Biologics : Targets & Therapy最新文献

{"title":"Late-Onset Ocular Myasthenia Gravis-Like Symptoms During Erenumab Therapy for Chronic Migraine: A Case Report.","authors":"Arwa Qaqish, Arwa Al Anber, Ghada Abdelhafez","doi":"10.2147/BTT.S579731","DOIUrl":"10.2147/BTT.S579731","url":null,"abstract":"<p><p>Chronic migraine (CM) is a disabling neurological disorder for which calcitonin gene-related peptide (CGRP)-targeted monoclonal antibodies, such as erenumab, provide effective prophylaxis. Although generally well tolerated, rare neuromuscular complications resembling ocular myasthenia gravis (MG) have been reported. A 46-year-old woman with CM achieved marked improvement with erenumab for over three years before developing diplopia and intermittent ptosis. Laboratory and imaging studies were unremarkable, but clinical suspicion for MG led to pyridostigmine therapy, resulting in rapid improvement. Brief episodes of dysarthria occurred but resolved within one month. Symptoms disappeared after discontinuation of erenumab and continued pyridostigmine. On re-initiation of erenumab, the patient maintained migraine control without recurrence of MG-like symptoms. This case illustrates a rare, late-onset, reversible MG-like complication of erenumab. Clinicians should remain alert to ocular manifestations even as delayed adverse effects of anti-CGRP therapy.</p>","PeriodicalId":9025,"journal":{"name":"Biologics : Targets & Therapy","volume":"20 ","pages":"579731"},"PeriodicalIF":4.5,"publicationDate":"2026-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12969706/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147430695","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"First-Line Serplulimab versus Other Anti-PD-1/PD-L1 Antibodies Plus Chemotherapy for Esophageal Squamous Cell Carcinoma: A Systematic Review with Benefit-Risk Assessment via Matching-Adjusted Indirect Comparison.","authors":"Yi Zhu, Xiao Qi, Senmiao Ni, Wenting Qiu, Mengkai Chen","doi":"10.2147/BTT.S602654","DOIUrl":"10.2147/BTT.S602654","url":null,"abstract":"<p><strong>Purpose: </strong>Blockade of the PD-L1/PD-1 pathway combined with chemotherapy has demonstrated significant survival benefits as first‑line therapy for esophageal squamous cell carcinoma (ESCC). However, comprehensive benefit-risk comparisons among approved agents remain limited. This study conducted an indirect comparison of serplulimab versus other anti-PD-1/PD-L1 antibodies plus chemotherapy in treatment-naïve ESCC patients.</p><p><strong>Patients and methods: </strong>A systematic review with matching-adjusted indirect comparisons (MAICs) was conducted using individual patient data (IPD) from ASTRUM-007 and aggregate data (AgD) from seven comparator trials, including CheckMate 648, ESCORT-1st, GEMSTONE-304, JUPITER-06, KEYNOTE-590, ORIENT-15, and RATIONALE-306. IPD were reweighted to match key baseline characteristics. Hazard ratios (HRs) for overall survival (OS) and progression-free survival (PFS) were estimated using the Bucher method. Subgroup analyses were further explored using Bayesian network meta-analysis.</p><p><strong>Results: </strong>Eight Phase 3 randomized controlled trials comprising 4,702 patients were included. After adjusting for baseline imbalances, serplulimab demonstrated comparable efficacy to other PD-1/PD-L1 inhibitors. The pooled adjusted OS HR was 0.98 (95% CI, 0.87-1.11), with numerically favorable OS versus nivolumab (HR, 0.76; 95% CI 0.47-1.24) and comparable OS versus pembrolizumab (HR, 0.93; 95% CI, 0.71-1.22) and camrelizumab (HR, 0.93; 95% CI, 0.70-1.24). The pooled adjusted PFS HR was 0.91 (95% CI, 0.81-1.02), significantly favoring serplulimab over nivolumab (HR, 0.56; 95% CI, 0.33-0.96), with favorable trends versus pembrolizumab (HR, 0.83; 95% CI, 0.63-1.10) and sugemalimab (HR, 0.86; 95% CI, 0.63-1.16). Subgroup analyses suggested greater relative benefit in women and patients with locally advanced disease. Grade 3-5 treatment-related adverse events occurred in 52.9% of serplulimab-treated patients, comparable to other PD-1/PD-L1 inhibitors (range, 47.4%-71.9%).</p><p><strong>Conclusion: </strong>This indirect comparison provides comparative benefit-risk evidence to inform first‑line treatment selection for locally advanced or metastatic ESCC. Serplulimab plus chemotherapy demonstrated a clinically meaningful PFS benefit, comparable OS after matching, and a manageable safety profile consistent with the PD-1/PD-L1 inhibitor class.</p>","PeriodicalId":9025,"journal":{"name":"Biologics : Targets & Therapy","volume":"20 ","pages":"602654"},"PeriodicalIF":4.5,"publicationDate":"2026-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12958973/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147364204","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Network Pharmacology-Based Exploration: Non-Targeted Metabolites of <i>Lactobacillus</i>-Fermented <i>Chaenomeles speciosa (Sweet) Nakai, Smilax glabra Roxb</i>. and <i>Pueraria montana var. Lobata</i> in Uric Acid Metabolism Intervention.","authors":"Wei Tan, Zongjun Li","doi":"10.2147/BTT.S578004","DOIUrl":"10.2147/BTT.S578004","url":null,"abstract":"<p><strong>Background: </strong>Previous studies have demonstrated that numerous medicine and food homology (MFH) possess the potential to regulate purine metabolism disorders, promote uric acid excretion, and alleviate hyperuricemia symptoms. Examples include CS (<i>Chaenomeles speciosa (Sweet) Nakai</i>), SR (<i>Smilax glabra Roxb.</i>) and PL (<i>Pueraria montana var. lobata</i>).</p><p><strong>Methods: </strong>Metabolomics was employed to analyze the compositional changes in medicinal and edible extracts before and after fermentation. Network pharmacology and molecular docking studies were further utilized to elucidate the interactions between these differential metabolites and the core targets of hyperuricemia. In vitro enzyme activity assays were conducted to confirm the therapeutic effects.</p><p><strong>Results: </strong>A total of 283, 248, and 18 differential metabolites were identified in CS,SR and PL samples, respectively. Among these, 54 significantly upregulated differential metabolites were selected for screening. Based on these metabolites, 53 HUA-related targets were identified for CS, SR and PL. Functional enrichment analysis revealed their roles in inflammatory stress and uric acid production pathways, particularly the MAPK signaling pathway and purine metabolism regulated by XDH. Additionally, other targets in the purine metabolism pathway, such as ADA, PNP, AMPD3, and IMPDH2, were co-regulated. Enzyme activity assays indicate that fermented MFH more effectively inhibits XOD, thereby regulating the conversion of xanthine and hypoxanthine into uric acid. Molecular docking revealed two significantly upregulated compounds in <i>CS</i>; and five in PL; and four in SR. exhibit strong binding to XOD.</p><p><strong>Conclusion: </strong>These findings provide theoretical support for FMFH as a potential effective component in preventing and treating hyperuricemia. Our research demonstrates that FMFH targets multiple pathways associated with hyperuricemia, offering a promising approach for preventing this condition.</p>","PeriodicalId":9025,"journal":{"name":"Biologics : Targets & Therapy","volume":"20 ","pages":"578004"},"PeriodicalIF":4.5,"publicationDate":"2026-02-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12949976/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147343485","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Net Present Value Impact of FDA's Phase 3 Waivers on Monoclonal Antibody Biosimilar Development.","authors":"Ranjit Ranbhor, Priyanka Kulkarni","doi":"10.2147/BTT.S581013","DOIUrl":"10.2147/BTT.S581013","url":null,"abstract":"<p><strong>Background: </strong>The FDA's October 2025 guidance proposes waiving Phase 3 comparative efficacy studies for biosimilars when analytical and pharmacokinetic similarity are demonstrated.</p><p><strong>Methods: </strong>We conducted a net present value (NPV) analysis comparing traditional biosimilar development pathways (with Phase 3 comparative efficacy studies) to streamlined pathways utilizing FDA's Phase 3 waiver framework. The model incorporates industry-benchmarked cost data (Phase 3 studies: $20-28M), development timelines (Phase 3 duration: 1-3 years). Economic outcomes were evaluated across three monoclonal antibody biosimilar programs representing high-, moderate-, and lower-complexity scenarios. Sensitivity analysis evaluated parameter variation across realistic ranges.</p><p><strong>Results: </strong>Waiving Phase 3 studies reduces development costs by $25 million per program (18% reduction) and shortens timelines by 1.5 years (21% reduction). Risk-adjusted NPV improves by $25 million (29%), and minimum viable peak sales threshold decreases from $300 million to $250 million.</p><p><strong>Conclusion: </strong>Phase 3 waivers can substantially reduce development costs (~$25M average), accelerate timelines (~1.5 years), and improve NPV (~25-29%) for well-characterized monoclonal antibody biosimilars meeting FDA's analytical similarity and pharmacokinetic equivalence criteria. Economic benefits are conditional on robust analytical data, regulatory approval of waiver requests, and appropriate product selection (Tier 1/2/3 classification). Real-world realization requires post-implementation surveillance of FDA approval patterns, achieved cost reductions, and timeline compression beginning 2026-2027.</p>","PeriodicalId":9025,"journal":{"name":"Biologics : Targets & Therapy","volume":"20 ","pages":"581013"},"PeriodicalIF":4.5,"publicationDate":"2026-02-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12912049/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146218494","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Successful and Risk-Minimizing Treatment of Ulcerative Colitis by Positive Switch from JAK Inhibitors to Ustekinumab.","authors":"Haruka Otake, Satohiro Matsumoto, Hirosato Mashima","doi":"10.2147/BTT.S561965","DOIUrl":"10.2147/BTT.S561965","url":null,"abstract":"<p><strong>Background: </strong>Janus kinase (JAK) inhibitors are highly effective at inducing remission in moderate-to-severe ulcerative colitis (UC). Because JAK inhibitors are small molecules, they can be administered orally, are rapidly absorbed, and have a rapid onset of action. However, potential adverse events, such as serious infections, opportunistic infections, herpes zoster infections, venous thrombosis, and cardiovascular events have been identified. To avoid the side effects associated with the long-term administration of JAK inhibitors, switching to biologics may be considered, even if remission is maintained with JAK inhibitors (positive switch).</p><p><strong>Case report: </strong>Case 1: A 53-year-old man with steroid-dependent UC achieved rapid symptomatic improvement and complete mucosal healing on upadacitinib. Due to recurrent common colds and concerns regarding long-term adverse events, he underwent a positive switch to ustekinumab. Clinical and endoscopic remission have been maintained for one year. Case 2: A 36-year-old woman with refractory UC achieved clinical remission and mucosal healing with filgotinib following inadequate response to vedolizumab and corticosteroids. Given her desire for pregnancy and the potential risks of long-term JAK inhibitor use, she was switched to ustekinumab, which is considered safe during pregnancy. Remission has been maintained for one year.</p><p><strong>Conclusion: </strong>In two UC patients who achieved mucosal healing with a JAK inhibitor, remission was successfully maintained after switching to ustekinumab. These cases suggest that a positive switch may be a reasonable option for patients who respond to JAK inhibitors but have concerns about long-term safety. Additional cases are required to better define the clinical role of this strategy.</p>","PeriodicalId":9025,"journal":{"name":"Biologics : Targets & Therapy","volume":"20 ","pages":"561965"},"PeriodicalIF":4.5,"publicationDate":"2026-01-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13003793/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147497546","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Teclistamab for Relapsed or Refractory Multiple Myeloma: A Review of Efficacy, Safety, Resistance Mechanisms and Future Directions.","authors":"Bénédicte Piron, Philippe Moreau, Cyrille Touzeau","doi":"10.2147/BTT.S539066","DOIUrl":"10.2147/BTT.S539066","url":null,"abstract":"<p><p>Teclistamab is the first bispecific antibody targeting B-cell maturation antigen (BCMA) approved for the treatment of relapsed or refractory multiple myeloma. Its significant efficacy as monotherapy, particularly in the Phase 1/2 MajesTEC-1 trial, has been also confirmed in the context of combination therapies. Early safety events are dominated by grade 1 or 2 cytokine release syndrome. Risk of infection is now better characterized and can be managed through systematic prophylaxis. Notably, real-world studies have confirmed its efficacy and safety, notably in patients under-represented or ineligible for clinical trials (elderly, with renal impairment or central nervous system involvement). Mechanisms of resistance to teclistamab including target loss and T-cell environment are increasingly understood. Consequently, several strategies to overcome immune escape or antigen loss are currently being evaluated in clinical trials. The use of teclistamab in earlier lines of treatment and in combination may yield better results and is evaluating but ongoing Phase 3 clinical trials.</p>","PeriodicalId":9025,"journal":{"name":"Biologics : Targets & Therapy","volume":"20 ","pages":"539066"},"PeriodicalIF":4.5,"publicationDate":"2026-01-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12811975/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145997309","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Research on the Role of Autophagy in Vascular Endothelial Cells in the Healing of Chronic Refractory Wounds.","authors":"Lao Riling, Fan Kunyue, Gan Liyan, Wang Yaya, Ni Baoling, Li Jiehui","doi":"10.2147/BTT.S573844","DOIUrl":"10.2147/BTT.S573844","url":null,"abstract":"<p><p>Chronic refractory wounds exhibit a complex etiology characterized by prolonged healing and pathological chronic inflammation, which pose significant challenges to wound recovery and may increase the risk of cancer over time. In recent years, the autophagy mechanism has emerged as a focal point of research. This process is regulated by nutritional status, growth factors, and cellular stress. Autophagy facilitates the removal of damaged organelles and misfolded proteins, recycles nutrients, contributes to immune defense, and aids in the elimination of pathogens. Endothelial autophagy is particularly crucial in the healing of chronic refractory wounds. It may be activated under conditions of ischemia, hypoxia, inflammation, and infection, thereby inhibiting cell proliferation and tissue repair while assisting cells in maintaining homeostasis and managing various stressors. Consequently, investigating the autophagic mechanisms in vascular endothelial cells during chronic refractory wound healing is essential for the development of novel wound treatment strategies.</p>","PeriodicalId":9025,"journal":{"name":"Biologics : Targets & Therapy","volume":"20 ","pages":"573844"},"PeriodicalIF":4.5,"publicationDate":"2026-01-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13003654/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147497533","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Mesenchymal Stem Cell Therapy in Osteoarthritis and Rheumatoid Arthritis: A Systematic Review of Exosomal microRNAs.","authors":"Seyyed Sina Hejazian, Seyyedeh Mina Hejazian, Seyede Saba Mostafavi Montazeri, Sima Abediazar, Sepideh Zununi Vahed, Abolfazl Barzegari","doi":"10.2147/BTT.S571417","DOIUrl":"10.2147/BTT.S571417","url":null,"abstract":"<p><strong>Summary: </strong>Osteoarthritis (OA) and rheumatoid arthritis (RA) are chronic diseases characterized by persistent inflammation and autoimmune responses that affect the joints and other organs. Scientific evidence indicates that the therapeutic effects of mesenchymal stem cells (MSCs) are mediated through the release of soluble factors and extracellular vesicles (EVs), particularly exosomes. The release of microRNAs from MSCs holds substantial potential for cell-free treatment in OA and RA.</p><p><strong>Methods: </strong>A comprehensive search was conducted on Web of Science, PubMed, Scopus, and Google Scholar to identify relevant publications until 24 March 2024. The systematic review aimed at illuminating the current understanding of MSC-derived exosomal microRNAs, the origin of MSCs, potential mechanisms of action, and their therapeutic implications in managing OA and RA.</p><p><strong>Results: </strong>A total of fifty-five articles (OA, n= 41 and RA, n= 14) were deemed eligible for inclusion in this study. Regardless of MSC origin, exosomal miRNAs could induce anti-inflammatory, protective, and chondroregenerative potential in in vitro and in vivo models of OA by targeting different signaling pathways. Fourteen studies have highlighted the role of MSC-derived exosomal miRNAs in modulating immune responses, reducing pro-inflammatory cytokine production, and potentially ameliorating synovial inflammation and joint symptoms associated with RA. To suppress joint inflammation and preserve cartilage, miR-140, miR-92a-3p, and miR-136-5p emerged as leading candidates for OA because they help restore the anabolic/catabolic balance and modulate key signaling pathways. For RA, the most effective candidates were miR-146a, miR-150-5p and miR-205-5p that target innate and adaptive immune signaling and synoviocyte activation, with NF-κB modulators such as miR-361-5p offering overlap across both diseases.</p><p><strong>Conclusion: </strong>The mounting body of preclinical evidence supports that MSC-exosomal-miRNAs present a promising solution for OA and RA as a novel therapeutic strategy. However, human studies and more clinical trials are warranted.</p>","PeriodicalId":9025,"journal":{"name":"Biologics : Targets & Therapy","volume":"19 ","pages":"747-785"},"PeriodicalIF":3.4,"publicationDate":"2025-12-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12777084/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145932035","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Erratum: Mechanism and Applications of CRISPR/Cas-9-Mediated Genome Editing [Corrigendum].","authors":"","doi":"10.2147/BTT.S585961","DOIUrl":"https://doi.org/10.2147/BTT.S585961","url":null,"abstract":"<p><p>[This corrects the article DOI: 10.2147/BTT.S326422.].</p>","PeriodicalId":9025,"journal":{"name":"Biologics : Targets & Therapy","volume":"19 ","pages":"745-746"},"PeriodicalIF":3.4,"publicationDate":"2025-12-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12757175/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145899389","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Efficacy, Safety, and Cost-Effectiveness of the Infliximab Biosimilar GP-1111 in Patients with Inflammatory Bowel Disease Who Underwent a Nonmedical Switch: A Prospective Cohort Study.","authors":"Máté Pápista, Tamás Resál, Péter Bacsur, Diána Kata, Bernadett Farkas, Anita Bálint, Anna Fábián, Renáta Bor, Emese Ivány, Zoltán Szepes, Klaudia Farkas, Zoltán Juhász, Norbert Buzás, Tamás Molnár","doi":"10.2147/BTT.S559503","DOIUrl":"10.2147/BTT.S559503","url":null,"abstract":"<p><strong>Purpose: </strong>Data regarding treatment switch from the originator infliximab (IFX) to GP-1111 in inflammatory bowel disease (IBD) are limited. Only a few studies have examined the financial aspects of biosimilar use, none of them regarding GP-1111. The study aimed to evaluate the long-term efficacy and safety of the IFX biosimilar GP-1111 in patients with IBD who underwent a nonmedical switch from the original IFX in real-life settings. Further, it investigated the switch from a health economics perspective.</p><p><strong>Patients and methods: </strong>A prospective cohort study was conducted on patients with IBD who were on maintenance IFX treatment and who switched to the IFX biosimilar GP-1111 due to financial constraints, with a 1-year follow-up period. Clinical and laboratory parameters were measured at baseline and at weeks 8, 16, and 52 and serum IFX levels were measured at baseline and at week 24. Statistical analyses were performed using the paired <i>t</i>-test, Pearson's chi-square test, Kaplan-Meier survival curves, Cox proportional hazard regression models, and univariate linear model.</p><p><strong>Results: </strong>This study included 142 patients (95 with Crohn's disease and 47 with ulcerative colitis). The average serum IFX level remained within the therapeutic range from baseline (3.2 ± 2.3 μg/mL) to week 24 (3.7 ± 2.7 μg/mL, p = 0.106). The corticosteroid-free remission (S-SFR) rates were stable (baseline: 69.7%, follow-up: 72.9%, p = 0.58). The 1-year treatment persistence rate was 83.1%. The adverse events included allergic reactions (IR: 6.3 per 100 patient-years) and paradoxical reactions (IR: 2.4 per 100 patient-years). Based on the estimated cost analysis, biosimilar use could lead to significant savings, with a total of 201.9 million HUF (514,000 €).</p><p><strong>Conclusion: </strong>The IFX biosimilar GP-1111 was safe and effective against IBD in real-world settings. The average serum IFX levels and S-SFR rates remained stable, while no identifiable factors leading to treatment discontinuation were observed. Biosimilar use has a cost advantage with a reassuring safety profile.</p>","PeriodicalId":9025,"journal":{"name":"Biologics : Targets & Therapy","volume":"19 ","pages":"731-743"},"PeriodicalIF":3.4,"publicationDate":"2025-12-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12722428/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145826825","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}