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4. A phase II randomised, double-blind, placebo-controlled, proof of concept study of oral seletalisib in patients with primary Sjögren’s syndrome (PSS)

Author

Juárez, Maria, Diaz, Nieves, Johnston, Geoffrey I, Nayar, Saba, Payne, Andrew, Helmer, Eric, Cain, Dionne, Williams, Paulette, Ng, Wan Fai, Fisher, Benjamin, Gottenberg, Jacques-Eric, Guggino, Giuliana, Mariette, Xavier, Kvarnström, Marika, Devauchelle-Pensec, Valérie, Rosas, Jose, Sanchez-Burson, Juan, Giacomelli, Roberto, Barone, Francesca, Bowman, Simon J, UCB Pharma Slough, University of Birmingham [Birmingham], UCB Pharma Raleigh, University of Newcastle, Newcastle upon Tyne, UK, University Hospital of Strasbourg, University of Palermo, Italy, Service de rhumatologie, Université Paris-Sud - Paris 11 (UP11)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Bicêtre, Unit of Experimental Rheumatology, Stockhom (Department of Medicine), CHRU Brest - Service de Rhumatologie (CHU - BREST - Rhumato), Centre Hospitalier Régional Universitaire de Brest (CHRU Brest), Lymphocyte B et Auto-immunité (LBAI), Université de Brest (UBO)-Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM), Hospital Marina Baixa, Villajoyosa, Infantaluisa Hospital, Sevilla, University of L'Aquila [Italy] (UNIVAQ), University Hospital Birmingham, UCB Pharma [Slough], UCB Pharma [Brussels], Lymphocytes B, Autoimmunité et Immunothérapies (LBAI), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-LabEX IGO Immunothérapie Grand Ouest-Institut Brestois Santé Agro Matière (IBSAM), and Université de Brest (UBO)

Subjects
[SDV.IMM]Life Sciences [q-bio]/Immunology, ComputingMilieux_MISCELLANEOUS
Abstract

International audience

Published
2019

5. Efficacy and Safety of Ixekizumab in the Treatment of Radiographic Axial Spondyloarthritis: Sixteen-Week Results From a Phase III Randomized, Double-Blind, Placebo-Controlled Trial in Patients With Prior Inadequate Response to or Intolerance of Tumor Necrosis Factor Inhibitors

Author

Deodhar, Atul, Poddubnyy, Denis, Pacheco‐Tena, Cesar, Salvarani, Carlo, Lespessailles, Eric, Rahman, Proton, Järvinen, Pentti, Sanchez‐Burson, Juan, Gaffney, Karl, Lee, Eun Bong, Krishnan, Eswar, Santisteban, Silvia, Li, Xiaoqi, Zhao, Fangyi, Carlier, Hilde, Reveille, John, Antolini, Christopher, Azevedo, Valderilio, Barkham, Magnus, Rodriguez, Aaron Alejandro Barrera, Berman, Alberto, Blicharski, Tomasz, Brzezicki, Jan, Burmester, Gerd, Carrio, Judith, Collantes, Eduardo, Combe, Bernard, Cons‐Molina, Fidencio, Cortes‐Maisonet, Gregorio, Dudek, Anna, Barragan, Sergio Duran, Elkayam, Ori, Flint, Kathleen, Galeazzi, Mauro, Gaylis, Norman, Goddard, David, Fernandez, Carlos Gonzalez, Goupille, Philippe, Masmitja, Jordi Gratacos, Greenwald, Maria, Gremese, Elisa, Hong, Seung Jae, Howell, Mary, Hrycaj, Pawel, Ince, Akgun, Ju, Ji Hyeon, Kaine, Jeffrey, Kang, Seong Wook, Keiserman, Mauro, Kim, Tae‐Hwan, Kivitz, Alan, Klein, Steven, Kremer, Joel, Lee, Sang Heon, Lee, Chang Keun, Lee, Sang‐Hoon, Lidman, Roger, Loveless, James, Lucero, Eleonora, Cocco, Jose Maldonado, Marcolino, Flora, Mariette, Xavier, Mehta, Daksha, Morin, Frederic, Moscovici, Yolanda, Mueller, Eric, Mysler, Eduardo, Blasco, Francisco Navarro, Nguyen, Minh, Pantojas, Carlos, Park, Min‐Chan, Jesus, Amarilis Perez‐De, Peters, Eric, Plebanski, Rafal, Querubin, Roel, Remus, Cesar Ramos, Reitblat, Tatiana, Rivera, Tania, Rodriguez, Juan Cruz Rizo, Sayers, Michael, Scotton, Antonio, Scoville, Craig, Shaw, David, Shin, Kichul, Singhal, Atul, Skinner, Cassandra, Soto‐Raices, Oscar, Soubrier, Martin, Szymanska, Malgorzata, Thai, Christine, Sande, Marleen, Wells, Alvin, Wojciechowski, Rafal, Xavier, Ricardo, Ximenes, Antonio, Zisman, Devy, Imagerie Multimodale Multiéchelle et Modélisation du Tissu Osseux et articulaire (I3MTO), Université d'Orléans (UO), Oregon Health and Science University [Portland] (OHSU), Universidad Autónoma de Chihuahua (UACH), Università degli Studi di Modena e Reggio Emilia, Memorial University of Newfoundland [St. John's], Seoul National University [Seoul] (SNU), Eli Lilly and Company [Indianapolis], Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Institut de Génétique Moléculaire de Montpellier (IGMM), and Centre National de la Recherche Scientifique (CNRS)-Université de Montpellier (UM)

Subjects
Adult, Male, Settore MED/16 - REUMATOLOGIA, Immunology, ankylosing spondylitis, axial spondyloarthritis, ixekizumab, radiographic, Antibodies, Monoclonal, Humanized, Rheumatology, Double-Blind Method, Spondylarthritis, Spondyloarthritis, Immunology and Allergy, Humans, ComputingMilieux_MISCELLANEOUS, Axis, Cervical Vertebra, Middle Aged, Spine, Radiography, Treatment Outcome, [SDV.MHEP.RSOA]Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, Antirheumatic Agents, Quality of Life, Female, Tumor Necrosis Factor Inhibitors, Original Article, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Abstract

International audience; OBJECTIVE:To investigate the efficacy and safety of ixekizumab in patients with active radiographic axial spondyloarthritis (SpA) and prior inadequate response to or intolerance of 1 or 2 tumor necrosis factor inhibitors (TNFi).METHODS:In this phase III randomized, double-blind, placebo-controlled trial, adult patients with an inadequate response to or intolerance of 1 or 2 TNFi and an established diagnosis of axial SpA (according to the Assessment of SpondyloArthritis international Society [ASAS] criteria for radiographic axial SpA, with radiographic sacroiliitis defined according to the modified New York criteria and ≥1 feature of SpA) were recruited and randomized 1:1:1 to receive placebo or 80-mg subcutaneous ixekizumab every 2 weeks (IXEQ2W) or 4 weeks (IXEQ4W), with an 80-mg or 160-mg starting dose. The primary end point was 40% improvement in disease activity according to the ASAS criteria (ASAS40) at week 16. Secondary outcomes and safety were also assessed.RESULTS:A total of 316 patients were randomized to receive placebo (n = 104), IXEQ2W (n = 98), or IXEQ4W (n = 114). At week 16, significantly higher proportions of IXEQ2W patients (n = 30 [30.6%]; P = 0.003) or IXEQ4W patients (n = 29 [25.4%]; P = 0.017) had achieved an ASAS40 response versus the placebo group (n = 13 [12.5%]), with statistically significant differences reported as early as week 1 with ixekizumab treatment. Statistically significant improvements in disease activity, function, quality of life, and spinal magnetic resonance imaging-evident inflammation were observed after 16 weeks of ixekizumab treatment versus placebo. Treatment-emergent adverse events (AEs) with ixekizumab treatment were more frequent than with placebo. Serious AEs were similar across treatment arms. One death was reported (IXEQ2W group).CONCLUSION:Ixekizumab treatment for 16 weeks in patients with active radiographic axial SpA and previous inadequate response to or intolerance of 1 or 2 TNFi yields rapid and significant improvements in the signs and symptoms of radiographic axial SpA versus placebo.

Published
2019

7. AB0458 A PHASE II RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PROOF OF CONCEPT STUDY OF ORAL SELETALISIB IN PATIENTS WITH PRIMARY SJÖGREN’S SYNDROME (PSS)

Author

Juarez, Maria, primary, Diaz, Nieves, additional, Johnston, Geoffrey I., additional, Nayar, Saba, additional, Payne, Andrew, additional, Helmer, Eric, additional, Cain, Dionne, additional, Williams, Paulette, additional, Ng, Wan Fai, additional, Fisher, Benjamin, additional, Gottenberg, Jacques-Eric, additional, Guggino, Giuliana, additional, Mariette, Xavier, additional, Kvarnström, Marika, additional, Devauchelle-Pensec, Valerie, additional, Rosas, Jose, additional, Sanchez-Burson, Juan, additional, Giacomelli, Roberto, additional, Barone, Francesca, additional, and Bowman, Simon J., additional

Published
2019
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8. 226 Summary of baricitinib effect on patient-reported outcomes (PROs) in methotrexate-inadequate responder patient population

Author

Dougados, Maxime, primary, Fautrel, Bruno J, additional, Van De Laar, Mart A F J, additional, Kirkham, Bruce, additional, Alten, Rieke, additional, Cseuz, Regina, additional, Smolen, Josef S, additional, Sanchez-Burson, Juan, additional, Bird, Paul, additional, Scheinberg, Morton, additional, Van Den Bosch, Filip, additional, Barry, Jane, additional, Durand, Frederick, additional, Zhu, Baojin, additional, De Leonardis, Francesco, additional, and Taylor, Peter C, additional

Published
2018
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9. Response to baricitinib based on prior biologic use in patients with refractory rheumatoid arthritis

Author

Genovese, Mark C, primary, Kremer, Joel M, additional, Kartman, Cynthia E, additional, Schlichting, Douglas E, additional, Xie, Li, additional, Carmack, Tara, additional, Pantojas, Carlos, additional, Sanchez Burson, Juan, additional, Tony, Hans-Peter, additional, Macias, William L, additional, Rooney, Terence P, additional, and Smolen, Josef S, additional

Published
2018
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10. EFFICACY AND SAFETY OF BARICITINIB VERSUS PLACEBO AND ADALIMUMAB IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS AND INADEQUATE RESPONSE TO METHOTREXATE: SUMMARY RESULTS FROM THE 52-WEEK PHASE 3 RA-BEAM STUDY

Author

Taylor, Peter C., Krogulec, Marek, Dudek, Anna, Dudler, Jean, Drescher, Edit, Cseuz, Regina, Kausiene, Rasa, Andersone, Daina, Unikiene, Dalia, Sanchez Burson, Juan, Blanco Alonso, Ricardo, Dvorak, Zdenek, Ghizdavescu, Andrei, Irto, Ildiko, Larsson, Esbjorn, Bello, Natalia, Barry, Jane, Durand, Frederick, Holzkaemper, Thorsten, Otawa, Susan, de Bono, Stephanie, Keystone, Edward C., Rubbert-Roth, Andrea, Combe, Bernard, De La Torre, Inmaculada, Taylor, Peter C., Krogulec, Marek, Dudek, Anna, Dudler, Jean, Drescher, Edit, Cseuz, Regina, Kausiene, Rasa, Andersone, Daina, Unikiene, Dalia, Sanchez Burson, Juan, Blanco Alonso, Ricardo, Dvorak, Zdenek, Ghizdavescu, Andrei, Irto, Ildiko, Larsson, Esbjorn, Bello, Natalia, Barry, Jane, Durand, Frederick, Holzkaemper, Thorsten, Otawa, Susan, de Bono, Stephanie, Keystone, Edward C., Rubbert-Roth, Andrea, Combe, Bernard, and De La Torre, Inmaculada

Published
2017

11. Efficacy and Safety of Baricitinib (BARI) in Patients with Active Rheumatoid Arthritis (RA) and Inadequate Response (IR) to Tumour Necrosis Factor inhibitors (TNFi): Summary Results from the 24-week Phase 3 RA-BEACON study

Author

Zamani, Omid, Combe, Bernard, Tony, Hans-Peter, Sanchez Burson, Juan, Tahir, Hasan, Østergaard, Mikkel, Augendre-Ferrante, Beatrice, Beselin, Anke, Larsson, Esbjörn, Casillas, Marta, Smolen, Josef, and Holzkämper, Thorsten

Subjects
ddc: 610, Rheumatoid Arthritis, Clinical Trial Phase III, 610 Medical sciences, Medicine, Protein Kinase Inhibitors
Abstract

Background: BARI, an oral JAK1/JAK2i, was investigated in the ph3 RA-BEACON study. Methods: 527 patients with active RA despite previously using ≥1 TNFi were randomised to placebo (PBO) or BARI (2 or 4mg,QD). Primary endpoint was wk12 ACR20 (BARI 4mg vs PBO). Subgroup efficacy by prior[for full text, please go to the a.m. URL], 44. Kongress der Deutschen Gesellschaft für Rheumatologie (DGRh); 30. Jahrestagung der Deutschen Gesellschaft für Orthopädische Rheumatologie (DGORh); 26. Jahrestagung der Gesellschaft für Kinder- und Jugendrheumatologie (GKJR)

Published
2016
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13. Patient-reported outcomes from a randomised phase III study of baricitinib in patients with rheumatoid arthritis and an inadequate response to biological agents (RA-BEACON)

Author

Bernard Combe, Amy M. DeLozier, Joel M. Kremer, Li Xie, Josef S Smolen, Ivaylo Stoykov, Mark C. Genovese, Terence Rooney, Paul Bird, Juan Sanchez Burson, Douglas E Schlichting, Carol L. Gaich, [Smolen, Josef S.] Med Univ Vienna, Vienna, Austria, [Smolen, Josef S.] Hietzing Hosp, Vienna, Austria, [Kremer, Joel M.] Albany Med Coll, Albany, NY 12208 USA, [Gaich, Carol L.] Eli Lilly & Co, Indianapolis, IN 46285 USA, [DeLozier, Amy M.] Eli Lilly & Co, Indianapolis, IN 46285 USA, [Schlichting, Douglas E.] Eli Lilly & Co, Indianapolis, IN 46285 USA, [Xie, Li] Eli Lilly & Co, Indianapolis, IN 46285 USA, [Stoykov, Ivaylo] Eli Lilly & Co, Indianapolis, IN 46285 USA, [Rooney, Terence] Eli Lilly & Co, Indianapolis, IN 46285 USA, [Bird, Paul] Univ New South Wales, Sydney, NSW, Australia, [Sanchez Burson, Juan Miguel] Valme Univ Hosp, Div Rheumatol, Seville, Spain, [Sanchez Burson, Juan Miguel] Valme Univ Hosp, Div Ophthalmol, Seville, Spain, [Sanchez Burson, Juan Miguel] Valme Univ Hosp, Div Immunol, Seville, Spain, [Genovese, Mark C.] Stanford Univ, Med Ctr, Palo Alto, CA 94304 USA, [Combe, Bernard] Univ Montpellier, Lapeyronie Hosp, Montpellier, France, Eli Lilly and Company, Incyte Corporation, Medizinische Universität Wien = Medical University of Vienna, Albany Medical College, University of New South Wales [Sydney] (UNSW), Valme University Hospital, Stanford University Medical Center, Institut de Génétique Moléculaire de Montpellier (IGMM), Centre National de la Recherche Scientifique (CNRS)-Université de Montpellier (UM), Albany medical college, University of New South Wales [Sydney] ( UNSW ), Institut de Génétique Moléculaire de Montpellier ( IGMM ), and Université de Montpellier ( UM ) -Centre National de la Recherche Scientifique ( CNRS )

Subjects
Baricitinib, [SDV]Life Sciences [q-bio], Arthritis, Efficiency, DMARDs (biologic), Clinical-trials, Logistic regression, Severity of Illness Index, Arthritis, Rheumatoid, 0302 clinical medicine, Surveys and Questionnaires, Immunology and Allergy, 030212 general & internal medicine, Pain Measurement, Sulfonamides, Connective tissue disease, 3. Good health, Outcomes research, Rheumatoid arthritis, DMARDs (synthetic), Adult, medicine.medical_specialty, Immunology, Rheumatoid Arthritis, Placebo, General Biochemistry, Genetics and Molecular Biology, Patient perspective, Abatacept, 03 medical and health sciences, Young Adult, Rheumatology, Double-Blind Method, Internal medicine, Disease-activity, medicine, Improvement, Humans, Necrosis-factor inhibitors, In patient, Patient Reported Outcome Measures, Protein Kinase Inhibitors, 030203 arthritis & rheumatology, [ SDV ] Life Sciences [q-bio], business.industry, Questionnaire, Presenteeism, Clinical and Epidemiological Research, medicine.disease, Methotrexate, Purines, Tofacitinib, Physical therapy, Quality of Life, Azetidines, Pyrazoles, Quality-of-life, Therapy, business
Abstract

Objectives To assess baricitinib on patient-reported outcomes (PROs) in patients with moderately to severely active rheumatoid arthritis, who had insufficient response or intolerance to >= 1 tumour necrosis factor inhibitors (TNFis) or other biological disease-modifying antirheumatic drugs (bDMARDs).Methods In this double-blind phase III study, patients were randomised to once-daily placebo or baricitinib 2 or 4 mg for 24 weeks. PROs included the Short Form36, EuroQol 5-D, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Health Assessment Questionnaire-Disability Index (HAQ-DI), Patient's Global Assessment of Disease Activity (PtGA), patient's assessment of pain, duration of morning joint stiffness (MJS) and Work Productivity and Activity Impairment Questionnaire-Rheumatoid Arthritis. Treatment comparisons were performed with logistic regression for categorical measures or analysis of covariance for continuous variables.Results 527 patients were randomised (placebo, 176; baricitinib 2 mg, 174; baricitinib 4 mg, 177). Both baricitinib-treated groups showed statistically significant improvements versus placebo in most PROs. Improvements were generally more rapid and of greater magnitude for patients receiving baricitinib 4 mg than 2 mg and were maintained to week 24. At week 24, more baricitinib-treated patients versus placebo-treated patients reported normal physical functioning (HAQ-DI = 1 tumour necrosis factor inhibitors (TNFis) or other biological disease-modifying antirheumatic drugs (bDMARDs).Methods In this double-blind phase III study, patients were randomised to once-daily placebo or baricitinib 2 or 4 mg for 24 weeks. PROs included the Short Form36, EuroQol 5-D, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Health Assessment Questionnaire-Disability Index (HAQ-DI), Patient's Global Assessment of Disease Activity (PtGA), patient's assessment of pain, duration of morning joint stiffness (MJS) and Work Productivity and Activity Impairment Questionnaire-Rheumatoid Arthritis. Treatment comparisons were performed with logistic regression for categorical measures or analysis of covariance for continuous variables.Results 527 patients were randomised (placebo, 176; baricitinib 2 mg, 174; baricitinib 4 mg, 177). Both baricitinib-treated groups showed statistically significant improvements versus placebo in most PROs. Improvements were generally more rapid and of greater magnitude for patients receiving baricitinib 4 mg than 2 mg and were maintained to week 24. At week 24, more baricitinib-treated patients versus placebo-treated patients reported normal physical functioning (HAQ-DI = 3.56; p

Published
2017

14. Genetic Analysis with the Immunochip Platform in Behcet Disease. Identification of Residues Associated in the HLA Class I Region and New Susceptibility Loci

Author

Ortiz-Fernández, Lourdes, Carmona, F. David, Montes-Cano, Marco-Antonio, García-Lozano, José-Raúl, Conde-Jaldón, Marta, Ortego-Centeno, Norberto, Castillo, María Jesús, Espinosa, Gerard, Graña, Jenaro, Sánchez-Bursón, Juan, Juliá, María Rosa, Solans, Roser, Blanco, Ricardo, Barnosi-Marín, Ana-Celia, Gómez de la Torre, Ricardo, Fanlo, Patricia, Rodríguez-Carballeira, Mónica, Rodriguez-Rodriguez, Luis, Camps i Miró, Teresa, Castañeda, Santos, Alegre-Sancho, Juan José, Martín, Javier, González-Escribano, María Francisca, Universitat Autònoma de Barcelona, [Ortiz-Fernandez, Lourdes] Hosp Univ Virgen Rocio IBiS CSIC US, Dept Immunol, Seville 41013, Spain, [Montes-Cano, Marco-Antonio] Hosp Univ Virgen Rocio IBiS CSIC US, Dept Immunol, Seville 41013, Spain, [Garcia-Lozano, Jose-Raul] Hosp Univ Virgen Rocio IBiS CSIC US, Dept Immunol, Seville 41013, Spain, [Conde-Jaldon, Marta] Hosp Univ Virgen Rocio IBiS CSIC US, Dept Immunol, Seville 41013, Spain, [Francisca Gonzalez-Escribano, Maria] Hosp Univ Virgen Rocio IBiS CSIC US, Dept Immunol, Seville 41013, Spain, [Carmona, Francisco-David] PTS Granada, CSIC, Inst Parasitol & Biomed Lopez Neyra, Granada 18016, Spain, [Martin, Javier] PTS Granada, CSIC, Inst Parasitol & Biomed Lopez Neyra, Granada 18016, Spain, [Ortego-Centeno, Norberto] Hosp Clin San Cecilio, Dept Internal Med, Granada 18003, Spain, [Jesus Castillo, Maria] Hosp Univ Virgen Rocio, Dept Internal Med, Seville 41003, Spain, [Espinosa, Gerard] Hosp Univ Clin, Dept Autoimmune Dis, Barcelona 08036, Spain, [Grana-Gil, Genaro] Dept Rheumatol, Complejo Hosp Univ A Coruna, La Coruna 15006, Spain, [Sanchez-Burson, Juan] Hosp Univ Valme, Dept Rheumatol, Seville 41014, Spain, [Rosa Julia, Maria] Hosp Univ Son Espases, Dept Immunol, Palma de Mallorca 07120, Spain, [Solans, Roser] Univ Autonoma Barcelona, Hosp Vall Hebron, Autoimmune Syst Dis Unit, Dept Internal Med, Barcelona 08035, Spain, [Blanco, Ricardo] Hosp Univ Marques Valdecilla, Dept Rheumatol, Santander 39008, Spain, [Barnosi-Marin, Ana-Celia] Dept Internal Med, Complejo Hosp Torrecardenas, Almeria 04009, Spain, [Gomez de la Torre, Ricardo] Hosp Univ Cent Asturias, Dept Internal Med, Asturias 33011, Spain, [Fanlo, Patricia] Hosp Virgen Camino, Dept Internal Med, Pamplona 31008, Spain, [Rodriguez-Carballeira, Monica] Hosp Univ Mutua Terrassa, Dept Internal Med, Terrassa 08221, Spain, [Rodriguez-Rodriguez, Luis] Hosp Clin San Carlos, Dept Rheumatol, Madrid 28040, Spain, [Camps, Teresa] Hosp Reg Univ Malaga, Dept Internal Med, Malaga 29010, Spain, [Castaneda, Santos] IIS Princesa, Hosp Princesa, Dept Rheumatol, Madrid 28006, Spain, [Alegre-Sancho, Juan-Jose] Hosp Univ Doctor Peset, Dept Rheumatol, Valencia 46017, Spain, Fondo de Investigaciones Sanitarias, Instituto de Salud Carlos III (ISCIII), Fondos FEDER, Plan Andaluz de Investigacion, ISCIII, RETICS Program (RIER, ISCIII), Instituto de Salud Carlos III, Junta de Andalucía, Red de Investigación en Inflamación y Enfermedades Reumáticas (España), [Ortiz-Fernández,L, Montes-Cano,MA, García-Lozano,JR, Conde-Jaldón,M, González-Escribano,MF] Department of Immunology, Hospital Universitario Virgen del Rocío (IBiS, CSIC, US), Sevilla, Spain. [Carmona,FD, Martín,J] Instituto de Parasitología y Biomedicina 'López-Neyra', CSIC, Granada, Spain. [Ortego-Centeno,N] Department of Internal Medicine, Hospital Clínico San Cecilio, Granada, Spain. [Castillo,MJ] Department of Internal Medicine, Hospital Universitario Virgen del Rocío, Sevilla, Spain. [Espinosa,G] Department Autoimmune Diseases, Hospital Universitari Clínic, Barcelona, Spain. [Graña-Gil,G] Department of Rheumatology, Complejo Hospitalario Universitario A Coruña, A Coruña, Spain. [Sánchez-Bursón,J] Department of Rheumatology, Hospital Universitario de Valme, Sevilla, Spain. [Juliá,MR] Department of Immunology, Hospital Universitari Son Espases, Palma de Mallorca, Spain. [Solans,R] Department of Internal Medicine, Autoimmune Systemic Diseases Unit, Hospital Vall d’Hebron, Universidad Autonoma de Barcelona, Barcelona, Spain. [Blanco,R] Department of Rheumatology, Hospital Universitario Marqués de Valdecilla, Santander, Spain. [Barnosi-Marín,AC] Department of Internal Medicine, Complejo Hospitalario Torrecárdenas, Almería, Spain. [Gómez de la Torre,R] Department of Internal Medicine, Hospital Universitario Central de Asturias, Asturias, Spain. [Fanlo,P] Department of Internal Medicine, Hospital Virgen del Camino, Pamplona, Spain. [Rodríguez-Carballeira,M] Deparment of Internal Medicine, Hospital Universitari Mútua Terrassa, Terrassa, Spain. [Rodríguez-Rodríguez,L] Department of Rheumatology, Hospital Clínico San Carlos, Madrid, Spain. [Camps,T] Department of Internal Medicine, Hospital Regional Universitario de Málaga, Málaga, Spain. [Castañeda,S] Department of Rheumatology, Hospital de la Princesa, IIS-Princesa, Madrid, Spain. [Alegre-Sancho,JJ] Department of Rheumatology, Hospital Universitario Doctor Peset, Valencia, Spain., and This work was supported by Fondo de Investigaciones Sanitarias, Instituto de Salud Carlos III (ISCIII, 13/01118), Fondos FEDER and Plan Andaluz de Investigación (CTS-0197). LOF is the recipient of a fellowship (ISCIII, FI11/00547) and FDC was funded by the RETICS Program (RIER, ISCIII, RD12/0009/0013).

Subjects
alelos, modelos logísticos, Genes clase I del complejo de histocompatibilidad (MHC), España, frecuencia génica, sitios genéticos, lcsh:Science, Diseases::Stomatognathic Diseases::Mouth Diseases::Behcet Syndrome [Medical Subject Headings], Chemicals and Drugs::Amino Acids, Peptides, and Proteins::Proteins::Glycoproteins::Membrane Glycoproteins::Histocompatibility Antigens Class I::HLA-B Antigens [Medical Subject Headings], Geographicals::Geographic Locations::Europe::Spain [Medical Subject Headings], Immunoassay, education.field_of_study, Behcet Syndrome, Genomics, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Statistics as Topic::Models, Statistical::Logistic Models [Medical Subject Headings], Phenomena and Processes::Genetic Phenomena::Genotype [Medical Subject Headings], Mhc class-i, Genotyping, estudios de casos y controles, Locus (genetics), Human leukocyte antigen, subunidad p35 de la interleucina-12, 03 medical and health sciences, Contactins, Rheumatoid-arthritis, Genetics, Genome-Wide Association Studies, Genetic predisposition, Humans, Molecular Biology Techniques, education, Molecular Biology, Chemicals and Drugs::Amino Acids, Peptides, and Proteins::Amino Acids [Medical Subject Headings], síndrome de Behçet, Alleles, Molecular Biology Assays and Analysis Techniques, Sclerosis, lcsh:R, Biology and Life Sciences, Computational Biology, Receptors, Interleukin, 030104 developmental biology, Logistic Models, Genetic Loci, HLA-B Antigens, Case-Control Studies, lcsh:Q, Síndrome de Behçet, Genotipo, Models, Molecular, 0301 basic medicine, humanos, lcsh:Medicine, HLA-A3 Antigen, Genetic analysis, Geographical Locations, Gene Frequency, antígeno HLA-A3, Il23r-il12rb2, Aminoácidos, Multidisciplinary, antígeno HLA-B51, Genome-wide association, Antígenos HLA-B, antígenos HLA-B, Modelos logísticos, Europe, Peptide, Amino Acid Analysis, HLA-B51 Antigen, Alelos, Research Article, Risk, Population, Biology, Research and Analysis Methods, Genetic Predisposition, inmunoanálisis, Interleukin-12 Subunit p35, Genetic Predisposition to Disease, Allele, Allele frequency, Phenomena and Processes::Genetic Phenomena::Genetic Structures::Genome::Genome Components::Genes::Alleles [Medical Subject Headings], Imputation, contactinas, Human Genetics, predisposición genética a la enfermedad, Binding, Genome Analysis, Microarray Analysis, Spain, Genetics of Disease, People and Places, análisis por micromatrices, Phenomena and Processes::Genetic Phenomena::Genetic Structures::Genome::Genome Components::Genes::Major Histocompatibility Complex::Genes, MHC Class I [Medical Subject Headings]
Abstract

Behcet's disease (BD) is an immuno-mediated vasculitis in which knowledge of its etiology and genetic basis is limited. To improve the current knowledge, a genetic analysis performed with the Immunochip platform was carried out in a population from Spain. A discovery cohort comprising 278 BD cases and 1,517 unaffected controls were genotyped using the Immunochip platform. The validation step was performed on an independent replication cohort composed of 130 BD cases and 600 additional controls. The strongest association signals were observed in the HLA class I region, being HLA-B*51 the highest peak (overall P = 6.82E-32, OR = 3.82). A step-wise conditional logistic regression with classical alleles identified HLA-B*57 and HLA-A*03 as additional independent markers. The amino acid model that best explained the association, includes the position 97 of the HLA-B molecule and the position 66 of the HLA-A. Among the non-HLA loci, the most significant in the discovery analysis were: IL23R (rs10889664: P = 3.81E-12, OR = 2.00), the JRKL/CNTN5 region (rs2848479: P = 5.00E-08, OR = 1.68) and IL12A (rs1874886: P = 6.67E-08, OR = 1.72), which were confirmed in the validation phase (JRKL/CNTN5 rs2848479: P = 3.29E-10, OR = 1.66; IL12A rs1874886: P = 1.62E-08, OR = 1.61). Our results confirm HLA-B*51 as a primary-association marker in predisposition to BD and suggest additional independent signals within the class I region, specifically in the genes HLA-A and HLA-B. Regarding the non-HLA genes, in addition to IL-23R, previously reported in our population; IL12A, described in other populations, was found to be a BD susceptibility factor also in Spaniards; finally, a new associated locus was found in the JRKL/CNTN5 region., This work was supported by Fondo de Investigaciones Sanitarias, Instituto de Salud Carlos III (ISCIII, 13/01118), Fondos FEDER and Plan Andaluz de Investigación (CTS-0197). LOF is the recipient of a fellowship (ISCIII, FI11/00547) and FDC was funded by the RETICS Program (RIER, ISCIII, RD12/0009/0013). Instituto de Salud Carlos III Junta de Andalucía Red de Investigación en Inflamación y Enfermedades Reumáticas (España) RIER

Published
2016

15. Efficacy and Safety of Ixekizumab in the Treatment of Radiographic Axial Spondyloarthritis: Sixteen-Week Results From a Phase III Randomized, Double-Blind, Placebo-Controlled Trial in Patients With Prior Inadequate Response to or Intolerance of Tumor Necrosis Factor Inhibitors.

Author

Deodhar A, Poddubnyy D, Pacheco-Tena C, Salvarani C, Lespessailles E, Rahman P, Järvinen P, Sanchez-Burson J, Gaffney K, Lee EB, Krishnan E, Santisteban S, Li X, Zhao F, Carlier H, and Reveille JD

Subjects
Adult, Axis, Cervical Vertebra diagnostic imaging, Double-Blind Method, Female, Humans, Male, Middle Aged, Quality of Life, Radiography, Spine diagnostic imaging, Spondylarthritis diagnostic imaging, Treatment Outcome, Tumor Necrosis Factor Inhibitors therapeutic use, Antibodies, Monoclonal, Humanized therapeutic use, Antirheumatic Agents therapeutic use, Spondylarthritis drug therapy
Abstract

Objective: To investigate the efficacy and safety of ixekizumab in patients with active radiographic axial spondyloarthritis (SpA) and prior inadequate response to or intolerance of 1 or 2 tumor necrosis factor inhibitors (TNFi)., Methods: In this phase III randomized, double-blind, placebo-controlled trial, adult patients with an inadequate response to or intolerance of 1 or 2 TNFi and an established diagnosis of axial SpA (according to the Assessment of SpondyloArthritis international Society [ASAS] criteria for radiographic axial SpA, with radiographic sacroiliitis defined according to the modified New York criteria and ≥1 feature of SpA) were recruited and randomized 1:1:1 to receive placebo or 80-mg subcutaneous ixekizumab every 2 weeks (IXEQ2W) or 4 weeks (IXEQ4W), with an 80-mg or 160-mg starting dose. The primary end point was 40% improvement in disease activity according to the ASAS criteria (ASAS40) at week 16. Secondary outcomes and safety were also assessed., Results: A total of 316 patients were randomized to receive placebo (n = 104), IXEQ2W (n = 98), or IXEQ4W (n = 114). At week 16, significantly higher proportions of IXEQ2W patients (n = 30 [30.6%]; P = 0.003) or IXEQ4W patients (n = 29 [25.4%]; P = 0.017) had achieved an ASAS40 response versus the placebo group (n = 13 [12.5%]), with statistically significant differences reported as early as week 1 with ixekizumab treatment. Statistically significant improvements in disease activity, function, quality of life, and spinal magnetic resonance imaging-evident inflammation were observed after 16 weeks of ixekizumab treatment versus placebo. Treatment-emergent adverse events (AEs) with ixekizumab treatment were more frequent than with placebo. Serious AEs were similar across treatment arms. One death was reported (IXEQ2W group)., Conclusion: Ixekizumab treatment for 16 weeks in patients with active radiographic axial SpA and previous inadequate response to or intolerance of 1 or 2 TNFi yields rapid and significant improvements in the signs and symptoms of radiographic axial SpA versus placebo., (© 2018 The Authors. Arthritis & Rheumatology published by Wiley Periodicals, Inc. on behalf of American College of Rheumatology.)

Published
2019
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