A report of 10 cases of paradoxical reaction to rituximab (RTX) in patients with pemphigus is presented.Of 10 included patients (six men and four women), nine had pemphigus vulgaris, and one had pemphigus foliaceus , with the mean age of 51.9 ± 10.8 years and all patients had received RTX biosimilar (Zytux, AryoGen Pharmed, Tehran, Iran) at the dose of 2 g; post-RTX worsening interval ranged from one day to three months after the first infusion of the index cycle.Cases safely received RTX for the first time, but experienced disease exacerbation following further administration.Results show that pemphigus worsening upon administration of RTX biosimilar or original RTX is an important adverse effect to consider.In conclusion, although being extremely rare, RTX therapy may exacerbate pemphigus for unknown reasons. Increasing in prednisolone dosage and/or IVIg administration seem practical approaches to control disease after such event.

2019-11-01·Multiple sclerosis and related disorders3区 · 医学

Evaluating the efficacy and safety of ZytuxTM (Rituximab, AryoGen pharmed) in Iranian multiple sclerosis patients: An observational study

3区 · 医学

Article

作者: Hashemi, Seyedeh Nafiseh ; Naser Moghadasi, Abdorreza ; Darki, Aala ; Masoumi, Peiman ; Ghadiri, Fereshteh

BACKGROUND:

Anti-CD20 monoclonal antibodies such as ocrelizumab, rituximab, and ofatumumab target B-cell lineage. Clinical trials have demonstrated their effect on reducing both magnetic resonance imaging (MRI) active lesion burden as well as clinical activity. Zytux™ (Rituximab, AryoGen Pharmed) used in the present study for multiple sclerosis (MS) patients is basically a biosimilar rituximab. In this observational study, a total of 100 patients receiving Zytux™ were collected to see its effect on the clinical course of the disease.

MATERIALS AND METHODS:

The files of 100 MS patients, who received Zytux™ in a referral center (Sina MS Clinic in Tehran, Iran), were analyzed as a hospital-based observational study. Patients' age and disease duration until the start of Zytux™, expanded disability status scale (EDSS) at the baseline and in the last visit after administration of the drug, and annual relapse rate (ARR) before and after initiating Zytux™ were studied. Disease activity was evaluated both clinically and via MRI.

RESULT:

A total of 100 MS patients including 36 males and 64 females participated in the present study. The patients included 20 relapsing remitting MS (RRMS), 20 primary progressive MS (PPMS), and 60 secondary progressive MS (SPMS) patients. Totally, the mean of EDSS score before and after the administration of drug was 5.50 ± 1.04 (ranging from 1 to 7) and 5.11 ± 1.59 (ranging from 0 to 7), respectively, with the difference between them being very significant (p-value: 0.000). Also, the mean of ARR before and after the initiation of the medication was 0.47 and 0.10, respectively, whose difference was also significant (p-value: 0.000). In our study, the greatest effect of Zytux™ was observed in RRMS patients. At the time of injection, 70 patients indicated some reactions including limb pain, skin sensitivity, and throat irritation. One month after the injection, one of the patients suffered from pneumonia and two patients had a urinary tract infection.

CONCLUSION:

The observed results revealed that the Zytux™ could have a positive and significant effect on all types of MS.

2018-04-01·International journal of hematology-oncology and stem cell research

A Double-Blind, Randomized Comparison Study between Zytux™ vs MabThera® in Treatment of CLL with FCR Regimen: Non-Inferiority Clinical Trial.

Article

作者: Razavi, Seyed Mohsen ; Ravanbod, Mohammad Reza ; Toogeh, Gholamreza ; Jalaeikhoo, Hassan ; Rezaei Darzi, Ehsan ; Allahyari, Abolghasem ; Alizadeh Fard, Shadi Sadat ; Fallahazad, Vahid ; Zarrabi, Fariba ; Faranoush, Mohammad

BACKGROUND:

Chronic lymphocytic leukemia (CLL) is characterized by accumulation of B cells in blood, lymphoid tissues and bone marrow. Addition of rituximab to CLL chemotherapy regimens has been associated with improved survival. The aim of this study was to establish efficacy and safety of Zytux™ in comparison to MabThera^® in treatment of CLL.

MATERIALS AND METHODS:

Seventy CLL patients who met the criteria for entering the study were randomized into two groups (35 patients in each group). Both groups received Fludarabine and Cyclophosphamide plus Rituximab as part of the FCR regimen. Group A was treated with Zytux™, and group B was treated with MabThera^®. A non-inferiority margin of 20% for the primary outcome was defined to examine the similarity between Zytux™ and MabThera^®.

RESULTS:

Baseline demographic characteristics showed no statistically signiﬁcant difference between the two groups. The two treatment groups were comparable in terms of laboratory and clinical findings, cellular index changes and CD (5, 19, 20 and 23) counts during therapy cycles and at the end of the treatment period. Regarding safety results, Zytux™ demonstrated a similar profile of adverse reactions in comparison to MabThera^®. Moreover, the overall response rate was 88% and 89% for Zytux™ and MabThera^®, respectively (CI -0.17, 0.18).

CONCLUSION:

Results showed non-inferiority of Zytux™ in terms of efficacy and adverse events as a biosimilar version of MabThera^®.

项与利妥昔单抗生物类似药(Aryogen) 相关的新闻（医药）

2023-01-19

·美通社

汉利康（利妥昔单抗注射液）新增RA适应症成功进入医保目录

将惠及更多类风湿关节炎患者北京 2023年1月19日 /美通社/ -- 类风湿关节炎（RA）是一种以侵蚀性关节炎症为主要临床表现的慢性、高致残性自身免疫病，患者往往表现为关节肿痛，病情多反复且逐渐加重，最终导致关节结构破坏进而致残，严重影响患者的身体机能、生活质量和社会功能。流行病学数据显示，RA是我国最常见的系统性风湿病，患者总数约达500万人，疾病负担颇为沉重 [1-2] 。此外，由于诊治延误、中-重症多、合并症多等原因，我国RA患者的诊疗现状并不理想，患者亟需更有效的治疗手段。而近年来涌现的一些RA创新治疗药物，例如精准靶向清除B细胞的利妥昔单抗，有望改善RA的临床治疗结局，为患者带来新的希望。 2023年01月18日，国家医保局正式公布了《国家基本医疗保险、工伤保险和生育保险药品目录（2022年）》（下文简称"国家医保目录"），让RA患者迎来了期盼已久的好消息：国内首个生物类似药，也是国内目前唯一获批 RA适应症的复星医药利妥昔单抗汉利康（HLX01）新增RA适应症成功进入本次国家医保目录，将大幅减轻RA患者的治疗负担，让这款强效安全的创新药物惠及更多患者！国家医保目录信息图汉利康 ® 2019年2月获国家药品监督管理局（NMPA）批准上市，用于非霍奇金淋巴瘤和慢性淋巴细胞白血病的治疗，全面覆盖了原研利妥昔单抗在中国获批的所有适应症。由于原研利妥昔单抗的RA适应症在中国尚未获批，汉利康 ® 又针对类风湿关节炎治疗进行了积极探索，并基于关键临床研究结果于2022年3月正式获NMPA批准，与甲氨蝶呤联合用于对一种及以上TNF-α抑制剂疗效不佳的中重度活动性RA成人患者。强效安全、长效便捷，汉利康 ® 强势入局 RA治疗汉利康 ® 获批治疗中重度活动性RA适应症，是基于随机、双盲、安慰剂对照临床III期研究HLX01-RA03的结果，该研究评估了在甲氨蝶呤治疗应答不完全（MTX-IR）的中重度活动性RA患者中，汉利康 ® 联合MTX治疗对比安慰剂+MTX治疗的有效性和安全性。 HLX01-RA03这项关键临床III期研究证实，汉利康 ® 联合MTX相较于安慰剂，在MTX治疗应答不完全的我国中重度活动性RA患者中，具有显著的临床疗效和良好的安全性，是RA患者安全有效的治疗选择。精准靶向清除 B细胞，是汉利康 ® 的制胜关键汉利康 ® 治疗RA的作用机制，是通过与B细胞表面的CD20特异性结合，通过抗体依赖细胞介导的细胞毒性作用（ADCC）、补体依赖的细胞毒性作用（CDC）和诱导凋亡三种机制，精准靶向清除与RA发病有关的B细胞。 [5] 。目前国内外RA诊疗指南中，普遍推荐将利妥昔单抗用于RA三线治疗，即用于对肿瘤坏死因子-α（TNF-α）抑制剂治疗应答不佳人群；或用于特殊RA患者的治疗，即类风湿因子（RF）/抗瓜氨酸抗体（CCP）阳性、合并间质性肺病（ILD）等情况。汉利康 ® 治疗仅需每年给药两次，每次药效持续可达6个月，而更低的用药频次往往意味着患者对治疗的依从性更好、持续用药比例更高，在HLX01-RA03研究中，有近85%的患者完成了为期48周的研究治疗。因此汉利康 ® 相较其他治疗方案具备疗效持久、用药便捷的优势，大大提升患者治疗依从性。汉利康®（利妥昔单抗注射液）汉利康 ® RA适应症本次成功入围国家医保目录，将为上述患者群体提供更加强效安全、长效便捷的治疗选择。作为国内首个且唯一获批 RA适应症的利妥昔单抗，汉利康 ® 开启了中国 B细胞靶向治疗RA的新时代。此次新增RA适应症纳入国家医保目录，患者治疗费用大幅降低，将让更多患者享受到更加强效安全、长效便捷的创新治疗药物，满足患者迫切的临床需求，助力RA的"长治久安"！参考文献： [1] 田新平, 李梦涛, 曾小峰. 我国类风湿关节炎诊治现状与挑战：来自中国类风湿关节炎2019年年度报告[J]. 中华内科杂志, 2021, 60(07): 593-598. [2] 耿研, 谢希, 王昱, 等. 类风湿关节炎诊疗规范[J]. 中华内科杂志, 2022, 61(01): 51-59. [3] Zeng X, Liu J, Liu X, et al. Efficacy and safety of HLX01 in patients with moderate-to-severe rheumatoid arthritis despite methotrexate therapy: a phase 3 study[J]. Arthritis Research & Therapy, 2022, 24: 136. [4] Wu F, Gao J, Kang J, et al. B Cells in Rheumatoid Arthritis： Pathogenic Mechanisms and Treatment Prospects[J]. Frontiers in Immunology, 2021,12: 750753. [5] Xu Y, Xie L, Zhang E, et al. Physicochemical and functional assessments demonstrating analytical similarity between rituximab biosimilar HLX01 and the MabThera®[C]//MAbs, 2019, 11(3): 606-620.

临床3期上市批准生物类似药

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适应症	国家/地区	公司	日期
肉芽肿伴多血管炎	伊朗	Aryogen Pharmed	2014-01-01
显微镜下多血管炎	伊朗	Aryogen Pharmed	2014-01-01
非霍奇金淋巴瘤	伊朗	Aryogen Pharmed	2014-01-01
费城染色体阳性慢性粒细胞白血病	伊朗	Aryogen Pharmed	2014-01-01
类风湿关节炎	伊朗	Aryogen Pharmed	2014-01-01