Tildrakizumab-ASMN

今晚7点！来药时代直播间，赢得心仪好书！ 2024年10月28日，礼来宣布了其IL-23抑制剂Omvoh（mirikizumab）在溃疡性结肠炎（UC）和克罗恩病（CD）中的III期研究长期疗效数据。其中，LUCENT-3 为针对中度至重度活动性UC的III期研究，VIVID-2 为针对中度至重度活动性CD的III期研究。结果显示，mirikizumab在两种炎症性肠病中均显示出长期稳定疗效，且安全性良好。 基于此次公布数据，礼来强调称，mirikizumab 是首个且唯一一个报告UC和CD长期、多年、持续疗效和安全性数据的 IL23p19抑制剂。 就在礼来公布数据的同天，强生也公布了其同靶点药物TREMFYA （guselkumab，古塞奇尤单抗）在中重度成人活动性CD中的III期研究结果。强生新闻稿中强调，古塞奇尤单抗是首个且唯一一个在CD的诱导和维持治疗中通过完全皮下给药显示出稳健结果的 IL-23 抑制剂。 值得一提的是，目前全球范围内仅获批上市四款IL-23抑制剂，分别为古塞奇尤单抗（强生）、替瑞奇珠单抗（康哲，Almirall SA，Sun Pharmaceutical Industries Ltd.等）、利生奇珠单抗（艾伯维）和Mirikizumab（礼来）。其中，仅利生奇珠单抗获批CD适应症。 礼来：mirikizumab mirikizumab与2023年10月获FDA首次批准用于成人中度至重度活动性UC的治疗，是礼来首个获批治疗UC的药物。目前这款药的CD适应症尚未获FDA批准。更多信息显示，mirikizumab此前曾被CDE纳入突破性治疗品种，拟开发用于治疗中重度活动性CD成人患者，其上市申请已于2024年10月被CDE正式受理。 此次公布的两项III期研究长期结果见下： LUCENT-3研究： LUCENT-3是LUCENT-1和LUCENT-2研究的长期扩展研究，旨在评估Mirikizumab在UC患者中的三年有效性和安全性。据悉，诱导期的LUCENT-1和维持期的LUCENT-2研究均纳入了对皮质类固醇、免疫调节剂、生物疗法/JAK抑制剂等治疗应答不足、无应答或不耐受的患者。其中，在LUCENT-1研究中，41%的患者至少对一种生物制剂无效，3%对JAK抑制剂无效，而57%的患者既往没有接受过生物制剂和JAK抑制剂的治疗。 综合三年治疗期内所得结果，mirikizumab在UC的长期治疗中有以下几点值得关注： 81%的患者维持了长期临床缓解（患者症状显著减少甚至消失，生活质量得到提高）； 82% 的患者实现了长期内镜缓解（肠道炎症得到持久缓解或完全消失）； 72% 的患者实现了黏膜愈合； 79% 的患者达到了无皮质类固醇的临床缓解； 患者的肠道急迫症状评分持续显著改善。 VIVID-2研究： VIVID-2研究是III期VIVID-1研究和II期SERENITY研究的长期扩展研究，旨在评估mirikizumab在CD患者中的5年安全性和有效性。其中，VIVID-2 研究的扩展研究数据显示，接受 mirikizumab 治疗的中重度活动性CD患者保持了较高的临床和内窥镜缓解率。根据额外治疗 3 年（总计长达 5 年）后观察到的病例分析，得出以下结果： 96% 的患者通过克罗恩病活动指数 （CDAI） 测量有临床反应（CDAI得分下降至少100分以上）； 根据 CDAI 测量，87%的患者处于临床缓解状态（症状得到了显著改善或消失）； 76% 的患者有内镜反应（患者炎症减少或损伤程度的改善）； 54% 的患者处于内镜缓解状态（几乎完全的黏膜愈合/症状消退）。 强生：古塞奇尤单抗 古塞奇尤单抗于2017年获FDA批准用于成人中重度斑块银屑病的治疗，是FDA批准的首款IL-23抑制剂。后又陆续有活动性银屑病关节炎、中重度活动性UC适应症获FDA批准。 此次强生公布的是古塞奇尤单抗III期 GRAVITI 研究结果，旨在评估古塞奇尤单抗在中重度活动性CD患者中的有效性和安全性，这些患者对传统疗法/生物制剂应答不足/不能耐受。研究包括12周诱导期和36周维持期，分为安慰剂组、 古塞奇尤单抗 400 mg SC q4w （x3）+古塞奇尤单抗 200 mg SC q4w组、古塞奇尤单抗 400 mg SC q4w （x3）+古塞奇尤单抗 100 mg SC q8w组。 研究12 周结果显示，56.1%的试验组患者达到临床缓解（安慰剂组为21.4%），且 41.3% 的患者有内镜反应（安慰剂组为 21.4%）。另外，与安慰剂相比，试验组在治疗第 4 周观察到更显著的临床缓解（说明起效快）。 48 周时，古塞奇尤单抗100 mg SC q8w 组、200 mg SC q4w 组及安慰剂组的临床缓解率分别为60.0%、 66.1%及17.1%；分别有 44.3% 、51.3%和 6.8%的患者有内镜反应；另有30.4%、38.3%及6.0%的患者达到内镜下缓解。 目前获批上市的四款IL-23抑制剂中，仅利生奇珠单抗获批了CD适应症，给药方案为：第 0 周、第 4 周和第 8 周通过静脉输注诱导剂量，第 12 周开始每8周皮下注射维持剂量。mirikizumab的III临床试验也采用了相同的诱导期静脉输注，维持期皮下给药的方案。相较之下，古塞奇尤单抗的GRAVITI 研究全程采用皮下注射给药将是一个极突出的优势，或将有机会为患者提供了更便捷的给药方式。这也是强生此次注重强调的点。 小结 CD容易复发、治疗周期较长，且治疗费用相对较高，对患者的生活和经济状况产生显著影响，因此又被称为“富贵病”。该病病因目前尚不明，但发病率有明显的地区差异性，早先多见于欧美发达国家/地区，近年来在我国的发病率逐年上升。且该病常见于青少年，患者平均年龄为15至25岁。 相关疾病诊疗指南中指出：尽管近年CD的治疗药物取得很大进展，但仍无法突破治疗的"天花板"，内镜下有效率报道大多在40%~60%。除了目前已有的生物制剂及小分子药物外，采用多靶点药物及联合治疗难治性CD、粪菌移植、干细胞注射治疗、探索新的治疗靶点药物等仍是当下研究的热点。且多项研究表明，联合生物制剂治疗相对于单独使用能够提高治疗效果。 参考资料： 1.各公司官网 2.其他公开资料 封面图来源：pixabay 版权声明/免责声明 本文为原创文章。 本文仅作信息交流之目的，不提供任何商用、医用、投资用建议。 文中图片、视频、字体、音乐等素材或为药时代购买的授权正版作品，或来自微信公共图片库，或取自公司官网/网络，部分素材根据CC0协议使用，版权归拥有者，药时代尽力注明来源。 如有任何问题，请与我们联系。 衷心感谢! 药时代官方网站:www.drugtimes.cn 联系方式: 电话:13651980212 微信:27674131 邮箱:contact@drugtimes.cn 诺华向你发送一条新消息：聚梦成就非凡，一起启程创想！ 保二冲一，ROCK2抑制剂为何能连续冲击cGVHD治疗前线？ 恒瑞、君实、亚虹纷纷任命全球BD高管！美知名议员反对《生物安全法案》。。。| 药时代视频 点击查看更多精彩！

Data from a wide range of the Sun Pharma dermatology portfolio, including data on alopecia areata, psoriasis, acne and actinic keratosis products, will be highlighted during the meeting. MUMBAI, India and PRINCETON, N.J., Oct. 25, 2024 /PRNewswire/ -- Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715 (together with its subsidiaries and/or affiliated companies, "Sun Pharma") today announced it will present more than a dozen posters at the 44th Annual Fall Clinical Dermatology Conference, being held October 24-27, 2024, in Las Vegas, Nevada. The presentations will include data from across the Sun Pharma dermatology portfolio, including study results for LEQSELVI™ (deuruxolitinib), WINLEVI® (clascoterone), ILUMYA® (tildrakizumab-asmn), ODOMZO® (sonidegib) and LEVULAN® KERASTICK® (aminolevulinic acid HCl) + BLU-U® (blue light photodynamic therapy). "As an organization dedicated to supporting the dermatology community, the Fall Clinical Dermatology Conference offers a vitally important forum to present new data and highlight how Sun's innovative dermatology portfolio can support those living with alopecia areata, psoriasis, acne and other skin-related diseases," said Marek Honczarenko, MD, PhD, Senior Vice President and Head of Global Development at Sun Pharma. "We look forward to sharing data from across our portfolio with the dermatology research community and our esteemed industry colleagues." Six abstracts, accepted for poster presentations, will highlight clinical efficacy and safety data of LEQSELVI™ (deuruxolitinib). Approved earlier this year by the U.S. Food and Drug Administration for the treatment of adults with severe alopecia areata, LEQSELVI™ is an oral JAK inhibitor that interrupts the pathways thought to contribute to hair loss in severe AA and delivered statistically significant efficacy at 24 weeks across two Phase 3 clinical trials. LEQSELVI™ data being presented at Fall Clinical showcase pooled long-term results for ongoing clinically meaningful improvements in scalp hair regrowth in adults with alopecia areata. Additionally, two posters will present patient and clinician preferences for the treatment of alopecia areata. The WINLEVI® poster presentations will include new data showing significant reductions in casual facial sebum levels from baseline, stability in the presence of other commonly prescribed acne medications, and efficacy and safety from a pilot study in patients with skin of color. The conference will also feature data from three additional WINLEVI® studies. Sun Pharma will present the following posters at the 2024 Fall Clinical Dermatology Conference: LEQSELVI™ Presentations: Deuruxolitinib results in ongoing clinically meaningful improvements in scalp hair regrowth in adults with alopecia areata: Pooled long-term efficacy and safety data from the open-label extension studies Patient Preferences for the Treatment of Alopecia Areata A Discrete Choice Experiment to Assess Clinician Preferences for the Treatment of Alopecia Optimization of deuruxolitinib dosing in adult patients with alopecia area: Results from a randomized, parallel-group, multicenter Phase 2 trial Change in patient-reported hair satisfaction during deuruxolitinib treatment of severe alopecia areata: Pooled data from the Phase 3 THRIVE-AA1 and THRIVE-AA2 trials Improvement in anxiety and depression in adult patients with severe alopecia areata treated with deuruxolitinib: Pooled data from the THRIVE-AA1 and THRIVE-AA2 Phase 3 trials WINLEVI® Presentations: Clinical evaluation of the sebum reduction induced by clascoterone cream 1%: Week 12 interim analysis Assessment of clascoterone cream 1% levels when layered with other topical acne medications Efficacy and safety of clascoterone cream 1% in patients with acne with skin of color: 16-week interim analysis The efficacy and safety of clascoterone cream 1% for the treatment of acne vulgaris are not dependent on patient age and sex: Results of a post hoc analysis Improvement in skin moisturization and lack of barrier damage with clascoterone cream 1% treatment: Results of a randomized, single-blind, split-face study in acne-prone individuals Comparison of the efficacy of clascoterone vs trifarotene and tazarotene for the treatment of acne vulgaris at Week 12: A systematic review and meta-analysis ILUMYA® Presentation: A systematic literature review and meta-analysis of the real-world effectiveness, quality of life, and safety of tildrakizumab for moderate-to-severe plaque psoriasis ODOMZO® Presentation: Lower rate of discontinuation of sonidegib compared to vismodegib in a real-world analysis of patients with basal cell carcinoma LEVULAN® KERASTICK® + BLU-U® Presentation: Evaluating the safety and efficacy of aminolevulinic acid 20% topical solution activated by blue light in the treatment of facial cutaneous squamous cell carcinoma in situ About Sun Pharmaceutical Industries Limited. (CIN – L24230GJ1993PLC019050) Sun Pharma is the world's leading specialty generics company with a presence in Specialty, Generics and Consumer Healthcare products. It is the largest pharmaceutical company in India and is a leading generic company in the US as well as Global Emerging Markets. Sun's high growth Global Specialty portfolio spans innovative products in dermatology, ophthalmology, and onco-dermatology and accounts for over 18% of company sales. The company's vertically integrated operations deliver high-quality medicines, trusted by physicians and consumers in over 100 countries. Its manufacturing facilities are spread across six continents. Sun Pharma is proud of its multi-cultural workforce drawn from over 50 nations. For further information, please visit and follow us on LinkedIn & X (Formerly Twitter). Disclaimer: Statements in this "document" describing Sun Pharma's objectives, projections, estimates, expectations, plans or predictions, industry conditions, or events may be "forward-looking statements" within the meaning of applicable securities laws and regulations. Actual results, performance, or achievements could differ materially from those expressed or implied. Sun Pharma does not undertake any obligation to update or revise forward-looking statements to reflect developments or circumstances that arise or to reflect the occurrence of unanticipated developments/circumstances after the date hereof. SOURCE Sun Pharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED