Gary S. Friedman
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View article: MXene interaction with electromagnetic radiation in the microwave range
MXene interaction with electromagnetic radiation in the microwave range Open
The rapid development of the Internet of Things (IoT) and new generations of telecommunication networks bring forward a demand for thin, lightweight shielding materials and microwave circuit components. An exponentially increasing number o…
View article: Early and Sensitive Detection of Cisplatin-Induced Kidney Injury Using Novel Biomarkers
Early and Sensitive Detection of Cisplatin-Induced Kidney Injury Using Novel Biomarkers Open
NBMs accurately and timely detected cisplatin exposure and identified "sub-clinical" DIKI undetected by standard acute kidney injury (AKI) criteria, highlighting the limitations of current functional BMs in estimating the true DIKI inciden…
View article: Comparing five equations to estimate glomerular filtration rate or creatinine clearance and assign individuals to KDIGO categories across the full age spectrum using real world data
Comparing five equations to estimate glomerular filtration rate or creatinine clearance and assign individuals to KDIGO categories across the full age spectrum using real world data Open
Five equations are commonly used by biopharma companies to estimate glomerular filtration rate (GFR) or creatinine clearance (CrCl) based on regulatory and stakeholder recommendations. Changes observed in GFR and/or CrCl can be challenging…
View article: Narrative Review of the Pathogenesis of Stasis Dermatitis: An Inflammatory Skin Manifestation of Venous Hypertension
Narrative Review of the Pathogenesis of Stasis Dermatitis: An Inflammatory Skin Manifestation of Venous Hypertension Open
Understanding the pathogenesis of SD may help clinicians identify drivers of inflammation to use as potential targets for the development of new treatment options.
View article: Tofacitinib for the Treatment of Ulcerative Colitis: Analysis of Nonmelanoma Skin Cancer Rates From the Ulcerative Colitis Clinical Program
Tofacitinib for the Treatment of Ulcerative Colitis: Analysis of Nonmelanoma Skin Cancer Rates From the Ulcerative Colitis Clinical Program Open
Background Tofacitinib is an oral, small molecule Janus kinase inhibitor for the treatment of ulcerative colitis (UC). We present integrated analyses of nonmelanoma skin cancer (NMSC) incidence in the tofacitinib UC clinical program. Metho…
View article: Tofacitinib for the Treatment of Ulcerative Colitis: Analysis of Infection Rates from the Ulcerative Colitis Clinical Programme
Tofacitinib for the Treatment of Ulcerative Colitis: Analysis of Infection Rates from the Ulcerative Colitis Clinical Programme Open
Background and Aims Tofacitinib is an oral, small molecule JAK inhibitor for the treatment of ulcerative colitis. We report integrated analyses of infections in the Phase [P]2 and P3 OCTAVE programmes. Methods Three cohorts were analysed: …
View article: Lipid Profiles in Patients With Ulcerative Colitis Receiving Tofacitinib—Implications for Cardiovascular Risk and Patient Management
Lipid Profiles in Patients With Ulcerative Colitis Receiving Tofacitinib—Implications for Cardiovascular Risk and Patient Management Open
Background Patients with ulcerative colitis (UC) are at elevated risk of cardiovascular disease vs the general population, despite a lower prevalence of traditional risk factors, including hyperlipidemia. Mechanistic studies in patients wi…
View article: Use of biomarkers to improve immunosuppressive drug development and outcomes in renal organ transplantation: A meeting report
Use of biomarkers to improve immunosuppressive drug development and outcomes in renal organ transplantation: A meeting report Open
On September 27-28, 2018 the Food and Drug Administration (FDA) and the Critical Path Institute's Transplant Therapeutics Consortium convened a public workshop titled "Evidence-Based Treatment Decisions in Transplantation: The Right Dose &…
View article: Magnetically Actuated Micro-Robotic Systems for Biomedical Applications
Magnetically Actuated Micro-Robotic Systems for Biomedical Applications Open
Magnetically driven micro-robotics has drawn the attention of researchers due to its emerging importance in biomedical applications. This interest is partly due to the physics of transporting and manipulating microscopic objects in a compl…
View article: Tofacitinib Treatment Is Associated With Modest and Reversible Increases in Serum Lipids in Patients With Ulcerative Colitis
Tofacitinib Treatment Is Associated With Modest and Reversible Increases in Serum Lipids in Patients With Ulcerative Colitis Open
In an analysis of data from 5 trials of patients with UC who received tofacitinib, we found reversible increases in lipids with treatment and inverse correlations with reduced levels of high-sensitivity C-reactive protein. We did not find …
View article: A202 TOFACITINIB FOR THE TREATMENT OF ULCERATIVE COLITIS: UP TO 5.4 YEARS OF SAFETY DATA FROM GLOBAL CLINICAL TRIALS
A202 TOFACITINIB FOR THE TREATMENT OF ULCERATIVE COLITIS: UP TO 5.4 YEARS OF SAFETY DATA FROM GLOBAL CLINICAL TRIALS Open
BACKGROUND: Tofacitinib is an oral, small molecule JAK inhibitor approved in several countries for the treatment of ulcerative colitis (UC). Efficacy and safety of tofacitinib as UC induction and maintenance therapy were evaluated in Phase…
View article: The Impact of Raising the Bar for Clinical Trials in Ulcerative Colitis
The Impact of Raising the Bar for Clinical Trials in Ulcerative Colitis Open
In order to identify the practical implications for both health care practitioners and patients in understanding differences between the results of trials assessing therapies for ulcerative colitis [UC], we reviewed clinical trials of ther…
View article: P466 Tofacitinib for the treatment of ulcerative colitis: Up to 5.4 years of safety data from global clinical trials
P466 Tofacitinib for the treatment of ulcerative colitis: Up to 5.4 years of safety data from global clinical trials Open
Tofacitinib is an oral, small-molecule Janus kinase inhibitor approved in several countries for the treatment of ulcerative colitis (UC). The efficacy and safety of tofacitinib as UC induction and maintenance therapy were evaluated in Phas…
View article: DOP41 Efficacy and safety of open-label treatment with tofacitinib 10 mg twice daily in patients with ulcerative colitis with clinical response, but not remission, after 52 weeks of maintenance therapy: data from the OCTAVE studies
DOP41 Efficacy and safety of open-label treatment with tofacitinib 10 mg twice daily in patients with ulcerative colitis with clinical response, but not remission, after 52 weeks of maintenance therapy: data from the OCTAVE studies Open
Tofacitinib is an oral, small-molecule JAK inhibitor approved in several countries for the treatment of ulcerative colitis (UC). We evaluated efficacy and safety of tofacitinib in patients with clinical response, but not remission, after 5…
View article: Tofacitinib Induction Therapy Reduces Symptoms Within 3 Days for Patients With Ulcerative Colitis
Tofacitinib Induction Therapy Reduces Symptoms Within 3 Days for Patients With Ulcerative Colitis Open
In a post-hoc analysis of data from phase 3 trials of induction therapy with tofacitinib in patients with UC, we found significant improvements in symptoms among patients given tofacitinib compared with placebo within 3 days. These finding…
View article: Control of Small Magnetic Object in Artificial Human Tissue Material
Control of Small Magnetic Object in Artificial Human Tissue Material Open
The increasing availability of microbiome survey data has led to the use of complex machine learning and statistical approaches to measure taxonomic diversity and extract relationships between taxa and their host or environment. Accurately…
View article: P487 Tofacitinib for the treatment of ulcerative colitis: Analysis of infection rates from the OCTAVE clinical programme
P487 Tofacitinib for the treatment of ulcerative colitis: Analysis of infection rates from the OCTAVE clinical programme Open
Tofacitinib is an oral, small molecule Janus kinase inhibitor that is being investigated for ulcerative colitis (UC). The safety of tofacitinib for treatment of moderate to severe UC was evaluated in 8-week Induction Phase (P) 2 (NCT007872…
View article: DOP026 Efficacy and safety of dose escalation to tofacitinib 10 mg BID for patients with ulcerative colitis following loss of response on tofacitinib 5 mg BID maintenance therapy: results from OCTAVE open
DOP026 Efficacy and safety of dose escalation to tofacitinib 10 mg BID for patients with ulcerative colitis following loss of response on tofacitinib 5 mg BID maintenance therapy: results from OCTAVE open Open
Tofacitinib is an oral, small-molecule Janus kinase inhibitor that is being investigated for ulcerative colitis (UC). We evaluated efficacy and safety of tofacitinib dose escalation in patients with UC participating in an ongoing, open-lab…
View article: DOP023 Tofacitinib for the treatment of ulcerative colitis: up to 4.4 years of safety data from global clinical trials
DOP023 Tofacitinib for the treatment of ulcerative colitis: up to 4.4 years of safety data from global clinical trials Open
Tofacitinib is an oral, small-molecule Janus kinase inhibitor that is being investigated for ulcerative colitis (UC). The safety and efficacy of tofacitinib for the treatment of moderate to severe UC was evaluated in OCTAVE induction and m…
View article: DOP024 Tofacitinib achieves symptomatic improvement within 3 days in moderately to severely active ulcerative colitis, regardless of prior tumour necrosis factor inhibitor treatment status: results from OCTAVE induction 1 and 2
DOP024 Tofacitinib achieves symptomatic improvement within 3 days in moderately to severely active ulcerative colitis, regardless of prior tumour necrosis factor inhibitor treatment status: results from OCTAVE induction 1 and 2 Open
Tofacitinib is an oral, small-molecule Janus kinase inhibitor that is being investigated for ulcerative colitis (UC). We evaluated the timing of onset of symptomatic improvement in a post hoc analysis of patient-reported diary data and eva…
View article: Tofacitinib in Patients with Ulcerative Colitis: Health-Related Quality of Life in Phase 3 Randomised Controlled Induction and Maintenance Studies
Tofacitinib in Patients with Ulcerative Colitis: Health-Related Quality of Life in Phase 3 Randomised Controlled Induction and Maintenance Studies Open
NCT01465763, NCT01458951 and NCT01458574.
View article: Tofacitinib as Induction and Maintenance Therapy for Ulcerative Colitis
Tofacitinib as Induction and Maintenance Therapy for Ulcerative Colitis Open
In patients with moderately to severely active ulcerative colitis, tofacitinib was more effective as induction and maintenance therapy than placebo. (Funded by Pfizer; OCTAVE Induction 1, OCTAVE Induction 2, and OCTAVE Sustain ClinicalTria…
View article: OP032 Efficacy and safety of oral tofacitinib as maintenance therapy in patients with moderate to severe ulcerative colitis: results from a phase 3 randomised controlled trial
OP032 Efficacy and safety of oral tofacitinib as maintenance therapy in patients with moderate to severe ulcerative colitis: results from a phase 3 randomised controlled trial Open
Background: Tofacitinib is an oral, small molecule Janus kinase inhibitor that is being investigated for ulcerative colitis (UC). Efficacy and safety of tofacitinib 10 mg twice daily (BID) were reported in OCTAVE Induction 1 & 2 [1]. Metho…
View article: P467 Maintenance of quality of life improvement in a phase 3 study of tofacitinib for patients with moderately to severely active ulcerative colitis
P467 Maintenance of quality of life improvement in a phase 3 study of tofacitinib for patients with moderately to severely active ulcerative colitis Open
Background: Tofacitinib is an oral, small molecule Janus kinase inhibitor that is being investigated for ulcerative colitis (UC). Tofacitinib 10 mg twice daily (BID) improved quality of life (QoL) in two Phase 3 induction studies of patien…
View article: DOP074 Pharmacokinetics and exposure-response of tofacitinib in a Phase 3 maintenance study in ulcerative colitis patients
DOP074 Pharmacokinetics and exposure-response of tofacitinib in a Phase 3 maintenance study in ulcerative colitis patients Open
Background: Tofacitinib is an oral small molecule Janus kinase inhibitor that is being investigated for ulcerative colitis (UC). A recently completed 52-week (wk) Phase 3 maintenance study (NCT01458574) demonstrated efficacy of tofacitinib…