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rituximab (Usmal / BCD020 / AcellBia)

✓ Approved

Grupo Biotoscana · MS4A1 · 单克隆抗体

什么是 rituximab？

rituximab 是一种单克隆抗体，由Grupo Biotoscana研发。该药已获批，用于治疗相关适应症，给药途径：Injectable (Others)、Intracerebral/cerebroventricular Injection、Intravenous (IV)、Subcutaneous Injection。

药物档案

商品名Usmal, BCD020, AcellBia
公司Grupo Biotoscana
药物类别单克隆抗体, 抗体
分子靶点MS4A1
给药途径Injectable (Others), Intracerebral/cerebroventricular Injection, Intravenous (IV), Subcutaneous Injection
状态Approved
来源： ClinicalTrials.gov, Grupo Biotoscana

作用机制

分子靶点

rituximab 作用于 1 个分子靶点：

MS4A1membrane spanning 4-domains A1 (S7, B1)
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

rituximab 针对 7 个适应症，涉及 4 个治疗领域。

治疗领域疾病/病症分期
Neoplasms benign, malignant and unspecified (incl cysts and polyps)B-cell lymphoma✓ Approved
Neoplasms benign, malignant and unspecified (incl cysts and polyps)Chronic lymphocytic leukaemia✓ Approved
Neoplasms benign, malignant and unspecified (incl cysts and polyps)Non-Hodgkin's lymphoma✓ Approved
Musculoskeletal and connective tissue disordersRheumatoid arthritis✓ Approved
Vascular disordersMicroscopic polyangiitisPreclinical

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相关研究文献

PubMedMedicine2026-10-27

Isolated necrotizing scleritis revealing silent pulmonary granulomatosis with polyangiitis: A case report of rare diagnostic clue.

Awadh Nabaa Ihsan NI, Gorial Faiq I FI, Al-Obaidi Ahmed Dheyaa AD, Alghannami Mohammed M et al.

Granulomatosis with polyangiitis (GPA) is a rare, life-threatening vasculitis characterized by necrotizing granulomatous inflammation. Isolated necrotizing anterior scleritis as the sole initial manifestation is distinctly rare. The presence of a clinically silent pulmonary mass without ear, nose, and throat or renal involvement makes this presentation exceptional and diagnostically challenging. A 31-year-old man presented with recurrent unilateral necrotizing anterior scleritis resistant to corticosteroids and immunosuppressants, without systemic symptoms. This single-patient case report, prepared in accordance with CAse REport guidelines, revealed mildly elevated anti-proteinase 3 antibodies (25 AU/mL) in laboratory tests. Chest computed tomography unexpectedly showed a 5-cm solitary pulmonary mass. Histopathology demonstrated necrotizing granulomatous inflammation with multinucleated giant cells and vasculitis, confirming GPA. The patient was treated with pulsed intravenous methylprednisolone followed by monthly cyclophosphamide, then transitioned to rituximab maintenance therapy. He achieved marked improvement in ocular inflammation and visual function, with no new systemic manifestations during follow-up. This case illustrates a rare diagnostic pathway in which isolated, treatment-resistant necrotizing scleritis led to the detection of clinically silent pulmonary GPA. It highlights the importance of considering systemic vasculitis in atypical or refractory scleritis and underscores the critical role of tissue biopsy when serologic findings are mild or nonspecific. Furthermore, this first documented Middle Eastern case adds educational value for ophthalmologists and rheumatologists, illustrating that early multidisciplinary evaluation and timely rituximab therapy can prevent irreversible ocular damage and systemic progression.

PMID 42937738
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PubMedBrain : a journal of neurology2026-10-27

Short-term outcomes, longer-term disability and relapse risk in LGI1-antibody encephalitis.

Ramanathan Sudarshini S, Soltys John J, Michael Sophia S, Mackrill Samuel V SV et al.

Leucine-rich glioma-inactivated-1 antibody encephalitis (LGI1-Ab-E) is a common and immunotherapy-responsive form of encephalitis. However, it is not known which immunotherapy regimens improve short-term outcomes, longer-term disability and relapse risk. Further, it is not known if the widely-utilised modified Rankin Scale (mRS) accurately captures quality of life (QoL) in LGI1-Ab-E, complicating disability measurements and interpretation of immunotherapy responses. A multicentre, international, real-world comparative analysis of patients with LGI1-Ab-E. Retrospective data from patient records evaluated short-term seizure and cognitive outcomes, 1-6 year disability, and future relapse risk associations, by integrating demographics, clinical features investigations and exposures to immunotherapies and antiseizure medications (ASMs). Patient- and neurologist-rated QoL assessments were used to establish an evidence-based mRS threshold for defining clinically significant disability. Cox proportional hazard models, Anderson-Gill, and generalised linear mixed-effects models were employed. 181 patients were included, with median age at onset 63 years (range 23 - 92); 122/181 (67%) were male. Short-term outcomes, evaluated at both five and ten weeks post-treatment initiation, identified exposure to immunotherapies associated with seizure resolution (OR = 13.97, 95%CI = 6.10-32.01; p < 0.0001 and OR = 8.53, 95%CI = 4.14-17.55; p < 0.0001, respectively), notably with corticosteroids, plasma exchange and rituximab, but not ASMs, intravenous immunoglobulins or steroid sparing agents. Conversely, seizure recurrence was observed after discontinuation of oral prednisolone, but not other immunotherapies or ASMs (OR = 39.53, 95%CI = 12.70-122.20, p < 0.0001). To evaluate longer-term disability, first, mRS scores were calibrated using QoL assessments: this identified a significant increase in patient-rated disability at mRS score of 2. Hence, using mRS 0-1 as a favourable outcome, we identified worse mRS at nadir associated with greater one-year disability (OR = 2.56, 95%CI = 1.56-4.20, p = 0.0003), and each month of delayed immunotherapy associated with a 16% increased risk of disability (HR = 1.16, 95%CI = 1.06-1.35, p = 0.004). Additionally, absence of immunotherapy associated both with greater one-year disability (OR = 5.67; 95% CI 1.19-26.54, p = 0.03) and a relapsing course (OR = 7.64, 95%CI = 2.51-21.77, p = 0.0002). Both a relapsing course, observed in 38% of patients, and the number of relapses associated with step-wise worsening of disability and QoL-outcomes. Rituximab exposure was the only identified clinical factor associated with reduced future relapse risk, by 93% (HR = 0.07, 95%CI = 0.01-0.48, p = 0.002). Persistent serum LGI1-IgMs, but not LGI1-IgGs, at one-year, associated with future relapses (HR = 11.69, 95%CI = 1.58-145.80, p = 0.02). Distinctive clinical factors and select immunotherapies, particularly intravenous methylprednisolone and plasma exchange, but not ASMs, associated with favourable short-term outcomes, patient-centric longer-term disability and relapses in LGI1-Ab-E. Our findings provide evidence-based disability thresholds, highlight novel prognostic biomarkers, and pragmatically guide LGI1-Ab-E care, pending randomized clinical trials.

PMID 42934970
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PubMedAnnals of hematology2026-10-27

Distinct clinical associations of baseline and treatment-emergent hypogammaglobulinemia in diffuse large B-cell lymphoma: a retrospective real-world cohort study.

Iltar Utku U, Karacamli Tugba T, Oztekin Sinem S, Atas Unal U et al.

Hypogammaglobulinemia is increasingly recognized in B-cell malignancies, but whether its clinical significance differs by timing, present at diagnosis versus developing after treatment, remains unclear in diffuse large B-cell lymphoma (DLBCL). We retrospectively evaluated 181 adults with newly diagnosed DLBCL treated with rituximab-based immunochemotherapy at a tertiary referral center. Hypogammaglobulinemia was defined as serum IgG < 7 g/L and classified as baseline hypogammaglobulinemia (BHG), treatment-emergent hypogammaglobulinemia (TEHG), or absent. Among the study population, 107 patients (59.1%) developed hypogammaglobulinemia, including 30 (16.6%) with BHG and 77 (42.5%) with TEHG. Patients with BHG exhibited a more adverse baseline clinical profile characterized by poorer performance status and higher-risk disease features. Complete response rates differed significantly across groups and were lowest in patients with BHG (73.3%) compared with TEHG (88.3%) and no hypogammaglobulinemia (94.6%) (p = 0.008). BHG was also associated with the poorest survival outcomes, with median progression-free survival (PFS) and overall survival (OS) of 26.4 and 30.9 months, respectively. In multivariable analyses, BHG independently predicted infectious complications but was not an independent predictor of PFS. TEHG was associated with shorter PFS in the primary multivariable model; however, this association was not confirmed in a prespecified 6-month landmark analysis. These findings suggest that BHG and TEHG represent distinct clinical states in DLBCL. While BHG identifies a clinically vulnerable subgroup with increased infection risk and inferior outcomes, the prognostic significance of TEHG should be interpreted cautiously because of non-protocolized monitoring and potential ascertainment bias.

PMID 42934312
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PubMedCancers2026-10-27

Clinical Characteristics, Progression of Disease Within 24 Months (POD24), and Real-World Outcomes of Follicular Lymphoma in Saudi Arabia: A Two-Centre Retrospective Analysis.

Al-Mansour Mubarak M, Alharbi Abdulrahman Salah AS, Sirdar Hadi Abdulhadi HA, Aljohani Aws A et al.

Real-world evidence describing the presentation, management, and outcomes of follicular lymphoma (FL) in Saudi Arabia remains limited, and the frequency and prognostic weight of progression of disease within 24 months of first-line therapy (POD24) have not been reported in this population. This study evaluated the clinicopathological characteristics, treatment patterns, POD24 incidence, and survival outcomes of patients with FL treated at two Saudi tertiary centres. This two-centre retrospective chart review included adults with histologically confirmed FL diagnosed between November 1999 and May 2025. Overall survival (OS) and first-line progression-free survival (PFS) were measured from the initiation of first-line treatment and estimated using the Kaplan-Meier method. POD24 was defined as progression, relapse, or death from any cause within 24 months of first-line initiation among patients evaluable for that endpoint. Outcomes were additionally examined by calendar era of diagnosis. All group comparisons were unadjusted and exploratory. A total of 139 patients were included. The mean age at diagnosis was 54.7 years (range, 18-91), 61.9% were male, 79.1% had Ann Arbor stage III-IV disease, and 51.1% had an FLIPI score ≥ 3. Bendamustine plus rituximab was the most frequent first-line regimen (43.9%), followed by R-CHOP (30.2%). The overall response rate was 77.0% in the whole cohort and 82.4% among the 125 patients who received response-evaluable systemic first-line therapy. After a median follow-up of 71.0 months, 5-year OS was 92.5% (95% CI, 84.8-96.4) and 5-year PFS was 66.1% (95% CI, 54.9-75.0); the corresponding medians were 210.0 and 114.6 months but were estimated with few patients at risk and should be interpreted cautiously. Among 97 patients evaluable for POD24, the event occurred in 24 (24.7%; 95% CI, 17.2-34.2), and the incidence was stable across calendar eras (23.4% before 2018 versus 24.5% thereafter; p = 1.000). Primary refractory disease accounted for 14 of the 24 events (58.3%). POD24 was associated with poorer ECOG performance status (odds ratio [OR] 11.08; 95% CI, 3.85-31.86), older age (OR 5.27; 95% CI, 2.00-13.89), and higher FLIPI score (OR 3.09; 95% CI, 1.13-8.42). In the 24-month landmark analysis, OS was significantly shorter after POD24 (log-rank p = 0.008), and both documented histological transformations occurred in the POD24 group. Patients with FL in this two-centre Saudi cohort frequently presented with advanced-stage and high-risk disease, yet contemporary anti-CD20-based treatment was associated with favourable long-term survival. Approximately one quarter of evaluable patients experienced POD24, predominantly as primary refractory disease, and this event identified a subgroup with materially inferior subsequent survival. POD24 may help identify patients who warrant closer surveillance and consideration for clinical trials or novel therapies.

PMID 42938847
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PubMedPediatric nephrology (Berlin, Germany)2026-10-26

Response to: "Clinical significance of anti-rituximab antibody status before rituximab administration in children with frequently relapsing or steroid-dependent nephrotic syndrome".

Wang Daojing D, Yang Huihui H, Wang Xiaowen X

PMID 42931892
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PubMedAntibodies (Basel, Switzerland)2026-10-26

Switching Beyond Rituximab in Primary Glomerular Diseases: A Systematic Review of Within-Patient Efficacy and Safety of Non-Rituximab Anti-CD20 Antibodies.

Martino Francesca K FK, Stefanelli Lucia F LF, Cattarin Leda L, Del Prete Dorella D et al.

Background/Objectives: Rituximab is widely used in primary glomerular diseases, but treatment may fail for several reasons, including primary non-response, incomplete response, relapse, intolerance or anti-rituximab antibodies. We assessed within-patient efficacy and safety after switching to another anti-CD20 antibody, considering the reason for switching. Methods: PubMed and Scopus were searched from inception to 15 May 2026 without language restrictions. Eligible reports included adults with primary glomerular disease treated with a non-rituximab anti-CD20 antibody after rituximab and reporting within-patient outcomes. Risk of bias was assessed with design-specific JBI tools and certainty with GRADE. Heterogeneity precluded meta-analysis, and findings were synthesized narratively. Results: A total of 309 patients were included across 43 studies: 283 had membranous nephropathy (MN), 18 had minimal change disease (MCD), 6 had focal segmental glomerulosclerosis (FSGS), and 2 had IgA nephropathy (IgAN). Obinutuzumab was the principal drug used, and the main reasons for switching were primary non-response, with immunization, relapse, or intolerance occurring less frequently. In MN, among the 262 patients with available response data, 217 achieved complete or partial remission, and relapse was rare. For MCD, 17 of 18 patients with active disease attained remission, and only one relapsed during follow-up. On the other hand, five out of the six FSGS patients responded, but three of them relapsed. The two patients with IgAN achieved either complete or partial remission. Notably, these results may not apply to conventional IgAN, since one biopsy showed contextually MCD and the other was proliferative and crescentic. Infusion-related reactions were the most frequent adverse events and were generally mild, while infections were the main issue during the follow-up. Evidence certainty for all outcomes was very low. Conclusions: Switching to a non-rituximab anti-CD20 antibody may be a feasible rescue strategy, most convincingly after intolerance, rituximab immunization, or relapse. The uncontrolled, very-low-certainty evidence precludes firm recommendations, and controlled studies are warranted.

PMID 42930037
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