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TR

trastuzumab (BP 02 / BP02)

✓ Approved

Aurobindo Pharma Limited · ERBB2 · 单克隆抗体

什么是 trastuzumab？

trastuzumab 是一种单克隆抗体，由Aurobindo Pharma Limited研发。该药已获批，用于治疗相关适应症，给药途径：Injectable (Others)、Intravenous (IV)。

药物档案

商品名BP 02, BP02
公司Aurobindo Pharma Limited
药物类别单克隆抗体, 抗体
分子靶点ERBB2, LRP1
给药途径Injectable (Others), Intravenous (IV)
状态Approved
来源： ClinicalTrials.gov, Aurobindo Pharma Limited

作用机制

分子靶点

trastuzumab 作用于 2 个分子靶点：

ERBB2erb-b2 receptor tyrosine kinase 2 (NEU, CD340)
LRP1LDL receptor related protein 1 (LRP1A, A2MR)
需要更深入的分析？Noah AI 可解释复杂机制并与同类药物比较。

治疗适应症

trastuzumab 针对 2 个适应症，涉及 1 个治疗领域。

治疗领域疾病/病症分期
Neoplasms benign, malignant and unspecified (incl cysts and polyps)Breast cancer✓ Approved
Neoplasms benign, malignant and unspecified (incl cysts and polyps)Gastric cancerBLA/NDA

相关研究文献

PubMedCureus2026-08-05

Identifying Predictors of Pathological Complete Response in Moroccan Patients With HER2-Positive Breast Cancer Treated With Neoadjuvant Therapy.

Atmane Boutaina B, El Afeya Jihad J, Toumi Safae S, Inrhaoun Hanane H et al.

Background The prognosis of human epidermal growth factor receptor 2 (HER2)-positive breast cancer has significantly improved with the use of neoadjuvant chemotherapy combined with anti-HER2 therapy. Achieving pathological complete response (pCR) is commonly associated with favorable long-term outcomes. However, real-world data on predictive factors influencing pCR remain limited, particularly in Morocco and North Africa, where evidence is scarce. Generating region-specific evidence is therefore essential to complement findings from other populations. This study aimed to assess pCR rates and identify predictors of response in Moroccan patients with HER2-positive breast cancer treated with neoadjuvant systemic therapy. Methods We retrospectively included 203 patients with stage I-III HER2-positive breast cancer treated with neoadjuvant chemotherapy plus trastuzumab, with or without pertuzumab, followed by surgery between October 2019 and April 2023. Predictors of pCR were assessed using logistic regression. Disease-free survival (DFS) was compared between patients achieving pCR and those without pCR using Cox proportional hazards regression analysis. Results Among 203 patients, 44.3% achieved pCR. Higher pCR rates were independently associated with hormone receptor-negative tumors (odds ratio (OR) = 2.20, 95% confidence interval (CI): 1.08-4.47), HER2 (score 3) status (OR = 4.80, 95% CI: 1.73-13.30), and the use of dual HER2 blockade (OR = 2.05, 95% CI: 1.03-4.07) compared with triple-positive tumors and HER2 (score 2) fluorescence in situ hybridization (FISH)-amplified tumors treated with trastuzumab alone. In contrast, lower pCR rates were observed in T3-T4 tumors (OR = 0.45, 95% CI: 0.23-0.92). After a median follow-up of 51.3 months, achieving pCR was significantly associated with improved DFS (HR = 0.07, 95% CI: 0.02-0.28; p < 0.001). Conclusions Tumor stage, hormone receptor status, HER2 expression, and neoadjuvant pertuzumab use were independently associated with pCR, emphasizing the importance of tailored neoadjuvant strategies in HER2-positive breast cancer.

PMID 42553770
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PubMedTherapeutic advances in gastroenterology2026-08-05

Pulmonary diffusion abnormalities in patients with inflammatory bowel disease: A longitudinal study.

Maisonneuve Hugo H, Caron Benedicte B, Guillaumot Anne A, Poussel Mathias M et al.

Impaired diffusing capacity of the lung for carbon monoxide (DLCO) has been frequently described among patients with inflammatory bowel diseases, but longitudinal data of DLCO impairment and its association with IBD activity remain unclear. To describe the longitudinal report of prevalence and clinical characteristics of chronic DLCO impairment among patients with IBD reporting respiratory symptoms. We conducted a prospective single-center study including consecutive patients with confirmed IBD and respiratory symptoms. Patients underwent longitudinal evaluation with chest CT scans and pulmonary function tests. Among 75 patients with DLCO measurements, 12 (16%) showed persistently reduced DLCO over a median follow-up of 26.9 [IQR 24.9-30.6] months. Median DLCO was 63.4% of predicted value. All patients had mild or inactive IBD and were on biologics. Imaging abnormalities were mild and did not explain the DLCO reduction. Chronic DLCO impairment was observed in 16.0% of IBD patients and no obvious association with clinically active IBD was observed in this selected symptomatic cohort.

PMID 42553422
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PubMedACR open rheumatology2026-08-05

Beyond Glucocorticoids: The Current Landscape and Prospects for Treating Immune Checkpoint Inhibitor-Induced Autoimmunity.

Hu Xizi X, Ryoo Ji Eun JE, Henick Brian S BS, Mor Adam A

The rapid integration of immune checkpoint inhibitors (ICIs) into standard oncology protocols has birthed a new frontier in clinical rheumatology: immune-related adverse events (irAEs). By disrupting the programmed cell death-1 (PD-1)/PD-L1 and cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) axes to restore antitumor T cell activity, these therapies inadvertently breach peripheral tolerance. This results in a spectrum of de novo autoimmune and inflammatory syndromes that frequently mimic established rheumatic diseases, including inflammatory arthritis and myositis. Although ICIs have revolutionized survival outcomes, the resultant irAEs pose a significant clinical challenge, affecting nearly 50% of patients and often necessitating the expertise of rheumatologists for management. This manuscript explores the unique rheumatologic phenotype of ICI-induced toxicities, emphasizing the urgent need for a shift from broad-spectrum glucocorticoid use toward targeted, mechanism-driven therapies that do not compromise the abscopal antitumor effect. We review the current landscape of clinical trials investigating the repurposing of traditional disease-modifying antirheumatic drugs and advanced biologics. Specifically, we discuss the efficacy and safety of tumor necrosis factor-alpha inhibitors, interleukin-6 receptor antagonists, and JAK inhibitors in the context of steroid-refractory irAEs. We further analyze the molecular commonalities between idiopathic autoimmune diseases and ICI-induced inflammation. As the patient population receiving ICIs grows, the rheumatologist's role as a co-manager is increasingly essential. This review highlights the need for standardized grading and treatment algorithms for rheumatologic irAEs and advocates collaborative research to separate immunotherapy toxicities from its oncological benefits.

PMID 42552647
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PubMedFrontiers in pharmacology2026-08-05

Severe non-atopic prurigo nodularis in an otherwise healthy elderly patient: rapid multidimensional response to dupilumab.

Ventre Alessandra A, Nuccio Federica F, Gangemi Sebastiano S, Ricciardi Luisa L

Prurigo nodularis (PN) is a chronic neuroimmune skin disorder characterized by intensely pruritic nodules, severe impairment of quality of life and significant psychosocial burden. Prior to the approval of targeted therapies, management relied on conventional agents with limited efficacy. Recent evidence of its neuroimmune pathogenesis have led to the approvement of targeted biologics. Dupilumab, a human monoclonal antibody targeting IL-4/IL-13-axis, has been the first targeted therapy approved for PN. We report a 75-year-old woman presenting with severe, treatment-naïve generalized pruritus (IGA PN-S 4; NRS 9/10; DLQI 21) with extensive nodular involvement of the trunk and extremities, complete sleep deprivation and important anxiety and depression (HADS.A 12; HADS-D 11). Following diagnosis of PN, treatment with dupilumab (600 mg loading dose, then 300 mg every 2 weeks) was initiated in October 2025. At approximately 6 weeks, marked pruritus reduction (NRS 3) and sleep restoration were observed. Progressive improvement continued over time. At 4 months follow-up, complete remission was nearly achieved (NRS 1, IGA PN-S 1, DLQI 2, HADS-A 4, HADS-D 3), with no adverse events reported. This case corroborates and extends the existing evidence on dupilumab efficacy in the treatment of moderate-to-severe PN, with particularly rapid and comprehensive responses across pruritus, skin lesions, sleep and psychosocial outcomes in an elderly patient, through IL-4/IL-13 inhibition. Our findings support dupilumab as a safe and effective targeted option for severe PN, also in older patients where conventional systemic therapies, such as corticosteroids or immunosuppressants, carry a high risk of adverse effects.

PMID 42553303
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PubMedAnnals of dermatology2026-08-04

Factors Associated With PASI90 Maintenance Without Flare-Up and Predictors of Biologics Discontinuation in Psoriasis: Two-Center Retrospective Cohort Study in Korea.

Choi Mi Soo MS, Yeom Kyujin K, Jung Seung-Won SW, Hong Seung Phil SP et al.

Biologics targeting key cytokines have enabled near-complete clearance in psoriasis treatment. As 90% reduction in the Psoriasis Area and Severity Index (PASI90) emerges as a meaningful goal of treatment, maintaining PASI90 without flare-up has become important. To identify factors associated with PASI90 maintenance for ≥1 year without flare-up and predictors of drug discontinuation. This multicenter retrospective cohort study included moderate-to-severe plaque psoriasis patients treated with adalimumab, ustekinumab, secukinumab, ixekizumab, guselkumab, or risankizumab (2010-2022). Treatment courses were defined as "Episodes." Patients with ≥2 years of therapy were analyzed. Relative risks (RR) for PASI90 maintenance were estimated using generalized linear mixed models, and Cox proportional hazards models assessed drug discontinuation. Among 136 patients (189 episodes), 40.1% of 162 eligible episodes achieved PASI90 maintenance without flare-up for ≥1 year. Secukinumab significantly increased the likelihood of PASI90 maintenance (RR, 2.1; 95% confidence interval [CI], 1.27-3.49). Body mass index (BMI) <30 and first biologic episode showed favorable with only trend toward significance. Psoriasis Area and Severity Index response at week 16 and first assessment strongly predicted maintenance (area under the curve, 0.80-0.82). Regarding drug discontinuation, drug were discontinued in 28.6% of episodes; BMI ≥30, family history of psoriasis, and adalimumab (hazard ratio, 4.50; 95% CI, 1.57-12.90 vs. ustekinumab) were associated with higher risk of drug discontinuation. Secukinumab, lower BMI, and biologic-naïve status favored durable PASI90 without flare-up. Obesity, family history, and adalimumab predicted drug discontinuation. Early treatment response strongly predicted long-term efficacy.

PMID 42547477
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PubMedInternational journal of pharmaceutics2026-08-04

A comparative study of the oxidative degradation of poloxamer 188, polysorbate 20 and polysorbate 80 in various buffered solutions.

Bollenbach Lukas L, Weber Johanna J, Schultz-Fademrecht Torsten T, Mäder Karsten K et al.

The importance of biologics has increased over the last few decades. Since proteins in liquid formulations tend to form protein particles in response to external stress factors, surfactants are added to prevent this. Currently, polysorbates (PSs) 20 and 80 are mainly used for this purpose. However, alternatives are being investigated, as PSs have stability issues, primarily due to oxidative or enzymatic degradation. The alternative that is discussed most frequently and already used in commercial biologics is poloxamer 188 (P188). However, this triblock copolymer, which consists of a polyoxypropylene block flanked by polyoxyethylene units, may also degrade through oxidative processes. Surprisingly, there are no direct comparative stability studies for PSs and P188. Therefore, the present study compared the oxidative degradation profiles of PS20 and PS80 with those of P188 in various relevant buffer systems. To this end, the formulations were subjected to stress in the form of 50 ppb (approximately 0.9 µM) of Fe2+ and light in the visible range, in line with their exposure during pharmaceutical production. Samples that received neither an iron spike nor light served as controls. The solutions contained 0.4 mg∙mL-1 PS20, PS80, or P188, respectively. The surfactants were formulated in either a 25 mM acetate, citrate, or histidine buffer solution (all pH 5.5) or in pure water. Significant differences were observed between these buffers, with greater effects at higher temperatures. The stability of the surfactant depended greatly on the buffer and the applied stress. All surfactants exhibited high rates of oxidative degradation when formulated in acetate buffer or pure water. PSs demonstrated the highest overall stability in citrate buffer, while P188 remained most stable in histidine, as well as in citrate buffer. However, both PSs exhibited instability in the presence of iron and light in histidine buffer, a phenomenon not observed in P188.

PMID 42546993
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