Negin Shojaee

Once-daily oral ritlecitinib or brepocitinib versus placebo in patients with moderate-to-severely active Crohn's disease (PIZZICATO): an international, randomised, phase 2a trial

Severine Vermeire, Jessica R. Allegretti, Hyo Jong Kim, Millie D. Long et autres

Background: Crohn's disease (CD) has a high unmet need for treatment. Ritlecitinib (Janus Kinase [JAK]3/tyrosine kinase expressed in hepatocellular carcinoma [TEC] family kinase inhibitor) or brepocitinib (tyrosine kinase 2 (TYK2)/JAK1 inhibitor) are promising therapeutic targets. We aimed to evaluate efficacy, safety, pharmacokinetics, …

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Efficacy and Safety of Zimlovisertib, Ritlecitinib, and Tofacitinib, Alone and in Combination, in Patients With Moderate to Severe Rheumatoid Arthritis and an Inadequate Response to Methotrexate

Spencer I. Danto, Mikhail P. Salganik, Anindita Banerjee, Paweł Hrycaj et autres

OBJECTIVE: We aimed to evaluate the efficacy and safety of zimlovisertib (interleukin-1 receptor-associated kinase 4 inhibitor) in combination with ritlecitinib (a JAK3 and tyrosine kinase expressed in hepatocellular carcinoma [TEC] kinase family inhibitors) or tofacitinib (a JAK inhibitor) versus tofacitinib alone. METHODS: …

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Virologic Response and Safety of Ibuzatrelvir, A Novel SARS-CoV-2 Antiviral, in Adults With COVID-19

Mahta Mortezavi, Abigail Sloan, Ravi Shankar Prasad Singh, Luke F. Chen et autres

BACKGROUND: Despite effective vaccines and treatments for COVID-19, clinical burden persists. An unmet need exists for additional effective agents with safety profiles allowing use across a broad population. Ibuzatrelvir is an orally bioavailable SARS-CoV-2 Mpro inhibitor with demonstrated in vitro antiviral activity …

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OP09 Oral ritlecitinib and brepocitinib in patients with moderate to severe active Crohn’s Disease: Data from the PIZZICATO umbrella study

Severine A.R.A. Vermeire, Jessica Ravikoff Allegretti, H J Kim, Millie D. Long et autres

Abstract Background Oral ritlecitinib (RIT; JAK3/TEC family kinase inhibitor) and brepocitinib (BRE; TYK2/JAK1 inhibitor) are being assessed in a 64-week (wk) phase 2a randomised, double-blind, induction-maintenance, umbrella study (PIZZICATO; NCT02958865) in participants (pts) with moderate-to-severe active Crohn’s disease (CD) with inadequate, loss …

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Safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06650833, a selective interleukin-1 receptor-associated kinase 4 (IRAK4) inhibitor, in single and multiple ascending dose randomized phase 1 studies in healthy subjects

Spencer I. Danto, Negin Shojaee, Ravi Shankar Prasad Singh, Cheryl Li et autres

Abstract Background PF-06650833 is a potent, selective inhibitor of interleukin-1 receptor-associated kinase 4 (IRAK4). Two randomized, double-blind, sponsor-open phase 1 studies evaluated the safety, pharmacokinetics, and pharmacodynamics of single (SAD) and multiple ascending doses (MAD) of PF-06650833 immediate-release (IR) and modified-release (MR) …

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Systemic inhibition of p38 MAPK improves lung function and inflammatory markers in moderate-severe COPD

Spencer I. Danto, Grant Langdon, Negin Shojaee, Jared L. Christensen et autres

COPD is characterized by inflammation and lung function decline. p38 MAPK inhibition may be an anti-inflammatory therapeutic approach to COPD. The efficacy and safety of PH-797804 (PH), a potent, selective oral p38 inhibitor, was tested in three studies including patients with GOLD …

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Comparison of Color Vision between Patients with Type II Diabetes Mellitus and Normal Subjects

Negin Shojaee, Ebrahim Jafarzadehpour, Mojtaba Mansouri, Maryam Yaseri et autres

Apolipoprotein A-I-Containing Particles and Reverse Cholesterol Transport in IDDM

Catherine Fiévet, Nathalie Théret, Negin Shojaee, Philippe N. Duchateau et autres

Lipoprotein particles containing apoA-I but not apoA-II are, among high-density lipoproteins, effective protectors against atherosclerosis that act by promoting the efflux of cellular cholesterol and the reverse cholesterol transport process. Because previous studies showed that in vitro nonenzymatic glycosylation of HDL impairs …

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