Zhejiang Hisun Pharmaceutical Co., Ltd. · TNF · Monoclonal Antibodies
infliximab is a monoclonal antibodies developed by Zhejiang Hisun Pharmaceutical Co., Ltd.. It is approved for therapeutic indications via injectable (others) or intravenous (iv).
| Brand Names | Anbaite, HS626, HS 626 |
| Company | Zhejiang Hisun Pharmaceutical Co., Ltd. |
| Drug Class | Monoclonal Antibodies, Antibody |
| Molecular Target | TNF |
| Route | Injectable (Others), Intravenous (IV) |
| Status | Approved |
infliximab acts on 1 molecular target:
| TNF | tumor necrosis factor (TNFA, TNF-alpha) |
infliximab is developed for 5 unique indications across 3 therapeutic areas.
| Therapeutic Area | Condition | Phase |
|---|---|---|
| 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 | Rheumatoid arthritis | ✓ Approved |
Patel Rishi R RR, Myers Katherine E KE, Mirsky Matthew M MM, Sheng Iris I et al.
Kwon Oh Chan OC, Ahn Soo Min SM, Hong Seokchan S, Seo Yeon Hong YH et al.
Acute anterior uveitis (AAU) is the most common extra-musculoskeletal manifestation of radiographic axial spondyloarthritis (r-axSpA) and is an important consideration when selecting biological therapy. Although adalimumab (ADA) and infliximab are commonly used in patients with r-axSpA and AAU, direct comparative evidence, particularly between ADA and subcutaneous infliximab (IFX-SC), remains limited. The objective of this study was to compare the risk of AAU flare between ADA and IFX-SC in patients with r-axSpA and a history of AAU. This multicenter, head-to-head, randomized, open-label trial enrolled patients with r-axSpA and a documented AAU event within the preceding 2 years. Participants were randomly assigned (1:1) to receive ADA (40 mg every 2 weeks) or IFX-SC (intravenous 5 mg/kg induction followed by subcutaneous 120 mg every 2 weeks) and were followed for 48 weeks. The primary endpoint was AAU flare occurrence. Hazard ratios (HRs) were estimated using Cox proportional hazards models. Secondary endpoints included changes in best-corrected visual acuity (BCVA), r-axSpA disease activity and functional indices, and safety outcomes. Fifty-six patients were randomized (ADA, n = 28; IFX-SC, n = 28). During follow-up, one AAU flare episode occurred in each group. The adjusted HR of IFX-SC (vs ADA) for an AAU flare was 0.496 (95% confidence interval 0.025-9.768, p = 0.645). No significant differences in secondary endpoints were observed between groups (right BCVA, p = 0.622; left BCVA, p = 0.306; Axial Spondyloarthritis Disease Activity Score, p = 0.293; Bath Ankylosing Spondylitis Disease Activity Index, p = 0.262; Bath Ankylosing Spondylitis Functional Index, p = 0.307). Adverse events were similar in frequency and severity, with no new safety signals identified. No statistically significant differences in AAU flare risk or secondary ocular and rheumatologic outcomes were observed between ADA and IFX-SC over 48 weeks in patients with r-axSpA and prior AAU. These findings suggest that IFX-SC may represent a potential alternative to ADA for AAU flare prevention as well as disease activity control in this population. Clinical Research Information Service (CRIS), Republic of Korea; KCT0007239.
Xia Ying Y, Zhu Ming-Mei MM, Xiao Meng-Qing MQ, Zhong Chen-Chun CC et al.
Infliximab (IFX) is a cornerstone biologic for pediatric inflammatory bowel disease, where therapeutic drug monitoring (TDM) is essential but complicated by inter-platform variability. Systematic comparison of automated immunoassays with reference methods is therefore warranted. This study aimed to validate an in-house chemiluminescence immunoassay (CLIA) for IFX quantification and evaluate its agreement with liquid chromatography-tandem mass spectrometry (LC-MS/MS). A CLIA kit was validated by assessing the limit of blank, specificity, linearity, accuracy, precision, matrix equivalence, and stability. IFX concentrations in 52 pediatric plasma samples were measured by CLIA and a reference LC-MS/MS method. Comparability was evaluated using linear regression, Passing-Bablok regression, and Bland-Altman analysis. CLIA showed excellent performance (lower limit of quantification: 0.640 µg/mL; specificity <10.0% interference; reportable range: 0.640-462 µg/mL). LC-MS/MS yielded higher concentrations than the CLIA (median: 6.25 vs. 2.87 µg/mL). Strong correlation was observed (r = 0.9101) with no significant deviation from linearity (Passing-Bablok, p > 0.05). However, Bland-Altman revealed substantial mean relative bias (67.9%) and poor categorical agreement (52% concordance) within the therapeutic range (3-7 µg/mL), indicating non-interchangeability. We validated a rapid, automated CLIA suitable for high-throughput TDM. Despite strong correlation, significant quantitative differences preclude direct result substitution, underscoring the need for method-specific therapeutic thresholds.
Singh Mandeep M, Seeralan Sharmila S, Seeralan Mayuran M, Oladipo Olanrewaju O
Disseminated sepsis with septic embolic disease can present with a wide spectrum of clinical manifestations and may closely mimic metastatic malignancy or immune-related adverse events in oncology patients. We report the case of a 50-year-old woman with cervical squamous cell carcinoma receiving pembrolizumab and infliximab who presented with fever, progressive blistering skin lesions, non-pruritic rash, and new right-sided neurological deficits. Initial concerns included toxic epidermal necrolysis, immunotherapy-related toxicity, metastatic disease, and severe infection. Examination revealed haemorrhagic blisters involving the fingers and toes, truncal rash, and transient right-sided weakness. Blood investigations demonstrated markedly elevated inflammatory markers. Imaging showed a cavitating left lower lobe lung lesion with air-fluid level, bilateral pulmonary infiltrates, hepatic lesions, and ring-enhancing lesions within the left frontal and parietal lobes concerning for cerebral abscesses or metastases. MRI brain findings favoured cerebral abscesses with surrounding vasogenic oedema. Wound cultures from hand and foot lesions grew Streptococcus pyogenes (Group A Streptococcus). Multidisciplinary input from dermatology, oncology, respiratory medicine, microbiology, vascular surgery, gastroenterology, and neurosurgery guided management. The patient initially received empirical piperacillin-tazobactam and gentamicin for severe sepsis. Following multidisciplinary microbiology review, antimicrobial therapy was escalated to meropenem and teicoplanin to provide broad-spectrum coverage while the diagnostic evaluation was ongoing because of extensive cerebral, pulmonary, and soft tissue infection in an immunocompromised host. The patient demonstrated significant clinical and biochemical improvement, and pembrolizumab and infliximab were withheld. Neurosurgical intervention was not considered appropriate due to the extent of systemic disease and favourable response to medical management. This case highlights the diagnostic complexity of disseminated infection in immunocompromised oncology patients, particularly when septic emboli and cerebral abscesses mimic metastatic disease or immune-related adverse events. Early multidisciplinary assessment and prompt antimicrobial therapy were essential in achieving clinical stabilisation.
Paglinco Samantha R SR, Abdel-Rasoul Mahmoud M, McNicol Megan M, Maltz Ross M RM
The introduction of infliximab biosimilars in the US has helped curb health care costs through competitive pricing. Many insurance payers have mandated switches from the originator to an infliximab biosimilar citing cost savings. This study assessed the cost savings to insurance payers and patients associated with switching infliximab products using a commercial claims database. This is a retrospective cohort study of commercially insured patients who received multiple infliximab products between 2015 and 2021 using administrative claims data. Infliximab outpatient claims from 2015 to 2021 were reviewed using the Merative MarketScan Commercial Claims and Encounters Database. Patients who switched infliximab products were identified by changes in Current Procedural Terminology codes. Cost savings to insurance payers and patients were calculated with infliximab product switches. A total of 1785 patients underwent at least 1 infliximab product switch, with the majority occurring in 2021. Of the first-time switches, 92% (n = 1642) were from the infliximab originator to a biosimilar, with 72% (n = 1286) switching to infliximab-dyyb (Inflectra; Celltrion, Inc). Thirteen percent (n = 232) underwent 2 or more switches. Insurance payers saw a peak savings from product switching in 2019, with a median (IQR) of $1088 ($612-$1888) saved per infusion. Savings decreased to $61 (-$321 to $639) per infusion in 2021. Median patient out-of-pocket savings remained $0 throughout the study. Switching to infliximab biosimilars increased over the study period. Cost savings for insurers peaked in 2019 but were negligible by 2021. Patients did not experience any savings from switching. Because nonmedical switching burdens providers and risks patient harm without clear economic benefits, mandatory switches demand greater system transparency to prioritize patient welfare.
Bertin Luisa L, Giraldi Lara L, Cavagna Camilla C, Caranfil Cristina C et al.
Validated biomarkers of biologic response in Crohn's disease (CD) are lacking. We assessed whether serum microRNAs (miRNAs) track disease activity and predict outcomes during biologic induction in CD. Thirty-nine adults with active CD initiating infliximab (n = 20) or vedolizumab (n = 19) and 10 controls were studied at a single centre. Serum was sampled at the first and fourth infusions. Six target miRNAs were qPCR-quantified and normalised to the geometric mean of miR-93-5p and miR-425-5p. Harvey-Bradshaw Index, C-reactive protein, faecal calprotectin and Simple Endoscopic Score for CD were recorded at baseline, post-induction and 12 months. Four pre-specified analysis families were tested with false discovery rate (FDR) correction for multiple testing. This was a single-centre, exploratory, hypothesis-generating study. miR-21-5p and miR-146b-5p were significantly reduced in CD versus controls (q < 0.05). Baseline miR-146b-5p inversely predicted post-induction CRP independently of baseline disease severity (partial r = -0.46, p = 0.010), supporting it as a candidate severity-independent predictor of biochemical response. Post-induction miR-424-5p strongly tracked concurrent inflammation (faecal calprotectin: Spearman ρ = +0.52, q = 0.004; CRP: ρ = +0.44, q = 0.030), these associations remained significant after adjustment for baseline disease severity, after leave-one-out removal of single patients, and under single-reference normalisation. An exploratory post-hoc analysis linked treatment-induced miR-106a-5p upregulation to penetrating (Montreal B3) disease (permutation p = 0.019). Serum miRNAs offer novel predictive (baseline miR-146b-5p and miR-106a-5p) and concurrent (post-induction miR-424-5p) biomarker signals during biologic induction in CD, providing information complementary to faecal calprotectin. Prospective independent validation is warranted before clinical translation.
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