Pfizer's Xeljanz meets goals in ulcerative colitis trials

(Reuters) - Pfizer Inc said on Friday its Xeljanz rheumatoid arthritis drug succeeded in meeting primary and secondary goals of a pair of late stage clinical trials in ulcerative colitis, results that could help pave the way for an additional approval for the oral medicine.
Source: Reuters: Health - Category: Consumer Health News Tags: healthNews Source Type: news

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Conclusion: Although safety concerns were inconclusive, these data do not report additional risk to pregnancy outcomes with adalimumab exposure.Dig Dis
Source: Digestive Diseases - Category: Gastroenterology Source Type: research
AbstractPF-06438179/GP1111 (Zessly®; Ixifi®) [hereafter referred to as GP1111] is a biosimilar of the reference monoclonal anti-TNF- α antibody infliximab, and is approved in the EU and USA for the same indications as the reference drug, including rheumatoid arthritis (RA), Crohn’s disease, ulcerative colitis (including paediatric ulcerative colitis in the EU), ankylosing spondylitis, psoriatic arthritis and plaque psoriasis; GP1111 is also approved in Japan. GP1111 has similar physicochemical characteristics and pharmacodynamic properties to those of reference infliximab, and the pharmacokinetic simila...
Source: BioDrugs - Category: Drugs & Pharmacology Source Type: research
AbstractSB5 (Imraldi®) is a biosimilar of the reference anti-TNF monoclonal antibody adalimumab. It is approved for use in the following indications for which reference adalimumab is approved: rheumatoid arthritis (RA), juvenile idiopathic arthritis [polyarticular juvenile idiopathic arthritis (pJIA) and enthesitis-related arthritis (ERA)], axial spondyloarthritis [ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA)], psoriatic arthritis (PsA), psoriasis, pediatric plaque psoriasis, hidradenitis suppurativa (HS), Crohn ’s disease, pediatric Crohn’s disease, ulcerative colitis...
Source: BioDrugs - Category: Drugs & Pharmacology Source Type: research
We report herein a 41-year-old woman with persistent erythema multiforme, that occurred 18 months after onset of golimumab treatment of her ulcerative colitis; the latter remains in full remission over a period of 36 months.
Source: Dermatology Online Journal - Category: Dermatology Source Type: research
Autoimmune disorders are a category of diseases in which the immune system attacks healthy cells as a result of a dysfunction of the acquired immune system. Clinical presentation and diagnosis are disease specific and often correspond with the degree of inflammation, as well as the systems involved. Treatment varies based on the specific disease, its stage of presentation, and patient symptoms. The primary goal of treatment is to decrease inflammation, minimize symptoms, and lessen the potential for relapse. Graves disease, Hashimoto thyroiditis, rheumatoid arthritis, Crohn disease, ulcerative colitis, systemic lupus eryth...
Source: Nursing Clinics of North America - Category: Nursing Authors: Source Type: research
We report a patient with active ulcerative colitis with primary non-response to three biologics (infliximab, adalimumab and vedolizumab), with different mechanisms of action, who refused surgical treatment and had a favorable response to tofacitinib with clinical and endoscopic remission. No adverse events were observed with the use of the agent. This case illustrates the difficulties we may face regarding the identification of the expression of proper mechanism of action involved in the pathogenesis of ulcerative colitis patients and the importance of having another treatment option with different mechanism of action, lik...
Source: Arquivos de Gastroenterologia - Category: Gastroenterology Source Type: research
In this study 476 subjects comprising healthy individuals and patients with anticitrullinated protein antibody (ACPA)-positive rheumatoid arthritis (RA), ACPA-negative RA, Crohn's disease (CD), ulcerative colitis (UC), psoriasis (PsO) and psoriatic arthritis (PsA) were subjected to high-resolution quantitative computed tomography (HR-pQCT) of the hand.
Source: Bone - Category: Orthopaedics Authors: Tags: Full Length Article Source Type: research
Tofacitinib has receivedexpanded approval to treat adults with moderate to severe ulcerative colitis. The drug was approved in 2012 to treat rheumatoid arthritis and in 2017 for patients with psoriatic arthritis.
Source: JAMA - Category: General Medicine Source Type: research
(University of Alabama at Birmingham) In preclinical experiments, Laurie Harrington and colleagues have discovered a subset of immune cells that create and sustain chronic inflammatory bowel disease. These cells could become potential therapeutic targets to ameliorate or cure Crohn's disease and ulcerative colitis. Furthermore, if this subset of CD4 T cells plays a similar role in other autoimmune diseases, such as Type 1 diabetes or rheumatoid arthritis, they could also be targets for therapy.
Source: EurekAlert! - Medicine and Health - Category: International Medicine & Public Health Source Type: news
ZURICH (Reuters)—Novartis said its Sandoz division received approval from the European Commission for its biosimilar Zessly (infliximab) in gastroenterological, rheumatological and dermatological diseases. Zessly is approved for use in all indications of the reference medicine including rheumatoid arthritis, adult and pediatric Crohn’s disease, adult and pediatric ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis,... [Read More]
Source: The Rheumatologist - Category: Rheumatology Authors: Tags: Drug Updates EU approval infliximab biosimilar Novartis Zessly Source Type: research
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