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3. LP-195 Design of a Phase 2 study evaluating the efficacy and safety of nipocalimab in adult patients with active systemic lupus erythematosus

Author

Liu-walsh, Fang, primary, Hartingsveldt, Bart van, additional, Zuraw, Qing, additional, Hoffman, Robert, additional, Rooney, Terence, additional, Gao, Sheng, additional, Lee, YoungJa, additional, Gordon, Robert, additional, Leu, Jocelyn, additional, Calderon, Cesar, additional, Zazzetti, Federico, additional, Stevens, Anne, additional, and Vratsanos, George, additional

Published
2023
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7. 611 Efficacy and safety of nipocalimab in adult patients with active systemic lupus erythematosus: design of a phase 2 study

Author

Liu-Walsh, Fang, primary, Hartingsveldt, Bart van, additional, Zuraw, Qing, additional, Hoffman, Robert W, additional, Rooney, Terence, additional, Gao, Sheng, additional, Gordon, Robert, additional, Leu, Jocelyn H, additional, Calderon, Cesar, additional, Zazzetti, Federico, additional, Stevens, Anne M, additional, and Vratsanos, George, additional

Published
2022
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9. Baricitinib, Methotrexate, or Combination in Patients With Rheumatoid Arthritis and No or Limited Prior Disease‐Modifying Antirheumatic Drug Treatment

Author

Fleischmann, Roy, Schiff, Michael, van der Heijde, Désirée, RamosRemus, Cesar, Spindler, Alberto, Stanislav, Marina, Zerbini, Cristiano A. F., Gurbuz, Sirel, Dickson, Christina, de Bono, Stephanie, Schlichting, Douglas, Beattie, Scott, Kuo, WenLing, Rooney, Terence, Macias, William, and Takeuchi, Tsutomu

Published
2017
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10. Baricitinib versus Placebo or Adalimumab in Rheumatoid Arthritis

Author

Taylor, Peter C., Keystone, Edward C., van der Heijde, Désirée, Weinblatt, Michael E., del Carmen Morales, Liliana, Gonzaga, Jaime Reyes, Yakushin, Sergey, Ishii, Taeko, Emoto, Kahaku, Beattie, Scott, Arora, Vipin, Gaich, Carol, Rooney, Terence, Schlichting, Douglas, Macias, William L., de Bono, Stephanie, and Tanaka, Yoshiya

Published
2017
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16. Additional file 3 of Temporary interruption of baricitinib: characterization of interruptions and effect on clinical outcomes in patients with rheumatoid arthritis

Author

Emery, Paul, Tanaka, Yoshiya, Cardillo, Tracy, Schlichting, Douglas, Rooney, Terence, Beattie, Scott, Helt, Cameron, and Smolen, Josef S.

Abstract

Additional file 3: Table S3. Nature and timing of increase in symptoms/disease activity during temporary interruptions of baricitinib or matching placebo tablets. NRS, numeric rating scale.

Published
2020
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18. Additional file 1 of Temporary interruption of baricitinib: characterization of interruptions and effect on clinical outcomes in patients with rheumatoid arthritis

Author

Emery, Paul, Tanaka, Yoshiya, Cardillo, Tracy, Schlichting, Douglas, Rooney, Terence, Beattie, Scott, Helt, Cameron, and Smolen, Josef S.

Abstract

Additional file 1: Table S1. Key study design features including patient population. Bari, baricitinib; bDMARD, biologic disease-modifying antirheumatic drugs; csDMARD, conventional synthetic disease-modifying antirheumatic drugs; IR, inadequate responder; MTX, methotrexate; SC, sub-cutaneous; TNFi, tumor necrosis factor inhibitor.

Published
2020
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21. Infections in baricitinib clinical trials for patients with active rheumatoid arthritis

Author

Winthrop, Kevin L, primary, Harigai, Masayoshi, additional, Genovese, Mark C, additional, Lindsey, Stephen, additional, Takeuchi, Tsutomu, additional, Fleischmann, Roy, additional, Bradley, John D, additional, Byers, Nicole L, additional, Hyslop, David L, additional, Issa, Maher, additional, Nishikawa, Atsushi, additional, Rooney, Terence P, additional, Witt, Sarah, additional, Dickson, Christina L, additional, Smolen, Josef S, additional, and Dougados, Maxime, additional

Published
2020
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22. Efficacy and Safety of Long‐Term Baricitinib With and Without Methotrexate for the Treatment of Rheumatoid Arthritis: Experience With Baricitinib Monotherapy Continuation or After Switching From Methotrexate Monotherapy or Baricitinib Plus Methotrexate

Author

Fleischmann, Roy, primary, Takeuchi, Tsutomu, additional, Schiff, Michael, additional, Schlichting, Douglas, additional, Xie, Li, additional, Issa, Maher, additional, Stoykov, Ivaylo, additional, Lisse, Jeffrey, additional, Martinez‐Osuna, Pindaro, additional, Rooney, Terence, additional, and Zerbini, Cristiano A. F., additional

Published
2020
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24. Additional file 1: of Comparison of baricitinib, upadacitinib, and tofacitinib mediated regulation of cytokine signaling in human leukocyte subpopulations

Author

McInnes, Iain, Byers, Nicole, Higgs, Richard, Lee, Jonathan, Macias, William, Songqing Na, Ortmann, Robert, Rocha, Guilherme, Rooney, Terence, Wehrman, Thomas, Zhang, Xin, Zuckerman, Steven, and Taylor, Peter

Abstract

Table S1. IC50 values in B cells and CD8+ T cells. Table S2. Hours per day above IC50 in B cells and CD8+ T cells: baricitinib 4-mg. Table S3. Hours per day above IC50 in CD4+ T cells, NK cells, and monocytes: baricitinib 2-mg. Table S4. Hours per day above IC50 in B cells and CD8+ T cells: baricitinib 2-mg. Table S5. Average daily percent STAT inhibition in B cells and CD8+ T cells: baricitinib 4-mg. Table S6. Average daily percent STAT inhibition in CD4+ T cells, NK cells, and monocytes: baricitinib 2-mg. Table S7. Average daily percent STAT inhibition in B cells and CD8+ T cells: baricitinib 2-mg. Figure S1. Select representative histogram plots for cytokine-induced STAT phosphorylation (DOCX 278 kb)

Published
2019
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26. THU0078 SAFETY PROFILE OF BARICITINIB FOR THE TREATMENT OF RHEUMATOID ARTHRITIS UP TO 7 YEARS: AN UPDATED INTEGRATED SAFETY ANALYSIS

Author

Genovese, Mark C., primary, Smolen, Josef S., additional, Takeuchi, Tsutomu, additional, Burmester, Gerd Rüdiger, additional, Brinker, Dennis, additional, Rooney, Terence, additional, Zhong, Jinglin, additional, Mo, Daojun, additional, Saifan, Chadi, additional, Cardoso, Anabela, additional, Issa, Maher, additional, Wu, Wen-Shuo, additional, and Winthrop, Kevin, additional

Published
2019
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27. Cardiovascular Safety During Treatment With Baricitinib in Rheumatoid Arthritis

Author

Taylor, Peter C., primary, Weinblatt, Michael E., additional, Burmester, Gerd R., additional, Rooney, Terence P., additional, Witt, Sarah, additional, Walls, Chad D., additional, Issa, Maher, additional, Salinas, Claudia A., additional, Saifan, Chadi, additional, Zhang, Xin, additional, Cardoso, Anabela, additional, González‐Gay, Miguel A., additional, and Takeuchi, Tsutomu, additional

Published
2019
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28. Clinical outcomes in patients switched from adalimumab to baricitinib due to non-response and/or study design: phase III data in patients with rheumatoid arthritis

Author

Tanaka, Yoshiya, primary, Fautrel, Bruno, additional, Keystone, Edward C, additional, Ortmann, Robert A, additional, Xie, Li, additional, Zhu, Baojin, additional, Issa, Maher, additional, Patel, Himanshu, additional, Gaich, Carol L, additional, de Bono, Stephanie, additional, Rooney, Terence P, additional, and Taylor, Peter C, additional

Published
2019
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29. Safety profile of baricitinib in Japanese patients with active rheumatoid arthritis with over 1.6 years median time in treatment: An integrated analysis of Phases 2 and 3 trials

Author

Harigai, Masayoshi, primary, Takeuchi, Tsutomu, additional, Smolen, Josef S., additional, Winthrop, Kevin L., additional, Nishikawa, Atsushi, additional, Rooney, Terence P., additional, Saifan, Chadi G., additional, Issa, Maher, additional, Isaka, Yoshitaka, additional, Akashi, Naotsugu, additional, Ishii, Taeko, additional, and Tanaka, Yoshiya, additional

Published
2019
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30. Characterization and Changes of Lymphocyte Subsets in Baricitinib‐Treated Patients With Rheumatoid Arthritis

Author

Tanaka, Yoshiya, primary, McInnes, Iain B., additional, Taylor, Peter C., additional, Byers, Nicole L., additional, Chen, Lei, additional, Bono, Stephanie, additional, Issa, Maher, additional, Macias, William L., additional, Rogai, Veronica, additional, Rooney, Terence P., additional, Schlichting, Douglas E., additional, Zuckerman, Steven H., additional, and Emery, Paul, additional

Published
2018
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32. Safety profile of baricitinib in Japanese patients with active rheumatoid arthritis with over 1.6 years median time in treatment: An integrated analysis of Phases 2 and 3 trials.

Author

Masayoshi Harigai, Tsutomu Takeuchi, Smolen, Josef S., Winthrop, Kevin L., Atsushi Nishikawa, Rooney, Terence P., Saifan, Chadi G., Maher Issa, Yoshitaka Isaka, Naotsugu Akashi, Taeko Ishii, and Yoshiya Tanaka

Subjects
RHEUMATOID arthritis, ADVERSE health care events, JANUS kinases, LYMPHOMAS, CARDIOVASCULAR agents
Abstract

Objectives: Baricitinib is a selective oral inhibitor of JAK1/JAK2 for patients with moderately-to-severely active rheumatoid arthritis (RA). Baricitinib's safety profile in Japanese patients was evaluated using six studies (five Ph2/Ph3 trials, one long-term extension study through 01 September 2016) from an integrated database (nine RA studies). Methods: Incidence rates (IRs) or exposure-adjusted IRs (EAIRs) of adverse events (AEs) per 100 patient-years (PY) were calculated using data which included RA patients exposed to any baricitinib dose. Results: Five hundred and fourteen Japanese patients received baricitinib for 851.5 total PY of exposure (median 1.7 years, maximum 3.2). The EAIR of treatment-emergent AEs was 57.4/100PY. There were no deaths; 31 patients had serious infections (IR: 3.6/100PY), 55 herpes zoster (6.5), 0 tuberculosis, 10 malignancies (1.1) including two lymphomas, two major cardiovascular AEs (0.3), one gastro- intestinal perforation (0.1), and four deep vein thrombosis (0.5). In Japanese patients, herpes zoster was more frequent than that of patients overall in the integrated database, but the events were considered manageable. Conclusion: In this analysis, baricitinib had acceptable safety profile in Japanese RA patients in the context of demonstrated efficacy. Aside from herpes zoster, baricitinib safety was not notably different between Japanese RA patients and those RA patients in the integrated database. [ABSTRACT FROM AUTHOR]

Published
2020
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33. Safety Profile of Baricitinib in Patients with Active Rheumatoid Arthritis with over 2 Years Median Time in Treatment

Author

Smolen, Josef S., primary, Genovese, Mark C., additional, Takeuchi, Tsutomu, additional, Hyslop, David L., additional, Macias, William L., additional, Rooney, Terence, additional, Chen, Lei, additional, Dickson, Christina L., additional, Riddle Camp, Jennifer, additional, Cardillo, Tracy E., additional, Ishii, Taeko, additional, and Winthrop, Kevin L., additional

Published
2018
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34. Dose reduction of baricitinib in patients with rheumatoid arthritis achieving sustained disease control: results of a prospective study

Author

Takeuchi, Tsutomu, primary, Genovese, Mark C, additional, Haraoui, Boulos, additional, Li, Zhanguo, additional, Xie, Li, additional, Klar, Rena, additional, Pinto-Correia, Ana, additional, Otawa, Susan, additional, Lopez-Romero, Pedro, additional, de la Torre, Inmaculada, additional, Macias, William, additional, Rooney, Terence P, additional, and Smolen, Josef S, additional

Published
2018
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35. Effects of baricitinib on radiographic progression of structural joint damage at 1 year in patients with rheumatoid arthritis and an inadequate response to conventional synthetic disease-modifying antirheumatic drugs

Author

van der Heijde, Desirée, primary, Dougados, Maxime, additional, Chen, Ying-Chou, additional, Greenwald, Maria, additional, Drescher, Edit, additional, Klar, Rena, additional, Xie, Li, additional, de la Torre, Inmaculada, additional, Rooney, Terence P, additional, Witt, Sarah L, additional, Schlichting, Douglas E, additional, de Bono, Stephanie, additional, and Emery, Paul, additional

Published
2018
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36. Lipid profile and effect of statin treatment in pooled phase II and phase III baricitinib studies

Author

Taylor, Peter C, primary, Kremer, Joel M, additional, Emery, Paul, additional, Zuckerman, Steven H, additional, Ruotolo, Giacomo, additional, Zhong, Jinglin, additional, Chen, Lei, additional, Witt, Sarah, additional, Saifan, Chadi, additional, Kurzawa, Monika, additional, Otvos, James D, additional, Connelly, Margery A, additional, Macias, William L, additional, Schlichting, Douglas E, additional, Rooney, Terence P, additional, de Bono, Stephanie, additional, and McInnes, Iain B, additional

Published
2018
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37. Response to baricitinib based on prior biologic use in patients with refractory rheumatoid arthritis

Author

Genovese, Mark C, primary, Kremer, Joel M, additional, Kartman, Cynthia E, additional, Schlichting, Douglas E, additional, Xie, Li, additional, Carmack, Tara, additional, Pantojas, Carlos, additional, Sanchez Burson, Juan, additional, Tony, Hans-Peter, additional, Macias, William L, additional, Rooney, Terence P, additional, and Smolen, Josef S, additional

Published
2018
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42. Baricitinib Versus Placebo or Adalimumab in Patients with Active Rheumatoid Arthritis (RA) and an Inadequate Response to Background Methotrexate (MTX) Therapy: Results of a 52-Week Phase 3 Study

Author

Taylor, Peter, Keystone, Ed, Van Der Heijde, Desiree, Tanaka, Yoshiya, Ishii, Taeko, Emoto, Kahaku, Yang, Lili, Arora, Vipin, Gaich, Carol, Rooney, Terence, Schlichting, Douglas, Macias, William, De Bono, Stephanie, Weinblatt, Michael E., and Rubbert-Roth, Andrea

Subjects
ddc: 610, Rheumatoid Arthritis, Clinical Trial Phase III, 610 Medical sciences, Medicine, Protein Kinase Inhibitors
Abstract

Background: In phase 3 studies, baricitinib improved disease activity in patients with active RA and an inadequate response (IR) to DMARDs. We report results from a 52-week study of baricitinib in MTX-IR RA patients. Methods: Patients with active RA (TJC≥6 & SJC≥6 & hsCRP≥6mg/L)[for full text, please go to the a.m. URL], 44. Kongress der Deutschen Gesellschaft für Rheumatologie (DGRh); 30. Jahrestagung der Deutschen Gesellschaft für Orthopädische Rheumatologie (DGORh); 26. Jahrestagung der Gesellschaft für Kinder- und Jugendrheumatologie (GKJR)

Published
2016
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43. Patient-reported outcomes of baricitinib in patients with rheumatoid arthritis and no or limited prior disease-modifying antirheumatic drug treatment

Author

Schiff, Michael, primary, Takeuchi, Tsutomu, additional, Fleischmann, Roy, additional, Gaich, Carol L., additional, DeLozier, Amy M., additional, Schlichting, Douglas, additional, Kuo, Wen-Ling, additional, Won, Ji-Eon, additional, Carmack, Tara, additional, Rooney, Terence, additional, Durez, Patrick, additional, Shaikh, Saeed, additional, Hidalgo, Rodolfo Pardo, additional, van Vollenhoven, Ronald, additional, and Zerbini, Cristiano A. F., additional

Published
2017
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46. Patient-reported outcomes from a phase III study of baricitinib in patients with conventional synthetic DMARD-refractory rheumatoid arthritis

Author

Emery, Paul, primary, Blanco, Ricardo, additional, Maldonado Cocco, Jose, additional, Chen, Ying-Chou, additional, Gaich, Carol L, additional, DeLozier, Amy M, additional, de Bono, Stephanie, additional, Liu, Jiajun, additional, Rooney, Terence, additional, Chang, Cecile Hsiao-Chun, additional, and Dougados, Maxime, additional

Published
2017
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47. Safety and efficacy of baricitinib through 128 weeks in an open-label, long-term extension study in patients with rheumatoid arthritis

Author

Keystone, Ed, Taylor, Peter, Genovese, Mark C., Schlichting, Douglas, De La Torre, Inmaculada, Beattie, Scott, Rooney, Terence, and Holzkämper, Thorsten

Subjects
stomatognathic diseases, ddc: 610, 610 Medical sciences, Medicine
Abstract

Introduction: Safety and efficacy findings of baricitinib (an oral JAK1/JAK2 inhibitor) treatment in RA patients (pts) to 128 wks are reported. Methods: Pts completing 24 wks of randomized and blinded treatment with 2, 4, or 8 mg baricitinib QD or 12 wks of randomized and blinded treatment with[for full text, please go to the a.m. URL], 43. Kongress der Deutschen Gesellschaft für Rheumatologie (DGRh); 29. Jahrestagung der Deutschen Gesellschaft für Orthopädische Rheumatologie (DGORh); 25. wissenschaftliche Jahrestagung der Gesellschaft für Kinder- und Jugendrheumatologie (GKJR)

Published
2015
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48. Patient-reported outcomes from a randomised phase III study of baricitinib in patients with rheumatoid arthritis and an inadequate response to biological agents (RA-BEACON)

Author

Smolen, Josef S, primary, Kremer, Joel M, additional, Gaich, Carol L, additional, DeLozier, Amy M, additional, Schlichting, Douglas E, additional, Xie, Li, additional, Stoykov, Ivaylo, additional, Rooney, Terence, additional, Bird, Paul, additional, Sánchez Bursón, Juan Miguel, additional, Genovese, Mark C, additional, and Combe, Bernard, additional

Published
2016
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49. Clinical outcomes in patients switched from adalimumab to baricitinib due to non-response and/or study design: phase III data in patients with rheumatoid arthritis.

Author

Yoshiya Tanaka, Fautrel, Bruno, Keystone, Edward C., Ortmann, Robert A., Li Xie, Baojin Zhu, Issa, Maher, Patel, Himanshu, Gaich, Carol L., de Bono, Stephanie, Rooney, Terence P., Taylor, Peter C., Tanaka, Yoshiya, Xie, Li, and Zhu, Baojin

Abstract

Objective: To evaluate clinical outcomes in patients who changed treatment from adalimumab to baricitinib, an oral Janus kinase (JAK)1/JAK2 inhibitor, during a phase III programme.Methods: In phase III RA-BEAM, patients were randomised 3:3:2 to placebo, baricitinib 4 mg once daily, or adalimumab 40 mg biweekly. At week 16 or subsequent visits, non-responders were rescued to open-label baricitinib 4 mg. At week 52, patients could enter a long-term extension (LTE) and continue on baricitinib or switch from adalimumab to baricitinib 4 mg with no adalimumab washout period. Percentage of patients achieving low disease activity and remission were assessed, along with physical function, patient's assessment of pain, and safety.Results: Thirty-five (7%) baricitinib-treated and 40 (12%) adalimumab-treated patients were rescued to baricitinib in RA-BEAM; 78% (381/487) of baricitinib-treated and 72% (238/330) of adalimumab-treated patients who were not rescued in RA-BEAM, entered the LTE and continued/were switched to baricitinib. In both baricitinib-rescued and adalimumab-rescued patients, there were significant improvements in all measures up to 12 weeks after rescue compared with the time of rescue. Patients who switched from adalimumab to baricitinib showed improvements in disease control through 12 weeks in the LTE. Exposure-adjusted incidence rates for treatment-emergent adverse events (TEAEs) and infections, including serious events, were similar for patients who switched from adalimumab to baricitinib and those who continued on baricitinib.Conclusions: Switching from adalimumab to baricitinib (without adalimumab washout) was associated with improvements in disease control, physical function and pain during the initial 12 weeks postswitch, without an increase in TEAEs, serious adverse events or infections.Trial Registration Numbers: NCT01710358, NCT01885078. [ABSTRACT FROM AUTHOR]

Published
2019
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50. Dose reduction of baricitinib in patients with rheumatoid arthritis achieving sustained disease control: results of a prospective study.

Author

Tsutomu Takeuchi, Genovese, Mark C., Haraoui, Boulos, Zhanguo Li, Li Xie, Klar, Rena, Pinto-Correia, Ana, Otawa, Susan, Lopez-Romero, Pedro, de la Torre, Inmaculada, Macias, William, Rooney, Terence P., Smolen, Josef S., Takeuchi, Tsutomu, Li, Zhanguo, and Xie, Li

Subjects
ANTIRHEUMATIC agents, DRUG therapy, COMBINATION drug therapy, COMPARATIVE studies, HETEROCYCLIC compounds, LONGITUDINAL method, RESEARCH methodology, MEDICAL cooperation, RESEARCH, RHEUMATOID arthritis, SULFONAMIDES, EVALUATION research, TREATMENT effectiveness, BLIND experiment, SEVERITY of illness index
Abstract

Objectives: This study investigated the effects of dose step-down in patients with rheumatoid arthritis (RA) who achieved sustained disease control with baricitinib 4 mg once a day.Methods: Patients who completed a baricitinib phase 3 study could enter a long-term extension (LTE). In the LTE, patients who received baricitinib 4 mg for ≥15 months and maintained CDAI low disease activity (LDA) or remission (REM) were blindly randomised to continue 4 mg or taper to 2 mg. Patients could rescue (to 4 mg) if needed. Efficacy and safety were assessed through 48 weeks.Results: Patients in both groups maintained LDA (80% 4 mg; 67% 2 mg) or REM (40% 4 mg; 33% 2 mg) over 48 weeks. However, dose reduction resulted in small, statistically significant increases in disease activity at 12, 24 and 48 weeks. Dose reduction also produced earlier and more frequent relapse (loss of step-down criteria) over 48 weeks compared with 4 mg maintenance (23% 4 mg vs 37% 2 mg, p=0.001). Rescue rates were 10% for baricitinib 4 mg and 18% for baricitinib 2 mg. Dose reduction was associated with a numerically lower rate of non-serious infections (30.6 for baricitinib 4 mg vs 24.9 for 2 mg). Rates of serious adverse events and adverse events leading to discontinuation were similar across groups.Conclusions: In a large randomised, blinded phase 3 study, maintenance of RA control following induction of sustained LDA/REM with baricitinib 4 mg was greater with continued 4 mg than after taper to 2 mg. Nonetheless, most patients tapered to 2 mg could maintain LDA/REM or recapture with return to 4 mg if needed. [ABSTRACT FROM AUTHOR]

Published
2019
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