Ustekinumab-Aauz

大国名医 陈旻湖 教授 主任医师 消化内科首席专家 学科带头人 国务院特殊津贴专家 中华医学会消化病学分会主任委员 中国医师协会消化医师分会副会长 第九届亚洲炎症性肠病协会主席 中华消化杂志副总编辑 中华炎性肠病杂志副总编辑 Journal of Digestive Disease共同主编 1 炎症性肠病 陈旻湖教授介绍，炎症性肠病虽然病变在胃肠道，但会累及全身，包括皮肤、关节、眼睛和肝脏都可能有损伤，临床上称为肠外表现。炎症性肠病的并发症很多，可以引起肠梗阻、肠穿孔、肠瘘，病史较长的患者可能癌变。炎症性肠病需要和其它疾病做鉴别，临床上易被误诊。　　 炎症性肠病的发病与自身免疫功能紊乱有关，目前临床上多针对免疫紊乱进行治疗，其他的治疗方法如粪菌移植、干细胞移植等疗法还都处于研究阶段。　 对于在国内已经开始较大范围应用的粪菌移植疗法，陈旻湖教授认为走的太快了一点，他不主张现在就大规模的开展临床应用，因为还有很多问题没有搞清楚。　　 陈旻湖教授解释，研究发现，炎症性肠病患者的肠道会发生菌群紊乱，或者叫微生态失衡。研究显示，接受健康人的粪菌移植后，部分溃疡性结肠炎患者症状可以得到不同程度的缓解，部分患者内镜下黏膜炎症也有改善。　　 但问题在于一是移植不方便，二是效果不能持久，停止粪菌移植后病人很快复发。人体肠道微生态十分复杂，我们不知道该移植什么菌种、移植多少菌量、多久移植一次，也许每个患者都不一样，需要进行个体化研究。现在不清楚的问题还太多，粪菌移植应该限于临床研究。　　 在国际上，公认的粪菌移植临床应用仅限于难辨梭状芽孢杆菌感染。“国际公认粪菌移植可用于难治性的难辨梭状芽孢杆菌感染的治疗，而且是一线治疗后复发的病人才需要使用粪菌移植来治疗，在其它疾病领域，欧美国家都没有批准用于临床治疗。”　　 得了炎症性肠病的患者，意味着要长期与药物相伴。陈旻湖教授表示，炎症性肠病患者没有统一的固定疗程。目前认为，当病人治疗后症状得到完全缓解，内镜下看到黏膜愈合，炎症生物指标正常后，最好再维持用药1-2年，化验检查依然正常，方可考虑逐渐停药并随访。 炎症性肠病（IBD），包括克罗恩病（CD）和溃疡性结肠炎（UC），是一组慢性、复发性肠道疾病，近年来在全球范围内发病率呈上升趋势。数据显示，中国的IBD患者数量不断增加，给患者的生活质量及医疗系统带来了巨大的挑战。 2 治疗炎症性肠病 克罗恩病，是一种典型的炎症性肠病（IBD），发病高峰年龄是15- 35岁，病因及发病机制尚未完全明确、易反复发作，目前没有治疗手段可以完全根治。一旦确诊，就意味着患者需终生与该疾病为伴，虽不致命，但严重影响生活质量，所以克罗恩病也被称为“绿色癌症”、“不死的癌症”。 “克罗恩病影响着整个消化道，主要症状为胃肠道溃疡，可以导致肠道狭窄和穿孔，非常容易复发且致残率高，超过一半的患者需要进行多次手术治疗。”陈旻湖道。 2023年由中山大学附属第一医院消化内科学科带头人陈旻湖牵头完成的研究，验证了全球首个白细胞介素-6（IL-6）反式信号通路抑制剂-Olamkicept（奥拉奇西普或TJ301）可有效治疗中重度溃疡性结肠炎，显著提高IBD患者的临床应答、临床缓解和黏膜愈合等疗效指标，且安全性良好。 陈旻湖表示，该研究将为中国炎症性肠病患者带来更有效、更安全的治疗方案，奥拉奇西普总体安全性、耐受性良好，更适合于早期及长期使用，可有效减少炎症性肠病疾病并发症和死亡率。 2024年是IBD治疗领域的关键之年，多种靶向机制的生物制剂获得全球范围的批准，彰显出治疗策略的多样性与精细化。紧随米利珠单抗（Mirikizumab）的上市，其他生物制剂，包括古塞奇尤单抗（Guselkumab）、利生奇珠单抗（Risankizumab）也在2024年相继获美国食品与药物管理局（Food and Drug Administration，FDA）批准用于中重度UC患者的治疗。 这些药物通过阻断IL-23的信号通路，调控过度活跃的免疫反应，为患者提供了一种高效、可控的新选择。而作为选择性 S1P1受体调节剂（sphingosine-1-phosphate receptor modulator）的伊曲莫德（etrasimod）也在欧洲药品管理局（European Medicines Agency ，EMA)批准下用于中重度UC患者的治疗。此外，多款生物类似药（biosimilars）兴起，如Otulfi、Fymskina等（Ustekinumab生物类似药）在美国和欧洲地区获批中重度UC和CD的适应证。这些药物在疗效、安全性与原研药相当的同时，大幅降低了治疗成本，为患者提供了更多选择。 3 推动中国炎症性肠病诊疗水平 陈旻湖为进一步推动我国IBD诊疗水平的全面提升，成立了中国炎症性肠病诊治质控评估中心（Inflammatory Bowel Disease Quality of Care Center，IBDQCC）。 自2018年成立以来，在中华医学会消化病学分会和IBD学组的指导下，致力于构建符合我国国情的IBD规范化诊疗体系。其核心任务包括制定内镜、病理及影像学检查的质量控制标准，规范化IBD药物治疗流程，推进IBD中心建设，培养IBD专科医生，以及建立分级诊疗制度，以满足全国各级医疗机构服务IBD患者的需求。 2024年，IBDQCC进一步深化其工作内容，通过加强区域协作，推动多级质控体系建设，并积极促进IBD诊疗的精准化和高质量发展。具体举措包括组织区域内的互动交流与学术会议，发起和支持IBD科研基金项目，提升基层和专科医生的科研能力，以及系统化开展专科医师培训。 2024年，IBDQCC专家组正式发布了《乌帕替尼治疗IBD患者临床规范化使用流程（SOP）》。这是我国首个针对小分子药物治疗IBD的规范性指导意见，为未来更多新型药物在中国的推广和应用奠定了基础。此外，IBDQCC成功将全国29家医疗单位纳入2024年度IBD区域中心名单。这一举措不仅进一步完善了IBD区域诊疗中心的覆盖范围，也为构建全国IBD专病医联体提供了有力支持。 通过持续优化标准、加强合作和推动科研创新，IBDQCC正在逐步引领中国IBD诊疗迈向高质量、国际化的道路，为患者提供更加精准和个体化的诊疗方案，也标志着中国IBD规范化管理水平正在稳步提升至国际前沿。 “一名优秀的医生，不能只考虑治疗某个患者，还要考虑如何通过个人能力影响到广大同行，继而为更多患者带来健康。”正是基于这样的医者担当与社会责任，陈旻湖推动我国在IBD领域直追西方甚至赶超西方。 【护卫通医事服务公司介绍】

45 mg/0.5 mL single dose vial provides dosing flexibility for pediatric patients LAKE ZURICH, Ill.--(BUSINESS WIRE)-- #CommittedToLife --Fresenius Kabi, an Operating Company of Fresenius, and a leading provider of essential medicines and medical technologies, announced today it has introduced a new presentation of Otulfi ® (ustekinumab-aauz) in a 45 mg/0.5 mL single-dose vial for subcutaneous injection. Otulfi ® is a prescription medicine and the brand name for Fresenius Kabi’s FDA-approved biosimilar of the reference product, Stelara ® (ustekinumab). With this addition, Fresenius Kabi now offers all dosage forms and strengths of the reference product, giving physicians flexibility and supporting patient treatment continuity. Fresenius Kabi’s Otulfi ® has also received interchangeability designation from the FDA. Otulfi ® was approved by the U.S. Food and Drug Administration in September 2024 for the treatment of adults with moderately to severely active Crohn’s disease and ulcerative colitis, and adults and pediatric patents ages 6 and older with moderate to severe plaque psoriasis (who are candidates for phototherapy or systemic therapy) and active psoriatic arthritis. The new dosage form provides dosing flexibility for pediatric patients under 60kg (132 lbs) who have plaque psoriasis and psoriatic arthritis. In March, Fresenius Kabi introduced Otulfi ® in 45 mg/0.5mL and 90mg/mL single-dose prefilled syringes for subcutaneous injection and a 130mg/26mL single-dose vial for intravenous infusion. “With this new presentation of Otulfi, we’re expanding treatment options for pediatric patients and reinforcing our commitment to improving access to biosimilars. Fresenius Kabi continues to grow its biosimilar portfolio to ensure patients of all ages benefit from therapies that meet the FDA’s rigorous standards for safety and efficacy," said Dr. Sang-Jin Pak, President Biopharma, Fresenius Kabi. In May 2025, the FDA designated Otulfi ® (ustekinumab-aauz) as an interchangeable biosimilar to the reference product Stelara ® (ustekinumab). Depending on state pharmacy laws in the U.S., an interchangeable biosimilar can be dispensed at the pharmacy as a substitute for the reference product without requiring direct approval from the prescribing healthcare provider 1 . This can lead to a reduced administrative burden. Not all biosimilars receive interchangeability status. About Otulfi ® (ustekinumab-aauz) Otulfi ® (ustekinumab-aauz) is indicated for the treatment of moderately to severely active Crohn’s disease and ulcerative colitis in adult patients; moderate to severe plaque psoriasis for adult patients and pediatric patients six years or older, who are candidates for phototherapy or systemic therapy; and active psoriatic arthritis in adults and pediatric patients six years or older. Otulfi ® is contraindicated in patients with clinically significant hypersensitivity to ustekinumab products or to any of the excipients in Otulfi ® . The drug received FDA approval in September 2024 and has been available in the U.S. since March 2025. Otulfi ® is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23, which play an important role in inflammatory and immune responses. The FDA approval of Otulfi ® was based on a thorough evaluation of a comprehensive data package including analytical, pre-clinical, clinical, and manufacturing data. Otulfi ® demonstrated comparable efficacy, safety, pharmacokinetics and immunogenicity to the reference drug Stelara ® in patients with moderate to severe plaque psoriasis. Otulfi ® was approved for both subcutaneous and intravenous formulations which will offer a comprehensive, alternative treatment solution for health care professionals and patients treated with ustekinumab in the U.S. Fresenius Kabi’s growing pipeline of autoimmune and oncology biosimilars has several molecules in early and late-stage development. Indications Otulfi ® (ustekinumab-aauz) is an IL-12/23 antagonist indicated for treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; active psoriatic arthritis; moderately to severely active Crohn’s disease; moderately to severely active ulcerative colitis. Otulfi ® is also indicated for pediatric patients ≥6 years of age with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy and active psoriatic arthritis. IMPORTANT SAFETY INFORMATION Otulfi ® (ustekinumab-aauz) is contraindicated in patients with clinically significant hypersensitivity to ustekinumab products or to any of the excipients in Otulfi ® (ustekinumab-aauz). Infections Ustekinumab products may increase the risk of infections and reactivation of latent infections. Serious bacterial, mycobacterial, fungal, and viral infections were observed in patients receiving ustekinumab products. Serious infections requiring hospitalization, or otherwise clinically significant infections, reported in clinical trials included the following: Plaque psoriasis: diverticulitis, cellulitis, pneumonia, appendicitis, cholecystitis, sepsis, osteomyelitis, viral infections, gastroenteritis, urinary tract infections; Psoriatic arthritis: cholecystitis; Crohn’s disease: anal abscess, gastroenteritis, ophthalmic herpes zoster, pneumonia, Listeria meningitis and Ulcerative colitis: gastroenteritis, ophthalmic herpes zoster, pneumonia, listeriosis. Avoid initiating treatment with Otulfi ® (ustekinumab-aauz) 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 initiating use of Otulfi ® (ustekinumab-aauz) in patients with a chronic infection or a history of recurrent infection. Instruct patients to seek medical advice if signs or symptoms suggestive of an infection occur while on treatment with Otulfi ® (ustekinumab-aauz). Discontinue Otulfi ® (ustekinumab-aauz) for serious or clinically significant infections until the infection resolves or is adequately treated. Theoretical Risk for Vulnerability to Particular Infections Individuals genetically deficient in IL-12/IL-23 are particularly vulnerable to disseminated infections from mycobacteria (including nontuberculous, environmental mycobacteria), Salmonella (including nontyphi strains), and Bacillus Calmette-Guerin (BCG) vaccinations. Serious infections and fatal outcomes have been reported in such patients. It is not known whether patients with pharmacologic blockade of IL-12/IL-23 from treatment with ustekinumab products may be susceptible to these types of infections. Consider appropriate diagnostic testing (e.g., tissue culture, stool culture, as dictated by clinical circumstances). Pre-Treatment Evaluation of Tuberculosis (TB) Evaluate patients for TB prior to initiating treatment with Otulfi ® (ustekinumab-aauz). Avoid administering Otulfi ® (ustekinumab-aauz) to patients with active TB infection. Initiate treatment of latent TB before administering Otulfi ® (ustekinumab-aauz). Consider anti-TB therapy prior to initiation of Otulfi (ustekinumab-aauz) in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Closely monitor patients receiving Otulfi ® (ustekinumab-aauz) for signs and symptoms of active TB during and after treatment. Malignancies Ustekinumab products are immunosuppressants and may increase the risk of malignancy. Malignancies were reported among subjects who received ustekinumab in clinical trials. In rodent models, inhibition of IL-12/IL-23p40 increased the risk of malignancy. The safety of ustekinumab products has not been evaluated in patients who have a history of malignancy or who have a known malignancy. There have been reports of the rapid appearance of multiple cutaneous squamous cell carcinomas in patients receiving ustekinumab products who had pre-existing risk factors for developing non-melanoma skin cancer (NMSC). Monitor all patients receiving Otulfi ® (ustekinumab-aauz) for the appearance of NMSC. Closely follow patients >60 years of age, those with a medical history of prolonged immunosuppressant therapy, and those with a history PUVA treatment. Hypersensitivity Reactions Hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with ustekinumab products. If an anaphylactic or other clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue Otulfi ® (ustekinumab-aauz). Posterior Reversible Encephalopathy Syndrome (PRES) Two cases of posterior reversible encephalopathy syndrome (PRES), also known as Reversible Posterior Leukoencephalopathy Syndrome (RPLS), were reported in clinical trials. Cases have also been reported in postmarketing experience in patients with psoriasis, psoriatic arthritis, and Crohn’s disease. Clinical presentation included headaches, seizures, confusion, visual disturbances, and imaging changes consistent with PRES a few days to several months after initiating ustekinumab products. A few cases reported latency of a year or longer. Patients recovered with supportive care following withdrawal of ustekinumab. Monitor all patients treated with Otulfi ® (ustekinumab-aauz) for signs and symptoms of PRES. If PRES is suspected, promptly administer appropriate treatment and discontinue Otulfi ® (ustekinumab-aauz). Immunizations Prior to initiating therapy with Otulfi ® (ustekinumab-aauz), patients should receive all age-appropriate immunizations as recommended by current immunization guidelines. Patients being treated with Otulfi ® (ustekinumab-aauz) should not receive live vaccines. Avoid administering BCG vaccines during treatment with Otulfi ® (ustekinumab-aauz), or for one year prior to initiating treatment or one year following discontinuation of treatment. Caution is advised when administering live vaccines to household contacts of patients receiving Otulfi ® (ustekinumab-aauz) because of the potential risk for shedding from the household contact and transmission to patient. Non-live vaccinations received during a course of Otulfi ® (ustekinumab-aauz) may not elicit an immune response sufficient to prevent disease. Noninfectious Pneumonia Cases of interstitial pneumonia, eosinophilic pneumonia, and cryptogenic organizing pneumonia have been reported during post-approval use of ustekinumab products. Clinical presentations included cough, dyspnea, and interstitial infiltrates following one to three doses. Serious outcomes have included respiratory failure and prolonged hospitalization. Patients improved with discontinuation of therapy and in certain cases, administration of corticosteroids. If diagnosis is confirmed, discontinue Otulfi ® (ustekinumab-aauz) and institute appropriate treatment. Most Common Adverse Reactions The most common adverse reactions (≥3%) seen in patients treated with Otulfi ® (ustekinumab-aauz) are: Psoriasis: nasopharyngitis, upper respiratory tract infection, headache, fatigue; Crohn’s disease, induction: vomiting; Crohn’s disease, maintenance: nasopharyngitis, injection site erythema, vulvovaginal candidiasis/mycotic infection, bronchitis, pruritus, urinary tract infection, sinusitis; Ulcerative colitis, induction: nasopharyngitis and Ulcerative colitis, maintenance: nasopharyngitis, headache, abdominal pain, influenza, fever, diarrhea, sinusitis, fatigue, nausea. To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or to report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or . Please click to see the full Prescribing Information and Medication Guide for Otulfi ® (ustekinumab-aauz) here . About Fresenius Kabi As a global healthcare company, Fresenius Kabi is Committed to Life. The company’s products, technologies, and services are used for the therapy and care of patients with critical and chronic conditions. With more than 41,000 employees and present in more than 100 countries, Fresenius Kabi’s expansive product portfolio focuses on providing access to essential medicines and technologies. In Biopharma, Fresenius Kabi offers cutting-edge biosimilars for autoimmune diseases and oncology. With leading market positions in Clinical Nutrition, a broad portfolio of enteral and parenteral products makes a distinct difference in patients’ nutritional status. In MedTech, the company provides vital infusion pumps, cell and gene therapy devices, disposables, and more. Fresenius Kabi is a global leader in supplying blood collection bags and devices, supporting blood banks and health care facilities worldwide. The company’s I.V. Generics and Fluids for infusion therapy help save millions of lives every year, in emergency medicine, surgery, oncology, and intensive care. Fresenius Kabi takes a holistic approach to health care and uniquely combines experience, expertise, innovation, and dedication – making a difference in the lives of 450 million patients annually. With the #FutureFresenius strategy, the company is developing, producing, and selling new products and technologies and aspires to expand its position as a leading global provider of therapies, improve patient care, generate sustainable value for stakeholders – shaping the future of healthcare. Fresenius Kabi is part of the Fresenius Group, founded in 1912, along with Helios and Quirónsalud. As ONE team, the companies in the Fresenius Group are committed to providing lifesaving and life-changing healthcare solutions on a global scale. For more information, please visit . To learn about U.S. career opportunities at Fresenius Kabi, visit us at and follow us on LinkedIn and Facebook . Reference: U.S. Food and Drug Administration. (2024, June 20). 9 Things to Know About Biosimilars and Interchangeable Biosimilars . This release contains forward-looking statements that are subject to various risks and uncertainties. Future results could differ materially from those described in these forward-looking statements due to certain factors, e.g., changes in business, economic and competitive conditions, regulatory reforms, results of clinical trials, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. Fresenius Kabi does not undertake any responsibility to update the forward-looking statements in this release. Otulfi ® (ustekinumab-aauz) is a trademark of Fresenius Kabi Deutschland GmbH in selected countries. Stelara ® is a registered trademark of Johnson & Johnson. Contacts Media contact Joanie Clougherty (614) 717-5741 Joan.Clougherty@fresenius-kabi.com