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1. Tocilizumab in systemic sclerosis: a randomised, double-blind, placebo-controlled, phase 3 trial

Author

Lucero, Eleonora, Pons-Estel, Bernardo, Rivero, Mariano, Tate, Guillermo, Smith, Vanessa, De Langhe, Ellen, Rashkov, Rasho, Batalov, Anastas, Goranov, Ivan, Stoilov, Rumen, Dunne, James, Johnson, Sindhu R., Pope, Janet E., Martinović Kaliterna, Dušanka, Mogensen, Mette, Olesen, Anne Braae, Allanore, Yannick, Henes, Joerg Christoph, Müller-Ladner, Ulf, Riemekasten, Gabriela, Skapenko, Alla, Vlachoyiannopoulos, Panayiotis, Kiss, Emese, Minier, Tünde, Beretta, Lorenzo, Gremese, Elisa, Matucci-Cerinic, Marco, Valentini, Gabriele, Asano, Yoshihide, Atsumi, Tatsuya, Ihn, Hironobu, Ishii, Tomonori, Ishikawa, Osamu, Kuwana, Masataka, Shima, Yoshihito, Takahashi, Hiroki, Takehara, Kazuhiko, Tanaka, Yoshiya, Yamasaki, Yoshioki, Bukauskiene, Loreta, Butrimiene, Irena, Medrano Ramirez, Gabriel, Ramos-Remus, Cesar, Sofia Rodriguez Reyna, Tatiana, de Vries-Bouwstra, Jeska, van Laar, Jacob M., Batko, Bogdan, Jeka, Slawomir, Kucharz, Eugeniusz, Majdan, Maria, Olesinska, Marzena, Smolenska, Zaneta, Alves, Jose, Santos, Maria, Mihai, Carmen Marina, Rednic, Simona, Castellvi Barranco, Ivan, Lopez Longo, Francisco Javier, Simeon Aznar, Carmen, Carreira, Patricia, Distler, Oliver, Walker, Ulrich A., Derrett-Smith, Emma, Griffiths, Bridget, McKay, Neil, Denton, Christopher P., Aelion, Jacob, Borofsky, Michael, Fleischmann, Roy, Forstot, Joseph Z., Furst, Daniel E., Kafaja, Suzanne, Khan, M. Faisal, Khanna, Dinesh, Kohen, Michael D., Martin, Richard W., Mendoza-Ballesteros, Fabian, Nami, Alireza, Pang, Shirley, Rios, Grissel, Simms, Robert, Sullivan, Keith Michael, Steen, Virginia D., Lin, Celia J F, Furst, Daniel E, Goldin, Jonathan, Kim, Grace, van Laar, Jacob M, Spotswood, Helen, Wagner, Bridget, Siegel, Jeffrey, Jahreis, Angelika, and Denton, Christopher P

Published
2020
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2. 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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3. Validation and adaptation of the Spanish version of the systemic lupus activity questionnaire (S-SLAQ) in an Argentinean population

Author

Catoggio, Cecilia, primary, Martínez Muñoz, Alejandro, additional, Chaparro del Moral, Rafael, additional, Klajn, Diana S, additional, Papasidero, Silvia B, additional, Machado Escobar, Maximiliano A, additional, Gonzalez Lucero, Luciana, additional, Lucero, Eleonora, additional, Martinez, Liliana, additional, Muñoz, Sebastian A, additional, Collado, María Victoria, additional, Gomez, Graciela N, additional, Sarano, Judith, additional, Marin, Josefina, additional, Scolnik, Marina, additional, Romero, Julia, additional, Barreira, Juan Carlos, additional, Zalazar, Maria M, additional, Rillo, Oscar L, additional, and Pisoni, Cecilia, additional

Published
2021
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5. Tocilizumab in systemic sclerosis: a randomised, double-blind, placebo-controlled, phase 3 trial

Author

Khanna, Dinesh, primary, Lin, Celia J F, additional, Furst, Daniel E, additional, Goldin, Jonathan, additional, Kim, Grace, additional, Kuwana, Masataka, additional, Allanore, Yannick, additional, Matucci-Cerinic, Marco, additional, Distler, Oliver, additional, Shima, Yoshihito, additional, van Laar, Jacob M, additional, Spotswood, Helen, additional, Wagner, Bridget, additional, Siegel, Jeffrey, additional, Jahreis, Angelika, additional, Denton, Christopher P, additional, Lucero, Eleonora, additional, Pons-Estel, Bernardo, additional, Rivero, Mariano, additional, Tate, Guillermo, additional, Smith, Vanessa, additional, De Langhe, Ellen, additional, Rashkov, Rasho, additional, Batalov, Anastas, additional, Goranov, Ivan, additional, Stoilov, Rumen, additional, Dunne, James, additional, Johnson, Sindhu R., additional, Pope, Janet E., additional, Martinović Kaliterna, Dušanka, additional, Mogensen, Mette, additional, Olesen, Anne Braae, additional, Henes, Joerg Christoph, additional, Müller-Ladner, Ulf, additional, Riemekasten, Gabriela, additional, Skapenko, Alla, additional, Vlachoyiannopoulos, Panayiotis, additional, Kiss, Emese, additional, Minier, Tünde, additional, Beretta, Lorenzo, additional, Gremese, Elisa, additional, Valentini, Gabriele, additional, Asano, Yoshihide, additional, Atsumi, Tatsuya, additional, Ihn, Hironobu, additional, Ishii, Tomonori, additional, Ishikawa, Osamu, additional, Takahashi, Hiroki, additional, Takehara, Kazuhiko, additional, Tanaka, Yoshiya, additional, Yamasaki, Yoshioki, additional, Bukauskiene, Loreta, additional, Butrimiene, Irena, additional, Medrano Ramirez, Gabriel, additional, Ramos-Remus, Cesar, additional, Sofia Rodriguez Reyna, Tatiana, additional, de Vries-Bouwstra, Jeska, additional, van Laar, Jacob M., additional, Batko, Bogdan, additional, Jeka, Slawomir, additional, Kucharz, Eugeniusz, additional, Majdan, Maria, additional, Olesinska, Marzena, additional, Smolenska, Zaneta, additional, Alves, Jose, additional, Santos, Maria, additional, Mihai, Carmen Marina, additional, Rednic, Simona, additional, Castellvi Barranco, Ivan, additional, Lopez Longo, Francisco Javier, additional, Simeon Aznar, Carmen, additional, Carreira, Patricia, additional, Walker, Ulrich A., additional, Derrett-Smith, Emma, additional, Griffiths, Bridget, additional, McKay, Neil, additional, Denton, Christopher P., additional, Aelion, Jacob, additional, Borofsky, Michael, additional, Fleischmann, Roy, additional, Forstot, Joseph Z., additional, Furst, Daniel E., additional, Kafaja, Suzanne, additional, Khan, M. Faisal, additional, Khanna, Dinesh, additional, Kohen, Michael D., additional, Martin, Richard W., additional, Mendoza-Ballesteros, Fabian, additional, Nami, Alireza, additional, Pang, Shirley, additional, Rios, Grissel, additional, Simms, Robert, additional, Sullivan, Keith Michael, additional, and Steen, Virginia D., additional

Published
2020
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6. Prevalence and incidence of systemic lupus erythematosus in Tucumán, Argentina

Author

Gonzalez Lucero, Luciana, primary, Barbaglia, Ana L, additional, Bellomio, Verónica I, additional, Bertolaccini, Maria C, additional, Machado Escobar, Maximiliano A, additional, Sueldo, Hector R, additional, Yacuzzi, Maria S, additional, Carrizo, Gustavo A, additional, Robles, Norma, additional, Rengel, Silvia, additional, Cristofari, Alexia, additional, Leal, Maria O, additional, Vasquez, Doralia L, additional, Quinteros, Ana, additional, Seleme, Gladys, additional, Molina, Maria J, additional, Pera, Oscar L, additional, Dip, Rodolfo, additional, Olea, Ana C, additional, Torres, Alberto Y, additional, Espindola Echazu, Mariana, additional, Arquez, Gustavo, additional, Lazaro, Hector, additional, Colombres, Francisco, additional, Juarez, Laura A, additional, Romano, Olga, additional, Paz, Silvia, additional, Santana, Mirta, additional, Galindo, Liliana, additional, and Lucero, Eleonora, additional

Published
2020
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7. Factors Associated With Disability in Patients With Rheumatoid Arthritis

Author

Schneeberger, Emilce E., Citera, Gustavo, Maldonado Cocco, José A., Salcedo, Mariana, Chiardola, Flavia, Rosemffet, Marcos G., Marengo, María F., Papasidero, Silvia, Chaparro del Moral, Rafael, Rillo, Oscar L., Bellomio, Verónica, Lucero, Eleonora, Spindler, Alberto, Berman, Alberto, Duartes Noe, Damian, Barreira, Juan C., Lázaro, María A., and Paira, Sergio O.

Published
2010
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8. Tocilizumab in systemic sclerosis:a randomised, double-blind, placebo-controlled, phase 3 trial

Author

Khanna, Dinesh, Lin, Celia J.F., Furst, Daniel E., Goldin, Jonathan, Kim, Grace, Kuwana, Masataka, Allanore, Yannick, Matucci-Cerinic, Marco, Distler, Oliver, Shima, Yoshihito, van Laar, Jacob M., Spotswood, Helen, Wagner, Bridget, Siegel, Jeffrey, Jahreis, Angelika, Denton, Christopher P., Lucero, Eleonora, Pons-Estel, Bernardo, Rivero, Mariano, Tate, Guillermo, Smith, Vanessa, De Langhe, Ellen, Rashkov, Rasho, Batalov, Anastas, Goranov, Ivan, Stoilov, Rumen, Dunne, James, Johnson, Sindhu R., Pope, Janet E., Martinović Kaliterna, Dušanka, Mogensen, Mette, Olesen, Anne Braae, Henes, Joerg Christoph, Müller-Ladner, Ulf, Riemekasten, Gabriela, Skapenko, Alla, Vlachoyiannopoulos, Panayiotis, Kiss, Emese, Minier, Tünde, Beretta, Lorenzo, Gremese, Elisa, Valentini, Gabriele, Asano, Yoshihide, Atsumi, Tatsuya, Ihn, Hironobu, Ishii, Tomonori, Ishikawa, Osamu, Takahashi, Hiroki, Takehara, Kazuhiko, Tanaka, Yoshiya, Yamasaki, Yoshioki, Bukauskiene, Loreta, Butrimiene, Irena, Medrano Ramirez, Gabriel, Ramos-Remus, Cesar, Sofia Rodriguez Reyna, Tatiana, de Vries-Bouwstra, Jeska, Batko, Bogdan, Jeka, Slawomir, Kucharz, Eugeniusz, Majdan, Maria, Olesinska, Marzena, Smolenska, Zaneta, Alves, Jose, Santos, Maria, Mihai, Carmen Marina, Rednic, Simona, Castellvi Barranco, Ivan, Lopez Longo, Francisco Javier, Simeon Aznar, Carmen, Carreira, Patricia, Walker, Ulrich A., Derrett-Smith, Emma, Griffiths, Bridget, McKay, Neil, Aelion, Jacob, Borofsky, Michael, Fleischmann, Roy, Forstot, Joseph Z., Kafaja, Suzanne, Khan, M. Faisal, Kohen, Michael D., Martin, Richard W., Mendoza-Ballesteros, Fabian, Nami, Alireza, Pang, Shirley, Rios, Grissel, Simms, Robert, Sullivan, Keith Michael, Steen, Virginia D., Khanna, Dinesh, Lin, Celia J.F., Furst, Daniel E., Goldin, Jonathan, Kim, Grace, Kuwana, Masataka, Allanore, Yannick, Matucci-Cerinic, Marco, Distler, Oliver, Shima, Yoshihito, van Laar, Jacob M., Spotswood, Helen, Wagner, Bridget, Siegel, Jeffrey, Jahreis, Angelika, Denton, Christopher P., Lucero, Eleonora, Pons-Estel, Bernardo, Rivero, Mariano, Tate, Guillermo, Smith, Vanessa, De Langhe, Ellen, Rashkov, Rasho, Batalov, Anastas, Goranov, Ivan, Stoilov, Rumen, Dunne, James, Johnson, Sindhu R., Pope, Janet E., Martinović Kaliterna, Dušanka, Mogensen, Mette, Olesen, Anne Braae, Henes, Joerg Christoph, Müller-Ladner, Ulf, Riemekasten, Gabriela, Skapenko, Alla, Vlachoyiannopoulos, Panayiotis, Kiss, Emese, Minier, Tünde, Beretta, Lorenzo, Gremese, Elisa, Valentini, Gabriele, Asano, Yoshihide, Atsumi, Tatsuya, Ihn, Hironobu, Ishii, Tomonori, Ishikawa, Osamu, Takahashi, Hiroki, Takehara, Kazuhiko, Tanaka, Yoshiya, Yamasaki, Yoshioki, Bukauskiene, Loreta, Butrimiene, Irena, Medrano Ramirez, Gabriel, Ramos-Remus, Cesar, Sofia Rodriguez Reyna, Tatiana, de Vries-Bouwstra, Jeska, Batko, Bogdan, Jeka, Slawomir, Kucharz, Eugeniusz, Majdan, Maria, Olesinska, Marzena, Smolenska, Zaneta, Alves, Jose, Santos, Maria, Mihai, Carmen Marina, Rednic, Simona, Castellvi Barranco, Ivan, Lopez Longo, Francisco Javier, Simeon Aznar, Carmen, Carreira, Patricia, Walker, Ulrich A., Derrett-Smith, Emma, Griffiths, Bridget, McKay, Neil, Aelion, Jacob, Borofsky, Michael, Fleischmann, Roy, Forstot, Joseph Z., Kafaja, Suzanne, Khan, M. Faisal, Kohen, Michael D., Martin, Richard W., Mendoza-Ballesteros, Fabian, Nami, Alireza, Pang, Shirley, Rios, Grissel, Simms, Robert, Sullivan, Keith Michael, and Steen, Virginia D.

Abstract

Background: A phase 2 trial of tocilizumab showed preliminary evidence of efficacy in systemic sclerosis. We assessed skin fibrosis and systemic sclerosis-associated interstitial lung disease (SSc-ILD) in a phase 3 trial to investigate the safety and efficacy of tocilizumab, an anti-interleukin-6 receptor antibody, in the treatment of systemic sclerosis. Methods: In this multicentre, randomised, double-blind, placebo-controlled, phase 3 trial, participants were recruited from 75 sites in 20 countries across Europe, North America, Latin America, and Japan. Adults with diffuse cutaneous systemic sclerosis for 60 months or less and a modified Rodnan skin score (mRSS) of 10–35 at screening were randomly assigned (1:1) with a voice-web-response system to receive subcutaneous tocilizumab 162 mg or placebo weekly for 48 weeks, stratified by IL-6 levels; participants and investigators were masked to treatment group. The primary endpoint was the difference in change from baseline to week 48 in mRSS. Percentage of predicted forced vital capacity (FVC% predicted) at week 48, time to treatment failure, and patient-reported and physician-reported outcomes were secondary endpoints. This trial is registered with ClinicalTrials.gov (number NCT02453256) and is closed to accrual. Findings: Between Nov 20, 2015, and Feb 14, 2017, 210 individuals were randomly assigned to receive tocilizumab (n=104) or placebo (n=106). In the intention-to-treat population, least squares mean [LSM] change from baseline to week 48 in mRSS was −6·14 for tocilizumab and −4·41 for placebo (adjusted difference −1·73 [95% CI −3·78 to 0·32]; p=0·10). The shift in distribution of change from baseline in FVC% predicted at week 48 favoured tocilizumab (van Elteren nominal p=0·002 vs placebo), with a difference in LSM of 4·2 (95% CI 2·0–6·4; nominal p=0·0002), as did time to treatment failure (hazard ratio 0·63 [95% CI 0·37–1·06]; nominal p=0·08). Change in LSM from baseline to week 48 in Health Assessment Ques

Published
2020

9. 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

11. 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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12. 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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13. ACTIVE THERAPEUTIC IMMUNIZATION WITH TNF-KINOID IN RHEUMATOID ARTHRITIS PATIENTS WITH SECONDARY RESISTANCE TO TNFα ANTAGONISTS IS SAFE AND IMMUNOGENIC

Author

Durez, Patrick, Miranda, Pedro, Toncheva, Antoaneta, Berman, Alberto, Rillo, Oscar Luis, Boutsen, Yves, Kehler, Tatjana, Mociran, Eugenia, Soto, Saez Lian, Fautrel, Bruno, Mariette, Xavier, Solakov, Panayot, Lucero, Eleonora, Vlak, Tonko, Grazio, Simeon, Maštrović, Ksenija, Chirieac, Rodica, and Boissier, Marie- Christophe

Subjects
rheumatoid arthritis, TNF alfa
Abstract

Background: Blocking TNF alpha (TNFα) with monoclonal antibodies (mAbs) has been successful in the treatment of rheumatoid arthritis. However primary and secondary resistances are frequent and impose treatment changes. Active immunization with a TNF-Kinoid that safely induces self polyclonal anti-TNFα antibodies (Abs) could be an alternative to anti-TNFα mAbs Objectives: We evaluated the immunogenicity and safety of TNF-K in patients with rheumatoid arthritis and secondary resistance to TNF blockers. Methods: TNFα-Kinoid (TNF-K, Neovacs SA, Paris, France) is an im- munotherapeutic composed of recombinant human TNFα conjugated to KLH, inactivated and adjuvanted with ISA-51 emulsion. 40 patients with active rheumatoid arthritis (DAS28≥3.2) with history of positive clinical response to TNF- blockers followed by secondary failure (35% IFX, 30% ADA, 42.5% ETA) were enrolled in a double-blind, placebo-controlled, phase 2 study to evaluate three different intramuscular doses of TNF-K (90, 180, 360 mcg) and two immunization schedules (D0 and 28 or D0, 7 and 28). Immune responses were evaluated through titration of anti-TNFα and anti-KLH Abs. Clinical response was evaluated by the ACR and EULAR core set response. Results: No related serious adverse event has been reported. Few minor transient local and systemic reactions have been recorded following immu- nization. Anti-TNFα Abs were induced in 50%, 75% and 91% of patients at 90 mcg, 180 mcg and 360 mcg, respectively. 100% of patients with three injections of 180 or 360 mcg had immunogenic response against 67% in two injections groups. Among the 21 patients who developed anti-TNF Abs, 48% present a moderate to good response according to EULAR score as opposed to only 31% of the 16 patients without Abs. A mean decrease of -14% of the C reactive protein level is measured in patients with Abs while in patients without Abs, the mean CRP level increased by 5%The mean decrease of the DAS28 score is -0.8 points in patients with Abs while it is only -0.5 in patients without Abs. Conclusions: Active immunization with TNFα kinoid to induce a polyclonal, self-anti-TNFα antibody response is safe and immunogenic. A clinical and biological response were observed in some patients included in this preliminary phase 2 study and further studies are needed to confirm this new approach in RA.

Published
2013

14. Active Immunization with TNF-Kinoid in Rheumatoid Arthritis Patients with Secondary Resistance to Tumor Necrosis Factor-Alpha Antagonists Is Safe and Immunogenic

Author

Durez, Patrick, Miranda, Pedro, Toncheva, Antoaneta, Berman, Alberto, Rillo, Oscar Luis, Boutsen, Yves, Kehler, Tatjana, Mociran, Eugenia, Soto, Saez Lian, Fautrel, Bruno, Mariette, Xavier, Solakov, Panayot, Lucero, Eleonora, Vlak, Tonko, Grazio, Simeon, Maštrović, Ksenija, Chirieac, Rodica, and Boissier, Marie-Christophe

Subjects
Rheumatoid arthritis – Anti-TNF therapy
Abstract

Blocking TNF alpha (TNFα) with monoclonal antibodies (mAbs) has been successful in the treatment of rheumatoid arthritis. However primary and secondary resistances are frequent and impose treatment changes. Active immunization with a TNF-Kinoid that safely induces self polyclonal anti-TNFα antibodies (Abs) could be an alternative to anti-TNFα mAbs. We evaluated the immunogenicity and safety of TNF-K in patients with rheumatoid arthritis and secondary resistance to TNF blockers. TNFα- Kinoid (TNF-K, Neovacs SA, Paris, France) is an immunotherapeutic composed of recombinant human TNFα conjugated to KLH, inactivated and adjuvanted with ISA-51 emulsion. 40 patients with active rheumatoid arthritis (DAS28≥3.2) with history of positive clinical response to TNF-blockers followed by secondary failure (35% IFX, 30% ADA, 42.5% ETA) were enrolled in a double-blind, placebo- controlled, phase 2 study to evaluate three different intramuscular doses of TNF-K (90, 180, 360 mcg) and two immunization schedules (D0 and 28 or D0, 7 and 28). Immune responses were evaluated through titration of anti-TNFα and anti-KLH Abs. Clinical response was evaluated by the ACR and EULAR core set response. No related serious adverse event has been reported. Few minor transient local and systemic reactions have been recorded following immunization. Anti-TNFα Abs were induced in 50%, 75% and 91% of patients at 90 mcg, 180 mcg and 360 mcg, respectively. 100% of patients with three injections of 180 or 360 mcg had immunogenic response against 67% in two injections groups. Among the 21 patients who developed anti-TNF Abs, 48% present a moderate to good response according to EULAR score as opposed to only 31% of the 16 patients without Abs. A mean decrease of -14% of the C reactive protein level is measured in patients with Abs while in patients without Abs, the mean CRP level increased by 5%The mean decrease of the DAS28 score is -0.8 points in patients with Abs while it is only -0.5 in patients without Abs. Active immunization with TNFα kinoid to induce a polyclonal, self-anti-TNFα antibody response is safe and immunogenic. A clinical and biological response were observed in some patients included in this preliminary phase 2 study and further studies are needed to confirm this new approach in RA. Disclosure of Interest: P. Durez: None Declared, P. Miranda: None Declared, A. Toncheva: None Declared, A. Berman: None Declared, O. L. Rillo: None Declared, Y. Boutsen: None Declared, T. Kehler: None Declared, E. Mociran: None Declared, L. Soto Saez: None Declared, B. Fautrel: None Declared, X. Mariette: None. Declared, P. Sokalov: None Declared, E. Lucero: None Declared, T. Vlak: None Declared, S. Grazio: None Declared, K. Mastrovic: None Declared, R. Chirieac: None Declared, G. Grouard-Vogel Employee of: Neovacs, O. Dhellin Employee of: Neovacs, S. Ouary Employee of: Neovacs, B. Fanget Employee of: Neovacs, P. Vandepapelière Employee of: Neovacs, M.-C. Boissier Consultant for: Neovacs

Published
2012

15. Prevalence of rheumatoid arthritis in Tucumán, Argentina.

Author

Spindler, Alberto, Bellomio, Verónica, Berman, Alberto, Lucero, Eleonora, Baigorria, Marcelo, Paz, Silvia, Garrone, Norma, Torres, Alberto Ives, Romano, Olga, Carraccio, Ana, Leal, Olga, Bazzano, Ana, Vazquez, Dora, Pera, Oscar, Arquez, Gustavo, Valdez, Marcos, Lazaro, Hector, Rengel, Silvia, Acosta, Emma, and Santana, Mirta

Abstract

OBJECTIVE: To ascertain the prevalence of rheumatoid arthritis (RA) in Tucumán, Argentina. METHODS: The study was conducted between January 1, 1998, and December 31, 1999, in Tucumán province in northwest Argentina. Outpatient and hospitalization medical records for all patients with RA aged > or = 16 years were reviewed. Diagnosis was by 1987 American College of Rheumatology (ACR) criteria for RA and the population data were based on the 1991 national census. Prevalence rates, with 95% CI, were calculated using the number of San Miguel de Tucumán residents who fulfilled the 1987 ACR criteria for RA as numerator, and the city population aged > or = 16 as denominator. Crude and age-specific prevalence rates were calculated as number of cases/1,000 inhabitants. RESULTS: We identified 695 cases of RA. Sex-specific and overall prevalence rates (per 1,000) were 1.97 (95% CI 1.8-2) for all, 0.6 (95% CI 0.49-0.73) for men, 3.2 (95% CI 2.9-3.5) for women. CONCLUSION: Prevalence of RA is low in residents of Tucumán, Argentina, and comparable with rates observed in epidemiological surveys from Southern European countries.

Published
2002

16. Active Immunization with TNF-Kinoid in Rheumatoid Arthritis Patients with Secondary Resistance to Tumor Necrosis Factor-Alpha Antagonists Is Safe and Immunogenic

Author

Durez, Patrick, Miranda, Pedro, Toncheva, Antoaneta, Berman, Alberto, Rillo, Oscar L., Boutsen, Yves, Kehler, Tatjana, Mociran, Eugenia, Soto Saez, Lian, Fautrel, Bruno, Mariette, Xavier, Solakov, Panayot, Lucero, Eleonora, Tonko Vlak, Grazio, Simeon, Mastrovic, Ksenija, Chiriac, Rodica, Grouard-Vogel, Geraldine, Dhellin, Olivier, Ouary, Stephane, Vandepapeliere, Pierre, and Boissier, Marie-Christophe

17. Factors associated with disability in patients with rheumatoid arthritis.

Author

Schneeberger EE, Citera G, Maldonado Cocco JA, Salcedo M, Chiardola F, Rosemffet MG, Marengo MF, Papasidero S, Chaparro Del Moral R, Rillo OL, Bellomio V, Lucero E, Spindler A, Berman A, Duartes Noe D, Barreira JC, Lázaro MA, and Paira SO

Subjects
Adult, Antirheumatic Agents therapeutic use, Argentina, Arthritis, Rheumatoid drug therapy, Arthritis, Rheumatoid epidemiology, Cohort Studies, Comorbidity, Disease Progression, Female, Foot Joints diagnostic imaging, Hand Joints diagnostic imaging, Health Surveys, Humans, Logistic Models, Male, Middle Aged, Radiography, Arthritis, Rheumatoid physiopathology, Disability Evaluation, Severity of Illness Index
Abstract

Objective: Analyze disability determinants in a cohort of Argentine patients with rheumatoid arthritis (RA)., Material and Methods: Consecutive patients with RA, according to ACR'87 criteria, were recruited from 6 rheumatology centers. Demographic and socioeconomic data, family history, comorbid diseases, extra-articular manifestations and information about received treatments were provided. Disease activity was assessed using Disease Activity Score 28 (DAS 28) and the Health Assessment Questionnaire (HAQ)-A was used for the functional capacity. Hand and feet radiographs were assessed using Sharp-van der Heijde score., Results: A total of 640 patients with RA were included, of which 85.2% were females. Mean age was 53 years (interquartile range [IQR], 44-62) and mean disease duration was 8 years (IQR, 4-14). DAS 28 mean was 2.72 (IQR, 1.7-3.7) and HAQ-A mean was 0.62 (IQR, 0.13-1.25). Multiple linear regression showed that the main variables associated with disability were DAS 28, radiologic damage and age. Main predictors of functional disability in the multiple logistic regression using severe HAQ (>2) as dependent variable were DAS 28 (OR, 2; P < 0.0001); age (OR, 1; P = 0.008); and structural damage (OR, 1; P = 0.001)., Conclusions: In this population, the disease activity was the variable that showed the highest impact on the physical function. Radiologic damage affected HAQ as the disease progressed.

Published
2010
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18. Validation and crosscultural adaptation of an argentine spanish version of the health assessment questionnaire disability index.

Author

Citera G, Arriola MS, Maldonado-Cocco JA, Rosemffet MG, Sánchez MM, Goñi MA, Spindler A, Lucero E, and Berman A

Abstract

Background: The Health Assessment Questionnaire (HAQ) is one of the most frequently used instruments to assess functional capacity in activities of daily living., Objective: The objective of our study was to determine the reproducibility and validity of an Argentinean version of the HAQ disability index (HAQ-DI) in patients with rheumatoid arthritis (RA)., Methods: Consecutive adult patients with RA from 3 different provinces in Argentina were included. The original English version of the HAQ-DI was translated and adapted into Spanish by 3 rheumatologists and the final version back translated into English by a bilingual person. The reproducibility of the questionnaire was assessed in 30 patients who came for a second visit 3 to 5 days later. The cross-sectional construct validity was assessed by comparing the HAQ with classic parameters of disease activity (number of swollen and tender joints, patient and physician visual analog scale for pain and activity as well as functional class, erythrocyte sedimentation rate, and C-reactive protein., Results: Two hundred patients with RA were included. The reproducibility was r = 0.97 (P = 1 x 10-5); intraitem correlation analysis did not show any redundancy. Correlation between HAQ-A and parameters of disease activity were all significant. A stepwise multiple regression analysis showed that the main variables associated with HAQ-A scores were visual analog scale for pain and duration of morning stiffness. A weak although significant negative correlation was found between the HAQ-A and economic level (r = -0.21, P = 0.03). The median time to complete the questionnaire was 5 minutes and there were no problems with any questions., Conclusion: This version of the HAQ-DI would allow for more availability so that Spanish-speaking countries can select the version most suitable to their sociocultural environment.

Published
2004
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