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1,400 results on '"Burmester, Gerd R"'

10. Abatacept inhibits inflammation and onset of rheumatoid arthritis in individuals at high risk (ARIAA): a randomised, international, multicentre, double-blind, placebo-controlled trial

Author

Rech, Juergen, Tascilar, Koray, Hagen, Melanie, Kleyer, Arnd, Manger, Bernhard, Schoenau, Verena, Hueber, Axel J, Kleinert, Stefan, Baraliakos, Xenofon, Braun, Jürgen, Kiltz, Uta, Fleck, Martin, Rubbert-Roth, Andrea, Kofler, David M, Behrens, Frank, Feuchtenberger, Martin, Zaenker, Michael, Voll, Reinhard, Venhoff, Nils, Thiel, Jens, Glaser, Cornelia, Feist, Eugen, Burmester, Gerd R, Karberg, Kirsten, Strunk, Johannes, Cañete, Juan D, Senolt, Ladislav, Filkova, Maria, Naredo, Esperanza, Largo, Raquel, Krönke, Gerhard, D'Agostino, Maria-Antonietta, Østergaard, Mikkel, and Schett, Georg

Published
2024
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13. Long-term outcomes of COVID-19 vaccination in patients with rare and complex connective tissue diseases: The ERN-ReCONNET VACCINATE study

Author

Tani, Chiara, Cardelli, Chiara, Depascale, Roberto, Gamba, Anna, Iaccarino, Luca, Doria, Andrea, Bandeira, Matilde, Dinis, Sara Paiva, Romão, Vasco C., Gotelli, Emanuele, Paolino, Sabrina, Cutolo, Maurizio, Di Giosaffatte, Niccolò, Ferraris, Alessandro, Grammatico, Paola, Cavagna, Lorenzo, Codullo, Veronica, Montecucco, Carlomaurizio, Longo, Valentina, Beretta, Lorenzo, Cavazzana, Ilaria, Fredi, Micaela, Peretti, Silvia, Guiducci, Serena, Matucci-Cerinic, Marco, Bombardieri, Stefano, Burmester, Gerd R., Fonseca, João E., Frank, Charissa, Galetti, Ilaria, Hachulla, Eric, Müller-Ladner, Ulf, Schneider, Matthias, Smith, Vanessa, Tamirou, Farah, Van Laar, Jacob M., Vieira, Ana, D'Urzo, Rossella, Cannizzo, Sara, Gaglioti, Andrea, Marinello, Diana, Talarico, Rosaria, and Mosca, Marta

Published
2023
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14. Methotrexate plus ustekinumab versus ustekinumab monotherapy in patients with active psoriatic arthritis (MUST): a randomised, multicentre, placebo-controlled, phase 3b, non-inferiority trial

Author

Alten, Rieke H.E., Benesova, Karolina, Bergner, Raoul, Braun, Jürgen, Demary, Winfried, Finzel, Stephanie, Kästner, Peter, Kleye, Arnd, Krüger, Klaus, Lorenz, Gabriele, Max, Regina, Poddubnyy, Denis, Rubbert-Roth, Andrea, Schwenke, Holger, Sieburg, Maren, Thaci, Diamant, Thiele, Astrid, Voll, Reinhard E., von Hinüber, Ulrich, Walter, Jochen, Wassenberg, Siegfried, Koehm, Michaela, Rossmanith, Tanja, Foldenauer, Ann C, Herrmann, Eva, Brandt-Jürgens, Jan, Burmester, Gerd R, Kellner, Herbert, Kiltz, Uta, Kofler, David M, Rech, Jürgen, Mojtahed-Poor, Sorwe, Jonetzko, Christin, Burkhardt, Harald, and Behrens, Frank

Published
2023
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15. Integrated safety analysis of filgotinib in patients with moderate-to-severe rheumatoid arthritis over a treatment duration of up to 8.3 years

Author

Burmester, Gerd R, primary, Gottenberg, Jacques-Eric, additional, Caporali, Roberto, additional, Winthrop, Kevin L, additional, Tanaka, Yoshiya, additional, Ekoka Omoruyi, Edmund V, additional, Rajendran, Vijay, additional, Van Hoek, Paul, additional, Van Beneden, Katrien, additional, Takeuchi, Tsutomu, additional, Westhovens, René, additional, and Aletaha, Daniel, additional

Published
2024
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20. EULAR recommendations for the management of psoriatic arthritis with pharmacological therapies: 2023 update

Author

Gossec, Laure, primary, Kerschbaumer, Andreas, additional, Ferreira, Ricardo J O, additional, Aletaha, Daniel, additional, Baraliakos, Xenofon, additional, Bertheussen, Heidi, additional, Boehncke, Wolf-Henning, additional, Esbensen, Bente Appel, additional, McInnes, Iain B, additional, McGonagle, Dennis, additional, Winthrop, Kevin L, additional, Balanescu, Andra, additional, Balint, Peter V, additional, Burmester, Gerd R, additional, Cañete, Juan D, additional, Claudepierre, Pascal, additional, Eder, Lihi, additional, Hetland, Merete Lund, additional, Iagnocco, Annamaria, additional, Kristensen, Lars Erik, additional, Lories, Rik, additional, Queiro, Rubén, additional, Mauro, Daniele, additional, Marzo-Ortega, Helena, additional, Mease, Philip J, additional, Nash, Peter, additional, Wagenaar, Wendy, additional, Savage, Laura, additional, Schett, Georg, additional, Shoop-Worrall, Stephanie J W, additional, Tanaka, Yoshiya, additional, Van den Bosch, Filip E, additional, van der Helm-van Mil, Annette, additional, Zabotti, Alen, additional, van der Heijde, Désirée, additional, and Smolen, Josef S, additional

Published
2024
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21. Pharmacokinetics and safety of candidate tocilizumab biosimilar CT-P47 administered by auto-injector or pre-filled syringe: a randomized, open‑label, single-dose phase I study

Author

Yu, Kyung-Sang, Ryu, Hyunwook, Shin, Dongseong, Park, MinKyu, Hwang, JunGi, Moon, Seol Ju, Kim, Min-Gul, Keystone, Edward, Smolen, Josef S, Kim, SungHyun, Bae, YunJu, Jeon, DaBee, Jang, JiYoung, Yang, GoEun, Bae, JiHun, Lee, JaeYong, and Burmester, Gerd R

Abstract

ABSTRACTBackgroundThis study compared the pharmacokinetics (PK), immunogenicity, and safety of candidate tocilizumab biosimilar, CT-P47, administered via auto-injector (CT-P47 AI) or pre-filled syringe (CT-P47 PFS), in healthy Asian adults.Research design and methodsIn this phase I, multicenter, open-label study, participants were randomized 1:1 to receive a single 162 mg/0.9 mL dose of CT-P47 via AI or PFS. Primary endpoints were area under the concentration – time curve from time zero to infinity (AUC0–inf) and maximum serum concentration (Cmax). PK equivalence was determined if 90% confidence intervals (CIs) for the ratios of geometric least-squares means (gLSMs) were within the predefined 80–125% equivalence margin. Secondary PK parameters, immunogenicity, and safety outcomes were also assessed.ResultsOf 314 participants randomized (155 CT-P47 AI; 159 CT-P47 PFS), 310 received the study drug (153 CT-P47 AI; 157 CT-P47 PFS). Primary and secondary PK results, immunogenicity and safety were similar between groups. Ninety percent CIs for the ratio of gLSMs were within the predefined equivalence margin for AUC0–inf(85.87–102.94) and Cmax(82.98–98.16).ConclusionsPK equivalence between CT-P47 AI and CT-P47 PFS was demonstrated in healthy Asian adults, with comparable immunogenicity and safety between the two devices.Trial registrationClinicalTrials.gov: NCT05617183.

Published
2024
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23. The impact of COVID-19 on rare and complex connective tissue diseases: the experience of ERN ReCONNET

Author

Talarico, Rosaria, Aguilera, Silvia, Alexander, Tobias, Amoura, Zahir, Antunes, Ana M., Arnaud, Laurent, Avcin, Tadej, Beretta, Lorenzo, Bombardieri, Stefano, Burmester, Gerd R., Cannizzo, Sara, Cavagna, Lorenzo, Chaigne, Benjamin, Cornet, Alain, Costedoat-Chalumeau, Nathalie, Doria, Andrea, Ferraris, Alessandro, Fischer-Betz, Rebecca, Fonseca, João E., Frank, Charissa, Gaglioti, Andrea, Galetti, Ilaria, Grunert, Jürgen, Guimarães, Vera, Hachulla, Eric, Houssiau, Frederic, Iaccarino, Luca, Krieg, Thomas, Limper, Marteen, Malfait, Fransiska, Mariette, Xavier, Marinello, Diana, Martin, Thierry, Matthews, Lisa, Matucci-Cerinic, Marco, Meyer, Alain, Montecucco, Carlomaurizio, Mouthon, Luc, Müller-Ladner, Ulf, Rednic, Simona, Romão, Vasco C., Schneider, Matthias, Smith, Vanessa, Sulli, Alberto, Tamirou, Farah, Taruscio, Domenica, Taulaigo, Anna V., Terol, Enrique, Tincani, Angela, Ticciati, Simone, Turchetti, Giuseppe, van Hagen, P. Martin, van Laar, Jacob M., Vieira, Ana, de Vries-Bouwstra, Jeska K., Cutolo, Maurizio, and Mosca, Marta

Published
2021
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24. Publisher Correction: The impact of COVID-19 on rare and complex connective tissue diseases: the experience of ERN ReCONNET

Author

Talarico, Rosaria, Aguilera, Silvia, Alexander, Tobias, Amoura, Zahir, Antunes, Ana M., Arnaud, Laurent, Avcin, Tadej, Beretta, Lorenzo, Bombardieri, Stefano, Burmester, Gerd R., Cannizzo, Sara, Cavagna, Lorenzo, Chaigne, Benjamin, Cornet, Alain, Costedoat-Chalumeau, Nathalie, Doria, Andrea, Ferraris, Alessandro, Fischer-Betz, Rebecca, Fonseca, João E., Frank, Charissa, Gaglioti, Andrea, Galetti, Ilaria, Grunert, Jürgen, Guimarães, Vera, Hachulla, Eric, Houssiau, Frederic, Iaccarino, Luca, Krieg, Thomas, Limper, Marteen, Malfait, Fransiska, Mariette, Xavier, Marinello, Diana, Martin, Thierry, Matthews, Lisa, Matucci-Cerinic, Marco, Meyer, Alain, Montecucco, Carlomaurizio, Mouthon, Luc, Müller-Ladner, Ulf, Rednic, Simona, Romão, Vasco C., Schneider, Matthias, Smith, Vanessa, Sulli, Alberto, Tamirou, Farah, Taruscio, Domenica, Taulaigo, Anna V., Terol, Enrique, Tincani, Angela, Ticciati, Simone, Turchetti, Giuseppe, van Hagen, P. Martin, van Laar, Jacob M., Vieira, Ana, de Vries-Bouwstra, Jeska K., Cutolo, Maurizio, and Mosca, Marta

Published
2022
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25. Correction: Post-Marketing Safety Surveillance of Tofacitinib over 9 Years in Patients with Psoriatic Arthritis and Rheumatoid Arthritis

Author

Burmester, Gerd R., primary, Coates, Laura C., additional, Cohen, Stanley B., additional, Tanaka, Yoshiya, additional, Vranic, Ivana, additional, Nagy, Edward, additional, Lazariciu, Irina, additional, Chen, All-shine, additional, Kwok, Kenneth, additional, Fallon, Lara, additional, and Kinch, Cassandra, additional

Published
2023
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27. Correction to: The citrullinated/native index of autoantibodies against hnRNP-DL predicts an individual “window of treatment success” in RA patients

Author

Marklein, Bianka, Jenning, Madeleine, Konthur, Zoltán, Häupl, Thomas, Welzel, Franziska, Nonhoff, Ute, Krobitsch, Sylvia, Mulder, Debbie M., Koenders, Marije I., Joshua, Vijay, Cope, Andrew P., Shlomchik, Mark J., Anders, Hans-Joachim, Burmester, Gerd R., Hensvold, Aase, Catrina, Anca I., Rönnelid, Johan, Steiner, Günter, and Skriner, Karl

Published
2021
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28. The citrullinated/native index of autoantibodies against hnRNP-DL predicts an individual “window of treatment success” in RA patients

Author

Marklein, Bianka, Jenning, Madeleine, Konthur, Zoltán, Häupl, Thomas, Welzel, Franziska, Nonhoff, Ute, Krobitsch, Sylvia, Mulder, Debbie M., Koenders, Marije I., Joshua, Vijay, Cope, Andrew P., Shlomchik, Mark J., Anders, Hans-Joachim, Burmester, Gerd R., Hensvold, Aase, Catrina, Anca I., Rönnelid, Johan, Steiner, Günter, and Skriner, Karl

Published
2021
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38. Rapid and sustained improvements in health-related quality of life, fatigue, and other patient-reported outcomes in rheumatoid arthritis patients treated with certolizumab pegol plus methotrexate over 1 year: results from the RAPID 1 randomized controlled trial

Author

Strand, Vibeke, Mease, Philip, Burmester, Gerd R, Nikaï, Enkeleida, Coteur, Geoffroy, van Vollenhoven, Ronald, Combe, Bernard, Keystone, Edward C, and Kavanaugh, Arthur

Abstract

Abstract Introduction The objective of this study was to assess the impact of certolizumab pegol (CZP) treatment on health-related quality of life (HRQoL), fatigue and other patient-reported outcomes (PROs) in patients with rheumatoid arthritis (RA). Methods Patients with active RA (N = 982) were randomized 2:2:1 to subcutaneous CZP (400 mg at weeks 0, 2 and 4; followed by CZP 200 mg or 400 mg) plus methotrexate (MTX) every other week, or placebo (PBO) plus MTX. PRO assessments included HRQoL, fatigue, physical function, arthritis pain and disease activity. Adjusted mean changes from baseline in all PROs were obtained using analysis of covariance (ANCOVA) applying last observation carried forward (LOCF) imputation. The proportion of patients achieving clinically meaningful improvements in each PRO was obtained using logistic regression and by applying non-responder imputation to missing values after rescue medication or withdrawal. The correlations between PRO responses and clinical responses were also assessed by tetrachoric correlation using non-responder imputation. Results Patients treated with CZP plus MTX reported significant (P < 0.001), clinically meaningful improvements in HRQoL at the first assessment (week 12); reductions in fatigue, disease activity and pain and improvements in physical function were reported at week 1. In particular, CZP-treated patients reported improvements in mental health. Mean changes from baseline in the SF-36 Mental Component Summary (MCS) at week 52 for CZP 200 mg and 400 mg plus MTX, and PBO plus MTX were 6.4, 6.4 and 2.1, respectively (P < 0.001). In addition, mental health and vitality scores in CZP-treated patients approached age- and gender-adjusted US population norms. Improvements in all PROs were sustained. Similar benefits were reported with both CZP doses. Changes in SF-36 MCS scores had the lowest correlation with disease activity scores (DAS28) and American College of Rheumatology 20% improvement (ACR20) response rates, while improvements in pain showed the highest correlation. Conclusions Treatment with CZP plus MTX resulted in rapid and sustained improvements in all PROs, indicating that the benefits of CZP extend beyond clinical efficacy endpoints into areas that are more relevant and meaningful for patients on a daily basis. Trial Registration ClinicalTrials.gov NCT00152386.

Published
2009

39. Intestinal Microbiota Reduction Followed by Fasting Discloses Microbial Triggering of Inflammation in Rheumatoid Arthritis

Author

Häupl, Thomas, primary, Sörensen, Till, additional, Smiljanovic, Biljana, additional, Darcy, Marine, additional, Scheder-Bieschin, Justus, additional, Steckhan, Nico, additional, Hartmann, Anika M., additional, Koppold, Daniela A., additional, Stuhlmüller, Bruno, additional, Skriner, Karl, additional, Walewska, Barbara M., additional, Hoppe, Berthold, additional, Bonin, Marc, additional, Burmester, Gerd R., additional, Schendel, Pascal, additional, Feist, Eugen, additional, Liere, Karsten, additional, Meixner, Martin, additional, Kessler, Christian, additional, Grützkau, Andreas, additional, and Michalsen, Andreas, additional

Published
2023
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40. Pharmacokinetics and safety of candidate tocilizumab biosimilar CT-P47 versus reference tocilizumab: a randomized, double-blind, single-dose phase I study

Author

Yu, Kyung-Sang, primary, Kim, Byungwook, additional, Shin, Dongseong, additional, Park, Min Kyu, additional, Hwang, Jun Gi, additional, Kim, Min-Gul, additional, Chung, Hyewon, additional, Ghim, JongLyul, additional, Chung, Jae-Yong, additional, Smolen, Josef S., additional, Burmester, Gerd R., additional, Kim, SungHyun, additional, Bae, YunJu, additional, Jeon, DaBee, additional, Yoo, JaeKyoung, additional, Yang, GoEun, additional, Bae, JiHun, additional, and Keystone, Edward, additional

Published
2023
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42. P111 Exploratory Analysis of Filgotinib Safety Data in Patients With Moderately to Severely Active Rheumatoid arthritis and an Increased Risk of Cardiovascular Events: Data From Phase 2 and 3 Clinical Trials

Author

Buch, Maya H, primary, Burmester, Gerd R, additional, Mariette, Xavier, additional, Charles-Schoeman, Christina, additional, Rajendran, Vijay, additional, Stiers, Pieter-Jan, additional, Cerani, Agustin, additional, Van Hoek, Paul, additional, Van Beneden, Katrien, additional, Tanaka, Yoshiya, additional, Schulze-Koops, Hendrik, additional, Westhovens, René, additional, and Favalli, Ennio, additional

Published
2023
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48. Long-term safety and efficacy of sarilumab with or without background csDMARDs in rheumatoid arthritis.

Author

Burmester, Gerd R, Strand, Vibeke, Kivitz, Alan J, Hu, Chih-Chi, Wang, Sheldon, Hoogstraten, Hubert van, Klier, Gabriella L, and Fleischmann, Roy

Subjects
*THERAPEUTIC use of monoclonal antibodies, *DRUG efficacy, *STATISTICS, *RESEARCH methodology, *ANTIRHEUMATIC agents, *RANDOMIZED controlled trials, *RHEUMATOID arthritis, *RESEARCH funding, *DESCRIPTIVE statistics, *QUESTIONNAIRES, *DATA analysis software, *DATA analysis, *PATIENT safety, *EVALUATION
Abstract

Objective To evaluate the long-term safety and efficacy of sarilumab with/without conventional synthetic (cs)DMARDs in RA. Methods The analyses evaluated two open-label extensions (OLEs): EXTEND and MONARCH OLE, which included patients from six randomized trials. Patients received sarilumab 200 mg once every 2 weeks (q2w) for at least 264 weeks up to 516 weeks (EXTEND: Sarilumab Monotherapy and Sarilumab + csDMARD groups) or for 276 weeks (MONARCH OLE: Continuation and Switch groups). Primary endpoints included safety, immunogenicity and changes in laboratory parameters. Secondary endpoints included clinical signs and symptoms along with health-related quality-of-life (HRQOL) questionnaires. Results The Sarilumab Monotherapy (n  =   111), Continuation (n  =   165) and Switch (n  =   155) groups received sarilumab monotherapy, while the Sarilumab + csDMARD group (n  =   1910) received sarilumab in combination with csDMARDs. Incidence of one or more treatment-emergent adverse events was 126 (Sarilumab Monotherapy group), 169 (Sarilumab + csDMARD group), 159 (Continuation group) and 159 (Switch group) events/100 patient-years. Neutropenia was the most common adverse event. Neutropenia was not associated with an increased incidence of infections. Most neutropenia cases normalized on-treatment. Adverse events of special interests, such as malignancies, major adverse cardiovascular events, venous thromboembolism and gastrointestinal perforations, were rare. Immunogenicity was low and not associated with hypersensitivity reactions or discontinuations due to lack or loss of efficacy. Improvements in clinical signs and symptoms and HRQOL, observed during the initial blinded trials, were maintained throughout the OLE assessment period. Conclusions Long-term sarilumab treatment with/without csDMARDs in patients with RA revealed no new safety findings. Efficacy and HRQOL were maintained or further increased over the open-label assessment period. Trial registration EXTEND, ClinicalTrials.gov, https://www.clinicaltrials.gov/ct2/show/NCT01146652 , NCT01146652; MONARCH OLE, ClinicalTrials.gov, https://clinicaltrials.gov/ct2/show/NCT02332590 , NCT02332590 [ABSTRACT FROM AUTHOR]

Published
2023
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50. Genomic stratification by expression of HLA-DRB4 alleles identifies differential innate and adaptive immune transcriptional patterns - A strategy to detect predictors of methotrexate response in early rheumatoid arthritis

Author

Stuhlmüller, Bruno, Mans, Karsten, Tandon, Neeraj, Bonin, Marc O., Smiljanovic, Biljana, Sörensen, Till A., Schendel, Pascal, Martus, Peter, Listing, Joachim, Detert, Jacqueline, Backhaus, Marina, Neumann, Thomas, Winchester, Robert J., Burmester, Gerd-R., and Häupl, Thomas

Published
2016
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