Safety signal detection and evaluation in clinical development programs: A case study of tofacitinib

por Dasic, Gorana, Jones, Thomas, Frajzyngier, Vera, Rojo, Ricardo, Madsen, Ann, Valdez, Hernan
Publicado 2017

Correction to: Population Pharmacokinetics of Abrocitinib in Healthy Individuals and Patients with Psoriasis or Atopic Dermatitis

por Wojciechowski, Jessica, Malhotra, Bimal K., Wang, Xiaoxing, Fostvedt, Luke, Valdez, Hernan, Nicholas, Timothy
Publicado 2022

Population Pharmacokinetics of Abrocitinib in Healthy Individuals and Patients with Psoriasis or Atopic Dermatitis

por Wojciechowski, Jessica, Malhotra, Bimal K., Wang, Xiaoxing, Fostvedt, Luke, Valdez, Hernan, Nicholas, Timothy
Publicado 2022

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

por Wojciechowski, Jessica, Malhotra, Bimal K., Wang, Xiaoxing, Fostvedt, Luke, Valdez, Hernan, Nicholas, Timothy
Publicado 2022

Herpes Zoster and Tofacitinib Therapy in Patients With Rheumatoid Arthritis

por Winthrop, Kevin L, Yamanaka, Hisashi, Valdez, Hernan, Mortensen, Eric, Chew, Robert, Krishnaswami, Sriram, Kawabata, Thomas, Riese, Richard
Publicado 2014

Effects of Maraviroc and Efavirenz on Markers of Immune Activation and Inflammation and Associations with CD4(+) Cell Rises in HIV-Infected Patients

por Funderburg, Nicholas, Kalinowska, Magdalena, Eason, James, Goodrich, James, Heera, Jayvant, Mayer, Howard, Rajicic, Natasa, Valdez, Hernan, Lederman, Michael M.
Publicado 2010

Effects of tofacitinib on lymphocyte sub-populations, CMV and EBV viral load in patients with plaque psoriasis

por Valenzuela, Fernando, Papp, Kim A, Pariser, David, Tyring, Stephen K, Wolk, Robert, Buonanno, Marjorie, Wang, Jeff, Tan, Huaming, Valdez, Hernan
Publicado 2015

Risk Factors for Major Adverse Cardiovascular Events in Phase III and Long‐Term Extension Studies of Tofacitinib in Patients With Rheumatoid Arthritis

por Charles‐Schoeman, Christina, DeMasi, Ryan, Valdez, Hernan, Soma, Koshika, Hwang, Lie‐Ju, Boy, Mary G., Biswas, Pinaki, McInnes, Iain B.
Publicado 2019

Rapidity of Improvement in Signs/Symptoms of Moderate-to-Severe Atopic Dermatitis by Body Region with Abrocitinib in the Phase 3 JADE COMPARE Study

por Alexis, Andrew, de Bruin-Weller, Marjolein, Weidinger, Stephan, Soong, Weily, Barbarot, Sebastien, Ionita, Ileana, Zhang, Fan, Valdez, Hernan, Clibborn, Claire, Yin, Natalie
Publicado 2022

Metabolic and Immune Activation Effects of Treatment Interruption in Chronic HIV-1 Infection: Implications for Cardiovascular Risk

por Tebas, Pablo, Henry, William Keith, Matining, Roy, Weng-Cherng, Deborah, Schmitz, John, Valdez, Hernan, Jahed, Nasreen, Myers, Laurie, Powderly, William G., Katzenstein, David
Publicado 2008

Long-term effectiveness of live herpes zoster vaccine in patients with rheumatoid arthritis subsequently treated with tofacitinib

por Winthrop, Kevin L, Wouters, Ann, Choy, Ernest H, Chen, Connie, Biswas, Pinaki, Wang, Lisy, Soma, Koshika, Needle, Elie, Valdez, Hernan, Rigby, William FC
Publicado 2020

Durability of Response to Abrocitinib in Patients with Moderate-to-Severe Atopic Dermatitis After Treatment Discontinuation in a Phase 2b Trial

por Gooderham, Melinda J., Girolomoni, Giampiero, Moore, Julian O., Silverberg, Jonathan I., Bissonnette, Robert, Forman, Seth, Peeva, Elena, Biswas, Pinaki, Valdez, Hernan, Chan, Gary
Publicado 2022

Adverse events of special interest in clinical trials of rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and psoriasis with 37 066 patient-years of tofacitinib exposu...

por Burmester, Gerd R, Nash, Peter, Sands, Bruce E, Papp, Kim, Stockert, Lori, Jones, Thomas V, Tan, Huaming, Madsen, Ann, Valdez, Hernan, Cohen, Stanley B
Publicado 2021

Modified- versus immediate-release tofacitinib in Japanese rheumatoid arthritis patients: a randomized, phase III, non-inferiority study

por Tanaka, Yoshiya, Sugiyama, Naonobu, Toyoizumi, Shigeyuki, Lukic, Tatjana, Lamba, Manisha, Zhang, Richard, Chen, Connie, Stock, Thomas, Valdez, Hernan, Mojcik, Christopher, Fan, Haiyun, Deng, Chenhui, Yuasa, Hirotoshi
Publicado 2019

Efficacy and Safety of Abrocitinib in Patients With Moderate-to-Severe Atopic Dermatitis: A Randomized Clinical Trial

por Silverberg, Jonathan I., Simpson, Eric L., Thyssen, Jacob P., Gooderham, Melinda, Chan, Gary, Feeney, Claire, Biswas, Pinaki, Valdez, Hernan, DiBonaventura, Marco, Nduaka, Chudy, Rojo, Ricardo
Publicado 2020

Impact of Oral Abrocitinib Monotherapy on Patient-Reported Symptoms and Quality of Life in Adolescents and Adults with Moderate-to-Severe Atopic Dermatitis: A Pooled Analysis of Pa...

por Silverberg, Jonathan I., Thyssen, Jacob P., Simpson, Eric L., Yosipovitch, Gil, Ständer, Sonja, Valdez, Hernan, Rojo, Ricardo, Biswas, Pinaki, Myers, Daniela E., Feeney, Claire, DiBonaventura, Marco
Publicado 2021

Rapid Improvement of Itch Associated With Atopic Dermatitis With Abrocitinib Is Partially Independent of Overall Disease Improvement: Results From Pooled Phase 2b and 3 Monotherapy...

por Kim, Brian S., Silverberg, Jonathan I., Ständer, Sonja, Yosipovitch, Gil, Simpson, Eric L., DiBonaventura, Marco, Kerkmann, Urs, Farooqui, Saleem A., Biswas, Pinaki, Valdez, Hernan, Cameron, Michael C.
Publicado 2021

Evaluation of the Short‐, Mid‐, and Long‐Term Effects of Tofacitinib on Lymphocytes in Patients With Rheumatoid Arthritis

por van Vollenhoven, Ronald, Lee, Eun Bong, Strengholt, Sander, Mojcik, Christopher, Valdez, Hernan, Krishnaswami, Sriram, Biswas, Pinaki, Lazariciu, Irina, Hazra, Anasuya, Clark, James D., Hodge, Jennifer, Wang, Lisy, Choy, Ernest
Publicado 2019

Contribution of a European‐Prevalent Variant near CD83 and an East Asian–Prevalent Variant near IL17RB to Herpes Zoster Risk in Tofacitinib Treatment: Results of Genome‐Wide Associ...

por Bing, Nan, Zhou, Huanyu, Chen, Xing, Hirose, Tomohiro, Kochi, Yuta, Tsuchida, Yumi, Ishigaki, Kazuyoshi, Sumitomo, Shuji, Fujio, Keishi, Zhang, Baohong, Valdez, Hernan, Vincent, Michael S., Martin, David, Clark, James D.
Publicado 2021

Herpes Zoster and Tofacitinib: Clinical Outcomes and the Risk of Concomitant Therapy

por Winthrop, Kevin L., Curtis, Jeffrey R., Lindsey, Stephen, Tanaka, Yoshiya, Yamaoka, Kunihiro, Valdez, Hernan, Hirose, Tomohiro, Nduaka, Chudy I., Wang, Lisy, Mendelsohn, Alan M., Fan, Haiyun, Chen, Connie, Bananis, Eustratios
Publicado 2017