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

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Fältnamn	Indikatorer	Metadata
000		08119naa a2201477 4500
001		oai:gup.ub.gu.se/266136
003		SwePub
008		240528s2018 \| \|\|\|\|\|\|\|\|\|\|\|000 \|\|eng\|
009		oai:prod.swepub.kib.ki.se:137940861
024	7	a https://gup.ub.gu.se/publication/2661362 URI
024	7	a https://doi.org/10.1016/S0140-6736(18)30475-62 DOI
024	7	a http://kipublications.ki.se/Default.aspx?queryparsed=id:1379408612 URI
040		a (SwePub)gud (SwePub)ki
041		a eng
042		9 SwePub
072	7	a ref2 swepub-contenttype
072	7	a art2 swepub-publicationtype
100	1	a Kappos, Ludwig4 aut
245	1 0	a Siponimod versus placebo in secondary progressive multiple sclerosis (EXPAND): a double-blind, randomised, phase 3 study
264	1	c 2018
520		a © 2018 Elsevier Ltd Background: No treatment has consistently shown efficacy in slowing disability progression in patients with secondary progressive multiple sclerosis (SPMS). We assessed the effect of siponimod, a selective sphingosine 1-phosphate (S1P) receptor 1,5 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 treatme nt 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.
650	7	a MEDICIN OCH HÄLSOVETENSKAPx Klinisk medicinx Neurologi0 (SwePub)302072 hsv//swe
650	7	a MEDICAL AND HEALTH SCIENCESx Clinical Medicinex Neurology0 (SwePub)302072 hsv//eng
700	1	a Bar-Or, Amit4 aut
700	1	a Cree, Bruce A.C.4 aut
700	1	a Fox, Robert J.4 aut
700	1	a Giovannoni, Gavin4 aut
700	1	a Gold, Ralf4 aut
700	1	a Vermersch, Patrick4 aut
700	1	a Arnold, Douglas L.4 aut
700	1	a Arnould, Sophie4 aut
700	1	a Scherz, Tatiana4 aut
700	1	a Wolf, Christian4 aut
700	1	a Wallström, Erik4 aut
700	1	a Dahlke, Frank4 aut
700	1	a Achiron, Anat4 aut
700	1	a Achtnichts, Lutz4 aut
700	1	a Agan, Kadriye4 aut
700	1	a Akman-Demir, Gulsen4 aut
700	1	a Allen, Alison B.4 aut
700	1	a Antel, Jack P.4 aut
700	1	a Antiguedad, Alfredo Rodriguez4 aut
700	1	a Apperson, Michelle4 aut
700	1	a Applebee, Angela M.4 aut
700	1	a Ayuso, Guillermo Izquierdo4 aut
700	1	a Baba, Masayuki4 aut
700	1	a Bajenaru, Ovidiu4 aut
700	1	a Balasa, Rodica4 aut
700	1	a Balci, Belgin Petek4 aut
700	1	a Barnett, Michael4 aut
700	1	a Bass, Ann4 aut
700	1	a Becker, Veit U.4 aut
700	1	a Bejinariu, Mihaela4 aut
700	1	a Bergh, Florian Then4 aut
700	1	a Bergmann, Arnfin4 aut
700	1	a Bernitsas, Evanthia4 aut
700	1	a Berthele, Achim4 aut
700	1	a Bhan, Virender4 aut
700	1	a Bischof, Felix4 aut
700	1	a Bjork, Randall John4 aut
700	1	a Blevins, Gregg4 aut
700	1	a Boehringer, Matthias4 aut
700	1	a Boerner, Thomas4 aut
700	1	a Bonek, Robert4 aut
700	1	a Bowen, James D.4 aut
700	1	a Bowling, Allen4 aut
700	1	a Boyko, Alexey N.4 aut
700	1	a Boz, Cavit4 aut
700	1	a Bracknies, Vera4 aut
700	1	a Braune, Stefan4 aut
700	1	a Brescia Morra, Vincenzo4 aut
700	1	a Brochet, Bruno4 aut
700	1	a Brola, Waldemar4 aut
700	1	a Brownstone, Paul Kenneth4 aut
700	1	a Brozman, Miroslav4 aut
700	1	a Brunet, Donald4 aut
700	1	a Buraga, Ioan4 aut
700	1	a Burnett, Margaret4 aut
700	1	a Buttmann, Mathias4 aut
700	1	a Butzkueven, Helmut4 aut
700	1	a Cahill, Jonathan4 aut
700	1	a Calkwood, Jonathan C.4 aut
700	1	a Camu, William4 aut
700	1	a Cascione, Mark4 aut
700	1	a Castelnovo, Giovani4 aut
700	1	a Centonze, Diego4 aut
700	1	a Cerqueira, Joao4 aut
700	1	a Chan, Andrew4 aut
700	1	a Cimprichova, Andrea4 aut
700	1	a Cohan, Stanley4 aut
700	1	a Comi, Giancarlo4 aut
700	1	a Conway, Jill4 aut
700	1	a Cooper, Joanna A.4 aut
700	1	a Corboy, John4 aut
700	1	a Correale, Jorge4 aut
700	1	a Costell, Brian4 aut
700	1	a Cottrell, David A.4 aut
700	1	a Coyle, Patricia K.4 aut
700	1	a Craner, Matthew4 aut
700	1	a Cui, Liying4 aut
700	1	a Cunha, Luis4 aut
700	1	a Czlonkowska, Anna4 aut
700	1	a da Silva, Ana Martins4 aut
700	1	a de Sa, Joao4 aut
700	1	a de Seze, Jérôme4 aut
700	1	a Debouverie, Marc4 aut
700	1	a Debruyne, Jan4 aut
700	1	a Decoo, Danny4 aut
700	1	a Defer, Gilles4 aut
700	1	a Derfuss, Tobias4 aut
700	1	a Deri, Norma H.4 aut
700	1	a Dihenia, Bhupesh4 aut
700	1	a Dioszeghy, Peter4 aut
700	1	a Donath, Vladimir4 aut
700	1	a Dubois, Benedicte4 aut
700	1	a Duddy, Martin4 aut
700	1	a Duquette, Pierre4 aut
700	1	a Edan, Gilles4 aut
700	1	a Efendi, Husnu4 aut
700	1	a Elias, Stanton4 aut
700	1	a Lycke, Jan,d 1956u Gothenburg University,Göteborgs universitet,Institutionen för neurovetenskap och fysiologi,Institute of Neuroscience and Physiology4 aut0 (Swepub:gu)xlycja
710	2	a Göteborgs universitetb Institutionen för neurovetenskap och fysiologi4 org
773	0	t The Lancetg 391, s. 1263-1273q 391<1263-1273x 0140-6736x 1474-547X
856	4 8	u https://gup.ub.gu.se/publication/266136
856	4 8	u https://doi.org/10.1016/S0140-6736(18)30475-6
856	4 8	u http://kipublications.ki.se/Default.aspx?queryparsed=id:137940861

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Av författaren/redakt...: Kappos, Ludwig; Bar-Or, Amit; Cree, Bruce A.C.; Fox, Robert J.; Giovannoni, Gavi ...; Gold, Ralf; visa fler...; Vermersch, Patri ...; Arnold, Douglas ...; Arnould, Sophie; Scherz, Tatiana; Wolf, Christian; Wallström, Erik; Dahlke, Frank; Achiron, Anat; Achtnichts, Lutz; Agan, Kadriye; Akman-Demir, Gul ...; Allen, Alison B.; Antel, Jack P.; Antiguedad, Alfr ...; Apperson, Michel ...; Applebee, Angela ...; Ayuso, Guillermo ...; Baba, Masayuki; Bajenaru, Ovidiu; Balasa, Rodica; Balci, Belgin Pe ...; Barnett, Michael; Bass, Ann; Becker, Veit U.; Bejinariu, Mihae ...; Bergh, Florian T ...; Bergmann, Arnfin; Bernitsas, Evant ...; Berthele, Achim; Bhan, Virender; Bischof, Felix; Bjork, Randall J ...; Blevins, Gregg; Boehringer, Matt ...; Boerner, Thomas; Bonek, Robert; Bowen, James D.; Bowling, Allen; Boyko, Alexey N.; Boz, Cavit; Bracknies, Vera; Braune, Stefan; Brescia Morra, V ...; Brochet, Bruno; Brola, Waldemar; Brownstone, Paul ...; Brozman, Mirosla ...; Brunet, Donald; Buraga, Ioan; Burnett, Margare ...; Buttmann, Mathia ...; Butzkueven, Helm ...; Cahill, Jonathan; Calkwood, Jonath ...; Camu, William; Cascione, Mark; Castelnovo, Giov ...; Centonze, Diego; Cerqueira, Joao; Chan, Andrew; Cimprichova, And ...; Cohan, Stanley; Comi, Giancarlo; Conway, Jill; Cooper, Joanna A ...; Corboy, John; Correale, Jorge; Costell, Brian; Cottrell, David ...; Coyle, Patricia ...; Craner, Matthew; Cui, Liying; Cunha, Luis; Czlonkowska, Ann ...; da Silva, Ana Ma ...; 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, Benedict ...; Duddy, Martin; Duquette, Pierre; Edan, Gilles; Efendi, Husnu; Elias, Stanton; Lycke, Jan, 1956; visa färre...

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