Trial of Fingolimod versus Interferon Beta-1a in Pediatric Multiple Sclerosis

In 215 patients with a median age of 16 years, fingolimod was superior to interferon beta-1a in reducing relapses of multiple sclerosis and the accumulation of new lesions on MRI over a 2-year period. Seizures occurred in 5.6% of patients in the fingolimod group.

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Vydané v:The New England journal of medicine Ročník 379; číslo 11; s. 1017 - 1027
Hlavní autori: Chitnis, Tanuja, Arnold, Douglas L, Banwell, Brenda, Brück, Wolfgang, Ghezzi, Angelo, Giovannoni, Gavin, Greenberg, Benjamin, Krupp, Lauren, Rostásy, Kevin, Tardieu, Marc, Waubant, Emmanuelle, Wolinsky, Jerry S, Bar-Or, Amit, Stites, Tracy, Chen, Yu, Putzki, Norman, Merschhemke, Martin, Gärtner, Jutta
Médium: Journal Article
Jazyk:English
Vydavateľské údaje: United States Massachusetts Medical Society 13.09.2018
Predmet:
Adults
Age
Body weight
Clinical trials
Convulsions
FDA approval
Interferon
Leukopenia
Life Sciences
Magnetic resonance imaging
Multiple sclerosis
NMR
Nuclear magnetic resonance
Patients
Pediatrics
Regulatory approval
Tachycardia
Technical communication
β-Interferon
Headache
Immunologic Factors
Brain
Administration
Relapsing-Remitting
Interferon-beta
Leukopenia
Humans
Fingolimod Hydrochloride
Male
Secondary Prevention
Oral
Intramuscular
Multiple Sclerosis
Infection
Magnetic Resonance Imaging
Injections
Adolescent
Female
Child
ISSN:0028-4793, 1533-4406, 1533-4406
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Abstract In 215 patients with a median age of 16 years, fingolimod was superior to interferon beta-1a in reducing relapses of multiple sclerosis and the accumulation of new lesions on MRI over a 2-year period. Seizures occurred in 5.6% of patients in the fingolimod group.
AbstractList In 215 patients with a median age of 16 years, fingolimod was superior to interferon beta-1a in reducing relapses of multiple sclerosis and the accumulation of new lesions on MRI over a 2-year period. Seizures occurred in 5.6% of patients in the fingolimod group.
Treatment of patients younger than 18 years of age with multiple sclerosis has not been adequately examined in randomized trials. We compared fingolimod with interferon beta-1a in this population.BACKGROUNDTreatment of patients younger than 18 years of age with multiple sclerosis has not been adequately examined in randomized trials. We compared fingolimod with interferon beta-1a in this population.In this phase 3 trial, we randomly assigned patients 10 to 17 years of age with relapsing multiple sclerosis in a 1:1 ratio to receive oral fingolimod at a dose of 0.5 mg per day (0.25 mg per day for patients with a body weight of ≤40 kg) or intramuscular interferon beta-1a at a dose of 30 μg per week for up to 2 years. The primary end point was the annualized relapse rate.METHODSIn this phase 3 trial, we randomly assigned patients 10 to 17 years of age with relapsing multiple sclerosis in a 1:1 ratio to receive oral fingolimod at a dose of 0.5 mg per day (0.25 mg per day for patients with a body weight of ≤40 kg) or intramuscular interferon beta-1a at a dose of 30 μg per week for up to 2 years. The primary end point was the annualized relapse rate.Of a total of 215 patients, 107 were assigned to fingolimod and 108 to interferon beta-1a. The mean age of the patients was 15.3 years. Among all patients, there was a mean of 2.4 relapses during the preceding 2 years. The adjusted annualized relapse rate was 0.12 with fingolimod and 0.67 with interferon beta-1a (absolute difference, 0.55 relapses; relative difference, 82%; P<0.001). The key secondary end point of the annualized rate of new or newly enlarged lesions on T2-weighted magnetic resonance imaging (MRI) was 4.39 with fingolimod and 9.27 with interferon beta-1a (absolute difference, 4.88 lesions; relative difference, 53%; P<0.001). Adverse events, excluding relapses of multiple sclerosis, occurred in 88.8% of patients who received fingolimod and 95.3% of those who received interferon beta-1a. Serious adverse events occurred in 18 patients (16.8%) in the fingolimod group and included seizures (in 4 patients), infection (in 4 patients), and leukopenia (in 2 patients). Serious adverse events occurred in 7 patients (6.5%) in the interferon beta-1a group and included infection (in 2 patients) and supraventricular tachycardia (in 1 patient).RESULTSOf a total of 215 patients, 107 were assigned to fingolimod and 108 to interferon beta-1a. The mean age of the patients was 15.3 years. Among all patients, there was a mean of 2.4 relapses during the preceding 2 years. The adjusted annualized relapse rate was 0.12 with fingolimod and 0.67 with interferon beta-1a (absolute difference, 0.55 relapses; relative difference, 82%; P<0.001). The key secondary end point of the annualized rate of new or newly enlarged lesions on T2-weighted magnetic resonance imaging (MRI) was 4.39 with fingolimod and 9.27 with interferon beta-1a (absolute difference, 4.88 lesions; relative difference, 53%; P<0.001). Adverse events, excluding relapses of multiple sclerosis, occurred in 88.8% of patients who received fingolimod and 95.3% of those who received interferon beta-1a. Serious adverse events occurred in 18 patients (16.8%) in the fingolimod group and included seizures (in 4 patients), infection (in 4 patients), and leukopenia (in 2 patients). Serious adverse events occurred in 7 patients (6.5%) in the interferon beta-1a group and included infection (in 2 patients) and supraventricular tachycardia (in 1 patient).Among pediatric patients with relapsing multiple sclerosis, fingolimod was associated with a lower rate of relapse and less accumulation of lesions on MRI over a 2-year period than interferon beta-1a but was associated with a higher rate of serious adverse events. Longer studies are required to determine the durability and safety of fingolimod in pediatric multiple sclerosis. (Funded by Novartis Pharma; PARADIGMS ClinicalTrials.gov number, NCT01892722 .).CONCLUSIONSAmong pediatric patients with relapsing multiple sclerosis, fingolimod was associated with a lower rate of relapse and less accumulation of lesions on MRI over a 2-year period than interferon beta-1a but was associated with a higher rate of serious adverse events. Longer studies are required to determine the durability and safety of fingolimod in pediatric multiple sclerosis. (Funded by Novartis Pharma; PARADIGMS ClinicalTrials.gov number, NCT01892722 .).
Background Treatment of patients younger than 18 years of age with multiple sclerosis has not been adequately examined in randomized trials. We compared fingolimod with interferon beta-1a in this population. Methods In this phase 3 trial, we randomly assigned patients 10 to 17 years of age with relapsing multiple sclerosis in a 1:1 ratio to receive oral fingolimod at a dose of 0.5 mg per day (0.25 mg per day for patients with a body weight of ≤40 kg) or intramuscular interferon beta-1a at a dose of 30 μg per week for up to 2 years. The primary end point was the annualized relapse rate. Results Of a total of 215 patients, 107 were assigned to fingolimod and 108 to interferon beta-1a. The mean age of the patients was 15.3 years. Among all patients, there was a mean of 2.4 relapses during the preceding 2 years. The adjusted annualized relapse rate was 0.12 with fingolimod and 0.67 with interferon beta-1a (absolute difference, 0.55 relapses; relative difference, 82%; P<0.001). The key secondary end point of the annualized rate of new or newly enlarged lesions on T -weighted magnetic resonance imaging (MRI) was 4.39 with fingolimod and 9.27 with interferon beta-1a (absolute difference, 4.88 lesions; relative difference, 53%; P<0.001). Adverse events, excluding relapses of multiple sclerosis, occurred in 88.8% of patients who received fingolimod and 95.3% of those who received interferon beta-1a. Serious adverse events occurred in 18 patients (16.8%) in the fingolimod group and included seizures (in 4 patients), infection (in 4 patients), and leukopenia (in 2 patients). Serious adverse events occurred in 7 patients (6.5%) in the interferon beta-1a group and included infection (in 2 patients) and supraventricular tachycardia (in 1 patient). Conclusions Among pediatric patients with relapsing multiple sclerosis, fingolimod was associated with a lower rate of relapse and less accumulation of lesions on MRI over a 2-year period than interferon beta-1a but was associated with a higher rate of serious adverse events. Longer studies are required to determine the durability and safety of fingolimod in pediatric multiple sclerosis. (Funded by Novartis Pharma; PARADIG MS ClinicalTrials.gov number, NCT01892722 .).
BackgroundTreatment of patients younger than 18 years of age with multiple sclerosis has not been adequately examined in randomized trials. We compared fingolimod with interferon beta-1a in this population.MethodsIn this phase 3 trial, we randomly assigned patients 10 to 17 years of age with relapsing multiple sclerosis in a 1:1 ratio to receive oral fingolimod at a dose of 0.5 mg per day (0.25 mg per day for patients with a body weight of ≤40 kg) or intramuscular interferon beta-1a at a dose of 30 μg per week for up to 2 years. The primary end point was the annualized relapse rate.ResultsOf a total of 215 patients, 107 were assigned to fingolimod and 108 to interferon beta-1a. The mean age of the patients was 15.3 years. Among all patients, there was a mean of 2.4 relapses during the preceding 2 years. The adjusted annualized relapse rate was 0.12 with fingolimod and 0.67 with interferon beta-1a (absolute difference, 0.55 relapses; relative difference, 82%; P<0.001). The key secondary end point of the annualized rate of new or newly enlarged lesions on T2-weighted magnetic resonance imaging (MRI) was 4.39 with fingolimod and 9.27 with interferon beta-1a (absolute difference, 4.88 lesions; relative difference, 53%; P<0.001). Adverse events, excluding relapses of multiple sclerosis, occurred in 88.8% of patients who received fingolimod and 95.3% of those who received interferon beta-1a. Serious adverse events occurred in 18 patients (16.8%) in the fingolimod group and included infection (in 4 patients) and leukopenia (in 2 patients). Six patients had convulsions. Serious adverse events occurred in 7 patients (6.5%) in the interferon beta-1a group and included infection (in 2 patients) and supraventricular tachycardia (in 1 patient).ConclusionsAmong pediatric patients with relapsing multiple sclerosis, fingolimod was associated with a lower rate of relapse and less accumulation of lesions on MRI over a 2-year period than interferon beta-1a but was associated with a higher rate of serious adverse events. Longer studies are required to determine the durability and safety of fingolimod in pediatric multiple sclerosis. (Funded by Novartis Pharma; PARADIGMS ClinicalTrials.gov number, NCT01892722.)
BACKGROUND: Treatment of patients younger than 18 years of age with multiple sclerosis has not been adequately examined in randomized trials. We compared fingolimod with interferon beta-1a in this population. METHODS: In this phase 3 trial, we randomly assigned patients 10 to 17 years of age with relapsing multiple sclerosis in a 1:1 ratio to receive oral fingolimod at a dose of 0.5 mg per day (0.25 mg per day for patients with a body weight of <=40 kg) or intramuscular interferon beta-1a at a dose of 30 μg per week for up to 2 years. The primary end point was the annualized relapse rate. RESULTS: Of a total of 215 patients, 107 were assigned to fingolimod and 108 to interferon beta-1a. The mean age of the patients was 15.3 years. Among all patients, there was a mean of 2.4 relapses during the preceding 2 years. The adjusted annualized relapse rate was 0.12 with fingolimod and 0.67 with interferon beta-1a (absolute difference, 0.55 relapses; relative difference, 82%; P\textless0.001). The key secondary end point of the annualized rate of new or newly enlarged lesions on T2-weighted magnetic resonance imaging (MRI) was 4.39 with fingolimod and 9.27 with interferon beta-1a (absolute difference, 4.88 lesions; relative difference, 53%; P\textless0.001). Adverse events, excluding relapses of multiple sclerosis, occurred in 88.8% of patients who received fingolimod and 95.3% of those who received interferon beta-1a. Serious adverse events occurred in 18 patients (16.8%) in the fingolimod group and included seizures (in 4 patients), infection (in 4 patients), and leukopenia (in 2 patients). Serious adverse events occurred in 7 patients (6.5%) in the interferon beta-1a group and included infection (in 2 patients) and supraventricular tachycardia (in 1 patient). CONCLUSIONS: Among pediatric patients with relapsing multiple sclerosis, fingolimod was associated with a lower rate of relapse and less accumulation of lesions on MRI over a 2-year period than interferon beta-1a but was associated with a higher rate of serious adverse events. Longer studies are required to determine the durability and safety of fingolimod in pediatric multiple sclerosis. (Funded by Novartis Pharma; PARADIGMS ClinicalTrials.gov number, NCT01892722 .).
Author Ghezzi, Angelo
Tardieu, Marc
Wolinsky, Jerry S
Bar-Or, Amit
Chitnis, Tanuja
Banwell, Brenda
Merschhemke, Martin
Chen, Yu
Greenberg, Benjamin
Putzki, Norman
Krupp, Lauren
Waubant, Emmanuelle
Arnold, Douglas L
Brück, Wolfgang
Giovannoni, Gavin
Gärtner, Jutta
Rostásy, Kevin
Stites, Tracy
Author_xml – sequence: 1
  givenname: Tanuja
  surname: Chitnis
  fullname: Chitnis, Tanuja
  organization: From the Partners Pediatric Multiple Sclerosis Center, Massachusetts General Hospital, Boston (T.C.); Montreal Neurological Institute, McGill University, and NeuroRx Research — both in Montreal (D.L.A.); Children’s Hospital of Philadelphia (B.B.) and the Center for Neuroinflammation and Experimental Neurotherapeutics and the Department of Neurology (A.B.-O.), Perelman School of Medicine, University of Pennsylvania — all in Philadelphia; the Department of Neuropathology (W.B.) and the Department of Pediatrics and Adolescent Medicine, German Center for Multiple Sclerosis in Childhood and Adolescence (J.G.), University Medical Center Göttingen, Göttingen, and the Division of Pediatric Neurology, Children’s Hospital Datteln, Witten/Herdecke University, Datteln (K.R.) — all in Germany; Gallarate Hospital, Gallarate, Italy (A.G.); Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London (G.G.); the University of Texas Southwestern Medical Center, Children’s Health, Dallas (B.G.), and McGovern Medical School, University of Texas Health Science Center at Houston, Houston (J.S.W.) — both in Texas; Pediatric Multiple Sclerosis Center at NYU Langone, New York (L.K.); Hôpitaux Universitaires Paris-Sud, Assistance Publique–Hôpitaux de Paris, Paris (M.T.); the Department of Neurology, University of California at San Francisco, San Francisco (E.W.); Novartis Pharmaceuticals, East Hanover, NJ (T.S., Y.C., N.P.); and Novartis Pharma, Basel, Switzerland (M.M.)
– sequence: 2
  givenname: Douglas L
  surname: Arnold
  fullname: Arnold, Douglas L
  organization: From the Partners Pediatric Multiple Sclerosis Center, Massachusetts General Hospital, Boston (T.C.); Montreal Neurological Institute, McGill University, and NeuroRx Research — both in Montreal (D.L.A.); Children’s Hospital of Philadelphia (B.B.) and the Center for Neuroinflammation and Experimental Neurotherapeutics and the Department of Neurology (A.B.-O.), Perelman School of Medicine, University of Pennsylvania — all in Philadelphia; the Department of Neuropathology (W.B.) and the Department of Pediatrics and Adolescent Medicine, German Center for Multiple Sclerosis in Childhood and Adolescence (J.G.), University Medical Center Göttingen, Göttingen, and the Division of Pediatric Neurology, Children’s Hospital Datteln, Witten/Herdecke University, Datteln (K.R.) — all in Germany; Gallarate Hospital, Gallarate, Italy (A.G.); Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London (G.G.); the University of Texas Southwestern Medical Center, Children’s Health, Dallas (B.G.), and McGovern Medical School, University of Texas Health Science Center at Houston, Houston (J.S.W.) — both in Texas; Pediatric Multiple Sclerosis Center at NYU Langone, New York (L.K.); Hôpitaux Universitaires Paris-Sud, Assistance Publique–Hôpitaux de Paris, Paris (M.T.); the Department of Neurology, University of California at San Francisco, San Francisco (E.W.); Novartis Pharmaceuticals, East Hanover, NJ (T.S., Y.C., N.P.); and Novartis Pharma, Basel, Switzerland (M.M.)
– sequence: 3
  givenname: Brenda
  surname: Banwell
  fullname: Banwell, Brenda
  organization: From the Partners Pediatric Multiple Sclerosis Center, Massachusetts General Hospital, Boston (T.C.); Montreal Neurological Institute, McGill University, and NeuroRx Research — both in Montreal (D.L.A.); Children’s Hospital of Philadelphia (B.B.) and the Center for Neuroinflammation and Experimental Neurotherapeutics and the Department of Neurology (A.B.-O.), Perelman School of Medicine, University of Pennsylvania — all in Philadelphia; the Department of Neuropathology (W.B.) and the Department of Pediatrics and Adolescent Medicine, German Center for Multiple Sclerosis in Childhood and Adolescence (J.G.), University Medical Center Göttingen, Göttingen, and the Division of Pediatric Neurology, Children’s Hospital Datteln, Witten/Herdecke University, Datteln (K.R.) — all in Germany; Gallarate Hospital, Gallarate, Italy (A.G.); Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London (G.G.); the University of Texas Southwestern Medical Center, Children’s Health, Dallas (B.G.), and McGovern Medical School, University of Texas Health Science Center at Houston, Houston (J.S.W.) — both in Texas; Pediatric Multiple Sclerosis Center at NYU Langone, New York (L.K.); Hôpitaux Universitaires Paris-Sud, Assistance Publique–Hôpitaux de Paris, Paris (M.T.); the Department of Neurology, University of California at San Francisco, San Francisco (E.W.); Novartis Pharmaceuticals, East Hanover, NJ (T.S., Y.C., N.P.); and Novartis Pharma, Basel, Switzerland (M.M.)
– sequence: 4
  givenname: Wolfgang
  surname: Brück
  fullname: Brück, Wolfgang
  organization: From the Partners Pediatric Multiple Sclerosis Center, Massachusetts General Hospital, Boston (T.C.); Montreal Neurological Institute, McGill University, and NeuroRx Research — both in Montreal (D.L.A.); Children’s Hospital of Philadelphia (B.B.) and the Center for Neuroinflammation and Experimental Neurotherapeutics and the Department of Neurology (A.B.-O.), Perelman School of Medicine, University of Pennsylvania — all in Philadelphia; the Department of Neuropathology (W.B.) and the Department of Pediatrics and Adolescent Medicine, German Center for Multiple Sclerosis in Childhood and Adolescence (J.G.), University Medical Center Göttingen, Göttingen, and the Division of Pediatric Neurology, Children’s Hospital Datteln, Witten/Herdecke University, Datteln (K.R.) — all in Germany; Gallarate Hospital, Gallarate, Italy (A.G.); Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London (G.G.); the University of Texas Southwestern Medical Center, Children’s Health, Dallas (B.G.), and McGovern Medical School, University of Texas Health Science Center at Houston, Houston (J.S.W.) — both in Texas; Pediatric Multiple Sclerosis Center at NYU Langone, New York (L.K.); Hôpitaux Universitaires Paris-Sud, Assistance Publique–Hôpitaux de Paris, Paris (M.T.); the Department of Neurology, University of California at San Francisco, San Francisco (E.W.); Novartis Pharmaceuticals, East Hanover, NJ (T.S., Y.C., N.P.); and Novartis Pharma, Basel, Switzerland (M.M.)
– sequence: 5
  givenname: Angelo
  surname: Ghezzi
  fullname: Ghezzi, Angelo
  organization: From the Partners Pediatric Multiple Sclerosis Center, Massachusetts General Hospital, Boston (T.C.); Montreal Neurological Institute, McGill University, and NeuroRx Research — both in Montreal (D.L.A.); Children’s Hospital of Philadelphia (B.B.) and the Center for Neuroinflammation and Experimental Neurotherapeutics and the Department of Neurology (A.B.-O.), Perelman School of Medicine, University of Pennsylvania — all in Philadelphia; the Department of Neuropathology (W.B.) and the Department of Pediatrics and Adolescent Medicine, German Center for Multiple Sclerosis in Childhood and Adolescence (J.G.), University Medical Center Göttingen, Göttingen, and the Division of Pediatric Neurology, Children’s Hospital Datteln, Witten/Herdecke University, Datteln (K.R.) — all in Germany; Gallarate Hospital, Gallarate, Italy (A.G.); Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London (G.G.); the University of Texas Southwestern Medical Center, Children’s Health, Dallas (B.G.), and McGovern Medical School, University of Texas Health Science Center at Houston, Houston (J.S.W.) — both in Texas; Pediatric Multiple Sclerosis Center at NYU Langone, New York (L.K.); Hôpitaux Universitaires Paris-Sud, Assistance Publique–Hôpitaux de Paris, Paris (M.T.); the Department of Neurology, University of California at San Francisco, San Francisco (E.W.); Novartis Pharmaceuticals, East Hanover, NJ (T.S., Y.C., N.P.); and Novartis Pharma, Basel, Switzerland (M.M.)
– sequence: 6
  givenname: Gavin
  surname: Giovannoni
  fullname: Giovannoni, Gavin
  organization: From the Partners Pediatric Multiple Sclerosis Center, Massachusetts General Hospital, Boston (T.C.); Montreal Neurological Institute, McGill University, and NeuroRx Research — both in Montreal (D.L.A.); Children’s Hospital of Philadelphia (B.B.) and the Center for Neuroinflammation and Experimental Neurotherapeutics and the Department of Neurology (A.B.-O.), Perelman School of Medicine, University of Pennsylvania — all in Philadelphia; the Department of Neuropathology (W.B.) and the Department of Pediatrics and Adolescent Medicine, German Center for Multiple Sclerosis in Childhood and Adolescence (J.G.), University Medical Center Göttingen, Göttingen, and the Division of Pediatric Neurology, Children’s Hospital Datteln, Witten/Herdecke University, Datteln (K.R.) — all in Germany; Gallarate Hospital, Gallarate, Italy (A.G.); Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London (G.G.); the University of Texas Southwestern Medical Center, Children’s Health, Dallas (B.G.), and McGovern Medical School, University of Texas Health Science Center at Houston, Houston (J.S.W.) — both in Texas; Pediatric Multiple Sclerosis Center at NYU Langone, New York (L.K.); Hôpitaux Universitaires Paris-Sud, Assistance Publique–Hôpitaux de Paris, Paris (M.T.); the Department of Neurology, University of California at San Francisco, San Francisco (E.W.); Novartis Pharmaceuticals, East Hanover, NJ (T.S., Y.C., N.P.); and Novartis Pharma, Basel, Switzerland (M.M.)
– sequence: 7
  givenname: Benjamin
  surname: Greenberg
  fullname: Greenberg, Benjamin
  organization: From the Partners Pediatric Multiple Sclerosis Center, Massachusetts General Hospital, Boston (T.C.); Montreal Neurological Institute, McGill University, and NeuroRx Research — both in Montreal (D.L.A.); Children’s Hospital of Philadelphia (B.B.) and the Center for Neuroinflammation and Experimental Neurotherapeutics and the Department of Neurology (A.B.-O.), Perelman School of Medicine, University of Pennsylvania — all in Philadelphia; the Department of Neuropathology (W.B.) and the Department of Pediatrics and Adolescent Medicine, German Center for Multiple Sclerosis in Childhood and Adolescence (J.G.), University Medical Center Göttingen, Göttingen, and the Division of Pediatric Neurology, Children’s Hospital Datteln, Witten/Herdecke University, Datteln (K.R.) — all in Germany; Gallarate Hospital, Gallarate, Italy (A.G.); Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London (G.G.); the University of Texas Southwestern Medical Center, Children’s Health, Dallas (B.G.), and McGovern Medical School, University of Texas Health Science Center at Houston, Houston (J.S.W.) — both in Texas; Pediatric Multiple Sclerosis Center at NYU Langone, New York (L.K.); Hôpitaux Universitaires Paris-Sud, Assistance Publique–Hôpitaux de Paris, Paris (M.T.); the Department of Neurology, University of California at San Francisco, San Francisco (E.W.); Novartis Pharmaceuticals, East Hanover, NJ (T.S., Y.C., N.P.); and Novartis Pharma, Basel, Switzerland (M.M.)
– sequence: 8
  givenname: Lauren
  surname: Krupp
  fullname: Krupp, Lauren
  organization: From the Partners Pediatric Multiple Sclerosis Center, Massachusetts General Hospital, Boston (T.C.); Montreal Neurological Institute, McGill University, and NeuroRx Research — both in Montreal (D.L.A.); Children’s Hospital of Philadelphia (B.B.) and the Center for Neuroinflammation and Experimental Neurotherapeutics and the Department of Neurology (A.B.-O.), Perelman School of Medicine, University of Pennsylvania — all in Philadelphia; the Department of Neuropathology (W.B.) and the Department of Pediatrics and Adolescent Medicine, German Center for Multiple Sclerosis in Childhood and Adolescence (J.G.), University Medical Center Göttingen, Göttingen, and the Division of Pediatric Neurology, Children’s Hospital Datteln, Witten/Herdecke University, Datteln (K.R.) — all in Germany; Gallarate Hospital, Gallarate, Italy (A.G.); Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London (G.G.); the University of Texas Southwestern Medical Center, Children’s Health, Dallas (B.G.), and McGovern Medical School, University of Texas Health Science Center at Houston, Houston (J.S.W.) — both in Texas; Pediatric Multiple Sclerosis Center at NYU Langone, New York (L.K.); Hôpitaux Universitaires Paris-Sud, Assistance Publique–Hôpitaux de Paris, Paris (M.T.); the Department of Neurology, University of California at San Francisco, San Francisco (E.W.); Novartis Pharmaceuticals, East Hanover, NJ (T.S., Y.C., N.P.); and Novartis Pharma, Basel, Switzerland (M.M.)
– sequence: 9
  givenname: Kevin
  surname: Rostásy
  fullname: Rostásy, Kevin
  organization: From the Partners Pediatric Multiple Sclerosis Center, Massachusetts General Hospital, Boston (T.C.); Montreal Neurological Institute, McGill University, and NeuroRx Research — both in Montreal (D.L.A.); Children’s Hospital of Philadelphia (B.B.) and the Center for Neuroinflammation and Experimental Neurotherapeutics and the Department of Neurology (A.B.-O.), Perelman School of Medicine, University of Pennsylvania — all in Philadelphia; the Department of Neuropathology (W.B.) and the Department of Pediatrics and Adolescent Medicine, German Center for Multiple Sclerosis in Childhood and Adolescence (J.G.), University Medical Center Göttingen, Göttingen, and the Division of Pediatric Neurology, Children’s Hospital Datteln, Witten/Herdecke University, Datteln (K.R.) — all in Germany; Gallarate Hospital, Gallarate, Italy (A.G.); Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London (G.G.); the University of Texas Southwestern Medical Center, Children’s Health, Dallas (B.G.), and McGovern Medical School, University of Texas Health Science Center at Houston, Houston (J.S.W.) — both in Texas; Pediatric Multiple Sclerosis Center at NYU Langone, New York (L.K.); Hôpitaux Universitaires Paris-Sud, Assistance Publique–Hôpitaux de Paris, Paris (M.T.); the Department of Neurology, University of California at San Francisco, San Francisco (E.W.); Novartis Pharmaceuticals, East Hanover, NJ (T.S., Y.C., N.P.); and Novartis Pharma, Basel, Switzerland (M.M.)
– sequence: 10
  givenname: Marc
  surname: Tardieu
  fullname: Tardieu, Marc
  organization: From the Partners Pediatric Multiple Sclerosis Center, Massachusetts General Hospital, Boston (T.C.); Montreal Neurological Institute, McGill University, and NeuroRx Research — both in Montreal (D.L.A.); Children’s Hospital of Philadelphia (B.B.) and the Center for Neuroinflammation and Experimental Neurotherapeutics and the Department of Neurology (A.B.-O.), Perelman School of Medicine, University of Pennsylvania — all in Philadelphia; the Department of Neuropathology (W.B.) and the Department of Pediatrics and Adolescent Medicine, German Center for Multiple Sclerosis in Childhood and Adolescence (J.G.), University Medical Center Göttingen, Göttingen, and the Division of Pediatric Neurology, Children’s Hospital Datteln, Witten/Herdecke University, Datteln (K.R.) — all in Germany; Gallarate Hospital, Gallarate, Italy (A.G.); Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London (G.G.); the University of Texas Southwestern Medical Center, Children’s Health, Dallas (B.G.), and McGovern Medical School, University of Texas Health Science Center at Houston, Houston (J.S.W.) — both in Texas; Pediatric Multiple Sclerosis Center at NYU Langone, New York (L.K.); Hôpitaux Universitaires Paris-Sud, Assistance Publique–Hôpitaux de Paris, Paris (M.T.); the Department of Neurology, University of California at San Francisco, San Francisco (E.W.); Novartis Pharmaceuticals, East Hanover, NJ (T.S., Y.C., N.P.); and Novartis Pharma, Basel, Switzerland (M.M.)
– sequence: 11
  givenname: Emmanuelle
  surname: Waubant
  fullname: Waubant, Emmanuelle
  organization: From the Partners Pediatric Multiple Sclerosis Center, Massachusetts General Hospital, Boston (T.C.); Montreal Neurological Institute, McGill University, and NeuroRx Research — both in Montreal (D.L.A.); Children’s Hospital of Philadelphia (B.B.) and the Center for Neuroinflammation and Experimental Neurotherapeutics and the Department of Neurology (A.B.-O.), Perelman School of Medicine, University of Pennsylvania — all in Philadelphia; the Department of Neuropathology (W.B.) and the Department of Pediatrics and Adolescent Medicine, German Center for Multiple Sclerosis in Childhood and Adolescence (J.G.), University Medical Center Göttingen, Göttingen, and the Division of Pediatric Neurology, Children’s Hospital Datteln, Witten/Herdecke University, Datteln (K.R.) — all in Germany; Gallarate Hospital, Gallarate, Italy (A.G.); Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London (G.G.); the University of Texas Southwestern Medical Center, Children’s Health, Dallas (B.G.), and McGovern Medical School, University of Texas Health Science Center at Houston, Houston (J.S.W.) — both in Texas; Pediatric Multiple Sclerosis Center at NYU Langone, New York (L.K.); Hôpitaux Universitaires Paris-Sud, Assistance Publique–Hôpitaux de Paris, Paris (M.T.); the Department of Neurology, University of California at San Francisco, San Francisco (E.W.); Novartis Pharmaceuticals, East Hanover, NJ (T.S., Y.C., N.P.); and Novartis Pharma, Basel, Switzerland (M.M.)
– sequence: 12
  givenname: Jerry S
  surname: Wolinsky
  fullname: Wolinsky, Jerry S
  organization: From the Partners Pediatric Multiple Sclerosis Center, Massachusetts General Hospital, Boston (T.C.); Montreal Neurological Institute, McGill University, and NeuroRx Research — both in Montreal (D.L.A.); Children’s Hospital of Philadelphia (B.B.) and the Center for Neuroinflammation and Experimental Neurotherapeutics and the Department of Neurology (A.B.-O.), Perelman School of Medicine, University of Pennsylvania — all in Philadelphia; the Department of Neuropathology (W.B.) and the Department of Pediatrics and Adolescent Medicine, German Center for Multiple Sclerosis in Childhood and Adolescence (J.G.), University Medical Center Göttingen, Göttingen, and the Division of Pediatric Neurology, Children’s Hospital Datteln, Witten/Herdecke University, Datteln (K.R.) — all in Germany; Gallarate Hospital, Gallarate, Italy (A.G.); Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London (G.G.); the University of Texas Southwestern Medical Center, Children’s Health, Dallas (B.G.), and McGovern Medical School, University of Texas Health Science Center at Houston, Houston (J.S.W.) — both in Texas; Pediatric Multiple Sclerosis Center at NYU Langone, New York (L.K.); Hôpitaux Universitaires Paris-Sud, Assistance Publique–Hôpitaux de Paris, Paris (M.T.); the Department of Neurology, University of California at San Francisco, San Francisco (E.W.); Novartis Pharmaceuticals, East Hanover, NJ (T.S., Y.C., N.P.); and Novartis Pharma, Basel, Switzerland (M.M.)
– sequence: 13
  givenname: Amit
  surname: Bar-Or
  fullname: Bar-Or, Amit
  organization: From the Partners Pediatric Multiple Sclerosis Center, Massachusetts General Hospital, Boston (T.C.); Montreal Neurological Institute, McGill University, and NeuroRx Research — both in Montreal (D.L.A.); Children’s Hospital of Philadelphia (B.B.) and the Center for Neuroinflammation and Experimental Neurotherapeutics and the Department of Neurology (A.B.-O.), Perelman School of Medicine, University of Pennsylvania — all in Philadelphia; the Department of Neuropathology (W.B.) and the Department of Pediatrics and Adolescent Medicine, German Center for Multiple Sclerosis in Childhood and Adolescence (J.G.), University Medical Center Göttingen, Göttingen, and the Division of Pediatric Neurology, Children’s Hospital Datteln, Witten/Herdecke University, Datteln (K.R.) — all in Germany; Gallarate Hospital, Gallarate, Italy (A.G.); Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London (G.G.); the University of Texas Southwestern Medical Center, Children’s Health, Dallas (B.G.), and McGovern Medical School, University of Texas Health Science Center at Houston, Houston (J.S.W.) — both in Texas; Pediatric Multiple Sclerosis Center at NYU Langone, New York (L.K.); Hôpitaux Universitaires Paris-Sud, Assistance Publique–Hôpitaux de Paris, Paris (M.T.); the Department of Neurology, University of California at San Francisco, San Francisco (E.W.); Novartis Pharmaceuticals, East Hanover, NJ (T.S., Y.C., N.P.); and Novartis Pharma, Basel, Switzerland (M.M.)
– sequence: 14
  givenname: Tracy
  surname: Stites
  fullname: Stites, Tracy
  organization: From the Partners Pediatric Multiple Sclerosis Center, Massachusetts General Hospital, Boston (T.C.); Montreal Neurological Institute, McGill University, and NeuroRx Research — both in Montreal (D.L.A.); Children’s Hospital of Philadelphia (B.B.) and the Center for Neuroinflammation and Experimental Neurotherapeutics and the Department of Neurology (A.B.-O.), Perelman School of Medicine, University of Pennsylvania — all in Philadelphia; the Department of Neuropathology (W.B.) and the Department of Pediatrics and Adolescent Medicine, German Center for Multiple Sclerosis in Childhood and Adolescence (J.G.), University Medical Center Göttingen, Göttingen, and the Division of Pediatric Neurology, Children’s Hospital Datteln, Witten/Herdecke University, Datteln (K.R.) — all in Germany; Gallarate Hospital, Gallarate, Italy (A.G.); Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London (G.G.); the University of Texas Southwestern Medical Center, Children’s Health, Dallas (B.G.), and McGovern Medical School, University of Texas Health Science Center at Houston, Houston (J.S.W.) — both in Texas; Pediatric Multiple Sclerosis Center at NYU Langone, New York (L.K.); Hôpitaux Universitaires Paris-Sud, Assistance Publique–Hôpitaux de Paris, Paris (M.T.); the Department of Neurology, University of California at San Francisco, San Francisco (E.W.); Novartis Pharmaceuticals, East Hanover, NJ (T.S., Y.C., N.P.); and Novartis Pharma, Basel, Switzerland (M.M.)
– sequence: 15
  givenname: Yu
  surname: Chen
  fullname: Chen, Yu
  organization: From the Partners Pediatric Multiple Sclerosis Center, Massachusetts General Hospital, Boston (T.C.); Montreal Neurological Institute, McGill University, and NeuroRx Research — both in Montreal (D.L.A.); Children’s Hospital of Philadelphia (B.B.) and the Center for Neuroinflammation and Experimental Neurotherapeutics and the Department of Neurology (A.B.-O.), Perelman School of Medicine, University of Pennsylvania — all in Philadelphia; the Department of Neuropathology (W.B.) and the Department of Pediatrics and Adolescent Medicine, German Center for Multiple Sclerosis in Childhood and Adolescence (J.G.), University Medical Center Göttingen, Göttingen, and the Division of Pediatric Neurology, Children’s Hospital Datteln, Witten/Herdecke University, Datteln (K.R.) — all in Germany; Gallarate Hospital, Gallarate, Italy (A.G.); Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London (G.G.); the University of Texas Southwestern Medical Center, Children’s Health, Dallas (B.G.), and McGovern Medical School, University of Texas Health Science Center at Houston, Houston (J.S.W.) — both in Texas; Pediatric Multiple Sclerosis Center at NYU Langone, New York (L.K.); Hôpitaux Universitaires Paris-Sud, Assistance Publique–Hôpitaux de Paris, Paris (M.T.); the Department of Neurology, University of California at San Francisco, San Francisco (E.W.); Novartis Pharmaceuticals, East Hanover, NJ (T.S., Y.C., N.P.); and Novartis Pharma, Basel, Switzerland (M.M.)
– sequence: 16
  givenname: Norman
  surname: Putzki
  fullname: Putzki, Norman
  organization: From the Partners Pediatric Multiple Sclerosis Center, Massachusetts General Hospital, Boston (T.C.); Montreal Neurological Institute, McGill University, and NeuroRx Research — both in Montreal (D.L.A.); Children’s Hospital of Philadelphia (B.B.) and the Center for Neuroinflammation and Experimental Neurotherapeutics and the Department of Neurology (A.B.-O.), Perelman School of Medicine, University of Pennsylvania — all in Philadelphia; the Department of Neuropathology (W.B.) and the Department of Pediatrics and Adolescent Medicine, German Center for Multiple Sclerosis in Childhood and Adolescence (J.G.), University Medical Center Göttingen, Göttingen, and the Division of Pediatric Neurology, Children’s Hospital Datteln, Witten/Herdecke University, Datteln (K.R.) — all in Germany; Gallarate Hospital, Gallarate, Italy (A.G.); Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London (G.G.); the University of Texas Southwestern Medical Center, Children’s Health, Dallas (B.G.), and McGovern Medical School, University of Texas Health Science Center at Houston, Houston (J.S.W.) — both in Texas; Pediatric Multiple Sclerosis Center at NYU Langone, New York (L.K.); Hôpitaux Universitaires Paris-Sud, Assistance Publique–Hôpitaux de Paris, Paris (M.T.); the Department of Neurology, University of California at San Francisco, San Francisco (E.W.); Novartis Pharmaceuticals, East Hanover, NJ (T.S., Y.C., N.P.); and Novartis Pharma, Basel, Switzerland (M.M.)
– sequence: 17
  givenname: Martin
  surname: Merschhemke
  fullname: Merschhemke, Martin
  organization: From the Partners Pediatric Multiple Sclerosis Center, Massachusetts General Hospital, Boston (T.C.); Montreal Neurological Institute, McGill University, and NeuroRx Research — both in Montreal (D.L.A.); Children’s Hospital of Philadelphia (B.B.) and the Center for Neuroinflammation and Experimental Neurotherapeutics and the Department of Neurology (A.B.-O.), Perelman School of Medicine, University of Pennsylvania — all in Philadelphia; the Department of Neuropathology (W.B.) and the Department of Pediatrics and Adolescent Medicine, German Center for Multiple Sclerosis in Childhood and Adolescence (J.G.), University Medical Center Göttingen, Göttingen, and the Division of Pediatric Neurology, Children’s Hospital Datteln, Witten/Herdecke University, Datteln (K.R.) — all in Germany; Gallarate Hospital, Gallarate, Italy (A.G.); Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London (G.G.); the University of Texas Southwestern Medical Center, Children’s Health, Dallas (B.G.), and McGovern Medical School, University of Texas Health Science Center at Houston, Houston (J.S.W.) — both in Texas; Pediatric Multiple Sclerosis Center at NYU Langone, New York (L.K.); Hôpitaux Universitaires Paris-Sud, Assistance Publique–Hôpitaux de Paris, Paris (M.T.); the Department of Neurology, University of California at San Francisco, San Francisco (E.W.); Novartis Pharmaceuticals, East Hanover, NJ (T.S., Y.C., N.P.); and Novartis Pharma, Basel, Switzerland (M.M.)
– sequence: 18
  givenname: Jutta
  surname: Gärtner
  fullname: Gärtner, Jutta
  organization: From the Partners Pediatric Multiple Sclerosis Center, Massachusetts General Hospital, Boston (T.C.); Montreal Neurological Institute, McGill University, and NeuroRx Research — both in Montreal (D.L.A.); Children’s Hospital of Philadelphia (B.B.) and the Center for Neuroinflammation and Experimental Neurotherapeutics and the Department of Neurology (A.B.-O.), Perelman School of Medicine, University of Pennsylvania — all in Philadelphia; the Department of Neuropathology (W.B.) and the Department of Pediatrics and Adolescent Medicine, German Center for Multiple Sclerosis in Childhood and Adolescence (J.G.), University Medical Center Göttingen, Göttingen, and the Division of Pediatric Neurology, Children’s Hospital Datteln, Witten/Herdecke University, Datteln (K.R.) — all in Germany; Gallarate Hospital, Gallarate, Italy (A.G.); Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London (G.G.); the University of Texas Southwestern Medical Center, Children’s Health, Dallas (B.G.), and McGovern Medical School, University of Texas Health Science Center at Houston, Houston (J.S.W.) — both in Texas; Pediatric Multiple Sclerosis Center at NYU Langone, New York (L.K.); Hôpitaux Universitaires Paris-Sud, Assistance Publique–Hôpitaux de Paris, Paris (M.T.); the Department of Neurology, University of California at San Francisco, San Francisco (E.W.); Novartis Pharmaceuticals, East Hanover, NJ (T.S., Y.C., N.P.); and Novartis Pharma, Basel, Switzerland (M.M.)
BackLink https://www.ncbi.nlm.nih.gov/pubmed/30207920$$D View this record in MEDLINE/PubMed
https://hal.science/hal-02316528$$DView record in HAL
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10.1177/1352458511430704
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10.1177/135245859700300105
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Issue 11
Keywords Headache
Immunologic Factors
Brain
Administration
Relapsing-Remitting
Interferon-beta
Leukopenia
Humans
Fingolimod Hydrochloride
Male
Secondary Prevention
Oral
Intramuscular
Multiple Sclerosis
Infection
Magnetic Resonance Imaging
Injections
Adolescent
Female
Child
Language English
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SSID ssj0000149
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Snippet In 215 patients with a median age of 16 years, fingolimod was superior to interferon beta-1a in reducing relapses of multiple sclerosis and the accumulation of...
Background Treatment of patients younger than 18 years of age with multiple sclerosis has not been adequately examined in randomized trials. We compared...
BackgroundTreatment of patients younger than 18 years of age with multiple sclerosis has not been adequately examined in randomized trials. We compared...
Treatment of patients younger than 18 years of age with multiple sclerosis has not been adequately examined in randomized trials. We compared fingolimod with...
BACKGROUND: Treatment of patients younger than 18 years of age with multiple sclerosis has not been adequately examined in randomized trials. We compared...
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SubjectTerms Adults
Age
Body weight
Clinical trials
Convulsions
FDA approval
Interferon
Leukopenia
Life Sciences
Magnetic resonance imaging
Multiple sclerosis
NMR
Nuclear magnetic resonance
Patients
Pediatrics
Regulatory approval
Tachycardia
Technical communication
β-Interferon
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Title Trial of Fingolimod versus Interferon Beta-1a in Pediatric Multiple Sclerosis
URI https://nejm.org/doi/full/10.1056/NEJMoa1800149
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Volume 379
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