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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. 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
Full Text
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