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Open-label Study Of Tofacitinib For Moderate To Severe Skin Involvement In Young Adults With Lupus PubMed articles on BioPortfolio. Our PubMed references draw on over 21 million records from the medical literature. Here you can see the latest Open-label Study Of Tofacitinib For Moderate To Severe Skin Involvement In Young Adults With Lupus articles that have been published worldwide.
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Atopic dermatitis is a chronic eczematous, pruritic, inflammatory skin condition affecting children and adults. Tofacitinib is a Janus kinase inhibitor. The efficacy, safety, and pharmacokinetics of 2% tofacitinib ointment twice daily have been evaluated in a 4-week phase 2a multisite randomized, double-blind, vehicle-controlled, parallel-group study (NCT02001181) in adult patients with mild to moderate atopic dermatitis and 2% to 20% body surface area (BSA) involvement. Tofacitinib ointment demonstrated si...
Although existing psoriasis treatments are effective and well tolerated in many patients, there is still a need for new effective targeted treatment options. Tofacitinib is an oral Janus kinase inhibitor. It has been investigated in patients with moderate to severe chronic plaque psoriasis.
Alopecia areata is an autoimmune disease involving the hair follicle with a chronic, relapsing course. Tofacitinib is Janus kinase inhibitor approved for treatment of rheumatoid arthritis that has been shown to be effective in treatment of alopecia areata. We present a case series of 11 patients with severe alopecia areata on longstanding, regular to high dose oral tofacitinib with marked hair regrowth. Additionally, we present a case of moderate to severe alopecia areata successfully treated with topical t...
Acute pancreatitis (AP) runs a moderately severe and severe course in 20%-30% of cases. The purpose of the present study was to determine the effect of low molecular weight heparin (LMWH) for the prevention of pancreatic necrosis (PN) in moderately severe and severe AP (MSAP).
Oral targeted synthetic disease-modifying anti-rheumatic drugs (DMARDs), including the Janus kinase inhibitors tofacitinib and baricitinib, are the latest addition to the therapeutic options for rheumatoid arthritis (RA). Tofacitinib 5 mg, twice daily, is approved for treatment, with or without methotrexate, of moderate to severe active RA in adults not adequately responding to, or not tolerating one or more DMARDs. In this narrative review we aimed to provide an overview of the real-world evidence for tofa...
Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are acute severe skin reactions with extensive apoptosis of the epidermis and mucous membranes. Ocular involvement occurs in up to 75% of patients at the acute phase, described as mild, moderate and severe involvement and may result in long-term severe sequelae with dryness, photophobia, cicatrising conjunctivitis complicated with corneal vascularisation and scarring, which may result in severe visual loss. The acute management of SJS/TEN o...
Tofacitinib is an oral, small-molecule inhibitor of JAK approved in several countries for the treatment of ulcerative colitis (UC). We report integrated safety analyses of tofacitinib-treated patients with moderate to severe UC.
Mirogabalin is an αδ ligand being developed to treat neuropathic pain. A small fraction of mirogabalin is metabolized by the liver, where hepatic impairment may affect exposure. The objective of this phase I, open-label single-dose study was to determine if mild or moderate hepatic impairment alters the pharmacokinetics of mirogabalin.
SSc is characterized by fibrotic changes in the skin and lung, and the mainstay of treatment has been CYC. B cell involvement suggests that rituximab (RTX) may also be of therapeutic benefit. The aim of the study was to compare the efficacy and safety of RTX compared with CYC in retarding the progression of interstitial lung disease and skin manifestations of primary SSc.
Long-term efficacy and safety of mepolizumab in patients with severe eosinophilic asthma has been evaluated by large-scale double-blinded placebo control studies. However, a prospective open-label study of a long-term subcutaneous administration of mepolizumab in Japanese patients with severe eosinophilic asthma has not been reported.
Atopic dermatitis (AD) is a complex chronic pruritic skin disease in which helper T cell (TH2)-type cytokines IL-4 and IL-13 are key contributors in the inflammatory response. Debate still exists as to whether disease initiation is due to immune responses or barrier dysregulation. The disease course is divided into infantile, childhood, and adolescent/adult stages and exhibits an extensive clinical spectrum. Topical agents have been the mainstay of treatment in childhood AD. Phototherapy has been successful...
The aim of the study was to observe the risk of hemorrhage from moderate and severe thrombocytopenia in systemic lupus erythematosus (SLE).A retrospective analysis was undertaken of cases admitted to Qilu Hospital, China. Blood platelet counts (BPCs) of ≤20 × 10/L represent severe thrombocytopenia, and a BPC of 21 to 50 × 10/L indicates moderate thrombocytopenia. A comparison was made from the perspective of severity with a view to determine the influence of thrombocytopenia on the risk of hemor...
Response to etanercept therapy in patients who have failed apremilast therapy has not been well characterized.
Psoriasis and psoriatic arthritis (PsA) are inflammatory immune mediated conditions which can cause considerable disability and reduced quality of life. Management can be complex as clinical heterogeneity may lead to different treatment pathways. Tofacitinib is a novel, oral janus kinase (JAK) inhibitor with proven efficacy in rheumatoid arthritis. Areas covered: This review analyses recent studies of tofacitinib in psoriatic disease treatment. The relevant literature was identified using clinicaltrials.gov...
EGFR-antibodies are associated with significant skin toxicity, including acneiform rash and folliculitis. It remains impossible to predict the occurrence of severe skin toxicity due to the lack of predictive markers. Here, we present the first genome-wide association study (GWAS) to find single nucleotide polymorphisms (SNPs) associated with EGFR inhibitor-induced skin toxicity using data of the multicentre randomized phase III CAIRO2 trial (clinicaltrials.gov NCT00208546). In this study, advanced or metast...
Mild to moderate pain is common following dental implant surgeries, although severe pain is reported in some patients. This randomized, open-label trial was designed to determine the efficacy and safety of an opioid-sparing postsurgical pain management protocol with or without local infiltration of liposomal bupivacaine for full-arch implant surgery. This procedure is used in edentulous and/or failing dentition patients and involves securing four or more implants to the maxilla and/or mandible to serve as a...
Risankizumab, an anti-interleukin 23 antibody, was superior to placebo in achieving clinical and endoscopic remission at week 12 in a randomised, phase 2 induction study in patients with moderately to severely active Crohn's disease. Here we aimed to assess the efficacy and safety of extended intravenous induction and subcutaneous maintenance therapy with risankizumab.
Data on treatment outcomes in patients with psoriasis who have skin of color are limited. Brodalumab has shown efficacy in patients with moderate-to-severe plaque psoriasis.
Golimumab, a tumor necrosis factor (TNF) antagonist, is an effective treatment for patients with moderate-to-severe ulcerative colitis (UC). However, more than 50% of initial responders lose their response to the drug within the first year of therapy. A gene expression signature identified in colon biopsies collected before treatment was associated with response to infliximab, and was subsequently refined to associate with mucosal healing in response to golimumab. We performed a phase 2a open label study of...
Human skin is a protective barrier against the toxic effects of cosmetics. Marketing of cosmetic products with ingredients tested on animals was prohibited in 2013. Since then, safety evaluation of cosmetic products is performed by using alternative in vitro toxicity tests. In vitro 3-D reconstructed human epidermis (RhE) tissue models are now used to define skin irritation/corrosion potentials of cosmetic ingredients and end-products. The main aim of this study was to evaluate skin irritation potentials of...
A simple, sensitive and rapid assay method has been developed and validated as per regulatory guideline for the estimation of tofacitinib on mice dried blood spots (DBS) using liquid chromatography coupled to tandem mass spectrometry with electro spray ionization in the positive-ion mode. The method employs liquid extraction of tofacitinib from DBS disk of mice whole blood followed by chromatographic separation using 5 mM ammonium acetate (pH 6.5):acetonitrile (20:80, v/v) at a flow rate of 0.60 mL/min ...
To investigate whether the skin barrier function is impaired with regard to the pH value, water content, transepidermal water loss (TEWL), and the integrity of the stratum corneum, and whether the expression of caspase-14 is altered in moderate to severe chronic hand eczema (CHE).
Adverse drug events associated with 5mg versus 10mg Tofacitinib (Janus kinase inhibitor) twice daily for the treatment of autoimmune diseases: A systematic review and meta-analysis of randomized controlled trials.
Several recently published clinical trials have shown tofacitinib to be effective in the treatment of autoimmune diseases. This drug is commonly prescribed either in a 5-mg or in a10-mg dosage twice daily. In this review, we aimed to systematically compare the adverse drug events which were observed with 5 mg versus 10 mg tofacitinib for the treatment of autoimmune diseases. MEDLINE, EMBASE, the Cochrane library, and www.ClinicalTrials.gov were searched (from March to April 2018) for suitable English publ...
To evaluate the safety and maintenance of efficacy with ABT-122, a bi-specific monoclonal antibody targeting TNF and IL-17A, in patients with RA or PsA in open-label, 24-week extensions [open-label extensions (OLEs)] of 12-week, randomized, double-blind studies.