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3. Association Between Achievement of Clinical Disease Control and Improvement in Patient‐Reported Outcomes and Quality of Life in Patients With Psoriatic Arthritis in the Phase 3 SELECT‐PsA 1 and 2 Randomized Controlled Trials.

Author

Kavanaugh, Arthur, Mease, Philip, Gossec, Laure, Ranza, Roberto, Tsuji, Shigeyoshi, Douglas, Kevin, Lane, Michael, Lippe, Ralph, Mittal, Manish, Gao, Tianming, Setty, Arathi, Ciecinski, Sandra, Aletaha, Daniel, and Nash, Peter

Subjects
PSORIATIC arthritis, INFECTION control, DATA analysis, RESEARCH funding, QUESTIONNAIRES, EVALUATION of medical care, ANTIRHEUMATIC agents, QUALITY of life, STATISTICS, HEALTH outcome assessment
Abstract

Objective: We explored the relationship between achievement of clinical disease control and improvements in and normative values for patient‐reported outcomes (PROs), including quality of life (QoL) measures, in patients with psoriatic arthritis (PsA). Methods: This was a post hoc analysis of 104‐week data from the SELECT‐PsA 1 and 2 trials in adults with PsA and inadequate response to one or more conventional synthetic (SELECT‐PsA 1) or biologic (SELECT‐PsA 2) disease‐modifying antirheumatic drug. Patients were initially randomized to upadacitinib 15 mg once daily (QD) to placebo switched to upadacitinib 15 mg QD at week 24 or to adalimumab 40 mg every other week (SELECT‐PsA 1 only), and data were pooled across treatments and analyzed. We evaluated several clinical disease control measures (minimal disease activity [MDA]; very low disease activity [VLDA]; and low disease activity [LDA] and/or remission by Disease Activity in Psoriatic Arthritis [DAPSA], Psoriatic Arthritis Disease Activity Score [PASDAS], and Routine Assessment of Patient Index Data 3 [RAPID3]) and examined their associations with improvements and normative values for various PROs. Results: A total of 1,069 and 317 patients were analyzed for SELECT‐PsA 1 and 2, respectively. In both studies, responders (patients who achieved MDA or VLDA, and DAPSA, PASDAS, and RAPID3 LDA or remission) at week 104 achieved more marked changes from baseline, and more responders achieved normative values in PROs compared with nonresponders (most nominal P < 0.0001). Furthermore, numerically larger proportions of responders achieved minimal clinically important differences across PROs compared with nonresponders in both studies. In addition, patients who achieved MDA or VLDA were more likely to achieve DAPSA, PASDAS, and RAPID3 LDA or remission (all nominal P < 0.0001) for upadacitinib 15 mg QD and when treatment arms were pooled. Conclusion: Patients with PsA who achieve clinical disease control are more likely to achieve improvements and normative values in PROs and QoL measures, which reinforces disease control as a treatment target. [ABSTRACT FROM AUTHOR]

Published
2024
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7. The effect of antimalarials on the safety and persistence of treatment with biologic agents or Janus kinase inhibitors in rheumatoid arthritis.

Author

Bredemeier, Markus, Duarte, Ângela L, Pinheiro, Marcelo M, Kahlow, Bárbara S, Macieira, José C, Ranza, Roberto, Miranda, José R, Valim, Valéria, Castro, Gláucio R de, Bértolo, Manoel B, Sauma, Maria F, Fernandes, Vander, Ribeiro, Ana C, Teodoro, Reginaldo B, Brenol, Claiton V, Carvalho, Hellen M, Studart, Sâmia A, Pinheiro, Geraldo R, Rocha, Laurindo F da, and Lima, Hugo D de

Subjects
BIOTHERAPY, COMBINATION drug therapy, CONFIDENCE intervals, BIOLOGICAL products, TREATMENT duration, REGRESSION analysis, JANUS kinases, ANTIRHEUMATIC agents, HEPATOTOXICOLOGY, RHEUMATOID arthritis, DESCRIPTIVE statistics, SURVIVAL analysis (Biometry), RESEARCH funding, NEUROTRANSMITTER uptake inhibitors, ANTIMALARIALS, DRUG side effects, PATIENT safety, PROPORTIONAL hazards models
Abstract

Objectives To test the association of use of antimalarials with the overall safety of treatment in RA patients receiving one or multiple courses of biologic (b)DMARDs or a Janus kinase inhibitor (JAKi). Methods BiobadaBrasil is a multicentric registry-based cohort study of Brazilian patients with rheumatic diseases starting their first bDMARD or JAKi. The present analysis includes RA patients recruited from January 2009 to October 2019, followed up over one or multiple (up to six) courses of treatment (latest date, 19 November 2019). The primary outcome was the incidence of serious adverse events (SAEs). Total and system-specific adverse events (AEs) and treatment interruption served as secondary outcomes. Negative binomial regression with generalized estimating equations (to estimate multivariate incidence rate ratios, mIRR) and frailty Cox proportional hazards models were used for statistical analyses. Results The number of patients enrolled was 1316 (2335 treatment courses, 6711 patient-years [PY]; 1254.5 PY on antimalarials). The overall incidence of SAEs was 9.2/100 PY. Antimalarials were associated with reduced risk of SAEs (mIRR: 0.49; 95% CI: 0.36, 0.68; P  < 0.001), total AEs (0.68; 95% CI: 0.56, 0.81; P  < 0.001), serious infections (0.53; 95% CI: 0.34, 0.84; P  = 0.007) and total hepatic AEs (0.21; 95% CI: 0.05, 0.85; P  = 0.028). Antimalarials were also related to better survival of treatment course (P  = 0.003). There was no significant increase in the risk of cardiovascular AEs. Conclusion Among RA patients on treatment with bDMARDs or JAKi, concomitant use of antimalarials was associated with reduced the incidence of serious and total AEs and with longer treatment course survival. [ABSTRACT FROM AUTHOR]

Published
2024
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8. Incidence of Infectious Adverse Events in Patients With Rheumatoid Arthritis and Spondyloarthritis on Biologic Drugs—Data From the Brazilian Registry for Biologics Monitoring

Author

Cecconi, Mariana, Ranza, Roberto, Titton, David C., Moraes, Júlio C. B., Bertolo, Manoel, Bianchi, Washington, Brenol, Claiton, Carvalho, Hellen M., de Castro, Glaucio R. W., Costa, Izaias P., Cunha, Maria F. L., Duarte, Ângela, Fernandes, Vander, Freire, Marlene, Louzada-Junior, Paulo, Macieira, José C., Miranda, José R. S., Pereira, Ivanio A., Pinheiro, Geraldo R. C., Stadler, Barbara, Toledo, Roberto A., Valim, Valeria, Descalzo, Miguel A., Pinto, Rogerio M. C., and Laurindo, Ieda

Published
2020
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9. Incidence of tuberculosis among patients with rheumatoid arthritis using TNF blockers in Brazil: data from the Brazilian Registry of Biological Therapies in Rheumatic Diseases (Registro Brasileiro de Monitoração de Terapias Biológicas – BiobadaBrasil)

Author

Yonekura, Claudia Leiko, Oliveira, Rene Donizeti Ribeiro, Titton, David C., Ranza, Roberto, Ranzolin, Aline, Hayata, André L., Duarte, Ângela, Silveira, Inês G., Carvalho, Hellen M. da S. de, Moraes, Júlio C. Bertacini de, Abreu, Mirhelen Mendes de, Valim, Valéria, Bianchi, Washington, Brenol, Claiton Viegas, Pereira, Ivanio A., Costa, Izaias, Macieira, José C., Miranda, José R.S., Guedes-Barbosa, Luiz S., Bertolo, Manoel B., Sauma, Maria Fátima Lobato da C., Silva, Marília B.G., Freire, Marlene, Scheinberg, Morton A., Toledo, Roberto A., Oliveira, Sheila K.F., Fernandes, Vander, Pinheiro, Marcelo M., Castro, Glaucio, Vieira, Walber Pinto, Baaklini, Cesar Emile, Ruffino-Netto, Antonio, Pinheiro, Geraldo da Rocha Castelar, Laurindo, Ieda Maria Magalhães, and Louzada-Junior, Paulo

Published
2017
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10. Incidence of Infectious Adverse Events in Patients With Rheumatoid Arthritis and Spondyloarthritis on Biologic Drugs—Data From the Brazilian Registry for Biologics Monitoring

Author

Cecconi, Mariana, Ranza, Roberto, Titton, David C., Moraes, Júlio C. B., Bertolo, Manoel, Bianchi, Washington, Brenol, Claiton, Carvalho, Hellen M., de Castro, Glaucio R. W., Costa, Izaias P., Cunha, Maria F. L., Duarte, Ângela, Fernandes, Vander, Freire, Marlene, Louzada-Junior, Paulo, Macieira, José C., Miranda, José R.S., Pereira, Ivanio A., Pinheiro, Geraldo R.C., Stadler, Barbara, Toledo, Roberto A., Valim, Valeria, Descalzo, Miguel A., Pinto, Rogerio M.C., and Laurindo, Ieda

Published
2018
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11. P134 Efficacy of Upadacitinib on Psoriatic Arthritis with Axial Involvement Defined by Investigator Assessment and PRO-Based Criteria: Results from two Phase 3 Studies

Author

Baraliakos, Xenofon, primary, Ranza, Roberto, additional, Ostor, Andrew, additional, Ciccia, Francesco, additional, Coates, Laura C, additional, Rednic, Simona, additional, Walsh, Jessica, additional, Gao, Tianming, additional, Lertratanakul, Apinya, additional, Song, In-Ho, additional, Fabiana Ganz, Fabiana, additional, Douglas, Kevin, additional, and Deodhar, Atul, additional

Published
2023
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12. Additional file 1 of Efficacy and safety of upadacitinib in patients with active psoriatic arthritis and axial involvement: results from two phase 3 studies

Author

Baraliakos, Xenofon, Ranza, Roberto, Östör, Andrew, Ciccia, Francesco, Coates, Laura C., Rednic, Simona, Walsh, Jessica A., Douglas, Kevin, Gao, Tianming, Kato, Koji, Song, In-Ho, Ganz, Fabiana, and Deodhar, Atul

Abstract

Additional file 1: Supplementary Fig. S1. BASDAI Components at Weeks 12 and 24 From SELECT-PsA 1(non-bDMARD-IR). Supplementary Fig. S2. BASDAI Components at Weeks 12 and 24 From SELECT-PsA 2 (bDMARD-IR). Supplementary Fig. S3. ASDAS Major Improvement (MI) and ASDAS Clinically Important Improvement (CII) at Weeks 12 and 24 From SELECT-PsA 1 (non-bDMARD-IR) and SELECT-PsA 2 (bDMARD-IR). Supplementary Table S1. Efficacy Endpoints at Week 56 From SELECT-PsA 1 (non-bDMARD-IR). Supplementary Table S2. Efficacy Endpoints at Week 56 From SELECT-PsA 2 (bDMARD-IR).

Published
2023
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13. 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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14. THE EFFECT OF ANTIMALARIALS ON THE RISK AND SEVERITY OF BACTERIAL, VIRAL, FUNGAL AND SYSTEMIC SPECIFIC INFECTIONS IN RHEUMATOID ARTHRITIS

Author

Bredemeier, Markus, primary, Campos, Monica, additional, Della, Felipe, additional, Duarte, Angela, additional, Pinheiro, Marcelo, additional, Stadler, Barbara, additional, Macieira, Jose Caetano, additional, Ranza, Roberto, additional, Miranda, Jose, additional, Valim, Valéria, additional, Castro, Glaucio, additional, Bertolo, Manoel, additional, Sauma, Maria de Fátima, additional, Fernandes, Vander, additional, Medeiros-Ribeiro, Ana Cristina, additional, Botelho, Reginaldo, additional, Brenol, Claiton, additional, Carvalho, Hellen Mary da Silveira de, additional, Studart, Samia, additional, Pinheiro, Geraldo da Rocha Castelar, additional, Rocha Junior, Laurindo, additional, Lima, Hugo de Leon de, additional, Pereira, Ivanio, additional, Gazzeta, Morgana Ohira, additional, Kakehasi, Adriana, additional, Louzada Junior, Paulo, additional, Hayata, Andre Luiz Shinji, additional, Lupo, Cristiano, additional, Silveira, Ines Guimaraes, additional, Kowalski, Sergio, additional, Titton, David, additional, Ranzolin, Aline, additional, Xavier, Ricardo, additional, Laurindo, Ieda, additional, and Loures, Marco Antonio Araujo da Rocha, additional

Published
2023
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15. SAFETY AND PERSISTENCE OF TREATMENT WITH GOLIMUMAB VERSUS CERTOLIZUMAB IN RHEUMATOID ARTHRITIS: RESULTS FROM A COHORT STUDY

Author

Bredemeier, Markus, primary, Ramos, Suelem, additional, Solórzano, Camila, additional, Duarte, Angela, additional, Pinheiro, Marcelo, additional, Stadler, Barbara, additional, Macieira, Jose Caetano, additional, Ranza, Roberto, additional, Miranda, José, additional, Valim, Valeria, additional, Castro, Glaucio, additional, Bertolo, Manoel, additional, Sauma, Maria de Fátima, additional, Fernandes, Vander, additional, Medeiros-Ribeiro, Ana Cristina, additional, Botelho, Reginaldo, additional, Brenol, Claiton, additional, Carvalho, Hellen Mary da Silveira de, additional, Studart, Samia, additional, Pinheiro, Geraldo da Rocha Castelar, additional, Rocha Junior, Laurindo, additional, Lima, Hugo Deleon de, additional, Pereira, Ivanio, additional, Gazzeta, Morgana Ohira, additional, Kakehasi, Adriana, additional, Louzada Junior, Paulo, additional, Hayata, Andre Luiz Shinji, additional, Lupo, Cristiano, additional, Silveira, Ines Guimaraes, additional, Kowalski, Sergio, additional, Titton, David, additional, Ranzolin, Aline, additional, Xavier, Ricardo, additional, Laurindo, Ieda, additional, and Loures, Marco Antonio Araujo da Rocha, additional

Published
2023
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16. Management of Enthesitis in Patients With Psoriatic Arthritis: An Updated Literature Review Informing the 2021 GRAPPA Treatment Recommendations

Author

Eder, Lihi, primary, Mathew, Ashish J., additional, Carron, Philippe, additional, Bertheussen, Heidi, additional, Cañete, Juan D., additional, Azem, May, additional, Sedie, Andrea Delle, additional, Salvarani, Carlo, additional, Ranza, Roberto, additional, Elliott, Ashley, additional, Turkiewicz, Anthony, additional, de Toledo, Ricardo Acayaba, additional, Bukulmez, Hulya, additional, Stoenoiu, Maria S., additional, Mandelin, Arthur M., additional, Koehm, Michaela, additional, Lindsay, Chris A., additional, Siegel, Evan, additional, and Mease, Philip J., additional

Published
2022
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17. Pan American League of Associations for Rheumatology Recommendations for the Treatment of Psoriatic Arthritis

Author

Fernández-Ávila, Daniel G., Bautista-Molano, Wilson, Brance, María Lorena, Ávila Pedretti, María Gabriela, Vargas, Rubén Burgos, Díaz Coto, José Francisco, Gutiérrez, Luis Arturo, Gutiérrez, Marwin, Ho, Enrique Giraldo, Ibáñez Vodnizza, Sebastián Eduardo, Jáuregui, Edwin, Ocampo, Vanessa, Palominos, Penélope Esther, Palleiro Rivero, Daniel Ruben, Quiceno, Guillermo Andrés, Sommerfleck, Fernando Andrés, Vega Espinoza, Luis Enrique, Hinojosa, Oscar Vega, Barrezueta, Claudia Vera, Corbacho, Inés, Cosentino, Vanesa Laura, Sariego, Annelise Goecke, Resende, Gustavo Gomes, Saldarriaga-Rivera, Lina María, Pacheco Tena, Cesar Francisco, Citera, Gustavo, Lozada, Carlos, Ranza, Roberto, Sampaio-Barros, Percival D., Schneeberger, Emilce, and Soriano, Enrique R.

Abstract

ObjectivePsoriatic arthritis (PsA) is chronic disease that compromises multiple domains and might be associated with progressive joint damage, increased mortality, functional limitation, and considerably impaired quality of life. Our objective was to generate evidence-based recommendations on the management of PsA in Pan American League of Associations for Rheumatology (PANLAR) countries.MethodsWe used the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE)-ADOLOPMENT approach to adapt the 2019 recommendations of the European Alliance of Associations for Rheumatology. A working group consisting of rheumatologists from various countries in Latin America identified relevant topics for the treatment of PsA in the region. The methodology team updated the evidence and synthesized the information used to generate the final recommendations. These were then discussed and defined by a panel of 31 rheumatologists from 15 countries.ResultsTheses guidelines report 15 recommendations addressing therapeutic targets, use of antiinflammatory agents and corticosteroids, treatment with disease-modifying antirheumatic drugs (conventional synthetic, biologic, and targeted synthetic), therapeutic failure, optimization of biologic therapy, nonpharmacological interventions, assessment tools, and follow-up of patients with PsA.ConclusionHere we present a set of recommendations to guide decision making in the treatment of PsA in Latin America, based on the best evidence available, considering resources, medical expertise, and the patient’s values and preferences. The successful implementation of these recommendations should be based on clinical practice conditions, healthcare settings in each country, and a tailored evaluation of patients.

Published
2024
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20. Drug survival and causes of discontinuation of the first anti-TNF in ankylosing spondylitis compared with rheumatoid arthritis: analysis from BIOBADABRASIL

Author

Fafá, Bárbara P., Louzada-Junior, Paulo, Titton, David C., Zandonade, Eliana, Ranza, Roberto, Laurindo, Ieda, Peçanha, Paula, Ranzolin, Aline, Hayata, André L., Duarte, Angela, Silveira, Inês G., Costa, Izaias, Macieira, José C., Guedes-Barbosa, Luiz S., Bertolo, Manoel B., Sauma, Maria Fátima Lobato da C., Silva, Marília B. G., Freire, Marlene, Scheinberg, Morton A., Fernandes, Vander, Bianchi, Washington, Miranda, José R. S., Pinheiro, Geraldo R. C., Carvalho, Hellen M. S., Brenol, Claiton Viegas, Pereira, Ivanio A., de Castro, Gláucio Ricardo Werner, de Morais, Júlio C. Bertacini, Oliveira, Sheila K. F., de Abreu, Mirhelen Mendes, Toledo, Roberto A., Pinheiro, Marcelo M., Vieira, Walber Pinto, Valim, Valéria, and On behalf of BIOBADABRASIL

Published
2015
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22. Management of Enthesitis in Patients With Psoriatic Arthritis: An Updated Literature Review Informing the 2021 GRAPPA Treatment Recommendations.

Author

Eder, Lihi, Mathew, Ashish J., Carron, Philippe, Bertheussen, Heidi, Cañete, Juan D., Azem, May, Sedie, Andrea Delle, Salvarani, Carlo, Ranza, Roberto, Elliott, Ashley, Turkiewicz, Anthony, de Toledo, Ricardo Acayaba, Bukulmez, Hulya, Stoenoiu, Maria S., Mandelin II, Arthur M., Koehm, Michaela, Lindsay, Chris A., Siegel, Evan, and Mease, Philip J.

Published
2023
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23. Safety of the Methotrexate–leflunomide Combination in Rheumatoid Arthritis: Results of a Multicentric, Registry-based, Cohort Study (BiobadaBrasil)

Author

Bredemeier, Markus, primary, Ranza, Roberto, additional, Kakehasi, Adriana M., additional, Ranzolin, Aline, additional, da Silveira, Inês G., additional, Ribeiro, Ana C.M., additional, Titton, David C., additional, Hayata, André L.S., additional, Carvalho, Hellen M.S., additional, Kahlow, Bárbara S., additional, Fernandes, Vander, additional, Louzada, Paulo, additional, Bértolo, Manoel B., additional, Duarte, Ângela L.B.P., additional, Macieira, José C., additional, Miranda, José R.S., additional, Pinheiro, Geraldo R.C., additional, Teodoro, Reginaldo B., additional, Pinheiro, Marcelo M., additional, Valim, Valéria, additional, Pereira, Ivânio A., additional, Sauma, Maria F.L.C., additional, de Castro, Gláucio R.W., additional, da Rocha, Laurindo F., additional, Studart, Sâmia A.S., additional, Gazzeta, Morgana O., additional, da Silveira, Leticia G., additional, Lupo, Cristiano M., additional, and Laurindo, Ieda M.M., additional

Published
2022
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25. Safety of the Methotrexate–leflunomide Combination in Rheumatoid Arthritis: Results of a Multicentric, Registry-based, Cohort Study (BiobadaBrasil)

Author

Bredemeier, Markus, primary, Ranza, Roberto, additional, Kakehasi, Adriana M., additional, Ranzolin, Aline, additional, da Silveira, Inês G., additional, Ribeiro, Ana C.M., additional, Titton, David C., additional, Hayata, André L.S., additional, Carvalho, Hellen M.S., additional, Kahlow, Bárbara S., additional, Fernandes, Vander, additional, Louzada, Paulo, additional, Bértolo, Manoel B., additional, Duarte, Ângela L.B.P., additional, Macieira, José C., additional, Miranda, José R.S., additional, Pinheiro, Geraldo R.C., additional, Teodoro, Reginaldo B., additional, Pinheiro, Marcelo M., additional, Valim, Valéria, additional, Pereira, Ivânio A., additional, Sauma, Maria F.L.C., additional, de Castro, Gláucio R.W., additional, da Rocha, Laurindo F., additional, Studart, Sâmia A.S., additional, Gazzeta, Morgana O., additional, da Silveira, Leticia G., additional, Lupo, Cristiano M., additional, and Laurindo, Ieda M.M., additional

Published
2021
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26. Treatment Mode Preferences in Psoriatic Arthritis: A Qualitative Multi-Country Study

Author

Aletaha,Daniel, Husni,M Elaine, Merola,Joseph F, Ranza,Roberto, Bertheussen,Heidi, Lippe,Ralph, Young,Pamela M, Cappelleri,Joseph C, Brown,T Michelle, Ervin,Claire, Hsu,Ming-Ann, and Fallon,Lara

Subjects
Patient Preference and Adherence
Abstract

Daniel Aletaha,1 M Elaine Husni,2 Joseph F Merola,3 Roberto Ranza,4 Heidi Bertheussen,5 Ralph Lippe,6 Pamela M Young,7 Joseph C Cappelleri,8 T Michelle Brown,9 Claire Ervin,9 Ming-Ann Hsu,10 Lara Fallon11 1Division of Rheumatology, Department of Internal Medicine 3, Medical University of Vienna, Vienna, Austria; 2Cleveland Clinic, Department of Rheumatic and Immunologic Diseases, Cleveland, OH, USA; 3Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA; 4Serviço de Reumatología, Universidade Federal de Uberlândia, Uberlândia, Minas Gerais, Brazil; 5Patient Representative, Oslo, Norway; 6Inflammation & Immunology, Pfizer Pharma GmbH, Berlin, Germany; 7Inflammation & Immunology, Pfizer Inc, Collegeville, PA, USA; 8Statistics, Pfizer Inc, Groton, CT, USA; 9RTI Health Solutions, Research Triangle Park, NC, USA; 10Health Economics & Outcomes Research, Pfizer Inc, Groton, CT, USA; 11Medical Affairs, Pfizer Inc, Montreal, QC, CanadaCorrespondence: Daniel AletahaDivision of Rheumatology, Department of Internal Medicine 3, Medical University of Vienna, Währinger Gürtel 18– 20, Vienna 1090, AustriaEmail daniel.aletaha@meduniwien.ac.atObjective: Qualitative research exploring patient preferences regarding the mode of treatment administration for psoriatic arthritis (PsA) is limited. We report patient preferences and their reasons across PsA treatment modes.Methods: In this global, cross-sectional, qualitative study, interviews were conducted with adult patients with PsA in Brazil, France, Germany, Italy, Spain, the UK, and the US. Patients were currently taking a disease-modifying antirheumatic drug (DMARD). Patients indicated the order and strength of preference (0– 100; 100 = strongest) across four modes of treatment administration: oral (once daily), self-injection (weekly), clinic injection (weekly), and infusion (monthly); reasons for preferences were qualitatively assessed. Descriptive statistics were reported. Fisher’s exact tests and t-tests were conducted for treatment mode outcomes.Results: Overall, 85 patients were interviewed (female, 60.0%; mean age, 49.8 years). First-choice ranking (%) and mean [standard deviation] preference points were: oral (49.4%; 43.9 [31.9]); self-injection (34.1%; 32.4 [24.8]); infusion (15.3%; 14.5 [20.0]); clinic injection (1.2%; 9.2 [10.0]). Of 48 (56.5%) patients with a strong first-choice preference (ie point allocation ≥ 60), 66.7% chose oral administration. Self-injection was most often selected as second choice (51.8%), clinic injection as third (49.4%), and infusion as fourth (47.1%). Oral administration was the first-choice preference in the US (88.0% vs 38.0% in Europe). The most commonly reported reason for oral administration as the first choice was speed and ease of administration (76.2%); for self-injection, this was convenience (75.9%). The most commonly reported reason for avoiding oral administration was concern about possible drug interactions (63.6%); for self-injection, this was a dislike of needles or the injection process (66.7%).Conclusion: Patients with PsA preferred oral treatment administration, followed by self-injection; convenience factors were common reasons for these preferences. Overall, 43.5% of patients did not feel strongly about their first-choice preference and may benefit from discussions with healthcare professionals about PsA treatment administration options.Keywords: psoriatic arthritis, patient preference, qualitative research, treatment administration

Published
2020

28. The development of candidate composite disease activity and responder indices for psoriatic arthritis (GRACE project)

Author

Helliwell, Philip S, FitzGerald, Oliver, Fransen, Jaap, Gladman, Dafna D, Kreuger, Gerald G, Callis-Duffin, Kristina, McHugh, Neil, Mease, Philip J, Strand, Vibeke, Waxman, Robin, Azevedo, Valderilio Feijo, Beltran Ostos, Adriana, Carneiro, Sueli, Cauli, Alberto, Espinoza, Luis R, Flynn, John A, Hassan, Nada, Healy, Paul, Kerzberg, Eduardo Mario, Lee, Yun Jong, Lubrano, Ennio, Marchesoni, Antonio, Marzo-Ortega, Helena, Porru, Giovanni, Moreta, Elvia G, Nash, Peter, Raffayova, Helena, Ranza, Roberto, Raychaudhuri, Siba P, Roussou, Euthalia, Scarpa, Raphael, Song, Yeong Wook, Soriano, Enrique R, Tak, Paul P, Ujfalussy, Ilona, de Vlam, Kurt, and Walsh, Jessica A

Published
2013
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29. SURVIVAL OF THE FIRST ANTI-TNF IN YOUNGER AND ELDERLY RHEUMATOID ARTHRITIS PATIENTS FROM BIOBADABRASIL REGISTRY

Author

Chakr, Rafael, primary, Bredemeier, Markus, additional, Duarte, Ângela, additional, Pinheiro, Marcelo, additional, Kahlow, Bárbara, additional, Macieira, José Caetano, additional, Ranza, Roberto, additional, Silva Miranda, José Roberto, additional, Valim Cristo, Valeria, additional, Ricardo Werner de Castro, Gláucio, additional, Barros Bértolo, Manoel, additional, Lobato da C. Sauma, Maria de Fátima, additional, Fernandes, Vander, additional, de Medeiros Ribeiro, Ana Cristina, additional, Botelho Teodoro, Reginaldo, additional, Viegas Brenol, Claiton, additional, Negrão Gonçalo Dias, Deborah, additional, da Silveira de Carvalho, Hellen Mary, additional, Araujo de Souza Studart, Samia, additional, da Rocha Castelar Pinheiro, Geraldo, additional, Ferreira da Rocha, Laurindo, additional, Alves Pereira, Ivânio, additional, Ohira Gazzeta, Morgana, additional, Kakehasi, Adriana Maria, additional, Louzada-Júnior, Paulo, additional, Shinji Hayata, André Luiz, additional, Pompeo de Pina, Fabiana, additional, Michelini Lupo, Cristiano, additional, Balarini, Lidia, additional, Guimarães da Silveira, Inês, additional, Kowalski, SérgiO, additional, Titton, David Cesar, additional, Ranzolin, Aline, additional, Laurindo, Ieda, additional, and Machado Xavier, Ricardo, additional

Published
2021
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30. BIOBADABRASIL: SAFETY PROFILE OF THE FIRST BIOLOGICAL AGENT OR JAK INHIBITOR FOR THE TREATMENT OF RA

Author

BREDMEIR, MARKUS, primary, BRANCO P DUARTE, ANGELA LUZIA, additional, DE MEDEIRO PINHEIRO, MARCELO, additional, STANDLER KAHLOW, BARBARA, additional, CAETANO MACIEIRA, JOSÉ, additional, RANZA, ROBERTO, additional, SILVA MIRANDA, JOSÉ ROBERTO, additional, RICARDO WERNER DE CASTRO, GLÁUCIO, additional, VALIM CRISTO, VALÉRIA, additional, BARROS BÉRTOLO, MANOEL, additional, DA ROCHA CASTELAR PINHEIRO, GERALDO, additional, ROCHA JR, LAURINDO, additional, ALVES PEREIRA, IVANIO, additional, LOZADA JR, PAULO, additional, OHIRA GAZZETA, MORGANA, additional, LOBATO DA CUNHA SAUMA, MARIA DE FATIMA, additional, FERNANDES, VANDER, additional, DE MEDEIROS RIBEIRO, ANA CRISTINA, additional, BOTELHO TEODORO, REGINALDO, additional, VIEGAS BRENOL, CLAITON, additional, NEGRÃO GONÇALO DIAS, DEBORAH, additional, DA SILVEIRA DE CARVALHO, HELLEN MARY, additional, STUDART, SÂMIA, additional, AMARAL, JOSE CARLOS, additional, NEUBARTH GIORGI, RINA DALVA, additional, KAKEHASI, ADRIANA MARIA, additional, PREVENZA, JOSE ROBERTO, additional, MAGALHÃES LAURINDO, IEDA MARIA, additional, KOWALSKI, SERGIO, additional, ALVES PEREIRA, HELENA LUCIA, additional, SZTAJNBOK, FLAVIO, additional, A. SCHEINBERG, MORTON, additional, TITTON, DAVID CEZAR, additional, RANZOLIN, ALINE, additional, LUPO, CRISTIANO MICHELINI, additional, GUIMARÃES DA SILVEIRA, INÊS, additional, and SHINJI HAYATA, ANDRÉ LUIZ, additional

Published
2021
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31. RELATIONSHIP OF THE PSORIATIC ARTHRITIS IMPACT OF DISEASE SCORE (PsAID-12) WITH RADIOLOGICAL DAMAGE AND DELAY IN THE DIAGNOSIS OF PSORIATIC ARTHRITIS: A MULTICENTER STUDY

Author

da Cruz Ribeiro e Souza, Elziane, primary, Coelho da Silva Carneiro, Sueli, additional, Yazbek, Michel Alexandre, additional, de Cássia Menin, Rita, additional, Ranza, Roberto, additional, Martis da Silva, Carlos Henrique, additional, Nascimento Carneiro, Jamille, additional, and Barbosa Campanholo, Cristiano, additional

Published
2021
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36. SAFETY OF THE METHOTREXATE-LEFLUNOMIDE COMBINATION IN THE BRAZILIAN REGISTRY OF BIOLOGICAL THERAPIES IN RHEUMATIC DISEASES (BIOBADABRASIL)

Author

BREDEMEIER, MARKUS, additional, LAURINDO, IÊDA MARIA, additional, PINHEIRO, MARCELO MEDEIROS, additional, MACIEIRA, JOSÉ CAETANO, additional, DUARTE, ANGELA LUIZA B P, additional, KAKEHASI, ADRIANA MARIA, additional, KAHLOW, BARBARA STADLER, additional, RANZA, ROBERTO, additional, MEDEIROS-RIBEIRO, ANA CRISTINA, additional, CRISTO, VALERIA VALIM, additional, BERTOLO, MANOEL BARROS, additional, MIRANDA, JOSÉ ROBERTO SILVA, additional, BRENOL, CLAITON VIEGAS, additional, CASTRO, GLAUCIO RICARDO WERNER, additional, FERNANDES, VANDER, additional, TITON, DAVID CESAR, additional, SAUMA, MARIA DE FÁTIMA LOBATO C, additional, PEREIRA, IVANIO ALVES, additional, TEODORO, REGINALDO BOTELHO, additional, CARVALHO, HELLEN MARY SILVEIRA, additional, HAYATA, ANDRE LUIZ SHINJI, additional, JR, PAULO LOUZADA, additional, RANZOLIN, ALINE, additional, SILVEIRA, INÊS GUIMARÃES, additional, KOWALSKI, SÉRGIO CÂNDIDO, additional, POLLAK, DANIEL FELDMAN, additional, STUDART, SÂMIA A S, additional, PINHEIRO, GERALDO R C, additional, BIANCHI, WASHINGTON ALVES, additional, TOLEDO, ROBERTO ACAYABA, additional, AMARAL, JÉSSICA MARTINS, additional, JÚNIOR, LAURINDO FERREIRA ROCHA, additional, GAZZETA, MORGANA OHIRA, additional, and CARVALHO, LINA OLIVEIRA, additional

Published
2019
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37. Onychomycosis in Psoriatic Patients with Nail Disorders: Aetiological Agents and Immunosuppressive Therapy.

Author

Alves, Núbia Carvalho Pena de Oliveira Praeiro, Moreira, Tomaz de Aquino, Malvino, Lucivânia Duarte Silva, Rodrigues, José Joaquim, Ranza, Roberto, Araújo, Lúcio Borges de, and Pedroso, Reginaldo dos Santos

Subjects
THERAPEUTIC use of monoclonal antibodies, CANDIDA, CANDIDA albicans, COMBINATION drug therapy, DERMATOLOGIC agents, FUNGI, IMMUNOSUPPRESSION, INTERVIEWING, METHOTREXATE, MYCOSES, PSORIASIS, PSORIATIC arthritis, YEAST, ONYCHOMYCOSIS, NAIL diseases, ETANERCEPT, CROSS-sectional method, DESCRIPTIVE statistics, MYCOLOGICAL typing techniques
Abstract

Psoriasis and psoriatic arthritis are chronic, relapsing, immune-based diseases. Psoriatic patients may have nail involvement in 50 to 80% of cases, and this may reach 85% in patients with joint disease, in spite of the fact that the relationship between psoriasis and onychomycosis is not well established. The aim of this study was to investigate the occurrence of onychomycosis in patients with nail disorders and diagnosis of psoriasis and psoriatic arthritis. This was a cross-sectional study in which 38 patients diagnosed with psoriasis and/or psoriatic arthritis were interviewed and had altered nail samples analysed by mycological and histopathological exams. Twenty-two (57.89%) patients had a confirmed diagnosis for onychomycosis. Seventeen (44.8%) had a positive direct mycological examination, 16 (42.1%) had positive cultures, and 12 (31.6%) were positive for fungi by histopathological examination. Dermatophytes were identified in nine (56.3%) cultures, and of these, eight were Trichophyton rubrum and one T. tonsurans. Yeasts were isolated in seven patients (43.75%), which included four Candida parapsilosis and three C. albicans. Six patients (15.78%) were not using immunosuppressive therapy, and the others were using methotrexate, etanercept, adalimumab, infliximab, secukinumab, or golimumab, in monotherapy or in combination with other drugs. The confirmed onychomycosis rate in patients using methotrexate alone was 92.8% (n = 13). We concluded that it is possible that there is a positive relationship between psoriatic disease and onychomycosis. And we highlight that it is also worth investigating in the future the possible role of immunosuppressive therapy (mainly methotrexate) as a predisposing factor for the development of fungal infections in psoriatic patients. [ABSTRACT FROM AUTHOR]

Published
2020
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38. Semantic and psychometric validation of the Brazilian Portuguese version (PASE-P) of the Psoriatic Arthritis Screening and Evaluation questionnaire

Author

Costa, Carolina Zorzanelli, primary, Goldenstein-Schainberg, Claudia, additional, Carneiro, Sueli, additional, Rodrigues, José Joaquim, additional, Romiti, Ricardo, additional, Barros, Thiago Bitar Martins, additional, Martins, Gladys, additional, Carneiro, Jamile, additional, Grynszpan, Rachel, additional, Sampaio, Ana Luisa, additional, Mendonça, Tânia Maria Silva, additional, Silva, Carlos Henrique Martins, additional, Qureshi, Abrar A., additional, Pinto, Rogerio de Melo Costa, additional, and Ranza, Roberto, additional

Published
2018
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39. Psoriatic Arthritis Screening and Evaluation Questionnaire--Brazilian Portuguese Version

Author

Costa, Carolina Zorzanelli, primary, Goldenstein-Schainberg, Claudia, additional, Carneiro, Sueli, additional, Joaquim Rodrigues, José, additional, Romiti, Ricardo, additional, Barros, Thiago Bitar Martins, additional, Martins, Gladys, additional, Carneiro, Jamile, additional, Grynszpan, Rachel, additional, Sampaio, Ana Luisa, additional, Mendonça, Tânia Maria Silva, additional, Silva, Carlos Henrique Martins, additional, Qureshi, Abrar A., additional, de Melo Costa Pinto, Rogerio, additional, and Ranza, Roberto, additional

Published
2018
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40. Changing rate of serious infections in biologic-exposed rheumatoid arthritis patients. Data from South American registries BIOBADABRASIL and BIOBADASAR.

Author

Ranza, Roberto, de la Vega, Maria Celina, Laurindo, Ieda Maria Magalhães, Gómez, Marìa Gimena, Titton, David Cezar, Kakehasi, Adriana Maria, Brigante, Alejandro, Benitez, Alejandro, Ranzolin, Aline, Granel, Amelia, Cappuccio, Ana María, Quinteros, Ana, Hayata, André Luiz Shinji, Smichowski, Andrea, Duarte, Ângela Luzia Branco P., Kahlow, Barbara Stadler, Andia, Carolina Sánchez, Brenol, Claiton Viegas, Velozo, Edson, and Mussano, Eduardo

Subjects
*RHEUMATOID arthritis, *THERAPEUTICS, *INFECTION, *BIOLOGICALS, *INFORMATION storage & retrieval systems
Abstract

Objective: Most reports on serious infections (SI) in rheumatoid arthritis (RA) patients treated with biological disease-modifying antirheumatic drugs (bDMARDs) are from the USA and Western Europe. Data from other regions are largely missing. We report data from South American countries with different backgrounds and health-care systems but similar registries. Methods: We merged 2010–2016 data from two registries, BIOBADABRASIL (Brazil) and BIOBADASAR (Argentina), which share the same protocol, online platform and data monitoring process. Patients with active RA were included when they began the first bDMARD or a conventional synthetic DMARD (csDMARD, control group). The SI incidence rate (IR) per 1000 patient/years and adjusted IR ratio (aIRR) were estimated for bDMARDs and csDMARDs. Results: Data were analysed for 3717 RA patients with an exposure of 13,380 patient/years. The 2591 patients treated with bDMARDs (64% tumour necrosis factor-α inhibitors (TNFi)) had a follow-up of 9300 years, and the 1126 treated with csDMARDs had an exposure of 4081 patient/years. The SI IR was 30.54 (CI 27.18–34.30) for all bDMARDs and 5.15 (CI 3.36–7.89) for csDMARDs. The aIRR between the two groups was 2.03 ([1.05, 3.9] p = 0.034) for the first 6 months of treatment but subsequently increased to 8.26 ([4.32, 15.76] p < 0.001). The SI IR for bDMARDs decreased over time in both registries, dropping from 36.59 (28.41–47.12) in 2012 to 7.27 (4.79–11.05) in 2016. Conclusion: While SI remains a major concern in South American patients with RA treated with bDMARDs, a favourable trend toward a reduction was observed in the last years. Key Points • New comprehensive data on biologic drugs safety from international collaboration in South America. • First proposal for national registries data merging in South America. • Serious infections remain a major concern in RA patients treated with biologics. • A significant reduction of serious infections in RA patients exposed to biologics was observed over a 7 years period. [ABSTRACT FROM AUTHOR]

Published
2019
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41. Incidência de tuberculose em pacientes com artrite reumatoide em uso de bloqueadores do TNF no Brasil: dados do Registro Brasileiro de Monitoração de Terapias Biológicas BiobadaBrasil

Author

Yonekura, Claudia Leiko, primary, Oliveira, Rene Donizeti Ribeiro, additional, Titton, David C., additional, Ranza, Roberto, additional, Ranzolin, Aline, additional, Hayata, André L., additional, Duarte, Ângela, additional, Silveira, Inês G., additional, Carvalho, Hellen M. da S. de, additional, Moraes, Júlio C. Bertacini de, additional, Abreu, Mirhelen Mendes de, additional, Valim, Valéria, additional, Bianchi, Washington, additional, Brenol, Claiton Viegas, additional, Pereira, Ivanio A., additional, Costa, Izaias, additional, Macieira, José C., additional, Miranda, José R.S., additional, Guedes-Barbosa, Luiz S., additional, Bertolo, Manoel B., additional, Sauma, Maria Fátima Lobato da C., additional, Silva, Marília B.G., additional, Freire, Marlene, additional, Scheinberg, Morton A., additional, Toledo, Roberto A., additional, Oliveira, Sheila K.F., additional, Fernandes, Vander, additional, Pinheiro, Marcelo M., additional, Castro, Glaucio, additional, Vieira, Walber Pinto, additional, Baaklini, Cesar Emile, additional, Ruffino-Netto, Antonio, additional, Pinheiro, Geraldo da Rocha Castelar, additional, Laurindo, Ieda Maria Magalhães, additional, and Louzada-Junior, Paulo, additional

Published
2017
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43. Prevalence of Psoriatic Arthritis in a Large Cohort of Brazilian Patients with Psoriasis

Author

Ranza, Roberto, primary, Carneiro, Sueli, additional, Qureshi, Abrar A., additional, Martins, Gladys, additional, Rodrigues, Jose Joaquim, additional, Romiti, Ricardo, additional, Barros, Thiago Bitar M., additional, Carneiro, Jamille, additional, Sampaio, Ana Luisa, additional, Grynszpan, Rachel, additional, Markus, Juliana, additional, Pinto, Rogerio Melo Costa, additional, and Goldenstein-Schainberg, Claudia, additional

Published
2015
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45. Recomendações sobre diagnóstico e tratamento da artrite psoriásica

Author

Carneiro, Sueli, primary, Azevedo, Valderílio Feijó, additional, glioli, Rubens Bonfi, additional, Ranza, Roberto, additional, Gonçalves, Célio Roberto, additional, Keiserman, Mauro, additional, Souza Meirelles, Eduardo de, additional, Medeiros Pinheiro, Marcelo de, additional, Ximenes, Antonio Carlos, additional, Bernardo, Wanderley, additional, and Sampaio-Barros, Percival Degrava, additional

Published
2013
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46. Recomendações sobre diagnóstico e tratamento da espondilite anquilosante

Author

Sampaio-Barros, Percival Degrava, primary, Keiserman, Mauro, additional, Souza Meirelles, Eduardo de, additional, Medeiros Pinheiro, Marcelo de, additional, Ximenes, Antonio Carlos, additional, Azevedo, Valderílio Feijó, additional, Bonfiglioli, Rubens, additional, Carneiro, Sueli, additional, Ranza, Roberto, additional, Marques Bernardo, Wanderley, additional, and Gonçalves, Célio Roberto, additional

Published
2013
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47. The development of candidate composite disease activity and responder indices for psoriatic arthritis (GRACE project)

Author

Helliwell, Philip S, primary, FitzGerald, Oliver, additional, Fransen, Jaap, additional, Gladman, Dafna D, additional, Kreuger, Gerald G, additional, Callis-Duffin, Kristina, additional, McHugh, Neil, additional, Mease, Philip J, additional, Strand, Vibeke, additional, Waxman, Robin, additional, Azevedo, Valderilio Feijo, additional, Beltran Ostos, Adriana, additional, Carneiro, Sueli, additional, Cauli, Alberto, additional, Espinoza, Luis R, additional, Flynn, John A, additional, Hassan, Nada, additional, Healy, Paul, additional, Kerzberg, Eduardo Mario, additional, Lee, Yun Jong, additional, Lubrano, Ennio, additional, Marchesoni, Antonio, additional, Marzo-Ortega, Helena, additional, Porru, Giovanni, additional, Moreta, Elvia G, additional, Nash, Peter, additional, Raffayova, Helena, additional, Ranza, Roberto, additional, Raychaudhuri, Siba P, additional, Roussou, Euthalia, additional, Scarpa, Raphael, additional, Song, Yeong Wook, additional, Soriano, Enrique R, additional, Tak, Paul P, additional, Ujfalussy, Ilona, additional, de Vlam, Kurt, additional, and Walsh, Jessica A, additional

Published
2012
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50. Registro brasileiro de biológicos: processo de implementação e resultados preliminares do BiobadaBrasil

Author

Titton, David C, primary, Silveira, Ines Guimarães, additional, Louzada-Junior, Paulo, additional, Hayata, Andre L, additional, Carvalho, Hellen Mary S, additional, Ranza, Roberto, additional, Rezende, Lucila S, additional, Pinheiro, Geraldo Castelar, additional, Santos, Jair Licio F, additional, Miranda, Jose Roberto, additional, Carvalho, Jozelio Freitas, additional, Bertolo, Manoel Barros, additional, Freire, Marlene, additional, Scheinberg, Morton A, additional, Skare, Thelma L, additional, Fernandes, Vander, additional, Bianchi, Washington, additional, and Laurindo, Ieda Maria M, additional

Published
2011
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