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1. To be or not to B27 positive: implications for the phenotypes of axial spondyloarthritis outcomes. Data from a large multiracial cohort from the Brazilian Registry of Spondyloarthritis

Author

Resende, Gustavo Gomes, Saad, Carla Goncalves Schahin, Marques, Claudia Diniz Lopes, Ribeiro, Sandra Lúcia Euzébio, de Oliveira Gavi, Maria Bernadete Renoldi, Yazbek, Michel Alexandre, de Oliveira Marinho, Adriana, de Cássia Menin, Rita, Ochtrop, Manuella Lima Gomes, Soares, Andressa Miozzo, Cavalcanti, Nara Gualberto, Carneiro, Jamille Nascimento, Werner de Castro, Glaucio Ricardo, Fernandes, José Mauro Carneiro, da Cruz Ribeiro E Souza, Elziane, de Menezes Alvarenga, Corina Quental, de Abreu Vieira, Rejane Maria Rodrigues, Machado, Natalia Pereira, Ximenes, Antônio Carlos, Gazzeta, Morgana Ohira, de Albuquerque, Cleandro Pires, Skare, Thelma Larocca, Waldemar Keiserman, Mauro, Kohem, Charles Lubianca, Benacon, Gabriel Sarkis, Rocha, Vítor Florêncio Santos, da Cruz Lage, Ricardo, Malheiro, Olivio Brito, Golebiovski, Rywka Tenenbaum Medeiros, Oliveira, Thauana Luiza, Duque, Ruben Horst, Londe, Ana Carolina, de Medeiros Pinheiro, Marcelo, and Sampaio-Barros, Percival Degrava

Published
2024
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4. 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 EB, 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, and Lawrence‐Ford, T

Subjects
Autoimmune Disease, Clinical Trials and Supportive Activities, Clinical Research, Lupus, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Inflammatory and immune system, Adult, Antibodies, Monoclonal, Humanized, Double-Blind Method, Female, Humans, Lupus Erythematosus, Systemic, Male, Severity of Illness Index, Treatment Outcome, EMBODY Investigator Group, Clinical Sciences, Immunology, Public Health and Health Services, Arthritis & Rheumatology
Abstract

ObjectiveEpratuzumab, 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).MethodsPatients 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.ResultsIn 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.ConclusionIn 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

7. Brazilian Society of Rheumatology 2020 guidelines for psoriatic arthritis

Author

Carneiro, Sueli, Palominos, Penelope Esther, Anti, Sônia Maria Alvarenga, Assad, Rodrigo Luppino, Gonçalves, Rafaela Silva Guimarães, Chiereghin, Adriano, Lyrio, Andre Marun, Ximenes, Antônio Carlos, Saad, Carla Gonçalves, Gonçalves, Célio Roberto, Kohem, Charles Lubianca, Marques, Cláudia Diniz Lopes, Schainberg, Cláudia Goldenstein, de Souza Meirelles, Eduardo, Resende, Gustavo Gomes, Pieruccetti, Lenise Brandao, Keiserman, Mauro Waldemar, Yazbek, Michel Alexandre, Sampaio-Barros, Percival Degrava, da Cruz Lage, Ricardo, Bonfiglioli, Rubens, Oliveira, Thauana Luíza, Azevedo, Valderílio Feijó, Bianchi, Washington Alves, Bernardo, Wanderley Marques, dos Santos Simões, Ricardo, de Medeiros Pinheiro, Marcelo, and Campanholo, Cristiano Barbosa

Published
2021
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8. Brazilian recommendations for the use of nonsteroidal anti-inflammatory drugs in patients with axial spondyloarthritis

Author

da Cruz Lage, Ricardo, Marques, Claudia Diniz Lopes, Oliveira, Thauana Luiza, Resende, Gustavo Gomes, Kohem, Charles Lubianca, Saad, Carla Gonçalves, Ximenes, Antônio Carlos, Gonçalves, Célio Roberto, Bianchi, Washington Alves, de Souza Meirelles, Eduardo, Keiserman, Mauro Waldemar, Chiereghin, Adriano, Campanholo, Cristiano Barbosa, Lyrio, André Marun, Schainberg, Cláudia Goldenstein, Pieruccetti, Lenise Brandao, Yazbek, Michel Alexandre, Palominos, Penelope Esther, Goncalves, Rafaela Silva Guimarães, Assad, Rodrigo Luppino, Bonfiglioli, Rubens, Lima, Sônia Maria Alvarenga Anti Loduca, Carneiro, Sueli, Azevedo, Valderílio Feijó, Albuquerque, Cleandro Pires, Bernardo, Wanderley Marques, Sampaio-Barros, Percival Degrava, and de Medeiros Pinheiro, Marcelo

Published
2021
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9. The Brazilian Society of Rheumatology guidelines for axial spondyloarthritis – 2019

Author

Resende, Gustavo Gomes, Meirelles, Eduardo de Souza, Marques, Cláudia Diniz Lopes, Chiereghin, Adriano, Lyrio, Andre Marun, Ximenes, Antônio Carlos, Saad, Carla Gonçalves, Gonçalves, Célio Roberto, Kohem, Charles Lubianca, Schainberg, Cláudia Goldenstein, Campanholo, Cristiano Barbosa, Bueno Filho, Júlio Silvio de Sousa, Pieruccetti, Lenise Brandao, Keiserman, Mauro Waldemar, Yazbek, Michel Alexandre, Palominos, Penelope Esther, Goncalves, Rafaela Silva Guimarães, Lage, Ricardo da Cruz, Assad, Rodrigo Luppino, Bonfiglioli, Rubens, Anti, Sônia Maria Alvarenga, Carneiro, Sueli, Oliveira, Thauana Luíza, Azevedo, Valderílio Feijó, Bianchi, Washington Alves, Bernardo, Wanderley Marques, Pinheiro, Marcelo de Medeiros, and Sampaio-Barros, Percival Degrava

Published
2020
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10. P185 Long-term efficacy and safety of upadacitinib in patients with psoriatic arthritis refractory to biologic therapies: 2-year results from the phase 3 SELECT-PsA 2 study

Author

Mease, Philip J, primary, Setty, Arathi, additional, Papp, Kim, additional, Van den Bosch, Filip, additional, Tsuji, Shigeyoshi, additional, Keiserman, Mauro, additional, Bu, Xianwei, additional, Chen, Liang, additional, Mccaskill, Reva, additional, Mcdearmon-Blondell, Erin, additional, Wung, Peter, additional, and Tillett, William, additional

Published
2023
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11. Efficacy and safety of risankizumab for active psoriatic arthritis:52-week results from the KEEPsAKE 1 study

Author

Kristensen, Lars Erik, Keiserman, Mauro, Papp, Kim, Mccasland, Leslie, White, Douglas, Lu, Wenjing, Soliman, Ahmed M., Eldred, Ann, Barcomb, Lisa, Behrens, Frank, Kristensen, Lars Erik, Keiserman, Mauro, Papp, Kim, Mccasland, Leslie, White, Douglas, Lu, Wenjing, Soliman, Ahmed M., Eldred, Ann, Barcomb, Lisa, and Behrens, Frank

Abstract

Objective PsA is a chronic disease with heterogeneous clinical manifestations requiring treatment options with long-term efficacy and safety. In this follow-up analysis, the 52-week efficacy and safety of risankizumab 150 mg in patients with active PsA who had previous inadequate response/intolerance to one or more conventional synthetic DMARDs (csDMARD-IR) were evaluated. Methods KEEPsAKE 1 is an ongoing, global, phase 3 study with a 24-week, double-blind, placebo-controlled period (period 1) and an open-label extension period (period 2). In period 1, eligible patients were randomized 1:1 to receive subcutaneous risankizumab 150 mg or placebo at weeks 0, 4 and 16. At week 24 (period 2), all continuing patients received open-label risankizumab 150 mg every 12 weeks through week 208. Results At week 24, 57.3% of risankizumab-treated patients (n = 483) achieved ≥20% improvement in ACR criteria (ACR20) vs 33.5% of placebo-treated patients (n = 481; P < 0.001). At week 52, 70.0% of patients who were randomized to receive continuous risankizumab therapy and 63.0% of patients who were randomized to receive placebo in period 1 and then receive risankizumab at week 24 achieved ACR20. Similar result trends were observed for other efficacy measures. Risankizumab was well tolerated through 52 weeks of treatment with a consistent safety profile from week 24 through week 52. Conclusion In patients with active PsA who were csDMARD-IR, continuous risankizumab treatment demonstrated robust long-term efficacy and was well tolerated through 52 weeks of treatment. Trial registration ClinicalTrials.gov, http://clinicaltrials.gov, KEEPsAKE1, NCT03675308., Objective: PsA is a chronic disease with heterogeneous clinical manifestations requiring treatment options with long-term efficacy and safety. In this follow-up analysis, the 52-week efficacy and safety of risankizumab 150 mg in patients with active PsA who had previous inadequate response/intolerance to one or more conventional synthetic DMARDs (csDMARD-IR) were evaluated. Methods: KEEPsAKE 1 is an ongoing, global, phase 3 study with a 24-week, double-blind, placebo-controlled period (period 1) and an open-label extension period (period 2). In period 1, eligible patients were randomized 1:1 to receive subcutaneous risankizumab 150 mg or placebo at weeks 0, 4 and 16. At week 24 (period 2), all continuing patients received open-label risankizumab 150 mg every 12 weeks through week 208. Results: At week 24, 57.3% of risankizumab-treated patients (n = 483) achieved ≥20% improvement in ACR criteria (ACR20) vs 33.5% of placebo-treated patients (n = 481; P < 0.001). At week 52, 70.0% of patients who were randomized to receive continuous risankizumab therapy and 63.0% of patients who were randomized to receive placebo in period 1 and then receive risankizumab at week 24 achieved ACR20. Similar result trends were observed for other efficacy measures. Risankizumab was well tolerated through 52 weeks of treatment with a consistent safety profile from week 24 through week 52. Conclusion: In patients with active PsA who were csDMARD-IR, continuous risankizumab treatment demonstrated robust long-term efficacy and was well tolerated through 52 weeks of treatment. Trial registration: ClinicalTrials.gov, http://clinicaltrials.gov, KEEPsAKE1, NCT03675308.

Published
2023

12. Quality of life in spondyloarthritis: analysis of a large Brazilian cohort

Author

Ribeiro, Sandra L.E., Albuquerque, Elisa N., Bortoluzzo, Adriana B., Gonçalves, Célio R., da Silva, José Antonio Braga, Ximenes, Antonio Carlos, Bértolo, Manoel B., Keiserman, Mauro, Menin, Rita, Skare, Thelma L., Carneiro, Sueli, Azevedo, Valderílio F., Vieira, Walber P., Bianchi, Washington A., Bonfiglioli, Rubens, Campanholo, Cristiano, Carvalho, Hellen M.S., Costa, Izaias P., Duarte, Angela L.B. Pinto, Kohem, Charles L., Leite, Nocy H., Lima, Sonia A.L., Meirelles, Eduardo S., Pereira, Ivânio A., Pinheiro, Marcelo M., Polito, Elizandra, Resende, Gustavo G., Rocha, Francisco Airton C., Santiago, Mittermayer B., Sauma, Maria de Fátima L.C., Valim, Valéria, and Sampaio-Barros, Percival D.

Published
2016
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13. Qualidade de vida nas espondiloartrites: análise de uma grande coorte brasileira

Author

Ribeiro, Sandra L.E., Albuquerque, Elisa N., Bortoluzzo, Adriana B., Gonçalves, Célio R., Silva, José Antonio Braga da, Ximenes, Antonio Carlos, Bértolo, Manoel B., Keiserman, Mauro, Menin, Rita, Skare, Thelma L., Carneiro, Sueli, Azevedo, Valderílio F., Vieira, Walber P., Bianchi, Washington A., Bonfiglioli, Rubens, Campanholo, Cristiano, Carvalho, Hellen M.S., Costa, Izaias P., Duarte, Angela L.B. Pinto, Kohem, Charles L., Leite, Nocy H., Lima, Sonia A.L., Meirelles, Eduardo S., Pereira, Ivânio A., Pinheiro, Marcelo M., Polito, Elizandra, Resende, Gustavo G., Rocha, Francisco Airton C., Santiago, Mittermayer B., Sauma, Maria de Fátima L.C., Valim, Valéria, and Sampaio‐Barros, Percival D.

Published
2016
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14. Upadacitinib in patients with psoriatic arthritis and inadequate response to biologics: 3-year results from the open-label extension of the randomised controlled phase 3 SELECT-PsA 2 study

Author

Mease, Philip, primary, Setty, Arathi, additional, Papp, Kim, additional, Van den Bosch, Filip, additional, Tsuji, Shigeyoshi, additional, Keiserman, Mauro, additional, Carter, Kyle, additional, Li, Yihan, additional, McCaskill, Reva, additional, McDearmon-Blondell, Erin, additional, Wung, Peter, additional, and Tillett, William, additional

Published
2023
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15. PREVALENCE AND ASSOCIATIONS OF HLA-B27 IN A LARGE MULTIRACIAL COHORT OF THE BRAZILIAN REGISTRY OF SPONDYLOARTHRITIS

Author

Rresende, Gustavo Gomes, primary, Saad, Carla Gonçalves Schahin, additional, Marques, Claudia Diniz Lopes, additional, Ribeiro, Sandra Lucia Euzébio, additional, Rocha, Vítor Florêncio Santos, additional, Lage, Ricardo da Cruz, additional, Malheiro, Olivio Brito, additional, Marinho, Adriana de Oliveira, additional, Gavi, Maria Bernadete de Oliveira, additional, Menin, Rita de Cassia, additional, Golebiovski, Rywka Tenenbaum Medeiros, additional, Carneiro, Jamille Nascimento, additional, Ochtrop, Manuella Lima Gomes, additional, Castro, Glaucio Ricardo Werner de, additional, Fernandes, José Mauro Carneiro, additional, Soares, Andressa Miozzo, additional, Ranza, Roberto, additional, Santos, Mario Sergio Ferreira, additional, Alvarenga, Corina Quental de Menezes, additional, Vieira, Rejane Maria de Abreu, additional, Braz, Alessandra de Sousa, additional, Soares, Maria Roberta Melo Pereira, additional, Yazbek, Michel Alexandre, additional, Ximenes, Antonio Carlos, additional, Machado, Natalia, additional, Bianchi, Washington Alves, additional, Carvalho, Lina Oliveira de, additional, Campanholo, Cristiano Barbosa, additional, Fernandes, Vander, additional, Campos, Ana Paula Beckhauser de, additional, Kohem, Charles Lubianca, additional, Albuquerque, Cleandro Pires de, additional, Ruiz, Danilo Garcia, additional, Meirelles, Eduardo de Souza, additional, Bezerra Neto, Francisco Alves, additional, Assis, Marcos Renato de, additional, Sauma, Maria de Fátima Lobato da Cunha, additional, Keiserman, Mauro Waldemar, additional, Santiago, Mittermayer Barreto, additional, Assad, Rodrigo Luppino, additional, Bonfiglioli, Rubens, additional, Lima, Sonia Maria Alvarenga Anti Loduca, additional, Carneiro, Sueli Coelho da Silva, additional, Pinna, Fabiana Pompeo de, additional, Milanez, Fernanda Manente, additional, Pacheco, Sula Glaucia Lage Drumond, additional, Chiereghin, Adriano, additional, Loures, Marco Antonio Araújo da Rocha, additional, Doreto, Debora Tobaldini Russo, additional, Rocha, Francisco Airton Castro da, additional, Pinheiro, Marcelo de Medeiros, additional, and Barros, Percival Degrava Sampaio, additional

Published
2023
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19. WHEN IT IS NOT POLYMYOSITIS: A CALL FOR ATTENTION TO DYSFERLINOPATHIES

Author

Farani, Júlia Boechat, primary, Passos, Giordani Rodrigues dos, additional, Tesheiner, Marcelo Bopp, additional, Hillal, José Pedro Duarte, additional, Dutra, Camila Ribeiro, additional, Villaça, Marcel Mathias, additional, Biegelmeyer, Erika, additional, Keiserman, Mauro Waldemar, additional, Silveira, Inês Guimarães da, additional, and Picarelli, Maria Mercedes Caracciolo, additional

Published
2023
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21. PROFILE OF ADMISSIONS IN A RHEUMATOLOGY TERTIARY UNIT DURING 2 YEARS

Author

Hillal, José Pedro Duarte, primary, Farani, Júlia Boechat, additional, Silveira, Inês Guimarães da, additional, Keiserman, Mauro Waldemar, additional, Xavier, Selena Coelho, additional, Pilau, Pedro Simões dos Santos, additional, Menetrier, Marina Michelon, additional, and Picarelli, Maria Mercedes Caracciolo, additional

Published
2023
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22. Evaluation of performance of BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) in a Brazilian cohort of 1492 patients with spondyloarthritis: data from the Brazilian Registry of Spondyloarthritides (RBE)

Author

Costa, Izaias Pereira da, Bortoluzzo, Adriana B., Gonçalves, Célio R., Silva, José Antonio Braga da, Ximenes, Antonio Carlos, Bértolo, Manoel B., Ribeiro, Sandra L.E., Keiserman, Mauro, Menin, Rita, Skare, Thelma L., Carneiro, Sueli, Azevedo, Valderílio F., Vieira, Walber P., Albuquerque, Elisa N., Bianchi, Washington A., Bonfiglioli, Rubens, Campanholo, Cristiano, Carvalho, Hellen M.S., Duarte, Angela L.B. Pinto, Kohem, Charles L., Leite, Nocy H., Lima, Sonia A.L., Meirelles, Eduardo S., Pereira, Ivânio A., Pinheiro, Marcelo M., Polito, Elizandra, Resende, Gustavo G., Rocha, Francisco Airton C., Santiago, Mittermayer B., Sauma, Maria de Fátima L.C., Valim, Valéria, and Sampaio-Barros, Percival D.

Published
2015
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23. Avaliação do desempenho do BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) numa coorte brasileira de 1.492 pacientes com espondiloartrites: dados do Registro Brasileiro de Espondiloartrites (RBE)

Author

Costa, Izaias Pereira da, Bortoluzzo, Adriana B., Gonçalves, Célio R., Silva, José Antonio Braga da, Ximenes, Antonio Carlos, Bértolo, Manoel B., Ribeiro, Sandra L.E., Keiserman, Mauro, Menin, Rita, Skare, Thelma L., Carneiro, Sueli, Azevedo, Valderílio F., Vieira, Walber P., Albuquerque, Elisa N., Bianchi, Washington A., Bonfiglioli, Rubens, Campanholo, Cristiano, Carvalho, Hellen M.S., Duarte, Angela L.B. Pinto, Kohem, Charles L., Leite, Nocy H., Lima, Sonia A.L., Meirelles, Eduardo S., Pereira, Ivânio A., Pinheiro, Marcelo M., Polito, Elizandra, Resende, Gustavo G., Rocha, Francisco Airton C., Santiago, Mittermayer B., Sauma, Maria de Fátima L.C., Valim, Valéria, and Sampaio‐Barros, Percival D.

Published
2015
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25. Epidemiologic profile of juvenile-onset compared to adult-onset spondyloarthritis in a large Brazilian cohort

Author

Duarte, Angela P., Marques, Cláudia D.L., Bortoluzzo, Adriana B., Gonçalves, Célio R., Silva, José Antonio Braga da, Ximenes, Antonio Carlos, Bértolo, Manoel B., Ribeiro, Sandra Lúcia E., Keiserman, Mauro, Skare, Thelma L., Carneiro, Sueli, Menin, Rita, Azevedo, Valderilio F., Vieira, Walber P., Albuquerque, Elisa N., Bianchi, Washington A., Bonfiglioli, Rubens, Campanholo, Cristiano, Carvalho, Hellen M.S., Costa, Izaias P., Kohem, Charles L., Leite, Nocy, Lima, Sonia A.L., Meirelles, Eduardo S., Pereira, Ivânio A., Pinheiro, Marcelo M., Polito, Elizandra, Resende, Gustavo G., Rocha, Francisco Airton C., Santiago, Mittermayer B., Sauma, Maria de Fátima L.C., Valim, Valéria, and Barros, Percival D. Sampaio

Published
2014
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26. Perfil epidemiológico da espondiloartrite de início juvenil comparada com a espondiloartrite de início na vida adulta em uma grande coorte brasileira

Author

Duarte, Angela P., Marques, Cláudia D.L., Bortoluzzo, Adriana B., Gonçalves, Célio R., Silva, José Antonio Braga da, Ximenes, Antonio Carlos, Bértolo, Manoel B., Ribeiro, Sandra Lúcia E., Keiserman, Mauro, Skare, Thelma L., Carneiro, Sueli, Menin, Rita, Azevedo, Valderilio F., Vieira, Walber P., Albuquerque, Elisa N., Bianchi, Washington A., Bonfiglioli, Rubens, Campanholo, Cristiano, Carvalho, Hellen M.S., Costa, Izaias P., Kohem, Charles L., Leite, Nocy, Lima, Sonia A.L., Meirelles, Eduardo S., Pereira, Ivânio A., Pinheiro, Marcelo M., Polito, Elizandra, Resende, Gustavo G., Rocha, Francisco Airton C., Santiago, Mittermayer B., Sauma, Maria de Fátima L.C., Valim, Valéria, and Barros, Percival D. Sampaio

Published
2014
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27. Profile of the use of disease modifying drugs in the Brazilian Registry of Spondyloarthritides

Author

Kohem, Charles L., Bortoluzzo, Adriana B., Gonçalves, Célio R., Silva, José Antonio Braga da, Ximenes, Antonio Carlos, Bértolo, Manoel B., Ribeiro, Sandra L.E., Keiserman, Mauro, Menin, Rita, Skare, Thelma L., Carneiro, Sueli, Azevedo, Valderílio F., Vieira, Walber P., Albuquerque, Elisa N., Bianchi, Washington A., Bonfiglioli, Rubens, Campanholo, Cristiano, Carvalho, Hellen M.S., Costa, Izaias Pereira da, Duarte, Angela L.B. Pinto, Leite, Nocy H., Lima, Sonia A.L., Meirelles, Eduardo S., Pereira, Ivânio A., Pinheiro, Marcelo M., Polito, Elizandra, Resende, Gustavo G., Rocha, Francisco Airton C., Santiago, Mittermayer B., Sauma, Maria de Fátima L.C., Valim, Valéria, and Sampaio-Barros, Percival D.

Published
2014
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28. Perfil do uso de drogas modificadoras de doença no Registro Brasileiro de Espondiloartrites

Author

Kohem, Charles L., Bortoluzzo, Adriana B., Gonçalves, Célio R., Silva, José Antonio Braga da, Ximenes, Antonio Carlos, Bértolo, Manoel B., Ribeiro, Sandra L.E., Keiserman, Mauro, Menin, Rita, Skare, Thelma L., Carneiro, Sueli, Azevedo, Valderílio F., Vieira, Walber P., Albuquerque, Elisa N., Bianchi, Washington A., Bonfiglioli, Rubens, Campanholo, Cristiano, Carvalho, Hellen M.S., Costa, Izaias Pereira da, Duarte, Angela L.B. Pinto, Leite, Nocy H., Lima, Sonia A.L., Meirelles, Eduardo S., Pereira, Ivânio A., Pinheiro, Marcelo M., Polito, Elizandra, Resende, Gustavo G., Rocha, Francisco Airton C., Santiago, Mittermayer B., Sauma, Maria de Fátima L.C., Valim, Valéria, and Sampaio-Barros, Percival D.

Published
2014
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31. Diffuse alveolar hemorrhage in eosinophilic granulomatosis with polyangiitis

Author

Souza, Marília Voges de, primary, Keiserman, Mauro Waldemar, additional, Rabelo, Cristina Ferreira, additional, Silveira, Inês Guimarães, additional, Villaça, Marcel Mathias, additional, Dutra, Camila Ribeiro, additional, Hillal, José Pedro Duarte, additional, Berlet, Evelise Mileski do Amaral, additional, Grill, Eduarda Rovere, additional, Farani, Julia Boechat, additional, and Biegelmeyer, Erika, additional

Published
2022
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32. REVERSIBLE POSTERIOR LEUKOENCEFALOPHATY SYNDROME POST-CYCLOPHOSPHAMIDE IN A PATIENT WITH GRANULOMATOSIS WITH POLYANGIITIS POST-COVID-19

Author

Villaça, Marcel Mathias, primary, Keiserman, Mauro Waldemar, additional, Rabelo, Cristina Ferreira, additional, Dutra, Camila Ribeiro, additional, Berlet, Evelise Mileski do Amaral, additional, Hillal, José Pedro Duarte, additional, Farani, Júlia Boechat, additional, and Souza, Marília Voges de, additional

Published
2022
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35. PROTEUS MIRABILIS SEPTIC OLIGOARTHRITIS FOLLOWING PULSE THERAPY

Author

Villaça, Marcel Mathias, primary, Keiserman, Mauro Waldemar, additional, Silveiras, Inês Guimarães da, additional, Dutra, Camila Ribeiro, additional, Grill, Eduarda Roveré, additional, Biegelmeyer, Erika, additional, Berlet, Evelise Mileski do Amaral, additional, Hillal, José Pedro Duarte, additional, Farani, Júlia Boecha, additional, and Souza, Marília Voges de, additional

Published
2022
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37. Enteropathic arthritis in Brazil: data from the Brazilian registry of spondyloarthritis

Author

Resende, Gustavo G., Lanna, Cristina C.D., Bortoluzzo, Adriana B., Gonçalves, Célio R., Sampaio-Barros, Percival D., Silva, José Antonio Braga da, Ximenes, Antonio Carlos, Bértolo, Manoel B., Ribeiro, Sandra L.E., Keiserman, Mauro, Menin, Rita, Skare, Thelma L., Carneiro, Sueli, Azevedo, Valderílio F., Vieira, Walber P., Albuquerque, Elisa N., Bianchi, Washington A., Bonfiglioli, Rubens, Campanholo, Cristiano, Carvalho, Hellen M.S., Costa, Izaias P., Duarte, Angela P., Kohem, Charles L., Leite, Nocy, Lima, Sonia A.L., Meirelles, Eduardo S., Pereira, Ivânio A., Pinheiro, Marcelo M., Polito, Elizandra, Rocha, Francisco Airton C., Santiago, Mittermayer B., Sauma, Maria de Fátima L.C., and Valim, Valeria

Published
2013
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38. Artrite enteropática no Brasil: dados do registro brasileiro de espondiloartrites

Author

Resende, Gustavo G., Lanna, Cristina C.D., Bortoluzzo, Adriana B., Gonçalves, Célio R., Sampaio-Barros, Percival D., Silva, José Antonio Braga da, Ximenes, Antonio Carlos, Bértolo, Manoel B., Ribeiro, Sandra L.E., Keiserman, Mauro, Menin, Rita, Skare, Thelma L., Carneiro, Sueli, Azevedo, Valderílio F., Vieira, Walber P., Albuquerque, Elisa N., Bianchi, Washington A., Bonfiglioli, Rubens, Campanholo, Cristiano, Carvalho, Hellen M.S., Costa, Izaias P., Duarte, Angela P., Kohem, Charles L., Leite, Nocy, Lima, Sonia A.L., Meirelles, Eduardo S., Pereira, Ivânio A., Pinheiro, Marcelo M., Polito, Elizandra, Rocha, Francisco Airton C., Santiago, Mittermayer B., Sauma, Maria de Fátima L.C., and Valim, Valeria

Published
2013
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43. Efficacy and safety of risankizumab for active psoriatic arthritis:24-week results from the randomised, double-blind, phase 3 KEEPsAKE 1 trial

Author

Kristensen, Lars Erik, Keiserman, Mauro, Papp, Kim, McCasland, Leslie, White, Douglas, Lu, Wenjing, Wang, Zailong, Soliman, Ahmed M., Eldred, Ann, Barcomb, Lisa, Behrens, Frank, Kristensen, Lars Erik, Keiserman, Mauro, Papp, Kim, McCasland, Leslie, White, Douglas, Lu, Wenjing, Wang, Zailong, Soliman, Ahmed M., Eldred, Ann, Barcomb, Lisa, and Behrens, Frank

Abstract

OBJECTIVE: To evaluate risankizumab, a biological therapy that inhibits interleukin 23, in patients with active psoriatic arthritis (PsA) who have responded inadequately or are intolerant to ≥1 conventional synthetic disease-modifying antirheumatic drug (csDMARD). METHODS: In the randomised, placebo-controlled, double-blind KEEPsAKE 1 trial, 964 patients with active PsA were randomised (1:1) to receive risankizumab 150 mg or placebo at weeks 0, 4 and 16. The primary endpoint was the proportion of patients achieving ≥20% improvement in American College of Rheumatology criteria (ACR20) at week 24. Here, we report the results from the 24-week double-blind period; the open-label period with all patients receiving risankizumab is ongoing. RESULTS: At week 24, a significantly greater proportion of patients receiving risankizumab achieved the primary endpoint of ACR20 (57.3% vs placebo, 33.5%; p<0.001). Significant differences were also observed for risankizumab versus placebo for the first eight ranked secondary endpoints, including skin and nail psoriasis endpoints, minimal disease activity and resolution of enthesitis and dactylitis (p<0.001). Adverse events and serious adverse events were reported at similar rates in the risankizumab and placebo groups. Serious infections were reported for 1.0% and 1.2% of patients receiving risankizumab and placebo, respectively. There was one death in the risankizumab group (urosepsis deemed unrelated to the study drug). CONCLUSIONS: Risankizumab treatment results in significantly greater improvement of signs and symptoms of PsA compared with placebo and is well tolerated in patients with active PsA who have responded inadequately or are intolerant to ≥1 csDMARD. TRIAL REGISTRATION NUMBER: NCT03675308.

Published
2022

44. Efficacy and safety of risankizumab for active psoriatic arthritis: 52-week results from the KEEPsAKE 1 study.

Author

Kristensen, Lars Erik, Keiserman, Mauro, Papp, Kim, McCasland, Leslie, White, Douglas, Lu, Wenjing, Soliman, Ahmed M, Eldred, Ann, Barcomb, Lisa, and Behrens, Frank

Subjects
*THERAPEUTIC use of monoclonal antibodies, *PSORIATIC arthritis, *DRUG efficacy, *TREATMENT effectiveness, *RANDOMIZED controlled trials, *RESEARCH funding, *QUESTIONNAIRES, *STATISTICAL sampling, *PATIENT safety
Abstract

Objective PsA is a chronic disease with heterogeneous clinical manifestations requiring treatment options with long-term efficacy and safety. In this follow-up analysis, the 52-week efficacy and safety of risankizumab 150 mg in patients with active PsA who had previous inadequate response/intolerance to one or more conventional synthetic DMARDs (csDMARD-IR) were evaluated. Methods KEEPsAKE 1 is an ongoing, global, phase 3 study with a 24-week, double-blind, placebo-controlled period (period 1) and an open-label extension period (period 2). In period 1, eligible patients were randomized 1:1 to receive subcutaneous risankizumab 150 mg or placebo at weeks 0, 4 and 16. At week 24 (period 2), all continuing patients received open-label risankizumab 150 mg every 12 weeks through week 208. Results At week 24, 57.3% of risankizumab-treated patients (n  =   483) achieved ≥20% improvement in ACR criteria (ACR20) vs 33.5% of placebo-treated patients (n  =   481; P  < 0.001). At week 52, 70.0% of patients who were randomized to receive continuous risankizumab therapy and 63.0% of patients who were randomized to receive placebo in period 1 and then receive risankizumab at week 24 achieved ACR20. Similar result trends were observed for other efficacy measures. Risankizumab was well tolerated through 52 weeks of treatment with a consistent safety profile from week 24 through week 52. Conclusion In patients with active PsA who were csDMARD-IR, continuous risankizumab treatment demonstrated robust long-term efficacy and was well tolerated through 52 weeks of treatment. Trial registration ClinicalTrials.gov, http://clinicaltrials.gov , KEEPsAKE1, NCT03675308. [ABSTRACT FROM AUTHOR]

Published
2023
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45. Efficacy and safety of risankizumab for active psoriatic arthritis: 24-week results from the randomised, double-blind, phase 3 KEEPsAKE 1 trial

Author

Kristensen, Lars Erik, primary, Keiserman, Mauro, additional, Papp, Kim, additional, McCasland, Leslie, additional, White, Douglas, additional, Lu, Wenjing, additional, Wang, Zailong, additional, Soliman, Ahmed M, additional, Eldred, Ann, additional, Barcomb, Lisa, additional, and Behrens, Frank, additional

Published
2021
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47. Additional file 1 of Brazilian recommendations for the use of nonsteroidal anti-inflammatory drugs in patients with axial spondyloarthritis

Author

Lage, Ricardo Da Cruz, Marques, Claudia Diniz Lopes, Thauana Luiza Oliveira, Resende, Gustavo Gomes, Kohem, Charles Lubianca, Saad, Carla Gonçalves, Antônio Carlos Ximenes, Célio Roberto Gonçalves, Washington Alves Bianchi, Meirelles, Eduardo De Souza, Keiserman, Mauro Waldemar, Chiereghin, Adriano, Campanholo, Cristiano Barbosa, Lyrio, André Marun, Schainberg, Cláudia Goldenstein, Lenise Brandao Pieruccetti, Yazbek, Michel Alexandre, Palominos, Penelope Esther, Goncalves, Rafaela Silva Guimarães, Assad, Rodrigo Luppino, Bonfiglioli, Rubens, Sônia Maria Alvarenga Anti Loduca Lima, Sueli Carneiro, Valderílio Feijó Azevedo, Cleandro Pires Albuquerque, Wanderley Marques Bernardo, Sampaio-Barros, Percival Degrava, and Pinheiro, Marcelo De Medeiros

Subjects
Data_FILES
Abstract

Additional file 1.

Published
2021
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48. Gender characterization in a large series of Brazilian patients with spondyloarthritis

Author

de Carvalho, Hellen M. S., Bortoluzzo, Adriana B., Gonçalves, Célio R., da Silva, José Antonio Braga, Ximenes, Antonio Carlos, Bértolo, Manoel B., Ribeiro, Sandra L. E., Keiserman, Mauro, Menin, Rita, Skare, Thelma L., Carneiro, Sueli, Azevedo, Valderílio F., Vieira, Walber P., Albuquerque, Elisa N., Bianchi, Washington A., Bonfiglioli, Rubens, Campanholo, Cristiano, Costa, Izaias P., Duarte, Angela P., Gavi, Maria Bernadete O., Kohem, Charles L., Leite, Nocy H., Lima, Sonia A. L., Meirelles, Eduardo S., Pereira, Ivânio A., Pinheiro, Marcelo M., Polito, Elizandra, Resende, Gustavo G., Rocha, Francisco Airton C., Santiago, Mittermayer B., de Fátima L. C. Sauma, Maria, Sampaio-Barros, Percival D., and from the Brazilian Registry on Spondyloarthritis

Published
2012
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49. Lupoid sclerosis

Author

Keiserman, Briele, da Silva, Luiz Fernando Garcias, Keiserman, Mauro W., von Mühlen, Carlos Alberto, and Staub, Henrique Luiz

Published
2010
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50. P171 Efficacy and safety of upadacitinib in patients with active PsA and inadequate response to biologic DMARDs (SELECT-PsA-2): a double-blind, randomised controlled Phase III trial

Author

Genovese, Mark C, primary, Lertratanakul, Apinya, additional, Anderson, Jaclyn, additional, Papp, Kim, additional, Tillett, William, additional, van den Bosch, Filip, additional, Tsuji, Shigeyoshi, additional, Dokoupilova, Eva, additional, Keiserman, Mauro, additional, Wang, Xin, additional, Zhong, Sheng, additional, Zueger, Patrick, additional, Pangan, Aileen, additional, and Mease, Philip, additional

Published
2021
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