infliximab (BCD055 / infliximab, Biocad)

✓ Approved

Grupo Biotoscana · TNF · 单克隆抗体

什么是 infliximab？

infliximab 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)、Intraocular Injection、Intravenous (IV)。

药物档案

商品名	BCD055, infliximab, Biocad
公司	Grupo Biotoscana
药物类别	单克隆抗体, 抗体
分子靶点	TNF
给药途径	Injectable (Others), Intraocular Injection, Intravenous (IV)
状态	Approved

来源： ClinicalTrials.gov, Grupo Biotoscana

作用机制

分子靶点

infliximab 作用于 1 个分子靶点：

TNF	tumor necrosis factor (TNFA, TNF-alpha)

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

infliximab 针对 7 个适应症，涉及 3 个治疗领域。

治疗领域	疾病/病症	分期
Musculoskeletal and connective tissue disorders	Ankylosing spondylitis	✓ Approved
Gastrointestinal disorders	Colitis ulcerative	✓ Approved
Gastrointestinal disorders	Crohn's disease	✓ Approved
Skin and subcutaneous tissue disorders	Psoriasis	✓ Approved
Musculoskeletal and connective tissue disorders	Psoriatic arthropathy	✓ Approved

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相关研究文献

PubMedAlimentary pharmacology & therapeutics2026-10-26

Baseline Clearance and Early Troughs Identify Candidates for Early Therapeutic Drug Monitoring During Infliximab Induction in Inflammatory Bowel Disease.

Mohamedi Juma A JA, Hoffert Yannick Y, Geukens Nick N, Rahier Jean-François JF et al.

The value of therapeutic drug monitoring during infliximab induction remains uncertain. We evaluated whether baseline infliximab clearance and early exposure metrics identify candidates for potential early proactive therapeutic drug monitoring during induction in inflammatory bowel disease. We analysed a multicenter Phase 4 study in which adults with Crohn's disease and ulcerative colitis initiated standard infliximab therapy (5 mg/kg at Weeks 0, 2, 6, 14, 22 and 30) with predefined peak, intermediate and trough sampling. A population pharmacokinetic model characterized disposition and covariates. Logistic regression assessed exposure-response relationships. The primary outcome was week-30 combined remission (Crohn's disease: Harvey-Bradshaw Index ≤ 4; ulcerative colitis: Partial Mayo score ≤ 2; with faecal calprotectin < 100 μg/g and C-reactive protein ≤ 5 mg/L). Seventy-five participants (33 female; median age 39 years, interquartile range 28-52) contributed pharmacokinetic data. Sixty-three were evaluable for exposure-response analyses. Twelve participants (19%) achieved combined remission (7/35 Crohn's disease; 5/28 ulcerative colitis). Lower serum albumin, higher body weight, and antibodies to infliximab increased clearance. In ulcerative colitis, baseline clearance and model-predicted week-6 trough concentration showed strong discrimination for combined remission (area under the receiver operating characteristic curve 0.88, 95% confidence interval 0.75-1.00; and 0.86, 0.69-1.00, respectively). Baseline clearance > 0.28 L/day and week-6 trough ≤ 21.6 mg/L identified high-risk subgroups with few remissions (0/18 and 1/20, respectively, p < 0.05). No robust predictors were identified in Crohn's disease. A pragmatic, risk-stratified, model-informed approach centered on baseline clearance and early troughs may guide personalized infliximab induction in ulcerative colitis. External validation is warranted. EudraCT number: 2015-004618-10.

PMID 42928429

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PubMedRevista espanola de enfermedades digestivas2026-10-26

Biosimilars in inflammatory bowel disease: from initial uncertainty to clinical normalization.

Argüelles-Arias Federico F, Zabana Yamile Y

Biosimilars have become an integral part of the treatment of inflammatory bowel disease (IBD), evolving from initial uncertainty regarding indication extrapolation and non-medical switching to widespread clinical acceptance. Early concerns focused mainly on the absence of disease-specific evidence and the potential impact of switching on effectiveness, safety, and immunogenicity. Over the past decade, however, extensive real-world evidence and randomized data have consistently supported the use of infliximab and adalimumab biosimilars in both biologic-naïve patients and patients switched from originator products. Recent systematic reviews and meta-analyses further reinforce these findings, showing preserved clinical remission, treatment persistence, inflammatory biomarkers, and immunogenicity after switching. The biosimilar landscape is now expanding to newer therapeutic targets, including ustekinumab, while biosimilar-to-biosimilar and multiple switching is becoming increasingly relevant in routine practice. Nevertheless, scientific interchangeability should not be equated to automatic substitution. Switching decisions should remain clinically supervised and involve gastroenterologists within a multidisciplinary framework, taking into account disease activity, previous response, safety, immunogenicity, and patient preferences. Appropriate communication is also essential to minimize a potential nocebo effect and to avoid unnecessary discontinuation. Biosimilars should therefore be considered fully established biological therapies rather than lower-tier alternatives to originator drugs. Future research should focus less on re-confirming single-switch equivalence and more on unresolved questions, including long-term outcomes after multiple switching, biosimilars of newer therapeutic targets, patient-reported outcomes, treatment persistence, and comparative pharmacoeconomic impact across healthcare systems.

PMID 42929266

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PubMedCase reports in gastroenterology2026-10-25

Transient Right Temporal Visual Field Loss Temporally Associated with Maintenance Infliximab in Crohn's Disease: A Case Report with Focused Literature Review.

Shahbaz Asad A, AlMohtasib Suliman S, Sajjadi Fatima F, Alqatati Fadel F et al.

Infliximab is an established therapy for Crohn's disease, but uncommon neuro-ophthalmic adverse events have been reported. Most published infliximab-associated visual complications have involved optic neuritis or optic neuropathy rather than transient, structurally unexplained visual field symptoms. We report a 32-year-old man with ileocolonic Crohn's disease in remission on maintenance infliximab who developed sudden right temporal visual field loss approximately 2 days after infusion. The episode of sudden right temporal visual field loss after infliximab infusion lasted 15-30 min and was followed by blurred vision in the same field for about 6 h, with mild periorbital pain and headache. Ophthalmologic examination, including funduscopy, was unremarkable. Computed tomography of the head and magnetic resonance imaging of the brain and orbits with contrast were also unremarkable. Electrocardiography showed normal sinus rhythm, and transthoracic echocardiography demonstrated normal biventricular function without evidence of patent foramen ovale. Symptoms resolved spontaneously. The patient also described a prior episode of transient right-sided limb weakness occurring after a previous infliximab exposure, suggesting a recurrent transient neurological pattern. Although causality cannot be established from a single case, this presentation appears to represent a recurrent, transient, imaging-negative neuro-ophthalmic syndrome temporally associated with maintenance infliximab exposure. The case underscores the need to exclude vascular, inflammatory, demyelinating, and migrainous causes while remaining alert to uncommon transient neurological events in patients receiving anti-tumor necrosis factor therapy.

PMID 42924097

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PubMedCureus2026-10-25

Infliximab Monotherapy as First-Line Treatment for Hepatic, Splenic, and Pulmonary Sarcoidosis in a Patient With High Cardiometabolic Risk.

Coimbra Matilde M, Saca Carolina C, Carvalho Maria Carolina MC, Neves Marisa M et al.

Glucocorticoids remain the first-line treatment for pulmonary and extrapulmonary sarcoidosis, with anti-tumor necrosis factor-alpha (TNF-α) agents such as infliximab typically reserved as steroid-sparing alternatives or for refractory disease. Data on anti-TNF-α monotherapy as first-line treatment, avoiding glucocorticoid exposure altogether, remain limited to isolated case reports. We report the case of a 46-year-old obese man with hypertension and dyslipidemia who presented with hepatic, splenic, and pulmonary sarcoidosis. Given his cardiometabolic risk profile, glucocorticoids were avoided entirely, and infliximab monotherapy was initiated as first-line treatment, resulting in marked clinical and radiological improvement within seven months. This case suggests that infliximab monotherapy may represent a safe and effective first-line alternative to glucocorticoids in selected patients with multiorgan sarcoidosis and significant cardiometabolic comorbidity.

PMID 42927362

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PubMedInternational journal of dermatology2026-10-25

Therapeutic Drug Monitoring of Infliximab in Hidradenitis Suppurativa: A Retrospective Cohort Study.

Young Albert A, Vazhappilly Joshua J, Zhan Xiaohan X, Pino José Labrador JL et al.

PMID 42925013

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PubMedCase reports in dermatology2026-10-25

Palisaded Neutrophilic and Granulomatous Dermatitis in Crohn's Disease under Infliximab Therapy with Concomitant Herpes Zoster Infection: A Case Report.

Abboud Sofie S, Titeca Géraldine G, Secco Léo-Paul LP

Palisaded neutrophilic and granulomatous dermatitis (PNGD) is a rare reactive dermatosis characterized clinically by symmetrical erythematous or violaceous umbilicated papules, typically involving acral sites, and histologically by a combination of neutrophilic dermatitis, interstitial granulomatous inflammation, and necrobiotic collagen. PNGD commonly arises in association with systemic conditions, especially autoimmune diseases, inflammatory arthritis, hematologic disorders, inflammatory bowel disease (IBD), infections, or medication exposure. We report a 52-year-old man with longstanding Crohn's disease treated with infliximab who developed asymptomatic erythematous papules on the nose, ear helices, and fingers following a recent herpes zoster episode and temporary interruption of infliximab therapy. Histopathology revealed an interstitial band-like infiltrate rich in neutrophils and histiocytes with basophilic necrotic collagen and leukocytoclasia, consistent with PNGD. Topical corticosteroid therapy led to complete resolution within 1 month, and no recurrence occurred after resuming infliximab over 1 year of follow-up. This case highlights the multifactorial nature of PNGD, in which Crohn's disease, anti-TNF therapy, and post-zoster immune dysregulation may act as synergistic triggers. Although anti-TNF agents are known to both treat and paradoxically induce PNGD, reports in IBD remain uncommon. PNGD shares overlapping histoclinical features with interstitial granulomatous dermatitis and neutrophilic dermatoses, supporting the concept of a spectrum of reactive granulomatous dermatitis. Recognition of PNGD is essential, as it may serve as a marker of underlying systemic disease or immune dysregulation. Management focuses on treating associated conditions, with topical or systemic anti-inflammatory therapies used as adjuncts. Further studies on immunopathogenesis may refine the classification of these overlapping entities.

PMID 42923337

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infliximab (BCD055 / infliximab, Biocad)

什么是 infliximab？

药物档案

作用机制

分子靶点

治疗适应症

相关研究文献

Baseline Clearance and Early Troughs Identify Candidates for Early Therapeutic Drug Monitoring During Infliximab Induction in Inflammatory Bowel Disease.

Biosimilars in inflammatory bowel disease: from initial uncertainty to clinical normalization.

Transient Right Temporal Visual Field Loss Temporally Associated with Maintenance Infliximab in Crohn's Disease: A Case Report with Focused Literature Review.

Infliximab Monotherapy as First-Line Treatment for Hepatic, Splenic, and Pulmonary Sarcoidosis in a Patient With High Cardiometabolic Risk.

Therapeutic Drug Monitoring of Infliximab in Hidradenitis Suppurativa: A Retrospective Cohort Study.

Palisaded Neutrophilic and Granulomatous Dermatitis in Crohn's Disease under Infliximab Therapy with Concomitant Herpes Zoster Infection: A Case Report.

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