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2. Native/citrullinated LL37-specific T-cells help autoantibody production in Systemic Lupus Erythematosus

Author

Lande, R., Palazzo, R., Gestermann, N., Jandus, C., Falchi, M., Spadaro, F., Riccieri, V., James, E. A., Butera, A., Boirivant, M., Feldmeyer, L., Surbeck, I., Di Lucca, J., Stuber, F., Spinelli, F. R., Botti, E., Marinari, B., Bianchi, L., Pica, R., Cerbelli, B., Giannakakis, K., Auteri, S. E., Daniels, I., Durrant, L. G., Horstman, S., Costanzo, A., Romero, P., Alessandri, C., Conti, F., Valesini, G., Gilliet, M., Chizzolini, C., and Frasca, L.

Published
2020
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4. Increased COVID-19 mortality in patients with rheumatic diseases: results from the CONTROL-19 study by the Italian Society for Rheumatology

Author

Zanetti, A, Carrara, G, Landolfi, G, Rozza, D, Chighizola, C, Alunno, A, Andreoli, L, Caporali, R, Gerli, R, Sebastiani, G, Valesini, G, Sinigaglia, L, Raffeiner, B, Lomater, C, Caprioli, M, Fredi, M, Romeo, N, Cuomo, G, Vadacca, M, Scire, C, Zanetti A., Carrara G., Landolfi G., Rozza D., Chighizola C. B., Alunno A., Andreoli L., Caporali R., Gerli R., Sebastiani G. D., Valesini G., Sinigaglia L., Raffeiner B., Lomater C., Caprioli M., Fredi M., Romeo N., Cuomo G., Vadacca M., Scire C. A., Zanetti, A, Carrara, G, Landolfi, G, Rozza, D, Chighizola, C, Alunno, A, Andreoli, L, Caporali, R, Gerli, R, Sebastiani, G, Valesini, G, Sinigaglia, L, Raffeiner, B, Lomater, C, Caprioli, M, Fredi, M, Romeo, N, Cuomo, G, Vadacca, M, Scire, C, Zanetti A., Carrara G., Landolfi G., Rozza D., Chighizola C. B., Alunno A., Andreoli L., Caporali R., Gerli R., Sebastiani G. D., Valesini G., Sinigaglia L., Raffeiner B., Lomater C., Caprioli M., Fredi M., Romeo N., Cuomo G., Vadacca M., and Scire C. A.

Abstract

Objective To investigate differences in coronavirus disease 2019 (COVID-19) mortality between patients with rheumatic musculoskeletal diseases (RMD) and the general population in Italy. Methods We analysed the data from the national surveillance study promoted by the Italian Society for Rheumatology (CONTROL-19 database) including patients with RMD and COVID-19 between 26 March 2020 and 29 November 2020, compared with official data from the Italian population (within the same period) adjusted for age, sex and geographic location. The main outcome of the analyses was mortality. The relationship between RMD and mortality was analysed using adjusted logistic models and sensitivity analyses were conducted to support the robustness of our results. Results We included 668 RMD patients (62.7% with inflammatory arthritis, 28.6% with systemic autoimmune diseases), who had a mean age of 58.4 years and of which 66% were female. Compared to the general population, the RMD population showed an increased risk of death (OR 3.10 (95% CI 2.29–4.12)), independently from the differences in age and sex distribution. Even after considering the potential influence of surveillance bias, the OR was 2.08 (95% CI: 1.55–2.73). Such excess of risk was more evident in the subgroup of younger patients, and more consistent in women. Subjects with systemic autoimmune diseases showed a higher risk of death than patients with any other RMDs. Conclusions Patients with RMD and COVID-19 infection evidenced a significant increase in mortality during the first pandemic phases in Italy. These findings support the need for strong SARS-CoV-2 prevention in patients with rheumatic diseases.

Published
2022

6. ACE inhibitors in SSc patients display a risk factor for scleroderma renal crisis—a EUSTAR analysis

Author

Bütikofer L, Varisco PA, Distler O, Kowal-Bielecka O, Allanore Y, Riemekasten G, Villiger PM, Adler S, Avouac J, Walker UA, Guiducci S, Airò P, Hachulla E, Valentini G, Carreira PE, Cozzi F, Gurman AB, Braun-Moscovici Y, Damjanov N, Ananieva LP, Scorza R, Jimenez S, Busquets J, Li M, Müller-Ladner U, Maurer B, Tyndall A, Lapadula G, Iannone F, Becvar R, Sierakowsky S, Bielecka OK, Cutolo M, Sulli A, Cuomo G, Vettori S, Rednic S, Nicoara I, Vlachoyiannopoulos P, Montecucco C, Caporali R, Novak S, Czirják L, Varju C, Chizzolini C, Kucharz EJ, Kotulska A, Kopec-Medrek M, Widuchowska M, Rozman B, Mallia C, Coleiro B, Gabrielli A, Farge D, Hij A, Hesselstrand R, Scheja A, Wollheim F, Martinovic D, Govoni M, Monaco AL, Hunzelmann N, Pellerito R, Bambara LM, Caramaschi P, Black C, Denton C, Henes J, Santamaria VO, Heitmann S, Krasowska D, Seidel M, Oleszowsky M, Burkhardt H, Himsel A, Salvador MJ, Stamenkovic B, Stankovic A, Tikly M, Starovoytova MN, Engelhart M, Strauss G, Nielsen H, Damgaard K, Szücs G, Mendoza AZ, de la Puente Buijdos C, Sifuentes Giraldo WA, Midtvedt Ø, Garen T, Launay D, Valesini G, Riccieri V, Ionescu RM, Opris D, Groseanu L, Wigley FM, Mihai CM, Cornateanu RS, Ionitescu R, Gherghe AM, Gorga M, Dobrota R, Bojinca M, Schett G, Distler JHW, Meroni P, Zeni S, Mouthon L, De Keyser F, Smith V, Cantatore FP, Corrado A, Ullman S, Iversen L, Pozzi MR, Eyerich K, Hein R, Knott E, Szechinski J, Wiland P, Szmyrka-Kaczmarek M, Sokolik R, Morgiel E, Krummel-Lorenz B, Saar P, Aringer M, Günther C, Anic B, Baresic M, Mayer M, Radominski SC, de Souza Müller C, Azevedo VF, Agachi S, Groppa L, Chiaburu L, Russu E, Zenone T, Stebbings S, Highton J, Stamp L, Chapman P, Baron M, O'Donnell J, Solanki K, Doube A, Veale D, O'Rourke M, Loyo E, Rosato E, Pisarri S, Tanaseanu CM, Popescu M, Dumitrascu A, Tiglea I, Chirieac R, Ancuta C, Furst DE, Kafaja S, de la Peña Lefebvre PG, Rubio SR, Exposito MV, Sibilia J, Chatelus E, Gottenberg JE, Chifflot H, Litinsky I, Venalis A, Butrimiene I, Venalis P, Rugiene R, Karpec D, Kerzberg E, Montoya F, Cosentino V, Castellvi I., Publica, Bütikofer, L, Varisco, Pa, Distler, O, Kowal-Bielecka, O, Allanore, Y, Riemekasten, G, Villiger, Pm, Adler, S, Avouac, J, Walker, Ua, Guiducci, S, Airò, P, Hachulla, E, Valentini, G, Carreira, Pe, Cozzi, F, Gurman, Ab, Braun-Moscovici, Y, Damjanov, N, Ananieva, Lp, Scorza, R, Jimenez, S, Busquets, J, Li, M, Müller-Ladner, U, Maurer, B, Tyndall, A, Lapadula, G, Iannone, F, Becvar, R, Sierakowsky, S, Bielecka, Ok, Cutolo, M, Sulli, A, Cuomo, G, Vettori, S, Rednic, S, Nicoara, I, Vlachoyiannopoulos, P, Montecucco, C, Caporali, R, Novak, S, Czirják, L, Varju, C, Chizzolini, C, Kucharz, Ej, Kotulska, A, Kopec-Medrek, M, Widuchowska, M, Rozman, B, Mallia, C, Coleiro, B, Gabrielli, A, Farge, D, Hij, A, Hesselstrand, R, Scheja, A, Wollheim, F, Martinovic, D, Govoni, M, Monaco, Al, Hunzelmann, N, Pellerito, R, Bambara, Lm, Caramaschi, P, Black, C, Denton, C, Henes, J, Santamaria, Vo, Heitmann, S, Krasowska, D, Seidel, M, Oleszowsky, M, Burkhardt, H, Himsel, A, Salvador, Mj, Stamenkovic, B, Stankovic, A, Tikly, M, Starovoytova, Mn, Engelhart, M, Strauss, G, Nielsen, H, Damgaard, K, Szücs, G, Mendoza, Az, de la Puente Buijdos, C, Sifuentes Giraldo, Wa, Midtvedt, Ø, Garen, T, Launay, D, Valesini, G, Riccieri, V, Ionescu, Rm, Opris, D, Groseanu, L, Wigley, Fm, Mihai, Cm, Cornateanu, R, Ionitescu, R, Gherghe, Am, Gorga, M, Dobrota, R, Bojinca, M, Schett, G, Distler, Jhw, Meroni, P, Zeni, S, Mouthon, L, De Keyser, F, Smith, V, Cantatore, Fp, Corrado, A, Ullman, S, Iversen, L, Pozzi, Mr, Eyerich, K, Hein, R, Knott, E, Szechinski, J, Wiland, P, Szmyrka-Kaczmarek, M, Sokolik, R, Morgiel, E, Krummel-Lorenz, B, Saar, P, Aringer, M, Günther, C, Anic, B, Baresic, M, Mayer, M, Radominski, Sc, de Souza Müller, C, Azevedo, Vf, Agachi, S, Groppa, L, Chiaburu, L, Russu, E, Zenone, T, Stebbings, S, Highton, J, Stamp, L, Chapman, P, Baron, M, O'Donnell, J, Solanki, K, Doube, A, Veale, D, O'Rourke, M, Loyo, E, Rosato, E, Pisarri, S, Tanaseanu, Cm, Popescu, M, Dumitrascu, A, Tiglea, I, Chirieac, R, Ancuta, C, Furst, De, Kafaja, S, de la Peña Lefebvre, Pg, Rubio, Sr, Exposito, Mv, Sibilia, J, Chatelus, E, Gottenberg, Je, Chifflot, H, Litinsky, I, Venalis, A, Butrimiene, I, Venalis, P, Rugiene, R, Karpec, D, Kerzberg, E, Montoya, F, Cosentino, V, and Castellvi, I.

Subjects
INVOLVEMENT, Male, Hypertension, Renal, ACE inhibitors, lcsh:Diseases of the musculoskeletal system, Scleroderma Renal Crisis, MULTICENTER, Angiotensin-Converting Enzyme Inhibitors, Scleroderma, Scleroderma renal crisis, 0302 clinical medicine, Risk Factors, Medicine and Health Sciences, Medicine, 030212 general & internal medicine, Prospective Studies, 610 Medicine & health, Renal, Antihypertensive drugs, Outcome, antihypertensive drugs, arterial hypertension, outcome, scleroderma renal crisis, Incidence (epidemiology), Incidence, Hazard ratio, Acute Kidney Injury, Middle Aged, Europe, Treatment Outcome, Population Surveillance, Cohort, Hypertension, Female, 360 Social problems & social services, Proto-oncogene tyrosine-protein kinase Src, Research Article, Arterial hypertension, medicine.medical_specialty, 03 medical and health sciences, ENDOTHELIN-1, Internal medicine, Humans, Risk factor, Aged, 030203 arthritis & rheumatology, Scleroderma, Systemic, business.industry, SYSTEMIC-SCLEROSIS, Systemic, medicine.disease, Concomitant, lcsh:RC925-935, business
Abstract

Objectives To investigate the effect of ACE inhibitors (ACEi) on the incidence of scleroderma renal crisis (SRC) when given prior to SRC in the prospectively collected cohort from the European Scleroderma Trial and Research Group (EUSTAR). Methods SSc patients without prior SRC and at least one follow-up visit were included and analyzed regarding SRC, arterial hypertension, and medication focusing on antihypertensive medication and glucocorticoids (GC). Results Out of 14,524 patients in the database, we identified 7648 patients with at least one follow-up. In 27,450 person-years (py), 102 patients developed SRC representing an incidence of 3.72 (3.06–4.51) per 1000 py. In a multivariable time-to-event analysis adjusted for age, sex, disease severity, and onset, 88 of 6521 patients developed SRC. The use of ACEi displayed an increased risk for the development of SRC with a hazard ratio (HR) of 2.55 (95% confidence interval (CI) 1.65–3.95). Adjusting for arterial hypertension resulted in a HR of 2.04 (95%CI 1.29–3.24). There was no evidence for an interaction of ACEi and arterial hypertension (HR 0.83, 95%CI 0.32–2.13, p = 0.69). Calcium channel blockers (CCB), angiotensin receptor blockers (ARB), endothelin receptor antagonists, and GC—mostly in daily dosages below 15 mg of prednisolone—did not influence the hazard for SRC. Conclusions ACEi in SSc patients with concomitant arterial hypertension display an independent risk factor for the development of SRC but are still first choice in SRC treatment. ARBs might be a safe alternative, yet the overall safety of alternative antihypertensive drugs in SSc patients needs to be further studied.

Published
2020

7. 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., AbuShakra, M., Agarwal, V., AgmonLevin, 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., ElShahawy, M., Gaylis, N., Grossman, J., Halpert, E., Huff, J., Jarjour, W., Kao, A., Katz, R., Kennedy, A., Khan, M., Kivitz, A., Kohen, M., LawrenceFord, 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., RomanMiranda, 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, A., Emery, P., FernándezNebro, A., Govoni, M., Hachulla, E., Hellmich, B., Houssiau, F., Malaise, M., Margaux, J., Maugars, Y., MuñozFernández, S., Navarro, F., OrdiRos, J., Pellerito, R., PenaSagredo, J., Roussou, E., Schmidt, R. E., UcarAngulo, E., Viallard, JF., 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., ZonGiebel, 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., CohenGadol, S., Conaway, D., Denburg, J., Escalante, A., Espinoza, L., Fiechtner, J., Fortin, I., Fraser, A., Furie, R., Gladman, D., Goddard, D., Goldberg, M., GonzalezRivera, 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., Lee, S., 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, GomezReino, J., Gordon, C., Hiepe, F., Hopkinson, N., Isenberg, D., Jacobi, A., Jorgensen, C., Guern, V. Le, Paul, C., PegoReigosa, J. M., Heredia, J. Rodriguez, RubbertRoth, A., Sabbadini, M., Schroeder, J., Schwarting, A., Spieler, W., Valesini, G., Wollenhaupt, J., Mendoza, A. Zea, and Zouboulis, C.

Published
2017
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10. List of Contributors

Author

Alunno, A., primary, Appel, S., additional, Astorri, E., additional, Baldini, C., additional, Barone, F., additional, Bartoloni, E., additional, Bombardieri, M., additional, Bombardieri, S., additional, Bowman, S.J., additional, Campos, J., additional, Carubbi, F., additional, Cipriani, P., additional, Colafrancesco, S., additional, De Vita, S., additional, Del Papa, N., additional, Devauchelle-Pensec, V., additional, Felten, R., additional, Fisher, B.A., additional, Fox, C.M., additional, Fox, R.I., additional, Gandolfo, S., additional, Gerli, R., additional, Giacomelli, R., additional, Gottenberg, J.-E., additional, Jonsson, R., additional, Kapsogeorgou, E.K., additional, Kyttaris, V.C., additional, Lucchesi, D., additional, Lunardi, C., additional, Manoussakis, M.N., additional, Mavragani, C.P., additional, Patuzzo, G., additional, Perricone, C., additional, Pers, J.-O., additional, Pitzalis, C., additional, Priori, R., additional, Quartuccio, L., additional, Shoenfeld, Y., additional, Sibilia, J., additional, Tinazzi, E., additional, Tsokos, G.C., additional, Tzioufas, A.G., additional, Valesini, G., additional, Vitali, C., additional, and Youinou, P., additional

Published
2016
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14. Disease activity assessment of rheumatic diseases during pregnancy: a comprehensive review of indices used in clinical studies

Author

Andreoli, L, Gerardi, M, Fernandes, M, Bortoluzzi, A, Bellando-Randone, S, Brucato, A, Caporali, R, Chighizola, C, Chimenti, M, Conigliaro, P, Cutolo, M, Cutro, M, D'Angelo, S, Doria, A, Elefante, E, Fredi, M, Galeazzi, M, Gerosa, M, Govoni, M, Iuliano, A, Larosa, M, Lazzaroni, M, Matucci-Cerinic, M, Meroni, M, Meroni, P, Mosca, M, Patane, M, Pazzola, G, Pendolino, M, Perricone, R, Ramoni, V, Salvarani, C, Sebastiani, G, Selmi, C, Spinelli, F, Valesini, G, Scire, C, Tincani, A, Andreoli L., Gerardi M. C., Fernandes M., Bortoluzzi A., Bellando-Randone S., Brucato A., Caporali R., Chighizola C. B., Chimenti M. S., Conigliaro P., Cutolo M., Cutro M. S., D'Angelo S., Doria A., Elefante E., Fredi M., Galeazzi M., Gerosa M., Govoni M., Iuliano A., Larosa M., Lazzaroni M. G., Matucci-Cerinic M., Meroni M., Meroni P. L., Mosca M., Patane M., Pazzola G., Pendolino M., Perricone R., Ramoni V., Salvarani C., Sebastiani G. D., Selmi C., Spinelli F. R., Valesini G., Scire C. A., Tincani A., Andreoli, L, Gerardi, M, Fernandes, M, Bortoluzzi, A, Bellando-Randone, S, Brucato, A, Caporali, R, Chighizola, C, Chimenti, M, Conigliaro, P, Cutolo, M, Cutro, M, D'Angelo, S, Doria, A, Elefante, E, Fredi, M, Galeazzi, M, Gerosa, M, Govoni, M, Iuliano, A, Larosa, M, Lazzaroni, M, Matucci-Cerinic, M, Meroni, M, Meroni, P, Mosca, M, Patane, M, Pazzola, G, Pendolino, M, Perricone, R, Ramoni, V, Salvarani, C, Sebastiani, G, Selmi, C, Spinelli, F, Valesini, G, Scire, C, Tincani, A, Andreoli L., Gerardi M. C., Fernandes M., Bortoluzzi A., Bellando-Randone S., Brucato A., Caporali R., Chighizola C. B., Chimenti M. S., Conigliaro P., Cutolo M., Cutro M. S., D'Angelo S., Doria A., Elefante E., Fredi M., Galeazzi M., Gerosa M., Govoni M., Iuliano A., Larosa M., Lazzaroni M. G., Matucci-Cerinic M., Meroni M., Meroni P. L., Mosca M., Patane M., Pazzola G., Pendolino M., Perricone R., Ramoni V., Salvarani C., Sebastiani G. D., Selmi C., Spinelli F. R., Valesini G., Scire C. A., and Tincani A.

Abstract

Pregnancy requires a special management in women with inflammatory rheumatic diseases (RDs), with the aim of controlling maternal disease activity and avoiding fetal complications. Despite the heterogeneous course of RDs during pregnancy, their impact on pregnancy largely relates to the extent of active inflammation at the time of conception. Therefore, accurate evaluation of disease activity is crucial for the best management of pregnant patients. Nevertheless, there are limitations in using conventional measures of disease activity in pregnancy, as some items included in these instruments can be biased by symptoms or by physiological changes related to pregnancy and the pregnancy itself may influence laboratory parameters used to assess disease activity. This article aims to summarize the current literature about the available instruments to measure disease activity during pregnancy in RDs. Systemic lupus erythematosus is the only disease with instruments that have been modified to account for several adaptations which might interfere with the attribution of signs or symptoms to disease activity during pregnancy. No modified-pregnancy indices exist for women affected by other RDs, but standard indices have been applied to pregnant patients. The current body of knowledge shows that the physiologic changes that occur during pregnancy need to be either adapted from existing instruments or developed to improve the management of pregnant women with RDs. Standardized instruments to assess disease activity during pregnancy would be helpful not only for clinical practice but also for research purposes.

Published
2019

18. Effectiveness and safety of baricitinib in rheumatoid arthritis. a monocentric, longitudinal, real-life experience

Author

Spinelli, F. R., Ceccarelli, F., Garufi, C., Duca, I., Mancuso, S., Cipriano, E., Dell’unto, E., Alessandri, C., Di Franco, M., Perricone, C., Priori, R., Valeria RICCIERI, Scrivo, R., Sili Scavalli, A., Truglia, S., Valesini, G., and Conti, F.

Subjects
rheumatoid arthritis, safety, Sulfonamides, therapy, Immunology, effectiveness, Middle Aged, Arthritis, Rheumatoid, remission, Rheumatology, Purines, Antirheumatic Agents, Immunology and Allergy, Azetidines, Humans, Pyrazoles, baricitinib, safety, remission, pain
Abstract

Baricitinib is a Janus-kinase (JAK) 1/2 inhibitor, approved for the treatment of moderate-to-severe rheumatoid arthritis (RA) patients with inadequate response to conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs). We report the first real-life experience with baricitinib in a monocentric cohort of unselected RA patients.We enrolled consecutive RA patients starting baricitinib. At baseline and after 4, 12, 24 and 48 weeks we assessed the disease activity by composite indices (SDAI, CDAI and DAS28CRP) and ultrasonography, and we recorded any adverse events. The primary endpoint was the percentage of patients achieving SDAI remission at week 4.We enrolled 59 patients [(F:M = 50:9, median age 58.1 years (IQR 12.8), median disease duration 144 (IQR 150) months] treated with baricitinib in combination with a csDMARD (52.5%) or monotherapy (47.5%) for a median follow-up of 24 weeks (IQR 36). The 12-month drug retention rate was 74%. At weeks 4, 12, 24 and 48 we observed a significant reduction of DAS28, CDAI and SDAI, global health and pain (p0.001 for all). After 4 weeks of treatment, 12% of patients achieved SDAI remission. Concomitant csDMARDs, previous biological DMARDs, gender, seropositivity and BMI did not affect the efficacy of baricitinib. Baricitinib allowed a significant reduction in prednisone dose after 12 and 24 weeks and a rapid and sustained ultrasound improvement. No serious adverse events, serious infections or cardiovascular events were recorded.Our study confirms the efficacy and safety profile and rapid onset of the effect of baricitinib in RA patients in a real-life setting.

Published
2021

21. Validation of thymic stromal lymphopoietin as a biomarker of primary Sjögren's syndrome and related lymphoproliferation: results in independent cohorts

Author

Saviana Gandolfo, Fabro, C., Kapsogeorgou, E., Colafrancesco, S., Ferro, F., Bartoloni, E., Quartuccio, L., Goules, A., Priori, R., Alunno, A., Conti, F., Valesini, G., Giacomelli, R., Baldini, C., Gerli, R., Tzioufas, A. G., and Vita, S.

Subjects
Biomarkers, Cytokines, Greece, Humans, Italy, Sjogren's Syndrome, Thymic Stromal Lymphopoietin, sjogren's syndrome, thymic stromal lymphopoietin, biomarkers, lymphoma, mucosa-associated lymphoid tissue
Abstract

Thymic stromal lymphopoietin (TSLP) has been implicated in primary Sjögren's syndrome (pSS) and related B-cell lymphoproliferation and lymphoma (NHL) by studies on salivary pathologic tissues and serum. The purpose of this work was to validate serum TSLP as biomarker of pSS and related lymphoproliferation by the study of two additional independent cohorts.Serum TSLP was measured by ELISA in the original published Cohort-1 from Udine, Italy, including 91 patients. Two additional cohorts were then studied for validation: Cohort-2, including 4 sub-cohorts comprising 125 patients from the Universities of Roma, L'Aquila, Pisa and Perugia, belonging to the Italian SS Study Group (GRISS), and Cohort-3, including 59 patients from the University of Athens, Greece. Overall, 159 control subjects were enrolled. Active pSS-NHL, as well as pre-lymphomatous conditions, i.e. persistent salivary gland swelling and mixed cryoglobulinaemia, were investigated in detail. In addition, serum samples from pSS-NHL in complete remission were analysed (n=27).TSLP serum levels were confirmed to be significantly higher in pSS compared to controls in both Cohort-2 and Cohort-3, in particular in patients with lymphoproliferation. Serum TSLP was much higher in pSS pre-lymphomatous conditions. Finally, active NHL showed the highest TSLP serum levels, while in NHL in remission TSLP resulted undetectable or significantly lower than in benign pSS.By the study of independent cohorts, it was again demonstrated that serum TSLP levels are increased in pSS, above all in more advanced B-cell lymphoproliferation and NHL. Serum TSLP can therefore represent a novel biomarker for pSS-related lymphoproliferation.

Published
2020

24. An observational prospective study on predictors of clinical response at six months in patients with active psoriatic arthritis treated with golimumab

Author

Scrivo, R., Giardino, A. M., Salvarani, C., Foti, R., Afeltra, A., Viapiana, O., Giacomelli, R., Salaffi, F., Galeazzi, M., Ramonda, R., Ciccia, F., Valesini, G., Florenzo Iannone, Scrivo, Rossana, Giardino, Angela M, Salvarani, Carlo, Foti, Rosario, Afeltra, Antonella, Viapiana, Ombretta, Giacomelli, Roberto, Salaffi, Fausto, Galeazzi, Mauro, Ramonda, Roberta, Ciccia, Francesco, Valesini, Guido, and Iannone, Florenzo

Subjects
psoriatic arthritis, Arthritis, Arthritis, Psoriatic, Antibodies, Monoclonal, Psoriatic, urologic and male genital diseases, Prognosis, Antibodies, Treatment Outcome, humans, prognosis, prospective studies, treatment outcome, antibodies, monoclonal, antirheumatic agents, Antirheumatic Agents, Monoclonal, Humans, Prospective Studies
Abstract

Recently, research has been focused on the identification of predictors of response to treatment in patients with active psoriatic arthritis (PsA). The objective of this study was to develop a model to predict the clinical response at 6 months in patients with PsA starting the anti-tumour necrosis factor-α golimumab.This prospective observational study explored a range of factors, including demographic data and baseline characteristics of the disease, measures of disease activity and functional disability, and potential laboratory biomarkers in the prediction of response, defined as the achievement of modified-minimal disease activity (mMDA), to golimumab in PsA patients.We studied 151 PsA patients starting golimumab because of their active disease. After 6 months, the rate of drug persistence on golimumab was 80%, and mMDA was achieved in 44.3% of patients. Using univariate and multivariate logistic regression models, lower disease activity in PsA score (DAPSA) at baseline (odds ratio [OR] 0.92; 95% confidence interval [CI] 0.89-0.96, p0.001) was independent predictor of mMDA at 6 months. High sensitivity C-reactive protein value (OR 1.06; 95% CI 1.00-1.13, p=0.026) at baseline also was a predictive factor of mMDA achievement at 6 months in the laboratory-enhanced prediction model. Golimumab was safe and well tolerated.The identification of factors predictive of response to treatment may help in better understanding the response to golimumab and in identifying PsA patients that are most likely to achieve mMDA following therapy with golimumab.

Published
2020

25. COVID-19 in rheumatic diseases in Italy: first results from the Italian registry of the Italian Society for Rheumatology (CONTROL-19)

Author

Scire, C, Carrara, G, Zanetti, A, Landolfi, G, Chighizola, C, Alunno, A, Andreoli, L, Caporali, R, Gerli, R, Sebastiani, G, Valesini, G, Sinigaglia, L, Scire, CA, Sebastiani, GD, Scire, C, Carrara, G, Zanetti, A, Landolfi, G, Chighizola, C, Alunno, A, Andreoli, L, Caporali, R, Gerli, R, Sebastiani, G, Valesini, G, Sinigaglia, L, Scire, CA, and Sebastiani, GD

Abstract

BackgroundItaly was one of the first countries significantly affected by the coronavirus disease 2019 (COVID-19) epidemic. The Italian Society for Rheumatology promptly launched a retrospective and anonymised data collection to monitor COVID-19 in patients with rheumatic and musculoskeletal diseases (RMDs), the CONTROL-19 surveillance database, which is part of the COVID-19 Global Rheumatology Alliance.MethodsCONTROL-19 includes patients with RMDs and proven severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) updated until May 3rd 2020. In this analysis, only molecular diagnoses were included. The data collection covered demographic data, medical history (general and RMD-related), treatments and COVID-19 related features, treatments, and outcome. In this paper,we report the first descriptive data from the CONTROL-19 registry.ResultsThe population of the first 232 patients (36% males) consisted mainly of elderly patients (mean age 62.2 years), who used corticosteroids (51.7%), and suffered from multi-morbidity (median comorbidities 2). Rheumatoid arthritis was the most frequent disease (34.1%), followed by spondyloarthritis (26.3%), connective tissue disease (21.1%) and vasculitis (11.2%). Most cases had an active disease (69.4%). Clinicalpresentationof COVID-19 was typical, with systemic symptoms (fever and asthenia)and respiratorysymptoms. The overall outcome was severe, with high frequencies of hospitalisation (69.8%), respiratorysupport oxygen (55.7%), non-invasive ventilation (20.9%) or mechanical ventilation (7.5%), and 19% of deaths. Male patients typically manifested a worse prognosis. Immunomodulatory treatments were not significantlyassociatedwith an increasedrisk of intensive care unit admission/mechanicalventilation! death.ConclusionAlthough the reportmainly includes the most severe cases, its temporal and spatial trend supports the validity of the nationalsurveillance system. More complete data are being acquired in order to both test the hypoth

Published
2020

26. Comparison of early vs. delayed anakinra treatment in patients with adult onset Still's disease and effect on clinical and laboratory outcomes

Author

Vitale, A, Cavalli, G, Ruscitti, P, Sota, J, Colafrancesco, S, Priori, R, Valesini, G, Argolini, Lm, Baldissera, E, Bartoloni, E, Cammelli, D, Canestrari, G, Cavallaro, E, Massaro, Mg, Cipriani, P, De Marchi, G, De Vita, S, Emmi, G, Frassi, M, Gerli, R, Gremese, Elisa, Iannone, F, Fornaro, M, Paladini, A, Lopalco, G, Manna, Raffaele, Mathieu, A, Montecucco, C, Mosca, M, Piazza, I, Piga, M, Pontikaki, I, Romano, M, Rossi, S, Rossini, M, Silvestri, E, Stagnaro, C, Talarico, R, Frediani, B, Tincani, A, Viapiana, O, Vitiello, G, Galozzi, P, Sfriso, P, Gaggiano, C, Grosso, S, Rigante, Donato, Dagna, L, Giacomelli, R, Cantarini, L., Gremese E (ORCID:0000-0002-2248-1058), Manna R (ORCID:0000-0003-1560-3907), Rigante D (ORCID:0000-0001-7032-7779), Vitale, A, Cavalli, G, Ruscitti, P, Sota, J, Colafrancesco, S, Priori, R, Valesini, G, Argolini, Lm, Baldissera, E, Bartoloni, E, Cammelli, D, Canestrari, G, Cavallaro, E, Massaro, Mg, Cipriani, P, De Marchi, G, De Vita, S, Emmi, G, Frassi, M, Gerli, R, Gremese, Elisa, Iannone, F, Fornaro, M, Paladini, A, Lopalco, G, Manna, Raffaele, Mathieu, A, Montecucco, C, Mosca, M, Piazza, I, Piga, M, Pontikaki, I, Romano, M, Rossi, S, Rossini, M, Silvestri, E, Stagnaro, C, Talarico, R, Frediani, B, Tincani, A, Viapiana, O, Vitiello, G, Galozzi, P, Sfriso, P, Gaggiano, C, Grosso, S, Rigante, Donato, Dagna, L, Giacomelli, R, Cantarini, L., Gremese E (ORCID:0000-0002-2248-1058), Manna R (ORCID:0000-0003-1560-3907), and Rigante D (ORCID:0000-0001-7032-7779)

Abstract

Background: Aim of this study was to search for any difference in the outcome of patients with adult onset Still's disease (AOSD) treated with anakinra (ANK) in relation with the interval between disease onset and the start of anti-interleukin(IL)-1 treatment and according with the different lines of ANK treatment. Patients and Methods: One hundred and forty-one AOSD patients treated with ANK have been retrospectively assessed. Statistically significant differences (p < 0.05) were analyzed in the frequency of ANK effectiveness, primary or secondary inefficacy to ANK and rate of resolution of clinical and laboratory AOSD manifestations after 3, 6, and 12 months since ANK treatment according with different lines of treatment and different times between AOSD onset and start of ANK. Results: No significant differences were identified in the ANK effectiveness and frequency of primary or secondary inefficacy for patients starting ANK within 6 months (p = 0.19, p = 0.14, and p = 0.81, respectively) or 12 months (p = 0.37, p = 0.23, and p = 0.81, respectively) since AOSD onset compared with patients starting ANK thereafter; no significant differences were identified in ANK effectiveness and primary or secondary inefficacy according with different lines of ANK treatment (p = 0.06, p = 0.19, and p = 0.13, respectively). Patients starting ANK within 6 and 12 months since AOSD onset showed a significantly quicker decrease of erythrocyte sedimentation rate and C-reactive protein than observed among patients undergoing ANK treatment after 6 and 12 months. The number of swollen joints at the 3 month follow-up visit was significantly lower among patients undergoing ANK within 6 months since AOSD onset (p = 0.01), while no significance was identified at the 6 and 12 month assessments (p = 0.23 and p = 0.45, respectively). At the 3 and 6 month visits, the number of swollen joints was significantly higher among patients previously treated with conventional and biological disease mo

Published
2020

27. 4P IgM-rheumatoid factor as a novel biomarker for a reduced survival in anti-PD-1 treated NSCLC patients through the decrease of CD137+ T-cells

Author

Ugolini, A., primary, Zizzari, I.G., additional, Ceccarelli, F., additional, Botticelli, A., additional, Colasanti, T., additional, Strigari, L., additional, Rughetti, A., additional, Rahimi, H., additional, Conti, F., additional, Valesini, G., additional, Marchetti, P., additional, and Nuti, M., additional

Published
2020
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34. Evidence for Caveolin-1 (CAV1) as a new susceptibility gene regulating tissue fibrosis in systemic sclerosis

Author

Manetti, M, Allanore, Y, Saad, M, Fatini, C, Cohignac, V, Guiducci, S, Romano, E, Airó, P, Caramaschi, P, Riccieri, V, Rossa, A Della, Abbate, R, Caporali, R, Cuomo, G, Valesini, G, Dieudé, P, Hachulla, E, Cracowski, J L, Tiev, K, Letenneur, L, Amouyel, P, Lambert, J C, Chiocchia, G, Martinez, M, Ibba-Manneschi, L, and Matucci-Cerinic, M

Published
2012
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35. European League Against Rheumatism recommendations for the management of psoriatic arthritis with pharmacological therapies

Author

Gossec, L, Smolen, J S, Gaujoux-Viala, C, Ash, Z, Marzo-Ortega, H, van der Heijde, D, FitzGerald, O, Aletaha, D, Balint, P, Boumpas, D, Braun, J, Breedveld, F C, Burmester, G, Cañete, J D, de Wit, M, Dagfinrud, H, de Vlam, K, Dougados, M, Helliwell, P, Kavanaugh, A, Kvien, T K, Landewé, R, Luger, T, Maccarone, M, McGonagle, D, McHugh, N, McInnes, I B, Ritchlin, C, Sieper, J, Tak, P P, Valesini, G, Vencovsky, J, Winthrop, K L, Zink, A, and Emery, P

Published
2012
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40. THU0281 EXPLORING THE GENETIC DIVERSITY OF STAPHYLOCOCCUS AUREUS IN PATIENTS AFFECTED BY SYSTEMIC LUPUS ERYTHEMATOSUS: ASSOCIATION WITH DISEASE-RELATED FEATURES AND ACTIVITY

Author

Olivieri, G., primary, Ceccarelli, F., additional, Lo Presti, A., additional, Angeletti, S., additional, Perricone, C., additional, Iaiani, G., additional, De Florio, L., additional, Antonelli, F., additional, Amori, L., additional, Garufi, C., additional, Spinelli, F. R., additional, Alessandri, C., additional, Valesini, G., additional, Cicozzi, M., additional, and Conti, F., additional

Published
2020
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45. THU0265 THYMIC STROMAL LYMPHOPOIETIN (TSLP) AS A BIOMARKER OF PRIMARY SJÖGREN’S SYNDROME (PSS) AND RELATED LYMPHOMA: VALIDATION IN INDEPENDENT COHORTS

Author

Gandolfo, S., primary, Fabro, C., additional, Colafrancesco, S., additional, Carubbi, F., additional, Ferro, F., additional, Bartoloni Bocci, E., additional, Kapsogeorgou, E., additional, Goules, A., additional, Quartuccio, L., additional, Priori, R., additional, Alunno, A., additional, Valesini, G., additional, Giacomelli, R., additional, Gerli, R., additional, Baldini, C., additional, Tzioufas, A., additional, and De Vita, S., additional

Published
2020
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47. FRI0350 FACTORS ASSOCIATED WITH PERIPHERAL EROSIVE RADIOGRAPHIC DISEASE IN A CONSECUTIVE SERIES OF 794 PSA PATIENTS

Author

Catanoso, M. G., primary, Macchioni, P., additional, Marchesoni, A., additional, D’angelo, S., additional, Ramonda, R., additional, Cauli, A., additional, Perrotta, F., additional, Bortolotti, R., additional, Lofrano, M., additional, Rotunno, L., additional, Lorenzin, M. G., additional, Valesini, G., additional, Mathieu, G., additional, Paolazzi, G., additional, and Salvarani, C., additional

Published
2020
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50. SAT0555 MUSCULOSKELETAL ULTRASOUND IN MONITORING RESPONSE TO JAKi IN RHEUMATOID ARTHRITIS PATIENTS: RESULTS FROM A LONGITUDINAL STUDY

Author

Cipriano, E., primary, Ceccarelli, F., additional, Spinelli, F. R., additional, Garufi, C., additional, Duca, I., additional, Mancuso, S., additional, Alessandri, C., additional, DI Franco, M., additional, Priori, R., additional, Riccieri, V., additional, Scrivo, R., additional, Perricone, C., additional, Valesini, G., additional, and Conti, F., additional

Published
2020
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