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1. Efficacy and Safety of Epratuzumab in Moderately to Severely Active Systemic Lupus Erythematosus: Results From Two Phase III Randomized, Double-Blind, Placebo-Controlled Trials

Author

Clowse, Megan E. B, Wallace, Daniel J., Furie, Richard A., Petri, Michelle A., Pike, Marilyn C., Leszczyński, Piotr, Neuwelt, C. Michael, Hobbs, Kathryn, Keiserman, Mauro, Duca, Liliana, Kalunian, Kenneth C., Galateanu, Catrinel, Bongardt, Sabine, Stach, Christian, Beaudot, Carolyn, Kilgallen, Brian, Gordon, Caroline, Batalov, A., Bojinca, M., Djerassi, R., Duca, L., Horak, P., Kolarov, Z., Milasiene, R., Monova, D., Otsa, K., Pileckyte, M., Popova, T., Radulescu, F., Rashkov, R., Rednic, S., Repin, M., Stoilov, R., Tegzova, D., Vezikova, N., Vitek, P., Zainea, C., East, Far, Baek, H., Chen, Y., Chiu, Y., Cho, C., Chou, C., Choe, J., Huang, C., Kang, Y., Kang, S., Lai, N., Lee, S., Park, W., Shim, S., Suh, C., Yoo, W., Armengol, H. Avila, Zapata, F. Avila, Santiago, M. Barreto, Cavalcanti, F., Chahade, W., Costallat, L., Keiserman, M., Alcala, J. Orozco, Remus, C. Ramos, Roimicher, L., Abu Shakra, M., Agarwal, V., Agmon Levin, N., Kadel, J., Levy, Y., Mevorach, D., Paran, D., Reitblat, T., Rosner, I., Shobha, V., Sthoeger, Z., Zisman, D., Ayesu, K., Berney, S., Box, J., Busch, H., Buyon, J., Carter, J., Chi, J., Clowse, M., Collins, R., Dao, K., Diab, I., Dikranian, A., El Shahawy, M., Gaylis, N., Grossman, J., Halpert, E., Huff, J., Jarjour, W., Kao, A., Katz, R., Kennedy, A., Khan, M., Kivitz, A., Kohen, M., Lawrence Ford, T., Lawson, J., Levesque, M., Lowenstein, M., Majjhoo, A., Mcarthur, R., Mclain, D., Merrill, J., Murillo, A., Neucks, S., Niemer, G., Noaiseh, G., Parker, C., Pantojas, C., Pattanaik, D., Petri, M., Pickrell, P., Reveille, J., Roman Miranda, A., Rothfield, N., Sankoorikal, A., Sayers, M., Singhal, A., Snyder, A., Striebich, C., Vo, Q., von Feldt, J., Wallace, D., Wasko, M., Young, C., Adelstein, S., Hall, S., Littlejohn, G., Nicholls, D., Suranyi, M., Amoura, Z., Bannert, B., Behrens, F., Perez, L. Carreno, Chakravarty, K., Gonzales, F. Diaz, Davies, K., Doria, Andrea, Emery, P., Fernández Nebro, A., Govoni, M., Hachulla, E., Hellmich, B., Houssiau, F., Malaise, M., Margaux, J., Maugars, Y., Muñoz Fernández, S., Navarro, F., Ordi Ros, J., Pellerito, R., Pena Sagredo, J., Roussou, E., Schmidt, R. E., Ucar Angulo, E., Viallard, J. F., Westhovens, R., Worm, M., Yee, C. S., Nayiager, S., Reuter, H., Spargo, C., Bazela, B., Brzosko, M., Chudzik, D., Gasztonyi, B., Geher, P., Ionescu, R., Jeka, S., Kemeny, L., Kiss, E., Kotyla, P., Kovacs, L., Kovalenko, V., Kucharz, E., Kwiatkowska, B., Leszczynski, P., Levchenko, E., Lysenko, G., Majdan, M., Mihailov, C., Nalotov, S., Nedelciu, M., Pavel, M., Raskina, T., Rebrov, B., Rezus, E., Semen, T., Smakotina, S., Stanislavchuk, M., Stanislav, M., Szombati, I., Szucs, G., Udrea, G., Zajdel, J., Zon Giebel, A., Bonfiglioli, R., Bustamante, R., Klumb, E., Ramirez, G. Medrano, Neiva, C., Olguin, M., Gonzaga, J. Reyes, Scotton, A., Ayala, S. Sicsik, Ximenes, A., Sharma, R., Srikantiah, C., Aelion, J., Aranow, C., Baker, M., Chadha, A., Chao, J., Chatham, W., Chow, A., Clay, C., Cohen Gadol, S., Conaway, D., Denburg, J., Escalante, A., Espinoza, L., Fiechtner, J., Fortin, I., Fraser, A., Furie, R., Gladman, D., Goddard, D., Goldberg, M., Gonzalez Rivera, R., Gorman, J., Griffin, R., Haaland, D., Halter, D., Hemaiden, A., Hobbs, K., Joshi, V., Lim, S., Kalunian, K., Karpouzas, G., Khraishi, M., Lafyatis, R., Lidman, R., Lue, C., Mohan, M., Mease, P., Mehta, C., Mizutani, W., Nami, A., Nascimento, J., Neuwelt, C., Pappas, J., Pope, J., Porges, A., Roane, G., Rosenberg, D., Ross, S., Saadeh, C., Scoville, C., Sherrer, Y., Solomon, M., Surbeck, W., Valenzuela, G., Waller, P., Alten, R., Baerwald, C., Bienvenu, B., Bombardieri, S., Braun, J., Dival, L., Espinosa, G., Fernandez, I. Figueroa, Gomez Reino, J., Gordon, C., Hiepe, F., Hopkinson, N., Isenberg, D., Jacobi, A., Jorgensen, C., Guern, V. Le, Paul, C., Pego Reigosa, J. M., Heredia, J. Rodriguez, Rubbert Roth, A., Sabbadini, M., Schroeder, J., Schwarting, A., Spieler, W., Valesini, G., Wollenhaupt, J., Mendoza, A. Zea, and Zouboulis, C.

Subjects
humanized, adult, rheumatology, monoclonal, antibodies, monoclonal, humanized, double-blind method, female, humans, lupus erythematosus, systemic, male, severity of illness index, treatment outcome, immunology and allergy, immunology, systemic, Antibodies, Monoclonal, Humanized, Systemic Lupus Erythematosus, NO, Immunology and Allergy, Rheumatology, Immunology, Lupus Erythematosus, Systemic, antibodies, lupus erythematosus
Abstract

Objective Epratuzumab, a monoclonal antibody that targets CD22, modulates B cell signaling without substantial reductions in the number of B cells. The aim of this study was to report the results of 2 phase III multicenter randomized, double‐blind, placebo‐controlled trials, the EMBODY 1 and EMBODY 2 trials, assessing the efficacy and safety of epratuzumab in patients with moderately to severely active systemic lupus erythematosus (SLE). Methods Patients met ≥4 of the American College of Rheumatology revised classification criteria for SLE, were positive for antinuclear antibodies and/or anti–double‐stranded DNA antibodies, had an SLE Disease Activity Index 2000 (SLEDAI‐2K) score of ≥6 (increased disease activity), had British Isles Lupus Assessment Group 2004 index (BILAG‐2004) scores of grade A (severe disease activity) in ≥1 body system or grade B (moderate disease activity) in ≥2 body systems (in the mucocutaneous, musculoskeletal, or cardiorespiratory domains), and were receiving standard therapy, including mandatory treatment with corticosteroids (5–60 mg/day). BILAG‐2004 grade A scores in the renal and central nervous system domains were excluded. Patients were randomized 1:1:1 to receive either placebo, epratuzumab 600 mg every week, or epratuzumab 1,200 mg every other week, with infusions delivered for the first 4 weeks of each 12‐week dosing cycle, for 4 cycles. Patients across all 3 treatment groups also continued with their standard therapy. The primary end point was the response rate at week 48 according to the BILAG‐based Combined Lupus Assessment (BICLA) definition, requiring improvement in the BILAG‐2004 score, no worsening in the BILAG‐2004 score, SLEDAI‐2K score, or physician's global assessment of disease activity, and no disallowed changes in concomitant medications. Patients who discontinued the study medication were classified as nonresponders. Results In the EMBODY 1 and EMBODY 2 trials of epratuzumab, 793 patients and 791 patients, respectively, were randomized, 786 (99.1%) and 788 (99.6%), respectively, received study medication, and 528 (66.6%) and 533 (67.4%), respectively, completed the study. There was no statistically significant difference in the primary end point between the groups, with the week 48 BICLA response rates being similar between the epratuzumab groups and the placebo group (response rates ranging from 33.5% to 39.8%). No new safety signals were identified. Conclusion In patients with moderate or severely active SLE, treatment with epratuzumab + standard therapy did not result in improvements in response rates over that observed in the placebo + standard therapy group.

Published
2017

2. Characteristics of joint involvement and relationships with systemic inflammation in systemic sclerosis: results from the EULAR Scleroderma Trial and Research Group (EUSTAR) database

Author

Avouac, Jerome, Walker, Ulrich, Tyndall, Alan, Kahan, André, Matucci Cerinic, Marco, Allanore, Yannick, Miniati, I., Müller, A., Iannone, F., Giacomelli, R., Distler, O., Becvar, R., Sierakowsky, S., Kowal Bielecka, O., Coelho, P., Cabane, J., Cutolo, M., Shoenfeld, Y., Rovensky, J., Riemekasten, G., Nicoara, I., Vlachoyiannopoulos, P., Caporali, R., Jiri, S., Inanc, M., Gorska, I. Zimmermann, Carreira, P., Novak, S., Czirjak, L., Ramos, F. Oliveira, Jendro, M., Chizzolini, C., Kucharz, E. J., Richter, J., Cozzi, F., Rozman, B., Mallia, C. M., Gabrielli, A., Farge, D., Kiener, H. P., Schöffel, D., Sticherling, M., Airo, P., Wollheim, F., Martinovic, D., Trotta, F., Hunzelmann, N., Jablonska, S., Reich, K., Bombardieri, S., Siakka, P., Pellerito, R., Bambara, L. M., Morovic Vergles, J., Denton, C., Hinrichs, R., Van Den Hoogen, F., Damjanov, N., Kötter, I., Ortiz, V., Heitmann, S., Krasowska, D., Seidel, M., Hasler, P., Van Laar, J. M., Kaltwasser, J. P., Foeldvari, I., Juan Mas, A., Bajocchi, G., Wislowska, M., Pereira Da Silva, J. A., Jacobsen, S., Worm, M., Graniger, W., Kuhn, A., Stankovic, A., Cossutta, R., Majdan, M., Rajcevska, L. Damjanovska, Tikly, M., Nasonov, E. L., Steinbrink, K., Herrick, A., Müller Ladner, U., Dinc, A., Scorza, R., Sondergaard, K., Indiveri, F., Nielsen, H., Szekanecz, Z., Silver, R. M., Antivalle, M., Espinosa, I. B., García De La Pena Lefebvre, P., Midtvedt, O., Launay, D., Valesini, F., Tuvik, P., Ionescu, R. M., Del Papa, N., Pinto, S., Wigley, F., Mihai, C., Capranu, M. Sinziana, Sunderkötter, C., Jun, J. B., Derk, C., Alhasani, S., Distler, J. H., Ton, E., Soukup, T., Seibold, J., Zeni, S., Nash, P., Mouthon, L., De Keyser, F., Duruöz, M. T., Cantatore, F. P., Strauss, G., Von Mülhen, C. A., Pozzi, M. R., Eyerich, K., Szechinski, J., Keiserman, M., Houssiau, F. A., Rom Ivorra, J. A., Krummel Lorenz, B., Aringer, M., Westhovens, R., Bellisai, F., Mayer, M., Stoeckl, F., Üprus, M., Volpe, A., Buslau, M., Yavuz, S., Granel, B., Feijó, A. Valderílio, Del Galdo, F., Popa, S., Zenone, T., Machado, X. Ricardo, Pileckyte, M., Stebbings, S., Mathieu, A., Tulli, A., Tourinho, T., Souza, R., Acayaba De Toledo, R., Stamp, L., Solanki, K., Veale, D., Neto, J. Francisco Marques, Bagnato, G. F., Loyo, E., Toloza, S., Li, M., Mohamed, W. Ahmed Abdel Atty, Cobankara, V., Olas, J., Salsano, F., Oksel, F., Tanaseanu, C. M., Foti, R., Ancuta, C., Vonk, M., Caramashi, P., Beretta, L., Balbir, A., Shine, B., Chiàla, A., Simic, K. Pasalic, Ghio, M., Stamenkovic, B., Rednic, S., Host, N., Hachulla, E., Furst, D. E., VALENTINI, Gabriele, Avouac, Jerome, Walker, Ulrich, Tyndall, Alan, Kahan, André, Matucci Cerinic, Marco, Allanore, Yannick, Miniati, I., Müller, A., Iannone, F., Giacomelli, R., Distler, O., Becvar, R., Sierakowsky, S., Kowal Bielecka, O., Coelho, P., Cabane, J., Cutolo, M., Shoenfeld, Y., Valentini, Gabriele, Rovensky, J., Riemekasten, G., Nicoara, I., Vlachoyiannopoulos, P., Caporali, R., Jiri, S., Inanc, M., Gorska, I. Zimmermann, Carreira, P., Novak, S., Czirjak, L., Ramos, F. Oliveira, Jendro, M., Chizzolini, C., Kucharz, E. J., Richter, J., Cozzi, F., Rozman, B., Mallia, C. M., Gabrielli, A., Farge, D., Kiener, H. P., Schöffel, D., Sticherling, M., Airo, P., Wollheim, F., Martinovic, D., Trotta, F., Hunzelmann, N., Jablonska, S., Reich, K., Bombardieri, S., Siakka, P., Pellerito, R., Bambara, L. M., Morovic Vergles, J., Denton, C., Hinrichs, R., Van Den Hoogen, F., Damjanov, N., Kötter, I., Ortiz, V., Heitmann, S., Krasowska, D., Seidel, M., Hasler, P., Van Laar, J. M., Kaltwasser, J. P., Foeldvari, I., Juan Mas, A., Bajocchi, G., Wislowska, M., Pereira Da Silva, J. A., Jacobsen, S., Worm, M., Graniger, W., Kuhn, A., Stankovic, A., Cossutta, R., Majdan, M., Rajcevska, L. Damjanovska, Tikly, M., Nasonov, E. L., Steinbrink, K., Herrick, A., Müller Ladner, U., Dinc, A., Scorza, R., Sondergaard, K., Indiveri, F., Nielsen, H., Szekanecz, Z., Silver, R. M., Antivalle, M., Espinosa, I. B., García De La Pena Lefebvre, P., Midtvedt, O., Launay, D., Valesini, F., Tuvik, P., Ionescu, R. M., Del Papa, N., Pinto, S., Wigley, F., Mihai, C., Capranu, M. Sinziana, Sunderkötter, C., Jun, J. B., Derk, C., Alhasani, S., Distler, J. H., Ton, E., Soukup, T., Seibold, J., Zeni, S., Nash, P., Mouthon, L., De Keyser, F., Duruöz, M. T., Cantatore, F. P., Strauss, G., Von Mülhen, C. A., Pozzi, M. R., Eyerich, K., Szechinski, J., Keiserman, M., Houssiau, F. A., Rom Ivorra, J. A., Krummel Lorenz, B., Aringer, M., Westhovens, R., Bellisai, F., Mayer, M., Stoeckl, F., Üprus, M., Volpe, A., Buslau, M., Yavuz, S., Granel, B., Feijó, A. Valderílio, Del Galdo, F., Popa, S., Zenone, T., Machado, X. Ricardo, Pileckyte, M., Stebbings, S., Mathieu, A., Tulli, A., Tourinho, T., Souza, R., Acayaba De Toledo, R., Stamp, L., Solanki, K., Veale, D., Neto, J. Francisco Marque, Bagnato, G. F., Loyo, E., Toloza, S., Li, M., Mohamed, W. Ahmed Abdel Atty, Cobankara, V., Olas, J., Salsano, F., Oksel, F., Tanaseanu, C. M., Foti, R., Ancuta, C., Vonk, M., Caramashi, P., Beretta, L., Balbir, A., Shine, B., Chiàla, A., Simic, K. Pasalic, Ghio, M., Stamenkovic, B., Rednic, S., Host, N., Hachulla, E., Furst, D. E., Chizzolini, Carlo, and Westhovens, Rene

Subjects
Male, Systemic disease, Databases, Factual, Cross-sectional study, Joint Diseases/etiology/pathology/physiopathology, Systemic inflammation, Joint involvement, Scleroderma, systemic sclrosis, systemic inflemmetion, joint involvement, Tendons, Systemic sclerosi, Scleroderma, Localized, 0302 clinical medicine, data base, Immunopathology, joint radiography, Immunology and Allergy, Joints/pathology, scleroderma, 030212 general & internal medicine, nuclear magnetic resonance imaging, Range of Motion, Articular, skin and connective tissue diseases, rheumatic disease, ddc:616, interstitial lung disease, Joint contracture, Clinical Trials as Topic, Synovitis, Inflammation/etiology/pathology/physiopathology, integumentary system, article, Tendons/pathology, Middle Aged, musculoskeletal system, cohort analysis, Connective tissue disease, priority journal, Joint, Synoviti, Systemic sclerosis, Female, medicine.symptom, Joint Diseases, Human, musculoskeletal diseases, Adult, medicine.medical_specialty, hand radiography, Immunology, Scleroderma, Localized/etiology/*pathology, Auto-immunity, transplantation and immunotherapy [N4i 4], 03 medical and health sciences, SYSTEMIC SCLEROSIS, JOINT INVOLVEMENT, SYNOVITIS, JOINT CONTRACTURE, TENDON FRICTION RUB, Tendon friction rub, Rheumatology, Internal medicine, medicine, Humans, Health care ethics [NCEBP 5], Tendon, Aged, 030203 arthritis & rheumatology, Cross-Sectional Studie, Inflammation, skin disease, Scleroderma, Systemic, business.industry, echography, medicine.disease, major clinical study, tenosynovitis, Synovitis/etiology/pathology, clinical feature, body regions, Cross-Sectional Studies, Evaluation of complex medical interventions [NCEBP 2], Scleroderma, Systemic/complications/pathology/physiopathology, Joints, disease duration, business, Joint Disease, disease activity
Abstract

Objective.To determine the prevalence of and independent factors associated with joint involvement in a large population of patients with systemic sclerosis (SSc).Methods.This study was cross-sectional, based on data collected on patients included in the European League Against Rheumatism (EULAR) Scleroderma Trials and Research (EUSTAR) registry. We queried this database to extract data regarding global evaluation of patients with SSc and the presence of any clinical articular involvement: synovitis (tender and swollen joints), tendon friction rubs (rubbing sensation detected as the tendon was moved), and joint contracture (stiffness of the joints that decreased their range of motion). Overall joint involvement was defined by the occurrence of synovitis and/or joint contracture and/or tendon friction rubs.Results.We recruited 7286 patients with SSc; their mean age was 56 ± 14 years, disease duration 10 ± 9 years, and 4210 (58%) had a limited cutaneous disease subset. Frequencies of synovitis, tendon friction rubs, and joint contractures were 16%, 11%, and 31%, respectively. Synovitis, tendon friction rubs, and joint contracture were more prevalent in patients with the diffuse cutaneous subset and were associated together and with severe vascular, muscular, renal, and interstitial lung involvement. Moreover, synovitis had the highest strength of association with elevated acute-phase reactants taken as the dependent variable.Conclusion.Our results highlight the striking level of articular involvement in SSc, as evaluated by systematic examination in a large cohort of patients with SSc. Our data also show that synovitis, joint contracture, and tendon friction rubs are associated with a more severe disease and with systemic inflammation.

Published
2010
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3. Systemic lupus erythematosus in Europe at the change of the millennium: lessons from the 'Euro-Lupus Project'

Author

Cervera, R, ABARCA-COSTALAGO, M, Abramovicz, D, Allegri, F, Annunziata, P, Aydintug, Ao, Bacarelli, Mr, Bellisai, F, Bernardino, I, BIERNAT-KALUZA, E, Blockmans, D, Boki, K, Bracci, L, Campanella, V, Camps, Mt, Carcassi, C, Cattaneo, R, Cauli, A, CHWALINSKA-SADOWSKA, H, Contu, L, Cosyns, Jp, Danieli, Mg, Dcruz, D, Depresseux, G, Direskeneli, H, Domenech, I, Espinosa, G, FERNANDEZ-NEBRO, A, Ferrara, Gb, Font, J, Frutos, Ma, Galeazzi, M., GARCIA-CARRASCO, M, GARCIA IGLESIAS MF, GARCIA-TOBARUELA, A, George, J, Gil, A, GONZALEZ-SANTOS, P, Grana, M, Gul, A, Haga, Hj, DE HARO-LIGER, M, Houssiau, F, Hughes, Gr, Ingelmo, M, JEDRYKA-GORAL, A, Khamashta, Ma, Lavilla, P, Levi, Y, LOPEZ-DULPA, M, LOPEZ-SOTO, A, Maldykowa, H, Marcolongo, R, Mathieu, A, Morozzi, G, Nicolopoulou, N, Papasteriades, C, Passiu, G, Perello, I, Petera, P, Petrovic, R, Piette, Jc, Pintado, V, DE PITA, O, Popovic, R, Pucci, G, Puddu, P, DE RAMON, E, RAMOS-CASALS, M, RODRIGUEZ-ANDREU, J, RUIZ-IRASTORZA, G, SANCHEZ-LORA, J, Sanna, G, Scorza, R, Sebastiani, Gd, Sherer, Y, Shoenfeld, Y, Simpatico, A, Sinico, Ra, Smolen, J, Tincani, A, Tokgoz, G, URBANO-MARQUEZ, A, Vasconcelos, C, Vazquez, Jj, Veronesi, J, Vianna, J, Vivancos, J, UCL - MD/MINT - Département de médecine interne, UCL - (SLuc) Service de rhumatologie, UCL - MD/MNOP - Département de morphologie normale et pathologique, UCL - (SLuc) Service d'anatomie pathologique, Cervera, R, Abarca Costalago, M, Abramovicz, D, Allegri, F, Annunziata, P, Aydintug, A, Bacarelli, M, Bellisai, F, Bernardino, I, Biernat Kaluza, E, Blockmans, D, Boki, K, Bracci, L, Campanella, V, Camps, M, Carcassi, C, Cattaneo, R, Cauli, A, Chwalinska Sadowska, H, Contu, L, Cosyns, J, Danieli, M, D́cruz, D, Depresseux, G, Direskeneli, H, Domènech, I, Espinosa, G, Fernández Nebro, A, Ferrara, G, Font, J, Frutos, M, Galeazzi, M, García Carrasco, M, García Iglesias, M, García Tobaruela, A, George, J, Gil, A, González Santos, P, Grana, M, Gül, A, Haga, H, de Haro Liger, M, Houssiau, F, Hughes, G, Ingelmo, M, Jedryka Góral, A, Khamashta, M, Lavilla, P, Levi, Y, López Dupla, M, López Soto, A, Maldykowa, H, Marcolongo, R, Mathieu, A, Morozzi, G, Nicolopoulou, N, Papasteriades, C, Passiu, G, Perelló, I, Petera, P, Petrovic, R, Piette, J, Pintado, V, de Pita, O, Popovic, R, Pucci, G, Puddu, P, de Ramón, E, Ramos Casals, M, Rodríguez Andreu, J, Ruiz Irastorza, G, Sánchez Lora, J, Sanna, G, Scorza, R, Sebastiani, G, Sherer, Y, Shoenfeld, Y, Simpatico, A, Sinico, R, Smolen, J, Tincani, A, Tokgöz, G, Urbano Márquez, A, Vasconcelos, C, Vázquez, J, Veronesi, M, Vianna, J, and Vivancos, J

Subjects
Male, medicine.medical_specialty, Prognosi, Epidemiology, Immunology, Systemic lupus erythematosu, Disease, Prognostic factors, Autoimmune Disease, Follow-Up Studie, Autoimmune Diseases, Cohort Studies, Systemic lupus erythematosus, immune system diseases, medicine, Immunology and Allergy, Humans, Lupus Erythematosus, Systemic, Prospective Studies, Age of Onset, Mortality, Prospective cohort study, skin and connective tissue diseases, Survival rate, Prognostic factor, business.industry, medicine.disease, Prognosis, Europe, Survival Rate, Prospective Studie, Family medicine, Antibodies, Antinuclear, Cohort, Female, Cohort Studie, Age of onset, Morbidity, business, Human, Cohort study, Follow-Up Studies
Abstract

The "Euro-Lupus Cohort" is composed by 1000 patients with systemic lupus erythematosus (SLE) that have been followed prospectively since 1991. These patients have been gathered by a European consortium-the "Euro-Lupus Project Group". This consortium was originated as part of the network promoted by the "European Working Party on SLE", a working group created in 1990 in order to promote research in Europe on the different problems related to this disease. The "Euro-Lupus Cohort" provides an updated information on the SLE morbidity and mortality characteristics in the present decade as well as defines several clinical and immunological prognostic factors. © 2005 Elsevier B.V. All rights reserved.

Published
2006

4. Immunosuppressive therapy in lupus nephritis: the Euro-Lupus Nephritis Trial, a randomized trial of low-dose versus high-dose intravenous cyclophosphamide

Author

Houssiau, F, Vasconcelos, C, D'Cruz, D, Sebastiani, G, De Ramon Garrido, E, Danieli, M, Abramovicz, D, Blockmans, D, Mathieu, A, Direskeneli, H, Galeazzi, M, Gül, A, Levy, Y, Petera, P, Popovic, R, Petrovic, R, Cattaneo, R, Font, J, Depresseux, G, Cosyns, J, Cervera, R., SINICO, RENATO ALBERTO, Houssiau, F, Vasconcelos, C, D'Cruz, D, Sebastiani, G, De Ramon Garrido, E, Danieli, M, Abramovicz, D, Blockmans, D, Mathieu, A, Direskeneli, H, Galeazzi, M, Gül, A, Levy, Y, Petera, P, Popovic, R, Petrovic, R, Sinico, R, Cattaneo, R, Font, J, Depresseux, G, Cosyns, J, and Cervera, R

Subjects
Adult, Male, Kidney Function Test, Adolescent, Dose-Response Relationship, Drug, Immunology, Remission Induction, Injections, Intravenou, Lupus Nephriti, Middle Aged, Kidney Function Tests, Lupus Nephritis, Immunosuppressive Agent, Rheumatology, Azathioprine, Injections, Intravenous, Humans, Female, Single-Blind Method, Treatment Failure, Cyclophosphamide, Immunosuppressive Agents, Human, Aged
Abstract

Objective. Glomerulonephritis is a severe manifestation of systemic lupus erythematosus (SLE) that is usually treated with an extended course of intravenous (IV) cyclophosphamide (CYC). Given the side effects of this regimen, we evaluated the efficacy and the toxicity of a course of low-dose IV CYC prescribed as a remission-inducing treatment, followed by azathioprine (AZA) as a remission-maintaining treatment. Methods. In this multicenter, prospective clinical trial (the Euro-Lupus Nephritis Trial [ELNT]), we randomly assigned 90 SLE patients with proliferative glomerulonephritis to a high-dose IV CYC regimen (6 monthly pulses and 2 quarterly pulses; doses increased according to the white blood cell count nadir) or a low-dose IV CYC regimen (6 fortnightly pulses at a fixed dose of 500 mg), each of which was followed by AZA. Intent-to-treat analyses were performed. Results. Followup continued for a median of 41.3 months in the low-dose group and 41 months in the high-dose group. Sixteen percent of those in the low-dose group and 20% of those in the high-dose group experienced treatment failure (not statistically significant by Kaplan-Meier analysis). Levels of serum creatinine, albumin, C3, 24-hour urinary protein, and the disease activity scores significantly improved in both groups during the first year of followup. Renal remission was achieved in 71% of the low-dose group and 54% of the high-dose group (not statistically significant). Renal flares were noted in 27% of the low-dose group and 29% of the high-dose group. Although episodes of severe infection were more than twice as frequent in the high-dose group, the difference was not statistically significant. Conclusion. The data from the ELNT indicate that in European SLE patients with proliferative lupus nephritis, a remission-inducing regimen of low-dose IV CYC (cumulative dose 3 gm) followed by AZA achieves clinical results comparable to those obtained with a high-dose regimen

Published
2002

5. A cascade of cytokines is responsible for IL-9 expression in human T cells. Involvement of IL-2, IL-4, and IL-10

Author

Houssiau, F. A., Schandene, L., Stevens, M., Cambiaso, C., Goldman, M., Snick, J., and Jean-Christophe Renauld

Subjects
Immunology, Immunology and Allergy
Abstract

We have previously demonstrated that IL-9 induction in human T cells stimulated with PMA and anti-CD3 Ab is mediated by IL-2, as it was blocked by anti-IL-2R Ab. The experiments reported here indicate that anti-IL-2R Ab also inhibited the expression of IL-4, IL-6, and IL-10, thereby raising the possibility that the blockade of IL-9 production by anti-IL-2R mAb could be secondary to the blockade of these cytokines. We found that the inhibition caused by anti-IL-2R Ab on IL-9 production could be reversed by the addition of a combination of IL-4 and IL-10. Moreover, IL-9 production by T cells stimulated with PMA and anti-CD3 Ab was blocked by the addition of anti-IL-4 and anti-IL-10 Abs. Similar results were obtained with T cells cultured on B7-1/Fc gamma RII-transfected fibroblasts in the presence of anti-CD3 Ab. Analysis of cytokine production by different T cell subsets revealed that IL-4, IL-9, and IL-10 were produced only by CD45 Ro+ T cells. Importantly, CD45 Ra+ T cells were capable of producing IL-9 provided that both IL-4 and IL-10 were added to the cultures. The possible relationship between IL-4 production and IL-10 production was clarified by experiments indicating that IL-10 production was inhibited by anti-IL-4 Ab. However, IL-4 was not sufficient to trigger IL-10 production, which required both IL-2 and IL-4. Taken together, our results demonstrate the existence of a cascade of cytokines responsible for IL-9 expression, with IL-2 being required for IL-4 production, a combination of IL-2 and IL-4 for IL-10 production, and a combination of IL-4 and IL-10 for IL-9 production. Kinetics studies of cytokine gene expression in T cells further validated this model.

Published
1995
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6. The autoimmune disease-associated IL2RA locus is involved in the clinical manifestations of systemic sclerosis

Author

Martin, J.E., Carmona, F.D., Broen, J.C.A., Simeon, C.P., Vonk, M.C., Carreira, P., Rios-Fernandez, R., Espinosa, G., Vicente-Rabaneda, E., Tolosa, C., Garcia-Hernandez, F.J., Castellvi, I., Fonollosa, V., Gonzalez-Gay, M.A., Saez-Comet, L., Portales, R.G., Pena, P.G. de la, Fernandez-Castro, M., Diaz, B., Martinez-Estupinan, L., Coenen, M., Voskuyl, A.E., Schuerwegh, A.J., Vanthuyne, M., Houssiau, F., Smith, V., Keyser, F. de, Langhe, E. de, Riemekasten, G., Witte, T., Hunzelmann, N., Kreuter, A., Palm, O., Chee, M.M., Laar, J.M. van, Denton, C., Herrick, A., Worthington, J., Koeleman, B.P.C., Radstake, T.R.D.J., Fonseca, C., Martin, J., Spanish Scleroderma Grp, Rheumatology, and CCA - Innovative therapy

Subjects
Adult, Interleukin 2, systemic sclerosis, Immunology, PATHOGENESIS, BETA, Genome-wide association study, Locus (genetics), Biology, Polymorphism, Single Nucleotide, anti-centromere auto-antibody, CLASSIFICATION, Autoimmune Diseases, Immune tolerance, Pathogenesis, INTERLEUKIN-2-RECEPTOR, SCLERODERMA, rs12722495, Genetics, medicine, Medicine and Health Sciences, Humans, REGULATORY T-CELLS, Allele, GENOME-WIDE ASSOCIATION, skin and connective tissue diseases, Genomic disorders and inherited multi-system disorders Molecular epidemiology [IGMD 3], Genetics (clinical), Autoimmune disease, Scleroderma, Systemic, IL2RA, rs2104286, Interleukin-2 Receptor alpha Subunit, Odds ratio, Middle Aged, medicine.disease, Infection and autoimmunity Auto-immunity, transplantation and immunotherapy [NCMLS 1], Genetic Loci, rs11594656, Evaluation of complex medical interventions Auto-immunity, transplantation and immunotherapy [NCEBP 2], medicine.drug
Abstract

Contains fulltext : 109760.pdf (Publisher’s version ) (Closed access) Regulatory T cells (T(regs)) are crucial in the maintenance of the immune tolerance and seem to have an important role in systemic sclerosis (SSc). The interleukin 2 receptor alpha (IL2RA) is an important T(reg) marker, and polymorphisms of IL2RA gene are associated with a number of autoimmune diseases. Therefore, we aimed to investigate for the first time the association of the IL2RA locus in SSc. For this purpose, a total of 3023 SSc patients and 2735 matched healthy controls, from six European Caucasian cohorts, were genotyped for the IL2RA gene variants rs11594656, rs2104286 and rs12722495 using the TaqMan allelic discrimination technology. The overall meta-analysis reached statistical significance when the three polymorphisms were tested for association with SSc, the limited subtype (lcSSc) and anti-centromere auto-antibodies (ACAs). However, no significant P-values were obtained when the ACA-positive patients were removed from the SSc and lcSSc groups, suggesting that these associations rely on ACA positivity. The strongest association signal with ACA production was detected for rs2104286 (P(FDR)=2.07 x 10(-4), odds ratio=1.30 (1.14-1.47)). The associations of rs11594656 and rs12722495 were lost after conditioning to rs2104286, and allelic combination tests did not evidence a combined effect, indicating that rs2104286 best described the association between IL2RA and ACA presence in SSc. 01 februari 2012

Published
2012
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7. Nonrenal disease activity following mycophenolate mofetil or intravenous cyclophosphamide as induction treatment for lupus nephritis: findings in a multicenter, prospective, randomized, open-label, parallel-group clinical trial

Author

Ginzler, Em, Wofsy, D, Isenberg, D, Gordon, C, Lisk, L, Dooley, Ma, ALMS Group: Abud, C, Adler, S, Alarcón, G, Albuquerque, E, Almeida, F, Alvarellos, A, Appel, G, Avila, H, Blume, C, Boletis, I, Bonnardeaux, A, Braun, A, Buyon, J, Cervera, R, Chen, N, Chen, S, Contreras, G, Da Costa AG, Davids, R, D'Cruz, D, De Ramón, E, Deodhar, A, Doria, Andrea, Dussol, B, Emery, P, Fiechtner, J, Floege, J, Fragoso Loyo, H, Furie, R, Ghazalli, R, Ghossein, C, Gilkeson, G, Ginzler, E, Grossman, J, Gu, J, Guillevin, L, Hatron, Py, Herrera, G, Hiepe, F, Houssiau, F, Hübscher, O, Hura, C, Kaplan, J, Kirsztajn, G, Kiss, E, Kutty, Ga, Laville, M, Lazaro, M, Lenz, O, Li, L, Lightstone, L, Lim, S, Malaise, M, Manzi, S, Marcos, J, Meyer, O, Monge, P, Naicker, S, Neal, N, Neuwelt, M, Nicholls, K, Olsen, N, Ordi Ros, J, Ostrov, B, Pestana, M, Petri, M, Pokorny, G, Pourrat, J, Qian, J, Radhakrishnan, J, Rovin, B, Sanchez Guerrero, J, Roman, Js, Shanahan, J, Shergy, W, Skopouli, F, Spindler, A, Striebich, C, Sundel, R, Swanepoel, C, Tan, Sy, Tate, G, Tesar, V, Tikly, M, Wang, H, Yahya, R, Yu, X, Zhang, F, and Zoruba, D.

Subjects
Adult, Male, medicine.medical_specialty, Cyclophosphamide, Immunology, Lupus nephritis, Mycophenolate, Gastroenterology, Severity of Illness Index, Mycophenolic acid, law.invention, Rheumatology, Randomized controlled trial, Prednisone, law, Internal medicine, medicine, Immunology and Allergy, Humans, Pharmacology (medical), Prospective Studies, skin and connective tissue diseases, Glucocorticoids, business.industry, Anti-Inflammatory Agents, Non-Steroidal, Remission Induction, Complement System Proteins, Mycophenolic Acid, medicine.disease, Lupus Nephritis, Surgery, Clinical trial, Treatment Outcome, Antibodies, Antinuclear, Injections, Intravenous, Drug Therapy, Combination, Female, business, Immunosuppressive Agents, medicine.drug, Kidney disease
Abstract

To assess the effect of mycophenolate mofetil compared with intravenous pulses of cyclophosphamide on the nonrenal manifestations of lupus nephritis.Patients with active lupus nephritis (renal biopsy class III, IV, or V) were recruited for the study (n = 370) and treated with mycophenolate mofetil (target dosage 3 gm/day) or intravenous cyclophosphamide (0.5-1.0 gm/m(2)/month), plus tapered prednisone, for 24 weeks. Nonrenal outcomes were determined using measures of whole body disease activity, including the British Isles Lupus Assessment Group (BILAG) disease activity index, the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) version of the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI), and immunologic variables.Both treatments were effective on whole body disease activity in the systems examined, as indicated by changes in the classic BILAG index. With either treatment, remission was induced, notably in the mucocutaneous, musculoskeletal, cardiovascular/respiratory, and vasculitis systems, and flares were rare, as measured by the SELENA-SLEDAI. Levels of complement C3, C4, and CH50 and titers of anti-double-stranded DNA antibodies were normalized after treatment with either mycophenolate mofetil or intravenous cyclophosphamide.In addition to the efficacy of both treatments on the renal system, this analysis showed that remission could also be induced in other systems. There was no clear difference in efficacy between mycophenolate mofetil and intravenous cyclophosphamide in ameliorating either the renal or nonrenal manifestations. Mycophenolate mofetil is, therefore, a suitable alternative to cyclophosphamide for the treatment of renal and nonrenal disease manifestations in patients with biopsy-proven lupus nephritis.

Published
2010

8. Anti-ganglioside antibodies in a large cohort of European patients with systemic lupus erythematosus: clinical, serological, and HLA class II gene associations

Author

Galeazzi, M., Annunziata, P., Sebastlani, G. D., Bellisai, F., Campanella, V., Ferrara, G. B., Font, J., Houssiau, F., Passiu, G., Ramon Garrido, E., Fernandez-Nebro, A., Bracci, L., Scorza, R., Puddu, P., Jedryka-Goral, A., Smolen, J., Tincani, A., Carlo Carcassi, Morozzi, G., and Marcolongo, R.

Subjects
HLA, Anti-GM1, Neuropsychiatric manifestations, Systemic lupus erythematosus, Rheumatology, Immunology and Allergy, Immunology
Published
2000

9. I-309/T Cell Activation Gene-3 Chemokine Protects Murine T Cell Lymphomas Against Dexamethasone-Induced Apoptosis

Author

Vansnick, J., Houssiau, F., Paul Proost, Vandamme, J., and Renauld, Jc

Subjects
Immunology, Immunology and Allergy
Abstract

We have previously reported that cytokines such as IL-9, IL-4, and IL-6 protect murine thymic lymphoma cell lines against dexamethasone-induced apoptosis. A similar activity, which could not be ascribed to any of these factors, was found in a number of human T cell supernatants that enabled mouse BW5147 thymic lymphoma not only to escape apoptosis but also to maintain proliferation. The protein responsible for this activity was purified to homogeneity from the culture medium of activated leukemic T cells and was found to be identical with the I-309 chemokine. Half-maximal anti-apoptotic activity was obtained with approximately 1 ng/ml, a concentration considerably lower than that required for the monocyte chemotactic activity of this molecule, as measured on THP-1 cells. The purified I-309 also improved the survival of two other mouse thymic lymphoma cell lines. This activity was as potent as that of IL-9, which was the strongest anti-apoptotic factor found to date for these cells. Similar results were obtained for BW5147 cells with recombinant I-309 and with T cell activation gene-3, the murine homologue of I-309, but not with other members of the chemokine family, including IL-8, neutrophil-activating peptide-2, granulocyte chemotactic protein-2, macrophage inflammatory protein-1a, RANTES (regulated upon activation, normal T cell expressed and secreted), monocyte chemotactic protein-1 (MCP-1), and MCP-2. MCP-3, however, showed a minor, but significant effect in this model. Unlike that of IL-9, the activity of I-309 was completely inhibited in the presence of pertussis toxin, indicating the involvement of a G protein in this process.

10. IL-2 dependence of IL-9 expression in human T lymphocytes

Author

Houssiau, F. A., Jean-Christophe Renauld, Fibbe, W. E., and Snick, J.

Subjects
Immunology, Immunology and Allergy
Abstract

Human IL-9 is a T cell-derived lymphokine that is abundantly expressed upon activation with mitogens. The observation that IL-9 induction peaks as late as 28 h after stimulation suggested the involvement of secondary signals in this process. The finding reported here that IL-9 expression is blocked by cycloheximide strongly supports this hypothesis. Moreover, we identify IL-2 as the critical element controlling IL-9 expression in T cells. We show (i) that anti-IL-2R antibodies block IL-9 expression in T cells stimulated with PMA and anti-CD3 and (ii) that IL-2, of a panel of cytokines, is the only molecule that synergizes with PMA for IL-9 induction. The latter finding is confirmed in a T cell leukemia line. Finally, we demonstrate that IL-2 plays a regulatory role in the induction of other cytokines, such as IL-4, IL-5, IL-6, and granulocyte/macrophage-CSF, in fresh peripheral T cells.

11. The added value of a European Reference Network on rare and complex connective tissue and musculoskeletal diseases: insights after the first 5 years of the ERN ReCONNET

Author

Rosaria Talarico, Silvia Aguilera, Tobias Alexander, Zahir Amoura, Janette Andersen, Laurent Arnaud, Tadej Avcin, Sara Marsal Barril, Lorenzo Beretta, Stefano Bombardieri, Alessandra Bortoluzzi, Coralie Bouillot, Inita Bulina, Gerd R. Burmester, Sara Cannizzo, Lorenzo Cavagna, Benjamin Chaigne, Alain Cornet, Paolo Corti, Nathalie Costedoat-Chalumeau, Zane Dāvidsone, Andrea Doria, Carol Fenech, Alessandro Ferraris, Rebecca Fischer-Betz, João Eurico Fonseca, Charissa Frank, Andrea Gaglioti, Ilaria Galetti, Vera Guimarães, Eric Hachulla, Monica Holmner, Frederic Houssiau, Luca Iaccarino, Søren Jacobsen, Maarten Limper, Fransiska Malfait, Xavier Mariette, Diana Marinello, Thierry Martin, Lisa Matthews, Marco Matucci-Cerinic, Alain Meyer, Jasminka Milas-Ahić, Pia Moinzadeh, Carlomaurizio Montecucco, Luc Mouthon, Ulf Müller-Ladner, György Nagy, Eunice Patarata, Margarita Pileckyte, Chris Pruunsild, Simona Rednic, Vasco C. Romão, Matthias Schneider, Carlo Alberto Scirè, Vanessa Smith, Alberto Sulli, Farah Tamirou, Chiara Tani, Domenica Taruscio, Anna V. Taulaigo, Angela Tincani, Simone Ticciati, Giuseppe Turchetti, P. Martin van Hagen, Jacob M. van Laar, Ana Viera, Jeska K. de Vries-Bouwstra, Johannes Zschocke, Maurizio Cutolo, Marta Mosca, Talarico, R, Aguilera, S, Alexander, T, Amoura, Z, Andersen, J, Arnaud, L, Avcin, T, Marsal Barril, S, Beretta, L, Bombardieri, S, Bortoluzzi, A, Bouillot, C, Bulina, I, Burmester, G, Cannizzo, S, Cavagna, L, Chaigne, B, Cornet, A, Corti, P, Costedoat-Chalumeau, N, Davidsone, Z, Doria, A, Fenech, C, Ferraris, A, Fischer-Betz, R, Fonseca, J, Frank, C, Gaglioti, A, Galetti, I, Guimaraes, V, Hachulla, E, Holmner, M, Houssiau, F, Iaccarino, L, Jacobsen, S, Limper, M, Malfait, F, Mariette, X, Marinello, D, Martin, T, Matthews, L, Matucci-Cerinic, M, Meyer, A, Milas-Ahic, J, Moinzadeh, P, Montecucco, C, Mouthon, L, Muller-Ladner, U, Nagy, G, Patarata, E, Pileckyte, M, Pruunsild, C, Rednic, S, Romao, V, Schneider, M, Scire, C, Smith, V, Sulli, A, Tamirou, F, Tani, C, Taruscio, D, Taulaigo, A, Tincani, A, Ticciati, S, Turchetti, G, van Hagen, P, van Laar, J, Vieira, A, de Vries-Bouwstra, J, Zschocke, J, Cutolo, M, Mosca, M, UCL - SSS/IREC/RUMA - Pôle de Pathologies rhumatismales, and UCL - (SLuc) Service de rhumatologie

Subjects
rare and complex diseases, Health Personnel, rare and complex disease, Immunology, patient care, European Reference Network, rheumatic and musculoskeletal diseases, rheumatic and musculoskeletal disease, Europe, European Reference Networks, Rare Diseases, Rheumatology, Connective Tissue, connective tissue disease, Immunology and Allergy, Humans, Musculoskeletal Diseases, connective tissue diseases, European Commission
Abstract

In order to address the main challenges related to the rare diseases (RDs) the European Commission launched the European Reference Networks (ERNs), virtual networks involving healthcare providers (HCPs) across Europe. The mission of the ERNs is to tackle low prevalence and RDs that require highly specialised treatment and a concentration of knowledge and resources. In fact, ERNs offer the potential to give patients and healthcare professionals across the EU access to the best expertise and timely exchange of lifesaving knowledge, trying to make the knowledge travelling more than patients. For this reason, ERNs were established as concrete European infrastructures, and this is particularly crucial in the framework of rare and complex diseases in which no country alone has the whole knowledge and capacity to treat all types of patients. It has been five years since their kick-off launch in Vilnius in 2017. The 24 ERNs have been intensively working on different transversal areas, including patient management, education, clinical practice guidelines, patients' care pathways and many other fundamental topics. The present work is therefore aimed not only at reporting a summary of the main activities and milestones reached so far, but also at celebrating the first 5 years of the ERN on Rare and Complex Connective Tissue and Musculo-skeletal Diseases (ReCONNET), in which the members of the network built together one of the 24 infrastructures that are hopefully going to change the scenario of rare diseases across the EU.

Published
2022
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12. Systemic sclerosis: state of the art on clinical practice guidelines

Author

Jeska K de Vries-Bouwstra, Jacob M van Laar, Ronald F van Vollenhoven, Els Vandecasteele, Alexandre E. Voskuyl, Charissa Frank, Tobias Alexander, Gemma Lepri, Fonseca João Eurico, Eric Hachulla, Angela Tincani, Alexis Mathian, Elisabetta Zanatta, Veronica Codullo, Alberto Sulli, Luc Mouthon, Marco Matucci-Cerinic, Vanessa Smith, Amber Vanhaecke, Gerd R Burmester, Marie Vanthuyne, Frank J. A. van den Hoogen, D. Launay, Matthias Schneider, Maurizio Cutolo, Rosaria Talarico, Yannick Allanore, Ilaria Galetti, Frédéric Houssiau, Virgil A. S. H. Dalm, Alessandra Della Rossa, Cosimo Bruni, Carlo Alberto Scirè, Ulf Mueller-Ladner, Oliver Distler, Stefano Bombardieri, Paolo Airò, Barbara Ruaro, Marta Mosca, Ana Rita Vieira, Immunology, Internal Medicine, Smith, V, Scire, C, Talarico, R, Airo, P, Alexander, T, Allanore, Y, Bruni, C, Codullo, V, Dalm, V, De Vries-Bouwstra, J, Della Rossa, A, Distler, O, Galetti, I, Launay, D, Lepri, G, Mathian, A, Mouthon, L, Ruaro, B, Sulli, A, Tincani, A, Vandecasteele, E, Vanhaecke, A, Vanthuyne, M, Van Den Hoogen, F, Van Vollenhoven, R, Voskuyl, A, Zanatta, E, Bombardieri, S, Burmester, G, Eurico, F, Frank, C, Hachulla, E, Houssiau, F, Mueller-Ladner, U, Schneider, M, Van Laar, J, Vieira, A, Cutolo, M, Mosca, M, Matucci-Cerinic, M, Scirè, Ca, Van den Hoogen, F, Voskuyl, Ae, Eurico, Fj, van Laar, Jm, and Matucci-Cerinic, M.

Subjects
ERN ReCONNET, European reference networks, clinical practice guidelines, nailfold videocapillaroscopy, systemic sclerosis, unmet needs, European reference network, Disease, INTERSTITIAL LUNG-DISEASE, RECOMMENDATIONS, DEVELOPING CRITERIA, PRACTICE PATHWAY, High morbidity, 0302 clinical medicine, Fibrosis, Medicine and Health Sciences, EXPERT CONSENSUS, Immunology and Allergy, 030212 general & internal medicine, skin and connective tissue diseases, integumentary system, Interstitial lung disease, unmet need, Clinical Practice, medicine.symptom, systemic sclerosi, clinical practice guideline, medicine.medical_specialty, Immunology, Systemic Sclerosis, NO, Pharmacological treatment, Unmet needs, 03 medical and health sciences, Rheumatology, medicine, SIMPLE CAPILLAROSCOPIC DEFINITIONS, Intensive care medicine, 030203 arthritis & rheumatology, business.industry, STEM-CELL TRANSPLANTATION, medicine.disease, Sexual dysfunction, SKIN ULCERS, FUNCTIONAL DISABILITY, clinical practice guidelines, ERN ReCONNET, European reference networks, nailfold videocapillaroscopy, systemic sclerosis, unmet needs, POINTS, business
Abstract

Systemic sclerosis (SSc) is an orphan disease characterised by autoimmunity, fibrosis of the skin and internal organs, and vasculopathy. SSc may be associated with high morbidity and mortality. In this narrative review we summarise the results of a systematic literature research, which was performed as part of the European Reference Network on Rare and Complex Connective Tissue and Musculoskeletal Diseases project, aimed at evaluating existing clinical practice guidelines or recommendations. Only in the domains ‘Vascular & Ulcers’ (ie, non-pharmacological approach to digital ulcer), ‘PAH’ (ie, screening and treatment), ‘Treatment’ and ‘Juveniles’ (ie, evaluation of juveniles with Raynaud’s phenomenon) evidence-based and consensus-based guidelines could be included. Hence there is a preponderance of unmet needs in SSc referring to the diagnosis and (non-)pharmacological treatment of several SSc-specific complications. Patients with SSc experience significant uncertainty concerning SSc-related taxonomy, management (both pharmacological and non-pharmacological) and education. Day-to-day impact of the disease (loss of self-esteem, fatigue, sexual dysfunction, and occupational, nutritional and relational problems) is underestimated and needs evaluation.

Published
2018

13. Systemic lupus erythematosus: state of the art on clinical practice guidelines

Author

Ricard Cervera, Sabrina Paolino, Angela Tincani, Ulf Mueller-Ladner, Hervé Devilliers, Gerd R Burmester, Zahir Amoura, Fabrizio Conti, Thierry Martin, Marcello Govoni, Laurent Arnaud, Carlo Alberto Scirè, Tadej Avcin, Matthias Schneider, Marta Mosca, Micaela Fredi, Ana Lladó, Carla Macieira, Maria G Tektonidou, Ilaria Galetti, Alain Cornet, Cristina Pamfil, Maurizio Cutolo, Vanessa Smith, Farah Tamirou, Stefano Bombardieri, Laura Massaro, Eric Hachulla, Frédéric Houssiau, Andrea Doria, Micol Frassi, Fonseca João Eurico, Ronald F van Vollenhoven, Rosaria Talarico, Tobias Alexander, Maria Francisca Moraes-Fontes, Sander W. Tas, Chiara Tani, Alessandra Bortoluzzi, N. Costedoat-Chalumeau, Université Catholique de Louvain = Catholic University of Louvain (UCL), Les Hôpitaux Universitaires de Strasbourg (HUS), Azienda Ospedaliero-Universitaria Pisana [Pisa, Italy], Università degli Studi di Ferrara (UniFE), Charité - UniversitätsMedizin = Charité - University Hospital [Berlin], CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), University Medical Centre Ljubljana [Ljubljana, Slovenia] (UMCL), Clinic Barcelona Hospital Universitari, Università degli Studi di Roma 'La Sapienza' = Sapienza University [Rome], Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Université de Bourgogne (UB), Azienda Ospedale Università di Padova = Hospital-University of Padua (AOUP), Spedali Civili Hospital [Brescia], Centro Hospitalar de Lisboa Central [Portugal], Centro Hospitalar Universitário Lisboa Norte [Lisbon, Portugal] (CHULN), University of Genoa (UNIGE), University of Amsterdam [Amsterdam] (UvA), Amsterdam Rheumatology & Immunology Center - ARC [Amsterdam, the Netherlands] (Amsterdam UMC), National and Kapodistrian University of Athens (NKUA), University of Pisa - Università di Pisa, Centre National de Référence des Maladies Auto-Immunes Systémiques Rares du Nord et Nord-Ouest de France (CeRAINO), Lille Inflammation Research International Center - U 995 (LIRIC), Institut Pasteur de Lille, Réseau International des Instituts Pasteur (RIIP)-Réseau International des Instituts Pasteur (RIIP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), CHU Lille, Kerckhoff clinic, Partenaires INRAE, Universitätsklinikum Düsseldorf, Universiteit Gent = Ghent University [Belgium] (UGENT), Hôpital Cochin [AP-HP], Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS (U1153 / UMR_A_1125 / UMR_S_1153)), Conservatoire National des Arts et Métiers [CNAM] (CNAM), HESAM Université (HESAM)-HESAM Université (HESAM)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPC)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Università degli Studi di Ferrara = University of Ferrara (UniFE), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Università degli Studi di Roma 'La Sapienza' = Sapienza University [Rome] (UNIROMA), Università degli studi di Genova = University of Genoa (UniGe), Universiteit Gent = Ghent University (UGENT), Institut National de la Recherche Agronomique (INRA)-Université Paris Diderot - Paris 7 (UPD7)-Université Paris Descartes - Paris 5 (UPD5)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM), UCL - SSS/IREC/RUMA - Pôle de Pathologies rhumatismales, UCL - (SLuc) Service de rhumatologie, Tamirou, F, Arnaud, L, Talarico, R, Scire, C, Alexander, T, Amoura, Z, Avcin, T, Bortoluzzi, A, Cervera, R, Conti, F, Cornet, A, Devilliers, H, Doria, A, Frassi, M, Fredi, M, Govoni, M, Houssiau, F, Llado, A, Macieira, C, Martin, T, Massaro, L, Moraes-Fontes, M, Pamfil, C, Paolino, S, Tani, C, Tas, S, Tektonidou, M, Tincani, A, Van Vollenhoven, R, Bombardieri, S, Burmester, G, Eurico, F, Galetti, I, Hachulla, E, Mueller-Ladner, U, Schneider, M, Smith, V, Cutolo, M, Mosca, M, and Costedoat-Chalumeau, N

Subjects
medicine.medical_specialty, HCC DAUTOIM, Immunology, MEDLINE, Lupus nephritis, Lupus, Guidelines, AMERICAN-COLLEGE, DIAGNOSIS, Systemic Lupus Erythematosus, Unmet needs, NO, 03 medical and health sciences, 0302 clinical medicine, Quality of life (healthcare), lupu, Rheumatology, immune system diseases, EUROPEAN LEAGUE, Immunology and Allergy, Internal medicine, medicine, Medicine and Health Sciences, MANAGEMENT, 030212 general & internal medicine, EVIDENCE-BASED RECOMMENDATIONS, Disease management (health), Intensive care medicine, RHEUMATIC-DISEASES, 030203 arthritis & rheumatology, RISK, business.industry, ASSOCIATION, medicine.disease, State of the Art, 3. Good health, Clinical Practice, EULAR RECOMMENDATIONS, PREGNANCY, [SDV.IMM]Life Sciences [q-bio]/Immunology, business
Abstract

Systemic lupus erythematosus (SLE) is the paradigm of systemic autoimmune diseases characterised by a wide spectrum of clinical manifestations with an unpredictable relapsing-remitting course. The aim of the present work was to identify current available clinical practice guidelines (CPGs) for SLE, to provide their review and to identify physicians' and patients' unmet needs. Twenty-three original guidelines published between 2004 and 2017 were identified. Many aspects of disease management are covered, including global disease management, lupus nephritis and neuropsychiatric involvement, management of pregnancies, vaccinations and comorbidities monitoring. Unmet needs relate with disease management of some clinical manifestations and adherence to treatment. Many patient's unmet needs have been identified starting with faster diagnosis, need for more therapeutic options, guidelines on lifestyle issues, attention to quality of life and adequate education. info:eu-repo/semantics/publishedVersion

Published
2018
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14. Long-term follow-up of the MAINTAIN Nephritis Trial, comparing azathioprine and mycophenolate mofetil as maintenance therapy of lupus nephritis

Author

Tamirou, Farah, D'Cruz, David, Sangle, Shirish, Remy, Philippe, Vasconcelos, Carlos, Fiehn, Christoph, Ayala Guttierez, Maria del Mar, Gilboe, Inge-Magrethe, Tektonidou, Maria, Blockmans, Daniel, Ravelingien, Isabelle, le Guern, Véronique, Depresseux, Geneviève, Guillevin, Loïc, Cervera, Ricard, Houssiau, Frédéric A, MAINTAIN Nephritis Trial Group, UCL - SSS/IREC/RUMA - Pôle de Pathologies rhumatismales, UCL - (SLuc) Service de rhumatologie, Universitat de Barcelona, The MAINTAIN Nephritis Trial Group, [Tamirou,F, Depresseux,G, Houssiau,F] Rheumatology Department, Cliniques Universitaires Saint-Luc, Université catholique de Louvain, Brussels, Belgium. D'Cruz,D, Sangle,S] Louise Coote Lupus Unit, St Thomas’ Hospital, London, UK. [Remy,P] Nephrology Department, Hôpital Henri Mondor, Créteil, France. [Vasconcelos,C] Clinical Immunology Unit, Hospital Santo Antonio, ICBAS, Porto, Portugal. [Fiehn,C] ACURA Center for Rheumatic Diseases, Baden-Baden, Germany. [Ayala Guttierez,MM]Department of General Internal Medicine, Hospital Regional Universitario Carlos Haya, Malaga, Spain. [Gilboe,IM] Rheumatology Department, Rikshospitalet University Hospital, Oslo, Norway. Tektonidou,M] First Department of Internal Medicine, National University of Athens, Athens, Greece. Blockmans,D] General Internal Medicine Department, UZ Gasthuisberg, Katholieke Universiteit Leuven, Leuven, Belgium. [Ravelingien,I] Rheumatology Department, Onze-Lieve-Vrouw Ziekenhuis, Aalst, Belgium. [le Guern,V, and Guillevin,L] General Internal Medicine Department, Hôpital Cochin, Paris, France. [Cervera,R] Department of Autoimmune Diseases, Hospital Clinic, Barcelona, Catalonia, Spain.

Subjects
Male, Diseases::Male Urogenital Diseases::Urologic Diseases::Kidney Diseases::Renal Insufficiency::Renal Insufficiency, Chronic::Kidney Failure, Chronic [Medical Subject Headings], Diseases::Immune System Diseases::Autoimmune Diseases::Lupus Erythematosus, Systemic::Lupus Nephritis [Medical Subject Headings], 030232 urology & nephrology, Lupus nephritis, Azathioprine, Named Groups::Persons::Age Groups::Adult::Middle Aged [Medical Subject Headings], Estudios longitudinales, urologic and male genital diseases, Gastroenterology, Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humans [Medical Subject Headings], 0302 clinical medicine, Maintenance therapy, Chemicals and Drugs::Organic Chemicals::Carboxylic Acids::Acids, Acyclic::Caproates::Mycophenolic Acid [Medical Subject Headings], Nefritis lúpica, Immunologie, Immunology and Allergy, Longitudinal Studies, Masculino, Fallo renal crónico, Proteinuria, Kidney diseases, Adulto, Femenino, Middle Aged, Connective tissue disease, Lupus Nephritis, Humanos, Rhumatologie, Treatment Outcome, Estudi de casos, Outcomes research, Disease Progression, Ácido micofenólico, Female, Estudios de seguimiento, medicine.symptom, Chemicals and Drugs::Chemical Actions and Uses::Pharmacologic Actions::Physiological Effects of Drugs::Immunologic Factors::Immunosuppressive Agents [Medical Subject Headings], Nephritis, Biologie, Immunosuppressive Agents, medicine.drug, Adult, medicine.medical_specialty, Allergie et immunopathologie, Immunology, Check Tags::Male [Medical Subject Headings], Renal function, Lupus, Azatioprina, Therapeutics, Chemicals and Drugs::Organic Chemicals::Sulfur Compounds::Thionucleosides::Azathioprine [Medical Subject Headings], General Biochemistry, Genetics and Molecular Biology, Mycophenolic acid, Maintenance Chemotherapy, 03 medical and health sciences, Rheumatology, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Epidemiologic Study Characteristics as Topic::Epidemiologic Studies::Cohort Studies::Longitudinal Studies [Medical Subject Headings], Internal medicine, Progresión de la enfermedad, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Epidemiologic Study Characteristics as Topic::Epidemiologic Studies::Cohort Studies::Longitudinal Studies::Follow-Up Studies [Medical Subject Headings], Named Groups::Persons::Age Groups::Adult [Medical Subject Headings], medicine, Humans, Quimioterapia de mantenimiento, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Diagnosis::Prognosis::Treatment Outcome [Medical Subject Headings], 030203 arthritis & rheumatology, Mediana edad, Diseases::Pathological Conditions, Signs and Symptoms::Pathologic Processes::Disease Attributes::Disease Progression [Medical Subject Headings], business.industry, Mycophenolic Acid, Inmunosupresores, medicine.disease, Terapèutica, Treatment, Diseases::Pathological Conditions, Signs and Symptoms::Signs and Symptoms::Urological Manifestations::Proteinuria [Medical Subject Headings], Check Tags::Female [Medical Subject Headings], Analytical, Diagnostic and Therapeutic Techniques and Equipment::Therapeutics::Drug Therapy::Maintenance Chemotherapy [Medical Subject Headings], Malalties del ronyó, Kidney Failure, Chronic, Case studies, Resultado del tratamiento, business, Follow-Up Studies
Abstract

Objective: To report the 10-year follow-up of the MAINTAIN Nephritis Trial comparing azathioprine (AZA) and mycophenolate mofetil (MMF) as maintenance therapy of proliferative lupus nephritis, and to test different definitions of early response as predictors of long-term renal outcome. Methods: In 2014, data on survival, kidney function, 24 h proteinuria, renal flares and other outcomes were collected for the 105 patients randomised between 2002 and 2006, except in 13 lost to follow-up. Results: Death (2 and 3 in the AZA and MMF groups, respectively) and end-stage renal disease (1 and 3, respectively) were rare events. Time to renal flare (22 and 19 flares in AZA and MMF groups, respectively) did not differ between AZA and MMF patients. Patients with good long-term renal outcome had a much more stringent early decrease of 24 h proteinuria compared with patients with poor outcome. The positive predictive value of a 24 h proteinuria, 0, SCOPUS: ar.j, info:eu-repo/semantics/published

Published
2016

15. The 10-year follow-up data of the Euro-Lupus Nephritis Trial comparing low-dose and high-dose intravenous cyclophosphamide

Author

David D'Cruz, Daniel Abramovicz, Yair Levy, Gian Domenico Sebastiani, Frédéric Houssiau, Alberto Cauli, Rajko Popovic, Mauro Galeazzi, Geneviève Depresseux, Roberto Cattaneo, Peter Petera, Haner Direskeneli, Ricard Cervera, Carlos Vasconcelos, Radmila Petrovic, E. De Ramon Garrido, Ahmet Gül, Maria Giovanna Danieli, J Font, J-P Cosyns, Renato Alberto Sinico, Daniel Engelbert Blockmans, Houssiau, F, Vasconcelos, C, D'Cruz, D, Sebastiani, G, De Ramon Garrido, E, Danieli, M, Abramovicz, D, Blockmans, D, Cauli, A, Direskeneli, H, Galeazzi, M, Gül, A, Levy, Y, Petera, P, Popovic, R, Petrovic, R, Sinico, R, Cattaneo, R, Font, J, Depresseux, G, Cosyns, J, and Cervera, R

Subjects
Adult, Male, medicine.medical_specialty, Adolescent, Cyclophosphamide, Immunology, Lupus nephritis, Urology, Renal function, Injections, Intravenou, Kidney Function Tests, General Biochemistry, Genetics and Molecular Biology, Immunosuppressive Agent, Young Adult, chemistry.chemical_compound, Rheumatology, Azathioprine, medicine, Humans, Immunology and Allergy, Creatinine, Kidney Function Test, Biochemistry, Genetics and Molecular Biology (all), Proteinuria, Dose-Response Relationship, Drug, business.industry, Lupus Nephriti, Middle Aged, medicine.disease, Lupus Nephritis, Surgery, Regimen, Treatment Outcome, chemistry, Epidemiologic Method, Injections, Intravenous, Drug Therapy, Combination, Female, medicine.symptom, Epidemiologic Methods, business, Nephritis, Immunosuppressive Agents, Human, medicine.drug, Kidney disease
Abstract

Objective:To update the follow-up of the Euro-Lupus Nephritis Trial (ELNT), a randomised prospective trial comparing low-dose (LD) and high-dose (HD) intravenous (IV) cyclophosphamide (CY) followed by azathioprine (AZA) as treatment for proliferative lupus nephritis.Patients and methods:Data for survival and kidney function were prospectively collected during a 10-year period for the 90 patients randomised in the ELNT, except in 6 lost to follow-up.Results:Death, sustained doubling of serum creatinine and end-stage renal disease rates did not differ between the LD and HD group (5/44 (11%) vs 2/46 (4%), 6/44 (14%) vs 5/46 (11%) and 2/44 (5%) vs 4/46 (9%), respectively) nor did mean serum creatinine, 24 h proteinuria and damage score at last follow-up. Most patients in both groups were still treated with glucocorticoids, other immunosuppressant agents and blood pressure lowering drugs. After 10 years of follow-up, the positive predictive value for a good outcome of an early drop in proteinuria in response to initial immunosuppressive therapy was confirmed.Conclusion:The data confirm that a LD IVCY regimen followed by AZA—the “Euro-Lupus regimen”—achieves good clinical results in the very long term.

Published
2009
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16. Early response to immunosuppressive therapy predicts good renal outcome in lupus nephritis: Lessons from long-term followup of patients in the euro-lupus nephritis trial

Author

Houssiau, Fa, Vasconcelos, C, D'Cruz, D, Sebastiani, Gd, DE RAMON GARRIDO, E, Danieli, Mg, Abramovicz, D, Blockmans, D, Mathieu, A, Direskeneli, H, Galeazzi, M, Gul, A, Levy, Y, Petera, P, Popovic, R, Petrovic, R, Sinico, Ra, Cattaneo, Roberto, Font, J, Depresseux, G, Cosyns, Jp, Cervera, R., Houssiau, F, Vasconcelos, C, D'Cruz, D, Sebastiani, G, De Ramon Garrido, E, Danieli, M, Abramovicz, D, Blockmans, D, Mathieu, A, Direskeneli, H, Galeazzi, M, Gül, A, Levy, Y, Petera, P, Popovic, R, Petrovic, R, Sinico, R, Cattaneo, R, Font, J, Depresseux, G, Cosyns, J, and Cervera, R

Subjects
Adult, Male, Time Factors, Adolescent, Time Factor, Immunology, Injections, Intravenou, Kidney Function Tests, Follow-Up Studie, Immunosuppressive Agent, Rheumatology, Azathioprine, Humans, Cyclophosphamide, Kidney Function Test, Dose-Response Relationship, Drug, Lupus Nephriti, Lupus Nephritis, Survival Rate, Proteinuria, Treatment Outcome, Injections, Intravenous, Female, Immunosuppressive Agents, Follow-Up Studies, Human
Abstract

Arthritis Rheum. 2004 Dec;50(12):3934-40. Early response to immunosuppressive therapy predicts good renal outcome in lupus nephritis: lessons from long-term followup of patients in the Euro-Lupus Nephritis Trial. Houssiau FA, Vasconcelos C, D'Cruz D, Sebastiani GD, de Ramon Garrido E, Danieli MG, Abramovicz D, Blockmans D, Mathieu A, Direskeneli H, Galeazzi M, Gül A, Levy Y, Petera P, Popovic R, Petrovic R, Sinico RA, Cattaneo R, Font J, Depresseux G, Cosyns JP, Cervera R. Université Catholique de Louvain, Brussels, Belgium. houssiau@ruma.ucl.ac.be Abstract OBJECTIVE: In the Euro-Lupus Nephritis Trial (ELNT), 90 patients with lupus nephritis were randomly assigned to a high-dose intravenous cyclophosphamide (IV CYC) regimen (6 monthly pulses and 2 quarterly pulses with escalating doses) or a low-dose IV CYC regimen (6 pulses of 500 mg given at intervals of 2 weeks), each of which was followed by azathioprine (AZA). After a median followup of 41 months, a difference in efficacy between the 2 regimens was not observed. The present analysis was undertaken to extend the followup and to identify prognostic factors. METHODS: Renal function was prospectively assessed quarterly in all 90 patients except 5 who were lost to followup. Survival curves were derived using the Kaplan-Meier method. RESULTS: After a median followup of 73 months, there was no significant difference in the cumulative probability of end-stage renal disease or doubling of the serum creatinine level in patients who received the low-dose IV CYC regimen versus those who received the high-dose regimen. At long-term followup, 18 patients (8 receiving low-dose and 10 receiving high-dose treatment) had developed permanent renal impairment and were classified as having poor long-term renal outcome. We demonstrated by multivariate analysis that early response to therapy at 6 months (defined as a decrease in serum creatinine level and proteinuria

Published
2004

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