Related Experiment Video
Updated: Jun 17, 2026
Two-photon Imaging of Cellular Dynamics in the Mouse Spinal Cord
Published on: February 22, 2015
Comparative Effectiveness of Natalizumab, Fingolimod, and Injectable Therapies in Pediatric-Onset Multiple Sclerosis:
Tim Spelman1, Gabrielle Simoneau1, Robert Hyde1
1From the MSBase Foundation (T.S.), Melbourne, Australia; Department of Clinical Neuroscience (T.S.), Karolinska Institute, Stockholm, Sweden; Biogen (G.S.), Toronto, Ontario, Canada; Biogen (R.H., Robert Kuhelj), Baar, Switzerland; Division of Neurology (R.A.), Department of Medicine, Amiri Hospital, Sharq, Kuwait; Dokuz Eylul University (S.O.), Konak/Izmir; Hacettepe University (Rana Karabudak), Ankara, Turkey; Nehme and Therese Tohme Multiple Sclerosis Center (B.I.Y., S.J.K.), American University of Beirut Medical Center, Lebanon; 19 Mayis University (M.T.), Samsun; KTU Medical Faculty Farabi Hospital (C.B.), Trabzon, Turkey; Department of Neurology and Center of Clinical Neuroscience (D.H., E.K.H.), First Faculty of Medicine, Charles University in Prague and General University Hospital, Czech Republic; Department of Neurology (B.W.-G.), Buffalo General Medical Center, Buffalo, NY; Department of Medical and Surgical Sciences and Advanced Technologies (F.P.), GF Ingrassia, Catania, Italy; Department of Neurology (A.A.), School of Medicine and Koc University Research Center for Translational Medicine (KUTTAM), Koc University, Istanbul, Turkey; Department of Neurology and Clinical Investigation Center Neurosciences and Mental Health (S.M.), Razi University Hospital; Department of Neurology (R.G.), Razi University Hospital, Tunis, Tunisia; Rashid Hospital (J.I.), Dubai, United Arab Emirates; Isfahan University of Medical Sciences (V.S.), Iran; Department of Neurology (S.E.), Hospital Universitario Virgen Macarena, Sevilla, Spain; Ashfield MedComms (W.L.W.), Middletown, CT; Department of Neuroscience (H.B.), Central Clinical School, Monash University, Melbourne; and Department of Neurology (H.B.), Box Hill Hospital, Monash University, Box Hill, Victoria, Australia.
Insights
Natalizumab is more effective than fingolimod in reducing relapses for pediatric multiple sclerosis (MS) patients. Both treatments outperformed older injectable therapies, offering better disease control for children with MS.
Area of Science:
- Neurology
- Immunology
- Pediatrics
Background:
- Pediatric-onset multiple sclerosis (POMS) presents with high inflammation and frequent relapses.
- Children with POMS experience better relapse recovery but reach irreversible disability earlier than adults.
- Limited randomized trials exist for POMS; most data comes from observational studies of adult-approved therapies.
Purpose of the Study:
- To compare the effectiveness of natalizumab and fingolimod in pediatric MS patients.
- To evaluate treatment efficacy against injectable disease-modifying therapies (DMTs) as a reference.
- To analyze relapse risk and disability progression in POMS patients treated with different DMTs.
Main Methods:
- Retrospective study of 1,218 POMS patients from the MSBase registry (2006-2021).
- Inclusion of patients initiating natalizumab, fingolimod, or injectable DMTs.
- Inverse probability treatment weighting (IPTW) for patient matching and analysis of outcomes including time to first relapse, relapse rates, and disability progression.
Main Results:
- Fingolimod showed a significantly lower relapse risk compared to injectable DMTs (HR 0.49, p=0.008).
- Natalizumab demonstrated a significantly lower relapse risk than both injectable DMTs (HR 0.15, p<0.001) and fingolimod (HR 0.37, p=0.049).
- Secondary outcomes and sensitivity analyses confirmed these findings, indicating natalizumab's superior efficacy in relapse control.
Conclusions:
- Natalizumab is more effective than fingolimod for controlling relapses in POMS patients.
- Both natalizumab and fingolimod are more effective than first-line injectable therapies for POMS.
- Findings align with previous studies in adult MS and POMS, supporting natalizumab's role in managing inflammatory activity.
Background And Objectives:
Patients with pediatric-onset multiple sclerosis (POMS) typically experience higher levels of inflammation with more frequent relapses, and though patients with POMS usually recover from relapses better than adults, patients with POMS reach irreversible disability at a younger age than adult-onset patients. There have been few randomized, placebo-controlled clinical trials of multiple sclerosis (MS) disease-modifying therapies (DMTs) in patients with POMS, and most available data are based on observational studies of off-label use of DMTs approved for adults. We assessed the effectiveness of natalizumab compared with fingolimod using injectable platform therapies as a reference in pediatric patients in the global MSBase registry.
Methods:
This retrospective study included patients with POMS who initiated treatment with an injectable DMT, natalizumab, or fingolimod between January 1, 2006, and May 3, 2021. Patients were matched using inverse probability treatment weighting. The primary outcome was time to first relapse from index therapy initiation. Secondary study outcomes included annualized relapse rate; proportions of relapse-free patients at 1, 2, and 5 years; time to treatment discontinuation; and times to 24-week confirmed disability worsening and confirmed disability improvement.
Results:
A total of 1,218 patients with POMS were included in this analysis. Patients treated with fingolimod had a significantly lower risk of relapse than patients treated with injectable DMTs (hazard ratio [HR], 0.49; 95% confidence interval [CI], 0.29-0.83; p = 0.008). After adjustment for prior DMT experience in the unmatched sample, patients treated with natalizumab had a significantly lower risk of relapse than patients treated either with injectable DMTs (HR, 0.15; 95% CI 0.07-0.31; p < 0.001) or fingolimod (HR, 0.37; 95% CI 0.14-1.00; p = 0.049). The adjusted secondary study outcomes were generally consistent with the primary outcome or with previous observations. The findings in the inverse probability treatment weighting-adjusted patient populations were confirmed in multiple sensitivity analyses.
Discussion:
Our analyses of relapse risk suggest that natalizumab is more effective than fingolimod in the control of relapses in this population with high rates of new inflammatory activity, consistent with previous studies of natalizumab and fingolimod in adult-onset patients and POMS. In addition, both fingolimod and natalizumab were more effective than first-line injectable therapies.
Classification Of Evidence:
This study provides Class II evidence that patients with POMS treated with natalizumab had a lower risk of relapse than those with fingolimod.
More Related Videos
09:38Determining Immune System Suppression versus CNS Protection for Pharmacological Interventions in Autoimmune Demyelination
Published on: September 12, 2016
05:44Author Spotlight: Creating a Versatile Experimental Autoimmune Encephalomyelitis Model Relevant for Both Male and Female Mice
Published on: October 13, 2023
Related Concept Videos
01:29Drugs for Treatment of Crohn's Disease in IBD Using Immunomodulatory Agents
01:24Drugs for Treatment of Crohn's Disease in IBD Using Biologic Agents: Anti-TNF
01:27Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence
01:21Drug Accumulation During Multiple Dosing: Repetitive IV Injections
01:23Pharmacokinetics in Pediatric Patients: Overview and Drug Absorption
01:19Multiple Sclerosis l: Introduction