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rituximab (Kikuzubam / PBO326)

✓ Approved

Probiomed · MS4A1 · Monoclonal Antibodies

What is rituximab?

rituximab is a monoclonal antibodies developed by Probiomed. It is approved for therapeutic indications via injectable (others) or intracerebral/cerebroventricular injection or intravenous (iv) or subcutaneous injection.

Drug Profile

Brand NamesKikuzubam, PBO326
CompanyProbiomed
Drug ClassMonoclonal Antibodies, Antibody
Molecular TargetMS4A1
RouteInjectable (Others), Intracerebral/cerebroventricular Injection, Intravenous (IV), Subcutaneous Injection
StatusApproved

Mechanism of Action

Molecular Targets

rituximab acts on 1 molecular target:

MS4A1membrane spanning 4-domains A1 (S7, B1)
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Therapeutic Indications

rituximab is developed for 8 unique indications across 4 therapeutic areas.

Therapeutic AreaConditionPhase
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)Diffuse large B-cell lymphoma✓ Approved
Neoplasms benign, malignant and unspecified (incl cysts and polyps)Non-Hodgkin's lymphoma✓ Approved
Musculoskeletal and connective tissue disordersRheumatoid arthritis✓ Approved

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Related Research Articles

PubMedDiscover oncology2026-05-24

Atypical cortical presentation of anti-Ri paraneoplastic encephalitis mimicking tumor.

Lee Seolah S

This report expands the known clinical phenotype of anti-Ri (ANNA-2)-associated paraneoplastic syndrome to include isolated neocortical involvement. We report the case of a 54-year-old woman who presented with transient apraxia, confusion, and headache. Brain MRI revealed a tumor-like lesion in the left frontal cortex. Stereotactic brain biopsy showed inflammatory changes without evidence of malignancy. Serum testing was strongly positive for anti-Ri antibodies, and systemic workup identified breast cancer with axillary lymph node metastasis. The patient received breast cancer surgery and chemotherapy alongside high-dose steroid pulse therapy and four weekly doses of rituximab, resulting in marked resolution of the cortical lesion. While current PNS-Care diagnostic criteria enabled a definitive diagnosis, further investigation is warranted to elucidate the underlying pathomechanism of cortical involvement in anti-Ri paraneoplastic neurological syndrome.

PubMedThe Journal of dermatology2026-05-23

Real-World Experience With Single Ultra-Low Dose Rituximab for Remission Induction in Pemphigus.

Jeng Yu-Chen YC, Liu Wei-Ting WT, Hsu Chao-Kai CK, Yang Chao-Chun CC

Standard-dose rituximab (SDRTX) is the established treatment for pemphigus, but optimization of cost-effectiveness and safety remains desirable. We retrospectively evaluated the efficacy of a single ultra-low dose RTX infusion (ULRTX; 100 or 200 mg) for remission induction in 12 patients with mild-to-severe pemphigus (median baseline Pemphigus Disease Area Index [PDAI] 29.5). 9 patients (75%) achieved complete remission on minimal therapy (CRMT), and among them 5 (41.7%) subsequently achieved complete remission off therapy (CROT), with a median time to CRMT and CROT of 24 weeks and 61 weeks, respectively. Significant corticosteroid sparing was achieved; 9 of 10 evaluable patients tapered prednisolone to ≤ 5 mg/day within 6 months. Despite the reduced dose of RTX, an overall decline in serum anti-desmoglein 1 and 3 IgG titers and effective peripheral B-cell depletion (≤ 1%) occurred in evaluable patients. However, early B-cell repopulation was observed in one patient who experienced an early relapse. Compared with the standard-dose group (n = 8), the ULRTX group demonstrated a favorable safety profile with significantly fewer drug-related adverse events (0% vs. 37.5%, p = 0.049), while maintaining effective clinical remission. Single-dose ULRTX appears to be a cost-efficient and biologically effective induction strategy, supporting a personalized, immunologically guided, on-demand treatment approach.

PubMedJournal of neuroimmunology2026-05-23

Clinical features and treatment response of anti-Neurofascin 155 antibody-positive neuropathy in neurological Institute of Thailand.

Suanprasert Narupat N, Sinthuwong Chaichana C, Apiwattanakul Metha M, Hanchaiphiboolkul Suchat S

Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) is an immune-mediated neuropathy that typically responds to conventional therapy. However, a subset of patients such as anti-neurofascin-155 (NF155) Ab-positive exhibit unique clinical features and a poor response to conventional therapy. To characterize the clinical, electrophysiological, pathological, and therapeutic features of Thai patients with anti-NF155 Ab-positive paranodopathy and to compare them with antibody-negative CIDP patients. A retrospective cohort study, anti-NF155 Ab-positive paranodopathy patients were compared to CIDP patients who were negative for all nodal/paranodal antibodies. Clinical data, nerve conduction studies, cerebrospinal fluid (CSF) profiles, sural nerve biopsies, and treatment outcomes were analyzed. Of 41 CIDP patients tested, 11 (26.8%) were anti-NF155 Ab-positive. These patients had a younger age of onset (median 32.8 years), a higher prevalence of tremor (54.5%) and sensory ataxia (36.4%), and more frequently exhibited a distal-predominant sensorimotor phenotype. All met the EAN/PNS 2021 diagnostic criteria. Nerve biopsies showed mild generalized fiber loss without clear demyelination. Onion bulb formations were not present in anti-NF155 Ab-positive patients. Only 20% responded to IVIg, compared to 92.9% of antibody-negative patients (p = 0.006). Rituximab led to clinical improvement in 83.3% of anti-NF155 Ab-positive patients, with the median onset of response at 102 days. Anti-NF155 Ab-positive paranodopathy represents a distinct clinical subtype associated with a poor IVIg response and good rituximab efficacy. Antibody testing should be considered in patients with distal weakness, tremor, high CSF protein, or IVIg refractoriness. Early identification may allow for tailored treatment and improved outcomes.

PubMedPharmacology research & perspectives2026-05-22

Impact of FCGR2A and FCGR3A Gene Variants on the Response to Rituximab in Patients With Glomerular Diseases.

Larrosa-García María M, Pamplona Irene Agraz IA, Tolosa Susana Rojo SR, Morales Alberto Jiménez AJ et al.

Rituximab is an anti-CD20 monoclonal antibody used in autoimmune diseases, including glomerular diseases. The FCGR2A (rs1801274) and FCGR3A (rs396991) variants have been suggested to affect rituximab efficacy; this study evaluates their impact on rituximab efficacy in glomerular diseases. A clinical trial was performed including adults with glomerular diseases who required rituximab (NEFRTX; EudraCT: 2020-000484-23). Patients received 1.0 g or 0.5 g of rituximab on day 1 (± day 14); biochemical parameters and rituximab concentration were measured, and FCGR2A and FCGR3A variants were characterized. Clinical outcome was evaluated at 6 and 12 months. 30 patients were included. FCGR2A (rs1801274) and FCGR3A (rs396991) variants did not show an effect on clinical response to rituximab. When the effect of the variant was corrected by rituximab exposure, the expression of the FCGR2A rs1801274-A allele vs. no expression was related to a poorer response at month 6 (odds ratio 0.034; 95% confidence interval 0.002-0.725; p = 0.030); this effect was not seen for FCGR3A. Additional studies involving larger cohorts are warranted to validate these findings.

PubMedRMD open2026-05-22

Potential stratification of TAFRO syndrome by anti-SS-A antibodies status and therapeutic response to rituximab.

Suzuki Tomohiro T, Yamada Saeko S, Toriumi Kanto K, Kono Masanori M et al.

Thrombocytopaenia, anasarca, fever, reticulin fibrosis, renal dysfunction and organomegaly (TAFRO) syndrome has been reported to be associated with anti-SS-A antibodies, which activate type I interferon (IFN) signalling. We propose a subclassification of TAFRO syndrome based on the anti-SS-A antibody status, with the aim of identifying effective treatment strategies. We reviewed TAFRO syndrome cases from the PubMed/MEDLINE databases from January 1977 to October 2024. The information on concomitant autoimmune diseases, the presence of anti-SS-A antibodies, serum IgG levels, treatment courses and clinical outcomes was collected and retrospectively analysed. Patients were stratified according to anti-SS-A antibody status, and response to tocilizumab (TCZ) or rituximab (RTX) was evaluated. Among 212 cases, 27 had concomitant autoimmune diseases, with Sjögren's disease (SjD) being the most common. Anti-SS-A antibody positivity was observed in 37 cases, of which 12 fulfilled the classification criteria for SjD. RTX was significantly more effective in anti-SS-A antibody-positive patients than in antibody-negative patients (88.9% vs 16.7%, p=0.011), whereas therapeutic response to TCZ was not affected by anti-SS-A antibody status. Serum IgG levels were significantly higher in anti-SS-A antibody-positive patients than in antibody-negative patients (p=0.020). TAFRO syndrome shows clinical heterogeneity and anti-SS-A antibody status may represent one potential factor associated with treatment response. Further studies are needed to confirm these findings and clarify the underlying mechanisms.

PubMedJournal of human immunity2026-05-22

A systematic literature review of CVID reveals pervasive detrimental noninfectious manifestations.

Ducasa G Michelle GM, Marsh Rebecca A RA, Mojebi Ali A, Ho Hsi-En HE et al.

Noninfectious manifestations of common variable immunodeficiency (CVID) are not formally summarized. We performed a systematic literature review to generate a comprehensive reference for the field. Splenomegaly was the most reported manifestation across 53 publications, occurring in a median of 35.2% of patients. Frequently reported digestive system manifestations included diarrhea (median 27.8%; 21 publications), hepato(spleno)megaly (median, 21.0%; 19 publications), portal hypertension (median 21.0%; 3 publications), nodular lymphoid hyperplasia (median, 17.0%; 9 publications), and enteropathy (median, 16.0%; 34 publications). Other notable manifestations included interstitial lung disease (median, 8.7%; 32 publications) and autoimmune cytopenias (median 18.0%; 21 publications). Steroids and rituximab were the most frequently reported treatments. Numerous manifestations significantly adversely affected survival, including lymphoma, granulomatous lymphocytic interstitial lung disease, splenomegaly, and liver diseases. These comprehensive data document the pervasiveness and negative impact of noninfectious manifestations in CVID and support a call to action to develop novel therapeutics.

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