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anti-hepatitis-B therapy (IMMUNO HBS / UMANBIG / IMMUNOHBS)

✓ Approved

Kedrion · 多克隆抗体 · 多克隆抗体

什么是 anti-hepatitis-B therapy？

anti-hepatitis-B therapy 是一种多克隆抗体，由Kedrion研发。该药已获批，用于治疗相关适应症，给药途径：Injectable (Others)、Intramuscular (IM) Injection、Intravenous (IV)。

药物档案

商品名IMMUNO HBS, UMANBIG, IMMUNOHBS
公司Kedrion
药物类别多克隆抗体, 抗体
给药途径Injectable (Others), Intramuscular (IM) Injection, Intravenous (IV)
状态Approved
来源： ClinicalTrials.gov, Kedrion

治疗适应症

anti-hepatitis-B therapy 针对 1 个适应症，涉及 1 个治疗领域。

治疗领域疾病/病症分期
Infections and infestationsHepatitis B✓ Approved

相关研究文献

PubMedInternational journal of cancer2026-09-10

Early Cessation of Adjuvant Anti-PD-1 Therapy in Stage III and IV Melanoma.

Bloem Manja M, de Meza Melissa M MM, Boreel Cato D M CDM, Aarts Maureen J B MJB et al.

One year of adjuvant anti-PD-1 has improved disease-free survival in Stage III melanoma. It is unknown whether shorter treatment duration affects outcomes. Real-world data may help clarify this. In this retrospective observational study, patients with resected Stage III/IV melanoma receiving adjuvant anti-PD-1 in the Netherlands from 2018 to 2023 were included from the Dutch Melanoma Treatment Registry. Three cohorts were identified: completion of 12 months adjuvant anti-PD-1 (A), early discontinuation due to toxicity (B), early discontinuation for other reasons (C). To reduce immortal time bias, 12-month landmark analyses were performed. Recurrence-free survival (RFS) and overall survival (OS) were compared; multivariable Cox regression was performed. We included 1502 patients: 605 in cohort A, 332 in cohort B, 565 in cohort C. Two-year RFS was 85.6% (95% CI: 82.6-88.7), 76.3% (95% CI: 71.4-81.6) and 80.0% (95% CI: 76.4-83.7) in cohort A, B and C, respectively. The adjusted hazard ratio (adjHR) for recurrence and all-cause death was 1.37 (95% CI: 1.03-1.82) in cohort B vs. A and 1.22 (95% CI: 0.95-1.56) in cohort C versus A. Two-year OS was 98.2% (95% CI: 97.0-99.4), 94.6% (95% CI: 91.9-97.4) and 96.7% (95% CI: 95.0-98.3) in cohort A, B and C. The adjHR of all-cause death was 1.82 (95% CI: 1.20-2.75) in cohort B versus A and 1.30 (95% CI: 0.89-1.89) in cohort C versus A. Early discontinuation of anti-PD-1 due to toxicity was associated with worse RFS and OS compared to completing treatment, which was not observed for early discontinuation for other reasons. These findings support prospective evaluation of adjuvant therapy duration in melanoma.

PMID 42717279
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PubMedEpidemiologia e servicos de saude : revista do Sistema Unico de Saude do Brasil2026-09-10

Risk factors associated with hepatitis C virus infection: population-based cross-sectional study, Paraná, 2007-2022.

Tiroli Carla Fernanda CF, Scholze Alessandro Rolim AR, Magnabosco Gabriela Tavares GT, Barreto Maynara Fernanda Carvalho MFC et al.

To analyze the association between hepatitis C virus antibody (anti-HCV) results and demographic characteristics and exposure categories among reported cases in adult individuals in municipalities of Paraná. An analytical cross-sectional study was conducted using records from the Notifiable Diseases Information System (Sinan) for viral hepatitis. Analyses were performed using logistic regression. The lowest Akaike information criterion value was considered for the final model. were presented as prevalence ratios (PR) with 95% confidence intervals (95%CI), and p-values <0.05 were considered significant. The sample consisted of 32,829 cases, of which 35.4% had reactive anti-HCV results. The variables that showed statistically significant associations were: injecting drug use (PR 1.26; 95%CI 1.21; 1.33), blood transfusion (PR 1.20; 95%CI 1.16; 1.25), inhaled drug use (PR 1.13; 95% CI 1.09; 1.18), tattooing and piercing (PR 1.05; 95%CI 1.02; 1.08), and surgical treatment (PR 1.03; 95%CI 1.01; 1.05). Among protective factors, the following stood out: age group (PR 0.94; 95%CI 0.91; 0.96) and educational level (PR 0.97; 95%CI 0.95; 0.98). An association of anti-HCV with injecting and inhaled drug use, tattooing/piercing, and surgical treatment was evidenced. The findings reinforce the importance of early detection and risk stratification in addressing hepatitis C.

PMID 42718369
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PubMedFrontiers in oncology2026-09-10

Cytomegalovirus infection in patients receiving bispecific antibodies for multiple myeloma and B-cell malignancies: a single-center cohort and meta-analysis.

Aparicio-Minguijón Eduardo E, Rodríguez-Goncer Isabel I, López-Muñoz Nieves N, Pérez-Jacoiste Asín María Asunción MA et al.

Bispecific antibodies (BsAbs) are transformative therapies for multiple myeloma (MM) and B-cell malignancies. Cytomegalovirus (CMV) infection has been reported as a potential complication of unclear clinical magnitude. We conducted a retrospective study of MM patients treated with BsAbs at our institution (2020-2025), alongside a systematic review and meta-analysis of clinical trials and observational studies evaluating BsAbs for MM, B-cell lymphoma, and acute lymphoblastic leukemia. Study outcomes included clinically significant CMV infection (csCMVi), any CMV DNAemia, and CMV disease. Our cohort included 98 BsAb therapy courses (74.5% anti-B-cell maturation antigen [BCMA]) with a median follow-up of 10.4 months. Cumulative incidence rates for csCMVi and CMV disease were 9.2% (9/98) and 3.1% (3/98), respectively. Factors associated with csCMVi at the univariable level were poorer functional status, prior allogeneic hematopoietic stem cell transplantation (allo-HSCT), grade 4 neutropenia, and grade ≥3 cytokine release syndrome (CRS). The meta-analysis (23 studies plus our single-center cohort comprising 2,956 BsAb courses) revealed a pooled cumulative incidence rates of 9% (95% confidence interval [CI]: 4-15%; I2 96.11%) for csCMVi and 1% (95% CI: 0-2%; I2 69.78%) for CMV disease. Incidence was notably higher in studies applying routine CMV DNAemia monitoring and with anti-BCMA agents. The occurrence of csCMVi or CMV disease during the course of BsAb therapy for MM or B-cell malignancies is uncommon, arguing against routine CMV DNAemia monitoring or antiviral prophylaxis. Prevention approaches, however, may be warranted in patients receiving anti-BCMA BsAbs with additional risk factors such as allo-HSCT or severe CRS. https://www.crd.york.ac.uk/prospero/, identifier CRD420251162657.

PMID 42718550
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PubMedTherapeutic advances in infectious disease2026-09-10

Association of alanine aminotransferase flares with hepatitis B surface antigen loss and clinical outcomes in treated and untreated patients with chronic hepatitis B virus infection: A US retrospective cohort study.

Drysdale Myriam M, Morais Eleonora E, Chang Rose R, Wang Shuang S et al.

Previous research has demonstrated the clinical significance of alanine aminotransferase (ALT) flares; however, studies have mostly been in Asian countries or populations, and it remains unclear whether ALT flares during treatment are associated with hepatitis B surface antigen (HBsAg) loss and long-term adverse clinical outcomes. To evaluate the association between ALT flares and virologic outcomes (HBsAg and hepatitis B e antigen [HBeAg] loss) as well as adverse clinical outcomes among patients with chronic hepatitis B in the United States, according to treatment status. Retrospective study using the Optum de-identified electronic health record dataset (2012-2019). Marginal structural models estimated the associations between ALT flares and outcomes, accounting for time-varying confounding; adjusted odds ratios and 95% confidence intervals were reported. A Cox proportional hazards regression model was used to assess risk factors for flares. 14,328 patients were included in the untreated cohort; of these, 2298 (16.0%) initiated and 1541 (10.7%) subsequently discontinued treatment. At least one ALT flare was experienced by 364 patients (2.5%) in the untreated cohort, 84 (3.7%) in the treatment initiation cohort, and 22 (1.4%) in the discontinuation cohort. Risk factors for ALT flares in the untreated group included male sex, history of flares, metabolic syndrome, liver fibrosis, compensated cirrhosis (CC), and hepatic decompensation. Risk factors after treatment initiation included younger age, White race, history of flares, and evidence of liver damage (liver fibrosis, CC, or hepatic decompensation). Flares in the untreated group were associated with spontaneous HBsAg loss and with an increased risk of hepatic decompensation, hospitalization, and death. Flares after treatment initiation were associated with HBsAg and HBeAg loss but not with adverse clinical outcomes investigated. ALT flares in untreated patients were associated with virologic and adverse clinical outcomes; no association with adverse clinical outcomes was observed in patients who initiated treatment.

PMID 42719439
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PubMedFrontiers in medicine2026-09-10

Baseline immune-organ 18F-FDG PET/CT metabolism is associated with immune-related adverse events in anti-PD-1-treated non-small cell lung cancer.

Zhu Haixu H, Na Renhua R, Yao Xiaolong X, Azhati Jureti J et al.

To investigate whether baseline 18F-FDG PET/CT immune-organ metabolic features are associated with immune-related adverse events (irAEs) in non-small cell lung cancer (NSCLC) patients receiving anti-PD-1 therapy. We retrospectively analyzed 120 stage III-IV NSCLC patients who underwent 18F-FDG PET/CT within 4 weeks before anti-PD-1 therapy and received ≥2 treatment cycles. The endpoint was any-grade irAE (CTCAE v5.0). Candidate predictors included tumor burden; spleen, bone-marrow, and thyroid metabolism; spleen-to-liver ratio (SLR); and bone-marrow-to-liver ratio. Standardized variables entered multivariable logistic regression with bootstrap optimism correction (1,000 resamples) and sensitivity analyses. irAEs occurred in 66 patients (55.0%) after a median of 61.5 days; 18 (27.3%) had grade 3-4 events, mainly pneumonitis and hepatitis. Compared with non-irAE patients, irAE patients showed higher SLR, spleen SUVmax, bone-marrow indices, thyroid SUVmax, and neutrophil-to-lymphocyte ratio (NLR). In the final multivariable model, SLR (odds ratio [OR] 4.13 per 1-SD; 95% CI, 2.28-7.49; p < 0.001), thyroid SUVmax (OR 3.57; 95% CI, 1.96-6.49; p < 0.001), and NLR (OR 2.00; 95% CI, 1.24-3.24; p = 0.005) were independently associated with irAEs. Model AUC was 0.863 (optimism-corrected, 0.850), and persisted after excluding thyroiditis-first cases (AUC 0.874). Discrimination was lower when grade 3-4 events were used as the outcome (AUC 0.724), indicating that the model predicted any-grade irAEs more accurately than severe events. Baseline splenic and thyroid FDG metabolism, combined with systemic inflammation, were independently associated with irAEs in anti-PD-1-treated NSCLC, providing candidate pretreatment risk-stratification markers pending external validation.

PMID 42718808
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PubMedCureus2026-09-10

Obinutuzumab for Rituximab-Intolerant Minimal Change Disease: A Case Report and Review of Recent Literature.

Shan Hui Yi HY

B lymphocytes play a central role in the pathogenesis of minimal change disease (MCD). Rituximab is a chimeric (murine-human) type I anti-CD20 monoclonal antibody that depletes B cells and is used in the management of frequently relapsing (FR) and steroid-dependent (SD) MCD. However, continued treatment with rituximab is not feasible in some patients because of severe infusion reactions or hypersensitivity. Obinutuzumab is a humanized type II anti-CD20 monoclonal antibody that produces potent B-cell depletion and has been used as an alternative B-cell-depleting therapy in selected immune-mediated diseases. Experience with its use in adults with FR/SD MCD remains limited. The author reports an adult patient with MCD who developed an immediate hypersensitivity reaction to rituximab, confirmed by positive skin testing, which precluded further treatment. The patient subsequently received obinutuzumab without adverse reactions and achieved clinical remission. To the author's knowledge, this represents one of the first reported cases of successful obinutuzumab treatment following confirmed rituximab allergy in an adult with MCD. Although based on a single case, this report suggests that obinutuzumab may represent a potential therapeutic alternative for selected patients with MCD who are unable to receive rituximab because of hypersensitivity. The current literature on the use of obinutuzumab in adult MCD is also reviewed.

PMID 42719894
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