دورية أكاديمية
Effectiveness and safety of tocilizumab in patients with systemic sclerosis: a propensity score matched controlled observational study of the EUSTAR cohort
| العنوان: | Effectiveness and safety of tocilizumab in patients with systemic sclerosis: a propensity score matched controlled observational study of the EUSTAR cohort |
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| المؤلفون: | Kuster S., Jordan S., Elhai M., Held U., Steigmiller K., Bruni C., Cacciapaglia F., Vettori S., Siegert E., Rednic S., Codullo V., Airo P., Braun-Moscovici Y., Hunzelmann N., Joao Salvador M., Riccieri V., Gheorghiu A. -M., Alegre Sancho J. J., Romanowska-Prochnicka K., Castellvi I., Kotter I., Truchetet M. -E., Lopez-Longo F. J., Novikov P. I., Giollo A., Shirai Y., Belloli L., Zanatta E., Hachulla E., Smith V., Denton C., Ionescu R. M., Schmeiser T., Distler J. H. W., Gabrielli A., Hoffmann-Vold A. -M., Kuwana M., Allanore Y., Distler O Radim Becvar, Maurizio Cutolo, Patricia E Carreira, László Czirják, Michele Iudici, Eugene J Kucharz, Bernard Coleiro, Dominique Farge Bancel, Roger Hesselstrand, Mislav Radic, Raffaele Pellerito, Nemanja Damjanov, Jörg Henes, Stefan Heitmann Vera Ortiz-Santamaria, Paul Hasler, Bojana Stamenkovic, Carlo Francesco Selmi, Mohammed Tikly, Lidia P Ananieva, Ulf Müller-Ladner, Merete Engelhart, Carlos de la Puente, Cord Sunderkötter, Francesca Ingegnoli, Luc Mouthon, Francesco Paolo Cantatore, Susanne Ullman, Maria Rosa Pozzi, Piotr Wiland, Marie Vanthuyne, Juan Jose Alegre-Sancho, Brigitte Krummel-Lorenz, Kristine Herrmann, Ellen De Langhe, Branimir Anic, Sule Yavuz, Carolina de Souza Müller, Svetlana Agachi, Thierry Zenone, Simon Stebbings, Alessandra Vacca, Lisa Stamp, Kamal Solanki, Douglas Veale, Esthela Loyo, Mengtao Li, Walid Ahmed Abdel Atty Mohamed, Edoardo Rosato, Cristina-Mihaela Tanaseanu, Rosario Foti, Codrina Ancuta, Britta Maurer, Paloma Garcíadela Peña Lefebvre, Jean Sibilia, Ira Litinsky, Francesco Del Galdo, Goda Seskute, Lesley Ann Saketkoo, Eduardo Kerzberg, Doron Rimar, Camillo Ribi, Vivien M Hsu, Thierry Martin, Lorinda S Chung, Tim Schmeiser, Dominik Majewski, Vera Bernardino, Piercarlo Sarzi Puttini |
| المساهمون: | S., Kuster, S., Jordan, M., Elhai, U., Held, K., Steigmiller, C., Bruni, F., Cacciapaglia, S., Vettori, E., Siegert, S., Rednic, V., Codullo, P., Airo, Y., Braun-Moscovici, N., Hunzelmann, M., Joao Salvador, V., Riccieri, A. -M., Gheorghiu, J. J., Alegre Sancho, K., Romanowska-Prochnicka, I., Castellvi, I., Kotter, M. -E., Truchetet, F. J., Lopez-Longo, P. I., Novikov, A., Giollo, Y., Shirai, L., Belloli, E., Zanatta, E., Hachulla, V., Smith, C., Denton, R. M., Ionescu, T., Schmeiser, J. H. W., Distler, A., Gabrielli, A. -M., Hoffmann-Vold, M., Kuwana, Y., Allanore, O Radim Becvar, Distler, Cutolo, Maurizio, E Carreira, Patricia, Czirják, László, Iudici, Michele, J Kucharz, Eugene, Coleiro, Bernard, Farge Bancel, Dominique, Hesselstrand, Roger, Radic, Mislav, Pellerito, Raffaele, Damjanov, Nemanja, Henes, Jörg, Heitmann Vera Ortiz-Santamaria, Stefan, Hasler, Paul, Stamenkovic, Bojana, Francesco Selmi, Carlo, Tikly, Mohammed, P Ananieva, Lidia, Müller-Ladner, Ulf, Engelhart, Merete, de la Puente, Carlo, Sunderkötter, Cord, Ingegnoli, Francesca, Mouthon, Luc, Cantatore, FRANCESCO PAOLO, Ullman, Susanne, Rosa Pozzi, Maria, Wiland, Piotr, Vanthuyne, Marie, Jose Alegre-Sancho, Juan, Krummel-Lorenz, Brigitte, Herrmann, Kristine, De Langhe, Ellen, Anic, Branimir, Yavuz, Sule, de Souza Müller, Carolina, Agachi, Svetlana, Zenone, Thierry, Stebbings, Simon, Vacca, Alessandra, Stamp, Lisa, Solanki, Kamal, Veale, Dougla, Loyo, Esthela, Li, Mengtao, Ahmed Abdel Atty Mohamed, Walid, Rosato, Edoardo, Tanaseanu, Cristina-Mihaela, Foti, Rosario, Ancuta, Codrina, Maurer, Britta, Garcíadela Peña Lefebvre, Paloma, Sibilia, Jean, Litinsky, Ira, Del Galdo, Francesco, Seskute, Goda, Ann Saketkoo, Lesley, Kerzberg, Eduardo, Rimar, Doron, Ribi, Camillo, M Hsu, Vivien |
| سنة النشر: | 2022 |
| المجموعة: | Università degli Studi di Foggia: CINECA IRIS Institutional Research Information System |
| مصطلحات موضوعية: | autoimmune disease, biological therapy, systemic sclerosis |
| الوصف: | Objectives Tocilizumab showed trends for improving skin fibrosis and prevented progression of lung fibrosis in systemic sclerosis (SSc) in randomised controlled clinical trials. We aimed to assess safety and effectiveness of tocilizumab in a real-life setting using the European Scleroderma Trial and Research (EUSTAR) database. Methods Patients with SSc fulfilling the American College of Rheumatology (ACR)/EULAR 2013 classification criteria, with baseline and follow-up visits at 12±3 months, receiving tocilizumab or standard of care as the control group, were selected. Propensity score matching was applied. Primary endpoints were the modified Rodnan skin score (mRSS) and FVC at 12±3 months compared between the groups. Secondary endpoints were the percentage of progressive/regressive patients for skin and lung at 12±3 months. Results Ninety-three patients with SSc treated with tocilizumab and 3180 patients with SSc with standard of care fulfilled the inclusion criteria. Comparison between groups did not show significant differences, but favoured tocilizumab across all predefined primary and secondary endpoints: mRSS was lower in the tocilizumab group (difference -1.0, 95% CI -3.7 to 1.8, p=0.48). Similarly, FVC % predicted was higher in the tocilizumab group (difference 1.5 (-6.1 to 9.1), p=0.70). The percentage of progressive/regressive patients favoured tocilizumab over controls. These results were robust regarding the sensitivity analyses. Safety analysis confirmed previously reported adverse event profiles. Conclusion Although this large, observational, controlled, real-life EUSTAR study did not show significant effectiveness of tocilizumab on skin and lung fibrosis, the consistency of direction of all predefined endpoints generates hypothesis for potential effectiveness in a broader SSc population. |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| العلاقة: | volume:8; issue:2; firstpage:002477; journal:RMD OPEN; https://hdl.handle.net/11369/427431Test; info:eu-repo/semantics/altIdentifier/scopus/2-s2.0-85141272177 |
| DOI: | 10.1136/rmdopen-2022-002477 |
| الإتاحة: | https://doi.org/10.1136/rmdopen-2022-002477Test https://hdl.handle.net/11369/427431Test |
| رقم الانضمام: | edsbas.C94CB817 |
| قاعدة البيانات: | BASE |
| DOI: | 10.1136/rmdopen-2022-002477 |
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