A5027087096- Inflammatory Bowel Disease
- Microscopic Colitis
- Amyloidosis: Diagnosis, Treatment, Outcomes
- Parathyroid Disorders and Treatments
- Autoimmune and Inflammatory Disorders Research
- Spondyloarthritis Studies and Treatments
- Rheumatoid Arthritis Research and Therapies
- Diagnosis and treatment of tuberculosis
- Biosimilars and Bioanalytical Methods
- Celiac Disease Research and Management
- Colorectal Cancer Treatments and Studies
- Psoriasis: Treatment and Pathogenesis
- Immunodeficiency and Autoimmune Disorders
- Neuroendocrine Tumor Research Advances
- Dermatological and Skeletal Disorders
- Peptidase Inhibition and Analysis
- Sarcoidosis and Beryllium Toxicity Research
- Coagulation, Bradykinin, Polyphosphates, and Angioedema
- Systemic Lupus Erythematosus Research
- Pharmacological Effects of Natural Compounds
- Lung Cancer Treatments and Mutations
- Tuberculosis Research and Epidemiology
- Lung Cancer Research Studies
- Cardiomyopathy and Myosin Studies
- Eosinophilic Disorders and Syndromes
Pfizer (United States)
2016-2025
Brigham and Women's Hospital
2017-2022
Harvard Vanguard Medical Associates
2015
Harvard University
2015
Emory University
2015
Johns Hopkins University
2015
Columbia University
2013
Mater Misericordiae Hospital
2009
Transthyretin (TTR) amyloidosis is a progressive systemic disorder caused by misfolded TTR monomers that cumulatively deposit in the heart and systemically as amyloid.This phase 2 open-label trial evaluated stabilization of tetramers using 20 mg tafamidis daily at week 6 (primary end point), month 6, 12, well safety treatment efficacy with respect to progression amyloid cardiomyopathy. Thirty-one wild-type patients (median age, 76.7 years; 93.5% men) median disease duration 55.6 months mild...
Abstract Background and Aims Tofacitinib is an oral small molecule Janus kinase [JAK] inhibitor for the treatment of ulcerative colitis. We report integrated summary tofacitinib safety [exposure: ≤7.8 years] from global clinical programme. Methods Patients receiving 5 or 10 mg twice daily [BID] completed phase [P]2/3 placebo-controlled studies, open-label, long-term extension study [final data cut-off: August 24, 2020], interim analysis a P3b/4 (interim February 20, 2020; Overall plus [2020]...
Transthyretin amyloidosis is a systemic disorder caused by amyloid deposits formed misfolded transthyretin monomers. Two main forms exist: hereditary and wild-type amyloidosis, the former associated with gene mutations. There are several disease manifestations; however, gastrointestinal complications common in form. The aim of this study was to explore prevalence distribution manifestations evaluate their impact on patients' nutritional status health-related quality life (HRQoL). Amyloidosis...
Abstract BACKGROUND: Sunitinib at 50 mg/day on the 4‐weeks‐on‐2‐weeks‐off schedule is current approved regimen for advanced/metastatic renal cell carcinoma (mRCC). Escudier et al reported that continuous, once‐daily dosing with sunitinib 37.5 mg had a manageable safety profile and significant antitumor activity as second‐line mRCC therapy. In this prospective, multicenter, phase II study, we evaluated of continuous first‐line treatment. METHODS: One hundred nineteen treatment‐naive patients...
Background Signs of cardiac transthyretin (TTR) amyloidosis (ATTR) in patients with echocardiographic increase interventricular septal thickness (IVST) are lacking. Objectives To identify clinical and ECG/echocardiographic signs associated increased IVST ATTR. Methods Analysis baseline echocardiography the Transthyretin Amyloidosis Outcomes Survey (THAOS) registry (N=1682). Patients were categorised into classes according to American Society Echocardiography classification adapted gender...
Aim Cardiac troponins and natriuretic peptides are established for risk stratification in light-chain amyloidosis. Data on cardiac biomarkers transthyretin amyloidosis (ATTR) lacking. Methods results Patients (n = 1617) with any of the following biomarkers, BNP 1079), NT-proBNP 550), troponin T 274), I 108), available at baseline Transthyretin Amyloidosis Outcomes Survey (THAOS) were analyzed differences between genotypes phenotypes their association survival. Median level was 68.0 pg/mL...
Tofacitinib is an oral, small-molecule Janus kinase inhibitor for the treatment of ulcerative colitis (UC). We summarize efficacy and safety data tofacitinib 5 or 10 mg twice daily in UC clinical program, stratified by prior tumor necrosis factor (TNFi) failure status.Efficacy was assessed pooled phase 3 OCTAVE Induction 1 2 studies (N = 1139), Sustain maintenance study 593), dose-escalation subpopulation open-label, long-term extension Open 59). Safety Sustain, subpopulation, Overall...
Background: Tofacitinib is an oral Janus kinase inhibitor for the treatment of ulcerative colitis (UC). Objectives: To investigate potential predictors efficacy in RIVETING. Design: This post hoc analysis included patients with UC stable remission (⩾6 months) on tofacitinib 10 mg twice daily (BID) maintenance therapy (⩾2 years treatment), who received 5/10 BID Methods: Achievement modified Mayo (mMayo) remission, (based total score), partial score (PMS) and PMS (mPMS) at month (M)6 was...
Objectives This post-hoc analysis explored the impact of body mass index (BMI) on tofacitinib efficacy/safety in patients with active psoriatic arthritis (PsA). Methods Data were pooled from two phase 3 studies ( NCT01877668 ; NCT01882439 ). Analyses included randomised to 5/10 mg times a day or placebo, stratified by baseline BMI: <25 kg/m 2 , ≥25–<30 ≥30–<35 ≥35 . Endpoints (month 3): American College Rheumatology (ACR20/50/70), Health Assessment Questionnaire-Disability Index...
Abstract Background Tofacitinib is an oral Janus kinase inhibitor for the treatment of ulcerative colitis (UC). This analysis assessed impact cigarette smoking on tofacitinib efficacy and safety in UC clinical program. Methods Efficacy endpoints adverse events (AEs) were evaluated by status (ever smokers [current ex-smokers] never smokers) phase (P)2 induction study (baseline demographics only), P3 studies (OCTAVE Induction 1&2, OCTAVE Sustain, Open), P3/4b RIVETING study. Results post...
Background: Early treatment initiation is one of the strongest predictors good response in axial spondyloarthritis (axSpA). Recently, Assessment SpondyloArthritis International Society (ASAS) defined early axSpA as a diagnosis with duration symptoms equal to or less than 2 years. Tofacitinib Janus kinase (JAK) inhibitor for ankylosing spondylitis. Objectives: Compare efficacy and safety tofacitinib versus placebo (both on non-steroidal anti-inflammatory drug (NSAID) background) patients...
Tofacitinib is an oral, small molecule JAK inhibitor for the treatment of ulcerative colitis. We report integrated analyses infections in Phase [P]2 and P3 OCTAVE programmes. Three cohorts were analysed: Induction [P2/3 induction studies]; Maintenance [P3 maintenance study]; Overall [all tofacitinib-treated patients induction, maintenance, or ongoing, open-label, long-term extension studies; as May 2019]. Proportions incidence rates [IRs; unique with events/100 patient-years] serious [SIs],...
Extraintestinal manifestations (EIMs) in patients with ulcerative colitis (UC) are common. Tofacitinib is an oral, small molecule Janus kinase inhibitor for the treatment of UC. We evaluated efficacy tofacitinib EIMs, and impact on EIMs UC OCTAVE clinical program.Data from two 8-week induction studies (OCTAVE Induction 1 2) a 52-week maintenance study Sustain) were analyzed. The effect outcomes stratified by EIM status, proportion predefined prior active at baseline, change baseline...
Abstract Background Tofacitinib is an oral, small molecule Janus kinase inhibitor for the treatment of ulcerative colitis (UC). We report herpes zoster (HZ) incidence and risk factors in tofacitinib UC clinical program (up to 7.8 years). Methods Proportions rates (IRs; unique patients with events/100 patient-years) HZ were evaluated 4 cohorts: Induction (phase 2 3 induction study data), Maintenance maintenance Overall (data from all phase 2, 3, open-label, long-term extension studies), plus...
ABSTRACT Transthyretin amyloidosis (ATTR) is characterized by the deposit of mutant or wild-type transthyretin that forms amyloid fibrils, which are extracellularly deposited within tissues and organs. Clinical manifestations familial polyneuropathy vary according to mutation, age at onset geographical location. This study aimed describe baseline disease characteristics Brazilian patients with (ATTR-FAP) enrolled in Amyloidosis Outcome Survey (THAOS). Methods: The THAOS an international,...
Randomized controlled trials have demonstrated tofacitinib efficacy for psoriatic arthritis (PsA); however, real-world effectiveness data are limited. This analysis assessed baseline demographics/disease characteristics and in patients with PsA the CorEvitas PsA/Spondyloarthritis Registry.
The effectiveness of tafamidis for the treatment transthyretin familial amyloid polyneuropathy (TTR-FAP) was evaluated using data from Transthyretin Amyloidosis Outcomes Survey (THAOS) registry.Subjects receiving (n = 252) were compared with untreated subjects in a non-randomized, matched cohort analysis. Subjects up to four controls by genetic mutation, region birth, and mean propensity score.The matched, treated sample consisted predominantly Val30Met genotype (92.5%), Portugal, age 40.4...
IntroductionAutonomic dysfunction, an early symptom of transthyretin amyloidosis (ATTR amyloidosis), requires investigations not readily available in many clinics. Although monitoring orthostatic hypotension (OH) will be a substitute for more specialized tests, it can add important information about initiation dysautonomia. The aim this study was to investigate whether simple blood pressure (BP) may useful tool evaluation disease progression and sign autonomic dysfunction.MethodsBP OH data...
S ummary Background Obesity may affect efficacy and safety of biologic treatments for ulcerative colitis (UC). Tofacitinib is an oral, small molecule Janus kinase inhibitor the treatment UC. Aims To assess tofacitinib in patients with UC, by baseline body mass index (BMI). Methods This post hoc analysis evaluated UC receiving placebo or from 8‐week OCTAVE Induction 1 2 (NCT01465763, NCT01458951) 52‐week Sustain (NCT01458574) studies. Patients were stratified BMI at (<25, 25 to <30 ≥30...
Tofacitinib is an oral, small molecule JAK inhibitor for the treatment of ulcerative colitis. We evaluate baseline characteristics as predictors sustained response and remission in patients with colitis receiving tofacitinib maintenance therapy.Patients clinical following OCTAVE Induction 1 2 entered Sustain were rerandomized to receive 5 or 10 mg twice daily placebo. Baseline stratified by week 52 efficacy endpoints (remission, remission, response, response). Associations between evaluated...
Despite growing numbers of patients diagnosed with late-onset hereditary ATTR V30M amyloidosis polyneuropathy (ATTRv-PN), this condition remains poorly characterized in Brazil.Characterize ATTRv-PN Brazil.Demographic and clinical data at the time enrolment for Brazilian subjects symptomatic were extracted from ongoing, multinational, longitudinal, observational Transthyretin Amyloidosis Outcomes Survey (THAOS; cut-off date: January 30, 2017). Subjects divided into those symptom onset age <50...
Tofacitinib is an oral, small molecule Janus kinase inhibitor for the treatment of ulcerative colitis (UC). We present integrated analyses nonmelanoma skin cancer (NMSC) incidence in tofacitinib UC clinical program.Nonmelanoma events were evaluated from 3 randomized, placebo-controlled studies: 2 identical, 8-week induction studies (NCT01465763, NCT01458951), a 52-week maintenance study (NCT01458574), and open-label, long-term extension (NCT01470612). Cohorts analyzed were: Induction,...