Cargando…

Bridging Efficacy of Tofacitinib Immediate‐Release to Extended‐Release Formulations for Treatment of Ulcerative Colitis: Application of a Model‐Informed Drug Development Approach

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 patients with UC. IR‐XR efficacy bri...

Descripción completa

Detalles Bibliográficos
Autores principales:	Mukherjee, Arnab, Tsuchiwata, Shinichi, Chang, Cheng, Nicholas, Timothy, Su, Chinyu, Le, Vu H., Kushner, Joseph, Kulisek, Nicole
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	John Wiley and Sons Inc. 2022
Materias:	Articles
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9542796/ https://www.ncbi.nlm.nih.gov/pubmed/35560874 http://dx.doi.org/10.1002/cpdd.1106

Ejemplares similares

Extended‐Release Once‐Daily Formulation of Tofacitinib: Evaluation of Pharmacokinetics Compared With Immediate‐Release Tofacitinib and Impact of Food
por: Lamba, Manisha, et al.
Publicado: (2016)

Exposure‐Response Characterization of Tofacitinib Efficacy in Moderate to Severe Ulcerative Colitis: Results From Phase II and Phase III Induction and Maintenance Studies
por: Mukherjee, Arnab, et al.
Publicado: (2022)

Population Pharmacokinetics of Tofacitinib in Patients With Moderate to Severe Ulcerative Colitis
por: Vong, Camille, et al.
Publicado: (2021)

Long-term Risk of Herpes Zoster Infection in Patients With Ulcerative Colitis Receiving Tofacitinib
por: Winthrop, Kevin L, et al.
Publicado: (2022)

Outcomes of Tofacitinib Dose Reduction in Patients with Ulcerative Colitis in Stable Remission from the Randomised RIVETING Trial
por: Vermeire, Séverine, et al.
Publicado: (2020)

Tofacitinib for the Treatment of Ulcerative Colitis: An Integrated Summary of up to 7.8 Years of Safety Data from the Global Clinical Programme
por: Sandborn, William J, et al.
Publicado: (2022)

Association of C-reactive Protein and Partial Mayo Score With Response to Tofacitinib Induction Therapy: Results From the Ulcerative Colitis Clinical Program
por: Dubinsky, Marla C, et al.
Publicado: (2022)

Clostridium difficile Infection in Patients with Ulcerative Colitis Treated with Tofacitinib in the Ulcerative Colitis Program
por: Loftus, Edward V, et al.
Publicado: (2022)

Exposure–response characterization of tofacitinib efficacy in moderate to severe ulcerative colitis: Results from a dose‐ranging phase 2 trial
por: Mukherjee, Arnab, et al.
Publicado: (2018)

Tofacitinib for the Treatment of Ulcerative Colitis: Analysis of Infection Rates from the Ulcerative Colitis Clinical Programme
por: Winthrop, Kevin L, et al.
Publicado: (2020)

Herpes Zoster Infection in Patients With Ulcerative Colitis Receiving Tofacitinib
por: Winthrop, Kevin L, et al.
Publicado: (2018)

Pharmacokinetics of immediate release, extended release, and gastric retentive gabapentin formulations in healthy adults
por: Swearingen, Dennis, et al.
Publicado: (2018)

Pharmacological and clinical evidence of nevirapine immediate- and extended-release formulations
por: Ena, Javier, et al.
Publicado: (2012)

Tofacitinib for the Treatment of Ulcerative Colitis: Analysis of Nonmelanoma Skin Cancer Rates From the Ulcerative Colitis Clinical Program
por: Sands, Bruce E, et al.
Publicado: (2021)

Venous thromboembolic events in the tofacitinib ulcerative colitis clinical development programme
por: Sandborn, William J., et al.
Publicado: (2019)

Impact of Concomitant Corticosteroids on Tofacitinib Induction Efficacy and Infection Rates in Ulcerative Colitis
por: Lichtenstein, Gary R., et al.
Publicado: (2023)

Abuse and Diversion of Immediate Release Opioid Analgesics as Compared to Extended Release Formulations in the United States
por: Iwanicki, Janetta L., et al.
Publicado: (2016)

Randomized trial of tofacitinib in active ulcerative colitis: analysis of efficacy based on patient-reported outcomes
por: Panés, Julián, et al.
Publicado: (2015)

Outcomes of Pregnancies With Maternal/Paternal Exposure in the Tofacitinib Safety Databases for Ulcerative Colitis
por: Mahadevan, Uma, et al.
Publicado: (2018)

Comparative steady-state pharmacokinetic study of an extended-release formulation of itopride and its immediate-release reference formulation in healthy volunteers
por: Yoon, Seonghae, et al.
Publicado: (2014)

Comparison of single-dose and multiple-dose pharmacokinetics between two formulations of hydrocodone bitartrate/acetaminophen: immediate-release versus biphasic immediate-release/extended release
por: Devarakonda, Krishna, et al.
Publicado: (2015)

Lipid Profiles in Patients With Ulcerative Colitis Receiving Tofacitinib—Implications for Cardiovascular Risk and Patient Management
por: Sands, Bruce E, et al.
Publicado: (2020)

Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials
por: Panaccione, Remo, et al.
Publicado: (2020)

Assessment of Safety and Efficacy of Tofacitinib, Stratified by Age, in Patients from the Ulcerative Colitis Clinical Program
por: Lichtenstein, Gary R, et al.
Publicado: (2022)

Extended-release tofacitinib for refractory Behçet disease: A case report
por: Wang, Chrong-Reen, et al.
Publicado: (2022)

The Effect of Intracellular Tacrolimus Exposure on Calcineurin Inhibition in Immediate- and Extended-Release Tacrolimus Formulations
por: Fontova, Pere, et al.
Publicado: (2023)

The role and prospect of tofacitinib in patients with ulcerative colitis
por: Lee, Jun
Publicado: (2023)

Tacrolimus Intrapatient Variability After Switching From Immediate or Prolonged-Release to Extended-Release Formulation, After an Organ Transplantation
por: Del Bello, Arnaud, et al.
Publicado: (2021)

Correction to: Characterization of Creatine Kinase Levels in Tofacitinib‑Treated Patients with Ulcerative Colitis: Results from Clinical Trials
por: Panaccione, Remo, et al.
Publicado: (2020)

Presence of risk factors associated with colectomy among patients with ulcerative colitis: a post hoc analysis of data from the tofacitinib OCTAVE ulcerative colitis clinical program
por: Rubin, David T., et al.
Publicado: (2023)

Maintaining remission in ulcerative colitis – role of once daily extended-release mesalamine
por: Oliveira, Lilliana, et al.
Publicado: (2011)

Insights into the Control of Drug Release from Complex Immediate Release Formulations
por: Dong, Runqiao, et al.
Publicado: (2021)

Economic Burden Associated With Extended-Release vs Immediate-Release Drug Formulations Among Medicare Part D and Medicaid Beneficiaries
por: Sumarsono, Andrew, et al.
Publicado: (2020)

Use of Tofacitinib for the Treatment of Arthritis Associated With Ulcerative Colitis
por: Wang, Wenfei, et al.
Publicado: (2019)

Efficacy and Safety of Tofacitinib Re-treatment for Ulcerative Colitis After Treatment Interruption: Results from the OCTAVE Clinical Trials
por: Panés, Julian, et al.
Publicado: (2021)

Tofacitinib Treatment Safety in Moderate to Severe Ulcerative Colitis: Comparison of Observational Population Cohort Data From the IBM MarketScan® Administrative Claims Database With Tofacitinib Trial Data
por: Curtis, Jeffrey R, et al.
Publicado: (2020)

Model‐Informed Development and Registration of a Once‐Daily Regimen of Extended‐Release Tofacitinib
por: Lamba, M, et al.
Publicado: (2017)

Agreement between local and central reading of endoscopic disease activity in ulcerative colitis: results from the tofacitinib OCTAVE trials
por: Feagan, Brian G., et al.
Publicado: (2021)

Influenza Adverse Events in Patients with Rheumatoid Arthritis, Ulcerative Colitis, or Psoriatic Arthritis in the Tofacitinib Clinical Development Programs
por: Winthrop, Kevin L., et al.
Publicado: (2022)

Modified Mayo score versus Mayo score for evaluation of treatment efficacy in patients with ulcerative colitis: data from the tofacitinib OCTAVE program
por: Sandborn, William J., et al.
Publicado: (2022)

Cannot write session to /tmp/vufind_sessions/sess_2iq9506impmufte0o707bhn4n7