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3. 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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4. Sharing for Caring? A Patients' and Clinicians' View on Handling Personal Medical Data in the Context of Digitization: An Exploratory Study.

Author

Frank, Kevin, Mengesdorf, Thorsten, Radić, Marija, Herrmann, Philipp, Appenzeller, Arno, Mucha, Henrik, Orak, Berna, Spiecker gen. Döhmann, Indra, Rüping, Stefan, Burkhardt, Harald, Köhm, Michaela, and Dauth, Stephanie

Subjects
DIGITAL technology, DATA security, DATABASE management, RESEARCH funding, STATISTICAL sampling, FISHER exact test, KRUSKAL-Wallis Test, ARTIFICIAL intelligence, MEDICAL care, MANN Whitney U Test, SURVEYS, ATTITUDES of medical personnel, MEDICAL records, RESEARCH, INFORMATION retrieval, PATIENTS' attitudes, TIME
Abstract

Background: The healthcare sector is currently undergoing a significant transformation, driven by an increased utilization of data. In this evolving landscape, surveys are of pivotal importance to the comprehension of patient needs and preferences. Moreover, the digital affinity of patients and physicians within the healthcare system is reforming the manner in which healthcare services are accessed and delivered. The utilization and donation of data are influencing the future of medical research and treatment, while artificial intelligence (AI) is empowering patients and physicians with knowledge and improving healthcare delivery. Methods: In order to evaluate the opinions of patients and physicians regarding the management of personal health data and the functionality of upcoming data management devices in the context of healthcare digitization, we conducted an exploratory study and designed a survey. The survey focused on a number of key areas, including demographics, experience with digitization, data handling, the identification of needs for upcoming digitization, and AI in healthcare. Results: A total of 40 patients and 15 physicians participated in the survey. The results indicate that data security, timesaving/administrative support, and digital communication are aspects that patients associate with patient-friendly digitization. Based on the responses provided by physicians, it might be concluded that future digital platforms should prioritize usability, time efficacy, data security, and interoperability. Conclusions: In terms of expectations for future digital platforms, there is a notable overlap between the needs expressed by patients and those identified by physicians, particularly in relation to usability, time management, data security, and digital communication. This suggests that the requirements of different stakeholders can be combined in a future system, although individual issues may still require attention. [ABSTRACT FROM AUTHOR]

Published
2024
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5. Human MHC Class II and Invariant Chain Knock‐in Mice Mimic Rheumatoid Arthritis with Allele Restriction in Immune Response and Arthritis Association

Author

Romero‐Castillo, Laura, primary, Li, Taotao, additional, Do, Nhu‐Nguyen, additional, Sareila, Outi, additional, Xu, Bingze, additional, Hennings, Viktoria, additional, Xu, Zhongwei, additional, Svensson, Carolin, additional, Oliveira‐Coelho, Ana, additional, Sener, Zeynep, additional, Urbonaviciute, Vilma, additional, Ekwall, Olov, additional, Burkhardt, Harald, additional, and Holmdahl, Rikard, additional

Published
2024
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6. Antigen-presenting autoreactive B cells activate regulatory T cells and suppress autoimmune arthritis in mice

Author

Aoun, Mike, Coelho, Ana, Krämer, Alexander, Saxena, Amit, Sabatier, Pierre, Beusch, Christian Michel, Lönnblom, Erik, Geng, Manman, Do, Nhu-Nguyen, Xu, Zhongwei, Zhang, Jingdian, He, Yibo, Romero Castillo, Laura, Abolhassani, Hassan, Xu, Bingze, Viljanen, Johan, Rorbach, Joanna, Fernandez Lahore, Gonzalo, Gjertsson, Inger, Kastbom, Alf, Sjöwall, Christopher, Kihlberg, Jan, Zubarev, Roman A, Burkhardt, Harald, Holmdahl, Rikard, Aoun, Mike, Coelho, Ana, Krämer, Alexander, Saxena, Amit, Sabatier, Pierre, Beusch, Christian Michel, Lönnblom, Erik, Geng, Manman, Do, Nhu-Nguyen, Xu, Zhongwei, Zhang, Jingdian, He, Yibo, Romero Castillo, Laura, Abolhassani, Hassan, Xu, Bingze, Viljanen, Johan, Rorbach, Joanna, Fernandez Lahore, Gonzalo, Gjertsson, Inger, Kastbom, Alf, Sjöwall, Christopher, Kihlberg, Jan, Zubarev, Roman A, Burkhardt, Harald, and Holmdahl, Rikard

Abstract

B cells undergo several rounds of selection to eliminate potentially pathogenic autoreactive clones, but in contrast to T cells, evidence of positive selection of autoreactive B cells remains moot. Using unique tetramers, we traced natural autoreactive B cells (C1-B) specific for a defined triple-helical epitope on collagen type-II (COL2), constituting a sizeable fraction of the physiological B cell repertoire in mice, rats, and humans. Adoptive transfer of C1-B suppressed arthritis independently of IL10, separating them from IL10-secreting regulatory B cells. Single-cell sequencing revealed an antigen processing and presentation signature, including induced expression of CD72 and CCR7 as surface markers. C1-B presented COL2 to T cells and induced the expansion of regulatory T cells in a contact-dependent manner. CD72 blockade impeded this effect suggesting a new downstream suppressor mechanism that regulates antigen-specific T cell tolerization. Thus, our results indicate that autoreactive antigen-specific naïve B cells tolerize infiltrating T cells against self-antigens to impede the development of tissue-specific autoimmune inflammation.

Published
2024

7. Therapy targeting antigen-specific T cells by a peptide-based tolerizing vaccine against autoimmune arthritis

Author

Urbonaviciute, Vilma, Romero-Castillo, Laura, Xu, Bingze, Luo, Huqiao, Schneider, Nadine, Weisse, Sylvia, Do, Nhu-Nguyen, Oliveira-Coelho, Ana, Fernandez Lahore, Gonzalo, Li, Taotao, Sabatier, Pierre, Beusch, Christian M, Viljanen, Johan, Zubarev, Roman A, Kihlberg, Jan, Bäcklund, Johan, Burkhardt, Harald, Holmdahl, Rikard, Urbonaviciute, Vilma, Romero-Castillo, Laura, Xu, Bingze, Luo, Huqiao, Schneider, Nadine, Weisse, Sylvia, Do, Nhu-Nguyen, Oliveira-Coelho, Ana, Fernandez Lahore, Gonzalo, Li, Taotao, Sabatier, Pierre, Beusch, Christian M, Viljanen, Johan, Zubarev, Roman A, Kihlberg, Jan, Bäcklund, Johan, Burkhardt, Harald, and Holmdahl, Rikard

Abstract

A longstanding goal has been to find an antigen-specific preventive therapy, i.e., a vaccine, for autoimmune diseases. It has been difficult to find safe ways to steer the targeting of natural regulatory antigen. Here, we show that the administration of exogenous mouse major histocompatibility complex class II protein bounding a unique galactosylated collagen type II (COL2) peptide (Aq-galCOL2) directly interacts with the antigen-specific TCR through a positively charged tag. This leads to expanding a VISTA-positive nonconventional regulatory T cells, resulting in a potent dominant suppressive effect and protection against arthritis in mice. The therapeutic effect is dominant and tissue specific as the suppression can be transferred with regulatory T cells, which downregulate various autoimmune arthritis models including antibody-induced arthritis. Thus, the tolerogenic approach described here may be a promising dominant antigen-specific therapy for rheumatoid arthritis, and in principle, for autoimmune diseases in general.

Published
2024

12. Epidemiological data and medical care situation of patients with chronic inflammatory diseases in Germany

Author

Riemekasten, Gabriela, primary, Schmelz, Renate, additional, Schäkel, Knut, additional, Thaci, Diamant, additional, Schreiber, Stefan, additional, Röcken, Marit, additional, Bartz, Holger, additional, Ploner, Tina, additional, Liao, Ximing, additional, Weber, Valeria, additional, Manz, Karina C., additional, Burkhardt, Harald, additional, and Leipe, Jan, additional

Published
2023
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14. Correction: Antigen-presenting autoreactive B cells activate regulatory T cells and suppress autoimmune arthritis in mice

Author

Aoun, Mike, primary, Coelho, Ana, additional, Krämer, Alexander, additional, Saxena, Amit, additional, Sabatier, Pierre, additional, Beusch, Christian Michel, additional, Lönnblom, Erik, additional, Geng, Manman, additional, Do, Nhu-Nguyen, additional, Xu, Zhongwei, additional, Zhang, Jingdian, additional, He, Yibo, additional, Castillo, Laura Romero, additional, Abolhassani, Hassan, additional, Xu, Bingze, additional, Viljanen, Johan, additional, Rorbach, Joanna, additional, Lahore, Gonzalo Fernandez, additional, Gjertsson, Inger, additional, Kastbom, Alf, additional, Sjöwall, Christopher, additional, Kihlberg, Jan, additional, Zubarev, Roman A., additional, Burkhardt, Harald, additional, and Holmdahl, Rikard, additional

Published
2023
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15. Antigen-presenting autoreactive B cells activate regulatory T cells and suppress autoimmune arthritis in mice

Author

Aoun, Mike, primary, Coelho, Ana, additional, Krämer, Alexander, additional, Saxena, Amit, additional, Sabatier, Pierre, additional, Beusch, Christian Michel, additional, Lönnblom, Erik, additional, Geng, Manman, additional, Do, Nhu-Nguyen, additional, Xu, Zhongwei, additional, Zhang, Jingdian, additional, He, Yibo, additional, Romero Castillo, Laura, additional, Abolhassani, Hassan, additional, Xu, Bingze, additional, Viljanen, Johan, additional, Rorbach, Joanna, additional, Fernandez Lahore, Gonzalo, additional, Gjertsson, Inger, additional, Kastbom, Alf, additional, Sjöwall, Christopher, additional, Kihlberg, Jan, additional, Zubarev, Roman A., additional, Burkhardt, Harald, additional, and Holmdahl, Rikard, additional

Published
2023
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19. Impact of different classes of immune-modulating treatments on B cell-related and T cell-related immune response before and after COVID-19 booster vaccination in patients with immune-mediated diseases and primary immunodeficiency: a cohort study

Author

Koehm, Michaela, primary, Klippstein, Maximilian, additional, Dauth, Stephanie, additional, Hallmann, Konstantin, additional, Kohmer, Niko, additional, Burkhardt, Harald, additional, Ciesek, Sandra, additional, Geisslinger, Gerd, additional, Rabenau, Holger F, additional, and Behrens, Frank, additional

Published
2023
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23. Antigen-presenting autoreactive B cells activate regulatory T cells and suppress autoimmune arthritis in mice

Author

Aoun, Mike, Coelho, Ana, Kraemer, Alexander, Saxena, Amit, Sabatier, Pierre, Beusch, Christian Michel, Loennblom, Erik, Geng, Manman, Do, Nhu-Nguyen, Xu, Zhongwei, Zhang, Jingdian, He, Yibo, Romero Castillo, Laura, Abolhassani, Hassan, Xu, Bingze, Viljanen, Johan V., Rorbach, Joanna, Fernandez Lahore, Gonzalo, Gjertsson, Inger, Kastbom, Alf, Sjoewall, Christopher, Kihlberg, Jan, Zubarev, Roman A., Burkhardt, Harald, Holmdahl, Rikard, Aoun, Mike, Coelho, Ana, Kraemer, Alexander, Saxena, Amit, Sabatier, Pierre, Beusch, Christian Michel, Loennblom, Erik, Geng, Manman, Do, Nhu-Nguyen, Xu, Zhongwei, Zhang, Jingdian, He, Yibo, Romero Castillo, Laura, Abolhassani, Hassan, Xu, Bingze, Viljanen, Johan V., Rorbach, Joanna, Fernandez Lahore, Gonzalo, Gjertsson, Inger, Kastbom, Alf, Sjoewall, Christopher, Kihlberg, Jan, Zubarev, Roman A., Burkhardt, Harald, and Holmdahl, Rikard

Abstract

B cells undergo several rounds of selection to eliminate potentially pathogenic autoreactive clones, but in contrast to T cells, evidence of positive selection of autoreactive B cells remains moot. Using unique tetramers, we traced natural autoreactive B cells (C1-B) specific for a defined triple-helical epitope on collagen type-II (COL2), constituting a sizeable fraction of the physiological B cell repertoire in mice, rats, and humans. Adoptive transfer of C1-B suppressed arthritis independently of IL10, separating them from IL10-secreting regulatory B cells. Single-cell sequencing revealed an antigen processing and presentation signature, including induced expression of CD72 and CCR7 as surface markers. C1-B presented COL2 to T cells and induced the expansion of regulatory T cells in a contact-dependent manner. CD72 blockade impeded this effect suggesting a new downstream suppressor mechanism that regulates antigen-specific T cell tolerization. Thus, our results indicate that autoreactive antigen-specific naive B cells tolerize infiltrating T cells against self-antigens to impede the development of tissue-specific autoimmune inflammation.

Published
2023
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24. Therapy targeting antigen-specific T cells by a peptide-based tolerizing vaccine against autoimmune arthritis

Author

Urbonaviciute, Vilma, Romero-Castillo, Laura, Xu, Bingze, Luo, Huqiao, Schneider, Nadine, Weisse, Sylvia, Do, Nhu-Nguyen, Oliveira-Coelho, Ana, Lahore, Gonzalo Fernandez, Li, Taotao, Sabatier, Pierre, Beusch, Christian M., Viljanen, Johan V., Zubarev, Roman A., Kihlberg, Jan, Baecklund, Johan, Burkhardt, Harald, Holmdahl, Rikard, Urbonaviciute, Vilma, Romero-Castillo, Laura, Xu, Bingze, Luo, Huqiao, Schneider, Nadine, Weisse, Sylvia, Do, Nhu-Nguyen, Oliveira-Coelho, Ana, Lahore, Gonzalo Fernandez, Li, Taotao, Sabatier, Pierre, Beusch, Christian M., Viljanen, Johan V., Zubarev, Roman A., Kihlberg, Jan, Baecklund, Johan, Burkhardt, Harald, and Holmdahl, Rikard

Abstract

A longstanding goal has been to find an antigen-specific preventive therapy, i.e., a vaccine, for autoimmune diseases. It has been difficult to find safe ways to steer the targeting of natural regulatory antigen. Here, we show that the administration of exog-enous mouse major histocompatibility complex class II protein bounding a unique galactosylated collagen type II (COL2) peptide (Aq-galCOL2) directly interacts with the antigen-specific TCR through a positively charged tag. This leads to expanding a VISTA-positive nonconventional regulatory T cells, resulting in a potent dominant suppressive effect and protection against arthritis in mice. The therapeutic effect is dom-inant and tissue specific as the suppression can be transferred with regulatory T cells, which downregulate various autoimmune arthritis models including antibody-induced arthritis. Thus, the tolerogenic approach described here may be a promising dominant antigen-specific therapy for rheumatoid arthritis, and in principle, for autoimmune diseases in general.

Published
2023
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25. The role of antidrug antibodies in ustekinumab therapy and the impact of methotrexate.

Author

Poor, Sorwe Mojtahed, Henke, Marina, Ulshöfer, Thomas, Köhm, Michaela, Behrens, Frank, Burkhardt, Harald, and Schiffmann, Susanne

Subjects
PSORIATIC arthritis, DRUG efficacy, IMMUNOGLOBULINS, MULTIPLE regression analysis, MONOCLONAL antibodies, METHOTREXATE, DRUG interactions, DESCRIPTIVE statistics, RESEARCH funding, SECONDARY analysis, PATIENT safety
Abstract

Objective We investigated the impact of concomitant MTX on ustekinumab (UST) levels and antidrug antibody (ADA) formation in PsA and evaluated consequences in pharmacodynamics and pharmacokinetics. Methods We conducted a post-hoc analysis on 112 PsA serum samples of subjects treated with open-label UST and either concomitant MTX (UST/MTX, n  = 58) or placebo (UST/pbo, n  = 54) obtained in a randomized (1:1), double-blind, multicentre trial. A validated antibody-binding-based multitiered testing was used to detect ADA and ADA with neutralizing capacity (nADA). The impact of MTX on UST immunogenicity was analysed by comparison of UST/pbo with UST/MTX cohorts at different time points. Patient- and disease-related predispositions for ADA formation were investigated with multiple linear regression analysis. Immunogenicity impact on pharmacokinetics, safety and efficacy was determined by cohort comparison between patients with and without ADA formation. Results Over 52 weeks, 11 UST/pbo- and 19 UST/MTX-treated patients developed ADA (P  > 0.05). In the UST/pbo cohort, the visit-dependent UST levels were in the range of 0.047 (0.05) –0.110 (0.07) µg/ml overall, and 0.037 (0.04)–0.091 (0.08) µg/ml in ADA-confirmed subjects. In UST/MTX-treated patients, the UST levels exhibited an intervisit variation in the range of 0.0502 (0.04)–0.106 (0.07) µg/ml overall and 0.029 (0.03)–0.097 (0.07) µg/ml in ADA positive subjects (P  > 0.05). At week 52, ADA-confirmed patients did not differ significantly (P  > 0.05) in safety or clinical outcomes from ADA-negative patients. Conclusion Concomitant MTX had no significant impact on UST immunogenicity. Furthermore, ADA formation was not associated with impairments in UST safety, efficacy or trough levels. Trial registration ClinicalTrials.gov, https://clinicaltrials.gov , NCT03148860. [ABSTRACT FROM AUTHOR]

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

Author

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

Published
2023
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30. Effectiveness of Different Rituximab Doses Combined with Leflunomide in the Treatment or Retreatment of Rheumatoid Arthritis: Part 2 of a Randomized, Placebo-Controlled, Investigator-Initiated Clinical Trial (AMARA)

Author

Koehm, Michaela, primary, Foldenauer, Ann C., additional, Rossmanith, Tanja, additional, Alten, Rieke, additional, Aringer, Martin, additional, Backhaus, Marina, additional, Burmester, Gerd R., additional, Feist, Eugen, additional, Kellner, Herbert, additional, Krueger, Klaus, additional, Müller-Ladner, Ulf, additional, Rubbert-Roth, Andrea, additional, Tony, Hans-Peter, additional, Wassenberg, Siegfried, additional, Burkhardt, Harald, additional, and Behrens, Frank, additional

Published
2022
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31. Fluorescence-optical imaging as a promising easy-to-use imaging biomarker to increase early psoriatic arthritis detection in patients with psoriasis: a cross-sectional cohort study with follow-up

Author

Koehm, Michaela, primary, Ohrndorf, Sarah, additional, Foldenauer, Ann C, additional, Rossmanith, Tanja, additional, Backhaus, Marina, additional, Werner, Stephanie G, additional, Burmester, Gerd R, additional, Wassenberg, Siegfried, additional, Koehler, Benjamin, additional, Burkhardt, Harald, additional, and Behrens, Frank, additional

Published
2022
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33. Prediction of improvement in skin fibrosis in diffuse cutaneous systemic sclerosis: a EUSTAR analysis

Author

Dobrota, Rucsandra, Maurer, Britta, Graf, Nicole, Jordan, Suzana, Mihai, Carina, Kowal-Bielecka, Otylia, Allanore, Yannick, Distler, Oliver, Cerinic, Marco Matucci, Guiducci, Serena, Walker, Ulrich, Lapadula, Giovanni, Iannone, Florenzo, Becvar, Radim, Sierakowsky, Stanislaw, Cutolo, Maurizio, Sulli, Alberto, Valentini, Gabriele, Cuomo, Giovanna, Vettori, Serena, Riemekasten, Gabriela, Siegert, Elise, Rednic, Simona, Nicoara, Ileana, Kahan, André, Vlachoyiannopoulos, P., Montecucco, C., Caporali, Roberto, Carreira, Patricia E., Novak, Srdan, Czirják, László, Varju, Cecilia, Chizzolini, Carlo, Kucharz, Eugene J., Kotulska, Anna, Kopec-Medrek, Magdalena, Widuchowska, Malgorzata, Cozzi, Franco, Rozman, Blaz, Mallia, Carmel, Coleiro, Bernard, Gabrielli, Armando, Farge, Dominique, Wu, Chen, Marjanovic, Zora, Faivre, Helene, Hij, Darin, Dhamadi, Roza, Airò, Paolo, Hesselstrand, Roger, Wollheim, Frank, Wuttge, Dirk M, Andréasson, Kristofer, Martinovic, Duska, Balbir-Gurman, Alexandra, Braun-Moscovici, Yolanda, Trotta, F., Lo Monaco, Andrea, Hunzelmann, Nicolas, Pellerito, Raffaele, Mauriziano, Ospedale, Bambara, Lisa Maria, Caramaschi, Paola, Black, Carol, Denton, Christopher, Damjanov, Nemanja, Henes, Jörg, Ortiz Santamaria, Vera, Heitmann, Stefan, Krasowska, Dorota, Seidel, Matthias, Burkhardt, Harald, Himsel, Andrea, Salvador, Maria J., Silva, José Antonio Pereira Da, Stamenkovic, Bojana, Stankovic, Aleksandra, Banja, Niska, Tikly, Mohammed, Ananieva, Lidia P., Denisov, Lev N., Müller-Ladner, Ulf, Frerix, Marc, Tarner, Ingo, Scorza, Raffaella, Clinica, U.O. Immunologia, Engelhart, Merete, Strauss, Gitte, Nielsen, Henrik, Damgaard, Kirsten, Mendoza, Antonio Zea, de la Puente, Carlos, Giraldo, Walter A. Sifuentes, Midtvedt, Øyvind, Reiseter, Silje, Hachulla, Eric, Launay, David, Valesini, Guido, Riccieri, Valeria, Ionescu, Ruxandra Maria, Opris, Daniela, Groseanu, Laura, Cornateanu, Roxana Sfrent, Ionitescu, Razvan, Gherghe, Ana Maria, Soare, Alina, Gorga, Marilena, Bojinca, Mihai, Schett, Georg, Distler, Jörg HW, Beyer, Christian, Meroni, Pierluigi, Ingegnoli, Francesca, Mouthon, Luc, De Keyser, Filip, Smith, Vanessa, Cantatore, Francesco P., Corrado, Ada, Pozzi, Maria R., Eyerich, Kilian, Hein, Rüdiger, Knott, Elisabeth, Wiland, Piotr, Szmyrka-Kaczmarek, Magdalena, Sokolik, Renata, Morgiel, Ewa, Madej, Marta, Krummel-Lorenz, Brigitte, Aringer, Martin, Günther, Claudia, Westhovens, Rene, de Langhe, Ellen, Lenaerts, Jan, Anic, Branimir, Baresic, Marko, Mayer, Miroslav, Radominski, Sebastião C., de Souza Müller, Carolina, Azevedo, Valderílio F., Agachi, Svetlana, Groppa, Liliana, Chiaburu, Lealea, Russu, Eugen, Popa, Sergei, Zenone, Thierry, Highton, John, Stamp, Lisa, Chapman, Peter, O’Donnell, John, Solanki, Kamal, Veale, Douglas, OʼRourke, Marie, Loyo, Esthela, Li, Mengtao, Rosato, Edoardo, Amoroso, Antonio, Tanaseanu, Cristina-Mihaela, Popescu, Monica, Dumitrascu, Alina, Tiglea, Isabela, Foti, Rosario, Chirieac, Rodica, Ancuta, Codrina, Villiger, Peter, Adler, Sabine, Sibilia, Jean, Chatelus, Emmanuel, Gottenberg, Jacques Eric, Chifflot, Hélène, Litinsky, Ira, Venalis, Algirdas, Butrimiene, Irena, Venalis, Paulius, Rugiene, Rita, Karpec, Diana, Saketkoo, Lesley Ann, Lasky, Joseph A., Kerzberg, Eduardo, Montoya, Fabiana, Cosentino, Vanesa, Limonta, Massimiliano, Brucato, Antonio Luca, Lupi, Elide, Spertini, François, Ribi, Camillo, Buss, Guillaume, Pasquali, Jean Louis, Martin, Thierry, and Gorse, Audrey

Published
2016
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34. Replication of a distinct psoriatic arthritis risk variant at the IL23R locus

Author

Budu-Aggrey, Ashley, Bowes, John, Loehr, Sabine, Uebe, Steffen, Zervou, Maria I, Helliwell, Philip, Ryan, Anthony W, Kane, David, Korendowych, Eleanor, Giardina, Emiliano, Packham, Jonathan, McManus, Ross, FitzGerald, Oliver, McHugh, Neil, Behrens, Frank, Burkhardt, Harald, Huffmeier, Ulrike, Ho, Pauline, Martin, Javier, Castañeda, Santos, Goulielmos, George, Reis, Andre, and Barton, Anne

Published
2016
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36. Eine fieberhafte Angelegenheit

Author

Ferdinand, Samantha, Bel, Ann Christin, Meier, Florian, and Burkhardt, Harald

Subjects
Medicine and health
Abstract

Vorgeschichte: Im Mai 2021 Einweisung des damals 77-jährigen Patienten aufgrund von seit 2018 zunehmender Schwäche, Fieberepisoden, Gewichtsverlust und Pancytopenie. Nach Ausschluss einer malignen Knochenmarkserkrankung bei V.a. Riesenzellarteriitis Versuch einer Therapie mit MTX, die trotz [zum vollständigen Text gelangen Sie über die oben angegebene URL]

Published
2022
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37. Impact of different classes of immune-suppressive treatments on the immune response before and after COVID booster vaccination

Author

Klippstein, Maximilian, Dauth, Stephanie, Köhm, Michaela, Kohmer, Niko, Burkhardt, Harald, Ciesek, Sandra, Rabenau, Holger F., and Behrens, Frank

Subjects
Medicine and health
Abstract

Introduction: The 2019 coronavirus disease (COVID-19) has become one of the most consequential pandemics ever. Fortunately, effective vaccines have been developed. However, a prerequisite for adequate response after vaccination is a competent immune system, which may be influenced by diseases or therapies. [for full text, please go to the a.m. URL]

Published
2022
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38. Add-on or withdrawal of methotrexate do not impact efficacy of IL12/23 inhibition in active PsA: Data from the multicenter investigator-initiated randomized placebo-controlled MUST trial

Author

Köhm, Michaela, Rossmanith, Tanja, Foldenauer, Ann Christina, Kellner, Herbert, Kiltz, Uta, Rech, Jürgen, Burmester, Gerd-Rüdiger, Kofler, David, Brandt-Jürgens, Jan, Braun, Jürgen, Finzel, Stephanie, Bergner, Raoul, Sieburg, Maren, Kästner, Peter, Jonetzko, Christin, Burkhardt, Harald, and Behrens, Frank

Subjects
Medicine and health
Abstract

Introduction: Methotrexate (MTX) is used as first-line DMARD-therapy in active psoriatic arthritis (PsA) according to local guidelines, but its value for a combination therapy with bDMARDs has remained unclear to date. Here we report the results of an investigator-initiated, randomized, placebo-controlled [for full text, please go to the a.m. URL]

Published
2022
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41. Key interactions in the trimolecular complex consisting of the rheumatoid arthritis-associated DRB1*04:01 molecule, the major glycosylated collagen II peptide and the T-cell receptor

Author

Ge, Changrong, Weisse, Sylvia, Xu, Bingze, Dobritzsch, Doreen, Viljanen, Johan V., Kihlberg, Jan, Do, Nhu-Nguyen, Schneider, Nadine, Lanig, Harald, Holmdahl, Rikard, Burkhardt, Harald, Ge, Changrong, Weisse, Sylvia, Xu, Bingze, Dobritzsch, Doreen, Viljanen, Johan V., Kihlberg, Jan, Do, Nhu-Nguyen, Schneider, Nadine, Lanig, Harald, Holmdahl, Rikard, and Burkhardt, Harald

Abstract

Objectives Rheumatoid arthritis (RA) is an autoimmune disease strongly associated with the major histocompatibility complex (MHC) class II allele DRB1*04:01, which encodes a protein that binds self-peptides for presentation to T cells. This study characterises the autoantigen-presenting function of DRB1*04:01 (HLA-DRA*01:01/HLA-DRB1*04:01) at a molecular level for prototypic T-cell determinants, focusing on a post-translationally modified collagen type II (Col2)-derived peptide. Methods The crystal structures of DRB1*04:01 molecules in complex with the peptides HSP70(289-306), citrullinated CILP982-996 and galactosylated Col2(259-273) were determined on cocrystallisation. T cells specific for Col2(259-273) were investigated in peripheral blood mononuclear cells from patients with DRB1*04:01-positive RA by cytofluorometric detection of the activation marker CD154 on peptide stimulation and binding of fluorescent DRB1*0401/Col2(259-273) tetramer complexes. The cDNAs encoding the T-cell receptor (TCR) alpha-chains and beta-chains were cloned from single-cell sorted tetramer-positive T cells and transferred via a lentiviral vector into TCR-deficient Jurkat 76 cells. Results The crystal structures identified peptide binding to DRB1*04:01 and potential side chain exposure to T cells. The main TCR recognition sites in Col2(259-273) were lysine residues that can be galactosylated. RA T-cell responses to DRB1*04:01-presented Col2(259-273) were dependent on peptide galactosylation at lysine 264. Dynamic molecular modelling of a functionally characterised Col2(259-273)-specific TCR complexed with DRB1*04:01/Col2(259-273) provided evidence for differential allosteric T-cell recognition of glycosylated lysine 264. Conclusions The MHC-peptide-TCR interactions elucidated in our study provide new molecular insights into recognition of a post-translationally modified RA T-cell determinant with a known dominant role in arthritogenic and tolerogenic responses in murine Col2-induced ar

Published
2022
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42. Routineeinsatz von Leflunomid bei Rheumatoider Arthritis: Wirksamkeit und unerwünschte Arzneimittelwirkungen in Monotherapie und Kombinationstherapie

Author

Aringer, Martin, Burkhardt, Harald, Technische Universität Dresden, Weigt, Gundula, Aringer, Martin, Burkhardt, Harald, Technische Universität Dresden, and Weigt, Gundula

Abstract

Die Rheumatoide Arthritis (RA) ist eine multifaktoriell bedingte Autoimmunerkrankung, die durch entzündlichen Gelenksbefall charakterisiert ist. Unter fehlender oder ungenügender therapeutischer Intervention nimmt die Erkrankung einen progressiven Verlauf, der zu Gelenkdestruktionen und damit zu zunehmender Behinderung, sowie Arbeitsunfähigkeit führt. Neben den Einschränkungen in der Gelenkfunktion können in jedem Krankheitsstadium Allgemeinsymptome und vielfältige extraartikuläre Manifestationen auftreten, sodass die Erkrankung mit einer verkürzten Lebenserwartung bzw. erhöhter Mortalität assoziiert ist. Obwohl in den letzten Jahren deutliche Fortschritte in der Therapie erzielt wurden, ist eine definitive Heilung nicht möglich. Gemäß der EULAR-Guidelines von 2019 ist Methotrexat (MTX) weiterhin als „anchor drug“ in der RA das Erstlinienmedikament der Wahl. Bei Therapieversagen von MTX und dem Fehlen von negativen Prognoseparametern kann als Zweitlinientherapie ein anderes konventionelles DMARD (csDMARD) in Monotherapie oder Kombination eingesetzt werden. Eine der Optionen ist Leflunomid (LEF), das in Studien seine Wirksamkeit als DMARD und seine Überlegenheit gegenüber Placebo bewiesen hat. Es ist aber nach wie vor nicht wirklich geklärt, ob Patienten im klinischen Alltag tatsächlich von einer Therapie mit LEF oder LEF/MTX profitieren, insbesondere nach dem Versagen einer Erstlinientherapie mit MTX. Dazu wurde in der vorliegenden Untersuchung der Alltagseinsatz und Nutzen von LEF sowohl in Monotherapie als auch in Kombination mit MTX analysiert. Es handelt sich um eine historisch prospektive Kohortenstudie mit Patienten der Rheumatologischen Ambulanz des Universitätsklinikums Dresden. Es erfolgte die Einteilung der Studienkohorte (n=158) in zwei Untergruppen. In der erweiterten LEF-Kohorte (eLEF) befanden sich alle Patienten, welche zu einem beliebigen Zeitpunkt zwischen 2007 und 2015 mit LEF (n=103) oder mit LEF/MTX (n=49) behandelt worden waren. In der post MTX, Rheumatoid arthritis (RA) is a multifactorial autoimmune disease characterized by inflammatory joint involvement. In the absence or inadequacy of therapeutic intervention, the disease takes a progressive course, leading to joint destruction, increasing disability, and incapacity to work. In addition to limitations in joint function, general symptoms and multiple extra-articular manifestations may occur at any stage of the disease, so that the disease is associated with a shortened life expectancy and increased mortality. Although significant advances in therapy have been made in recent years, a definitive cure is not possible. According to the 2019 EULAR guidelines, Methotrexate (MTX) remains the first-line drug of choice as the 'anchor drug' in RA. In case of treatment failure of MTX and the absence of poor prognostic factors, another conventional DMARD (csDMARD) can be used as second-line therapy in monotherapy or combination. One of the options is Leflunomide (LEF), which has demonstrated its efficacy as a DMARD and its superiority to placebo in trials. However, it is still not really clear whether patients actually benefit from therapy with LEF or LEF/MTX in daily clinical practice, especially after failure of first-line therapy with MTX. To this end, the present study analyzed the everyday use and benefit of LEF both in monotherapy and in combination with MTX. It is a historical prospective cohort study with patients of the Rheumatologic Outpatient Clinic of the University Hospital of Dresden. The study cohort (n=158) was divided into two subgroups. The extended LEF cohort (eLEF) included all patients who had been treated with LEF (n=103) or with LEF/MTX (n=49) at any time between 2007 and 2015. The post MTX cohort (pMTX group) included all patients who had been treated with LEF (n=39) or LEF/MTX (n=16) as second-line therapy after failure of first-line MTX between 2007 and 2015. Treatment survival was assessed using Kaplan-Meier curves, and clinical outcome in

Published
2022

43. Digital ulcers predict a worse disease course in patients with systemic sclerosis

Author

Mihai, Carina, Landewé, Robert, van der Heijde, Désirée, Walker, Ulrich A, Constantin, Paul I, Gherghe, Ana Maria, Ionescu, Ruxandra, Rednic, Simona, Allanore, Yannick, Avouac, Jérôme, Czirják, László, Hachulla, Eric, Riemekasten, Gabriela, Cozzi, Franco, Airò, Paolo, Cutolo, Maurizio, Mueller-Ladner, Ulf, Matucci-Cerinic, Marco, Launay, David, Dobrotă, Rucsandra, Sfrenţ-Cornăţeanu, Roxana, Zingarelli, Stefania, Pigatto, Erika, Cuomo, Giovanna, Caramaschi, Paola, Ananieva, Lidia, Ullman, Susanne, Iversen, Line, Gurman, Alexandra Balbir, Braun-Moscovici, Yolanda, Carreira, Patricia E., Joven, Beatriz E, Minier, Tünde, Guiducci, Serena, Bellando-Randone, Silvia, Pellerito, Raffaele, Hunzelmann, Nicolas, Tarner, Ingo H., Radominski, Sebastião Cezar, de Souza Müller, Carolina, Iannone, Florenzo, Henes, Jörg, Bancel, Dominique Farge, Damjanov, Nemanja, Ostojić, Predrag, Pozzi, Maria Rosa, Hesselstrand, Roger, Denton, Christopher, Krasowska, Dorota, Tikly, Mohammed, Riccieri, Valeria, Cantatore, Francesco Paolo, Corrado, Ada, Da Silva, José Antonio Pereira, Salvador, Maria João, Tyndall, Alan, Gabrielli, Armando, Distler, Oliver, Jordan, Suzan, Heitmann, Stefan, Burkhardt, Harald, Himsel, Andrea, Rozman, Blaz, Smith, Vanessa, De Keyser, Filip, Kalitena, Dusanka Martinovic, Radic, Mislav, Filipescu, Ileana, Petcu, Ana, Vlachoyiannopoulos, Panayiotis, Kucharz, Eugene J., Widuchowska, Malgorzata, Kopec-Medrek, Magdalena, Kotulska, Anna, Szücs, Gabriella, Stankovic, Aleksandra, Stamenkovic, Bojana, Selmi, Carlo Francesco, De Santis, Maria, Marasini, Bianca, Coleiro, Bernard, Santamaria, Vera Ortiz, Westhovens, René, Bečvář, Radim, Novak, Srdan, Engelhart, Merete, Meroni, Pierluigi, Ingegnoli, Francesca, Zeni, Silvana, Sulli, Alberto, Distler, Jörg, Yavuz, Sule, Montecucco, Carlomaurizio, Eyerich, Kilian, Krummel-Lorenz, Brigitte, Zenone, Thierry, Midtvedt, Øyvind, Chizzolini, Carlo, Seidel, Matthias, Oleszowsky, Mara, Üprus, Maria, Opriş, Daniela, Groşeanu, Laura, Bielecka, Otylia Kowal, Antonio, Zea Mendoza, Szechinski, Jacek, Morović-Vergles, Jadranka, Scorza, Raffaella, Puppo, Francesco, Mathieu, Alessandro, Anic, Branimir, Stork, Jiri, Stebbings, Simon, Inanc, Murat, Hasler, Paul, von Mühlen, Carlos Alberto, Aringer, Martin, Popa, Sergei, Li, Mengtao, and Rosato, Edoardo

Published
2016
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44. Key interactions in the trimolecular complex consisting of the rheumatoid arthritis-associated DRB1*04:01 molecule, the major glycosylated collagen II peptide and the T-cell receptor

Author

Ge, Changrong, primary, Weisse, Sylvia, additional, Xu, Bingze, additional, Dobritzsch, Doreen, additional, Viljanen, Johan, additional, Kihlberg, Jan, additional, Do, Nhu-Nguyen, additional, Schneider, Nadine, additional, Lanig, Harald, additional, Holmdahl, Rikard, additional, and Burkhardt, Harald, additional

Published
2022
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45. Sarilumab reduces disease activity in rheumatoid arthritis patients with inadequate response to janus kinase inhibitors or tocilizumab in regular care in Germany

Author

Tony, Hans-Peter, primary, Feist, Eugen, additional, Aries, Peer Malte, additional, Zinke, Silke, additional, Krüger, Klaus, additional, Ahlers, Jonas, additional, Albrecht, Inka, additional, Barrionuevo, Christian, additional, Kalus, Stefanie, additional, and Burkhardt, Harald, additional

Published
2022
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46. Fluorescence-optical imaging technique discriminates signs of early joint inflammation in patients suspect of Rheumatoid Arthritis in the PANORA trial

Author

Köhm, Michaela, Ohrndorf, Sarah, Glimm, Anne-Marie, Dauth, Stephanie, Henkemeier, Ulf, Rossmanith, Tanja, Burkhardt, Harald Louis, and Behrens, Frank

Subjects
genetic structures, ddc: 610, sense organs, 610 Medical sciences, Medicine, skin and connective tissue diseases, eye diseases
Abstract

Introduction: Rheumatoid Arthritis (RA) is a chronic inflammatory joint disease affecting about 1% of the European adults. Fluorescence-optical imaging (FOI) technique is an indocyanine-green (ICG) based procedure to assess changes of microvascularization in the hands. Purpose of the study was [for full text, please go to the a.m. URL], Deutscher Rheumatologiekongress 2021, 49. Kongress der Deutschen Gesellschaft für Rheumatologie (DGRh), 35. Jahrestagung der Deutschen Gesellschaft für Orthopädische Rheumatologie (DGORh), Wissenschaftliche Herbsttagung der Gesellschaft für Kinder- und Jugendrheumatologie (GKJR)

Published
2021
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47. Feuer unter der Haut

Author

Meier, Florian, Ferdinand, Samantha, Braner, Axel, and Burkhardt, Harald Louis

Subjects
ddc: 610, 610 Medical sciences, Medicine
Abstract

Vorgeschichte: Eine 53-jährige Syrerin präsentierte sich erstmalig Ende 2018 in einer chirurgischen Notaufnahme bei rasch zunehmender, schmerzhafter Weichteilschwellung mit Blasenbildung und Knistern der Haut beider Unterarme. Es erfolgte eine IV-Antibiose, sowie chirurgische Sanierung mit[zum vollständigen Text gelangen Sie über die oben angegebene URL], Deutscher Rheumatologiekongress 2021, 49. Kongress der Deutschen Gesellschaft für Rheumatologie (DGRh), 35. Jahrestagung der Deutschen Gesellschaft für Orthopädische Rheumatologie (DGORh), Wissenschaftliche Herbsttagung der Gesellschaft für Kinder- und Jugendrheumatologie (GKJR)

Published
2021

49. Genetic Analysis of MPO Variants in Four Psoriasis Subtypes in Patients from Germany

Author

Haskamp, Stefan, Horowitz, Joseph Simon, Oji, Vinzenz, Philipp, Sandra, Sticherling, Michael, Schäkel, Knut, Schuhmann, Sarah, Prinz, Jörg C., Burkhardt, Harald, Behrens, Frank, Böhm, Beate, Köhm, Michaela, Rech, Jürgen, Simon, David, Schett, Georg, Morrison, Kirsten, Gerdes, Sascha, Assmann, Gunter, Nimeh, Ali, Schuster, Volker, Jacobi, Arnd, Weyergraf, Ansgar, Reis, André, Uebe, Steffen, Wilsmann-Theis, Dagmar, Mößner, Rotraut, and Hüffmeier, Ulrike

Published
2021
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50. A gender gap in primary and secondary heart dysfunctions in systemic sclerosis: a EUSTAR prospective study

Author

Elhai, Muriel, Avouac, Jérôme, Walker, Ulrich A, Matucci-Cerinic, Marco, Riemekasten, Gabriela, Airò, Paolo, Hachulla, Eric, Valentini, Gabriele, Carreira, Patricia E, Cozzi, Franco, Balbir Gurman, Alexandra, Braun-Moscovici, Yolanda, Damjanov, Nemanja, Ananieva, Lidia P, Scorza, Raffaella, Jimenez, Sergio, Busquets, Joanna, Li, Mengtao, Müller-Ladner, Ulf, Kahan, André, Distler, Oliver, Allanore, Yannick, Guiducci, Serena, Tyndall, Alan, Lapadula, Giovanni, Iannone, Florenzo, Becvar, Radim, Sierakowsky, Stanislaw, Bielecka, Otylia Kowal, Cutolo, Maurizio, Sulli, Alberto, Cuomo, Giovanna, Vettori, Serena, Rednic, Simona, Nicoara, Ileana, Vlachoyiannopoulos, P., Montecucco, C., Caporali, Roberto, Novak, Srdan, Czirják, László, Varju, Cecilia, Chizzolini, Carlo, Kucharz, Eugene J., Kotulska, Anna, Kopec-Medrek, Magdalena, Widuchowska, Malgorzata, Rozman, Blaz, Mallia, Carmel, Coleiro, Bernard, Gabrielli, Armando, Farge, Dominique, Hij, Adrian, Hesselstrand, Roger, Scheja, Agneta, Wollheim, Frank, Martinovic, Duska, Govoni, M., Monaco, Andrea Lo, Hunzelmann, Nicolas, Pellerito, Raffaele, Bambara, Lisa Maria, Caramaschi, Paola, Black, Carol, Denton, Christopher, Henes, Jörg, Santamaria, Vera Ortiz, Heitmann, Stefan, Krasowska, Dorota, Seidel, Matthias, Oleszowsky, Mara, Burkhardt, Harald, Himsel, Andrea, Salvador, Maria J., Stamenkovic, Bojana, Stankovic, Aleksandra, Tikly, Mohammed, Starovoytova, Maya N., Engelhart, Merete, Strauss, Gitte, Nielsen, Henrik, Damgaard, Kirsten, Szücs, Gabriella, Zea Mendoza, Antonio, de la Puente Buijdos, Carlos, Sifuentes Giraldo, Walter A., Midtvedt, Øyvind, Garen, Torhild, Launay, David, Valesini, Guido, Riccieri, Valeria, Ionescu, Ruxandra Maria, Opris, Daniela, Groseanu, Laura, Wigley, Fredrick M., Mihai, Carmen M., Cornateanu, Roxana Sfrent, Ionitescu, Razvan, Gherghe, Ana Maria, Gorga, Marilena, Dobrota, Rucsandra, Bojinca, Mihai, Schett, Georg, Distler, Jörg HW, Meroni, Pierluigi, Zeni, Silvana, Mouthon, Luc, Keyser, Filip De, Smith, Vanessa, Cantatore, Francesco P., Corrado, Ada, Ullman, Susanne, Iversen, Line, Pozzi, Maria R., Eyerich, Kilian, Hein, Rüdiger, Knott, Elisabeth, Szechinski, Jacek, Wiland, Piotr, Szmyrka-Kaczmarek, Magdalena, Sokolik, Renata, Morgiel, Ewa, Krummel-Lorenz, Brigitte, Saar, Petra, Aringer, Martin, Günther, Claudia, Anic, Branimir, Baresic, Marko, Mayer, Miroslav, Radominski, Sebastião C., Müller, Carolina de Souza, Azevedo, Valderílio F., Agachi, Svetlana, Groppa, Liliana, Chiaburu, Lealea, Russu, Eugen, Zenone, Thierry, Stebbings, Simon, Highton, John, Stamp, Lisa, Chapman, Peter, Baron, Murray, OʼDonnell, John, Solanki, Kamal, Doube, Alan, Veale, Douglas, OʼRourke, Marie, Loyo, Esthela, Rosato, Edoardo, Pisarri, Simonetta, Tanaseanu, Cristina-Mihaela, Popescu, Monica, Dumitrascu, Alina, Tiglea, Isabela, Chirieac, Rodica, Ancuta, Codrina, Furst, Daniel E., Kafaja, Suzanne, Lefebvre, Paloma García de la Peña, Rubio, Silvia Rodriguez, Exposito, Marta Valero, Sibilia, Jean, Chatelus, Emmanuel, Gottenberg, Jacques Eric, Chifflot, Hélène, Litinsky, Ira, Venalis, Algirdas, Butrimiene, Irena, Venalis, Paulius, Rugiene, Rita, Karpec, Diana, Kerzberg, Eduardo, Montoya, Fabiana, and Cosentino, Vanesa

Published
2016
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