Immunogenicity of Biosimilars for Rheumatic Diseases, Plaque Psoriasis, and Inflammatory Bowel Disease: A Review from Clinical Trials and Regulatory Documents

In conclusion, immunogenicity data of biosimilars or biosimilar candidates for TNFα or CD20 inh ibitors were collected in trials that varied in design and procedures for ADAb/nAb detection. In general, immunogenicity parameters of biosimilars are similar to those of their reference products.
Source: BioDrugs - Category: Drugs & Pharmacology Source Type: research

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Authors: Carli L, Calabresi E, Governato G, Braun J Abstract Spondyloarthritis (SpA) is the umbrella term for a broad spectrum of inflammatory rheumatic diseases with typical but also rather different clinical manifestations, limited laboratory abnormalities and characteristic imaging features. For classification purposes, a so-called non-radiographic form (nr-axSpA) is differentiated from a radiographic one (r-axSpA) which is almost identical to the classical ankylosing spondylitis (AS) that is genetically strongly associated with the major histocompatibility complex class 1 antigen HLA-B27. In axSpA, the axial sk...
Source: Clinical and Experimental Rheumatology - Category: Rheumatology Tags: Clin Exp Rheumatol Source Type: research
CONCLUSIONS: At adolescence, both Crohn's disease and ulcerative colitis are associated with multiple comorbidities, not limited to autoimmune disorders. PMID: 31801156 [PubMed - as supplied by publisher]
Source: Pediatric Research - Category: Pediatrics Authors: Tags: Pediatr Res Source Type: research
Pfizer Inc. (NYSE: PFE) announced the United States (U.S.) Food and Drug Administration (FDA) has approved ABRILADA™ (adalimumab-afzb), as a biosimilar to Humira® (adalimumab),(1) for the treatment of certain patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis and plaque psoriasis.(2)
Source: World Pharma News - Category: Pharmaceuticals Tags: Featured Pfizer Business and Industry Source Type: news
ConclusionOur findings indicate that flares or IRAEs occur frequently but are mostly manageable without ICI discontinuation in patients with a preexisting autoimmune disease. Immunosuppressive therapy at baseline is associated with poorer outcomes.
Source: Arthritis and Rheumatology - Category: Rheumatology Authors: Tags: Original Article Source Type: research
Objectives: To test the hypothesis that familial Mediterranean fever (FMF)-associated autoinflammation may exaggerate the tendency toward adaptive immunopathology or spondyloarthritis (SpA)-associated disorders including major histocompatibility complex (MHC) class I associated disorders but not classical MHC class II-associated disorders that exhibit transplacental autoimmunity including myasthenia gravis and pemphigus.Methods: Seven thousand seven hundred forty-seven FMF patients and 10,080 age- and sex-matched controls in the Clalit Health Services medical database were identified and compared in terms of prevalence of ...
Source: Frontiers in Immunology - Category: Allergy & Immunology Source Type: research
ConclusionThe safety profile of adalimumab was consistent with previous findings and no new safety signals were observed.
Source: Advances in Therapy - Category: Drugs & Pharmacology Source Type: research
ConclusionsThe decrease in rates of TEAEs and the stable rates of SAEs, other malignancies and MACE during up to 5  years of ixekizumab dosing are consistent with previous reports describing a favorable safety profile of ixekizumab following shorter durations of exposure.FundingEli Lilly and Company.
Source: Dermatology and Therapy - Category: Dermatology Source Type: research
Authors: Dutzan N, Abusleme L Abstract T helper 17 (Th17) cells were first described as a T helper subset involved in the pathogenesis of experimental autoimmune inflammation. Since then, these cells have been described as orchestrators of immunopathology in several human inflammatory conditions including psoriasis, rheumatoid arthritis, and inflammatory bowel disease. More recently, the crucial role of Th17 cells in the regulation of immunity and protection of barrier sites has been unveiled. In the present work, we review the available evidence regarding Th17 cells in health and disease with a focus on the oral m...
Source: Advances in Experimental Medicine and Biology - Category: Research Tags: Adv Exp Med Biol Source Type: research
Publication date: Available online 15 November 2019Source: Autoimmunity ReviewsAuthor(s): José María G. Ruiz de Morales, Lluís Puig, Esteban Daudén, Juan D. Cañete, José Luis Pablos, Antonio Olveira Martín, Carlos González Juanatey, Alfredo Adán, Xavier Montalbán, Natalia Borruel, Guillermo Ortí, Esther Holgado Martín, Carolina García-Vidal, Cynthia Vizcaya Morales, Víctor Martín Vázquez, Miguel Ángel González-GayAbstractInterleukin 17 (IL-17) is a proinflammatory cytokine that has been the focus of...
Source: Autoimmunity Reviews - Category: Allergy & Immunology Source Type: research
Authors: Cui XF, Cui XG, Leng N Abstract Papillary renal cell carcinoma (PRCC) accounts for about 10 percent of all renal cell carcinomas, and the prognosis is poor for people with advanced disease. Interleukin-20 receptor subunit beta (IL20RB) is a single-pass type I membrane protein of the type II cytokine receptor family and is related to the pathogenesis of chronic inflammation and autoimmune diseases, including psoriasis, glaucoma, vitiligo, rheumatoid arthritis, and inflammatory bowel disease. However, little has been reported on IL20RB with respect to cancer, especially in PRCC. Thus, we performed this study...
Source: Journal of Toxicologic Pathology - Category: Toxicology Tags: J Toxicol Pathol Source Type: research
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