BioDrugs最新文献

{"title":"Phase I, Randomized, Placebo-Controlled, Dose-Escalation Study of GB223, a Fully-Humanized Monoclonal Antibody to RANKL, in Healthy Chinese Adults.","authors":"Chen Li,&nbsp;Haiyan Liu,&nbsp;Yixiang Liao,&nbsp;Yu Zhu,&nbsp;Jingyuan Tian,&nbsp;Xuan Wang,&nbsp;Zhiqin Hu,&nbsp;Yaoxuan Zhan,&nbsp;Xianbo Li,&nbsp;Xintong Liang,&nbsp;Jin He,&nbsp;Yongmei Li,&nbsp;Dewei Shang,&nbsp;Qingshan Zheng,&nbsp;Tenghua Wang,&nbsp;Haifeng Song,&nbsp;Yi Fang","doi":"10.1007/s40259-023-00604-7","DOIUrl":"https://doi.org/10.1007/s40259-023-00604-7","url":null,"abstract":"<p><strong>Background: </strong>GB223 is a novel, fully-humanized monoclonal antibody against the receptor activator of nuclear factor-kappa B ligand (RANKL). In this phase I study, the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of GB223 were investigated.</p><p><strong>Patients and methods: </strong>This was a randomized, double-blinded, placebo-controlled, single-dose escalation study conducted in 44 healthy Chinese adults. Participants were randomly assigned to receive a single subcutaneous injection dose of 7, 21, 63, 119, or 140 mg of GB223 (n = 34) or placebo (n = 10) and were followed up for 140-252 days.</p><p><strong>Results: </strong>The results of noncompartmental analysis showed that GB223 was slowly absorbed after dosing, with a time to reach maximum concentration (T_max) ranging from 5 to 11 days. Serum GB223 concentrations decreased slowly, with a long half-life ranging from 7.91 to 19.60 days. A two-compartment Michaelis-Menten model was found to best describe the pharmacokinetics of GB223, and the absorption rate of GB223 differed between males (0.0146 h^-1) and females (0.0081 h^-1). Serum C-terminal telopeptide of type I collagen decreased significantly postdose, and the inhibition lasted 42-168 days. No deaths or drug-related serious adverse events occurred. The most frequent adverse events were blood parathyroid hormone increased (94.1%), blood phosphorus decreased (67.6%) and blood calcium decreased (58.8%). In the GB223 group, 44.1% (15/34) of subjects were antidrug antibody positive after dosing.</p><p><strong>Conclusion: </strong>In this study, we demonstrated for the first time that a single subcutaneous injection of GB223, from 7 to 140 mg, is safe and well tolerated in healthy Chinese subjects. GB223 has a nonlinear pharmacokinetic profile, and sex was a potential covariate that may affect the absorption rate of GB223.</p><p><strong>Clinical trial registration: </strong>NCT04178044 and ChiCTR1800020338.</p>","PeriodicalId":9022,"journal":{"name":"BioDrugs","volume":"37 5","pages":"721-735"},"PeriodicalIF":6.8,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10012862","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Home-Based Infusion of Alglucosidase Alfa Can Safely be Implemented in Adults with Late-Onset Pompe Disease: Lessons Learned from 18,380 Infusions.","authors":"Imke A M Ditters,&nbsp;Harmke A van Kooten,&nbsp;Nadine A M E van der Beek,&nbsp;Jacqueline F Hardon,&nbsp;Gamida Ismailova,&nbsp;Esther Brusse,&nbsp;Michelle E Kruijshaar,&nbsp;Ans T van der Ploeg,&nbsp;Johanna M P van den Hout,&nbsp;Hidde H Huidekoper","doi":"10.1007/s40259-023-00609-2","DOIUrl":"https://doi.org/10.1007/s40259-023-00609-2","url":null,"abstract":"<p><strong>Background: </strong>Enzyme replacement therapy (ERT) with alglucosidase alfa is the treatment for patients with Pompe disease, a hereditary metabolic myopathy. Home-based ERT is unavailable in many countries because of the boxed warning alglucosidase alfa received due to the risk of infusion-associated reactions (IARs). Since 2008, home infusions have been provided in The Netherlands.</p><p><strong>Objectives: </strong>This study aimed to provide an overview of our experience with home-based infusions with alglucosidase alfa in adult Pompe patients, focusing on safety, including management of IARs.</p><p><strong>Method: </strong>We analysed infusion data and IARs from adult patients starting ERT between 1999 and 2018. ERT was initially given in the hospital during the first year. Patients were eligible for home treatment if they were without IARs for multiple consecutive infusions and if a trained home nurse, with on-call back-up by a doctor, was available. The healthcare providers graded IARs.</p><p><strong>Results: </strong>We analysed data on 18,380 infusions with alglucosidase alfa in 121 adult patients; 4961 infusions (27.0%) were given in hospital and 13,419 (73.0%) were given at home. IARs occurred in 144 (2.9%) hospital infusions and 113 (0.8%) home infusions; 115 (79.9% of 144) IARs in hospital and 104 (92.0% of 113) IARs at home were mild, 25 IARs (17.4%) in hospital and 8 IARs (7.1%) at home were moderate, and very few severe IARs occurred (4 IARs in hospital [2.8%] and 1 IAR at home [0.9%]). Only one IAR in the home situation required immediate clinical evaluation in the hospital.</p><p><strong>Conclusion: </strong>Given the small numbers of IARs that occurred with the home infusions, of which only one was severe, we conclude that alglucosidase alfa can be administered safely in the home situation, provided the appropriate infrastructure is present.</p>","PeriodicalId":9022,"journal":{"name":"BioDrugs","volume":"37 5","pages":"685-698"},"PeriodicalIF":6.8,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/5c/12/40259_2023_Article_609.PMC10432339.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10380486","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Antibody-Drug Conjugates in the Treatment of Urothelial Cancer.","authors":"Avani M Singh,&nbsp;Jose A Guevara-Patino,&nbsp;Xuefeng Wang,&nbsp;Roger Li,&nbsp;Guru Sonpavde,&nbsp;Rohit K Jain","doi":"10.1007/s40259-023-00606-5","DOIUrl":"https://doi.org/10.1007/s40259-023-00606-5","url":null,"abstract":"<p><p>Antibody-drug conjugates (ADCs) have transformed the treatment landscape in oncology and become an essential therapeutic modality. In urothelial carcinoma (UC), the two ADCs that have been especially successful in clinical practice are enfortumab vedotin and sacituzumab govitecan. These drugs are currently approved as monotherapy for later lines of treatment in locally advanced or metastatic UC and have had a significant impact for patients with limited treatment options. Combinational trials, as well as additional ADCs, are currently being investigated in the treatment of UC for subsequent lines of therapy as overall survival rates remain dismal.</p>","PeriodicalId":9022,"journal":{"name":"BioDrugs","volume":"37 4","pages":"505-520"},"PeriodicalIF":6.8,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9682345","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Assessing the Interchangeability of AVT02 and Humira^® in Participants with Moderate‑to‑Severe Chronic Plaque Psoriasis: Pharmacokinetics, Efficacy, Safety, and Immunogenicity Results from a Multicenter, Double-Blind, Randomized, Parallel-Group Study.","authors":"Steven R Feldman,&nbsp;Richard Kay,&nbsp;Nataliya Reznichenko,&nbsp;Joanna Sobierska,&nbsp;Roshan Dias,&nbsp;Hendrik Otto,&nbsp;Halimu N Haliduola,&nbsp;Abid Sattar,&nbsp;Ruth Ruffieux,&nbsp;Heimo Stroissnig,&nbsp;Fausto Berti","doi":"10.1007/s40259-023-00600-x","DOIUrl":"https://doi.org/10.1007/s40259-023-00600-x","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;The US Food and Drug Administration (FDA) interchangeability guidelines state that the primary endpoint in a switching study should assess the impact of switching between the proposed interchangeable product and the reference product on clinical pharmacokinetics (PK) and pharmacodynamics (if available), as these assessments are generally sensitive to changes in immunogenicity and/or exposure that may arise due to switching. In addition, interchangeability designation requires no clinically meaningful difference in safety and efficacy of switching between the biosimilar and reference, compared with when using the reference product alone.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objectives: &lt;/strong&gt; The aim of this study was to investigate the PK, immunogenicity, efficacy, and safety in participants undergoing repeated switches between Humira&lt;sup&gt;®&lt;/sup&gt; and AVT02 as part of a global interchangeable development program.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This multicenter, randomized, double-blind, parallel-group study in patients with moderate-to-severe plaque psoriasis comprises three parts: lead-in period (weeks 1-12), switching module (weeks 12-28), and the optional extension phase (weeks 28-52). Following the lead-in period during which all participants received the reference product (80 mg in week 1, followed by 40 mg every other week), participants with a clinical response of ≥ 75% improvement in the Psoriasis Area and Severity Index (PASI75) were randomized 1:1 to receive AVT02 alternating with the reference product (switching arm) or reference product only (non-switching arm). At week 28, participants who were PASI50 responders could opt to take part in an open-label extension phase receiving AVT02 up to week 50, with an end of study visit at week 52. PK, safety, immunogenicity, and efficacy were evaluated at various timepoints throughout the study for both switching and non-switching arms.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;In total, 550 participants were randomized to switching (277) and non-switching arms (273). The switching versus non-switching arithmetic least square means ratio [90% confidence intervals (CIs)] was 101.7% (91.4-112.0%) for the area under the concentration-time curve over the dosing interval from weeks 26-28 (AUC&lt;sub&gt;tau, W26-28&lt;/sub&gt;) and 108.1% (98.3-117.9%) for maximum concentration over the dosing interval from weeks 26-28 (C&lt;sub&gt;max, W26-28&lt;/sub&gt;). The 90% CIs for the switching versus non-switching arithmetic means ratio for primary endpoints AUC&lt;sub&gt;tau, W26-28&lt;/sub&gt; and C&lt;sub&gt;max, W26-28&lt;/sub&gt; were within the prespecified limits of 80-125%, demonstrating comparable PK profiles between groups. In addition, the PASI, Dermatology Life Quality Index, and static Physician's Global Assessment efficacy scores were highly similar for both treatment groups. There were no clinically meaningful differences between the immunogenicity and safety assessments of repeated switching between AVT02 and the reference product, versu","PeriodicalId":9022,"journal":{"name":"BioDrugs","volume":"37 4","pages":"551-567"},"PeriodicalIF":6.8,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/26/8c/40259_2023_Article_600.PMC10197027.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9687201","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Characterization for the Similarity Assessment between Proposed Biosimilar SB12 and Eculizumab Reference Product Using a State-of-the-Art Analytical Method.","authors":"Hyunsoo Kim,&nbsp;Eunkyoung Hong,&nbsp;Jungmin Lee,&nbsp;Seokku Hong,&nbsp;Jihye Kim,&nbsp;Miju Cho,&nbsp;Yikwon Kim,&nbsp;Taekyung Yoo","doi":"10.1007/s40259-023-00591-9","DOIUrl":"https://doi.org/10.1007/s40259-023-00591-9","url":null,"abstract":"<p><strong>Background: </strong>SB12 is being developed as a proposed biosimilar to eculizumab reference product (RP), a humanized monoclonal antibody (IgG2/4 kappa immunoglobulin) that binds to the human C5 complement protein. Binding to this protein inhibits complement-mediated intravascular hemolysis by blocking its cleavage into C5a and C5b. Eculizumab RP is indicated for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis, atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy, generalized myasthenia gravis who are anti-acetylcholine receptor antibody-positive, and neuromyelitis optica spectrum disorder in adult patients who are anti-aquaporin-4 antibody-positive.</p><p><strong>Objective: </strong>The objective of this study was to demonstrate structural, physicochemical, and biological similarity between eculizumab RP and SB12 using various state-of-the-art analytical methods.</p><p><strong>Methods: </strong>Comprehensive analytical characterization was conducted with side-by-side comparison of SB12 with European Union (EU) and United States (US) eculizumab RPs using various analytical methods (more than 40 state-of-the-art assays). Comparisons included purity, product-related impurity, charge heterogeneity, primary structure, post-translational modification, higher-order structure, quantity, Fab-related biological activities (potency and binding activity), and Fc-related biological activities.</p><p><strong>Results: </strong>Based on the analytical similarity assessment, the structural, physicochemical, and biological characterization results demonstrated that SB12 is highly similar to the EU and US eculizumab RP. In the structural aspects, it was confirmed that there is no difference between post-translational modification profiles and higher-order structures of SB12 compared with the eculizumab RP. Product-related impurities in the form of aggregates and charge variants were also confirmed to be similar. Mechanism of action (MoA)-related biological activities showed that SB12 is highly similar to the EU and US eculizumab RP with respect to overall critical and non-critical quality attributes analyzed. Moreover, similarity of comparative binding tendency of SB12 and eculizumab RP to Fc gamma receptors and C1q was confirmed through additional characterization methods. Based on these results, SB12 is expected to have highly similar safety and efficacy compared with eculizumab RP.</p><p><strong>Conclusion: </strong>In summary, the overall analytical characterization and similarity assessment results show that SB12 is highly similar to the EU and US eculizumab RP in terms of structural, physicochemical, biophysical, and biological attributes.</p>","PeriodicalId":9022,"journal":{"name":"BioDrugs","volume":"37 4","pages":"569-581"},"PeriodicalIF":6.8,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/60/04/40259_2023_Article_591.PMC10287819.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10062822","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Novel Immunotherapeutic Approaches for the Treatment of Glioblastoma.","authors":"Saïf Eddine Zaidi, Eliese Moelker, Kirit Singh, Aditya Mohan, Miguel A Salgado, Muhammed Amir Essibayi, Kelly Hotchkiss, Steven Shen, William Lee, John Sampson, Mustafa Khasraw","doi":"10.1007/s40259-023-00598-2","DOIUrl":"10.1007/s40259-023-00598-2","url":null,"abstract":"<p><p>Glioblastoma is highly aggressive and remains difficult to treat despite being the most common malignant primary brain tumor in adults. Current standard-of-care treatment calls for maximum resection of the tumor mass followed by concurrent chemotherapy and radiotherapy and further adjuvant chemotherapy if necessary. Despite this regimen, prognosis remains grim. Immunotherapy has shown promising success in a variety of solid tumor types, but efficacy in glioblastoma is yet to be demonstrated. Barriers to the success of immunotherapy in glioblastoma include: a heterogeneous tumor cell population, a highly immunosuppressive microenvironment, and the blood-brain barrier, to name a few. Several immunotherapeutic approaches are actively being investigated and developed to overcome these limitations. In this review, we present different classes of immunotherapy targeting glioblastoma, their most recent results, and potential future directions.</p>","PeriodicalId":9022,"journal":{"name":"BioDrugs","volume":"37 4","pages":"489-503"},"PeriodicalIF":5.4,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9682347","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Lupus Nephritis: New and Emerging Biologic and Targeted Therapies.","authors":"Ajinath Kale,&nbsp;Maciej Lech,&nbsp;Hans-Joachim Anders,&nbsp;Anil Bhanudas Gaikwad","doi":"10.1007/s40259-023-00597-3","DOIUrl":"https://doi.org/10.1007/s40259-023-00597-3","url":null,"abstract":"<p><p>Lupus nephritis (LN) is a severe complication of systemic lupus erythematosus (SLE), a polyclonal systemic autoimmunity directed against nuclear and other self-antigens. SLE/LN affects mostly females during childbearing age, which puts them at risk for the progression of chronic kidney disease (CKD), cardiovascular disease, and pregnancy complications. The current management of LN involves the use of drugs with significant toxicities, and despite many attempts at novel drug interventions, the overall treatment efficacy has remained low. In this article, we discuss recent drug approvals and the upcoming pipeline of novel medications tested in clinical trials to improve effectiveness in terms of LN disease activity, LN relapse, and progression of LN-related CKD. In this context, we discuss (1) drugs with the potential to achieve these treatment goals by modulating SLE activity as the driving force for LN (e.g., belimumab, obinutuzumab, anifrolumab, and others); (2) drugs with SLE-non specific renoprotective effects by targeting non-immune mechanisms of LN progression (dapagliflozin, empagliflozin); and (3) drugs with dual immunosuppressive and antiproteinuric effects (voclosporin). Increasing the number of possible drug options will help to improve the management of LN in terms of efficacy and safety, and enable a more personalized treatment approach.</p>","PeriodicalId":9022,"journal":{"name":"BioDrugs","volume":"37 4","pages":"463-475"},"PeriodicalIF":6.8,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9686619","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Historical Overview of Regulatory Approvals and PMDA Assessments for Biosimilar Products in Japan During 2009-2022.","authors":"Ryosuke Kuribayashi,&nbsp;Ayuki Nakano,&nbsp;Aya Hariu,&nbsp;Yasuhiro Kishioka,&nbsp;Futaba Honda","doi":"10.1007/s40259-023-00605-6","DOIUrl":"https://doi.org/10.1007/s40259-023-00605-6","url":null,"abstract":"<p><p>A biosimilar product is defined as \"a biological product that is highly similar to an existing, approved biological product (known as originator or reference product) in terms of structure, function, quality, and clinical efficacy and safety\". Recently, biosimilar products have been actively developed around the world, and part of the reason for this is to combat the rapid growth of medical expenses in many countries, including Japan, the United States (US), and Europe. The use of biosimilar products has been promoted as a measure to address this issue. The review of marketing authorization applications for biosimilar products in Japan is conducted by the Pharmaceuticals and Medical Devices Agency (PMDA), which reviews the comparability of the quality, efficacy, and safety based on the data submitted by the applicants. As of December 2022, 32 biosimilar products have been approved in Japan. Through this process, the PMDA has gained much experience and knowledge regarding the development and regulatory approval of biosimilar products; however, details of the regulatory approvals for biosimilar products in Japan have not been reported until now. Therefore, in this article, we present the details of regulatory history and revised guidelines for approval of biosimilar products in Japan, questions and answers, other relevant notifications, and consideration for comparability evaluations for analytical, non-clinical, and clinical studies. In addition, we provide details about the approval history, number, and types of biosimilar products that have been approved between 2009 and 2022 in Japan.</p>","PeriodicalId":9022,"journal":{"name":"BioDrugs","volume":"37 4","pages":"443-451"},"PeriodicalIF":6.8,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9687698","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Recurring Fatigue After Biologic Administration: Patient-Reported Data from the Dutch Biologic Monitor.","authors":"Jette A van Lint,&nbsp;Naomi T Jessurun,&nbsp;Sander W Tas,&nbsp;Harald E Vonkeman,&nbsp;Martijn B A van Doorn,&nbsp;Frank Hoentjen,&nbsp;Michael T Nurmohamed,&nbsp;Eugene P van Puijenbroek,&nbsp;Bart J F van den Bemt","doi":"10.1007/s40259-023-00592-8","DOIUrl":"https://doi.org/10.1007/s40259-023-00592-8","url":null,"abstract":"<p><strong>Background: </strong>Fatigue is a common problem in immune-mediated inflammatory disease (IMID) patients, significantly impacting their quality of life.</p><p><strong>Objectives: </strong>In this study, we describe the pattern and characteristics of fatigue as a patient-reported adverse drug reaction (ADR) of biologics, and compared patient and treatment characteristics with patients reporting other ADRs or no ADRs.</p><p><strong>Methods: </strong>In this cohort event monitoring study, the description and characteristics of fatigue reported as a possible ADR in the Dutch Biologic Monitor were assessed and analysed for commonly recurring themes or patterns. Baseline and treatment characteristics of patients with fatigue and patients reporting other ADRs or no ADRs were compared.</p><p><strong>Results: </strong>Of 1382 participating patients, 108 patients (8%) reported fatigue as an ADR of a biologic. Almost half of these patients (50 patients, 46%) described episodes of fatigue during or shortly after biologic injection, which often recurred following subsequent injections. Patients with fatigue were significantly younger than patients with other ADRs or patients without ADRs (median age for patients with fatigue, 52 years; median age for patients with other ADRs, 56 years; and median age for patients without ADRs, 58 years); significantly more often smoked (25% vs. 16% and 15%); used infliximab (22% vs. 9% and 13%), rituximab (9% vs. 3% and 1%) or vedolizumab (6% vs. 2% and 1%); and significantly more often had Crohn's disease (28% vs. 13% and 13%) and other comorbidities (31% vs. 20% and 15%). Patients with fatigue significantly less frequently used etanercept (12% vs. 29% and 34%) or had rheumatoid arthritis (30% vs. 45% and 43%).</p><p><strong>Conclusions: </strong>IMID patients may experience fatigue as a postdosing effect of biologics.</p>","PeriodicalId":9022,"journal":{"name":"BioDrugs","volume":"37 4","pages":"541-550"},"PeriodicalIF":6.8,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/82/27/40259_2023_Article_592.PMC10287789.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9706325","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Role of Biologics in the Treatment of Chronic Rhinosinusitis.","authors":"Nora Haloob,&nbsp;Katerina Karamali,&nbsp;Claire Hopkins","doi":"10.1007/s40259-023-00602-9","DOIUrl":"https://doi.org/10.1007/s40259-023-00602-9","url":null,"abstract":"<p><p>The last decade has seen significant developments in the field of biologics for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP). Translational research borne from knowledge of the pathophysiology of type 2 inflammatory disease of the lower airways and the strong association with CRSwNP, has led to major therapeutic breakthroughs, with phase 3 trials of four biologics completed at the time of writing, and more underway. This article explores the evidence behind biologics for CRSwNP, the guidance on their use and the health economic factors influencing their position amongst the established therapeutic options for this common chronic condition.</p>","PeriodicalId":9022,"journal":{"name":"BioDrugs","volume":"37 4","pages":"477-487"},"PeriodicalIF":6.8,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9682827","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}