Tildrakizumab-ASMN

*仅供医学专业人士阅读参考 银屑病是一种需要长期管理的慢性炎症性皮肤病，不仅累及皮肤，还常伴随心血管疾病、肥胖、糖尿病、银屑病关节炎等共病，给患者带来沉重的身心负担。对于中重度斑块状银屑病患者，系统治疗是控制病情的主要手段。近年来，以IL-23为靶点的生物制剂在临床试验中展现出优异的疗效和安全性，但其在真实世界临床实践中的长期表现如何，仍需更多数据验证。 替瑞奇珠单抗是一种靶向IL-23 p19亚基的人源化单克隆抗体，其有效性和安全性在随机对照试验中已得到证实，且长期扩展研究显示疗效可持续长达5年[1,2]。然而，随机对照试验的严格入排标准限制了其结果向真实世界人群的外推。真实世界研究作为补充，能够反映药物在日常临床实践中的实际表现。 2024年，一项发表于Journal of Drugs in Dermatology的Ⅳ期、多中心、开放标签真实世界研究[3]，评估了替瑞奇珠单抗100 mg方案在中重度斑块状银屑病患者中长达64周的有效性和安全性，为其在真实世界中的长期应用提供了循证依据。 图1 替瑞奇珠单抗治疗中重度斑块状银屑病的64周真实世界有效性与安全性 本期特邀文献解读嘉宾 临汾市人民医院 房洁 主任医师 研究方法 这项Ⅳ期、多中心、非对照、开放标签真实世界研究在美国2个研究中心开展（NCT03718299），共纳入55例中重度斑块状银屑病患者。纳入标准包括：年龄≥18岁、诊断为斑块状银屑病至少6个月、受累体表面积≥3%、适合光疗或系统治疗。排除标准包括：红皮病型、仅表现为脓疱型、点滴型或反向型银屑病；存在其他可能干扰银屑病评估的皮肤病变；基线前1周内使用过替瑞奇珠单抗以外的生物制剂；基线前12周内使用过任何研究药物或器械。 所有患者接受替瑞奇珠单抗100 mg皮下注射，给药方案为第0周、第4周各一次，之后每12周一次至第52周。研究随访至第64周，访视时间点包括第4、8、12、16、28、40、52和64周。本次报告的疗效指标包括在所有访视点评估受累BSA百分比和静态医生整体评估（sPGA，0-5分制）；在第0、4、16、28、52周评估PASI评分，并计算达到PASI 75、PASI 90和PASI 100应答的患者比例。 研究结果 在筛选的60例患者中，55例入组，其中45例（81.8%）完成研究并在第64周接受评估；36例（65.5%）接受了直至第52周的全部剂量的替瑞奇珠单抗。结果表明，替瑞奇珠单抗治疗显著改善了受试者的皮损症状，疗效从第4周起即显现，并持续维持至64周。 在皮损范围方面，平均BSA从基线的14.5%降至第64周的2.1%，降幅达83.1%（P<0.001）。在皮损严重程度方面，平均sPGA评分从基线的3.2分降至第64周的1.0分，降幅为67.6%（P<0.001）。综合反映皮损范围和严重程度的BSA×sPGA复合指标从基线的47.0降至第64周的4.6，降幅高达89.6%（P<0.001）。 图2 从基线到第64周，BSA（A）、sPGA（B）以及BSA与sPGA乘积（C）平均值的变化 受试者的平均PASI评分从基线11.6分持续下降，第4周降至6.5分（降幅45.3%），第16周降至2.2分（降幅80.2%），第28周降至1.8分（降幅82.1%），第52周进一步降至1.6分，较基线降幅达到84.7%（P<0.001）。第52周时，PASI 75、PASI 90和PASI 100应答率分别达到87.0%、56.5%和32.6%，即超过半数患者实现了90%以上的皮损改善，近三分之一患者实现了皮损完全清除。 图3 从基线到第52周，受试者平均PASI评分（A）与PASI 75/90/100应答率（B）的变化 在安全性方面，大多数治疗期间不良事件（TEAE）为轻度，安全性特征与既往研究一致，未发现新的安全性信号。 讨论 这项真实世界研究首次报告了替瑞奇珠单抗100 mg在中重度斑块状银屑病患者中长达64周的长期有效性和安全性数据。研究结果显示，替瑞奇珠单抗治疗可显著改善BSA、sPGA、BSA×sPGA复合指标及PASI评分，且疗效从第4周起即显现并持续至64周。第52周时，超过半数患者达到PASI 90，近三分之一实现皮损完全清除。这些结果与既往Ⅲ期临床试验及其长期扩展研究的数据高度一致，证实了替瑞奇珠单抗在真实世界中的稳定疗效[1]。 值得注意的是，本研究的患者人群与Ⅲ期临床试验存在一定差异，基线BSA和PASI评分相对较低，提示真实世界中的患者疾病严重程度可能更为多样。尽管如此，疗效数据仍与Ⅲ期试验的长期随访结果相当[1]，表明替瑞奇珠单抗在不同疾病严重程度的患者中均能保持稳定的疗效。与其他真实世界研究（如德国TILOT研究）的结果相比，本研究的PASI应答率和安全性数据也表现出良好的一致性，进一步验证了替瑞奇珠单抗在真实临床实践中的可靠表现[4]。 总体而言，替瑞奇珠单抗100 mg方案在中重度斑块状银屑病患者中展现出持续稳定的疗效和良好的安全性。治疗第4周即见改善，疗效维持至64周，52周时约三分之一的患者可实现皮损完全清除。不良事件多为轻中度，且均与治疗无关，未发现新的安全性信号。这些结果为替瑞奇珠单抗在真实世界临床实践中的长期应用提供了有力循证支持。 病例分享：中重度斑块状银屑病患者使用替瑞奇珠单抗治疗近20个月，实现皮损全清 病例概况 患者为61岁男性，银屑病史10余年。因“中重度斑块状银屑病”就诊。既往曾先后使用外用糖皮质激素软膏、卡泊三醇软膏，口服阿维A、甲氨蝶呤等治疗，症状可减轻但易反复。专科查体可见全身散在红斑，红斑上覆盖银白色鳞屑，奥氏征阳性，疾病活动明显，PASI评分64.8分，评估为极重度。 治疗方案 经评估排除治疗禁忌（结核感染T细胞阴性，乙肝五项、丙肝抗体、肝肾功能、血常规及胸片均无异常）后，患者于2024年8月启动替瑞奇珠单抗治疗。治疗方案严格遵循药品说明书及临床指南：于第0周、第4周分别皮下注射替瑞奇珠单抗100 mg进行诱导治疗，随后转入维持期，每12周皮下注射100 mg。 疗效观察 治疗启动后，患者皮损得到持续、显著改善。治疗前（2024年8月5日）可见全身散在红斑，鳞屑明显，皮损广泛；治疗1个月后（2024年9月5日）皮损明显减轻，部分区域已清除，PASI评分下降至1.1；治疗3个月后（2024年10月31日）皮损进一步减少，仅少量残留；至治疗19.5个月后（2026年3月24日），皮损全清，仅余少许色沉。治疗过程中未报告严重不良事件，患者耐受性良好。 图4 治疗前后效果对比 病例小结 本例中重度斑块状银屑病患者在既往多种传统治疗疗效不佳、易复发的情况下，换用替瑞奇珠单抗后，接受了近20个月的持续治疗与随访，最终达到皮损完全清除，且长期维持过程中未见复发，安全性良好。该案例充分体现了替瑞奇珠单抗在银屑病长期管理中的稳定疗效与良好耐受性，为临床中追求深度、持久缓解的治疗目标提供了真实世界的有力参考。 专家简介 房洁 主任医师 临汾市人民医院 主任医师，现任临汾市人民医院皮肤性病科副主任 曾在北京空军总医院进修，系统学习了皮肤性病多发病、常见病及各种疑难杂症的诊治，对重症银屑病及重症药疹的诊治与抢救有丰富的临床经验。完成院内首例白癜风自体表皮移植手术。目前主要从事银屑病、痤疮、过敏性皮肤病、毛发疾病等方面的研究。 现任第二届中国白癜风研究联盟委员 山西省医学会皮肤科分会委员 山西省医学会变态反应学会委员 山西省老年医学会白癜风分会委员 山西省预防医学会皮肤科分会委员 临汾市医学会皮肤科分会委员 临汾市医学会变态反应学会委员 临汾市皮肤与性病科质控部主任 参考文献： [1]Reich K, Warren RB, Iversen L, et al. Long-term efficacy and safety of tildrakizumab for moderate-to-severe psoriasis: pooled analyses of two randomized phase III clinical trials (reSURFACE 1 and reSURFACE 2) through 148 weeks. Br J Dermatol. 2020;182(3):605-617. [2]Thaçi D, Piaserico S, Warren R, et al. Five-year efficacy and safety of tildrakizumab in patients with moderate-to-severe psoriasis who respond at week 28: pooled analyses of two randomized phase III clinical trials (reSURFACE 1 and reSURFACE 2). Br J Dermatol. 2021;185(2):323-334. [3]Heim J, Vasquez JG, Bhutani T, et al. Tildrakizumab Real-World Effectiveness and Safety Over 64 Weeks in Patients With Moderate-to-Severe Plaque Psoriasis. J Drugs Dermatol. 2024 Aug 1;23(8):612-618.  [4]Tsianakas A, Schwichtenberg U, Pierchalla P, et al. Real-world effectiveness and safety of tildrakizumab in long-term treatment of plaque psoriasis: results from the non-interventional, prospective, multicentre study TILOT. J Eur Acad Dermatol Venereol. 2023;37(1):85-92. *"医学界"力求所发表内容专业、可靠，但不对内容的准确性做出承诺；请相关各方在采用或以此作为决策依据时另行核查。 ↓↓↓点击【阅读原文】获取文献原文

Data presentations underscore category leadership and expertise in dermatology and immunology MUMBAI, India and PRINCETON, N.J., March 27, 2026 /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 the company will present 14 abstracts during the 2026 American Academy of Dermatology (AAD) Annual Meeting on March 27-31, 2026 in Denver, Colorado. The breadth of data reinforces the company's expertise across dermatology and immunology, and reflects the ongoing commitment to safe, effective medications that advance care for patients living with psoriasis, alopecia areata and acne. "The data we are presenting at AAD underscore our commitment to advancing dermatology and immunology through meaningful science – spanning not only clinical efficacy and safety, but also how these therapies perform over time and in real-world practice," said Ahmad Naim, MD, Senior Vice President and North American Chief Medical Officer, Sun Pharma. "Behind every data point is a person, and our responsibility is to continue investment in science that translates into clinically meaningful outcomes for people living with these chronic conditions." The podium and poster presentations span psoriasis, alopecia areata and acne. Notable presentations include: Data evaluating ILUMYA® (tildrakizumab-asmn) included a Phase 3b study in moderate-to-severe psoriasis affecting the nails showing sustained efficacy and safety over 52 weeks, as well as documented real-world evidence demonstrating that ILUMYA delivers holistic disease management achieving sustained disease control on skin and beyond, across diverse patient populations worldwide. These data are significant, as ILUMYA is indicated for moderate-to-severe plaque psoriasis in several countries, including the U.S., Australia and Japan, and Europe, where it is marketed under the brand name ILUMETRI®. Pooled data from THRIVE-AA1 and THRIVE-AA2 pivotal trials of LEQSELVI™ (deuruxolitinib) in severe alopecia areata demonstrated significant scalp hair regrowth as early as Week 8 and Week 12, with continuous improvements over time. A landmark survey of both patient and clinician perspectives in alopecia areata further revealed meaningful gaps in perceptions of disease burden and treatment goals, underscoring the need for stronger communication and better alignment to support patient-centered care. An open-label, 52-week study evaluating WINLEVI® (clascoterone cream 1%) demonstrated significant and progressive reduction in casual facial sebum production and acne severity, further reinforcing its ability to directly target the androgen-sebum pathway. Additionally, pilot combination therapies showed that WINLEVI may provide benefit in multimodal acne therapies, signaling broader applicability in clinical use. At AAD, Sun Pharma will also offer hands-on, immersive engagement opportunities for clinicians at its booth exhibit (Booth #2915), bringing the science behind the portfolio to life. Attendees will be able to explore interactive experiences that highlight the full dermatology and immunology portfolio. The 2026 AAD Annual Meeting e-Posters are available here. All abstracts accepted for presentation by the company are outlined below. * Indicates data generated by Almirall; Sun Pharma and Almirall operate under a licensing agreement on the development and commercialization of tildrakizumab for psoriasis in Europe About ILUMYA® ILUMYA (tildrakizumab-asmn) is a humanized lgG1/k monoclonal antibody designed to selectively bind to the p19 subunit of interleukin-23 (IL-23) and inhibit its interaction with the IL-23 receptor, leading to inhibition of the release of pro-inflammatory cytokines and chemokines. ILUMYA is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy, in the United States. ILUMYA has also been approved for moderate-to-severe plaque psoriasis in Australia and Japan, and under the brand name ILUMETRI® in Europe, where it is marketed by Almirall. INDICATIONS AND USAGE ILUMYA (tildrakizumab-asmn) is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. CONTRAINDICATIONS ILUMYA is contraindicated in patients with a previous serious hypersensitivity reaction to tildrakizumab or to any of the excipients. IMPORTANT SAFETY INFORMATION WARNINGS AND PRECAUTIONS Hypersensitivity Cases of angioedema and urticaria occurred in ILUMYA-treated subjects in clinical trials. If a serious allergic reaction occurs, discontinue ILUMYA immediately and initiate appropriate therapy. Infections ILUMYA may increase the risk of infection. Treatment with ILUMYA should not be initiated in patients with a clinically important active infection until the infection resolves or is adequately treated. Consider the risks and benefits of treatment prior to prescribing ILUMYA in patients with a chronic infection or a history of recurrent infection. Instruct patients receiving ILUMYA to seek medical help if signs or symptoms of clinically important chronic or acute infection occur. If a patient develops a clinically important or serious infection, or is not responding to standard therapy, closely monitor and consider discontinuation of ILUMYA until the infection resolves. Pretreatment Evaluation for Tuberculosis Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with ILUMYA. Do not administer ILUMYA to patients with active TB infection. Initiate treatment of latent TB prior to administering ILUMYA. Consider anti-TB therapy prior to initiation of ILUMYA in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Patients receiving ILUMYA should be monitored closely for signs and symptoms of active TB during and after treatment. Immunizations Prior to initiating therapy with ILUMYA, consider completion of all age-appropriate immunizations according to current immunization guidelines. Patients treated with ILUMYA should not receive live vaccines. Adverse Reactions The most common (≥1%) adverse reactions associated with ILUMYA treatment that were more frequent than in the placebo group are upper respiratory infections, injection-site reactions, and diarrhea. Please see Full Prescribing Information. About LEQSELVI™ LEQSELVI (deuruxolitinib) 8 mg tablets is an oral selective inhibitor of Janus kinases JAK1 and JAK2 approved for the treatment of adults with severe alopecia areata. Alopecia areata is an autoimmune disease in which the immune system attacks hair follicles, resulting in partial or complete loss of hair on the scalp and body. Alopecia areata may affect up to 2.5% of the United States and global population during their lifetime. The scalp is the most commonly affected area, but any hair-bearing site can be affected alone or together with the scalp. Onset of the disease can occur throughout life and affects both women and men. Alopecia areata can be associated with serious psychological consequences, including anxiety and depression. There are currently limited approved treatment options available for alopecia areata. LEQSELVI Important Safety Information Please click here for full Prescribing Information Including BOXED WARNING and Medication Guide. Indications and Usage LEQSELVI (deuruxolitinib) is a Janus kinase (JAK) inhibitor indicated for the treatment of adults with severe alopecia areata. Limitations of Use LEQSELVI is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants. Contraindications LEQSELVI is contraindicated in patients who are CYP2C9 poor metabolizers or who are using moderate or strong CYP2C9 inhibitors. Warnings Serious Infections Increased risk of serious bacterial, fungal, viral and opportunistic infections including tuberculosis (TB) that may lead to hospitalization or death. Interrupt treatment with LEQSELVI if a serious infection occurs until the infection is controlled. Test for latent TB before and during therapy; treat latent TB prior to use. Monitor all patients for active TB during treatment, even patients with initial negative, latent TB test. Mortality Higher rate of all-cause mortality, including sudden cardiovascular death with another Janus kinase inhibitor (JAK) vs. TNF blockers in rheumatoid arthritis (RA) patients. LEQSELVI is not approved for use in RA patients. Malignancy Malignancies have occurred in patients treated with LEQSELVI. Higher rate of lymphomas and lung cancers with another JAK inhibitor vs. TNF blockers in RA patients. Major Adverse Cardiovascular Events Higher rate of MACE (defined as cardiovascular death, myocardial infarction, and stroke) with another Janus kinase inhibitor (JAK) vs. TNF blockers in rheumatoid arthritis (RA) patients. Thrombosis Thrombosis, including PE, DVT & CVT, has occurred in patients treated with LEQSELVI. Increased incidence of pulmonary embolism, venous and arterial thrombosis with another JAK inhibitor vs. TNF blockers. Increased risk of serious adverse reactions in CYP2C9 poor metabolizers or with concomitant use of moderate or strong CYP2C9 inhibitors Do not treat patients who are CYP2C9 poor metabolizers or patients taking a moderate or strong CYP2C9 inhibitor with LEQSELVI. Gastrointestinal Perforations GI perforations have occurred in patients treated with LEQSELVI. Monitor patients who may be at increased risk for gastrointestinal perforation. Evaluate promptly patients presenting with new onset abdominal symptoms. Lipid elevations, anemia, neutropenia, and lymphopenia Monitor for changes in lipids, hemoglobin, neutrophils, and lymphocytes. Immunizations Avoid use of live vaccines during or immediately prior to LEQSELVI treatment. Prior to initiating LEQSELVI, it is recommended that patients be brought up to date with all immunizations. Dosage The recommended dosage of LEQSELVI for the treatment of severe alopecia areata is 8 mg orally twice daily, with or without food. Before treatment with LEQSELVI, perform the following evaluations: CYP2C9 genotype & use of moderate or strong CYP2C9 inhibitors; Active and latent tuberculosis evaluation; Viral hepatitis screening; Complete blood count (LEQSELVI treatment is not recommended in patients with an absolute lymphocyte count (ALC) <500 cells/mm3 absolute neutrophil count (ANC) <1,000 cells/mm3, or hemoglobin level <8 g/dl). Adverse Reactions Most common adverse reactions (≥1%) are headache, acne, nasopharyngitis, blood creatine phosphokinase increased, hyperlipidemia, fatigue, weight increased, lymphopenia, thrombocytosis, anemia, skin and soft tissue infections, neutropenia, and herpes. Use in Specific Populations Based on animal studies, LEQSELVI may cause fetal harm during pregnancy. Pregnant women should be advised of a risk to the fetus. Consider pregnancy planning and prevention for women of reproductive potential. LEQSELVI should not be used by women who are breastfeeding until one day after the last dose. LEQSELVI should not be used by patients with severe renal impairment or severe hepatic impairment. To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1- 800-818-4555 or FDA at 1-800-FDA-1088 or . About WINLEVI® INDICATION WINLEVI (clascoterone) cream 1% is an androgen receptor inhibitor indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS: None. WARNINGS AND PRECAUTIONS Local Irritation: Pruritus, burning, skin redness or peeling may be experienced with WINLEVI cream. If these effects occur, discontinue or reduce the frequency of application of WINLEVI cream. Hypothalamic-pituitary-adrenal (HPA) axis suppression may occur during or after treatment with WINLEVI. In the pharmacokinetics (PK) trial, HPA axis suppression was observed in 1/20 (5%) of adult subjects and 2/22 (9%) of adolescent subjects at Day 14. All subjects returned to normal HPA axis function at follow-up 4 weeks after stopping treatment. Conditions which augment systemic absorption include use over large surface areas, prolonged use, and the use of occlusive dressings. Attempt to withdraw use if HPA axis suppression develops. Pediatric patients may be more susceptible to systemic toxicity. Hyperkalemia: Elevated potassium levels were observed in some subjects during the clinical trials. Shifts from normal to elevated potassium levels were observed in 5% of WINLEVI-treated subjects and 4% of vehicle-treated subjects. ADVERSE REACTIONS Most common adverse reactions occurring in 7 to 12% of patients are erythema/reddening, pruritus and scaling/dryness. Additionally, edema, stinging, and burning occurred in >3% of patients and were reported in a similar percentage of subjects treated with vehicle. 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 U.S. as well as global emerging markets. Sun Pharma's high-growth global specialty portfolio spans innovative products in dermatology, ophthalmology, and oncodermatology 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 multicultural workforce drawn from over 50 nations. For further information, please visit and follow us on LinkedIn & X. Contacts: Sun Pharma CORP-US-SUN-0059 © 2026 Sun Pharmaceutical Industries, Inc. All rights reserved. WINLEVI is a registered trademark of Cassiopea S.p.A., used under exclusive license. All other trademarks are property of their respective owners. SOURCE Sun Pharma 21% more press release views with Request a Demo