符为NCT05139602.2

About Hidradenitis SuppurativaHidradenitis Suppurativa, sometimes referred to as 'acne inversa' by dermatologists, is an inflammatory, chronic, recurrent, progressive disease that causes irreversible skin damage and disability due to the formation of painful cysts, abscesses and draining fistula.3,4,5,6,7 While advances in treatment have been made, limited treatment options are available.

关于化脓性汗腺炎化脓性汗腺炎，有时被皮肤科医生称为“痤疮反转”，是一种炎症性，慢性，复发性，进行性疾病，由于形成疼痛的囊肿，脓肿和引流瘘而导致不可逆的皮肤损伤和残疾[3,4,5,6,7]。虽然治疗取得了进展，但治疗选择有限。

Globally, HS affects up to 1 percent of the population14 and can take on average 7-10 years for a person to be diagnosed.15,16.

在全球范围内，HS影响多达1%的人口14，一个人平均需要7-10年才能被诊断出来[15,16]。

About Lutikizumab (ABT-981) Lutikizumab (ABT-981) is a dual-variable-domain interleukin (IL) 1α/1β antagonist being investigated in several immune-mediated diseases, including HS and ulcerative colitis. Studies have shown IL 1α and 1β are elevated in HS lesions.8 Lutikizumab is an investigational agent and is not approved by regulatory authorities.

关于Lutikizumab（ABT-981）Lutikizumab（ABT-981）是一种双可变结构域白细胞介素（IL）1α/1β拮抗剂，正在几种免疫介导的疾病中进行研究，包括HS和溃疡性结肠炎。研究表明，HS病变中IL 1α和1β升高[8]。鲁替单抗是一种研究药物，未经监管机构批准。

Safety and efficacy have not been established..

安全性和有效性尚未确定。。

About AbbVie in DermatologyFor more than a decade, AbbVie has worked to uncover new solutions and improve care for people with serious skin diseases, including psoriasis, psoriatic arthritis, hidradenitis suppurativa and atopic dermatitis. With a broad clinical trial program, we continue to actively research and adapt to the evolving needs of the dermatology community and advance our pipeline to help people achieve their treatment goals and live beyond their skin disease..

关于皮肤病学中的AbbVie十多年来，AbbVie一直致力于发现新的解决方案，并改善对严重皮肤病患者的护理，包括牛皮癣，银屑病关节炎，化脓性汗腺炎和特应性皮炎。通过广泛的临床试验计划，我们继续积极研究并适应皮肤病界不断变化的需求，并推进我们的管道，以帮助人们实现治疗目标并超越皮肤病。。

About AbbVieAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – in addition to products and services in our Allergan Aesthetics portfolio.

AbbVieAbbVie的使命是发现并提供创新药物和解决方案，以解决当今严重的健康问题，并应对未来的医疗挑战。除了Allergan美学产品组合中的产品和服务外，我们还致力于在免疫学、肿瘤学、神经科学和眼部护理等几个关键治疗领域对人们的生活产生重大影响。

For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X (formerly Twitter), and YouTube..

有关AbbVie的更多信息，请访问www.AbbVie.com。在LinkedIn、Facebook、Instagram、X（以前的Twitter）和YouTube上关注@AbbVie。。

Forward-Looking StatementsSome statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words 'believe,' 'expect,' 'anticipate,' 'project' and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements.

前瞻性声明本新闻稿中的某些声明是或可能被视为1995年《私人证券诉讼改革法案》中的前瞻性声明。单词“相信”、“期望”、“预期”、“项目”以及类似的将来动词或条件动词的表达和用法通常表示前瞻性陈述。

AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied 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.

AbbVie警告称，这些前瞻性声明存在风险和不确定性，可能导致实际结果与前瞻性声明中明示或暗示的结果存在重大差异。此类风险和不确定性包括但不限于知识产权的挑战、其他产品的竞争、研发过程中固有的困难、不利的诉讼或政府行为以及适用于本行业的法律法规的变化。

Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, 'Risk Factors,' of AbbVie's 2022 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q.

有关可能影响艾伯维运营的经济、竞争、政府、技术和其他因素的其他信息，请参见艾伯维2022年年度报告表10-K第1A项“风险因素”，该报告已提交给美国证券交易委员会，随后的季度报告表10-Q对其进行了更新。

AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law..

除法律要求外，AbbVie没有义务（特别拒绝）因后续事件或事态发展而公开发布对前瞻性声明的任何修订。。

References

参考文献

1 AbbVie Data on File ABVRRTI77645.2 A Study to Assess Disease Activity and Safety of Subcutaneous Lutikizumab (ABT-981) in Adult Participants With Moderate to Severe Hidradenitis Suppurativa Who Have Failed Anti-Tumor Necrosis Factor (TNF) Therapy. ClinicalTrials.gov. Available at: clinicaltrials.gov/study/NCT05139602.

1 ABVRRTI77645.2文件中的AbbVie数据一项评估抗肿瘤坏死因子（TNF）治疗失败的中度至重度化脓性汗腺炎成年参与者皮下鲁替珠单抗（ABT-981）的疾病活动性和安全性的研究。ClinicalTrials.gov。网址：ClinicalTrials.gov/study/NCT05139602。

Accessed December 8, 2023.3 Negus D, Ahn C, Huang W. An update on the pathogenesis of hidradenitis suppurativa: implications for therapy. Expert Rev Clin Immunol. 2018;14(4):275-283.4 Patel ZS et al. Pain, Psychological Comorbidities, Disability, and Impaired Quality of Life in Hidradenitis Suppurativa [corrected].

2023年12月8日访问.3 Negus D，Ahn C，Huang W.化脓性汗腺炎发病机制的最新进展：对治疗的影响。专家Rev Clin Immunol。2018年；14（4）：275-283.4 Patel ZS等人。化脓性汗腺炎的疼痛，心理合并症，残疾和生活质量受损[已纠正]。

Curr Pain Headache Rep. 2017;21(12):49.5 Chen WT, et al. JAMA Dermatol. 2019 Jul 10.6 Jemec G. Hidradenitis Suppurativa. N Engl J Med. 2012; 366:158-64.7 Kimball A, et al. Two Phase 3 Trials of Adalimumab for Hidradenitis Suppurativa. New England Journal of Medicine 375.5; 2016: 422-34.8 VanderZee et al British Journal of Dermatology (2011) 164, p1292–98; Kanni et al (2015) PLoS ONE 10(6): e0130522.9 Tannenbaum R, Strunk A, Garg A.

Curr Pain头痛代表2017；21（12）：49.5 Chen WT等。JAMA Dermatol。2019年7月10日6日Jemec G.Hidradenitis Suppurativa。英格兰医学杂志2012；366:158-64.7 Kimball A等人。阿达木单抗治疗化脓性汗腺炎的两项3期临床试验。新英格兰医学杂志375.5；2016:422-34.8 VanderZee等英国皮肤病学杂志（2011）164，p1292-98；Kanni等人（2015）PLoS ONE 10（6）：e0130522.9 Tannenbaum R，Strunk A，Garg A。

Association Between Hidradenitis Suppurativa and Lymphoma. JAMA Dermatol. 2019 May 1;155(5):624-625.10 Jemec G. Hidradenitis Suppurativa. N Engl J Med. 2012; 366:158-64.11 Hamzavi HI, et al. J Am Acad Dermatol 2017;77:1038–46.12 Von der Werth. Br J Dermatol 2001;144:809–13.13 Assessing the validity and clinical meaningfulness of skin pain response (NRS30) assessed using numerical rating scale in hidradenitis suppurativa: Results from the SUNSHINE and SUNRISE trials.

化脓性汗腺炎与淋巴瘤的关系。JAMA皮肤病。2019年5月1日；155（5）：624-625.10 Jemec G.Hidradenitis pupurativa。英格兰医学杂志2012；366:158-64.11 Hamzavi HI等人，J Am Acad Dermatol 2017；77:1038–46.12冯·德沃斯。Br J Dermatol 2001；144:809–13.13使用数字评定量表评估化脓性汗腺炎皮肤疼痛反应（NRS30）的有效性和临床意义：阳光和日出试验的结果。

Journal of the American Academy of Dermatology, Accessed December 8, 2023.14 Egeberg A, et al. JAMA Dermatol 2016;152:429–34.15 Garg A, et al. JAMA Dermatol. 2018 Jul 1;154(7):814-818.16 Saunte DM, et al. Br J Dermatol 2015;173:1546–9..

美国皮肤病学会杂志，2023年12月8日访问。14 Egeberg A等人，JAMA Dermatol 2016；152:429–34.15 Garg A等人，JAMA Dermatol。2018年7月1日；154（7）：814-818.16 Saunte DM等。Br J Dermatol 2015；173:1546年至1549年。。

SOURCE AbbVie

来源AbbVie