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Josef S Smolen - One of the best experts on this subject based on the ideXlab platform.
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fri0089 effect of starting dose of baricitinib in achieving sustained low disease activity
Annals of the Rheumatic Diseases, 2017Co-Authors: Jeffrey R Curtis, Arthur Kavanaugh, D Van Der Heijde, David Muram, Jahangir Alam, Scott D Beattie, Josef S SmolenAbstract:Background In Phase 3 studies, baricitinib (bari) treatment with 2 different doses (2 mg and 4 mg once daily) demonstrated significant improvements across multiple measures of disease activity in patients (pts) with active RA and an inadequate response (IR) to conventional synthetic (cs) DMARDs (RA-BUILD1) or biologic (b) DMARDs (RA-BEACON2). Objectives To determine the effect of starting dose of bari on achieving and sustaining low disease activity (LDA). Methods RA-BUILD and RA-BEACON trials were 24 week (wk), placebo (PBO) controlled studies. Pts completing the studies on bari treatment could enter a long-term extension (LTE) study, RA-BEYOND, continuing blinded treatment with the same dose, while pts on PBO switched to bari 4 mg. This post hoc analysis assessed disease activity in pts who achieved CDAI ≤10 at ≥1 visit (LDA) or at ≥2 consecutive visits (sustained LDA) within the originating study (24 wks) and continued into the LTE. The length of time required by pts to achieve LDA was determined by the incidence rate (percent pts responding per month) for each group. Results Treatment with bari 2 mg and 4 mg, when compared to PBO, resulted in higher rates of LDA and sustained LDA, as well as higher incidence rates (shorter time to achieve LDA/sustained LDA) within 24 wks of each originating study. Across studies, treatment with bari 4 mg demonstrated higher incidence rates when compared to bari 2 mg, both in achieving LDA and sustained LDA, indicating that these pts reached the desired LDA state faster. Incidence rates were lower in all treatment groups in bDMARD-IR pts compared with csDMARD-IR pts. Conclusions The most robust benefit in terms of achieving LDA and sustained LDA was observed with bari 4 mg treatment, which required shorter time to response, than treatment with 2 mg. This was observed in both the short (24 wks) and in the long-term in pts with IR to csDMARDs or bDMARDs. References Dougados M et al. Ann Rheum Dis 2017; 76(1):88–95. Genovese M et al. N Engl J Med 2016; 374(13):1243–52. Disclosure of Interest J. Curtis Grant/research support from: Abbvie, Amgen, BMS, Corrona, Eli Lilly and Company, Janssen, Myriad, Pfizer, Roche/Genentech, UCB, Consultant for: Abbvie, Amgen, BMS, Corrona, Eli Lilly and Company, Janssen, Myriad, Pfizer, Roche/Genentech, UCB, A. Kavanaugh Consultant for: Eli Lilly and Company, D. van der Heijde Consultant for: Abbvie, Amgen, Astellas, Astra-Zeneca, BMS, Boeringer Ingelheim, Celgene, Daiichi Sankyo, Eli Lilly and Company, Galapagos, Gilead, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi-Aventis, UCB, Employee of: Director of Imaging Rheumatology bv, D. Muram Employee of: Eli Lilly and Company, J. Alam Employee of: Eli Lilly and Company, S. Beattie Employee of: Eli Lilly and Company, J. Smolen Grant/research support from: Abbvie, Janssen, Eli Lilly and Company, MSD, Pfizer, Roche, Consultant for: Abbvie, Amgen, Astra-Zeneca, Astro, BMS, Celgene, Celltrion, Chugai, Gilead, Glaxo, ILTOO, Janssen, Eli Lilly and Company, Medimmune, MSD, Novartis-Sandoz, Pfizer, Roche, Samsung, Sanofi-Aventis, UCB, Speakers bureau: Abbvie, Amgen, Astra-Zeneca, Astro, BMS, Celgene, Celltrion, Chugai, Gilead, Glaxo, ILTOO, Janssen, Eli Lilly and Company, Medimmune, MSD, Novartis-Sandoz, Pfizer, Roche, Samsung, Sanofi-Aventis, UCB
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ab0235 effect of baseline disease activity on achieving sustained low disease activity in baricitinib phase 3 studies
Annals of the Rheumatic Diseases, 2017Co-Authors: Jeffrey R Curtis, Arthur Kavanaugh, D Van Der Heijde, David Muram, Jahangir Alam, Josef S SmolenAbstract:Background In the Phase 3 studies RA-BUILD1 and RA-BEAM2, baricitinib (bari) has demonstrated clinical efficacy including reduced disease activity in RA patients (pts) with an inadequate response (IR) to conventional synthetic DMARDs (csDMARDs). Objectives To determine whether disease activity at baseline (BL) affects the achievement of sustained low disease activity (LDA) with bari treatment. Methods In this post hoc analysis, pts from the placebo (PBO) and bari 4 mg treatment arms of the RA-BUILD and RA-BEAM studies were categorised based on their level of disease activity at BL; either CDAI ≤median or CDAI >median, where median was 34.8 for RA-BUILD and 36.2 for RA-BEAM. Pts who achieved CDAI ≤10 at ≥2 consecutive visits (sustained LDA) within 12 and 24 weeks (wks) were considered as responders. The length of time required by pts to achieve sustained LDA was determined for each group using the incidence rate (percent pts responding per month). In addition, the association between response and dose of bari was explored in csDMARD-IR pts randomised to bari (2 mg or 4 mg) once daily from the RA-BUILD study. Results Within the bari 4 mg arm, a greater proportion of pts with CDAI ≤median at BL achieved sustained LDA and within a shorter treatment duration as indicated by higher incidence rates, compared to pts with CDAI >median at BL. In pts with CDAI ≤34.8 at BL, the 2 mg and 4 mg doses showed similar efficacy, but a larger proportion of pts with CDAI >34.8 reached sustained LDA at 24 wks with bari 4 mg than 2 mg (41.4% and 32.4%, respectively). Conclusions Pts with CDAI ≤35–36 at BL achieved sustained LDA more frequently and more rapidly than pts in the higher disease category at BL. In pts with higher disease activity at BL a more robust response was observed with bari 4 mg treatment. References Dougados M et al. Ann Rheum Dis 2017; 76(1):88–95. Taylor P et al. Arthritis Rheumatol 2015; 67(Suppl 10):1–4046. Disclosure of Interest J. Curtis Grant/research support from: AbbVie, Amgen, BMS, Corrona, Eli Lilly and Company, Janssen, Myriad, Pfizer, Roche/Genentech, UCB, Consultant for: AbbVie, Amgen, BMS, Corrona, Eli Lilly and Company, Janssen, Myriad, Pfizer, Roche/Genentech, UCB, A. Kavanaugh Consultant for: Eli Lilly and Company, D. van der Heijde Consultant for: AbbVie, Amgen, Astellas, Astra-Zeneca, BMS, Boeringer Ingelheim, Celgene, Daiichi Sankyo, Eli Lilly and Company, Galapagos, Gilead, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi-Aventis, UCB, Employee of: Director of Imaging Rheumatology bv, D. Muram Employee of: Eli Lilly and Company, J. Alam Employee of: Eli Lilly and Company, J. Smolen Grant/research support from: Abbvie, Janssen, Eli Lilly and Company, MSD, Pfizer, Roche, Consultant for: Abbvie, Amgen, Astra-Zeneca, Astro, BMS, Celgene, Celltrion, Chugai, Gilead, Glaxo, ILTOO, Janssen, Eli Lilly and Company, Medimmune, MSD, Novartis-Sandoz, Pfizer, Roche, Samsung, Sanofi-Aventis, UCB, Speakers bureau: Abbvie, Amgen, Astra-Zeneca, Astro, BMS, Celgene, Celltrion, Chugai, Gilead, Glaxo, ILTOO, Janssen, Eli Lilly and Company, Medimmune, MSD, Novartis-Sandoz, Pfizer, Roche, Samsung, Sanofi-Aventis, UCB
L Crino - One of the best experts on this subject based on the ideXlab platform.
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efficacy and patient pt reported outcomes pros aith selumetinib azd6244 arry 142866 sel docetaxel doc in kras mutant advanced non small cell lung cancer nsclc a randomized phase ii trial
Annals of Oncology, 2012Co-Authors: Pasi A Janne, Alice T Shaw, Jose Rodrigues Pereira, Gaelle Jeannin, Johan Vansteenkiste, Carlos H Barrios, F Franke, Lynda Grinsted, Ian C P Smith, L CrinoAbstract:ABSTRACT Objectives This randomized, double-blind, placebo (PBO)-controlled, phase II trial evaluated the efficacy and safety of SEL + DOC as second-line treatment for pts with KRAS-mutant advanced NSCLC. Assessment of the prevalence, severity, and change over time of lung cancer symptoms was an exploratory objective. Methods Pts with stage IIIB-IV, second-line KRAS-mutant advanced NSCLC, received iv DOC 75mg/m2, and po SEL 75mg or PBO BD. PROs were assessed using the Lung Cancer-Specific Symptom Questionnaire (LSSQ), which includes the Lung Cancer Subscale (LCS) plus items relating to symptoms and functional activities from the FACT-L. Pts completed the questionnaire on Day 1, and every 3 weeks until discontinuation from study treatment, and at discontinuation. Results 422 pts were screened across 67 centers in 12 countries; 87 were randomized (SEL + DOC, 44; PBO + DOC, 43). Baseline characteristics were reasonably balanced. OS was longer for SEL + DOC vs PBO + DOC (9.4 vs 5.2 mo), but not statistically significant (HR 0.80; 80% CI 0.56–1.14) and hazards were non-proportional. All secondary endpoints, including response rate (37% vs 0%; p Conclusions This is the first prospective study to demonstrate a clinical benefit of targeted therapy (SEL + DOC) for pts with KRAS-mutant cancer of any type. In a post-hoc analysis, more pts experienced clinically meaningful improvements in lung cancer symptoms with SEL + DOC than PBO + DOC. Disclosure P.A. Janne: I have served as a consultant to Astra Zeneca and have been compensated. A.T. Shaw: Research funding from Astra Zeneca and funding for costs of clinical trials. J.F. Vansteenkiste: Dr. Vansteenkiste is the holder of the Astra Zeneca Chair in personalized lung cancer care which provides research funding. L. Grinsted: Lynda Grinsted is an employee of Astra Zeneca and receives stock shares. I. Smith: Ian Smith is an employee of Astra Zeneca and receives stock. All other authors have declared no conflicts of interest.
Douglas Marthaler - One of the best experts on this subject based on the ideXlab platform.
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senecavirus a an emerging pathogen causing vesicular disease and mortality in pigs
Veterinary Pathology, 2017Co-Authors: Joaquim Segales, D E S N De Barcellos, A Alfieri, Eric R Burrough, Douglas MarthalerAbstract:Senecavirus A (SVA) is the only member of the genus Senecavirus within the family Picornaviridae. This virus was discovered as a serendipitous finding in 2002 (and named Seneca Valley virus 001 [SV...
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identification and complete genome of seneca valley virus in vesicular fluid and sera of pigs affected with idiopathic vesicular disease brazil
Transboundary and Emerging Diseases, 2015Co-Authors: Fabio A Vannucci, D E S N De Barcellos, Daniel C L Linhares, Ham Ching Lam, James E Collins, Douglas MarthalerAbstract:Numerous, ongoing outbreaks in Brazilian swine herds have been characterized by vesicular lesions in sows and acute losses of neonatal piglets. The complete genome of Seneca Valley virus (SVV) was identified in vesicular fluid and sera of sows, providing evidence of association between SVV and vesicular disease and viraemia in affected animals.
Jeffrey R Curtis - One of the best experts on this subject based on the ideXlab platform.
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fri0089 effect of starting dose of baricitinib in achieving sustained low disease activity
Annals of the Rheumatic Diseases, 2017Co-Authors: Jeffrey R Curtis, Arthur Kavanaugh, D Van Der Heijde, David Muram, Jahangir Alam, Scott D Beattie, Josef S SmolenAbstract:Background In Phase 3 studies, baricitinib (bari) treatment with 2 different doses (2 mg and 4 mg once daily) demonstrated significant improvements across multiple measures of disease activity in patients (pts) with active RA and an inadequate response (IR) to conventional synthetic (cs) DMARDs (RA-BUILD1) or biologic (b) DMARDs (RA-BEACON2). Objectives To determine the effect of starting dose of bari on achieving and sustaining low disease activity (LDA). Methods RA-BUILD and RA-BEACON trials were 24 week (wk), placebo (PBO) controlled studies. Pts completing the studies on bari treatment could enter a long-term extension (LTE) study, RA-BEYOND, continuing blinded treatment with the same dose, while pts on PBO switched to bari 4 mg. This post hoc analysis assessed disease activity in pts who achieved CDAI ≤10 at ≥1 visit (LDA) or at ≥2 consecutive visits (sustained LDA) within the originating study (24 wks) and continued into the LTE. The length of time required by pts to achieve LDA was determined by the incidence rate (percent pts responding per month) for each group. Results Treatment with bari 2 mg and 4 mg, when compared to PBO, resulted in higher rates of LDA and sustained LDA, as well as higher incidence rates (shorter time to achieve LDA/sustained LDA) within 24 wks of each originating study. Across studies, treatment with bari 4 mg demonstrated higher incidence rates when compared to bari 2 mg, both in achieving LDA and sustained LDA, indicating that these pts reached the desired LDA state faster. Incidence rates were lower in all treatment groups in bDMARD-IR pts compared with csDMARD-IR pts. Conclusions The most robust benefit in terms of achieving LDA and sustained LDA was observed with bari 4 mg treatment, which required shorter time to response, than treatment with 2 mg. This was observed in both the short (24 wks) and in the long-term in pts with IR to csDMARDs or bDMARDs. References Dougados M et al. Ann Rheum Dis 2017; 76(1):88–95. Genovese M et al. N Engl J Med 2016; 374(13):1243–52. Disclosure of Interest J. Curtis Grant/research support from: Abbvie, Amgen, BMS, Corrona, Eli Lilly and Company, Janssen, Myriad, Pfizer, Roche/Genentech, UCB, Consultant for: Abbvie, Amgen, BMS, Corrona, Eli Lilly and Company, Janssen, Myriad, Pfizer, Roche/Genentech, UCB, A. Kavanaugh Consultant for: Eli Lilly and Company, D. van der Heijde Consultant for: Abbvie, Amgen, Astellas, Astra-Zeneca, BMS, Boeringer Ingelheim, Celgene, Daiichi Sankyo, Eli Lilly and Company, Galapagos, Gilead, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi-Aventis, UCB, Employee of: Director of Imaging Rheumatology bv, D. Muram Employee of: Eli Lilly and Company, J. Alam Employee of: Eli Lilly and Company, S. Beattie Employee of: Eli Lilly and Company, J. Smolen Grant/research support from: Abbvie, Janssen, Eli Lilly and Company, MSD, Pfizer, Roche, Consultant for: Abbvie, Amgen, Astra-Zeneca, Astro, BMS, Celgene, Celltrion, Chugai, Gilead, Glaxo, ILTOO, Janssen, Eli Lilly and Company, Medimmune, MSD, Novartis-Sandoz, Pfizer, Roche, Samsung, Sanofi-Aventis, UCB, Speakers bureau: Abbvie, Amgen, Astra-Zeneca, Astro, BMS, Celgene, Celltrion, Chugai, Gilead, Glaxo, ILTOO, Janssen, Eli Lilly and Company, Medimmune, MSD, Novartis-Sandoz, Pfizer, Roche, Samsung, Sanofi-Aventis, UCB
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ab0235 effect of baseline disease activity on achieving sustained low disease activity in baricitinib phase 3 studies
Annals of the Rheumatic Diseases, 2017Co-Authors: Jeffrey R Curtis, Arthur Kavanaugh, D Van Der Heijde, David Muram, Jahangir Alam, Josef S SmolenAbstract:Background In the Phase 3 studies RA-BUILD1 and RA-BEAM2, baricitinib (bari) has demonstrated clinical efficacy including reduced disease activity in RA patients (pts) with an inadequate response (IR) to conventional synthetic DMARDs (csDMARDs). Objectives To determine whether disease activity at baseline (BL) affects the achievement of sustained low disease activity (LDA) with bari treatment. Methods In this post hoc analysis, pts from the placebo (PBO) and bari 4 mg treatment arms of the RA-BUILD and RA-BEAM studies were categorised based on their level of disease activity at BL; either CDAI ≤median or CDAI >median, where median was 34.8 for RA-BUILD and 36.2 for RA-BEAM. Pts who achieved CDAI ≤10 at ≥2 consecutive visits (sustained LDA) within 12 and 24 weeks (wks) were considered as responders. The length of time required by pts to achieve sustained LDA was determined for each group using the incidence rate (percent pts responding per month). In addition, the association between response and dose of bari was explored in csDMARD-IR pts randomised to bari (2 mg or 4 mg) once daily from the RA-BUILD study. Results Within the bari 4 mg arm, a greater proportion of pts with CDAI ≤median at BL achieved sustained LDA and within a shorter treatment duration as indicated by higher incidence rates, compared to pts with CDAI >median at BL. In pts with CDAI ≤34.8 at BL, the 2 mg and 4 mg doses showed similar efficacy, but a larger proportion of pts with CDAI >34.8 reached sustained LDA at 24 wks with bari 4 mg than 2 mg (41.4% and 32.4%, respectively). Conclusions Pts with CDAI ≤35–36 at BL achieved sustained LDA more frequently and more rapidly than pts in the higher disease category at BL. In pts with higher disease activity at BL a more robust response was observed with bari 4 mg treatment. References Dougados M et al. Ann Rheum Dis 2017; 76(1):88–95. Taylor P et al. Arthritis Rheumatol 2015; 67(Suppl 10):1–4046. Disclosure of Interest J. Curtis Grant/research support from: AbbVie, Amgen, BMS, Corrona, Eli Lilly and Company, Janssen, Myriad, Pfizer, Roche/Genentech, UCB, Consultant for: AbbVie, Amgen, BMS, Corrona, Eli Lilly and Company, Janssen, Myriad, Pfizer, Roche/Genentech, UCB, A. Kavanaugh Consultant for: Eli Lilly and Company, D. van der Heijde Consultant for: AbbVie, Amgen, Astellas, Astra-Zeneca, BMS, Boeringer Ingelheim, Celgene, Daiichi Sankyo, Eli Lilly and Company, Galapagos, Gilead, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi-Aventis, UCB, Employee of: Director of Imaging Rheumatology bv, D. Muram Employee of: Eli Lilly and Company, J. Alam Employee of: Eli Lilly and Company, J. Smolen Grant/research support from: Abbvie, Janssen, Eli Lilly and Company, MSD, Pfizer, Roche, Consultant for: Abbvie, Amgen, Astra-Zeneca, Astro, BMS, Celgene, Celltrion, Chugai, Gilead, Glaxo, ILTOO, Janssen, Eli Lilly and Company, Medimmune, MSD, Novartis-Sandoz, Pfizer, Roche, Samsung, Sanofi-Aventis, UCB, Speakers bureau: Abbvie, Amgen, Astra-Zeneca, Astro, BMS, Celgene, Celltrion, Chugai, Gilead, Glaxo, ILTOO, Janssen, Eli Lilly and Company, Medimmune, MSD, Novartis-Sandoz, Pfizer, Roche, Samsung, Sanofi-Aventis, UCB
David M Jackman - One of the best experts on this subject based on the ideXlab platform.
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long term survival clinical activity and safety of nivolumab anti pd 1 bms 936558 ono 4538 in patients pts with advanced non small cell lung cancer nsclc
International Journal of Radiation Oncology Biology Physics, 2014Co-Authors: Scott N Gettinger, Leena Gandhi, David R Spigel, Scott Antonia, Naiyer A Rizvi, John D Powderly, Richard D Carvajal, Rebecca Suk Heist, Leora Horn, David M JackmanAbstract:Other; Novartis, Roche, Boehringer-Ingelheim. M. Thomas: F. Honoraria; Lilly, Bristol Meyers Squibb, Roche. G. Consultant; Lilly, Bristol Meyers Squibb, Roche, Novartis. M. Schuler: E. Research Grant; Boehringer Ingelheim, Novartis. F. Honoraria; Boehringer Ingelheim, Celgene, GlaxoSmithKline, Lilly, Novartis, Pfizer. G. Consultant; AstraZeneca, Boehringer Ingelheim, Novartis, Pfizer. G. Liu: G. Consultant; Astra Zeneca, Pfizer, Novartis. A. Santoro: None. M. Geraldes: A. Employee; Novartis Pharmaceuticals. M. Stock; Novartis Pharmaceuticals. A.L. Boral: A. Employee; Novartis Pharmaceuticals. A. Yovine: A. Employee; Novartis Pharma AG. A.T. Shaw: G. Consultant; Ignyta. K. Advisory Board; Novartis, Pfizer, Ariad, Chugai, Genentech.
