Innovative approaches to biologic development on the trail of CT-P13: biosimilars, value-added medicines, and biobetters DOI Creative Commons
HoUng Kim, Rieke Alten, Fraser Cummings

и другие.

mAbs, Год журнала: 2021, Номер 13(1)

Опубликована: Янв. 1, 2021

The biosimilar concept is now well established. Clinical data accumulated pre- and post-approval have supported uptake, in turn stimulating competition the biologics market increasing patient access to biologics. Following technological advances, other innovative biologics, such as "biobetters" or "value-added medicines," are reaching market. These differ from reference product by offering additional clinical non-clinical benefits. We discuss these with CT-P13, initially available an intravenous (IV) of infliximab. A subcutaneous (SC) formulation, CT-P13 SC, has been developed. Relative IV, SC offers benefits terms pharmacokinetics, comparable efficacy, safety, immunogenicity, increased convenience for patients reduced demands on healthcare system resources. As was once case biosimilars, nomenclature regulatory pathways require clarification support their uptake ultimately benefit patients.

Язык: Английский

Tackling TNF-α in autoinflammatory disorders and autoimmune diseases: From conventional to cutting edge in biologics and RNA- based nanomedicines DOI Creative Commons
Valentina Andretto, Silvia Dusi, Serena Zilio

и другие.

Advanced Drug Delivery Reviews, Год журнала: 2023, Номер 201, С. 115080 - 115080

Опубликована: Сен. 1, 2023

Язык: Английский

Процитировано

20
The use of proteins and peptides-based therapy in managing and preventing pathogenic viruses DOI
Esmail M. El‐Fakharany, Hamada El‐Gendi, Ahmed K. Saleh

и другие.

International Journal of Biological Macromolecules, Год журнала: 2024, Номер 270, С. 132254 - 132254

Опубликована: Май 9, 2024

Язык: Английский

Процитировано

8
Therapeutic drug monitoring and neutralizing anti-drug antibody detection to optimize TNF-alpha inhibitor treatment for uveitis DOI Creative Commons

H Chen,

Jenny Shunyakova,

Amit K. Reddy

и другие.

Frontiers in Ophthalmology, Год журнала: 2025, Номер 5

Опубликована: Янв. 28, 2025

Background Adalimumab taken every other week is an effective treatment in patients with chronic refractory uveitis. Patients who have a suboptimal response to this may suffer from recurrent inflammation and vision loss. Here, we investigated the use of therapeutic drug monitoring neutralizing anti-drug antibody detection as strategy optimize tumor necrosis factor (TNF)-alpha inhibitor initial dosing adalimumab. Method Retrospective cohort study performed two tertiary referral uveitis services United States between 2015 2023. non-infectious had two-week adalimumab underwent serum level reflex testing were followed. considered antibodies when levels low (less than or equal 6 mcg/mL) anti-adalimumab present on testing. Treatment adjustment was made by clinicians knowledge presence absence antibodies. Every either escalated weekly switched infliximab, alternate TNF-alpha inhibitor, based these findings. The primary outcome success failure at 12 months, determined disease inactivity steroid-sparing therapy. Results 32 included. 31.2% (n=10) found All medication switch infliximab remission rate 40% months. without (n=22) dose escalation (77.3%; n=17) (22.7%; n=5) achieved 68.2% Altogether, detection, our cohort, resulted 62.5%. Conclusions For experiencing dosed weeks, help treatment.

Язык: Английский

Процитировано

1
Toward Overcoming Treatment Failure in Rheumatoid Arthritis DOI Creative Commons
Zhuqian Wang, Jie Huang, Duoli Xie

и другие.

Frontiers in Immunology, Год журнала: 2021, Номер 12

Опубликована: Дек. 23, 2021

Rheumatoid arthritis (RA) is an autoimmune disorder characterized by inflammation and bone erosion. The exact mechanism of RA still unknown, but various immune cytokines, signaling pathways effector cells are involved. Disease-modifying antirheumatic drugs (DMARDs) commonly used in treatment classified into different categories. Nevertheless, based on a "trial-and-error" approach, substantial proportion patients show failed therapy for each DMARD. Over the past decades, great efforts have been made to overcome failure, including identification biomarkers, exploration reasons loss efficacy, development sequential or combinational DMARDs strategies approval new DMARDs. Here, we summarize these efforts, which would provide valuable insights accurate clinical medication. While gratifying, researchers realize that far from enough recommend specific individual patients. Precision medicine emerging medical model proposes highly individualized tailored approach disease management. In this review, also discuss potential precision overcoming with introduction cutting-edge technologies big data.

Язык: Английский

Процитировано

35
Immune-Mediated Diseases from the Point of View of Psychoneuroimmunoendocrinology DOI Creative Commons
Miguel Á. Ortega, Cielo García‐Montero, Oscar Fraile‐Martínez

и другие.

Biology, Год журнала: 2022, Номер 11(7), С. 973 - 973

Опубликована: Июнь 28, 2022

Immune-mediated inflammatory diseases (IMIDs) represent a large group of (Crohn's, ulcerative colitis, psoriasis, lupus, and rheumatoid arthritis) evidenced by systemic inflammation multiorgan involvement. IMIDs result in reduced quality life an economic burden for individuals, health care systems, countries. In this brief descriptive review, we will focus on some the common biological pathways these from point view psychoneuroimmunoendocrinology (PNIE). PNIE consists four medical disciplines (psychology, nervous system, immune endocrine system), which are key drivers behind health-disease concept that human being functions as unit. We examine emphasize need integrative treatments addresses disease psychosomatic view.

Язык: Английский

Процитировано

25
Updates on HTLV-1 Uveitis DOI Creative Commons
Koju Kamoi, Toshiki Watanabe, Kaoru Uchimaru

и другие.

Viruses, Год журнала: 2022, Номер 14(4), С. 794 - 794

Опубликована: Апрель 12, 2022

HTLV-1 uveitis (HU) is the third clinical entity to be designated as an HTLV-1-associated disease. Although HU considered second-most frequent disease in Japan, information on limited compared that adult T-cell leukemia/lymphoma (ATL) and myelopathy (HAM). Recent studies have addressed several long-standing uncertainties about HU. HTLV-1-related diseases are known caused mainly through vertical transmission (mother-to-child transmission), but emerging infection by horizontal (such sexual transmission) has become a major problem metropolitan areas, such Tokyo, Japan. Investigation Tokyo showed of was responsible for with severe persistent ocular inflammation. The development ATL HAM related high provirus load hence involves long latency period. On other hand, factors contributing poorly understood. investigations revealed occurs against background Graves’ despite low short This review highlights recent knowledge provides update topic consideration nationwide survey.

Язык: Английский

Процитировано

24
mRNA Lipid Nanoparticles for Ex Vivo Engineering of Immunosuppressive T Cells for Autoimmunity Therapies DOI
Ajay S. Thatte, Alex G. Hamilton,

Benjamin E. Nachod

и другие.

Nano Letters, Год журнала: 2023, Номер 23(22), С. 10179 - 10188

Опубликована: Окт. 31, 2023

Cell-based therapies for autoimmune diseases have gained significant traction, with several approaches centered around the regulatory T (Treg) cell─a well-known immunosuppressive cell characterized by its expression of transcription factor Foxp3. Unfortunately, due to low numbers Treg cells available in circulation, harvesting and culturing remains a challenge. It has been reported that engineering Foxp3 CD4+ can result Treg-like phenotype; however, current methods inefficient these cells. Here, we develop an ionizable lipid nanoparticle (LNP) platform effectively deliver mRNA We successfully engineer into Foxp3-T (FP3T) transiently exhibit phenotype functionally suppress proliferation effector These results demonstrate promise LNP potential applications autoimmunity therapies.

Язык: Английский

Процитировано

16
Therapeutic potential of TNFα inhibitors in chronic inflammatory disorders: Past and future DOI Creative Commons
Hongtao Zhang,

Nelson Shi,

Zhuo Diao

и другие.

Genes & Diseases, Год журнала: 2020, Номер 8(1), С. 38 - 47

Опубликована: Март 3, 2020

In the past 20 years, patients with rheumatoid arthritis (RA), Crohn's disease (CD), and other immune diseases have witnessed impact of a great treatment advance availability biological TNFα inhibitors. With 5 approved anti-TNFα biologics on market soon available biosimilars, more options benefited from understanding biology TNFα. Nevertheless, many unmet needs remain for people living TNFα-related diseases, namely some side effects tolerance current resistance to therapies. Furthermore, common such as osteoarthritis back/neck pain may respond therapies at early onset symptoms. Development new inhibitors focusing TNFR1 specific inhibitors, preferably small molecules that can be delivered orally, is much needed.

Язык: Английский

Процитировано

35
Anti-Inflammatory Therapeutic Approaches to Prevent or Delay Post-Traumatic Osteoarthritis (PTOA) of the Knee Joint with a Focus on Sustained Delivery Approaches DOI Open Access

Christine M. Khella,

Judith M. Horvath,

Rojiar Asgarian

и другие.

International Journal of Molecular Sciences, Год журнала: 2021, Номер 22(15), С. 8005 - 8005

Опубликована: Июль 27, 2021

Inflammation plays a central role in the pathogenesis of knee PTOA after trauma. While comprehensive therapy capable preventing or delaying post-traumatic osteoarthritis (PTOA) progression joint injury does not yet clinically exist, current literature suggests that certain aspects early pathology may be prevented delayed by anti-inflammatory therapeutic interventions. We discuss multifaceted approaches effectively reducing continuous cycle inflammation and concomitant processes lead to cartilage degradation as well those can simultaneously promote intrinsic repair processes. Within this context, we focus on disease prevention, optimal timeframe treatment possible long-lasting sustained delivery local modes treatments could prevent joint-associated symptoms. Specifically, identify candidates are only but also anti-degenerative, anti-apoptotic pro-regenerative.

Язык: Английский

Процитировано

33
Subcutaneous Infliximab [CT-P13], a True Biologic 2.0. Real Clinical Practice Multicentre Study DOI Creative Commons
José María Huguet, V. García,

Lidia Martí

и другие.

Biomedicines, Год журнала: 2022, Номер 10(9), С. 2130 - 2130

Опубликована: Авг. 30, 2022

Inflammatory bowel disease (IBD), including Crohn's and ulcerative colitis, is characterized by chronic relapsing intestinal inflammation. There are few data on the efficacy safety in clinical practice of infliximab (CT-P13) subcutaneous formulation (SC) for treatment patients with IBD.

Язык: Английский

Процитировано

23