ArticleMultiple sclerosis journal - experimental, translational and clinical
A comparison of multiple sclerosis disease activity after discontinuation of fingolimod and placebo.
Article in Multiple sclerosis journal - experimental, translational and clinical. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 1 of them a synthesis that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
17 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Immunomodulators and immunosuppressants for relapsing-remitting multiple sclerosis: a network meta-analysis.The Cochrane database of systematic reviews · 2024Pooled it
- Article
- Impact of Fingolimod Discontinuation Strategy on Recurrence of Disease Activity in Individuals With Multiple Sclerosis.International journal of MS care · 2024Article
- Risk of TBrain communications · 2024Article
- Multiple Sclerosis Disease Activity and Disability Following Cessation of Fingolimod for Pregnancy.Neurology(R) neuroimmunology & neuroinflammation · 2023Article
- Evaluation of frequency, severity, and independent risk factors for recurrence of disease activity after fingolimod discontinuation in a large real-world cohort of patients with multiple sclerosis.Therapeutic advances in neurological disorders · 2023Article
- Clickable Biomaterials for Modulating Neuroinflammation.International journal of molecular sciences · 2022Review
- Transitioning From S1P Receptor Modulators to B Cell-Depleting Therapies in Multiple Sclerosis: Clinical, Radiographic, and Laboratory Data.Neurology(R) neuroimmunology & neuroinflammation · 2022Article
- What happens after fingolimod discontinuation? A multicentre real-life experience.Journal of neurology · 2022Article
- Abuse and dependence potential of sphingosine-1-phosphate (S1P) receptor modulators used in the treatment of multiple sclerosis: a review of literature and public data.Psychopharmacology · 2022Review
- Case Report: Persisting Lymphopenia During Neuropsychiatric Tumefactive Multiple Sclerosis Rebound Upon Fingolimod Withdrawal.Frontiers in neurology · 2021Article
- Fingolimod Rebound: A Review of the Clinical Experience and Management Considerations.Neurology and therapy · 2019Review
- Outcomes after fingolimod to alemtuzumab treatment shift in relapsing-remitting MS patients: a multicentre cohort study.Journal of neurology · 2019Article
- Severe Exacerbation of Multiple Sclerosis Following Withdrawal of Fingolimod.Clinical drug investigation · 2019Review
- Different MRI patterns in MS worsening after stopping fingolimod.Neurology(R) neuroimmunology & neuroinflammation · 2019Article
- Severe rebound after cessation of fingolimod treated with ocrelizumab with coincidental transient aggravation: report of two cases.Therapeutic advances in neurological disorders · 2019Article
- Extensive Multiple Sclerosis Reactivation after Switching from Fingolimod to Rituximab.Case reports in neurological medicine · 2018Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundCases of higher-than-expected disease activity have been reported following fingolimod discontinuation.
objectiveThe objective of this paper is to assess the risk of substantially higher-than-expected disease activity post-study drug discontinuation (SDD) at the individual patient level using data from the Phase III, placebo-controlled FREEDOMS and FREEDOMS II trials.
methodsBaseline gadolinium-enhancing T1-lesion volumes were used to statistically model the expected level of MRI disease activity post-SDD. Patients exceeding this level were classed as "MRI outliers." Patients with an unusually high increase in Expanded Disability Status Scale score, hospitalization for relapse, severe relapse, or relapse with incomplete recovery post-SDD were classed as "clinical outliers."
resultsIn FREEDOMS, the number of MRI outliers post-SDD was 2/69 (2.9%), 1/65 (1.5%) and 7/83 (8.4%) for the placebo, fingolimod 0.5 mg, and fingolimod 1.25 mg groups, respectively. In FREEDOMS II, the corresponding numbers were 4/72 (5.6%), 6/79 (7.6%) and 3/73 (4.1%). The number of clinical outliers across both trials was low. No consistent evidence of placebo vs fingolimod, dose-related or inter-trial patterns was discernable.
conclusionThe low number of clinical and MRI outliers and lack of any discernible pattern within and between trials, including between placebo and fingolimod, argues against a systematic risk of higher-than-expected recurrence of disease activity following discontinuation of fingolimod.
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