Bridging Efficacy of Tofacitinib Immediate‐Release to Extended‐Release Formulations for Treatment of Ulcerative Colitis: Application of a Model‐Informed Drug Development Approach
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DOI: 10.1002/cpdd.1106
Abstract: Tofacitinib is an oral, small molecule Janus kinase inhibitor for the treatment of ulcerative colitis (UC). We report a model‐informed drug development approach for bridging efficacy from immediate‐release (IR) to extended‐release (XR) tofacitinib formulations in… read more here.
Keywords: tofacitinib; efficacy; release; drug development ... See more keywords
Exposure‐Response Characterization of Tofacitinib Efficacy in Moderate to Severe Ulcerative Colitis: Results From Phase II and Phase III Induction and Maintenance Studies
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DOI: 10.1002/cpt.2601
Abstract: Tofacitinib is an oral small molecule JAK inhibitor for the treatment of ulcerative colitis. Relationships between plasma tofacitinib concentration and efficacy were characterized using exposure‐response (E‐R) models, with demographic and disease covariates evaluated as potential… read more here.
Keywords: maintenance; tofacitinib; efficacy; phase iii ... See more keywords
Model‐Informed Development and Registration of a Once‐Daily Regimen of Extended‐Release Tofacitinib
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DOI: 10.1002/cpt.576
Abstract: Extended‐release (XR) formulations enable less frequent dosing vs. conventional (e.g., immediate release (IR)) formulations. Regulatory registration of such formulations typically requires pharmacokinetic (PK) and clinical efficacy data. Here we illustrate a model‐informed, exposure–response (E‐R) approach… read more here.
Keywords: tofacitinib; extended release; model informed; registration ... See more keywords
Challenges of securing insurance approval for oral tofacitinib for the treatment of alopecia areata: a multi-institution retrospective review
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DOI: 10.1007/s00403-020-02158-y
Abstract: Alopecia areata (AA) is a psychologically distressing disorder for which few reliable treatments exist. Although oral tofacitinib has demonstrated efficacy in treating AA, it is not approved by the Food and Drug Administration (FDA) for… read more here.
Keywords: oral tofacitinib; tofacitinib; insurance approval; approval ... See more keywords
Real-World Efficacy and Safety Monitoring for Predicting Continuation of Tofacitinib Therapy in Patients with Ulcerative Colitis
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DOI: 10.1007/s10620-021-07233-6
Abstract: Although the clinical efficacy of tofacitinib in patients with ulcerative colitis (UC) has been assessed in the OCTAVE trial, there is a lack of adequate data on its efficacy in real-world clinical settings. To analyze… read more here.
Keywords: tofacitinib; continuation; efficacy; ulcerative colitis ... See more keywords
The JAK Inhibitor Tofacitinib Inhibits Structural Damage in Osteoarthritis by Modulating JAK1/TNF-alpha/IL-6 Signaling Through Mir-149-5p.
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DOI: 10.1016/j.bone.2021.116024
Abstract: BACKGROUND Osteoarthritis (OA), a common articular bone degenerative disease, is exacerbated by proinflammatory cytokine signaling. Mounting evidence suggests that epigenetic modifiers, namely microRNAs (miRs), are dysregulated in articular chondrocytes (ACs) during OA. METHODS An initial… read more here.
Keywords: tofacitinib; jak1 tnf; expression; mir 149 ... See more keywords
TOFACITINIB - BOON OR A BANE?
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DOI: 10.1016/j.chest.2021.07.1954
Abstract: TOPIC: Pulmonary Vascular Disease TYPE: Medical Student/Resident Case Reports INTRODUCTION: Tofacitinib (Xeljanz) is common and popular Disease Modifying Anti-Rheumatic Drug used in the treatment of moderate to severe Rheumatoid Arthritis (RA) that was approved by… read more here.
Keywords: tofacitinib; risk; relevant relationships; disease ... See more keywords
Experience with oral tofacitinib in 8 adolescent patients with alopecia universalis
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DOI: 10.1016/j.jaad.2016.11.038
Abstract: SALT, Severity of Alopecia Tool. To the Editor: Alopecia areata, especially alopecia universalis, can be challenging to treat in children and adolescents. Standard therapies, including oral, topical, and intralesional corticosteroids, usually fail or have high… read more here.
Keywords: oral tofacitinib; tofacitinib; experience oral; alopecia universalis ... See more keywords
Herpes zoster in psoriasis patients treated with tofacitinib
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DOI: 10.1016/j.jaad.2017.03.023
Abstract: Background Tofacitinib is an oral Janus kinase (JAK) inhibitor. Immunomodulatory therapies can increase the risk for herpes zoster (HZ) in patients with psoriasis. Objective To evaluate the relationship between tofacitinib use and HZ risk. Methods… read more here.
Keywords: tofacitinib; risk; zoster psoriasis; herpes zoster ... See more keywords
Association of first, second, and third-line bDMARDs and tsDMARD with drug survival among seropositive rheumatoid arthritis patients: Cohort study in A real world setting.
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DOI: 10.1016/j.semarthrit.2021.06.002
Abstract: OBJECTIVES To determine the association of first, second, and third-line biologic disease-modifying antirheumatic drugs (bDMARDs) and tofacitinib with drug survival among seropositive rheumatoid arthritis (RA) patients. METHODS The study population was composed of 8,018 seropositive… read more here.
Keywords: tofacitinib; third line; first second; ahr ... See more keywords
Tofacitinib is a mechanism-based inactivator of cytochrome P450 3A4.
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DOI: 10.1021/acs.chemrestox.9b00141
Abstract: Tofacitinib (TFT) is an oral JAK inhibitor which has been approved for the treatment of moderately and severely active rheumatoid arthritis. TFT was found to show concentration-, time- and NADPH-dependent inhibition of CYP3A4, and irreversibility… read more here.
Keywords: tofacitinib; mechanism based; based inactivator; inactivation ... See more keywords