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1. ERN ReCONNET points to consider for treating patients living with autoimmune rheumatic diseases with antiviral therapies and anti-SARS-CoV-2 antibody products

Author

Talarico, R, Ramirez, G, Barreira, S, Cardamone, C, Triggianese, P, Aguilera, S, Andersen, J, Avcin, T, Benistan, K, Bertsias, G, Bortoluzzi, A, Bouillot, C, Bulina, I, Burmester, G, Callens, S, Carreira, P, Cervera, R, Cutolo, M, Damian, L, Della-Torre, E, Faria, R, Fonseca, J, Galetti, I, Hachulla, E, Iaccarino, L, Jacobsen, S, Khmelinskii, N, Limper, M, Marinello, D, Meyer, A, Moroncini, G, Nagy, G, Olesinska, M, Pamfil, C, Pileckyte, M, Pistello, M, Rednic, S, Richez, C, Romao, V, Schneider, M, Sciascia, S, Scire, C, Simonini, G, Smith, V, Sulli, A, Tani, C, Tas, S, Tincani, A, Vonk, M, Tektonidou, M, Mosca, M, Talarico R., Ramirez G. A., Barreira S. C., Cardamone C., Triggianese P., Aguilera S., Andersen J., Avcin T., Benistan K., Bertsias G., Bortoluzzi A., Bouillot C., Bulina I., Burmester G. R., Callens S., Carreira P. E., Cervera R., Cutolo M., Damian L., Della-Torre E., Faria R., Fonseca J. E., Galetti I., Hachulla E., Iaccarino L., Jacobsen S., Khmelinskii N., Limper M., Marinello D., Meyer A., Moroncini G., Nagy G., Olesinska M., Pamfil C., Pileckyte M., Pistello M., Rednic S., Richez C., Romao V. C., Schneider M., Sciascia S., Scire C. A., Simonini G., Smith V., Sulli A., Tani C., Tas S. W., Tincani A., Vonk M. C., Tektonidou M., Mosca M., Talarico, R, Ramirez, G, Barreira, S, Cardamone, C, Triggianese, P, Aguilera, S, Andersen, J, Avcin, T, Benistan, K, Bertsias, G, Bortoluzzi, A, Bouillot, C, Bulina, I, Burmester, G, Callens, S, Carreira, P, Cervera, R, Cutolo, M, Damian, L, Della-Torre, E, Faria, R, Fonseca, J, Galetti, I, Hachulla, E, Iaccarino, L, Jacobsen, S, Khmelinskii, N, Limper, M, Marinello, D, Meyer, A, Moroncini, G, Nagy, G, Olesinska, M, Pamfil, C, Pileckyte, M, Pistello, M, Rednic, S, Richez, C, Romao, V, Schneider, M, Sciascia, S, Scire, C, Simonini, G, Smith, V, Sulli, A, Tani, C, Tas, S, Tincani, A, Vonk, M, Tektonidou, M, Mosca, M, Talarico R., Ramirez G. A., Barreira S. C., Cardamone C., Triggianese P., Aguilera S., Andersen J., Avcin T., Benistan K., Bertsias G., Bortoluzzi A., Bouillot C., Bulina I., Burmester G. R., Callens S., Carreira P. E., Cervera R., Cutolo M., Damian L., Della-Torre E., Faria R., Fonseca J. E., Galetti I., Hachulla E., Iaccarino L., Jacobsen S., Khmelinskii N., Limper M., Marinello D., Meyer A., Moroncini G., Nagy G., Olesinska M., Pamfil C., Pileckyte M., Pistello M., Rednic S., Richez C., Romao V. C., Schneider M., Sciascia S., Scire C. A., Simonini G., Smith V., Sulli A., Tani C., Tas S. W., Tincani A., Vonk M. C., Tektonidou M., and Mosca M.

Abstract

Recent studies have shown that people who are immunocompromised may inadvertently play a role in spurring the mutations of the virus that create new variants. This is because some immunocompromised individuals remain at risk of getting COVID-19 despite vaccination, experience more severe disease, are susceptible to being chronically infected and remain contagious for longer if they become infected and considering that immunocompromised individuals represent approximately 2% of the overall population, this aspect should be carefully considered. So far, some autoimmune rheumatic disease (ARD) patients with COVID-19 have been treated with antiviral therapies or anti-SARS-CoV-2 antibody products. However, there is no homogeneous approach to these treatment strategies. This issue was addressed within the European Reference Network (ERN) on Rare and Complex Connective Tissue and Musculoskeletal Diseases (ReCONNET) in a discussion among experts and patient's representatives in the context of the rare and complex connective tissue diseases (rCTDs) covered by the Network. ERN ReCONNET is one of the 24 ERNs launched by the European Commission in 2017 with the aim of tackling low prevalence and rare diseases that require highly specialised treatment and promoting concentration of knowledge and resources through virtual networks involving healthcare providers (HCPs) across the European Union (EU). Considering the urgent need to provide guidance not only to the rCTDs community, but also to the whole ARDs community, a multidisciplinary Task Force, including expert clinicians and European Patient Advocacy Group (ePAG) Advocates, was created in the framework of ERN ReCONNET with the aim of developing overarching principles (OP) and points-to-consider (PtC) on a homogenous approach to treat immunocompromised patients with ARDs (with a particular focus on CTDs) affected by COVID-19 using antiviral therapies and anti-SARS-CoV-2 antibody products. The present work reports the final OP

Published
2023

2. ERN ReCONNET points to consider for treating patients living with autoimmune rheumatic diseases with antiviral therapies and anti-SARS-CoV-2 antibody products.

Author

Talarico, R., Ramirez, G.A., Barreira, S.C., Cardamone, C., Triggianese, P., Aguilera, S., Andersen, J., Avcin, T., Benistan, K., Bertsias, G., Bortoluzzi, A., Bouillot, C., Bulina, I., Burmester, G.R., Callens, S., Carreira, P.E., Cervera, R., Cutolo, M., Damian, L., Della-Torre, E., Faria, R., Fonseca, J.E., Galetti, I., Hachulla, E., Iaccarino, L., Jacobsen, S., Khmelinskii, N., Limper, M., Marinello, D., Meyer, A, Moroncini, G., Nagy, G., Olesinska, M., Pamfil, C., Pileckyte, M., Pistello, M., Rednic, S., Richez, C., Romão, V.C., Schneider, M., Sciascia, S., Scirè, C.A., Simonini, G., Smith, V., Sulli, A., Tani, C., Tas, S.W., Tincani, A., Vonk, M.C., Tektonidou, M., Mosca, M., Talarico, R., Ramirez, G.A., Barreira, S.C., Cardamone, C., Triggianese, P., Aguilera, S., Andersen, J., Avcin, T., Benistan, K., Bertsias, G., Bortoluzzi, A., Bouillot, C., Bulina, I., Burmester, G.R., Callens, S., Carreira, P.E., Cervera, R., Cutolo, M., Damian, L., Della-Torre, E., Faria, R., Fonseca, J.E., Galetti, I., Hachulla, E., Iaccarino, L., Jacobsen, S., Khmelinskii, N., Limper, M., Marinello, D., Meyer, A, Moroncini, G., Nagy, G., Olesinska, M., Pamfil, C., Pileckyte, M., Pistello, M., Rednic, S., Richez, C., Romão, V.C., Schneider, M., Sciascia, S., Scirè, C.A., Simonini, G., Smith, V., Sulli, A., Tani, C., Tas, S.W., Tincani, A., Vonk, M.C., Tektonidou, M., and Mosca, M.

Abstract

Item does not contain fulltext, Recent studies have shown that people who are immunocompromised may inadvertently play a role in spurring the mutations of the virus that create new variants. This is because some immunocompromised individuals remain at risk of getting COVID-19 despite vaccination, experience more severe disease, are susceptible to being chronically infected and remain contagious for longer if they become infected and considering that immunocompromised individuals represent approximately 2% of the overall population, this aspect should be carefully considered. So far, some autoimmune rheumatic disease (ARD) patients with COVID-19 have been treated with antiviral therapies or anti-SARS-CoV-2 antibody products. However, there is no homogeneous approach to these treatment strategies. This issue was addressed within the European Reference Network (ERN) on Rare and Complex Connective Tissue and Musculoskeletal Diseases (ReCONNET) in a discussion among experts and patient's representatives in the context of the rare and complex connective tissue diseases (rCTDs) covered by the Network. ERN ReCONNET is one of the 24 ERNs launched by the European Commission in 2017 with the aim of tackling low prevalence and rare diseases that require highly specialised treatment and promoting concentration of knowledge and resources through virtual networks involving healthcare providers (HCPs) across the European Union (EU). Considering the urgent need to provide guidance not only to the rCTDs community, but also to the whole ARDs community, a multidisciplinary Task Force, including expert clinicians and European Patient Advocacy Group (ePAG) Advocates, was created in the framework of ERN ReCONNET with the aim of developing overarching principles (OP) and points-to-consider (PtC) on a homogenous approach to treat immunocompromised patients with ARDs (with a particular focus on CTDs) affected by COVID-19 using antiviral therapies and anti-SARS-CoV-2 antibody products. The present work reports the final OP

Published
2023

3. ERN ReCONNET points to consider for treating patients living with autoimmune rheumatic diseases with antiviral therapies and anti-SARS-CoV-2 antibody products

Author

Talarico, Rosaria R., Ramirez, G. A., Barreira, S. C., Cardamone, C., Triggianese, P., Aguilera, S., Andersen, J., Avcin, T., Benistan, K., Bertsias, G., Bortoluzzi, A., Bouillot, C., Bulina, I., Burmester, G. R., Callens, S., Carreira, P. E., Cervera, R., Cutolo, M., Damian, L., Torre, E. Della, Faria, R., Fonseca, J. E., Galetti, I., Hachulla, E., Iaccarino, L., Jacobsen, S., Khmelinskii, N., Limper, M., Marinello, D., Meyer, A., Moroncini, G., Nagy, G., Olesinska, M., Pamfil, C., Pileckyte, M., Pistello, M., Rednic, S., Richez, C., Romão, V. C., Schneider, M., Sciascia, S., Scirè, C. A., Simonini, G., Smith, V., Sulli, A., Tani, C., Tas, S. W., Tincani, A., Vonk, M. C., Tektonidou, M., Mosca, M., Talarico, Rosaria R., Ramirez, G. A., Barreira, S. C., Cardamone, C., Triggianese, P., Aguilera, S., Andersen, J., Avcin, T., Benistan, K., Bertsias, G., Bortoluzzi, A., Bouillot, C., Bulina, I., Burmester, G. R., Callens, S., Carreira, P. E., Cervera, R., Cutolo, M., Damian, L., Torre, E. Della, Faria, R., Fonseca, J. E., Galetti, I., Hachulla, E., Iaccarino, L., Jacobsen, S., Khmelinskii, N., Limper, M., Marinello, D., Meyer, A., Moroncini, G., Nagy, G., Olesinska, M., Pamfil, C., Pileckyte, M., Pistello, M., Rednic, S., Richez, C., Romão, V. C., Schneider, M., Sciascia, S., Scirè, C. A., Simonini, G., Smith, V., Sulli, A., Tani, C., Tas, S. W., Tincani, A., Vonk, M. C., Tektonidou, M., and Mosca, M.

Abstract

Recent studies have shown that people who are immunocompromised may inadvertently play a role in spurring the mutations of the virus that create new variants. This is because some immunocompromised individuals remain at risk of getting COVID-19 despite vaccination, experience more severe disease, are susceptible to being chronically infected and remain contagious for longer if they become infected and considering that immunocompromised individuals represent approximately 2% of the overall population, this aspect should be carefully considered. So far, some autoimmune rheumatic disease (ARD) patients with COVID-19 have been treated with antiviral therapies or anti-SARS-CoV-2 antibody products. However, there is no homogeneous approach to these treatment strategies. This issue was addressed within the European Reference Network (ERN) on Rare and Complex Connective Tissue and Musculoskeletal Diseases (ReCONNET) in a discussion among experts and patient’s representatives in the context of the rare and complex connective tissue diseases (rCTDs) covered by the Network. ERN ReCONNET is one of the 24 ERNs launched by the European Commission in 2017 with the aim of tackling low prevalence and rare diseases that require highly specialised treatment and promoting concentration of knowledge and resources through virtual networks involving healthcare providers (HCPs) across the European Union (EU). Considering the urgent need to provide guidance not only to the rCTDs community, but also to the whole ARDs community, a multidisciplinary Task Force, including expert clinicians and European Patient Advocacy Group (ePAG) Advocates, was created in the framework of ERN ReCONNET with the aim of developing overarching principles (OP) and points-to-consider (PtC) on a homogenous approach to treat immunocompromised patients with ARDs (with a particular focus on CTDs) affected by COVID-19 using antiviral therapies and anti-SARS-CoV-2 antibody products. The present work reports the final OP, Recent studies have shown that people who are immunocompromised may inadvertently play a role in spurring the mutations of the virus that create new variants. This is because some immunocompromised individuals remain at risk of getting COVID-19 despite vaccination, experience more severe disease, are susceptible to being chronically infected and remain contagious for longer if they become infected and considering that immunocompromised individuals represent approximately 2% of the overall population, this aspect should be carefully considered. So far, some autoimmune rheumatic disease (ARD) patients with COVID-19 have been treated with antiviral therapies or anti-SARS-CoV-2 antibody products. However, there is no homogeneous approach to these treatment strategies. This issue was addressed within the European Reference Network (ERN) on Rare and Complex Connective Tissue and Musculoskeletal Diseases (ReCONNET) in a discussion among experts and patient's representatives in the context of the rare and complex connective tissue diseases (rCTDs) covered by the Network. ERN ReCONNET is one of the 24 ERNs launched by the European Commission in 2017 with the aim of tackling low prevalence and rare diseases that require highly specialised treatment and promoting concentration of knowledge and resources through virtual networks involving healthcare providers (HCPs) across the European Union (EU). Considering the urgent need to provide guidance not only to the rCTDs community, but also to the whole ARDs community, a multidisciplinary Task Force, including expert clinicians and European Patient Advocacy Group (ePAG) Advocates, was created in the framework of ERN ReCONNET with the aim of developing overarching principles (OP) and points-to-consider (PtC) on a homogenous approach to treat immunocompromised patients with ARDs (with a particular focus on CTDs) affected by COVID-19 using antiviral therapies and anti-SARS-CoV-2 antibody products. The present work reports the final

Published
2023

5. B-cell targeted therapy in systemic lupus erythematosus: potential of rituximab

Author

Wiesik-Szewczyk E and Olesinska M

Subjects
Medicine (General), R5-920
Abstract

E Wiesik-Szewczyk, M OlesinskaInstitute of Rheumatology, Department of Connective Tissue Diseases, Warsaw, PolandAbstract: Systemic lupus erythematosus (SLE) is a complex autoimmune disease of unknown etiology, and the limited available therapeutic options for this disease, are frustrating to both clinicians and patients. However, recent advances in the understanding of disease mechanisms have given rise to numerous studies on specific approaches to SLE treatment. Rituximab, the first chimeric, mouse-human monoclonal antibody which is directed against CD20, seems to be a new therapeutic option. The purpose of this review is to explain the current clinical evidence on the therapeutic use of rituximab in adult SLE patients. Two randomized clinical trials with rituximab (the EXPLORER and LUNAR studies) failed to prove efficacy of this drug on SLE. Ongoing data analysis continues to explain the reasons behind why this treatment fails to work. However data from open source and observational studies contrast with clinical trials results. The global analysis of this data supports the off-label use of rituximab in subsets of SLE that are refractory to standard treatment.Keywords: B cells, systemic lupus erythematosus, rituximab, off-label use, clinical trials

Published
2012

10. 2016 ACR-EULAR adult dermatomyositis and polymyositis and juvenile dermatomyositis response criteria—methodological aspects

Author

Rider, L. G., Ruperto, N., Pistorio, A., Erman, B., Bayat, N., Lachenbruc, P. A., Rockette, H., Feldman, B. M., Huber, A. M., Hansen, P., Oddis, C. V., Lundberg, I. E., Amato, A. A., Chinoy, H., Cooper, R. G., Chung, L., Danko, K., Fiorentino, D., De la Torre, I. G., Reed, A. M., Song, Y. W., Cimaz, R., Cuttica, R. J., Pilkington, C. A., Martini, A., van der Net, J., Maillard, S., Miller, F. W., Vencovsky, J., Aggarwal, R., Christopher-Stine, L., Criscione-Schreiber, L., Crofford, L., Cronin, M. E., Gordon, P., Hengstman, G., Katz, J. D., Mammen, A., Marder, G., Mchugh, N., Schiopu, E., Wolfe, G., Wortmann, R., Apaz, M., Bowyer, S., Constantin, T., Curran, M., Davidson, J., Griffin, T., Jones, O., Kim, S., Lang, B., Lindsley, C., Lovell, D., Magalhaes, C. S., Pachman, L. M., Ponyi, A., Punaro, M., Quartier, P., Ramanan, A. V., Ravelli, A., Rennebohm, R., Van Royen-Kerkhof, A., Sherry, D. D., Silva, C. A., Stringer, E., Wallace, C., Ascherman, D., Barohn, R., Benveniste, O., De Bleecker, J., Callen, J., Charles-Schoeman, C., Danoff, S., Dastmalchi, M., Dimachkie, M., Di Martino, S., Dourmishev, L., Ernste, F., Gono, T., Isenberg, D., Katsumata, Y., Kissel, J., Leff, R. L., Levine, T., Mann, H., Marie, I., Merola, J., Olesinska, M., Olsen, N., Pipitone, N., Ramchandren, S., Rutkove, S., Saketkoo, L. A., Schiffenbauer, A., Selva-O'Callaghan, A., Shinjo, S. K., Shupak, R., Swierkocka, K., de Visser, M., Wanschitz, J., Werth, V. P., Whitt, I., Ytterberg, S., Avcin, T., Becker, M., Beresford, M. W., Dressler, F., Dvergsten, J., Ferriani, V. P. L., Flato, B., Gerloni, V., Henrickson, M., Hinze, C., Hoeltzel, M., BUNES IBARRA, MIGUEL ANGEL, Ilowite, N., Imundo, L., Kingsbury, D., Magnusson, B., Maguiness, S., Mathiesen, P., Mccann, L., Nielsen, S., de Oliveira, S. K. F., Passo, M., Rabinovich, E., Rivas-Chacon, R., Robinson, A. B., Rouster-Stevens, K., Russo, R., Rutkowska-Sak, L., Sallum, A., Sanner, H., Schmeling, H., Selcen, D., Shaham, B., Spencer, C. H., Sundel, R., Tardieu, M., Thatayatikom, A., Wahezi, D., and Zulian, F.

Subjects
medicine.medical_specialty, dermatomyositis, Hybrid measure, 1000Minds software, Minimal Clinically Important Difference, response criteria, Klinikai orvostudományok, Logistic regression, Polymyositis, Dermatomyositis, polymyositis, 03 medical and health sciences, 0302 clinical medicine, Rheumatology, Response criteria, medicine, Humans, Pharmacology (medical), Conjoint analysis, outcome assessment, Juvenile dermatomyositis, Myositis, 030203 arthritis & rheumatology, hybrid measure, juvenile dermatomyositis, business.industry, Minimal clinically important difference, Outcome assessment, Area Under Curve, Logistic Models, Treatment Outcome, Orvostudományok, Clinical Science, medicine.disease, Adult dermatomyositis, Clinical trial, Physical therapy, conjoint analysis, business, 030217 neurology & neurosurgery
Abstract

Objective: The objective was to describe the methodology used to develop new response criteria for adult DM/PM and JDM.Methods: Patient profiles from prospective natural history data and clinical trials were rated by myositis specialists to develop consensus gold-standard ratings of minimal, moderate and major improvement. Experts completed a survey regarding clinically meaningful improvement in the core set measures (CSM) and a conjoint-analysis survey (using 1000Minds software) to derive relative weights of CSM and candidate definitions. Six types of candidate definitions for response criteria were derived using survey results, logistic regression, conjoint analysis, application of conjoint-analysis weights to CSM and published definitions. Sensitivity, specificity and area under the curve were defined for candidate criteria using consensus patient profile data, and selected definitions were validated using clinical trial data.Results: Myositis specialists defined the degree of clinically meaningful improvement in CSM for minimal, moderate and major improvement. The conjoint-analysis survey established the relative weights of CSM, with muscle strength and Physician Global Activity as most important. Many candidate definitions showed excellent sensitivity, specificity and area under the curve in the consensus profiles. Trial validation showed that a number of candidate criteria differentiated between treatment groups. Top candidate criteria definitions were presented at the consensus conference.Conclusion: Consensus methodology, with definitions tested on patient profiles and validated using clinical trials, led to 18 definitions for adult PM/DM and 14 for JDM as excellent candidates for consideration in the final consensus on new response criteria for myositis.

Published
2017
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11. Update of EULAR recommendations for the treatment of systemic sclerosis

Author

Kowal-Bielecka O., Fransen J., Avouac J., Becker M., Kulak A., Allanore Y., Distler O., Clements P., Cutolo M., Czirjak L., Damjanov N., Del Galdo F., Denton C. P., Distler J. H. W., Foeldvari I., Figelstone K., Frerix M., Furst D. E., Guiducci S., Hunzelmann N., Khanna D., Matucci-Cerinic M., Herrick A. L., Van Den Hoogen F., Van Laar J. M., Riemekasten G., Silver R., Smith V., Sulli A., Tarner I., Tyndall A., Welling J., Wigley F., Valentini G., Walker U. A., Zulian F., Muller-Ladner U., Daikeler T., Lanciano E., Becvar R., Tomcik M., Gindzienska-Sieskiewicz E., Cuomo G., Iudici M., Rednic S., Vlachoyiannopoulos P. G., Caporali R., Carreira P. E., Novak S., Minier T., Kucharz E. J., Gabrielli A., Moroncini G., Airo' P., Hesselstrand R., Martinovic D., Radic M., Marasovic-Krstulovic D., Braun-Moscovici Y., Balbir-Gurman A., Lo Monaco A., Caramaschi P., Morovic-Vergles J., Henes J., Ortiz Santamaria V., Heitmann S., Krasowska D., Seidel M. F., Hasler P., Pereira Da Silva J. A., Salvador M. J., Stamenkovic B., Stankovic A., Tikly M., Ananieva L. P., Beretta L., Szucs G., Szamosi S., de la Puente Bujidos C., Midtvedt O., Hoffmann-Vold A. -M., Launay D., Hachulla E., Riccieri V., Ionescu R., Opris D., Mihai C., Herrgott I., Beyer C., Ingegnoli F., von Muhlen C. A., Alegre-Sancho J. J., Beltran-Catalan E., Aringer M., Fantana J., Leuchten N., Tausche A. -K., De Langhe E., Vanthuyne M., Anic B., Baresic M., Mayer M., Uprus M., Otsa K., Yavuz S., Granel B., Azevedo V. F., Muller C., Jimenez S. A., Popa S., Agachi S., Zenone T., Stebbings S., Dockerty J., Vacca A., Schollum J., Veale D. J., Toloza S., Xu D., Olas J., Rosato E., Foti R., Adler S., Dan D., Wiesik-Szewczyk E., Olesinska M., Kayser C., Fathi N., de la Pena Lefebvre P. G., Imbert B., Kowal-Bielecka, O., Fransen, J., Avouac, J., Becker, M., Kulak, A., Allanore, Y., Distler, O., Clements, P., Cutolo, M., Czirjak, L., Damjanov, N., Del Galdo, F., Denton, C. P., Distler, J. H. W., Foeldvari, I., Figelstone, K., Frerix, M., Furst, D. E., Guiducci, S., Hunzelmann, N., Khanna, D., Matucci-Cerinic, M., Herrick, A. L., Van Den Hoogen, F., Van Laar, J. M., Riemekasten, G., Silver, R., Smith, V., Sulli, A., Tarner, I., Tyndall, A., Welling, J., Wigley, F., Valentini, G., Walker, U. A., Zulian, F., Muller-Ladner, U., Daikeler, T., Lanciano, E., Becvar, R., Tomcik, M., Gindzienska-Sieskiewicz, E., Cuomo, G., Iudici, M., Rednic, S., Vlachoyiannopoulos, P. G., Caporali, R., Carreira, P. E., Novak, S., Minier, T., Kucharz, E. J., Gabrielli, A., Moroncini, G., Airo', P., Hesselstrand, R., Martinovic, D., Radic, M., Marasovic-Krstulovic, D., Braun-Moscovici, Y., Balbir-Gurman, A., Lo Monaco, A., Caramaschi, P., Morovic-Vergles, J., Henes, J., Ortiz Santamaria, V., Heitmann, S., Krasowska, D., Seidel, M. F., Hasler, P., Pereira Da Silva, J. A., Salvador, M. J., Stamenkovic, B., Stankovic, A., Tikly, M., Ananieva, L. P., Beretta, L., Szucs, G., Szamosi, S., de la Puente Bujidos, C., Midtvedt, O., Hoffmann-Vold, A. -M., Launay, D., Hachulla, E., Riccieri, V., Ionescu, R., Opris, D., Mihai, C., Herrgott, I., Beyer, C., Ingegnoli, F., von Muhlen, C. A., Alegre-Sancho, J. J., Beltran-Catalan, E., Aringer, M., Fantana, J., Leuchten, N., Tausche, A. -K., De Langhe, E., Vanthuyne, M., Anic, B., Baresic, M., Mayer, M., Uprus, M., Otsa, K., Yavuz, S., Granel, B., Azevedo, V. F., Muller, C., Jimenez, S. A., Popa, S., Agachi, S., Zenone, T., Stebbings, S., Dockerty, J., Vacca, A., Schollum, J., Veale, D. J., Toloza, S., Xu, D., Olas, J., Rosato, E., Foti, R., Adler, S., Dan, D., Wiesik-Szewczyk, E., Olesinska, M., Kayser, C., Fathi, N., de la Pena Lefebvre, P. G., Imbert, B., UCL - SSS/IREC/SLUC - Pôle St.-Luc, UCL - (MGD) Service de rhumatologie, Kowal Bielecka, Otylia, Fransen, Jaap, Avouac, Jerome, Becker, Mike, Kulak, Agnieszka, Allanore, Yannick, Distler, Oliver, Clements, Philip, Cutolo, Maurizio, Czirjak, Laszlo, Damjanov, Nemanja, del Galdo, Francesco, Denton, Christopher P., Distler, Jörg H. W., Foeldvari, Ivan, Figelstone, Kim, Frerix, Marc, Furst, Daniel E., Guiducci, Serena, Hunzelmann, Nicola, Khanna, Dinesh, Matucci Cerinic, Marco, Herrick, Ariane L., van den Hoogen, Frank, van Laar, Jacob M., Riemekasten, Gabriela, Silver, Richard, Smith, Vanessa, Sulli, Alberto, Tarner, Ingo, Tyndall, Alan, Welling, Joep, Wigley, Frederic, Valentini, Gabriele, Walker, Ulrich A., Zulian, Francesco, Müller Ladner, Ulf, Daikeler, Thoma, Lanciano, Elisabetta, Becvã¡r, Radim, Tomcik, Michal, Gindzienska Sieskiewicz, Ewa, Iudici, Michele, Rednic, Simona, Vlachoyiannopoulos, Panayiotis G., Caporali, Roberto, Carreira, Patricia E., Novak, Srdan, Minier, Tã¼nde, Kucharz, Eugene J., Gabrielli, Armando, Moroncini, Gianluca, Airo, Paolo, Hesselstrand, Roger, Martinovic, Duska, Radic, Mislav, Marasovic Krstulovic, Daniela, Braun Moscovici, Yolanda, Monaco, Andrea Lo, Morovic Vergles, Jadranka, Culo, Melanie I., Henes, Jã¶rg, Santamaria, Vera Ortiz, Heitmann, Stefan, Krasowska, Dorota, Michalska Jakubus, Malgorzata, Seidel, Matthias F., Klinik III, Medizinische, Hasler, Paul, Da Silva, José A. Pereira, Salvador, Maria J., Stamenkovic, Bojana, Stankovic, Aleksandra, Tikly, Mohammed, Ananieva, Lidia P., Beretta, Lorenzo, Szucs, Gabriella, Szamosi, Szilvia, de la Puente Bujidos, Carlo, Midtvedt, Øyvind, Hoffmann Vold, Anna Maria, Launay, David, Hachulla, Eric, Riccieri, Valeria, Ionescu, Ruxandra, Opris, Daniela, Mihai, Carina, Herrgott, Ilka, Beyer, Christian, Ingegnoli, Francesca, von Mühlen, Carlos Alberto, Alegre Sancho, Juan José, Beltran Catalan, Emma, Aringer, Martin, Fantana, Julia, Leuchten, Nicolai, Tausche, Anne Kathrin, Langhe, Ellen De, Vanthuyne, Marie, Anic, Branimir, Bareå¡ic, Marko, Mayer, Miroslav, Ãœprus, Maria, Otsa, Kati, Yavuz, Sule, Granel, Brigitte, Jimenez, Sergio A., Popa, Serghei, Agachi, Svetlana, Zenone, Thierry, Stebbings, Simon, Dockerty, Joanne, Vacca, Alessandra, Schollum, Joanna, Veale, Douglas J., Toloza, Sergio, Xu, Dong, Olas, Jacek, Rosato, Edoardo, Foti, Rosario, Adler, Sabine, Dan, Diana, Wiesik Szewczyk, Ewa, Olesinska, Marzena, Kayser, Cristiane, Fathi, Nihal, de la Peña Lefebvre, Paloma García, Imbert, Bernard, and Cuomo, Giovanna

Subjects
Endothelin Receptor Antagonists, Lung Diseases, Kidney Disease, Delphi Technique, Gastrointestinal Diseases, systemic sclerosis, Scleroderma Renal Crisis, Placebo-controlled study, Angiotensin-Converting Enzyme Inhibitors, Lung Disease, Scleroderma, 0302 clinical medicine, Glucocorticoid, Phosphodiesterase 5 Inhibitor, Immunology and Allergy, skin and connective tissue diseases, BIOMEDICINA I ZDRAVSTVO. Kliničke medicinske znanosti. Interna medicina, integumentary system, treatment, genetics and molecular biology (all), Hematopoietic Stem Cell Transplantation, cyclophosphamide, methotrexate, Pulmonary, Orvostudományok, Serotonin Uptake Inhibitor, 3. Good health, Europe, Systematic review, Hypertension, Serotonin Uptake Inhibitors, Cyclophosphamide, Methotrexate, Systemic Sclerosis, Treatment, Fingers, Fluoxetine, Glucocorticoids, Humans, Hypertension, Pulmonary, Kidney Diseases, Phosphodiesterase 5 Inhibitors, Prostaglandins I, Pyrazoles, Pyrimidines, Raynaud Disease, Rheumatology, Scleroderma, Systemic, Ulcer, Immunology, Biochemistry, Genetics and Molecular Biology (all), 030211 gastroenterology & hepatology, Endothelin Receptor Antagonist, Selective Serotonin Reuptake Inhibitors, medicine.drug, Human, medicine.medical_specialty, Gastrointestinal Disease, Klinikai orvostudományok, Riociguat, General Biochemistry, Genetics and Molecular Biology, 03 medical and health sciences, medicine, Finger, biochemistry, Intensive care medicine, BIOMEDICINE AND HEALTHCARE. Clinical Medical Sciences. Internal Medicine, Systemic Sclerosi, 030203 arthritis & rheumatology, business.industry, Systemic, Angiotensin-Converting Enzyme Inhibitor, medicine.disease, Transplantation, Clinical research, Pyrimidine, immunology and allergy, rheumatology, immunology, Pyrazole, Physical therapy, business, Rheumatism
Abstract

The aim was to update the 2009 European League against Rheumatism (EULAR) recommendations for the treatment of systemic sclerosis (SSc), with attention to new therapeutic questions. Update of the previous treatment recommendations was performed according to EULAR standard operating procedures. The task force consisted of 32 SSc clinical experts from Europe and the USA, 2 patients nominated by the pan-European patient association for SSc (Federation of European Scleroderma Associations (FESCA)), a clinical epidemiologist and 2 research fellows. All centres from the EULAR Scleroderma Trials and Research group were invited to submit and select clinical questions concerning SSc treatment using a Delphi approach. Accordingly, 46 clinical questions addressing 26 different interventions were selected for systematic literature review. The new recommendations were based on the available evidence and developed in a consensus meeting with clinical experts and patients. The procedure resulted in 16 recommendations being developed (instead of 14 in 2009) that address treatment of several SSc-related organ complications: Raynaud's phenomenon (RP), digital ulcers (DUs), pulmonary arterial hypertension (PAH), skin and lung disease, scleroderma renal crisis and gastrointestinal involvement. Compared with the 2009 recommendations, the 2016 recommendations include phosphodiesterase type 5 (PDE-5) inhibitors for the treatment of SSc-related RP and DUs, riociguat, new aspects for endothelin receptor antagonists, prostacyclin analogues and PDE-5 inhibitors for SSc-related PAH. New recommendations regarding the use of fluoxetine for SSc-related RP and haematopoietic stem cell transplantation for selected patients with rapidly progressive SSc were also added. In addition, several comments regarding other treatments addressed in clinical questions and suggestions for the SSc research agenda were formulated. These updated data-derived and consensus-derived recommendations will help rheumatologists to manage patients with SSc in an evidence-based way. These recommendations also give directions for future clinical research in SSc.

Published
2017
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12. Preservation of Lung Function Observed in a Phase 3 Randomized Controlled Trial of Tocilizumab for the Treatment of Early Systemic Sclerosis

Author

Khanna, D., primary, Lin, C.J.F., additional, Goldin, J., additional, Kim, G., additional, Kuwana, M., additional, Allanore, Y., additional, Batalov, A., additional, Butrimiene, I., additional, Carreira, P., additional, Matucci-Cerinic, M., additional, Distler, O., additional, Martinovic Kaliterna, D., additional, Mihai, C.-M., additional, Mogensen, M., additional, Olesinska, M., additional, Pope, J.E., additional, Riemekasten, G., additional, Rodriguez-Reyna, T.S., additional, Santos, M.J., additional, van Laar, J., additional, Spotswood, H., additional, Siegel, J., additional, Jahreis, A., additional, Furst, D., additional, and Denton, C.P., additional

Published
2019
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13. A framework for remission in SLE: Consensus findings from a large international task force on definitions of remission in SLE (DORIS)

Author

Van Vollenhoven, R. Voskuyl, A. Bertsias, G. Aranow, C. Aringer, M. Arnaud, L. Askanase, A. Balážová, P. Bonfa, E. Bootsma, H. Boumpas, D. Bruce, I. Cervera, R. Clarke, A. Coney, C. Costedoat-Chalumeau, N. Czirják, L. Derksen, R. Doria, A. Dörner, T. Fischer-Betz, R. Fritsch-Stork, R. Gordon, C. Graninger, W. Györi, N. Houssiau, F. Isenberg, D. Jacobsen, S. Jayne, D. Kuhn, A. Le Guern, V. Lerstrøm, K. Levy, R. MacHado-Ribeiro, F. Mariette, X. Missaykeh, J. Morand, E. Mosca, M. Inanc, M. Navarra, S. Neumann, I. Olesinska, M. Petri, M. Rahman, A. Rekvig, O.P. Rovensky, J. Shoenfeld, Y. Smolen, J. Tincani, A. Urowitz, M. Van Leeuw, B. Vasconcelos, C. Voss, A. Werth, V.P. Zakharova, H. Zoma, A. Schneider, M. Ward, M.

Subjects
skin and connective tissue diseases
Abstract

Objectives Treat-to-target recommendations have identified 'remission' as a target in systemic lupus erythematosus (SLE), but recognise that there is no universally accepted definition for this. Therefore, we initiated a process to achieve consensus on potential definitions for remission in SLE. Methods An international task force of 60 specialists and patient representatives participated in preparatory exercises, a face-to-face meeting and follow-up electronic voting. The level for agreement was set at 90%. Results The task force agreed on eight key statements regarding remission in SLE and three principles to guide the further development of remission definitions: 1. Definitions of remission will be worded as follows: remission in SLE is a durable state characterised by ...................... (reference to symptoms, signs, routine labs). 2. For defining remission, a validated index must be used, for example, clinical systemic lupus erythematosus disease activity index (SLEDAI)=0, British Isles lupus assessment group (BILAG) 2004 D/E only, clinical European consensus lupus outcome measure (ECLAM)=0; with routine laboratory assessments included, and supplemented with physician's global assessment. 3. Distinction is made between remission off and on therapy: remission off therapy requires the patient to be on no other treatment for SLE than maintenance antimalarials; and remission on therapy allows patients to be on stable maintenance antimalarials, low-dose corticosteroids (prednisone ≤5 mg/day), maintenance immunosuppressives and/or maintenance biologics. The task force also agreed that the most appropriate outcomes (dependent variables) for testing the prognostic value (construct validity) of potential remission definitions are: death, damage, flares and measures of health-related quality of life. Conclusions The work of this international task force provides a framework for testing different definitions of remission against long-term outcomes. © Published by the BMJ Publishing Group Limited.

Published
2017

15. A framework for remission in SLE: Consensus findings from a large international task force on definitions of remission in SLE (DORIS).

Author

Tincani A., Voskuyl A., Bertsias G., Aranow C., Aringer M., Arnaud L., Askanase A., Balazova P., Bonfa E., Bootsma H., Boumpas D., Bruce I., Cervera R., Clarke A., Coney C., Costedoat-Chalumeau N., Czirjak L., Rekvig O.P., Rovensky J., Shoenfeld Y., Smolen J., Van Vollenhoven R., Urowitz M., Van Leeuw B., Vasconcelos C., Voss A., Werth V.P., Zakharova H., Zoma A., Schneider M., Ward M., Derksen R., Doria A., Dorner T., Fischer-Betz R., Fritsch-Stork R., Gordon C., Graninger W., Gyori N., Houssiau F., Isenberg D., Jacobsen S., Jayne D., Kuhn A., Le Guern V., Lerstrom K., Levy R., MacHado-Ribeiro F., Mariette X., Missaykeh J., Morand E., Mosca M., Inanc M., Navarra S., Neumann I., Olesinska M., Petri M., Rahman A., Tincani A., Voskuyl A., Bertsias G., Aranow C., Aringer M., Arnaud L., Askanase A., Balazova P., Bonfa E., Bootsma H., Boumpas D., Bruce I., Cervera R., Clarke A., Coney C., Costedoat-Chalumeau N., Czirjak L., Rekvig O.P., Rovensky J., Shoenfeld Y., Smolen J., Van Vollenhoven R., Urowitz M., Van Leeuw B., Vasconcelos C., Voss A., Werth V.P., Zakharova H., Zoma A., Schneider M., Ward M., Derksen R., Doria A., Dorner T., Fischer-Betz R., Fritsch-Stork R., Gordon C., Graninger W., Gyori N., Houssiau F., Isenberg D., Jacobsen S., Jayne D., Kuhn A., Le Guern V., Lerstrom K., Levy R., MacHado-Ribeiro F., Mariette X., Missaykeh J., Morand E., Mosca M., Inanc M., Navarra S., Neumann I., Olesinska M., Petri M., and Rahman A.

Abstract

Objectives Treat-to-target recommendations have identified 'remission' as a target in systemic lupus erythematosus (SLE), but recognise that there is no universally accepted definition for this. Therefore, we initiated a process to achieve consensus on potential definitions for remission in SLE. Methods An international task force of 60 specialists and patient representatives participated in preparatory exercises, a face-to-face meeting and follow-up electronic voting. The level for agreement was set at 90%. Results The task force agreed on eight key statements regarding remission in SLE and three principles to guide the further development of remission definitions: 1. Definitions of remission will be worded as follows: remission in SLE is a durable state characterised by ...................... (reference to symptoms, signs, routine labs). 2. For defining remission, a validated index must be used, for example, clinical systemic lupus erythematosus disease activity index (SLEDAI)=0, British Isles lupus assessment group (BILAG) 2004 D/E only, clinical European consensus lupus outcome measure (ECLAM)=0; with routine laboratory assessments included, and supplemented with physician's global assessment. 3. Distinction is made between remission off and on therapy: remission off therapy requires the patient to be on no other treatment for SLE than maintenance antimalarials; and remission on therapy allows patients to be on stable maintenance antimalarials, low-dose corticosteroids (prednisone <=5 mg/day), maintenance immunosuppressives and/or maintenance biologics. The task force also agreed that the most appropriate outcomes (dependent variables) for testing the prognostic value (construct validity) of potential remission definitions are: death, damage, flares and measures of health-related quality of life. Conclusions The work of this international task force provides a framework for testing different definitions of remission against long-term outcomes.Copyright © Publish

Published
2017

23. Disease activity and damage accrual during the early disease course in a multinational inception cohort of patients with systemic lupus erythematosus

Author

Nossent, J. Kiss, E. Rozman, B. Pokorny, G. Vlachoyiannopoulos, P. Olesinska, M. Marchesoni, A. Mosca, M. Påi, S. Manger, K. Schneider, M. Nielsen, H. Van Vollenhoven, R. Swaak, T.

Subjects
skin and connective tissue diseases
Abstract

An inception cohort of patients with systemic lupus erythematosus from 14 European centres was followed for up to 5 years in order to describe the current early disease course. At inclusion patients (n = 200, 89% female, mean age 35 years, 97% Caucasian, mean SLEDAI 12.2) fulfilled a mean of 6.5 ACR classification criteria. The most prevalent criteria were antinuclear Ab presence (97%) followed by anti-dsDNA Ab (74%), arthritis (69%), leukocytopenia (54%) and malar rash (53%), antiphospholipid Ab (48%) and anti-synovial membrane Ab (21.6%). Clinical signs of lupus nephritis (LN) were present in 39% with biopsy-confirmed LN seen in 25%. Frequent additional findings were hypocomplementaemia (54%), anti-SSA Ab (49%), alopecia (26%) and Raynaud's phenomenon (31%). There were few regional differences in disease presentation and management. One and 5-year survival rates were 99% and 97% respectively. During the mean follow-up of 4.1 years 25% entered a state of early disease quiescence by global physician assessment, but the overall risk of subsequent flare was 60%. Maximum SLEDAI scores decreased over time, but 45% of patients accrued damage (SDI ≥1) for which baseline presence of proteinuria and persistent disease activity were independent predictors. The results indicate minor differences in SLE presentation and treatment within various regions of Europe and a high diagnostic reliance on anti-dsDNA Ab. Despite early reductions in disease activity and improved mortality, the risk for disease flare and damage development is, however, still substantial, especially in patients not entering an early remission. © The Author(s), 2010.

Published
2010

24. Current causes of death in systemic lupus erythematosus in Europe, 2000-2004: relation to disease activity and damage accrual

Author

Nossent, J. Cikes, N. Kiss, E. Marchesoni, A. Nassonova, V. Mosca, M. Olesinska, M. Pokorny, G. Rozman, B. and Schneider, M. Vlachoyiannopoulosi, Pg Swaak, A.

Abstract

Current therapeutic and diagnostic resources have turned systemic lupus erythematosus (SLE) into a chronic disease by reducing mortality rates. The exact contribution of disease activity and disease related damage to mortality is not well studied. The aim of this study was to describe the current causes of death (COD) in a multinational European cohort of patients with SLE in relation to quantified measures of disease activity and damage. Prospective five-year observational study of case fatalities in SLE patients at 12 European centres was performed. Demographics, disease manifestations, interventions and quantified disease activity (by ECLAM and SLEDAI) and damage (by SLICC-DI) at the time of death were related to the various COD. Ninety-one case fatalities (89% females) occurred after median disease duration of 10.2 years (range 0.2-40) corresponding to a annual case fatality of one for each of the participating cohorts. Cumulative mortality correlated linearly with disease duration with nearly 10% of fatalities occurring in the first year and 40% after more than 10 years of disease. Death occurred during SLE remission in one third of cases. In the remaining cases a mixture of disease activity (median ECLAM 5.5, median SLEDAI 15) and accrued damage (median SLICC-DI 5.0) with opposing relationships to disease duration contributed to death. Infections and cardiovascular events were the most frequent COD in both early and late fatalities with no gender differences for type of COD, disease activity, damage or comorbidity. In Europe, case fatalities have become uncommon events in dedicated SLE cohort,. The bimodal mortality curve has flattened out and deaths now occur evenly throughout the disease course with infectious and cardiovascular complications as the main direct COD in both early and late fatalities. Accrued damage supplants disease activity over time as the main SLE specific contributor to death over time.

Published
2007

26. AB1034 Satisfaction and Dissatisfaction of Patients with Rheumatic Diseases Receiving Biologics

Author

Kotulska, A., primary, Wiland, P., additional, Kucharz, E.J., additional, Olesinska, M., additional, Felis-Giemza, A., additional, Kopec-Medrek, M., additional, Zon-Giebel, A., additional, Romanowski, W., additional, Szymczak-Bartz, L., additional, Tlustochowicz, M., additional, Lewandowicz, J., additional, Kowalska-Majka, J., additional, Bucka, J., additional, Majdan, M., additional, Kielbik, Z., additional, Korkosz, M., additional, Bielinska, A., additional, Leszczynski, P., additional, Pawlas-Bus, K., additional, Puszczewicz, M., additional, and Majewski, D., additional

Published
2014
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27. OP0289 A Prospective, Randomized, Open-Label, Assessor-Blind, Multicenter Study of Efficacy and Safety of Combined Treatment of Methotrexate + Glucocorticoids versus Glucocorticoids Alone in Patients with Polymyositis and Dermatomyositis (Prometheus Trial)

Author

Tomasova Studynkova, J., primary, Mann, H., additional, Jarosova, K., additional, Blumhardt, S., additional, Maurer, B., additional, Dastmalchi, M., additional, Danko, K., additional, Świerkocka, K., additional, Olesinska, M., additional, Distler, O., additional, Lundberg, I.E., additional, and Vencovsky, J., additional

Published
2014
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28. B-cell targeted therapy in systemic lupus erythematosus: potential of rituximab

Author

Wiesik-Szewczyk,E, Olesinska,M, Wiesik-Szewczyk,E, and Olesinska,M

Abstract

E Wiesik-Szewczyk, M OlesinskaInstitute of Rheumatology, Department of Connective Tissue Diseases, Warsaw, PolandAbstract: Systemic lupus erythematosus (SLE) is a complex autoimmune disease of unknown etiology, and the limited available therapeutic options for this disease, are frustrating to both clinicians and patients. However, recent advances in the understanding of disease mechanisms have given rise to numerous studies on specific approaches to SLE treatment. Rituximab, the first chimeric, mouse-human monoclonal antibody which is directed against CD20, seems to be a new therapeutic option. The purpose of this review is to explain the current clinical evidence on the therapeutic use of rituximab in adult SLE patients. Two randomized clinical trials with rituximab (the EXPLORER and LUNAR studies) failed to prove efficacy of this drug on SLE. Ongoing data analysis continues to explain the reasons behind why this treatment fails to work. However data from open source and observational studies contrast with clinical trials results. The global analysis of this data supports the off-label use of rituximab in subsets of SLE that are refractory to standard treatment.Keywords: B cells, systemic lupus erythematosus, rituximab, off-label use, clinical trials

Published
2012

29. Disease activity and damage accrual during the early disease course in a multinational inception cohort of patients with systemic lupus erythematosus

Author

Nossent, J., Kiss, Adrian Emil, Rozman, B., Pokorny, G., Vlachoyiannopoulos, P., Olesinska, M., Marchesoni, A., Mosca, M., Pai, S., Manger, K., Schneider, Mia, Nielsen, H., van Vollenhoven, R., Swaak, T., Nossent, J., Kiss, Adrian Emil, Rozman, B., Pokorny, G., Vlachoyiannopoulos, P., Olesinska, M., Marchesoni, A., Mosca, M., Pai, S., Manger, K., Schneider, Mia, Nielsen, H., van Vollenhoven, R., and Swaak, T.

Abstract

An inception cohort of patients with systemic lupus erythematosus from 14 European centres was followed for up to 5 years in order to describe the current early disease course. At inclusion patients (n = 200, 89% female, mean age 35 years, 97% Caucasian, mean SLEDAI 12.2) fulfilled a mean of 6.5 ACR classification criteria. The most prevalent criteria were antinuclear Ab presence (97%) followed by anti-dsDNA Ab (74%), arthritis (69%), leukocytopenia (54%) and malar rash (53%), antiphospholipid Ab (48%) and anti-synovial membrane Ab (21.6%). Clinical signs of lupus nephritis (LN) were present in 39% with biopsy-confirmed LN seen in 25%. Frequent additional findings were hypocomplementaemia (54%), anti-SSA Ab (49%), alopecia (26%) and Raynaud's phenomenon (31%). There were few regional differences in disease presentation and management. One and 5-year survival rates were 99% and 97% respectively. During the mean follow-up of 4.1 years 25% entered a state of early disease quiescence by global physician assessment, but the overall risk of subsequent flare was 60%. Maximum SLEDAI scores decreased over time, but 45% of patients accrued damage (SDI >= 1) for which baseline presence of proteinuria and persistent disease activity were independent predictors. The results indicate minor differences in SLE presentation and treatment within various regions of Europe and a high diagnostic reliance on anti-dsDNA Ab. Despite early reductions in disease activity and improved mortality, the risk for disease flare and damage development is, however, still substantial, especially in patients not entering an early remission. Lupus (2010) 19, 949-956

Published
2010

30. AB0819 Clinical course and nailfold capillaroscopy patterns of 69 patients with mixed connective tissue disease (MCTD)

Author

Olesinska, M., primary, Czuszynska, Z., additional, Felis-Giemza, A., additional, Walkiewicz-Pielaszek, K., additional, Wiesik-Szewczyk, E., additional, Wierzba, K., additional, Paradowska-Gorycka, A., additional, Rutkowska-Sak, L., additional, Szczygielska, I., additional, Zabek, J., additional, and Zdrojewski, Z., additional

Published
2013
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32. AB0820 Physical disability in mixed connective tissue disease

Author

Olesinska, M., primary, Czuszynska, Z., additional, Felis-Giemza, A., additional, Walkiewicz-Pielaszek, K., additional, Paradowska-Gorycka, A., additional, Rutkowska-Sak, L., additional, Szczygielska, I., additional, Wiesik-Szewczyk, E., additional, and Zdrojewski, Z., additional

Published
2013
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33. Differential association of juvenile and adult systemic lupus erythematosus with genetic variants of oestrogen receptors alpha and beta

Author

Kisiel, BM, primary, Kosińska, J, additional, Wierzbowska, M, additional, Rutkowska-Sak, L, additional, Musiej-Nowakowska, E, additional, Wudarski, M, additional, Olesinska, M, additional, Krajewski, P, additional, Łącki, J, additional, Rell-Bakalarska, M, additional, Jagodziński, PP, additional, Tłustochowicz, W, additional, and Płoski, R, additional

Published
2010
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35. Disease activity and damage accrual during the early disease course in a multinational inception cohort of patients with systemic lupus erythematosus

Author

Nossent, J., primary, Kiss, E., additional, Rozman, B., additional, Pokorny, G., additional, Vlachoyiannopoulos, P., additional, Olesinska, M., additional, Marchesoni, A., additional, Mosca, M., additional, Påi, S., additional, Manger, K., additional, Schneider, M., additional, Nielsen, H., additional, van Vollenhoven, R., additional, and Swaak, T., additional

Published
2010
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37. Differential association of juvenile and adult systemic lupus erythematosus with genetic variants of oestrogen receptors alpha and beta.

Author

Kisiel, B. M., Kosińska, J., Wierzbowska, M., Rutkowska-Sak, L., Musiej-Nowakowska, E., Wudarski, M., Olesinska, M., Krajewski, P., Łącki, J., Rell-Bakalarska, M., Jagodziński, P. P., Tłustochowicz, W., and Płoski, R.

Subjects
SYSTEMIC lupus erythematosus, GENETICS, ESTROGEN receptors, GENETIC polymorphisms, GENETICS of autoimmune diseases, VASCULAR diseases, PATIENTS
Abstract

Oestrogens acting via nuclear receptors (encoded by ESR1 or ESR2) are important for pathogenesis of systemic lupus erythematosus (SLE). rs2234693 and rs4986938 are two single nucleotide polymorphisms (SNPs) whose C and A variants increase transcription of ESR1 and ESR2, respectively. The T allele of rs2234693 was associated with early onset SLE, whereas the role of rs4986938 in SLE was not reported. Our aim was to examine the role of rs2234693 and rs4986938 in conferring susceptibility to juvenile and adult SLE (jSLE and aSLE). Genotype distribution of both SNPs was analysed in 84 jSLE, 112 aSLE patients and 1001 controls. Allele C of rs2234693 was associated with jSLE (OR = 1.87, p = 0.006, pcorrected = 0.02), whereas allele A of rs4986938 showed an association with aSLE (OR = 1.46, p = 0.008, pcorrected = 0.03). In jSLE, rs2234693 C had lower frequency in patients with central nervous system involvement (OR = 0.39, p = 0.005, pcorrected = 0.04) and showed a trend for increase among males, patients with renal involvement and those without DR2/3 (p < 0.05, pcorrected > 0.05). Whereas our results are consistent with a role of ESR1 variation in jSLE, more studies are needed since the direction of association was the opposite of that reported previously. The association between rs4986938 (ESR2) and aSLE is a novel finding, consistent with our recent report associating this variant with Graves’ disease. [ABSTRACT FROM AUTHOR]

Published
2011
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42. Immobilisation and stabilisation of glycosylated enzymes on boronic acid-functionalised silica nanoparticles

Author

Magdalena Olesińska, Cinzia Pezzella, Patrick Shahgaldian, Philippe F.-X. Corvini, Seyed Amirabbas Nazemi, Chia-Wei Lin, Simona Varriale, Nazemi, S. A., Olesinska, M., Pezzella, C., Varriale, S., Lin, C. -W., Corvini, P. F. -X., Shahgaldian, P., University of Zurich, and Shahgaldian, Patrick

Subjects
inorganic chemicals, Glycan, 1503 Catalysis, 2506 Metals and Alloys, Covalent binding, 610 Medicine & health, 10071 Functional Genomics Center Zurich, 2503 Ceramics and Composites, 1600 General Chemistry, Catalysis, Coatings and Films, Silica nanoparticles, chemistry.chemical_compound, Electronic, Materials Chemistry, Optical and Magnetic Materials, 2505 Materials Chemistry, chemistry.chemical_classification, biology, 2508 Surfaces, Coatings and Films, Metals and Alloys, 2504 Electronic, Optical and Magnetic Materials, General Chemistry, Combinatorial chemistry, Surfaces, Coatings and Films, Electronic, Optical and Magnetic Materials, Surfaces, Enzyme, Leaching (chemistry), chemistry, Ceramics and Composites, biology.protein, 570 Life sciences, Vicinal, Derivative (chemistry), Boronic acid
Abstract

We report a method of glycosylated enzymes' surface immobilisation and stabilisation. The enzyme is immobilised at the surface of silica nanoparticles through the reversible covalent binding of vicinal diols of the enzyme glycans with a surface-attached boronate derivative. A soft organosilica layer of controlled thickness is grown at the silica surface, entrapping the enzyme and thus avoiding enzyme leaching. We demonstrate that this approach results not only in high and durable activity retention but also enzyme stabilisation.

Published
2021
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43. Health-related quality of life impairment is equal for antiphospholipid syndrome whether primary or associated with systemic lupus erythematosus.

Author

Haladyj E, Matusiewicz A, Wysocki T, and Olesinska M

Abstract

Introduction: Antiphospholipid syndrome (APS) manifests with thrombosis and pregnancy losses and may significantly impair the health-related quality of life (HRQoL). So far, APS has been perceived as a less burdensome disease than systemic lupus erythematosus (SLE), but data on this are scarce. The purpose of the present study was to evaluate HRQoL in APS patients by applying the Short Form 36 Health Survey (SF-36) and World Health Organization Quality-of-Life Scale (WHOQoL-BREF); to examine the impact of primary APS and with coexisting SLE (APS/SLE) on patient HRQoL; and to provide a description of the APS patient population., Material and Methods: One hundred twelve patients with APS were included in the study, 57 of them with primary APS and 55 with coexisting SLE. HRQoL was measured by the 36-Item SF-36 and WHOQoL questionnaires., Results: Mean age was 47 years (47.6 ±13.8), and 96 patients were (85.7%) women. The mean disease duration was 72 months. Health-related quality of life impairment was found in both components for all APS patients in comparison to the healthy Polish population ( p < 0.0001). There was no difference between APS and APS/SLE groups in HRQoL (mental component p = 1.0, physical component p = 0.337). The history of venous thrombosis was associated with HRQoL impairment only in the APS/SLE group in the physical component ( p = 0.0118), not in primary APS ( p = 0.6862). The mental component of SF-36 was associated with all domains of WHOQoL-BREF, while the physical component was associated only with physical health ( p < 0.001)., Conclusions: Primary APS and APS secondary to SLE lead to equal impairment in HRQoL. Diagnosis and proper management of all patients with APS are essential to prevent thrombosis and miscarriages, which ultimately will lead to longer survival with optimal life quality., Competing Interests: Ewa Haladyj since June 2017 has been an employee and shareholder of Eli Lilly and Co., but at the time of this research she was an employee of the National Institute of Geriatrics, Rheumatology and Rehabilitation in Warsaw. Agata Wieczorek, Tomasz Wysocki and Marzena Olesinska do not state any conflict of interest., (Copyright: © 2024 Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji w Warszawie.)

Published
2024
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44. ERN ReCONNET points to consider for treating patients living with autoimmune rheumatic diseases with antiviral therapies and anti-SARS-CoV-2 antibody products.

Author

Talarico R, Ramirez GA, Barreira SC, Cardamone C, Triggianese P, Aguilera S, Andersen J, Avcin T, Benistan K, Bertsias G, Bortoluzzi A, Bouillot C, Bulina I, Burmester GR, Callens S, Carreira PE, Cervera R, Cutolo M, Damian L, Della-Torre E, Faria R, Fonseca JE, Galetti I, Hachulla E, Iaccarino L, Jacobsen S, Khmelinskii N, Limper M, Marinello D, Meyer A, Moroncini G, Nagy G, Olesinska M, Pamfil C, Pileckyte M, Pistello M, Rednic S, Richez C, Romão VC, Schneider M, Sciascia S, Scirè CA, Simonini G, Smith V, Sulli A, Tani C, Tas SW, Tincani A, Vonk MC, Tektonidou M, and Mosca M

Subjects
Humans, Antiviral Agents therapeutic use, COVID-19, Autoimmune Diseases drug therapy, Rheumatic Diseases drug therapy, Rheumatic Diseases epidemiology, Respiratory Distress Syndrome
Abstract

Recent studies have shown that people who are immunocompromised may inadvertently play a role in spurring the mutations of the virus that create new variants. This is because some immunocompromised individuals remain at risk of getting COVID-19 despite vaccination, experience more severe disease, are susceptible to being chronically infected and remain contagious for longer if they become infected and considering that immunocompromised individuals represent approximately 2% of the overall population, this aspect should be carefully considered. So far, some autoimmune rheumatic disease (ARD) patients with COVID-19 have been treated with antiviral therapies or anti-SARS-CoV-2 antibody products. However, there is no homogeneous approach to these treatment strategies. This issue was addressed within the European Reference Network (ERN) on Rare and Complex Connective Tissue and Musculoskeletal Diseases (ReCONNET) in a discussion among experts and patient's representatives in the context of the rare and complex connective tissue diseases (rCTDs) covered by the Network. ERN ReCONNET is one of the 24 ERNs launched by the European Commission in 2017 with the aim of tackling low prevalence and rare diseases that require highly specialised treatment and promoting concentration of knowledge and resources through virtual networks involving healthcare providers (HCPs) across the European Union (EU). Considering the urgent need to provide guidance not only to the rCTDs community, but also to the whole ARDs community, a multidisciplinary Task Force, including expert clinicians and European Patient Advocacy Group (ePAG) Advocates, was created in the framework of ERN ReCONNET with the aim of developing overarching principles (OP) and points-to-consider (PtC) on a homogenous approach to treat immunocompromised patients with ARDs (with a particular focus on CTDs) affected by COVID-19 using antiviral therapies and anti-SARS-CoV-2 antibody products. The present work reports the final OP and PtC agreed by the Task Force.

Published
2023
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45. IL-1β, IL-10 and TNF-α polymorphisms may affect systemic lupus erythematosus risk and phenotype.

Author

Rzeszotarska E, Sowinska A, Stypinska B, Lutkowska A, Felis-Giemza A, Olesinska M, Puszczewicz M, Majewski D, Jagodzinski PP, Haładyj E, and Paradowska-Gorycka A

Subjects
Cytokines, Genotype, Humans, Phenotype, Polymorphism, Genetic, Interleukin-10 blood, Interleukin-10 genetics, Interleukin-1beta blood, Interleukin-1beta genetics, Lupus Erythematosus, Systemic blood, Lupus Erythematosus, Systemic diagnosis, Lupus Erythematosus, Systemic genetics, Tumor Necrosis Factor-alpha blood, Tumor Necrosis Factor-alpha genetics
Abstract

Objectives: Systemic lupus erythematosus (SLE) is an autoimmune disease, and IL-1β, IL-10, and TNF-α genes are important in the pathogenesis of this disease. We studied the impact of IL-1β-511, IL-1β +3953, IL-10 -592, IL-10 -1082, TNF-α -308, TNF-α -238, and TNF-α +489 polymorphisms on SLE risk and phenotype in SLE patients and healthy controls., Methods: We genotyped SLE patients and healthy controls by real-time PCR on QuantStudio 5 (Applied Biosystems) and measured levels of cytokines by enzyme-linked immunosorbent assay (ELISA)., Results: We indicated that TNF-α -308, IL-10 -592, IL-10 -1082, IL-1β-511 and IL-1β +3953 polymorphisms affect SLE risk. Furthermore, we exposed that some of the TNF-α +489, TNF-α -238, IL-10 -1082 and IL-1β +3953 genotypes are connected with the SLE phenotype. Moreover, we discovered the linking between specific genotypes and the serum concentrations of TNF-α, IL-1β, and IL-10., Conclusions: In conclusion, our study revealed that IL-1β-511, IL-1β +3953, IL-10 -592, IL-10 -1082, and TNF-α -308 polymorphisms may affect SLE risk and phenotype.

Published
2022
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46. An Overview of Neonatal Lupus with Anti-Ro Characteristics.

Author

Gryka-Marton M, Szukiewicz D, Teliga-Czajkowska J, and Olesinska M

Subjects
Humans, Infant, Newborn, Lupus Erythematosus, Systemic complications, Lupus Erythematosus, Systemic etiology, Lupus Erythematosus, Systemic immunology, Lupus Erythematosus, Systemic physiopathology, Antibodies, Antinuclear, Lupus Erythematosus, Systemic congenital
Abstract

Neonatal lupus erythematosus (NLE) is a syndrome of clinical symptoms observed in neonates born to mothers with antibodies to soluble antigens of the cell nucleus. The main factors contributing to the pathogenesis of this disease are anti-Sjögren Syndrome A (anti-SS-A) antibodies, known as anti-Ro, and anti-Sjögren Syndrome B (anti-SS-B) antibodies, known as anti-La. Recent publications have also shown the significant role of anti-ribonucleoprotein antibodies (anti-RNP). Seropositive mothers may have a diagnosed rheumatic disease or they can be asymptomatic without diagnosis at the time of childbirth. These antibodies, after crossing the placenta, may trigger a cascade of inflammatory reactions. The symptoms of NLE can be divided into reversible symptoms, which concern skin, hematological, and hepatological changes, but 2% of children develop irreversible symptoms, which include disturbances of the cardiac stimulatory and conduction system. Preconceptive care and pharmacological prophylaxis of NLE in the case of mothers from the risk group are important, as well as the monitoring of the clinical condition of the mother and fetus throughout pregnancy and the neonatal period. The aim of this manuscript is to summarize the previous literature and current state of knowledge about neonatal lupus and to discuss the role of anti-Ro in the inflammatory process.

Published
2021
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47. Global miRNA and mRNA expression profiles identify miRNA-26a-2-3p-dependent repression of IFN signature in systemic sclerosis human monocytes.

Author

Ciechomska M, Wojtas B, Swacha M, Olesinska M, Benes V, and Maslinski W

Subjects
Adult, Aged, Aged, 80 and over, Female, Humans, Male, Middle Aged, Scleroderma, Systemic pathology, THP-1 Cells, Gene Expression Regulation immunology, Interferons immunology, MicroRNAs immunology, Monocytes immunology, RNA, Messenger immunology, Scleroderma, Systemic immunology
Abstract

Dysregulation in type I IFN and IFN-stimulated genes (ISGs) induced by monocytes is one of the key features of systemic sclerosis (SSc) pathogenesis. Abnormalities in microRNA (miRNA) expression are related to excessive IFN production, however the role of miRNA remains largely elusive in SSc monocytes. This study explores global miRNA-mRNA profiling of SSc monocytes and functional attenuation of IFN and ISGs by specific miRNAs. Global sequencing of mRNA (mRNA-seq) and miRNA (miRNA-seq) samples were performed simultaneously on healthy controls and SSc monocytes. Following computational analysis, selected miRNAs-mRNA candidates were validated, correlated with clinical parameters, and tested by functional assays. Transcriptomics data and qPCR analysis confirmed IFN signature in SSc but not in rheumatoid arthritis monocytes. Based on miRNA-seq analysis, five miRNAs were selected for further validation. Only the expression patterns of miRNA-26a-2-3p and miRNA-485-3p were confirmed and negatively correlated with clinical parameters. Exogenous delivery of miRNA-26a-2-3p to TLR-stimulated monocytic THP-1 cells specifically inhibited ISGs but not inflammasome activity in functional assays. In conclusion, our miRNA-mRNA co-sequencing and functional analysis identify miRNA-26a-2-3p as a new candidate, which is predicated to negatively regulate ISGs. This implies that reduced expression of miRNA-26a-2-3 may be involved in pathogenic IFN signature in SSc monocytes., (© 2020 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.)

Published
2020
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48. The Role of MECP2 and CCR5 Polymorphisms on the Development and Course of Systemic Lupus Erythematosus.

Author

Rzeszotarska E, Sowinska A, Stypinska B, Walczuk E, Wajda A, Lutkowska A, Felis-Giemza A, Olesinska M, Puszczewicz M, Majewski D, Jagodzinski PP, Czerewaty M, Malinowski D, Pawlik A, Jaronczyk M, and Paradowska-Gorycka A

Subjects
Adult, Aged, Aged, 80 and over, Female, Humans, Male, Middle Aged, Risk Factors, Alleles, Genetic Predisposition to Disease, Lupus Erythematosus, Systemic genetics, Methyl-CpG-Binding Protein 2 genetics, Polymorphism, Restriction Fragment Length, Polymorphism, Single Nucleotide, Receptors, CCR5 genetics
Abstract

Systemic lupus erythematosus (SLE) is a chronic and systemic autoimmune disease. SLE is described by production of autoantibodies and causes damage of many organs. T-cells play a crucial role in SLE pathogenesis. T-cells intensify inflammation through a number of processes, which leads to autoimmunization. CCR5 and MECP2 genes are linked with T-cells and pathogenesis of SLE. Polymorphisms in these genes are related with the prognostic factors of risk of disease onset and disease severity. The aim of this study was to estimate the influence of polymorphisms in MECP2 and CCR5 genes on the development and course of systemic lupus erythematosus. We examined 137 SLE patients and 604 healthy controls. We studied polymorphisms for CCR5 gene: rs333 and for MECP2: rs2075596, rs1734787, rs17435, and rs2239464. We genotyped our MECP2 samples and we performed a restriction fragment length polymorphism (RFLP) analysis for CCR5 samples. We showed a risk factor for allele T in rs17435 and for allele A in rs2075596 in MECP2. We noticed that MECP2 rs2075596 G/A, rs1734787 C/A, rs17435 A/T, and rs2239464 G/A polymorphisms are more prevalent in SLE patients than in healthy controls. We believe that above-mentioned MECP2 polymorphisms can be considered as SLE susceptibility factor., Competing Interests: The authors declare no conflict of interest.

Published
2020
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49. The Serum Cell-Free microRNA Expression Profile in MCTD, SLE, SSc, and RA Patients.

Author

Stypinska B, Wajda A, Walczuk E, Olesinska M, Lewandowska A, Walczyk M, and Paradowska-Gorycka A

Abstract

Mixed connective tissue disease (MCTD) is a rare disorder characterized by symptoms that overlap two or more Autoimmune Connective Tissue Diseases (ACTDs). The aim of this study was to determine whether miRNAs participating in the TLRs signaling pathway could serve as biomarkers differentiating MCTD or other ACTD entities from a healthy control group and between groups of patients. Although the selected miRNA expression level was not significantly different between MCTD and control, we observed that miR-126 distinguishes MCTD patients from all other ACTD groups. The expression level of miRNAs was significantly higher in the serum of systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA) patients compared to controls. The miR-145 and -181a levels distinguished RA from other ACDT patients. miR-155 was specific for SLE patients. MiR-132, miR-143, and miR-29a distinguished RA and SLE patients from the systemic sclerosis (SSc) group. Additionally, some clinical parameters were significantly related to the miRNA expression profile in the SLE group. SLE and RA are characterized by a specific serum expression profile of the microRNAs associated with the Toll-like receptors (TLRs) signaling pathway. The analysis showed that their level distinguishes these groups from the control and from other ACTD patients. The present study did not reveal a good biomarker for MCTD patients., Competing Interests: The authors declare no conflict of interest.

Published
2020
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50. IL-6 and TGF-β gene polymorphisms, their serum levels, as well as HLA profile, in patients with systemic lupus erythematosus.

Author

Paradowska-Gorycka A, Roszak M, Stypinska B, Lutkowska A, Walczyk M, Olesinska M, Wajda A, Piotrowski P, Puszczewicz M, Majewski D, and Jagodzinski PP

Subjects
Alleles, Case-Control Studies, Gene Frequency, Genetic Predisposition to Disease, Genotype, HLA-DRB1 Chains, Humans, Poland, Interleukin-6 blood, Interleukin-6 genetics, Lupus Erythematosus, Systemic genetics, Polymorphism, Genetic, Transforming Growth Factor beta blood, Transforming Growth Factor beta genetics
Abstract

Objectives: The aim of the study was to explore whether TGF-β and IL-6 gene polymorphisms may be associated with SLE and assess the frequency of HLA-DRB1 alleles in Polish systemic lupus erythematosus (SLE) patients., Methods: 216 SLE patients and 552 healthy individuals were examined for TGF-β rs1800469 and rs1800470 by TaqMan SNP genotyping assay and for and IL-6(rs2069827 and rs1800795 using the PCR- RFLP method., Results: An increased frequency of TT genotype and T allele of the TGF β -509 C/T was found in SLE patients (p=0.02). The TGF-β 869 C allele was more frequent in SLE patients. The genotype-phenotype analysis showed association between the TGF β -509 C/T and mean value of CRP, ESR, haemoglobin, APTT, Pt and INR (p=0.05, p=0.03, p<0.001, p=0.03, p=0.03 and p=0.05, respectively) as well as anti-SSA and anti-Sm presence (p=0.04 and p=0.03, respectively); the TGF- β 869 T/C and mean value of APTT and INR (p=0.01 and p=0.05, respectively); the IL-6 -174 G/C and SLICC (p=0.05), anti-SSA (p=0.05) and anti-SSB (p=0.05). A higher TGF-β and IL-6 serum level were found in SLE patients compared to controls (both p<0.0001). In SLE patients with the TGF-β -509 TT genotype have shown positive association with the TGF-β serum levels. Polish SLE patients have strong positive association with HLA-DRB1*52.1, and negative with the HLA-DRB1*07:01 allele. HLA-DRB1*52.1 was also associated with higher TGF-β serum levels in the Polish population., Conclusions: Our results suggested that the TGF β -509 C/T variant may be considered as a genetic marker for SLE in the Polish population.

Published
2019

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