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Your search keyword '"Valdez, Hernan"' showing total 22 results
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22 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. 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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12. 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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15. Comparing how well abrocitinib and dupilumab treat atopic dermatitis signs and symptoms: a plain language summary

Author

Reich, Kristian, primary, Thyssen, Jacob P., additional, Blauvelt, Andrew, additional, Eyerich, Kilian, additional, Soong, Weily, additional, Rice, Zakiya P., additional, Hong, H. Chih-ho, additional, Katoh, Norito, additional, Valenzuela, Fernando, additional, DiBonaventura, Marco, additional, Bratt, Tamara A., additional, Zhang, Fan, additional, Clibborn, Claire, additional, Rojo, Ricardo, additional, Valdez, Hernan, additional, and Kerkmann, Urs, additional

Published
2023
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16. 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, primary, Gooderham, Melinda J., additional, Ständer, Sonja, additional, Fonacier, Luz, additional, Szepietowski, Jacek C., additional, Deleuran, Mette, additional, Girolomoni, Giampiero, additional, Su, John C., additional, Bushmakin, Andrew G., additional, Cappelleri, Joseph C., additional, Feeney, Claire, additional, Chan, Gary, additional, Thorpe, Andrew J., additional, Valdez, Hernan, additional, Biswas, Pinaki, additional, Rojo, Ricardo, additional, DiBonaventura, Marco, additional, and Myers, Daniela E., additional

Published
2023
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17. Early Itch Response with Abrocitinib Is Associated with Later Efficacy Outcomes in Patients with Moderate-to-Severe Atopic Dermatitis:Subgroup Analysis of the Randomized Phase III JADE COMPARE Trial

Author

Ständer, Sonja, Kwatra, Shawn G., Silverberg, Jonathan I., Simpson, Eric L., Thyssen, Jacob P., Yosipovitch, Gil, Zhang, Fan, Cameron, Michael C., Cella, Ricardo Rojo, Valdez, Hernan, DiBonaventura, Marco, Feeney, Claire, Ständer, Sonja, Kwatra, Shawn G., Silverberg, Jonathan I., Simpson, Eric L., Thyssen, Jacob P., Yosipovitch, Gil, Zhang, Fan, Cameron, Michael C., Cella, Ricardo Rojo, Valdez, Hernan, DiBonaventura, Marco, and Feeney, Claire

Abstract

Background: Abrocitinib, an oral Janus kinase 1 inhibitor, provided significant itch relief by week 2 in patients with moderate-to-severe atopic dermatitis (AD) in the phase III JADE COMPARE trial. Objectives: This post-hoc analysis of JADE COMPARE aimed to further characterize itch response and determined whether early itch relief could predict subsequent improvements in AD severity. Methods: JADE COMPARE was a randomized, double-blind, double-dummy, placebo-controlled trial. Adult patients (aged ≥ 18 years) with moderate-to-severe AD were randomly assigned to receive oral abrocitinib 200 mg or 100 mg once daily, subcutaneous dupilumab 300 mg every other week (after a 600-mg loading dose), or placebo, plus medicated topical therapy for 16 weeks. Assessments were ≥ 4-point improvement in Peak Pruritus Numerical Rating Scale (PP-NRS4) from days 2 to 15, Eczema Area and Severity Index (EASI), Investigator’s Global Assessment (IGA) response, and Dermatology Life Quality Index (DLQI) scores at week 12. Association between week 2 PP-NRS4 and efficacy at week 12 was evaluated by chi-squared tests. The predictive value of early response for later efficacy was assessed by area under the receiver operating characteristic curve. Results: As early as day 4 after treatment, a significantly greater proportion of patients achieved PP-NRS4 response with abrocitinib 200 mg (18.6%) versus dupilumab (5.6%; p < 0.001) and placebo (6.0%; p < 0.003). A similar trend was observed with abrocitinib at the 100-mg dose, with significantly greater PP-NRS4 response rates versus placebo as early as day 9. With both doses of abrocitinib, week 12 IGA 0/1, EASI-75, EASI-90, and DLQI 0/1 response rates were greater in week 2 PP-NRS4 responders than nonresponders; no differences were observed between week 2 PP-NRS4 responders and nonresponders in the dupilumab and placebo groups. Early improvement in PP-NRS at week 2 was associated with skin clearance at week 12 in abrocitinib-treated patie

Published
2023

18. Safety of Abrocitinib in 3582 Patients With Moderate-to-Severe Atopic Dermatitis With Over 900 Patients Exposed for Almost 2 Years

Author

Simpson, Eric L., primary, Silverberg, Johnathan, additional, Nosbaum, Audrey, additional, Winthrop, Kevin, additional, Guttman-Yassky, Emma, additional, Hoffmeister, Karin M., additional, Egeberg, Alexander, additional, Valdez, Hernan, additional, Fan, Haiyun, additional, Farooqui, Saleem A., additional, Chan, Gary L., additional, Alderfer, Justine, additional, Romero, William, additional, and Johnson, Susan, additional

Published
2023
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20. 330 Safety of abrocitinib in 3582 patients with moderate-to-severe atopic dermatitis with over 900 patients exposed for almost 2 years

Author

Simpson, Eric L, primary, Silverberg, Jonathan I, additional, Nosbaum, Audrey, additional, Winthrop, Kevin, additional, Guttman-Yassky, Emma, additional, Hoffmeister, Karin M, additional, Egeberg, Alexander, additional, Valdez, Hernan, additional, Fan, Haiyun, additional, Farooqui, Saleem A, additional, Chan, Gary, additional, Alderfer, Justine, additional, Romero, William, additional, and Johnson, Susan, additional

Published
2023
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21. Early Itch Response with Abrocitinib Is Associated with Later Efficacy Outcomes in Patients with Moderate-to-Severe Atopic Dermatitis: Subgroup Analysis of the Randomized Phase III JADE COMPARE Trial

Author

Ständer, Sonja, primary, Kwatra, Shawn G., additional, Silverberg, Jonathan I., additional, Simpson, Eric L., additional, Thyssen, Jacob P., additional, Yosipovitch, Gil, additional, Zhang, Fan, additional, Cameron, Michael C., additional, Cella, Ricardo Rojo, additional, Valdez, Hernan, additional, DiBonaventura, Marco, additional, and Feeney, Claire, additional

Published
2022
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