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1. Ixekizumab for patients with non-radiographic axial spondyloarthritis (COAST-X): a randomised, placebo-controlled trial

Author

Morin, Frederic, Rahman, Proton, Ariel, Federico, Berman, Alberto, Carrio, Judith, Lucero, Eleonora, Cocco, Jose Maldonado, Hidalgo, Rodolfo Pardo, Velasco, Jorge, Viola, Diego O., Grisar, Johannes, Resch, Heinrich, Scheinecker, Clemens, Melazzi, Ana Claudia, Roimicher, Luis, Scotton, Antonio Scafuto, Rodriguez, Aaron Alejandro Barrera, Molina, Francisco Fidencio Cons, Barragan, Sergio Duran, Skinner, Cassandra M., Tena, Cesar Francisco Pacheco, Remus, Cesar Ricardo Ramos, Rodriguez, Juan Cruz Rizo, Hong, Seung-Jae, Kang, Seong Wook, Lee, Chang Keun, Lee, Eun Bong, Lee, Sang Heon, Park, Min-Chan, Lee, Sang-Hoon, Dokoupilova, Eva, Dvorak, Zdenek, Malcova, Martina, Pvelka, Karel, Eklund, Kari K., Jarvinen, Pentti, Karjalainen, Anna, Paimela, Leena, Taniguchi, Yoshinori, Tsuda, Tokutaro, Tada, Kurisu, Dobashi, Hiroaki, Inui, Kentaro, Ueki, Yukitaka, Matsumoto, Yoshifuji, Hatta, Kazuhiro, Atsumi, Tatsuya, Goto, Hitoshi, Honjo, Shigeru, Matsui, Kiyoshi, Takakubo, Yuya, Neeck, Gunther, Wagner, Sylke, Braun, Jürgen, Blicharshi, Tomasz, Dudek, Anna, Hrycai, Pawel, Plebanski, Rafal, Drabiszcak-Piatkowska, Janina, Brzezicki, Jan, Krogulec, Marek, Opris-Belinski, Daniela, Ramazan, Ana Maria, Tronaru, Luminita, van de Sande, Marleen G., Matsievskaya, Galina, Schmidt, Evgeniya, Stanislav, Marina, Yakushin, Sergey, Ershova, Olga, Rebroy, Andrey, Churchill, Melvin A., Flint, Kathleen P., Greenwald, Maria, Howell, Mary P., Kaine, Jeffrey L., Kivitz, Alan, Klein, Steven J., Mueller, Eric C., Peters, Eric A., Querubin, Roel, Sayers, Michael E., Scoville, Craig D., Shanahan, Joseph C., Roseff, Richard, Hull, John E., Mallepalli, Jyothi R., Sebai, Mohamed B., Kimmel, Steven C., Goddard, David H., Mease, Philip J., Harris, Mark D., Mabaquiao, Arthur R., Diegel, Roger J., Thai, Christine, Rivera, Tania L., Perez-De Jesus, Amarilis, Soto-Raices, Oscar, Toro-Torres, Ramon, Pantojas, Carlos, Deodhar, Atul, van der Heijde, Désirée, Gensler, Lianne S, Kim, Tae-Hwan, Maksymowych, Walter P, Østergaard, Mikkel, Poddubnyy, Denis, Marzo-Ortega, Helena, Bessette, Louis, Tomita, Tetsuya, Leung, Ann, Hojnik, Maja, Gallo, Gaia, Li, Xiaoqi, Adams, David, Carlier, Hilde, and Sieper, Joachim

Published
2020
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2. Ixekizumab for patients with non-radiographic axial spondyloarthritis (COAST-X):a randomised, placebo-controlled trial

Author

Deodhar, Atul, van der Heijde, Désirée, Gensler, Lianne S., Kim, Tae Hwan, Maksymowych, Walter P., Østergaard, Mikkel, Poddubnyy, Denis, Marzo-Ortega, Helena, Bessette, Louis, Tomita, Tetsuya, Leung, Ann, Hojnik, Maja, Gallo, Gaia, Li, Xiaoqi, Adams, David, Carlier, Hilde, Sieper, Joachim, Morin, Frederic, Rahman, Proton, Ariel, Federico, Berman, Alberto, Carrio, Judith, Lucero, Eleonora, Cocco, Jose Maldonado, Hidalgo, Rodolfo Pardo, Velasco, Jorge, Viola, Diego O., Grisar, Johannes, Resch, Heinrich, Scheinecker, Clemens, Melazzi, Ana Claudia, Roimicher, Luis, Scotton, Antonio Scafuto, Rodriguez, Aaron Alejandro Barrera, Molina, Francisco Fidencio Cons, Barragan, Sergio Duran, Skinner, Cassandra M., Tena, Cesar Francisco Pacheco, Remus, Cesar Ricardo Ramos, Rodriguez, Juan Cruz Rizo, Hong, Seung Jae, Kang, Seong Wook, Lee, Chang Keun, Lee, Eun Bong, Lee, Sang Heon, Park, Min Chan, Lee, Sang Hoon, Dokoupilova, Eva, Dvorak, Zdenek, Malcova, Martina, Deodhar, Atul, van der Heijde, Désirée, Gensler, Lianne S., Kim, Tae Hwan, Maksymowych, Walter P., Østergaard, Mikkel, Poddubnyy, Denis, Marzo-Ortega, Helena, Bessette, Louis, Tomita, Tetsuya, Leung, Ann, Hojnik, Maja, Gallo, Gaia, Li, Xiaoqi, Adams, David, Carlier, Hilde, Sieper, Joachim, Morin, Frederic, Rahman, Proton, Ariel, Federico, Berman, Alberto, Carrio, Judith, Lucero, Eleonora, Cocco, Jose Maldonado, Hidalgo, Rodolfo Pardo, Velasco, Jorge, Viola, Diego O., Grisar, Johannes, Resch, Heinrich, Scheinecker, Clemens, Melazzi, Ana Claudia, Roimicher, Luis, Scotton, Antonio Scafuto, Rodriguez, Aaron Alejandro Barrera, Molina, Francisco Fidencio Cons, Barragan, Sergio Duran, Skinner, Cassandra M., Tena, Cesar Francisco Pacheco, Remus, Cesar Ricardo Ramos, Rodriguez, Juan Cruz Rizo, Hong, Seung Jae, Kang, Seong Wook, Lee, Chang Keun, Lee, Eun Bong, Lee, Sang Heon, Park, Min Chan, Lee, Sang Hoon, Dokoupilova, Eva, Dvorak, Zdenek, and Malcova, Martina

Abstract

Background: Ixekizumab, a high-affinity interleukin-17A (IL-17A) monoclonal antibody, has previously shown efficacy in radiographic axial spondyloarthritis (also known as ankylosing spondylitis). We aimed to evaluate the efficacy and safety of ixekizumab, an IL-17 inhibitor, in non-radiographic axial spondyloarthritis. Here, we report the primary results of COAST-X. Methods: COAST-X was a 52-week, randomised, double-blind, placebo-controlled, parallel-group study done at 107 sites in 15 countries in Europe, Asia, North America, and South America. Eligible participants were adults (aged ≥18 years) with active axial spondyloarthritis without definite radiographic sacroiliitis (non-radiographic axial spondyloarthritis), objective signs of inflammation (via MRI or C-reactive protein), and an inadequate response or intolerance to non-steroidal anti-inflammatory drugs (NSAIDs). Patients were randomly assigned (1:1:1) to receive subcutaneous 80 mg ixekizumab every 4 weeks (Q4W) or every 2 weeks (Q2W), or placebo. Changing background medications or switching to open-label ixekizumab Q2W, or both, was allowed after week 16 at investigator discretion. Primary endpoints were Assessment of SpondyloArthritis international Society-40 (ASAS40) response (defined as an improvement of 40% or more and an absolute improvement from baseline of 2 units or more [range 0–10] in at least three of the four domains [patient global, spinal pain, function, and inflammation] without any worsening in the remaining one domain) at weeks 16 and 52. Patients who switched to open-label ixekizumab were imputed as non-responders in logistic regression analysis. This trial is registered with ClinicalTrials.gov, number NCT02757352. Findings: Between Aug 2, 2016, and Jan 29, 2018, 303 patients were enrolled (105 to placebo, 96 to ixekizumab Q4W, and 102 to ixekizumab Q2W). Both primary endpoints were met: ASAS40 at week 16 (ixekizumab Q4W: 34 [35%] of 96, p=0·0094 vs placebo; ixekizumab Q2W: 41 [40%] of

Published
2020

3. 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
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4. Ixekizumab for patients with non-radiographic axial spondyloarthritis (COAST-X): a randomised, placebo-controlled trial

Author

Deodhar, Atul, primary, van der Heijde, Désirée, additional, Gensler, Lianne S, additional, Kim, Tae-Hwan, additional, Maksymowych, Walter P, additional, Østergaard, Mikkel, additional, Poddubnyy, Denis, additional, Marzo-Ortega, Helena, additional, Bessette, Louis, additional, Tomita, Tetsuya, additional, Leung, Ann, additional, Hojnik, Maja, additional, Gallo, Gaia, additional, Li, Xiaoqi, additional, Adams, David, additional, Carlier, Hilde, additional, Sieper, Joachim, additional, Morin, Frederic, additional, Rahman, Proton, additional, Ariel, Federico, additional, Berman, Alberto, additional, Carrio, Judith, additional, Lucero, Eleonora, additional, Cocco, Jose Maldonado, additional, Hidalgo, Rodolfo Pardo, additional, Velasco, Jorge, additional, Viola, Diego O., additional, Grisar, Johannes, additional, Resch, Heinrich, additional, Scheinecker, Clemens, additional, Melazzi, Ana Claudia, additional, Roimicher, Luis, additional, Scotton, Antonio Scafuto, additional, Rodriguez, Aaron Alejandro Barrera, additional, Molina, Francisco Fidencio Cons, additional, Barragan, Sergio Duran, additional, Skinner, Cassandra M., additional, Tena, Cesar Francisco Pacheco, additional, Remus, Cesar Ricardo Ramos, additional, Rodriguez, Juan Cruz Rizo, additional, Hong, Seung-Jae, additional, Kang, Seong Wook, additional, Lee, Chang Keun, additional, Lee, Eun Bong, additional, Lee, Sang Heon, additional, Park, Min-Chan, additional, Lee, Sang-Hoon, additional, Dokoupilova, Eva, additional, Dvorak, Zdenek, additional, Malcova, Martina, additional, Pvelka, Karel, additional, Eklund, Kari K., additional, Jarvinen, Pentti, additional, Karjalainen, Anna, additional, Paimela, Leena, additional, Taniguchi, Yoshinori, additional, Tsuda, Tokutaro, additional, Tada, Kurisu, additional, Dobashi, Hiroaki, additional, Inui, Kentaro, additional, Ueki, Yukitaka, additional, Matsumoto, Yoshifuji, additional, Hatta, Kazuhiro, additional, Atsumi, Tatsuya, additional, Goto, Hitoshi, additional, Honjo, Shigeru, additional, Matsui, Kiyoshi, additional, Takakubo, Yuya, additional, Neeck, Gunther, additional, Wagner, Sylke, additional, Braun, Jürgen, additional, Blicharshi, Tomasz, additional, Dudek, Anna, additional, Hrycai, Pawel, additional, Plebanski, Rafal, additional, Drabiszcak-Piatkowska, Janina, additional, Brzezicki, Jan, additional, Krogulec, Marek, additional, Opris-Belinski, Daniela, additional, Ramazan, Ana Maria, additional, Tronaru, Luminita, additional, van de Sande, Marleen G., additional, Matsievskaya, Galina, additional, Schmidt, Evgeniya, additional, Stanislav, Marina, additional, Yakushin, Sergey, additional, Ershova, Olga, additional, Rebroy, Andrey, additional, Churchill, Melvin A., additional, Flint, Kathleen P., additional, Greenwald, Maria, additional, Howell, Mary P., additional, Kaine, Jeffrey L., additional, Kivitz, Alan, additional, Klein, Steven J., additional, Mueller, Eric C., additional, Peters, Eric A., additional, Querubin, Roel, additional, Sayers, Michael E., additional, Scoville, Craig D., additional, Shanahan, Joseph C., additional, Roseff, Richard, additional, Hull, John E., additional, Mallepalli, Jyothi R., additional, Sebai, Mohamed B., additional, Kimmel, Steven C., additional, Goddard, David H., additional, Mease, Philip J., additional, Harris, Mark D., additional, Mabaquiao, Arthur R., additional, Diegel, Roger J., additional, Thai, Christine, additional, Rivera, Tania L., additional, Perez-De Jesus, Amarilis, additional, Soto-Raices, Oscar, additional, Toro-Torres, Ramon, additional, and Pantojas, Carlos, additional

Published
2020
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5. AB1259 EVALUATION OF ENALAPRIL ON ARTERIAL STIFFNESS IN RHEUMATOID ARTHRITIS IN A RANDOMISED CLINICAL TRIAL

Author

Perez-Vazquez, Felipe, primary, Barragan, Sergio Duran, additional, Gomez-Bañuelos, Eduardo, additional, Avila, Efrain Chavarria, additional, Becerra, Carlos Ramos, additional, Diaz-Rubio, Gustavo-Ignacio, additional, Salazar-Paramo, Mario, additional, Páez, Fernando Grover, additional, Nava-Zavala, Arnulfo Hernán, additional, Cardona-Muñoz, Ernesto G., additional, Müller, David Cardona, additional, Navarro-Hernández, Rosa E., additional, Mera-Riofrio, Valeria-Nicole, additional, Prado-Bachega, Natalia, additional, and Vazquez-Del-Mercado, Monica, additional

Published
2019
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