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231 results on '"Valdez, Hernan"'

2. Interpreting the Relationship Among Itch, Sleep, and Work Productivity in Patients with Moderate-to-Severe Atopic Dermatitis: A Post Hoc Analysis of JADE MONO-2

Author

Yosipovitch, Gil, Gooderham, Melinda J., Ständer, Sonja, Fonacier, Luz, Szepietowski, Jacek C., Deleuran, Mette, Girolomoni, Giampiero, Su, John C., Bushmakin, Andrew G., Cappelleri, Joseph C., Feeney, Claire, Chan, Gary, Thorpe, Andrew J., Valdez, Hernan, Biswas, Pinaki, Rojo, Ricardo, DiBonaventura, Marco, and Myers, Daniela E.

Published
2024
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11. Abrocitinib induction, randomized withdrawal, and retreatment in patients with moderate-to-severe atopic dermatitis: Results from the JAK1 Atopic Dermatitis Efficacy and Safety (JADE) REGIMEN phase 3 trial

Author

Blauvelt, Andrew, Silverberg, Jonathan I., Lynde, Charles W., Bieber, Thomas, Eisman, Samantha, Zdybski, Jacek, Gubelin, Walter, Simpson, Eric L., Valenzuela, Fernando, Criado, Paulo Ricardo, Lebwohl, Mark G., Feeney, Claire, Khan, Tahira, Biswas, Pinaki, DiBonaventura, Marco, Valdez, Hernan, Cameron, Michael C., and Rojo, Ricardo

Published
2022
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14. Relationship between lymphocyte count and risk of infection in Japanese rheumatoid arthritis patients treated with tofacitinib.

Author

Tanaka, Yoshiya, Takeuchi, Tsutomu, Valdez, Hernan, Collinge, Mark, Zwillich, Samuel H, Toyoizumi, Shigeyuki, Kwok, Kenneth, and Hirose, Tomohiro

Subjects
LYMPHOCYTE count, LYMPHOCYTE subsets, HERPES zoster, JAPANESE people, RHEUMATOID arthritis
Abstract

Objectives: We characterised changes in absolute lymphocyte counts (ALCs) and lymphocyte subset counts (LSCs), and their relationship to incidence of serious infection events (SIEs) and herpes zoster (HZ) events in Japanese patients with moderate to severe rheumatoid arthritis enrolled in the tofacitinib clinical programme. Methods: Data included 765 patients receiving tofacitinib in Phase 2, Phase 3, and long-term extension studies. ALCs/LSCs and incidence rates (patients with events/100 patient-years) of SIEs and HZ were analysed over 75 months. Results: Median ALCs were generally stable over 75 months of treatment. Transient numerical increases from baseline in median LSCs were observed at Month 3; LSCs were generally lower than baseline for Months 36–75. SIE/HZ incidence rates were higher in patients with ALC <0.5 × 103 cells/mm3 versus those with ALC ≥0.5 × 103 cells/mm3 during tofacitinib treatment. Baseline LSCs were similar in patients with/without SIEs or HZ events. Conclusions: SIE/HZ risk was highest in patients with ALC <0.5 × 103 cells/mm3, supporting this threshold as clinically relevant for defining increased SIE/HZ risk in Japanese patients with rheumatoid arthritis receiving tofacitinib. However, SIEs and HZ events did not necessarily occur simultaneously with confirmed lymphopenia, preventing conclusions on possible causal relationships being drawn. [ABSTRACT FROM AUTHOR]

Published
2024
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15. Meta‐Analysis of Noncompartmental Pharmacokinetic Parameters to Evaluate the Impact of CYP2C19 and CYP2C9 Genetic Polymorphisms on Abrocitinib Exposure.

Author

Fostvedt, Luke, Liu, Jian, Wang, Xiaoxing, Li, Yinhua, Johnson, Jillian, Wood, Linda, Dowty, Martin, Malhotra, Bimal, Valdez, Hernan, Nicholas, Timothy, and Xue, Wei

Subjects
CYTOCHROME P-450, CYTOCHROME P-450 CYP2C19, GENETIC polymorphisms, ATOPIC dermatitis, MOIETIES (Chemistry)
Abstract

Abrocitinib is a selective Janus kinase 1 inhibitor approved for the treatment of atopic dermatitis. It is metabolized primarily by cytochrome P450 (CYP) 2C19 (approximately 53%) and CYP2C9 (approximately 30%), which form 2 active metabolites. The pharmacologic activity of abrocitinib is attributable to the unbound exposures of abrocitinib and those metabolites with active moiety area under the plasma concentration–time curve (AUC) considered the best measure of the total pharmacological effect. The effect of CYP2C19 and/or CYP2C9 genotypes on abrocitinib and active moiety exposures were evaluated using a meta‐analysis of the noncompartmental estimates of exposure pooled from 10 clinical studies. A linear mixed‐effects model was developed on the basis of the power model to evaluate the effect of CYP2C19 and/or CYP2C9 genotypes on exposure (i.e., abrocitinib AUC and peak plasma concentration, active moiety AUC and peak plasma concentration). The genotypes were evaluated individually and as a combined phenotype effect. When evaluating the poor metabolizers of CYP2C19 or CYP2C9 individually, the estimated increases were 44.9% and 42.0% in active moiety AUC, respectively. The combined phenotype models showed a 0.6% decrease, and 25.1% and 10.5% increases in the active moiety AUC for "elevated," "mixed," and "reduced" metabolizers, respectively. Overall, the active moiety exposures did not appear to be affected to a clinically meaningful extent by different genotypes of CYP2C19 and/or CYP2C9. [ABSTRACT FROM AUTHOR]

Published
2024
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16. Efficacy and safety of abrocitinib in adults and adolescents with moderate-to-severe atopic dermatitis (JADE MONO-1): a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial

Author

Simpson, Eric L, Sinclair, Rodney, Forman, Seth, Wollenberg, Andreas, Aschoff, Roland, Cork, Michael, Bieber, Thomas, Thyssen, Jacob P, Yosipovitch, Gil, Flohr, Carsten, Magnolo, Nina, Maari, Catherine, Feeney, Claire, Biswas, Pinaki, Tatulych, Svitlana, Valdez, Hernan, and Rojo, Ricardo

Published
2020
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34. Granulocyte-Macrophage Colony-Stimulating Factor Induces Modest Increases in Plasma Human Immunodeficiency Virus (HIV) Type 1 RNA Levels and CD4⁺ Lymphocyte Counts in Patients with Uncontrolled HIV Infection

Author

National Institute of Allergy and Infectious Diseases AIDS Clinical Trials Group, Jacobson, Jeffrey M., Lederman, Michael M., Spritzler, John, Valdez, Hernan, Tebas, Pablo, Skowron, Gail, Wang, Rui, Jackson, J. Brooks, Fox, Lawrence, Landay, Alan, Gilbert, Mark J., O'Neil, Dorothy, Bancroft, Lynne, Al-Harthi, Lena, Jacobson, Mark A., Merigan, Thomas C., and Glesby, Marshall J.

Published
2003

46. Population pharmacokinetic‐pharmacodynamic modelling of platelet time‐courses following administration of abrocitinib.

Author

Wojciechowski, Jessica, Malhotra, Bimal K., Wang, Xiaoxing, Fostvedt, Luke, Valdez, Hernan, and Nicholas, Timothy

Subjects
PLATELET count, BLOOD platelets, ATOPIC dermatitis, THROMBOCYTOPENIA, PATIENTS' attitudes, KINASE inhibitors
Abstract

Aims: Abrocitinib is a selective Janus kinase 1 inhibitor for the treatment of moderate‐to‐severe atopic dermatitis. Herein we describe the time‐course of drug‐induced platelet reduction following abrocitinib administration, identify covariates affecting platelet counts, and determine the probability of patients experiencing thrombocytopaenia while receiving abrocitinib. Methods: This analysis included data from two Phase 2 and three Phase 3 studies in psoriasis and atopic dermatitis patient populations administered abrocitinib 10–400 mg QD orally for up to 12 weeks, with platelet counts determined up to week 16. A semi‐mechanistic model was developed to assess the impact of baseline platelet counts (170, 220 and 270 × 1000/μL), age and race on the platelet nadir and week 12 counts with once‐daily abrocitinib 200 mg or 100 mg. Results: Decreases in platelet counts were transient with the nadir occurring on average 24 days (95% prediction interval, 23–24) after continuous administration of abrocitinib 200 mg QD. Following administration of once‐daily abrocitinib 200 mg, the probabilities of thrombocytopaenia (<150 × 1000/μL) at the nadir were 8.6% and 95.5% for the typical patient with baseline platelet count of 270 × 1000/μL or 170 × 1000/μL, respectively. Adolescents had a lower probability of thrombocytopaenia compared with adults; platelet count distribution was similar in Asian and Western patients at the nadir and at week 12. Conclusion: This analysis supports the safety of once‐daily abrocitinib 200 mg and 100 mg dosing regimens, with low probability of thrombocytopaenia during treatment, except for higher risk of low‐grade thrombocytopaenia that diminished after 4 weeks in patients with low baseline platelet counts. [ABSTRACT FROM AUTHOR]

Published
2022
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47. Durable efficacy of tipranavir-ritonavir in combination with an optimised background regimen of antiretroviral drugs for treatment-experienced HIV-1-infected patients at 48 weeks in the Randomized Evaluation of Strategic Intervention in multi-drug reSistant patients with Tipranavir (RESIST) studies: an analysis of combined data from two randomised open-label trials

Author

Hicks, Charles B, Cahn, Pedro, Cooper, David A, Walmsley, Sharon L, Katlama, Christine, Clotet, Bonaventura, Lazzarin, Adriano, Johnson, Margaret A, Neubacher, Dietmar, Mayers, Douglas, and Valdez, Hernan

Published
2006
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