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Siponimod versus placebo in secondary progressive multiple sclerosis (EXPAND): a double-blind, randomised, phase 3 study

Kappos, Ludwig; Bar-Or, Amit; Cree, Bruce A C; Fox, Robert J; Giovannoni, Gavin; Gold, Ralf; Vermersch, Patrick; Arnold, Douglas L; Arnould, Sophie; Scherz, Tatiana; Wolf, Christian; Wallström, Erik; Dahlke, Frank; Achiron, Anat; Achtnichts, Lutz; Agan, Kadriye; Akman-Demir, Gulsen; Allen, Alison B; Antel, Jack P; Antiguedad, Alfredo Rodriguez; Apperson, Michelle; Applebee, Angela M; Ayuso, Guillermo Izquierdo; Baba, Masayuki; Bajenaru, Ovidiu; Balasa, Rodica; Balci, Belgin Petek; Barnett, Michael; Bass, Ann; Becker, Veit U; Bejinariu, Mihaela; Bergh, Florian Then; Bergmann, Arnfin; Bernitsas, Evanthia; Berthele, Achim; Bhan, Virender; Bischof, Felix; Bjork, Randall John; Blevins, Gregg; Boehringer, Matthias; Boerner, Thomas; Bonek, Robert; Bowen, James D; Bowling, Allen; Boyko, Alexey N; Boz, Cavit; Bracknies, Vera; Braune, Stefan; Brescia Morra, Vincenzo; Brochet, Bruno; Brola, Waldemar; Brownstone, Paul Kenneth; Brozman, Miroslav; Brunet, Donald; Buraga, Ioan; Burnett, Margaret; Buttmann, Mathias; Butzkueven, Helmut; Cahill, Jonathan; Calkwood, Jonathan C; Camu, William; Cascione, Mark; Castelnovo, Giovani; Centonze, Diego; Cerqueira, Joao; Chan, Andrew; Cimprichova, Andrea; Cohan, Stanley; Comi, Giancarlo; Conway, Jill; Cooper, Joanna A; Corboy, John; Correale, Jorge; Costell, Brian; Cottrell, David A; Coyle, Patricia K; Craner, Matthew; Cui, Liying; Cunha, Luis; Czlonkowska, Anna; da Silva, Ana Martins; de Sa, Joao; de Seze, Jérôme; Debouverie, Marc; Debruyne, Jan; Decoo, Danny; Defer, Gilles; Derfuss, Tobias; Deri, Norma H; Dihenia, Bhupesh; Dioszeghy, Peter; Donath, Vladimir; Dubois, Benedicte; Duddy, Martin; Duquette, Pierre; Edan, Gilles; Efendi, Husnu; Elias, Stanton; Emrich, Peter J; Estruch, Bonaventura Casanova; Evdoshenko, Evgeniy P; Faiss, Juergen; Fedyanin, Alexander S; Feneberg, Wolfgang; Fermont, Jiske; Fernandez, Oscar Fernandez; Ferrer, Francisco Coret; Fink, Katharina; Ford, Helen; Ford, Corey; Francia, Ada; Freedman, Mark; Frishberg, Benjamin; Galgani, Simonetta; Garmany, George P; Gehring, Klaus; Gitt, Jeffrey; Gobbi, Claudio; Goldstick, Lawrence P; Gonzalez, Rafael Arroyo; Grandmaison, Francois; Grigoriadis, Nikolaos; Grigorova, Olga; Grimaldi, Luigi Maria Edoardo; Gross, Jeffrey; Gross-Paju, Katrin; Gudesblatt, Mark; Guillaume, Daniel; Haas, Judith; Hancinova, Viera; Hancu, Anca; Hardiman, Orla; Harmjanz, Arndt; Heidenreich, Fedor R; Hengstman, G J D; Herbert, Joseph; Herring, Mark; Hodgkinson, Suzanne; Hoffmann, Olaf M; Hofmann, Werner E; Honeycutt, William D; Hua, Le Hanh; Huang, Dehui; Huang, Yining; Huang, DeRen; Hupperts, Raymond; Imre, Piroska; Jacobs, Alan Keith; Jakab, Gabor; Jasinska, Elzbieta; Kaida, Kenichi; Kalnina, Jolanta; Kaprelyan, Ara; Karelis, Guntis; Karussis, Dimitrios; Katz, Amos; Khabirov, Farit A; Khatri, Bhupendra; Kimura, Takashi; Kister, Ilya; Kizlaitiene, Rasa; Klimova, Eleonora; Koehler, Juergen; Komatineni, Aparna; Kornhuber, Anselm; Kovacs, Krisztina; Koves, Agnes; Kozubski, Wojciech; Krastev, Georgi; Krupp, Lauren B; Kurca, Egon; Lassek, Christoph; Laureys, Guy; Lee, Liesly; Lensch, Eckart; Leutmezer, Fritz; Li, Hongzeng; Linker, Ralf A; Linnebank, Michael; Liskova, Petra; Llanera, Cristina; Lu, Jiahong; Lutterotti, Andreas; Lycke, Jan; Macdonell, Richard; Maciejowski, Maciej; Maeurer, Mathias; Magzhanov, Rim V; Maida, Eva-Maria; Malciene, Lina; Mao-Draayer, Yang; Marfia, Girolama Alessandra; Markowitz, Clyde; Mastorodimos, Vasileios; Matyas, Klotild; Meca-Lallana, Jose; Merino, Juan Antonio Garcia; Mihetiu, Ioan Gheorghe; Milanov, Ivan; Miller, Aaron E; Millers, Andrejs; Mirabella, Massimiliano; Mizuno, Masanori; Montalban, Xavier; Montoya, Lilina; Mori, Masahiro; Mueller, Stefanie; Nakahara, Jin; Nakatsuji, Yuji; Newsome, Scott; Nicholas, Richard; Nielsen, A Scott; Nikfekr, Esmaeil; Nocentini, Ugo; Nohara, Chiyoko; Nomura, Kyoichi; Odinak, Miroslav M; Olsson, Tomas; van Oosten, B W; Oreja-Guevara, Celia; Oschmann, Patrick; Overell, James; Pachner, Andrew; Panczel, Gyula; Pandolfo, Massimo; Papeix, Caroline; Patrucco, Liliana; Pelletier, Jean; Piedrabuena, Raul; Pless, Misha; Polzer, Udo; Pozsegovits, Krisztian; Rastenyte, Daiva; Rauer, Sebastian; Reifschneider, Gerd; Rey, Roberto; Rizvi, Syed A; Robertson, Derrick; Rodriguez, Jose Martinez; Rog, David; Roshanisefat, Homayoun; Rowe, Vernon; Rozsa, Csilla; Rubin, Susan; Rusek, Stanislaw; Saccà, Francesco; Saida, Takahiko; Salgado, Antonio Vasco; Sanchez, Victoria Eugenia Fernandez; Sanders, Kalina; Satori, Maria; Sazonov, Denis V; Scarpini, Elio Angelo; Schlegel, Eugen; Schluep, Myriam; Schmidt, Stephan; Scholz, Erich; Schrijver, H M; Schwab, Matthias; Schwartz, Raymond; Scott, James; Selmaj, Krzysztof; Shafer, Stuart; Sharrack, Basil; Shchukin, Ivan A; Shimizu, Yuko; Shotekov, Penko; Siever, Arno; Sigel, Karl-Otto; Silliman, Scott; Simo, Magdolna; Simu, Mihaela; Sinay, Vladimiro; Siquier, Antonio Escartin; Siva, Aksel; Skoda, Ondrej; Solomon, Andrew; Stangel, Martin; Stefoski, Dusan; Steingo, Brian; Stolyarov, Igor D; Stourac, Pavel; Strassburger-Krogias, Katrin; Strauss, Erik; Stuve, Olaf; Tarnev, Ivaylo; Tavernarakis, Antonios; Tello, Cristina Ramo; Terzi, Murat; Ticha, Veronika; Ticmeanu, Marina; Tiel-Wilck, Klaus; Toomsoo, Toomas; Tubridy, Niall; Tullman, Mark J; Tumani, Hayrettin; Turcani, Peter; Turner, Ben; Uccelli, Antonio; Urtaza, Francisco Javier Olascoaga; Vachova, Marta; Valikovics, Attila; Walter, Silke; Van Wijmeersch, Bart; Vanopdenbosch, Ludo; Weber, Joerg R; Weiss, Sara; Weissert, Robert; Vermersch, Patrick; West, Timothy; Wiendl, Heinz; Wiertlewski, Sandrine; Wildemann, Brigitte; Willekens, Barbara; Visser, L H; Vorobeychik, Galina; Xu, Xianhao; Yamamura, Takashi; Yang, Yi N; Yelamos, Sergio Martinez; Yeung, Michael; Zacharias, Alan; Zelkowitz, Marvin; Zettl, Uwe; Zhang, Meini; Zhou, Hongyu; Zieman, Ulf; Ziemssen, Tjalf
BACKGROUND:modulator, on disability progression in patients with SPMS. METHODS:This event-driven and exposure-driven, double-blind, phase 3 trial was done at 292 hospital clinics and specialised multiple sclerosis centres in 31 countries. Using interactive response technology to assign numbers linked to treatment arms, patients (age 18-60 years) with SPMS and an Expanded Disability Status Scale score of 3·0-6·5 were randomly assigned (2:1) to once daily oral siponimod 2 mg or placebo for up to 3 years or until the occurrence of a prespecified number of confirmed disability progression (CDP) events. The primary endpoint was time to 3-month CDP. Efficacy was assessed for the full analysis set (ie, all randomly assigned and treated patients); safety was assessed for the safety set. This trial is registered with ClinicalTrials.gov, number NCT01665144. FINDINGS:1651 patients were randomly assigned between Feb 5, 2013, and June 2, 2015 (1105 to the siponimod group, and 546 to the placebo group). One patient did not sign the consent form, and five patients did not receive study drug, all of whom were in the siponimod group. 1645 patients were included in the analyses (1099 in the siponimod group and 546 in the placebo). At baseline, the mean time since first multiple sclerosis symptoms was 16·8 years (SD 8·3), and the mean time since conversion to SPMS was 3·8 years (SD 3·5); 1055 (64%) patients had not relapsed in the previous 2 years, and 918 (56%) of 1651 needed walking assistance. 903 (82%) patients receiving siponimod and 424 (78%) patients receiving placebo completed the study. 288 (26%) of 1096 patients receiving siponimod and 173 (32%) of 545 patients receiving placebo had 3-month CDP (hazard ratio 0·79, 95% CI 0·65-0·95; relative risk reduction 21%; p=0·013). Adverse events occurred in 975 (89%) of 1099 patients receiving siponimod versus 445 (82%) of 546 patients receiving placebo; serious adverse events were reported for 197 (18%) patients in the siponimod group versus 83 (15%) patients in the placebo group. Lymphopenia, increased liver transaminase concentration, bradycardia and bradyarrhythmia at treatment initiation, macular oedema, hypertension, varicella zoster reactivation, and convulsions occurred more frequently with siponimod than with placebo. Initial dose titration mitigated cardiac first-dose effects. Frequencies of infections, malignancies, and fatalities did not differ between groups. INTERPRETATION:Siponimod reduced the risk of disability progression with a safety profile similar to that of other S1P modulators and is likely to be a useful treatment for SPMS. FUNDING:Novartis Pharma AG.
PMID: 29576505
ISSN: 1474-547x
CID: 5348122

Musculoskeletal examination

Gross, Jeffrey M.; Fetto, Joseph; Rosen, Elaine
Chichester, West Sussex ; Hobken, NJ : John Wiley & Sons, 2016
Extent: viii, 445 p.; 28 cm
ISBN: 1118962761
CID: 2544572

Ji gu ge jian cha fa = [Muskuloskeletal examination]

Gross, Jeffrey; Fetto, Joseph; Rosen, Elaine; Chen tong yi
Shen yang : Liao ning ke xue ji zhu chu ban she, 2015
ISBN: 7538189017
CID: 2544612

Kin kokkakukei kensaho = [Musculoskeletal examination]

Gross, Jeffrey; Fetto, Joseph; Rosen, Elaine; Ishikawa, Hitoshi; Shimada, Tomoaki
Tokyo : Ishiyakushuppan, 2011
Extent: 467 p. ; 28 cm.
ISBN: 4263213696
CID: 2545012

Badanie ukladu miesniowo-szkieletowego = [Musculoskeletal Examination]

Gross, Jeffrey M; Fetto, Joseph; Rosen, Elaine; Kujawa, Jolanta; Darewski, Marek
Warszawa : Wydawnictwo Lekarskie PZWL, 2011
Extent: [8], 468 s. ; 29 cm.
ISBN: 8320042054
CID: 2544952

Musculoskeletal examination

Gross, Jeffrey M; Fetto, Joseph; Rosen, Elaine
Hoboken NJ : Wiley-Blackwell, 2009
Extent: v, 463 p. ; 28cm
ISBN: 1405180498
CID: 1823

Ji rou gu ge jian cha = [Muskuloskeletal examination]

Gross, Jeffrey M; Fetto, Joseph; Rosen, Elaine; Chen, Yunruc
Tai bei shi : He ji tu shu fa xing : He ji shu ju zong jing xiao, 2009
Extent: 466 p. ; 26 cm
ISBN: 9861265422
CID: 2545022

Vysetreni pohyboveho aparatu : preklad druheho anglickeho vydani = Musculoskeletal examination

Gross, Jeffrey M; Fetto, Joseph; Rosen, Elaine
Praha : Triton, 2005
Extent: 599 s ; 24cm
ISBN: 8072547208
CID: 1824

Kin kokkaku kei kensaho = [Musculoskeletal examination]

Gross, Jeffrey; Fetto, Joseph; Rosen, Elaine; Ishikawa, Hitoshi; Shimada, Tomoaki
Tokyo : Ishiyaku Shuppan, 2005
Extent: 476 p. ; 28 cm
ISBN: 9784263211694
CID: 2544962

Esame obiettivo dell'apparato muscolo-scheletrico = [Musculoskeletal examination]

Gross, Jeffrey; Fetto, Joseph; Rosen, Elaine; Casonato, Oscar; Aloj, Domenico; Di Gregorio, Giuseppe
Torino : UTET scienze mediche, [2004]
Extent: XVI, 463 p. ; 29 cm.
ISBN: 9788802061702
CID: 2544602