20 results on '"Rog, David"'
Number of results to display per page
Search Results
2. sj-docx-1-msj-10.1177_13524585221148094 – Supplemental material for Developing evidence-based guidelines for the safety of symptomatic drugs in multiple sclerosis during pregnancy and breastfeeding: A systematic review and Delphi consensus
- Author
-
Iyer, Priyanka, Wiles, Kate, Ismail, Azza, Nanda, Surabhi, Murray, Katy, Hughes, Stella, Ford, Helen L, Pearson, Owen R, White, Sarah, Bonham, Nicola, Hoyle, Natasha, Witts, James, Middleton, Rod, Brex, Peter A, Rog, David, and Dobson, Ruth
- Subjects
FOS: Clinical medicine ,111702 Aged Health Care ,FOS: Health sciences ,110904 Neurology and Neuromuscular Diseases - Abstract
Supplemental material, sj-docx-1-msj-10.1177_13524585221148094 for Developing evidence-based guidelines for the safety of symptomatic drugs in multiple sclerosis during pregnancy and breastfeeding: A systematic review and Delphi consensus by Priyanka Iyer, Kate Wiles, Azza Ismail, Surabhi Nanda, Katy Murray, Stella Hughes, Helen L Ford, Owen R Pearson, Sarah White, Nicola Bonham, Natasha Hoyle, James Witts, Rod Middleton, Peter A Brex, David Rog and Ruth Dobson in Multiple Sclerosis Journal
- Published
- 2023
- Full Text
- View/download PDF
3. sj-docx-2-msj-10.1177_13524585221148094 – Supplemental material for Developing evidence-based guidelines for the safety of symptomatic drugs in multiple sclerosis during pregnancy and breastfeeding: A systematic review and Delphi consensus
- Author
-
Iyer, Priyanka, Wiles, Kate, Ismail, Azza, Nanda, Surabhi, Murray, Katy, Hughes, Stella, Ford, Helen L, Pearson, Owen R, White, Sarah, Bonham, Nicola, Hoyle, Natasha, Witts, James, Middleton, Rod, Brex, Peter A, Rog, David, and Dobson, Ruth
- Subjects
FOS: Clinical medicine ,111702 Aged Health Care ,FOS: Health sciences ,110904 Neurology and Neuromuscular Diseases - Abstract
Supplemental material, sj-docx-2-msj-10.1177_13524585221148094 for Developing evidence-based guidelines for the safety of symptomatic drugs in multiple sclerosis during pregnancy and breastfeeding: A systematic review and Delphi consensus by Priyanka Iyer, Kate Wiles, Azza Ismail, Surabhi Nanda, Katy Murray, Stella Hughes, Helen L Ford, Owen R Pearson, Sarah White, Nicola Bonham, Natasha Hoyle, James Witts, Rod Middleton, Peter A Brex, David Rog and Ruth Dobson in Multiple Sclerosis Journal
- Published
- 2023
- Full Text
- View/download PDF
4. sj-docx-2-msj-10.1177_13524585221148094 – Supplemental material for Developing evidence-based guidelines for the safety of symptomatic drugs in multiple sclerosis during pregnancy and breastfeeding: A systematic review and Delphi consensus
- Author
-
Iyer, Priyanka, Wiles, Kate, Ismail, Azza, Nanda, Surabhi, Murray, Katy, Hughes, Stella, Ford, Helen L, Pearson, Owen R, White, Sarah, Bonham, Nicola, Hoyle, Natasha, Witts, James, Middleton, Rod, Brex, Peter A, Rog, David, and Dobson, Ruth
- Subjects
FOS: Clinical medicine ,111702 Aged Health Care ,FOS: Health sciences ,110904 Neurology and Neuromuscular Diseases - Abstract
Supplemental material, sj-docx-2-msj-10.1177_13524585221148094 for Developing evidence-based guidelines for the safety of symptomatic drugs in multiple sclerosis during pregnancy and breastfeeding: A systematic review and Delphi consensus by Priyanka Iyer, Kate Wiles, Azza Ismail, Surabhi Nanda, Katy Murray, Stella Hughes, Helen L Ford, Owen R Pearson, Sarah White, Nicola Bonham, Natasha Hoyle, James Witts, Rod Middleton, Peter A Brex, David Rog and Ruth Dobson in Multiple Sclerosis Journal
- Published
- 2023
- Full Text
- View/download PDF
5. sj-docx-4-msj-10.1177_13524585221148094 – Supplemental material for Developing evidence-based guidelines for the safety of symptomatic drugs in multiple sclerosis during pregnancy and breastfeeding: A systematic review and Delphi consensus
- Author
-
Iyer, Priyanka, Wiles, Kate, Ismail, Azza, Nanda, Surabhi, Murray, Katy, Hughes, Stella, Ford, Helen L, Pearson, Owen R, White, Sarah, Bonham, Nicola, Hoyle, Natasha, Witts, James, Middleton, Rod, Brex, Peter A, Rog, David, and Dobson, Ruth
- Subjects
FOS: Clinical medicine ,111702 Aged Health Care ,FOS: Health sciences ,110904 Neurology and Neuromuscular Diseases - Abstract
Supplemental material, sj-docx-4-msj-10.1177_13524585221148094 for Developing evidence-based guidelines for the safety of symptomatic drugs in multiple sclerosis during pregnancy and breastfeeding: A systematic review and Delphi consensus by Priyanka Iyer, Kate Wiles, Azza Ismail, Surabhi Nanda, Katy Murray, Stella Hughes, Helen L Ford, Owen R Pearson, Sarah White, Nicola Bonham, Natasha Hoyle, James Witts, Rod Middleton, Peter A Brex, David Rog and Ruth Dobson in Multiple Sclerosis Journal
- Published
- 2023
- Full Text
- View/download PDF
6. sj-docx-4-msj-10.1177_13524585221148094 – Supplemental material for Developing evidence-based guidelines for the safety of symptomatic drugs in multiple sclerosis during pregnancy and breastfeeding: A systematic review and Delphi consensus
- Author
-
Iyer, Priyanka, Wiles, Kate, Ismail, Azza, Nanda, Surabhi, Murray, Katy, Hughes, Stella, Ford, Helen L, Pearson, Owen R, White, Sarah, Bonham, Nicola, Hoyle, Natasha, Witts, James, Middleton, Rod, Brex, Peter A, Rog, David, and Dobson, Ruth
- Subjects
FOS: Clinical medicine ,111702 Aged Health Care ,FOS: Health sciences ,110904 Neurology and Neuromuscular Diseases - Abstract
Supplemental material, sj-docx-4-msj-10.1177_13524585221148094 for Developing evidence-based guidelines for the safety of symptomatic drugs in multiple sclerosis during pregnancy and breastfeeding: A systematic review and Delphi consensus by Priyanka Iyer, Kate Wiles, Azza Ismail, Surabhi Nanda, Katy Murray, Stella Hughes, Helen L Ford, Owen R Pearson, Sarah White, Nicola Bonham, Natasha Hoyle, James Witts, Rod Middleton, Peter A Brex, David Rog and Ruth Dobson in Multiple Sclerosis Journal
- Published
- 2023
- Full Text
- View/download PDF
7. sj-docx-2-msj-10.1177_13524585221114004 – Supplemental material for Measuring coping in multiple sclerosis: The Coping Index-MS
- Author
-
Young, Carolyn A, Mills, Roger J, Langdon, Dawn, Rog, David J, Sharrack, Basil, Kalra, Seema, Majeed, Tahir, Footit, David, Harrower, Tim, Nicholas, Richard S, Ford, Helen L, Woolmore, John, Johnstone, Clare, Thorpe, John, Paling, David, Ellis, Cathy, Hanneman, C Oliver, and Tennant, Alan
- Subjects
FOS: Clinical medicine ,111702 Aged Health Care ,FOS: Health sciences ,110904 Neurology and Neuromuscular Diseases - Abstract
Supplemental material, sj-docx-2-msj-10.1177_13524585221114004 for Measuring coping in multiple sclerosis: The Coping Index-MS by Carolyn A Young, Roger J Mills, Dawn Langdon, David J Rog, Basil Sharrack, Seema Kalra, Tahir Majeed, David Footit, Tim Harrower, Richard S Nicholas, Helen L Ford, John Woolmore, Clare Johnstone, John Thorpe, David Paling, Cathy Ellis, C Oliver Hanneman and Alan Tennant in Multiple Sclerosis Journal
- Published
- 2022
- Full Text
- View/download PDF
8. sj-docx-2-msj-10.1177_13524585221114004 – Supplemental material for Measuring coping in multiple sclerosis: The Coping Index-MS
- Author
-
Young, Carolyn A, Mills, Roger J, Langdon, Dawn, Rog, David J, Sharrack, Basil, Kalra, Seema, Majeed, Tahir, Footit, David, Harrower, Tim, Nicholas, Richard S, Ford, Helen L, Woolmore, John, Johnstone, Clare, Thorpe, John, Paling, David, Ellis, Cathy, Hanneman, C Oliver, and Tennant, Alan
- Subjects
FOS: Clinical medicine ,111702 Aged Health Care ,FOS: Health sciences ,110904 Neurology and Neuromuscular Diseases - Abstract
Supplemental material, sj-docx-2-msj-10.1177_13524585221114004 for Measuring coping in multiple sclerosis: The Coping Index-MS by Carolyn A Young, Roger J Mills, Dawn Langdon, David J Rog, Basil Sharrack, Seema Kalra, Tahir Majeed, David Footit, Tim Harrower, Richard S Nicholas, Helen L Ford, John Woolmore, Clare Johnstone, John Thorpe, David Paling, Cathy Ellis, C Oliver Hanneman and Alan Tennant in Multiple Sclerosis Journal
- Published
- 2022
- Full Text
- View/download PDF
9. sj-docx-1-msj-10.1177_13524585221114004 – Supplemental material for Measuring coping in multiple sclerosis: The Coping Index-MS
- Author
-
Young, Carolyn A, Mills, Roger J, Langdon, Dawn, Rog, David J, Sharrack, Basil, Kalra, Seema, Majeed, Tahir, Footit, David, Harrower, Tim, Nicholas, Richard S, Ford, Helen L, Woolmore, John, Johnstone, Clare, Thorpe, John, Paling, David, Ellis, Cathy, Hanneman, C Oliver, and Tennant, Alan
- Subjects
FOS: Clinical medicine ,111702 Aged Health Care ,FOS: Health sciences ,110904 Neurology and Neuromuscular Diseases - Abstract
Supplemental material, sj-docx-1-msj-10.1177_13524585221114004 for Measuring coping in multiple sclerosis: The Coping Index-MS by Carolyn A Young, Roger J Mills, Dawn Langdon, David J Rog, Basil Sharrack, Seema Kalra, Tahir Majeed, David Footit, Tim Harrower, Richard S Nicholas, Helen L Ford, John Woolmore, Clare Johnstone, John Thorpe, David Paling, Cathy Ellis, C Oliver Hanneman and Alan Tennant in Multiple Sclerosis Journal
- Published
- 2022
- Full Text
- View/download PDF
10. sj-pdf-1-cns-10.1177_11795735211028781 – Supplemental material for Efficacy and Safety of Teriflunomide in Multiple Sclerosis across Age Groups: Analysis from Pooled Pivotal and Real-world Studies
- Author
-
Oh, Jiwon, Vukusic, Sandra, Tiel-Wilck, Klaus, Inshasi, Jihad Said, Rog, David, Baker, Darren P, Pyatkevich, Yelena, Poole, Elizabeth M, and Vermersch, Patrick
- Subjects
FOS: Clinical medicine ,110904 Neurology and Neuromuscular Diseases - Abstract
Supplemental material, sj-pdf-1-cns-10.1177_11795735211028781 for Efficacy and Safety of Teriflunomide in Multiple Sclerosis across Age Groups: Analysis from Pooled Pivotal and Real-world Studies by Jiwon Oh, Sandra Vukusic, Klaus Tiel-Wilck, Jihad Said Inshasi, David Rog, Darren P Baker, Yelena Pyatkevich, Elizabeth M Poole and Patrick Vermersch in Journal of Central Nervous System Disease
- Published
- 2021
- Full Text
- View/download PDF
11. sj-pdf-1-msj-10.1177_13524585211020435 – Supplemental material for Mental health of people with multiple sclerosis during the COVID-19 outbreak: A prospective cohort and cross-sectional case–control study of the UK MS Register
- Author
-
Garjani, Afagh, Hunter, Rachael, Law, Graham R, Middleton, Rodden M, Tuite-Dalton, Katherine A, Dobson, Ruth, Ford, David V, Hughes, Stella, Pearson, Owen R, Rog, David, Tallantyre, Emma C, Nicholas, Richard, Morriss, Richard, Evangelou, Nikos, and das Nair, Roshan
- Subjects
FOS: Clinical medicine ,111702 Aged Health Care ,FOS: Health sciences ,110904 Neurology and Neuromuscular Diseases - Abstract
Supplemental material, sj-pdf-1-msj-10.1177_13524585211020435 for Mental health of people with multiple sclerosis during the COVID-19 outbreak: A prospective cohort and cross-sectional case–control study of the UK MS Register by Afagh Garjani, Rachael Hunter, Graham R Law, Rodden M Middleton, Katherine A Tuite-Dalton, Ruth Dobson, David V Ford, Stella Hughes, Owen R Pearson, David Rog, Emma C Tallantyre, Richard Nicholas, Richard Morriss, Nikos Evangelou and Roshan das Nair in Multiple Sclerosis Journal
- Published
- 2021
- Full Text
- View/download PDF
12. sj-pdf-2-msj-10.1177_13524585211020435 – Supplemental material for Mental health of people with multiple sclerosis during the COVID-19 outbreak: A prospective cohort and cross-sectional case–control study of the UK MS Register
- Author
-
Garjani, Afagh, Hunter, Rachael, Law, Graham R, Middleton, Rodden M, Tuite-Dalton, Katherine A, Dobson, Ruth, Ford, David V, Hughes, Stella, Pearson, Owen R, Rog, David, Tallantyre, Emma C, Nicholas, Richard, Morriss, Richard, Evangelou, Nikos, and das Nair, Roshan
- Subjects
FOS: Clinical medicine ,111702 Aged Health Care ,FOS: Health sciences ,110904 Neurology and Neuromuscular Diseases - Abstract
Supplemental material, sj-pdf-2-msj-10.1177_13524585211020435 for Mental health of people with multiple sclerosis during the COVID-19 outbreak: A prospective cohort and cross-sectional case–control study of the UK MS Register by Afagh Garjani, Rachael Hunter, Graham R Law, Rodden M Middleton, Katherine A Tuite-Dalton, Ruth Dobson, David V Ford, Stella Hughes, Owen R Pearson, David Rog, Emma C Tallantyre, Richard Nicholas, Richard Morriss, Nikos Evangelou and Roshan das Nair in Multiple Sclerosis Journal
- Published
- 2021
- Full Text
- View/download PDF
13. sj-pdf-1-msj-10.1177_13524585211020435 – Supplemental material for Mental health of people with multiple sclerosis during the COVID-19 outbreak: A prospective cohort and cross-sectional case–control study of the UK MS Register
- Author
-
Garjani, Afagh, Hunter, Rachael, Law, Graham R, Middleton, Rodden M, Tuite-Dalton, Katherine A, Dobson, Ruth, Ford, David V, Hughes, Stella, Pearson, Owen R, Rog, David, Tallantyre, Emma C, Nicholas, Richard, Morriss, Richard, Evangelou, Nikos, and das Nair, Roshan
- Subjects
FOS: Clinical medicine ,111702 Aged Health Care ,FOS: Health sciences ,110904 Neurology and Neuromuscular Diseases - Abstract
Supplemental material, sj-pdf-1-msj-10.1177_13524585211020435 for Mental health of people with multiple sclerosis during the COVID-19 outbreak: A prospective cohort and cross-sectional case–control study of the UK MS Register by Afagh Garjani, Rachael Hunter, Graham R Law, Rodden M Middleton, Katherine A Tuite-Dalton, Ruth Dobson, David V Ford, Stella Hughes, Owen R Pearson, David Rog, Emma C Tallantyre, Richard Nicholas, Richard Morriss, Nikos Evangelou and Roshan das Nair in Multiple Sclerosis Journal
- Published
- 2021
- Full Text
- View/download PDF
14. sj-pdf-2-msj-10.1177_13524585211020435 – Supplemental material for Mental health of people with multiple sclerosis during the COVID-19 outbreak: A prospective cohort and cross-sectional case–control study of the UK MS Register
- Author
-
Garjani, Afagh, Hunter, Rachael, Law, Graham R, Middleton, Rodden M, Tuite-Dalton, Katherine A, Dobson, Ruth, Ford, David V, Hughes, Stella, Pearson, Owen R, Rog, David, Tallantyre, Emma C, Nicholas, Richard, Morriss, Richard, Evangelou, Nikos, and das Nair, Roshan
- Subjects
FOS: Clinical medicine ,111702 Aged Health Care ,FOS: Health sciences ,110904 Neurology and Neuromuscular Diseases - Abstract
Supplemental material, sj-pdf-2-msj-10.1177_13524585211020435 for Mental health of people with multiple sclerosis during the COVID-19 outbreak: A prospective cohort and cross-sectional case–control study of the UK MS Register by Afagh Garjani, Rachael Hunter, Graham R Law, Rodden M Middleton, Katherine A Tuite-Dalton, Ruth Dobson, David V Ford, Stella Hughes, Owen R Pearson, David Rog, Emma C Tallantyre, Richard Nicholas, Richard Morriss, Nikos Evangelou and Roshan das Nair in Multiple Sclerosis Journal
- Published
- 2021
- Full Text
- View/download PDF
15. Alemtuzumab for patients with relapsing multiple sclerosis after disease-modifying therapy: a randomised controlled phase 3 trial
- Author
-
Coles, Alasdair J., Twyman, Cary L., Arnold, Douglas L., Cohen, Jeffrey A., Christian, Confavreux, Fox, Edward J., Hans Peter Hartung, Eva, Havrdova, Selmaj, Krzysztof W., Weiner, Howard L., Tamara, Miller, Elizabeth, Fisher, Rupert, Sandbrink, Lake, Stephen L., Margolin, David H., Pedro, Oyuela, Panzara, Michael A., Compston, D Alastair S., Gupta, the CARE MS II investigators: Ajay S., Edward, Fox, Glyman, Steven A., Thoits, Timothy K., Sullivan, Herman C., Cascione, Mark C., Rammohan, Kottil W., Gazda, Suzanne K., Wynn, Daniel R., Wray, Sibyl E., Stanton, Elias, Ford, Corey C., Andrew, Goodman, Hughes, Bruce L., Omar Azhar Khan, Vaishnav, Anand G., Stephen, Kirzinger, Lynch, Sharon G., Mattson, David H., Braley, Tiffany J., Mikol, Daniel D., Stephen, Krieger, Tamara Ann Miller, Riskind, Peter N., Roberto, Bomprezzi, Wingerchuk, Dean M., Brian, Steingo, Jeffrey Alan Cohen, Crayton, Heidi J., Cooper, Joanna A., Weiner, Leslie P., Harold Moses, J. r., Agius, Mark A., Ann Doan Do Bass, Lallana, Enrico C., Mitchell, Galen W., Krolczyk, Stanley J., Alireza, Minagar, Burk, Jubelt, Evans, Bradley K., Hunter, Samuel F., Rizvi, Syed A., Sheppard, Christopher A., David Honeycutt, W. M., Joseph, Herbert, Lathi, Ellen S., Gabriel, Pardo, Lily Jung Ilenson, Rothstein, Ted L., Thrower, Ben W., Mary Ann Picone, Mariko, Kita, Grazioli, Erica M., Silliman, Scott L., Thomas, Giancarlo, Gottesman, Malcolm H., Abou Zeid, Nuhad E., Rowe, Vernon D., Boutwell, Christine M., Schaeffer, John D., Riley, Claire S., Edwards, Keith R., Wendt, Jeanette K., G. Kim Bigley J. r., Shubin, Richard A., Silva Markovic Plese, Jones, Davis E., Gary, Clauser, Freedman, Mark S., Francois, Grand’Maison, Jacques, Francois H., Traboulsee, Anthony L., Brunet, Donald G., Marcelo, Kremenchutzky, Charles, Ayotte, Lava, Neil S., Waldman, Stephen R., Janus, Todd J., Stephen Gerard Vincent, Mark, Gudesblatt, Michael, Rossen, Stein, Lee S., Bennett Irving Machanic, Timothy, Vollmer, Gitt, Jeffrey S., Jeffrey, Dunn, Donald, Negroski, Fletcher, Mark H., Adil, Javed, Frohman, Elliot M., Richard, Macdonell, John Owen King, Paine, Mark A., Karyn, Boundy, Simon, Broadley, Steve, Vucic, Stephen, Reddel, Dreyer, Michael D., Raymond, Schwartz, Pamela Ann McCombe, Suzanne, Hodgkinson, Charles, Tilbery, Ferreira, Maria Lucia B., Dagoberto, Callegaro, Marcio Mena Barreto Martins, Jesus Arturo Violante Villanueva, Noemi Santos Caballero, Claudia Venzor Mendoza, Norma Haydee Deri, Alasdair, Coles, Neil James Scolding, Gavin, Giovannoni, Basil, Sharrack, Rog, David J., Giancarlo, Comi, Angelo, Ghezzi, Mancardi, Giovanni L., Durelli, Luca, Antonio, Bertolotto, Ruggero, Capra, Carlo, Pozzilli, Maria Giovanna Marrosu, Hupperts, Raymond M. M., Erik van Munster, Xavier, Montalbán, Rafael Arroyo González, Guillermo Izquierdo Ayuso, Óscar Fernández Fernández, Patrick, Vermersch, Jerome de Seze, Thibault, Moreau, Pierre, Clavelou, Catherine, Lubetzki, Michel, Clanet, Marc, Debouverie, Gilles, Edan, Judith, Haas, Martin, Stangel, Tjalf, Ziemssen, Bernhard, Hemmer, Karl, Baum, Klaus Zettl, U., Herrlinger, U., Wolfgang, Köhler, Gunter, Ochs, Patrick, Oschmann, Klaus Tiel Wilck, Hayrettin, Tumani, Urban, Peter P., Jan, Lycke, Anders, Svenningsson, Ivana, Kovarova, Marta, Vachova, Ivan, Rektor, Radomir, Talab, Krzysztof, Selmaj, Zbigniew, Stelmasiak, Wojciech, Kozubski, Dubois, Benedicte D. P., Dominique, Dive, Christian, Sindic, Karl, Vass, Per Soelberg Sørensen, Thor, Petersen, Mads, Ravnborg, Anat, Achiron, Adi Vaknin Dembinsky, Arnon, Karni, Gusev, Evgeny I., Stolyarov, Igor D., Zavalishin, Igor A., Skoromets, Alexander A., Boyko, Alexei N., Belova, Anna N., Malkova, Nadezhda A., Barantsevich, Evgeniy R., Yakupov, Eduard Z., Perfiliev, Semen V., Poverennova, Irina E., Voloshyna, Natalia P., Nehrych, Tetyana I., Kobys, Tetyana O., Mario, Habek, Vesna, Brinar, Zlatko, Trkanjec, Anton, Vladić, Spomenka Kidemet Piskać, Licia, Antonelli, Jelena, Drulović, Čongor, Nadj, Evica, Dinčić, Gordana, Tončev, UCL - SSS/IONS/CEMO - Pôle Cellulaire et moléculaire, Klinische Neurowetenschappen, RS: MHeNs - R1 - Cognitive Neuropsychiatry and Clinical Neuroscience, MUMC+: MA Med Staf Spec Neurologie (9), RS: MHeNs School for Mental Health and Neuroscience, Radiology and nuclear medicine, and NCA - Multiple Sclerosis and Other Neuroinflammatory Diseases
- Subjects
Male ,Adult ,medicine.medical_specialty ,Adolescent ,CD52 ,multiple sclerosis ,Administration, Cutaneous ,Antibodies, Monoclonal, Humanized ,law.invention ,Young Adult ,Multiple Sclerosis, Relapsing-Remitting ,Adjuvants, Immunologic ,Randomized controlled trial ,Recurrence ,law ,Internal medicine ,Humans ,Medicine ,Glatiramer acetate ,Infusions, Intravenous ,Adverse effect ,Alemtuzumab ,disease ,business.industry ,Multiple sclerosis ,Interferon beta-1a ,Glatiramer Acetate ,General Medicine ,Middle Aged ,medicine.disease ,Treatment Outcome ,Immunology ,Female ,Ocrelizumab ,Peptides ,business ,Immunosuppressive Agents ,medicine.drug - Abstract
The anti-CD52 monoclonal antibody alemtuzumab reduces disease activity in previously untreated patients with relapsing-remitting multiple sclerosis. We aimed to assess efficacy and safety of alemtuzumab compared with interferon beta 1a in patients who have relapsed despite first-line treatment.In our 2 year, rater-masked, randomised controlled phase 3 trial, we enrolled adults aged 18-55 years with relapsing-remitting multiple sclerosis and at least one relapse on interferon beta or glatiramer. Eligible participants were randomly allocated in a 1:2:2 ratio by an interactive voice response system, stratified by site, to receive subcutaneous interferon beta 1a 44 μg, intravenous alemtuzumab 12 mg per day, or intravenous alemtuzumab 24 mg per day. Interferon beta 1a was given three-times per week and alemtuzumab was given once per day for 5 days at baseline and for 3 days at 12 months. The 24 mg per day group was discontinued to aid recruitment, but data are included for safety assessments. Coprimary endpoints were relapse rate and time to 6 month sustained accumulation of disability, comparing alemtuzumab 12 mg and interferon beta 1a in all patients who received at least one dose of study drug. This study is registered with ClinicalTrials.gov, number NCT00548405.202 (87%) of 231 patients randomly allocated interferon beta 1a and 426 (98%) of 436 patients randomly allocated alemtuzumab 12 mg were included in the primary analyses. 104 (51%) patients in the interferon beta 1a group relapsed (201 events) compared with 147 (35%) patients in the alemtuzumab group (236 events; rate ratio 0·51 [95% CI 0·39-0·65]; p0·0001), corresponding to a 49·4% improvement with alemtuzumab. 94 (47%) patients in the interferon beta 1a group were relapse-free at 2 years compared with 278 (65%) patients in the alemtuzumab group (p0·0001). 40 (20%) patients in the interferon beta 1a group had sustained accumulation of disability compared with 54 (13%) in the alemtuzumab group (hazard ratio 0·58 [95% CI 0·38-0·87]; p=0·008), corresponding to a 42% improvement in the alemtuzumab group. For 435 patients allocated alemtuzumab 12 mg, 393 (90%) had infusion-associated reactions, 334 (77%) had infections (compared with 134 [66%] of 202 patients in the interferon beta 1a group) that were mostly mild-moderate with none fatal, 69 (16%) had thyroid disorders, and three (1%) had immune thrombocytopenia.For patients with first-line treatment-refractory relapsing-remitting multiple sclerosis, alemtuzumab could be used to reduce relapse rates and sustained accumulation of disability. Suitable risk management strategies allow for early identification of alemtuzumab's main adverse effect of secondary autoimmunity.Genzyme (Sanofi) and Bayer Schering Pharma.
- Published
- 2012
16. THUR 196 Pregnancy outcomes in alemtuzumab-treated rrms patients
- Author
-
Chung Luke, Compston D Alastair S, McCombe Pamela, Chambers Christina, Rog David, Oh Jiwon, Hellwig Kerstin, and Daizadeh Nadia
- Subjects
musculoskeletal diseases ,medicine.medical_specialty ,Pregnancy ,education.field_of_study ,business.industry ,Obstetrics ,Incidence (epidemiology) ,Population ,medicine.disease ,Psychiatry and Mental health ,Female patient ,Medicine ,Alemtuzumab ,Surgery ,Observational study ,Neurology (clinical) ,Dosing ,business ,Pregnancy outcomes ,education ,human activities ,medicine.drug - Abstract
Murine studies show no alemtuzumab-related teratogenicity, but no controlled human clinical studies of alemtuzumab in pregnancy exist. In phase 2 (CAMMS223 [NCT00050778]) and phase 3 (CARE-MS I [NCT00530348], CARE-MS II [NCT00548405]) studies, patients received 2 annual alemtuzumab courses. Two extension studies provided longer-term evaluation (NCT00930553; TOPAZ [NCT02255656]). Pregnant/lactating patients were ineligible for further treatment but were followed up for safety. As of 1 April 2017, 248 pregnancies occurred in 156/972 alemtuzumab-treated female patients (mean [SD] age at conception, 32.5 [4.4] years; mean [SD] time from last alemtuzumab dose to conception, 33.5 [22.6] months; 16 within 4 months of dosing), with 218 completed, 14 ongoing, and 16 with unknown outcomes. Of completed pregnancies with known outcomes, 147 (67%) were live births with no congenital abnormalities or birth defects. There were 48 (22%) spontaneous abortions, 22 (10%) elective abortions, and 1 (0.5%) stillbirth. To date, there has been no signal for teratogenicity. Incidence of spontaneous abortions was comparable with treatment-naive MS patients (5%–21%) and the general population (17%–22%). Real-world data are currently collected by the International Lemtrada Pregnancy Exposure Registry, a prospective, non-interventional, observational safety study enrolling patients in ≥19 countries who become pregnant within 4 months of alemtuzumab exposure.Study Support: Sanofi.
- Published
- 2018
17. WED 190 Teriflunomide pregnancy registry: design and enrolment
- Author
-
Seferta Nicola, Lebrun-Frenay Christine, Rog David, Benamor Myriam, Truffinet Philippe, Ghezzi Angelo, and Colilla Susan
- Subjects
Pregnancy registry ,Pregnancy ,medicine.medical_specialty ,Obstetrics ,business.industry ,Developmental toxicity ,medicine.disease ,Psychiatry and Mental health ,chemistry.chemical_compound ,Contraceptive use ,chemistry ,Informed consent ,Teriflunomide ,medicine ,Infant development ,Surgery ,Observational study ,Neurology (clinical) ,business - Abstract
IntroductionTeriflunomide is contraindicated in pregnancy, based on developmental toxicity in rats and rabbits. During clinical development, despite requirements for contraceptive use, some pregnancies occurred. There were no signs of structural or functional deficits in newborns.MethodsThe multinational, prospective, observational International Teriflunomide Pregnancy Exposure Registry is enrolling teriflunomide-exposed pregnant women with MS. Signed informed consent is obtained prior to enrolment. In the UK, healthcare professionals submit information to the National Coordinating Centre (Manchester, UK). Infants are followed until 1 year old. Pregnancy outcomes, including birth defects and infant characteristics, are collected. Target recruitment: 196 women to achieve 104 live births, providing 80% power to detect 3.95-fold increase in risk of birth defects associated with teriflunomide exposure vs the European Surveillance of Congenital Anomalies (EUROCAT) network.ResultsAs of 26/04/2017, 14 patients have been recruited from 7 European countries (none in the UK). Six healthy babies have been born to date. One patient had an elective termination not motivated by abnormal prenatal test results or concerns regarding potential birth defects.ConclusionThis registry aims to provide data on pregnancy outcomes and infant development from teriflunomide-exposed women, which may help physicians provide better patient advice.Study supported by Sanofi.
- Published
- 2018
18. THUR 158 Susac’s syndrome: treatment and outcomes in three cases
- Author
-
Chua Wei Xin, Smith David, Enevoldson Peter, Huda Saif, Whittam Dan, Rog David, Jacob Anu, and Wilson Martin
- Subjects
Pediatrics ,medicine.medical_specialty ,business.industry ,Hearing loss ,Microangiopathy ,Azathioprine ,medicine.disease ,Psychiatry and Mental health ,medicine ,Prednisolone ,Surgery ,Rituximab ,Sensorineural hearing loss ,Neurology (clinical) ,medicine.symptom ,business ,Off Treatment ,medicine.drug ,Susac's syndrome - Abstract
BackgroundSusac’s syndrome (SS) is a rare, autoimmune microangiopathy causing a triad of branch retinal artery occlusions, sensorineural hearing loss and brain lesions. Published data on immunotherapy and outcomes is very limited.MethodSingle centre case note review. Electronic hospital records between 1996 and 2017 were searched. 277 possible cases were reviewed.Results3 cases (2 female, 1 male) with the full SS triad were identified. Median age of disease onset was 35.2 years with headache (n=3), confusion (n=1), hearing loss (n=3), vertigo (n=2) and visual field loss (n=2). Time from onset to diagnosis with the full triad was 3–23 months. MRIs showed characteristic corpus callosum involvement. All patients received high-dose corticosteroids as acute therapy. Case 1 was treated with Mycophenolate Mofetil (MMF) and Prednisolone for 27 months, and followed up for a further 8 months. She remained relapse-free. Case 2 relapsed on steroid-reduction, so received Rituximab followed by MMF and Prednisolone. She has now been stable for 14 months. Case 3 was intolerant to high-dose corticosteroids, Cyclophoshamide and MMF. He relapsed off treatment then commenced Azathioprine. Duration on Azathioprine is 14 months with one further relapse.ConclusionSS is rare but causes significant morbidity. Recognition of characteristic findings and early immunotherapy improves outcomes.
- Published
- 2018
19. Self-diagnosed COVID-19 in people with multiple sclerosis: a community-based cohort of the UK MS Register
- Author
-
Evangelou, Nikos, Garjani, Afagh, DasNair, Roshan, Hunter, Rachael, Tuite-Dalton, Katherine A, Craig, Elaine M, Rodgers, William J, Coles, Alasdair, Dobson, Ruth, Duddy, Martin, Ford, David Vincent, Hughes, Stella, Pearson, Owen, Middleton, Linda A, Rog, David, Tallantyre, Emma Clare, Friede, Tim, Middleton, Rodden M, and Nicholas, Richard
- Subjects
epidemiology ,10. No inequality ,multiple sclerosis ,3. Good health
20. Siponimod versus placebo in secondary progressive multiple sclerosis (EXPAND): a double-blind, randomised, phase 3 study
- Author
-
Ludwig Kappos, Amit Bar-Or, Bruce A C Cree, Robert J Fox, Gavin Giovannoni, Ralf Gold, Patrick Vermersch, Douglas L Arnold, Sophie Arnould, Tatiana Scherz, Christian Wolf, Erik Wallström, Frank Dahlke, Anat Achiron, Lutz Achtnichts, Kadriye Agan, Gulsen Akman-Demir, Alison B Allen, Jack P Antel, Alfredo Rodriguez Antiguedad, Michelle Apperson, Angela M Applebee, Guillermo Izquierdo Ayuso, Masayuki Baba, Ovidiu Bajenaru, Rodica Balasa, Belgin Petek Balci, Michael Barnett, Ann Bass, Veit U Becker, Mihaela Bejinariu, Florian Then Bergh, Arnfin Bergmann, Evanthia Bernitsas, Achim Berthele, Virender Bhan, Felix Bischof, Randall John Bjork, Gregg Blevins, Matthias Boehringer, Thomas Boerner, Robert Bonek, James D Bowen, Allen Bowling, Alexey N Boyko, Cavit Boz, Vera Bracknies, Stefan Braune, Vincenzo Brescia Morra, Bruno Brochet, Waldemar Brola, Paul Kenneth Brownstone, Miroslav Brozman, Donald Brunet, Ioan Buraga, Margaret Burnett, Mathias Buttmann, Helmut Butzkueven, Jonathan Cahill, Jonathan C Calkwood, William Camu, Mark Cascione, Giovani Castelnovo, Diego Centonze, Joao Cerqueira, Andrew Chan, Andrea Cimprichova, Stanley Cohan, Giancarlo Comi, Jill Conway, Joanna A Cooper, John Corboy, Jorge Correale, Brian Costell, David A Cottrell, Patricia K Coyle, Matthew Craner, Liying Cui, Luis Cunha, Anna Czlonkowska, Ana Martins da Silva, Joao de Sa, Jérôme de Seze, Marc Debouverie, Jan Debruyne, Danny Decoo, Gilles Defer, Tobias Derfuss, Norma H Deri, Bhupesh Dihenia, Peter Dioszeghy, Vladimir Donath, Benedicte Dubois, Martin Duddy, Pierre Duquette, Gilles Edan, Husnu Efendi, Stanton Elias, Peter J Emrich, Bonaventura Casanova Estruch, Evgeniy P Evdoshenko, Juergen Faiss, Alexander S Fedyanin, Wolfgang Feneberg, Jiske Fermont, Oscar Fernandez Fernandez, Francisco Coret Ferrer, Katharina Fink, Helen Ford, Corey Ford, Ada Francia, Mark Freedman, Benjamin Frishberg, Simonetta Galgani, George P Garmany, Klaus Gehring, Jeffrey Gitt, Claudio Gobbi, Lawrence P Goldstick, Rafael Arroyo Gonzalez, Francois Grandmaison, Nikolaos Grigoriadis, Olga Grigorova, Luigi Maria Edoardo Grimaldi, Jeffrey Gross, Katrin Gross-Paju, Mark Gudesblatt, Daniel Guillaume, Judith Haas, Viera Hancinova, Anca Hancu, Orla Hardiman, Arndt Harmjanz, Fedor R Heidenreich, G J D Hengstman, Joseph Herbert, Mark Herring, Suzanne Hodgkinson, Olaf M Hoffmann, Werner E Hofmann, William D Honeycutt, Le Hanh Hua, Dehui Huang, Yining Huang, DeRen Huang, Raymond Hupperts, Piroska Imre, Alan Keith Jacobs, Gabor Jakab, Elzbieta Jasinska, Kenichi Kaida, Jolanta Kalnina, Ara Kaprelyan, Guntis Karelis, Dimitrios Karussis, Amos Katz, Farit A Khabirov, Bhupendra Khatri, Takashi Kimura, Ilya Kister, Rasa Kizlaitiene, Eleonora Klimova, Juergen Koehler, Aparna Komatineni, Anselm Kornhuber, Krisztina Kovacs, Agnes Koves, Wojciech Kozubski, Georgi Krastev, Lauren B Krupp, Egon Kurca, Christoph Lassek, Guy Laureys, Liesly Lee, Eckart Lensch, Fritz Leutmezer, Hongzeng Li, Ralf A Linker, Michael Linnebank, Petra Liskova, Cristina Llanera, Jiahong Lu, Andreas Lutterotti, Jan Lycke, Richard Macdonell, Maciej Maciejowski, Mathias Maeurer, Rim V Magzhanov, Eva-Maria Maida, Lina Malciene, Yang Mao-Draayer, Girolama Alessandra Marfia, Clyde Markowitz, Vasileios Mastorodimos, Klotild Matyas, Jose Meca-Lallana, Juan Antonio Garcia Merino, Ioan Gheorghe Mihetiu, Ivan Milanov, Aaron E Miller, Andrejs Millers, Massimiliano Mirabella, Masanori Mizuno, Xavier Montalban, Lilina Montoya, Masahiro Mori, Stefanie Mueller, Jin Nakahara, Yuji Nakatsuji, Scott Newsome, Richard Nicholas, A Scott Nielsen, Esmaeil Nikfekr, Ugo Nocentini, Chiyoko Nohara, Kyoichi Nomura, Miroslav M Odinak, Tomas Olsson, B W van Oosten, Celia Oreja-Guevara, Patrick Oschmann, James Overell, Andrew Pachner, Gyula Panczel, Massimo Pandolfo, Caroline Papeix, Liliana Patrucco, Jean Pelletier, Raul Piedrabuena, Misha Pless, Udo Polzer, Krisztian Pozsegovits, Daiva Rastenyte, Sebastian Rauer, Gerd Reifschneider, Roberto Rey, Syed A Rizvi, Derrick Robertson, Jose Martinez Rodriguez, David Rog, Homayoun Roshanisefat, Vernon Rowe, Csilla Rozsa, Susan Rubin, Stanislaw Rusek, Francesco Saccà, Takahiko Saida, Antonio Vasco Salgado, Victoria Eugenia Fernandez Sanchez, Kalina Sanders, Maria Satori, Denis V Sazonov, Elio Angelo Scarpini, Eugen Schlegel, Myriam Schluep, Stephan Schmidt, Erich Scholz, H M Schrijver, Matthias Schwab, Raymond Schwartz, James Scott, Krzysztof Selmaj, Stuart Shafer, Basil Sharrack, Ivan A Shchukin, Yuko Shimizu, Penko Shotekov, Arno Siever, Karl-Otto Sigel, Scott Silliman, Magdolna Simo, Mihaela Simu, Vladimiro Sinay, Antonio Escartin Siquier, Aksel Siva, Ondrej Skoda, Andrew Solomon, Martin Stangel, Dusan Stefoski, Brian Steingo, Igor D Stolyarov, Pavel Stourac, Katrin Strassburger-Krogias, Erik Strauss, Olaf Stuve, Ivaylo Tarnev, Antonios Tavernarakis, Cristina Ramo Tello, Murat Terzi, Veronika Ticha, Marina Ticmeanu, Klaus Tiel-Wilck, Toomas Toomsoo, Niall Tubridy, Mark J Tullman, Hayrettin Tumani, Peter Turcani, Ben Turner, Antonio Uccelli, Francisco Javier Olascoaga Urtaza, Marta Vachova, Attila Valikovics, Silke Walter, Bart Van Wijmeersch, Ludo Vanopdenbosch, Joerg R Weber, Sara Weiss, Robert Weissert, Timothy West, Heinz Wiendl, Sandrine Wiertlewski, Brigitte Wildemann, Barbara Willekens, L H Visser, Galina Vorobeychik, Xianhao Xu, Takashi Yamamura, Yi N Yang, Sergio Martinez Yelamos, Michael Yeung, Alan Zacharias, Marvin Zelkowitz, Uwe Zettl, Meini Zhang, Hongyu Zhou, Ulf Zieman, Tjalf Ziemssen, Neurologic Clinic and Policlinic, Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital, University of Basel, Basel, Center for Neuroinflammation and Neurotherapeutics, and Multiple Sclerosis Division, Department of Neurology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, Neuroimmunology Unit, Montreal Neurological Institute and Hospital, McGill University, Montreal, QC, UCSF Weill Institute for Neurosciences, Department of Neurology, University of California San Francisco, San Francisco, CA, Mellen Centre for Multiple Sclerosis Treatment and Research, Neurological Institute, Cleveland Clinic, Cleveland, OH, Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, Department of Neurology St. Josef-Hospital, Ruhr University Bochum, Germany, Institute for Translational Research in Inflammation - U 1286 (INFINITE (Ex-Liric)), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Montreal Neurological Institute, McGill University, Montreal, QC, Canada, NeuroRx Research, Montreal, QC, Novartis Pharma AG, Lycalis, Brussels, AP-HM, CHU Timone, Pole de Neurosciences Cliniques, Department of Neurology, Marseille, France., Centre de résonance magnétique biologique et médicale (CRMBM), Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM)-Centre National de la Recherche Scientifique (CNRS), Centre d'Exploration Métabolique par Résonance Magnétique [Hôpital de la Timone - APHM] (CEMEREM), Hôpital de la Timone [CHU - APHM] (TIMONE)-Centre de résonance magnétique biologique et médicale (CRMBM), Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM)-Centre National de la Recherche Scientifique (CNRS)-Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM)-Centre National de la Recherche Scientifique (CNRS), 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, Matthia, Boerner, Thoma, 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, Mathia, 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, Lui, Czlonkowska, Anna, da Silva, Ana Martin, de Sa, Joao, de Seze, Jérôme, Debouverie, Marc, Debruyne, Jan, Decoo, Danny, Defer, Gille, Derfuss, Tobia, Deri, Norma H, Dihenia, Bhupesh, Dioszeghy, Peter, Donath, Vladimir, Dubois, Benedicte, Duddy, Martin, Duquette, Pierre, Edan, Gille, 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, Klau, Gitt, Jeffrey, Gobbi, Claudio, Goldstick, Lawrence P, Gonzalez, Rafael Arroyo, Grandmaison, Francoi, Grigoriadis, Nikolao, 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, Gunti, Karussis, Dimitrio, Katz, Amo, Khabirov, Farit A, Khatri, Bhupendra, Kimura, Takashi, Kister, Ilya, Kizlaitiene, Rasa, Klimova, Eleonora, Koehler, Juergen, Komatineni, Aparna, Kornhuber, Anselm, Kovacs, Krisztina, Koves, Agne, 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, Andrea, Lycke, Jan, Macdonell, Richard, Maciejowski, Maciej, Maeurer, Mathia, Magzhanov, Rim V, Maida, Eva-Maria, Malciene, Lina, Mao-Draayer, Yang, Marfia, Girolama Alessandra, Markowitz, Clyde, Mastorodimos, Vasileio, Matyas, Klotild, Meca-Lallana, Jose, Merino, Juan Antonio Garcia, Mihetiu, Ioan Gheorghe, Milanov, Ivan, Miller, Aaron E, Millers, Andrej, 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, Toma, van Oosten, B W, Oreja-Guevara, Celia, Oschmann, Patrick, Overell, Jame, 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, Matthia, Schwartz, Raymond, Scott, Jame, 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, Antonio, Tello, Cristina Ramo, Terzi, Murat, Ticha, Veronika, Ticmeanu, Marina, Tiel-Wilck, Klau, Toomsoo, Tooma, 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, 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, and EXPAND Clinical Investigators
- Subjects
Adult ,Male ,0301 basic medicine ,Relative risk reduction ,medicine.medical_specialty ,Adolescent ,Placebo ,law.invention ,Cohort Studies ,Young Adult ,03 medical and health sciences ,chemistry.chemical_compound ,Multiple Sclerosis, Chronic Progressive / drug therapy ,0302 clinical medicine ,Double-Blind Method ,Randomized controlled trial ,law ,Internal medicine ,Benzyl Compounds ,Clinical endpoint ,Humans ,Medicine ,ComputingMilieux_MISCELLANEOUS ,Settore MED/36 - DIAGNOSTICA PER IMMAGINI E RADIOTERAPIA ,Expanded Disability Status Scale ,Dose-Response Relationship, Drug ,business.industry ,Hazard ratio ,General Medicine ,Middle Aged ,Multiple Sclerosis, Chronic Progressive ,Fingolimod ,Treatment Outcome ,Settore M-EDF/01 - METODI E DIDATTICHE DELLE ATTIVITÀ MOTORIE ,030104 developmental biology ,Siponimod ,chemistry ,Disease Progression ,Azetidines ,Female ,Settore MED/26 - Neurologia ,Human medicine ,business ,[SDV.MHEP]Life Sciences [q-bio]/Human health and pathology ,030217 neurology & neurosurgery ,medicine.drug - Abstract
Summary 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 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.
- Published
- 2018
Catalog
Books, media, physical & digital resources
Discovery Service for Jio Institute Digital Library
For full access to our library's resources, please sign in.