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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. 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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3. 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

4. Three Multicenter, Randomized, Double‐Blind, Placebo‐Controlled Studies Evaluating the Efficacy and Safety of Ustekinumab in Axial Spondyloarthritis

Author

Deodhar, Atul, primary, Gensler, Lianne S., additional, Sieper, Joachim, additional, Clark, Michael, additional, Calderon, Cesar, additional, Wang, Yuhua, additional, Zhou, Yiying, additional, Leu, Jocelyn H., additional, Campbell, Kim, additional, Sweet, Kristen, additional, Harrison, Diane D., additional, Hsia, Elizabeth C., additional, Heijde, Désirée, additional, Ariel, Frederico, additional, Asnal, Cecilia Adma, additional, Berman, Alberto, additional, Citera, Gustavo, additional, Rodriguez, Graciela, additional, Savio, Veronica Gabriela, additional, Bird, Paul, additional, Griffiths, Hedley, additional, Nicholls, David, additional, Rischmueller, Maureen, additional, Zochling, Jane, additional, De Vlam, Kurt, additional, Malaise, Michel, additional, Toukap, Adrien Nzeusseu, additional, Van den Bosch, Filip, additional, Vanhoof, Johan, additional, Bonfiglioli, Rubens, additional, Keiserman, Mauro, additional, Scotton, Antonio Scafuto, additional, Xavier, Ricardo, additional, Ximenes, Antonio Carlos, additional, Atanasov, Assen, additional, Goranov, Ivan, additional, Kazmin, Ivan, additional, Licheva, Rodina Nestorova, additional, Nikolov, Nikolay, additional, Oparanov, Boycho, additional, Stoilov, Rumen, additional, Bessette, Louis, additional, Rodrigues, Jude, additional, Bortilik, Ladislav, additional, Dokoupilova, Eva, additional, Dvoarak, Zdenek, additional, Galatikova, Dagmar, additional, Nemec, Petr, additional, Podrazilova, Lucie, additional, Simkova, Gabriela, additional, Stejfova, Zuzana, additional, Moravcova, Radka, additional, Vitek, Petr, additional, Cantagrel, Alain, additional, Baillet, Athan, additional, Banneville, Beatrice, additional, Combe, Bernard, additional, Breban, Maxime, additional, Nguyen, Minh, additional, Goupille, Philippe, additional, Braun, Juergen, additional, Everding, Andrea, additional, Kekow, Joern, additional, Koenig, Ramona, additional, Rubbert‐Roth, Andrea, additional, Witte, Torsten, additional, Bartha, Attila, additional, Drescher, Edit, additional, Kerekes, Kata, additional, Kovacs, Attila, additional, Pulai, Judit, additional, Rojkovich, Bernadette, additional, Szanto, Sandor, additional, Toth, Edit, additional, Avila, Hilario, additional, Torre, Igancio Garcia, additional, Irazoque, Fedra, additional, Maradiaga, Marco, additional, Pacheco, Cesar, additional, Brzosko, Marek, additional, Dudek, Anna, additional, Jeka, Slawomir, additional, Krogulec, Marek, additional, Kwiatkowska, Brygida, additional, Wiland, Piotr, additional, Wojciechowski, Rafal, additional, Zielinska, Agnieszka, additional, Santos, Helena, additional, Bugrova, Olga, additional, Christyakov, Valery, additional, Gorbunov, Vladimir, additional, Ilivanova, Elena, additional, Zemerova, Elena, additional, Kamalova, Rima, additional, Kameneva, Tatyana, additional, Macievskaya, Galina, additional, Marusenko, Irina, additional, Maslyansky, Alexey, additional, Myasoedova, Svetlana, additional, Myasoutova, Leisan, additional, Nemtsov, Boris, additional, Nesmeyanova, Olga, additional, Plaksina, Tatyana, additional, Pokrovskaya, Tatyana, additional, Polyakova, Svetlana, additional, Rebrov, Andrey, additional, Savina, Liudmila, additional, Smakotina, Svetlana, additional, Stanislav, Marina, additional, Ukhanova, Olga, additional, Vinogradova, Irina, additional, Zonova, Elena, additional, Baek, Han Joo, additional, Kim, Tae‐Hwan, additional, Lee, ChangKeun, additional, Lee, SangHeon, additional, Lee, Sang‐Hoon, additional, Lee, Shin‐Seok, additional, Park, Sung‐Hwan, additional, Song, YeongWook, additional, Suh, Chang‐Hee, additional, Ramos, Juan Amarelo, additional, Blanco, Franciso Javier, additional, Collantes, Eduardo, additional, Diaz, Miguel Consuelo, additional, Vivar, Maria Luz Garcia, additional, Gratacos, Jordi, additional, Juanola, Xavier, additional, Chen, Der‐Yuan, additional, Chen, Hsiang‐Cheng, additional, Chen, Kun‐Hung, additional, Chen, Ying‐Chou, additional, Chiu, Ying‐Ming, additional, Luo, Shue‐Fen, additional, Tsai, Shih‐Tzu, additional, Tseng, Jui‐Cheng, additional, Wei, Cheng‐Chung, additional, Weng, Meng‐Yu, additional, Abrahamovych, Orest, additional, Reshotko, Dmytro, additional, Golovchenko, Oleksandr, additional, Hospodarsky, Ihor, additional, Iaremenko, Oleg, additional, Levchenko, Olena, additional, Dudnyk, Oleksandr, additional, Garmish, Olena, additional, Grishyna, Olena, additional, Protsenko, Galyna, additional, Rekalov, Dmytro, additional, Smiyan, Svitlana, additional, Stanislavchuk, Mykola, additional, Trypilka, Svitlana, additional, Tseluyko, Vira, additional, Turianytsia, Samvel, additional, Vasylets, Viktoriya, additional, Virstyuk, Nataliya, additional, Kleban, Yaroslav, additional, Ciurtin, Coziana, additional, Gaffney, Karl, additional, Gunasekera, Wiranthi, additional, Mackay, Kirsten, additional, Packham, Jon, additional, Sengupta, Raj, additional, Tahir, Hasan, additional, Aelion, Jacob, additional, Bennett, Ralph, additional, Deodhar, Atul, additional, Gonzalez‐Paoli, Julio, additional, Griffin, Robert M., additional, Grisanti, Michael, additional, Mallepalli, Jyothi, additional, Peters, Eric, additional, Schechtman, Joy, additional, and Singhal, Atul, additional

Published
2018
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