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163 results on '"Jahreis, Angelika"'

1. Osteopontin Links Myeloid Activation and Disease Progression in Systemic Sclerosis.

Author

Gao, Xia, Jia, Guiquan, Guttman, Anna, DePianto, Daryle J, Morshead, Katrina B, Sun, Kai-Hui, Ramamoorthi, Nandhini, Vander Heiden, Jason A, Modrusan, Zora, Wolters, Paul J, Jahreis, Angelika, Arron, Joseph R, Khanna, Dinesh, and Ramalingam, Thirumalai R

Subjects
IL-6, ILD, SPP1, SSc, biomarker, fibrosis, immune complex, macrophages, osteopontin, systemic sclerosis
Abstract

Progressive lung fibrosis is a major cause of mortality in systemic sclerosis (SSc) patients, but the underlying mechanisms remain unclear. We demonstrate that immune complexes (ICs) activate human monocytes to promote lung fibroblast migration partly via osteopontin (OPN) secretion, which is amplified by autocrine monocyte colony stimulating factor (MCSF) and interleukin-6 (IL-6) activity. Bulk and single-cell RNA sequencing demonstrate that elevated OPN expression in SSc lung tissue is enriched in macrophages, partially overlapping with CCL18 expression. Serum OPN is elevated in SSc patients with interstitial lung disease (ILD) and prognosticates future lung function deterioration in SSc cohorts. Serum OPN levels decrease following tocilizumab (monoclonal anti-IL-6 receptor) treatment, confirming the connection between IL-6 and OPN in SSc patients. Collectively, these data suggest a plausible link between autoantibodies and lung fibrosis progression, where circulating OPN serves as a systemic proxy for IC-driven profibrotic macrophage activity, highlighting its potential as a promising biomarker in SSc ILD.

Published
2020

2. Tocilizumab in systemic sclerosis: a randomised, double-blind, placebo-controlled, phase 3 trial

Author

Lucero, Eleonora, Pons-Estel, Bernardo, Rivero, Mariano, Tate, Guillermo, Smith, Vanessa, De Langhe, Ellen, Rashkov, Rasho, Batalov, Anastas, Goranov, Ivan, Stoilov, Rumen, Dunne, James, Johnson, Sindhu R., Pope, Janet E., Martinović Kaliterna, Dušanka, Mogensen, Mette, Olesen, Anne Braae, Allanore, Yannick, Henes, Joerg Christoph, Müller-Ladner, Ulf, Riemekasten, Gabriela, Skapenko, Alla, Vlachoyiannopoulos, Panayiotis, Kiss, Emese, Minier, Tünde, Beretta, Lorenzo, Gremese, Elisa, Matucci-Cerinic, Marco, Valentini, Gabriele, Asano, Yoshihide, Atsumi, Tatsuya, Ihn, Hironobu, Ishii, Tomonori, Ishikawa, Osamu, Kuwana, Masataka, Shima, Yoshihito, Takahashi, Hiroki, Takehara, Kazuhiko, Tanaka, Yoshiya, Yamasaki, Yoshioki, Bukauskiene, Loreta, Butrimiene, Irena, Medrano Ramirez, Gabriel, Ramos-Remus, Cesar, Sofia Rodriguez Reyna, Tatiana, de Vries-Bouwstra, Jeska, van Laar, Jacob M., Batko, Bogdan, Jeka, Slawomir, Kucharz, Eugeniusz, Majdan, Maria, Olesinska, Marzena, Smolenska, Zaneta, Alves, Jose, Santos, Maria, Mihai, Carmen Marina, Rednic, Simona, Castellvi Barranco, Ivan, Lopez Longo, Francisco Javier, Simeon Aznar, Carmen, Carreira, Patricia, Distler, Oliver, Walker, Ulrich A., Derrett-Smith, Emma, Griffiths, Bridget, McKay, Neil, Denton, Christopher P., Aelion, Jacob, Borofsky, Michael, Fleischmann, Roy, Forstot, Joseph Z., Furst, Daniel E., Kafaja, Suzanne, Khan, M. Faisal, Khanna, Dinesh, Kohen, Michael D., Martin, Richard W., Mendoza-Ballesteros, Fabian, Nami, Alireza, Pang, Shirley, Rios, Grissel, Simms, Robert, Sullivan, Keith Michael, Steen, Virginia D., Lin, Celia J F, Furst, Daniel E, Goldin, Jonathan, Kim, Grace, van Laar, Jacob M, Spotswood, Helen, Wagner, Bridget, Siegel, Jeffrey, Jahreis, Angelika, and Denton, Christopher P

Published
2020
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3. The complement C5 inhibitor crovalimab in paroxysmal nocturnal hemoglobinuria

Author

Röth, Alexander, Nishimura, Jun-ichi, Nagy, Zsolt, Gaàl-Weisinger, Julia, Panse, Jens, Yoon, Sung-Soo, Egyed, Miklos, Ichikawa, Satoshi, Ito, Yoshikazu, Kim, Jin Seok, Ninomiya, Haruhiko, Schrezenmeier, Hubert, Sica, Simona, Usuki, Kensuke, Sicre de Fontbrune, Flore, Soret, Juliette, Sostelly, Alexandre, Higginson, James, Dieckmann, Andreas, Gentile, Brittany, Anzures-Cabrera, Judith, Shinomiya, Kenji, Jordan, Gregor, Biedzka-Sarek, Marta, Klughammer, Barbara, Jahreis, Angelika, Bucher, Christoph, and Peffault de Latour, Régis

Published
2020
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5. Safety and efficacy of subcutaneous tocilizumab in adults with systemic sclerosis (faSScinate): a phase 2, randomised, controlled trial

Author

Khanna, Dinesh, Denton, Christopher P, Jahreis, Angelika, van Laar, Jacob M, Frech, Tracy M, Anderson, Marina E, Baron, Murray, Chung, Lorinda, Fierlbeck, Gerhard, Lakshminarayanan, Santhanam, Allanore, Yannick, Pope, Janet E, Riemekasten, Gabriela, Steen, Virginia, Müller-Ladner, Ulf, Lafyatis, Robert, Stifano, Giuseppina, Spotswood, Helen, Chen-Harris, Haiyin, Dziadek, Sebastian, Morimoto, Alyssa, Sornasse, Thierry, Siegel, Jeffrey, and Furst, Daniel E

Published
2016
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6. Safety and efficacy of subcutaneous tocilizumab in systemic sclerosis: results from the open-label period of a phase II randomised controlled trial (faSScinate)

Author

Khanna, Dinesh, Denton, Christopher P, Lin, Celia J F, van Laar, Jacob M, Frech, Tracy M, Anderson, Marina E, Baron, Murray, Chung, Lorinda, Fierlbeck, Gerhard, Lakshminarayanan, Santhanam, Allanore, Yannick, Pope, Janet E, Riemekasten, Gabriela, Steen, Virginia, Müller-Ladner, Ulf, Spotswood, Helen, Burke, Laura, Siegel, Jeffrey, Jahreis, Angelika, and Furst, Daniel E

Published
2018
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9. Integrated safety analysis of filgotinib in patients with moderately to severely active rheumatoid arthritis receiving treatment over a median of 1.6 years

Author

Winthrop, Kevin L, primary, Tanaka, Yoshiya, additional, Takeuchi, Tsutomu, additional, Kivitz, Alan, additional, Matzkies, Franziska, additional, Genovese, Mark C, additional, Jiang, Deyuan, additional, Chen, Kun, additional, Bartok, Beatrix, additional, Jahreis, Angelika, additional, Besuyen, Robin, additional, Burmester, Gerd R, additional, and Gottenberg, Jacques-Eric, additional

Published
2021
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10. Filgotinib in combination with methotrexate or as monotherapy versus methotrexate monotherapy in patients with active rheumatoid arthritis and limited or no prior exposure to methotrexate

Author

Westhovens, René, Rigby, William F C, van der Heijde, Désirée, Ching, Daniel W T, Stohl, William, Kay, Jonathan, Chopra, Arvind, Bartok, Beatrix, Matzkies, Franziska, Yin, Zhaoyu, Guo, Ying, Tasset, Chantal, Sundy, John S, Jahreis, Angelika, Mozaffarian, Neelufar, Messina, Osvaldo Daniel, Landewé, Robert BM, Atsumi, Tatsuya, Burmester, Gerd R, Clinical Immunology and Rheumatology, and AII - Inflammatory diseases

Subjects
musculoskeletal diseases, rheumatoid, antirheumatic agents, Pyridines, Rheumatoid Arthritis, Triazoles, Arthritis, Rheumatoid, Methotrexate, Treatment Outcome, Double-Blind Method, arthritis, immune system diseases, therapeutics, Animals, Humans, Drug Therapy, Combination, heterocyclic compounds, Finches, skin and connective tissue diseases
Abstract

OBJECTIVES: To investigate efficacy and safety of the Janus kinase-1 inhibitor filgotinib in patients with active rheumatoid arthritis (RA) with limited or no prior methotrexate (MTX) exposure. METHODS: This 52-week, phase 3, multicentre, double-blind clinical trial (NCT02886728) evaluated once-daily oral filgotinib in 1252 patients with RA randomised 2:1:1:2 to filgotinib 200 mg with MTX (FIL200 +MTX), filgotinib 100 mg with MTX (FIL100 +MTX), filgotinib 200 mg monotherapy (FIL200), or MTX. The primary endpoint was proportion achieving 20% improvement in American College of Rheumatology criteria (ACR20) at week 24. RESULTS: The primary endpoint was achieved by 81% of patients receiving FIL200+ MTX versus 71% receiving MTX (p

Published
2021
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11. Long-term safety and efficacy of etanercept in patients with psoriasis: an open-label study

Author

Leonardi, Craig, Strober, Bruce, Gottlieb, Alice B., Elewski, Boni E., Ortonne, Jean-Paul, Kerkhof, Peter van de, Chiou, Chiun-Fang, Dunn, Meleana, and Jahreis, Angelika

Subjects
Etanercept -- Dosage and administration, Etanercept -- Complications and side effects, Psoriasis -- Drug therapy, Psoriasis -- Development and progression, Psoriasis -- Patient outcomes, Health, Pharmaceuticals and cosmetics industries
Abstract

ABSTRACT Background: In two previous phase 3 studies, up to 60 weeks of etanercept therapy significantly improved the symptoms of psoriasis and was well tolerated. Objective: To evaluate the long-term [...]

Published
2010

12. Etanercept treatment for children and adolescents with plaque psoriasis

Author

Paller, Amy S., Siegfried, Elaine C., Langley, Richard G., Gottlieb, Alice B., Pariser, David, Landells, Ian, Hebert, Adelaide A., Eichenfield, Lawrence F., Patel, Vaishali, Creamer, Kara, and Jahreis, Angelika

Subjects
Etanercept -- Dosage and administration, Etanercept -- Complications and side effects, Psoriasis -- Drug therapy, Psoriasis -- Patient outcomes, Tumor necrosis factor -- Dosage and administration, Tumor necrosis factor -- Complications and side effects
Abstract

A study analyzes the efficacy and safety of etanercept in children and adolescents with moderate-to-severe plaque psoriasis. Findings reveal the capability of etanercept in significantly reducing disease severity in children and adolescents with moderate-to-severe plaque psoriasis.

Published
2008

13. Etanercept and clinical outcomes, fatigue, and depression in psoriasis: double-blind placebo-controlled randomised phase III trial

Author

Tyring, Stephen, Gottlieb, Alice, Papp, Kim, Gordon, Ken, Leonardi, Craig, Wang, Andrea, Lalla, Deepa, Woolley, Michael, Jahreis, Angelika, Zitnik, Ralph, Cella, David, and Krishnan, Ranga

Subjects
Psoriasis -- Drug therapy, Cytokines -- Physiological aspects, Etanercept -- Dosage and administration, Etanercept -- Patient outcomes, Etanercept -- Product development, Clinical trials -- Management, Company business management
Published
2006

14. P133 Filgotinib in patients with RA with inadequate response to methotrexate: FINCH 1 52-week efficacy and patient reported outcomes data

Author

Walker, David, primary, Kivitz, Alan, additional, Tanaka, Yoshiya, additional, Lee, Susan, additional, Ye, Lei, additional, Hu, Hao, additional, Matzkies, Franziska, additional, Bartok, Beatrix, additional, Guo, Ying, additional, Sundy, John S, additional, Jahreis, Angelika, additional, Besuyen, Robin, additional, Combe, Bernard, additional, van der Heijde, Désirée, additional, Simon-Campos, J-Abraham, additional, Baraf, Herbert S B, additional, Kumar, Uma, additional, Tasset, Chantal, additional, Mozaffarian, Neelufar, additional, Landewé, Robert B M, additional, Bae, Sang-Cheol, additional, Keystone, Edward, additional, and Nash, Peter, additional

Published
2021
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15. Filgotinib versus placebo or adalimumab in patients with rheumatoid arthritis and inadequate response to methotrexate: a phase III randomised clinical trial

Author

Combe, Bernard, primary, Kivitz, Alan, additional, Tanaka, Yoshiya, additional, van der Heijde, Désirée, additional, Simon, J Abraham, additional, Baraf, Herbert S B, additional, Kumar, Uma, additional, Matzkies, Franziska, additional, Bartok, Beatrix, additional, Ye, Lei, additional, Guo, Ying, additional, Tasset, Chantal, additional, Sundy, John S, additional, Jahreis, Angelika, additional, Genovese, Mark C, additional, Mozaffarian, Neelufar, additional, Landewé, Robert B M, additional, Bae, Sang-Cheol, additional, Keystone, Edward C, additional, and Nash, Peter, additional

Published
2021
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16. Tocilizumab in systemic sclerosis: a randomised, double-blind, placebo-controlled, phase 3 trial

Author

Khanna, Dinesh, primary, Lin, Celia J F, additional, Furst, Daniel E, additional, Goldin, Jonathan, additional, Kim, Grace, additional, Kuwana, Masataka, additional, Allanore, Yannick, additional, Matucci-Cerinic, Marco, additional, Distler, Oliver, additional, Shima, Yoshihito, additional, van Laar, Jacob M, additional, Spotswood, Helen, additional, Wagner, Bridget, additional, Siegel, Jeffrey, additional, Jahreis, Angelika, additional, Denton, Christopher P, additional, Lucero, Eleonora, additional, Pons-Estel, Bernardo, additional, Rivero, Mariano, additional, Tate, Guillermo, additional, Smith, Vanessa, additional, De Langhe, Ellen, additional, Rashkov, Rasho, additional, Batalov, Anastas, additional, Goranov, Ivan, additional, Stoilov, Rumen, additional, Dunne, James, additional, Johnson, Sindhu R., additional, Pope, Janet E., additional, Martinović Kaliterna, Dušanka, additional, Mogensen, Mette, additional, Olesen, Anne Braae, additional, Henes, Joerg Christoph, additional, Müller-Ladner, Ulf, additional, Riemekasten, Gabriela, additional, Skapenko, Alla, additional, Vlachoyiannopoulos, Panayiotis, additional, Kiss, Emese, additional, Minier, Tünde, additional, Beretta, Lorenzo, additional, Gremese, Elisa, additional, Valentini, Gabriele, additional, Asano, Yoshihide, additional, Atsumi, Tatsuya, additional, Ihn, Hironobu, additional, Ishii, Tomonori, additional, Ishikawa, Osamu, additional, Takahashi, Hiroki, additional, Takehara, Kazuhiko, additional, Tanaka, Yoshiya, additional, Yamasaki, Yoshioki, additional, Bukauskiene, Loreta, additional, Butrimiene, Irena, additional, Medrano Ramirez, Gabriel, additional, Ramos-Remus, Cesar, additional, Sofia Rodriguez Reyna, Tatiana, additional, de Vries-Bouwstra, Jeska, additional, van Laar, Jacob M., additional, Batko, Bogdan, additional, Jeka, Slawomir, additional, Kucharz, Eugeniusz, additional, Majdan, Maria, additional, Olesinska, Marzena, additional, Smolenska, Zaneta, additional, Alves, Jose, additional, Santos, Maria, additional, Mihai, Carmen Marina, additional, Rednic, Simona, additional, Castellvi Barranco, Ivan, additional, Lopez Longo, Francisco Javier, additional, Simeon Aznar, Carmen, additional, Carreira, Patricia, additional, Walker, Ulrich A., additional, Derrett-Smith, Emma, additional, Griffiths, Bridget, additional, McKay, Neil, additional, Denton, Christopher P., additional, Aelion, Jacob, additional, Borofsky, Michael, additional, Fleischmann, Roy, additional, Forstot, Joseph Z., additional, Furst, Daniel E., additional, Kafaja, Suzanne, additional, Khan, M. Faisal, additional, Khanna, Dinesh, additional, Kohen, Michael D., additional, Martin, Richard W., additional, Mendoza-Ballesteros, Fabian, additional, Nami, Alireza, additional, Pang, Shirley, additional, Rios, Grissel, additional, Simms, Robert, additional, Sullivan, Keith Michael, additional, and Steen, Virginia D., additional

Published
2020
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17. Integrated safety analysis of filgotinib in patients with moderately to severely active rheumatoid arthritis receiving treatment over a median of 1.6 years.

Author

Winthrop, Kevin L., Tanaka, Yoshiya, Takeuchi, Tsutomu, Kivitz, Alan, Matzkies, Franziska, Genovese, Mark C., Jiang, Deyuan, Kun Chen, Bartok, Beatrix, Jahreis, Angelika, Besuyen, Robin, Burmester, Gerd R., Gottenberg, Jacques-Eric, and Chen, Kun

Subjects
PYRIDINE, RESEARCH, HETEROCYCLIC compounds, RESEARCH methodology, EVALUATION research, ANTIRHEUMATIC agents, COMPARATIVE studies, RHEUMATOID arthritis
Abstract

Objective: To characterise safety of the Janus kinase-1 preferential inhibitor filgotinib in patients with moderately to severely active rheumatoid arthritis.Methods: Data were integrated from seven trials (NCT01668641, NCT01894516, NCT02889796, NCT02873936, NCT02886728, NCT02065700, NCT03025308). Results are from placebo (PBO)-controlled (through week (W)12) and long-term, as-treated (all available data for patients receiving ≥1 dose filgotinib 200 (FIL200) or 100 mg (FIL100) daily) datasets. We calculated exposure-adjusted incidence rates (EAIRs)/100 patient-years filgotinib exposure (100PYE) for treatment-emergent adverse events (TEAEs).Results: 3691 patients received filgotinib for 6080.7 PYE (median 1.6, maximum 5.6 years). During the PBO-controlled period, TEAEs, including those of grade ≥3, occurred at comparable rates with filgotinib or PBO; long-term EAIRs of TEAEs grade ≥3 were 6.4 and 7.6/100PYE for FIL200 and FIL100. EAIRs for deaths were 0.6/100PYE for FIL200, FIL100 and PBO; long-term EAIRs were 0.5 and 0.3/100PYE for FIL200 and FIL100. EAIRs for serious infection were 3.9, 3.3 and 2.4/100PYE for FIL200, FIL100 and PBO; long-term EAIRs were 1.6 and 3.1/100PYE for FIL200 and FIL100. EAIRs for herpes zoster were 0.6, 1.1, and 1.1/100PYE for FIL200, FIL100 and PBO; long-term EAIRs were 1.8 and 1.1/100PYE for FIL200 and FIL100. EAIRs for major adverse cardiovascular events were 0, 1.7 and 1.1/100PYE for FIL200, FIL100 and PBO; long-term EAIRs were 0.4 and 0.6/100PYE for FIL200 and FIL100. No venous thromboembolism occurred during the PBO-controlled period; long-term EAIRs were 0.2 and 0/100PYE for FIL200 and FIL100.Conclusions: Over a median of 1.6 and maximum of 5.6 years of exposure, safety/tolerability of FIL200 and FIL100 were similar, with a lower incidence of infections with FIL200 among the long-term, as-treated dataset. [ABSTRACT FROM AUTHOR]

Published
2022
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21. Tocilizumab in systemic sclerosis:a randomised, double-blind, placebo-controlled, phase 3 trial

Author

Khanna, Dinesh, Lin, Celia J.F., Furst, Daniel E., Goldin, Jonathan, Kim, Grace, Kuwana, Masataka, Allanore, Yannick, Matucci-Cerinic, Marco, Distler, Oliver, Shima, Yoshihito, van Laar, Jacob M., Spotswood, Helen, Wagner, Bridget, Siegel, Jeffrey, Jahreis, Angelika, Denton, Christopher P., Lucero, Eleonora, Pons-Estel, Bernardo, Rivero, Mariano, Tate, Guillermo, Smith, Vanessa, De Langhe, Ellen, Rashkov, Rasho, Batalov, Anastas, Goranov, Ivan, Stoilov, Rumen, Dunne, James, Johnson, Sindhu R., Pope, Janet E., Martinović Kaliterna, Dušanka, Mogensen, Mette, Olesen, Anne Braae, Henes, Joerg Christoph, Müller-Ladner, Ulf, Riemekasten, Gabriela, Skapenko, Alla, Vlachoyiannopoulos, Panayiotis, Kiss, Emese, Minier, Tünde, Beretta, Lorenzo, Gremese, Elisa, Valentini, Gabriele, Asano, Yoshihide, Atsumi, Tatsuya, Ihn, Hironobu, Ishii, Tomonori, Ishikawa, Osamu, Takahashi, Hiroki, Takehara, Kazuhiko, Tanaka, Yoshiya, Yamasaki, Yoshioki, Bukauskiene, Loreta, Butrimiene, Irena, Medrano Ramirez, Gabriel, Ramos-Remus, Cesar, Sofia Rodriguez Reyna, Tatiana, de Vries-Bouwstra, Jeska, Batko, Bogdan, Jeka, Slawomir, Kucharz, Eugeniusz, Majdan, Maria, Olesinska, Marzena, Smolenska, Zaneta, Alves, Jose, Santos, Maria, Mihai, Carmen Marina, Rednic, Simona, Castellvi Barranco, Ivan, Lopez Longo, Francisco Javier, Simeon Aznar, Carmen, Carreira, Patricia, Walker, Ulrich A., Derrett-Smith, Emma, Griffiths, Bridget, McKay, Neil, Aelion, Jacob, Borofsky, Michael, Fleischmann, Roy, Forstot, Joseph Z., Kafaja, Suzanne, Khan, M. Faisal, Kohen, Michael D., Martin, Richard W., Mendoza-Ballesteros, Fabian, Nami, Alireza, Pang, Shirley, Rios, Grissel, Simms, Robert, Sullivan, Keith Michael, Steen, Virginia D., Khanna, Dinesh, Lin, Celia J.F., Furst, Daniel E., Goldin, Jonathan, Kim, Grace, Kuwana, Masataka, Allanore, Yannick, Matucci-Cerinic, Marco, Distler, Oliver, Shima, Yoshihito, van Laar, Jacob M., Spotswood, Helen, Wagner, Bridget, Siegel, Jeffrey, Jahreis, Angelika, Denton, Christopher P., Lucero, Eleonora, Pons-Estel, Bernardo, Rivero, Mariano, Tate, Guillermo, Smith, Vanessa, De Langhe, Ellen, Rashkov, Rasho, Batalov, Anastas, Goranov, Ivan, Stoilov, Rumen, Dunne, James, Johnson, Sindhu R., Pope, Janet E., Martinović Kaliterna, Dušanka, Mogensen, Mette, Olesen, Anne Braae, Henes, Joerg Christoph, Müller-Ladner, Ulf, Riemekasten, Gabriela, Skapenko, Alla, Vlachoyiannopoulos, Panayiotis, Kiss, Emese, Minier, Tünde, Beretta, Lorenzo, Gremese, Elisa, Valentini, Gabriele, Asano, Yoshihide, Atsumi, Tatsuya, Ihn, Hironobu, Ishii, Tomonori, Ishikawa, Osamu, Takahashi, Hiroki, Takehara, Kazuhiko, Tanaka, Yoshiya, Yamasaki, Yoshioki, Bukauskiene, Loreta, Butrimiene, Irena, Medrano Ramirez, Gabriel, Ramos-Remus, Cesar, Sofia Rodriguez Reyna, Tatiana, de Vries-Bouwstra, Jeska, Batko, Bogdan, Jeka, Slawomir, Kucharz, Eugeniusz, Majdan, Maria, Olesinska, Marzena, Smolenska, Zaneta, Alves, Jose, Santos, Maria, Mihai, Carmen Marina, Rednic, Simona, Castellvi Barranco, Ivan, Lopez Longo, Francisco Javier, Simeon Aznar, Carmen, Carreira, Patricia, Walker, Ulrich A., Derrett-Smith, Emma, Griffiths, Bridget, McKay, Neil, Aelion, Jacob, Borofsky, Michael, Fleischmann, Roy, Forstot, Joseph Z., Kafaja, Suzanne, Khan, M. Faisal, Kohen, Michael D., Martin, Richard W., Mendoza-Ballesteros, Fabian, Nami, Alireza, Pang, Shirley, Rios, Grissel, Simms, Robert, Sullivan, Keith Michael, and Steen, Virginia D.

Abstract

Background: A phase 2 trial of tocilizumab showed preliminary evidence of efficacy in systemic sclerosis. We assessed skin fibrosis and systemic sclerosis-associated interstitial lung disease (SSc-ILD) in a phase 3 trial to investigate the safety and efficacy of tocilizumab, an anti-interleukin-6 receptor antibody, in the treatment of systemic sclerosis. Methods: In this multicentre, randomised, double-blind, placebo-controlled, phase 3 trial, participants were recruited from 75 sites in 20 countries across Europe, North America, Latin America, and Japan. Adults with diffuse cutaneous systemic sclerosis for 60 months or less and a modified Rodnan skin score (mRSS) of 10–35 at screening were randomly assigned (1:1) with a voice-web-response system to receive subcutaneous tocilizumab 162 mg or placebo weekly for 48 weeks, stratified by IL-6 levels; participants and investigators were masked to treatment group. The primary endpoint was the difference in change from baseline to week 48 in mRSS. Percentage of predicted forced vital capacity (FVC% predicted) at week 48, time to treatment failure, and patient-reported and physician-reported outcomes were secondary endpoints. This trial is registered with ClinicalTrials.gov (number NCT02453256) and is closed to accrual. Findings: Between Nov 20, 2015, and Feb 14, 2017, 210 individuals were randomly assigned to receive tocilizumab (n=104) or placebo (n=106). In the intention-to-treat population, least squares mean [LSM] change from baseline to week 48 in mRSS was −6·14 for tocilizumab and −4·41 for placebo (adjusted difference −1·73 [95% CI −3·78 to 0·32]; p=0·10). The shift in distribution of change from baseline in FVC% predicted at week 48 favoured tocilizumab (van Elteren nominal p=0·002 vs placebo), with a difference in LSM of 4·2 (95% CI 2·0–6·4; nominal p=0·0002), as did time to treatment failure (hazard ratio 0·63 [95% CI 0·37–1·06]; nominal p=0·08). Change in LSM from baseline to week 48 in Health Assessment Ques

Published
2020

22. Tocilizumab in systemic sclerosis: a randomised, double-blind, placebo-controlled, phase 3 trial

Author

MS Reumatologie/Immunologie/Infectie, Infection & Immunity, Regenerative Medicine and Stem Cells, Khanna, Dinesh, Lin, Celia J F, Furst, Daniel E, Goldin, Jonathan, Kim, Grace, Kuwana, Masataka, Allanore, Yannick, Matucci-Cerinic, Marco, Distler, Oliver, Shima, Yoshihito, van Laar, Jacob M, Spotswood, Helen, Wagner, Bridget, Siegel, Jeffrey, Jahreis, Angelika, Denton, Christopher P, focuSSced investigators, MS Reumatologie/Immunologie/Infectie, Infection & Immunity, Regenerative Medicine and Stem Cells, Khanna, Dinesh, Lin, Celia J F, Furst, Daniel E, Goldin, Jonathan, Kim, Grace, Kuwana, Masataka, Allanore, Yannick, Matucci-Cerinic, Marco, Distler, Oliver, Shima, Yoshihito, van Laar, Jacob M, Spotswood, Helen, Wagner, Bridget, Siegel, Jeffrey, Jahreis, Angelika, Denton, Christopher P, and focuSSced investigators

Published
2020

30. PRESERVATION OF LUNG FUNCTION OBSERVED IN A PHASE 3 RANDOMIZED CONTROLLED TRIAL OF TOCILIZUMAB FOR THE TREATMENT OF EARLY SSC

Author

Khanna, Dinesh, Lin, Celia J. F., Goldin, Jonathan, Kim, Grace, Kuwana, Masataka, Allanore, Yannick, Batalov, Anastas, Butrimiene, Irena, Carreira, Patricia, Matucci-Cerinic, Marco, Distler, Oliver, Martinović Kaliterna, Dušanka, Mihai, Carina, Mogensen, Mette, Olesińska, Marzena, Pope, Janet, Riemekasten, Gabriela, Rodriguez-Reyne, Tatiana Sofía, Santos, Maria Jose, van Laar, Jacob M., Spotswood, Helen, Siege, Jeffrey, Jahreis, Angelika, Furst, Daniel, and Denton, Christopher

Subjects
LUNG FUNCTION, TOCILIZUMAB, SSc, respiratory system, respiratory tract diseases
Abstract

The primary mRSS endpoint was not met ; however, TCZ Tx resulted in clinically relevant differences in FVC with preservation of LFS and improvement in fibrosis, measured by HRCT, in SSc pts.

Published
2019

32. Lung function preservation in a phase 3 trial of tocilizumab (TCZ) in systemic sclerosis (SSc)

Author

Denton, Christopher P., primary, Lin, Celia J. F., additional, Goldin, Jonathan, additional, Kim, Grace, additional, Kuwana, Masataka, additional, Allanore, Yannick, additional, Batalov, Anastas, additional, Butrimiene, Irena, additional, Carreira, Patricia, additional, Matucci-Cerinic, Marco, additional, Distler, Oliver, additional, Martinović Kaliterna, Dušanka, additional, Mihai, Carmen-Marina, additional, Mogensen, Mette, additional, Olesińska, Marzena, additional, Pope, Janet E., additional, Riemekasten, Gabriela, additional, Rodriguez-Reyne, Tatiana Sofía, additional, Santos, Maria José, additional, Van Laar, Jacob, additional, Spotswood, Helen, additional, Siegel, Jeffrey, additional, Jahreis, Angelika, additional, Furst, Daniel E., additional, and Khanna, Dinesh, additional

Published
2019
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33. Long‐Term Safety of Rituximab in Patients With Rheumatoid Arthritis: Results of a Five‐Year Observational Study

Author

Winthrop, Kevin L., primary, Saag, Kenneth, additional, Cascino, Matthew D., additional, Pei, Jinglan, additional, John, Ani, additional, Jahreis, Angelika, additional, Haselkorn, Tmirah, additional, Furst, Daniel E., additional, Abdulky, M., additional, Abeles, M., additional, Adelglass, H., additional, Ahmed, A., additional, Alloway, J., additional, Alper, J., additional, Anand, A., additional, Anderson, J., additional, Arora, M., additional, Askari, A., additional, Baca, S., additional, Bacha, D., additional, Bagheri, S., additional, Ballou, S., additional, Bennett, R., additional, Bidula, L., additional, Blumstein, H., additional, Bognar, M., additional, Bohan, A., additional, Boniske, C., additional, Borofsky, M., additional, Box, E., additional, Braun, A., additional, Brennan, T., additional, Brent, L., additional, Cabalar, I., additional, Carteron, N., additional, Chaudhary, K., additional, Chauhan, A., additional, Cima, M., additional, Cochinwala, A., additional, Cohen, H., additional, Colburn, K., additional, Conaway, D., additional, Danning, C., additional, Dao, K., additional, Dean, J., additional, Diab, I., additional, Diegel, R., additional, Ditzian‐Kadanoff, R., additional, Dowd, J., additional, Dugowson, C., additional, Eggebeen, A., additional, El‐Kadi, H., additional, Feinberg, H., additional, Feinman, M., additional, Feinstein, J., additional, Fischer, A., additional, Foad, B., additional, Fondal, M., additional, Fraser, S., additional, Fraser, A., additional, Freeman, P., additional, Garber, M., additional, Goldstein, A., additional, Golombek, S., additional, Greenstein, N., additional, Greenwald, M., additional, Hakim, C., additional, Halla, J., additional, Hallegua, D., additional, Han, K., additional, Harris, B., additional, Hauptman, H., additional, Hirsh, J., additional, Hoffman, M., additional, Huntwork, J., additional, Husni, M., additional, Hyer, F., additional, Hymowitz, R., additional, Jones, R., additional, Kanagasegar, S., additional, Kappes, J., additional, Keating, R., additional, Kelly, G., additional, Kim, J., additional, King, C., additional, Klashman, D., additional, Knee, C., additional, Kolba, K., additional, Krick, G., additional, Krug, H., additional, Kumar, U., additional, Lakhanpal, S., additional, Lang, T., additional, Lauter, S., additional, Lawrence Ford, T., additional, Lee, W., additional, Lee, Y., additional, Leisen, J., additional, Levine, J., additional, Lidman, R., additional, Lipstate, J., additional, Malinak, J., additional, Marcus, R., additional, Martin, D., additional, Mehta, C., additional, Melton, G., additional, Metyas, S., additional, Miller, K., additional, Moidel, R., additional, Moore, C., additional, Mossell, J., additional, Munoz, G., additional, Murphy, F., additional, Nami, A., additional, Nascimento, J., additional, Neal, N., additional, Neiman, R., additional, Neuwelt, C., additional, Nguyen, P., additional, Niemer, M., additional, Oelke, K., additional, Oza, M., additional, Pachaidee, S., additional, Patel, S., additional, Pegram, S., additional, Penmetcha, M., additional, Perkins, J., additional, Perl, A., additional, Peterson, L., additional, Pittsley, R., additional, Portnoff, K., additional, Rahmani, D., additional, Raja, N., additional, Ratnoff, W., additional, Rezaian, M., additional, Rhea, C., additional, Rice, D., additional, Ridley, D., additional, Rivadeneira, A., additional, Rizzo, W., additional, Roane, G., additional, Rocca, P., additional, Rosen, M., additional, Saikali, W., additional, Saitta, M., additional, Sankoorikal, A., additional, Saway, P., additional, Schneider, P., additional, Schwartzman, S., additional, Scoville, C., additional, Shergy, W., additional, Shiel, W, additional, Shurmur, R., additional, Sikes, D., additional, Singhal, A., additional, Snyder, A., additional, Songcharoen, S., additional, Sosenko, M., additional, Soto Raices, O., additional, Stahl, N., additional, Stark, K., additional, Strachan, M., additional, Stupi, A., additional, Sullivan, N., additional, Sylvester, R., additional, Tabechian, D., additional, Tagoe, C., additional, Taylor, P., additional, Thakker, S., additional, Thakor, M., additional, Thakur, N., additional, Tidmore, W., additional, Toth, M., additional, Trostle, D., additional, Udell, J., additional, Van de Stouwe, M., additional, Venuturupalli, R., additional, Weiss, D., additional, Weselman, K., additional, Winn, D., additional, Yung, C., additional, Zable, E., additional, and Zamiri, B., additional

Published
2019
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34. OP0245 PRESERVATION OF LUNG FUNCTION OBSERVED IN A PHASE 3 RANDOMIZED CONTROLLED TRIAL OF TOCILIZUMAB FOR THE TREATMENT OF EARLY SSC

Author

Khanna, Dinesh, primary, Lin, Celia J. F., additional, Goldin, Jonathan, additional, Kim, Grace, additional, Kuwana, Masataka, additional, Allanore, Yannick, additional, Batalov, Anastas, additional, Butrimiene, Irena, additional, Carreira, Patricia, additional, Matucci-Cerinic, Marco, additional, Distler, Oliver, additional, Kaliterna, Dušanka Martinović, additional, Mihai, Carina, additional, Mogensen, Mette, additional, Olesińska, Marzena, additional, Pope, Janet, additional, Riemekasten, Gabriela, additional, Rodriguez-Reyne, Tatiana Sofía, additional, Santos, Maria Jose, additional, van Laar, Jacob M., additional, Spotswood, Helen, additional, Siegel, Jeffrey, additional, Jahreis, Angelika, additional, Furst, Daniel, additional, and Denton, Christopher, additional

Published
2019
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36. The SMART Anti-hC5 Antibody (SKY59/RO7112689) Shows Good Safety and Efficacy in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH)

Author

Röth, Alexander, primary, Egyed, Miklos, additional, Ichikawa, Satochi, additional, Kim, Jin Seok, additional, Nagy, Zsolt, additional, Gaàl Weisinger, Julia, additional, Panse, Jens P., additional, Peffault De Latour, Regis, additional, Sicre De Fontbrune, Flore, additional, Sica, Simona, additional, Usuki, Kensuke, additional, Yoon, Sung-Soo, additional, Winter, Erica, additional, Hsu, Joy C., additional, Dieckmann, Andreas, additional, Anzures-Cabrera, Judith, additional, Jordan, Gregor, additional, Shinomiya, Kenji, additional, Klughammer, Barbara, additional, Bucher, Christoph, additional, Jahreis, Angelika, additional, and Nishimura, Jun-Ichi, additional

Published
2018
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38. Therapeutic interleukin-6 blockade reverses transforming growth factor-beta pathway activation in dermal fibroblasts: insights from the faSScinate clinical trial in systemic sclerosis

Author

Denton, Christopher P, primary, Ong, Voon H, additional, Xu, Shiwen, additional, Chen-Harris, Haiyin, additional, Modrusan, Zora, additional, Lafyatis, Robert, additional, Khanna, Dinesh, additional, Jahreis, Angelika, additional, Siegel, Jeffrey, additional, and Sornasse, Thierry, additional

Published
2018
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40. Patient acceptable symptom state in scleroderma: results from the tocilizumab compared with placebo trial in active diffuse cutaneous systemic sclerosis

Author

Arnold, Michael B, primary, Khanna, Dinesh, additional, Denton, Christopher P, additional, van Laar, Jacob M, additional, Frech, Tracy M, additional, Anderson, Marina E, additional, Baron, Murray, additional, Chung, Lorinda, additional, Fierlbeck, Gerhard, additional, Lakshminarayanan, Santhanam, additional, Allanore, Yannick, additional, Riemekasten, Gabriela, additional, Steen, Virginia, additional, Müller-Ladner, Ulf, additional, Spotswood, Helen, additional, Burke, Laura, additional, Siegel, Jeffrey, additional, Jahreis, Angelika, additional, Furst, Daniel E, additional, and Pope, Janet E, additional

Published
2017
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41. Safety and efficacy of subcutaneous tocilizumab in systemic sclerosis: results from the open-label period of a phase II randomised controlled trial (faSScinate)

Author

Khanna, Dinesh, primary, Denton, Christopher P, additional, Lin, Celia J F, additional, van Laar, Jacob M, additional, Frech, Tracy M, additional, Anderson, Marina E, additional, Baron, Murray, additional, Chung, Lorinda, additional, Fierlbeck, Gerhard, additional, Lakshminarayanan, Santhanam, additional, Allanore, Yannick, additional, Pope, Janet E, additional, Riemekasten, Gabriela, additional, Steen, Virginia, additional, Müller-Ladner, Ulf, additional, Spotswood, Helen, additional, Burke, Laura, additional, Siegel, Jeffrey, additional, Jahreis, Angelika, additional, and Furst, Daniel E, additional

Published
2017
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42. Long-Term Safety of Rituximab in Rheumatoid Arthritis: Analysis From the SUNSTONE Registry.

Author

Winthrop, Kevin L., Saag, Kenneth, Cascino, Matthew D., Pei, Jinglan, John, Ani, Jahreis, Angelika, Haselkorn, Tmirah, Furst, Daniel E., Abdulky, M., Abeles, M., Adelglass, H., Ahmed, A., Alloway, J., Alper, J., Anand, A., Anderson, J., Arora, M., Askari, A., Baca, S., and Bacha, D.

Abstract

Objective: To evaluate the long-term safety of rituximab in an observational cohort of patients with rheumatoid arthritis (RA) who had an inadequate response to ≥ 1 antitumor necrosis factor therapies in the United States (SUNSTONE Registry).Methods: In this prospective, observational cohort study, patients received rituximab according to their physician's standard practice and were evaluated at standard-of-care follow-up visits at least every 6 months. The primary outcome was the incidence of protocol-defined significant infections. Secondary outcomes included serious adverse events potentially associated with rituximab, cardiovascular or thrombotic (CVT) events, seizures, deaths and pregnancies. Posthoc analyses assessed outcomes by concomitant medication use.Results: Overall, 989 patients (safety-evaluable population) received ≥ 1 dose of rituximab, with a total follow-up of 3844 patient-years (PYs; mean duration, 3.9 years). In total, 341 significant infections occurred in 197 patients (19.9%). The incidence rates (95% CI) for significant infections, CVT events, and seizures were 8.87 (7.98, 9.86), 1.95 (1.56, 2.45), and 0.18 (0.09, 0.38) per 100 PYs, respectively. The incidence of significant infections did not increase with time or with cumulative rituximab exposure. During the study, 64 patients died (crude mortality [95% CI]: 1.66 per 100 PYs [1.30, 2.13]). The most common causes of death were infections (19 patients), malignancy (14), and cardiovascular events (13). Eight pregnancies were reported in 7 patients.Conclusion: In patients with RA treated with rituximab for up to 5 years, the rates of significant infections were stable over time and higher in patients who received long-term systemic steroid treatment. This article is protected by copyright. All rights reserved. [ABSTRACT FROM AUTHOR]

Published
2019
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44. Safety and efficacy of subcutaneous tocilizumab in adults with systemic sclerosis (faSScinate): a phase 2, randomised, controlled trial

Author

MS Reumatologie/Immunologie/Infectie, Infection & Immunity, Khanna, Dinesh, Denton, Christopher P., Jahreis, Angelika, van Laar, Jacob M., Frech, Tracy M., Anderson, Marina E., Baron, Murray, Chung, Lorinda, Fierlbeck, Gerhard, Lakshminarayanan, Santhanam, Allanore, Yannick, Pope, Janet E., Riemekasten, Gabriela, Steen, Virginia, Müller-Ladner, Ulf, Lafyatis, Robert, Stifano, Giuseppina, Spotswood, Helen, Chen-Harris, Haiyin, Dziadek, Sebastian, Morimoto, Alyssa, Sornasse, Thierry, Siegel, Jeffrey, Furst, Daniel E., MS Reumatologie/Immunologie/Infectie, Infection & Immunity, Khanna, Dinesh, Denton, Christopher P., Jahreis, Angelika, van Laar, Jacob M., Frech, Tracy M., Anderson, Marina E., Baron, Murray, Chung, Lorinda, Fierlbeck, Gerhard, Lakshminarayanan, Santhanam, Allanore, Yannick, Pope, Janet E., Riemekasten, Gabriela, Steen, Virginia, Müller-Ladner, Ulf, Lafyatis, Robert, Stifano, Giuseppina, Spotswood, Helen, Chen-Harris, Haiyin, Dziadek, Sebastian, Morimoto, Alyssa, Sornasse, Thierry, Siegel, Jeffrey, and Furst, Daniel E.

Published
2016

45. Primary cutaneous nocardiosis in a husband and wife

Author

Glander Hans-Jürgen, Jahreis Angelika, and Haustein Uwe-Frithjof

Subjects
Male, Pathology, medicine.medical_specialty, Nocardia Infections, Dermatology, Skin infection, medicine, Humans, Aged, integumentary system, biology, business.industry, Nocardiosis, Nocardia, Skin Diseases, Bacterial, Middle Aged, medicine.disease, biology.organism_classification, Primary cutaneous nocardiosis, Lymphatic system, Subcutaneous nodule, Acute Disease, Wound Infection, Female, Actinomycosis, business
Abstract

A 62-year-old woman suffered from acute purulent skin disease with multiple subcutaneous abscesses. At the same time, her 65-year-old husband presented with multiple subcutaneous nodules along the lymphatic vessels of his right arm. Both had a history of a minor scratch by a thorn of a bush at the site of infection. Nocardia was identified as causative bacterium from the woman's lesions. Therefore the rare phenomenon of 2 different forms of acute primary cutaneous nocardiosis after simultaneous infection, lymphocutaneous infection, and superficial skin infection was diagnosed.

Published
1999
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47. Using Registries to Identify Adverse Events in Rheumatic Diseases

Author

Lionetti, Geraldina, primary, Kimura, Yukiko, additional, Schanberg, Laura E., additional, Beukelman, Timothy, additional, Wallace, Carol A., additional, Ilowite, Norman T., additional, Winsor, Jane, additional, Fox, Kathleen, additional, Natter, Marc, additional, Sundy, John S., additional, Brodsky, Eric, additional, Curtis, Jeffrey R., additional, Del Gaizo, Vincent, additional, Iyasu, Solomon, additional, Jahreis, Angelika, additional, Meeker-O’Connell, Ann, additional, Mittleman, Barbara B., additional, Murphy, Bernard M., additional, Peterson, Eric D., additional, Raymond, Sandra C., additional, Setoguchi, Soko, additional, Siegel, Jeffrey N., additional, Sobel, Rachel E., additional, Solomon, Daniel, additional, Southwood, Taunton R., additional, Vesely, Richard, additional, White, Patience H., additional, Wulffraat, Nico M., additional, and Sandborg, Christy I., additional

Published
2013
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48. Effect of rituximab on physical function and quality of life in patients with rheumatoid arthritis previously untreated with methotrexate

Author

Rigby, William, primary, Ferraccioli, Gianfranco, additional, Greenwald, Maria, additional, Zazueta-Montiel, Beatriz, additional, Fleischmann, Roy, additional, Wassenberg, Siegfried, additional, Ogale, Sarika, additional, Armstrong, Gillian, additional, Jahreis, Angelika, additional, Burke, Laura, additional, Mela, Christopher, additional, and Chen, Annie, additional

Published
2011
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50. A phase 2 randomized, double-blind study of AMG 108, a fully human monoclonal antibody to IL-1R, in patients with rheumatoid arthritis

Author

Cardiel, Mario H, primary, Tak, Paul P, additional, Bensen, William, additional, Burch, Francis X, additional, Forejtova, Sarka, additional, Badurski, Janusz E, additional, Kakkar, Tarundeep, additional, Bevirt, Terry, additional, Ni, Liyun, additional, McCroskery, Ellen, additional, Jahreis, Angelika, additional, and Zack, Debra J, additional

Published
2010
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