Efficacy and safety of tofacitinib monotherapy, tofacitinib with methotrexate, and adalimumab with methotrexate in patients with rheumatoid arthritis (ORAL Strategy): a phase 3b/4, double-blind, head-to-head, randomised controlled trial

Autor: Adams, Luthando, Ally, Mahmood M, du Plooy, Maria C, Louw, Ingrid C, Nayiager, Savithree, Nel, Christoffel B, Nel, Debra, Reuter, Helmuth, Soloman, Ahmed S, Spargo, Catherine E, Hall, Stephen, Rischmueller, Maureen, Sharma, Shunil D, Will, Robert K, Youssef, Peter P, Arroyo, Caroline, Baes, Rosario P, Dulos, Roger B, Hao, Llewellyn T, Lanzon, Allan E, Lichauco, Juan Javier T, Mangubat, Jill H, Ramiterre, Edgar B, Reyes, Bernadette Heizel M, Tan, Perry P, Choe, Jung-Yoon, Kang, Young Mo, Kwon, Seong Ryul, Lee, Sang-Heon, Lee, Shin-Seok, Yoo, Dae-Hyun, Lin, Hsiao-Yi, Luo, Shue-Fen, Tsai, Shih-Tzu, Tsai, Wen-Chan, Tseng, Jui-Cheng, Wei, Cheng-Chung C, Asavatanabodee, Paijit, Nantiruj, Kanokrat, Nilganuwong, Surasak, Uea-Areewongsa, Parichat, Majstorovic, Ljubinka Bozic, Bacic, Suada Mulic, Batalov, Anastas Z, Georgieva-Slavcheva, Gabriela, Mihailova, Mariyana, Nikolov, Nikolay G, Penev, Dimitar P, Spasov, Yuliy A, Stanimirova, Krasimira, Todorov, Stoyan, Toncheva, Antoaneta R, Yordanova, Nadezhda, Mosterova, Zdenka, Novosad, Libor, Prochazkova, Leona, Stehlikova, Helena, Stejfova, Zuzana, Kiseleva, Natalia, Pank, Lea, Savi, Triin, Alexandra, Balbir-Gurman, Amital, Howard, Mevorach, Dror, Rosner, Itzhak A, Mihailova, Anna, Stumbra-Stumberga, Evija, Basijokiene, Vida, Lietuvininkiene, Virginija, Unikiene, Dalia, Brzezicki, Jan, Dudek, Anna M, Glowacka-Kulesz, Maria B, Grabowicz-Wasko, Barbara, Hajduk-Kubacka, Sabina, Hilt, Joanna, Hrycaj, Pawel, Jeka, Slawomir, Kolasa, Renata, Krogulec, Marek, Mastalerz, Hanna, Olak-Popko, Anna, Owczarek, Elzbieta, Ruzga, Zofia, Walczak, Alina, Ancuta, Codrina I, Ancuta, Ioan, Balanescu, Andra R, Berghea, Florian, Bojin, Silvia, Arvunescu, Mihaela A Ianuli, Ionescu, Ruxandra M, Mociran, Eugenia, Pavel, Mariana, Rednic, Simona, Voie, Adriana, Zainea, Carmen M, Bugrova, Olga V, Demin, Alexander, Ershova, Olga B, Gavrisheva, Inna A, Krechikova, Diana G, Kuropatkin, Gennady V, Marusenko, Irina M, Menshikova, Irina V, Noskov, Sergey M, Rebrov, Andrey P, Smakotina, Svetlana A, Yakushin, Sergey S, Zhilyaev, Evgeny, Ramos, Juan Jose Amarelo, Garcia, Francisco Javier Blanco, Nebro, Antonio Fernandez, Esteban, Silvia Perez, Burson, Juan Miguel Sanchez, Sala, Raimon Sanmarti, Ataman, Sebnem, Hizmetli, Sami, Kuru, Omer, Douglas, Karen M, Emery, Paul, Moots, Robert J, Ong, Voon H, Sheeran, Thomas P, Faraawi, Rafat Y, Lessard, Clode, Mendoza, Carlos Abud, Avila-Armengol, Hilario Ernesto, Zapata, Francisco I Avila, Irazoque-Palazuelos, Fedra Consuelo, Cecena, Marco Antonio Maradiaga, Pacheco-Tena, Cesar F, Rizo-Rodriguez, Juan C, Rodriguez-Torres, Isaura M, Aelion, Jacob A, Caciolo, Barbara A, Calmes, James M, Chatpar, Prem, Dayal, Nimesh, De Jesus, Alex, Dikranian, Ara H, Diri, Erdal, Fairfax, Michael J, Fenton, Ira F, Fleischmann, Roy M, Gaylis, Norman B, George, Ronald L, Halter, Dale G, Hernandez, Paul, Hole, Susan A, Hou, Antony C, Huff, John P, Kafaja, Suzanne, Kennedy, Alastair C, Kenney, Howard, Kimmel, Steven C, Kirby, Brian S, Kivitz, Alan J, Legerton, Clarence W, Lindsey, Stephen M, Mallepalli, Jyothi R, Mathews, Steven D, Metyas, Samy K, Mizutani, Wesley T, Najam, Sabeen, Nascimento, Joao M, Pang, Shirley W, Patel, Rakesh C, Poiley, Jeffrey E, Ramirez, Carlos E, Reddy, Riteesha, Rehman, Qaiser, Schnitz, William M, Scoville, Craig D, Shergy, William J, Silverfield, Joel C, Singhal, Atul K, Smallwood-Sherrer, Yvonne R, Songcharoen, Suthin N, Stack, Michael T, Stohl, William, Su, Tien-I K, Udell, James, Waraich, Saleem, Weidmann, Charles E, Wei, Nathan, Wiesenhutter, Craig W, Winkler, Anne E, Zagar, Karen E, Berman, Alberto, Mysler, Eduardo F, Hidalgo, Rodolfo A Pardo, Venarotti, Horacio O, Sariego, Irmgadt Annelise Goecke, Calabresse, Renato E Jimenez, Ruiz-Tagle, Juan Ignacio Vargas, Vargas, Luis Fernando M Bellatin, Berrocal, Alfredo E, Portocarrero, Manuel Gustavo Leon, Jesus, Felix, Pena, Romero, Fleischmann, Roy, Mysler, Eduardo, Luo, Zhen, DeMasi, Ryan, Soma, Koshika, Zhang, Richard, Takiya, Liza, Tatulych, Svitlana, Mojcik, Christopher, Krishnaswami, Sriram, Menon, Sujatha, Smolen, Josef S

Publikováno v: In The Lancet 29 July-4 August 2017 390(10093):457-468

Additional file 7: of Safety and efficacy of tofacitinib for up to 9.5 years in the treatment of rheumatoid arthritis: final results of a global, open-label, long-term extension study

Autor: Wollenhaupt, Jürgen, Eun-Bong Lee, Curtis, Jeffrey, Silverfield, Joel, Ketti Terry, Koshika Soma, Mojcik, Chris, DeMasi, Ryan, Strengholt, Sander, Kwok, Kenneth, Lazariciu, Irina, Lisy Wang, Cohen, Stanley

Table S4. Confirmed AST and ALT > 1×, ≥ 2×, and ≥ 3× ULN.

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::120ce381c50887b06b3b5786b9e5dc84

Additional file 2: of Safety and efficacy of tofacitinib for up to 9.5 years in the treatment of rheumatoid arthritis: final results of a global, open-label, long-term extension study

Autor: Wollenhaupt, Jürgen, Eun-Bong Lee, Curtis, Jeffrey, Silverfield, Joel, Ketti Terry, Koshika Soma, Mojcik, Chris, DeMasi, Ryan, Strengholt, Sander, Kwok, Kenneth, Lazariciu, Irina, Lisy Wang, Cohen, Stanley

Figure S1. Patient disposition (a) and discontinuation over time (b). aFour patients in the tofacitinib 10 mg BID arm had a missing end-of-study page. bEvaluable for AEs (evaluable for laboratory data: tofacitinib 5 mg BID n = 1118, tofacitinib 10 mg

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::0b709fa56fb9e2471dce8390db1fb439

Additional file 4: of Safety and efficacy of tofacitinib for up to 9.5â years in the treatment of rheumatoid arthritis: final results of a global, open-label, long-term extension study

Autor: JĂźrgen Wollenhaupt, Eun-Bong Lee, Curtis, Jeffrey, Silverfield, Joel, Ketti Terry, Koshika Soma, Mojcik, Chris, DeMasi, Ryan, Strengholt, Sander, Kwok, Kenneth, Lazariciu, Irina, Lisy Wang, Cohen, Stanley

Figure S2. All-cause AEs (a) and all-cause AEs leading to discontinuation (b) over time. Baseline qualifying index study data were used for approximately 90% of patients. Database lock: March 2, 2017. AE adverse event, BID twice daily.

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::15de483fb127ad863da5dd42f1ae5d6c

Additional file 5: of Safety and efficacy of tofacitinib for up to 9.5â years in the treatment of rheumatoid arthritis: final results of a global, open-label, long-term extension study

Autor: JĂźrgen Wollenhaupt, Eun-Bong Lee, Curtis, Jeffrey, Silverfield, Joel, Ketti Terry, Koshika Soma, Mojcik, Chris, DeMasi, Ryan, Strengholt, Sander, Kwok, Kenneth, Lazariciu, Irina, Lisy Wang, Cohen, Stanley

Table S3. Incidence of all mortality (a) and mortality listings (b).

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::199a26b593ea00ba142a2b05f064bdd5