- |||||||||| Leustatin (cladribine) / J&J, Tecfidera (dimethyl fumarate) / Biogen, Mavenclad (cladribine) / EMD Serono
Review, Journal: Advances in oral immunomodulating therapies in relapsing multiple sclerosis. (Pubmed Central) - Jul 10, 2020 The oral immunomodulator laquinimod did not reach the primary endpoint of reduction in confirmed disability progression in a phase 3 trial of patients with relapsing multiple sclerosis...This treatment scheme might lead to higher efficacy but also to new safety concerns. These sequential treatments were largely excluded in phase 2 and 3 trials; therefore, monitoring both short-term and long-term effects of sequential disease-modifying therapies in phase 4 studies, cohort studies, and registries will be necessary.
- |||||||||| Tecfidera (dimethyl fumarate) / Biogen, Lemtrada (alemtuzumab) / Sanofi
Journal, Adverse events: Liver injury with drugs used for multiple sclerosis: A contemporary analysis of the FDA Adverse Event Reporting System. (Pubmed Central) - Jul 9, 2020 These sequential treatments were largely excluded in phase 2 and 3 trials; therefore, monitoring both short-term and long-term effects of sequential disease-modifying therapies in phase 4 studies, cohort studies, and registries will be necessary. These real-world pharmacovigilance findings suggest that DILI might be a common feature of MS drugs and call for (1) formal population-based study to verify the risk of fampridine and (2) awareness by clinicians, who should assess the possible responsibility of MS drugs when they diagnose DILI.
- |||||||||| apogossypol (CNDO103) / Fortress
Journal: Apogossypol-mediated reorganisation of the endoplasmic reticulum antagonises mitochondrial fission and apoptosis. (Pubmed Central) - Jul 7, 2020 However, neither genetic inhibition of DHODH using RNA interference nor metabolic supplementation with orotate or uridine to circumvent the consequences of a loss of DHODH activity rescued the effects of DHODH inhibitors, suggesting that the effects of these inhibitors in preventing ER membrane reorganisation is most likely independent of their ability to antagonise DHODH activity. Our results strengthen the hypothesis that ER is fundamental for key mitochondrial functions, such as fusion-fission dynamics and apoptosis.
- |||||||||| evobrutinib (M2951) / EMD Serono
Enrollment open: EVOLUTION RMS1: Study of Evobrutinib in Participants With RMS (evolutionRMS 1) (clinicaltrials.gov) - Jul 1, 2020 P3, N=930, Recruiting, In conclusion, our findings suggest that teriflunomide alleviates inflammation in EAU mice by down-regulating Th17 and Th1 cells and suppresses the maturation and function of DCs for the first time. Not yet recruiting --> Recruiting
- |||||||||| Tysabri (natalizumab) / Biogen, Royalty
Enrollment open: MAIN STUDY: SWITCH SUB-STUDY: SWITCH-JCV (clinicaltrials.gov) - Jun 17, 2020 P4, N=70, Recruiting, Several factors are associated with higher switch risk in patients starting a first-line therapy and could be integrated in the decision-making process of first treatment choice. Active, not recruiting --> Recruiting
- |||||||||| Tecfidera (dimethyl fumarate) / Biogen
Clinical, Journal: Assessment of safety and effectiveness of oral multiple sclerosis medication. (Pubmed Central) - May 28, 2020 The study results were able to capture the effectiveness rate for the targeted treatment in the studied population, with the frequency of incidence of side effects. However, as these results cannot be generalized for the entire Saudi population.
- |||||||||| teriflunomide / Generic mfg.
Journal: Teriflunomide Does Not Change Dynamics of Nadph Oxidase Activation and Neuronal Dysfunction During Neuroinflammation. (Pubmed Central) - May 20, 2020 Concerning drug safety, we can confirm that teriflunomide has no metabolic effects on neuronal function in the CNS tissue during neuroinflammation at concentrations expected in orally treated patients. The combined endogenous FLIM and calcium imaging approach developed by us and employed here uniquely meets the need to monitor cellular metabolism as a basic mechanism of tissue functions in vivo.
- |||||||||| Tysabri (natalizumab) / Biogen, Royalty
Trial completion date: MAIN STUDY: SWITCH SUB-STUDY: SWITCH-JCV (clinicaltrials.gov) - May 19, 2020 P4, N=70, Active, not recruiting, The combined endogenous FLIM and calcium imaging approach developed by us and employed here uniquely meets the need to monitor cellular metabolism as a basic mechanism of tissue functions in vivo. Trial completion date: Dec 2020 --> Dec 2021
- |||||||||| teriflunomide / Generic mfg.
Trial completion date, Trial primary completion date: AUBACOG: Cognition and MRI Markers in MS Patients With Aubagio (clinicaltrials.gov) - May 17, 2020 P=N/A, N=80, Recruiting, Trial completion date: Dec 2020 --> Dec 2021 Trial completion date: May 2022 --> May 2023 | Trial primary completion date: May 2022 --> May 2023
- |||||||||| Tecfidera (dimethyl fumarate) / Biogen, Mavenclad (cladribine) / EMD Serono, Lemtrada (alemtuzumab) / Sanofi
Clinical, Review, Journal: Immune Reconstitution Therapy or Continuous Immunosuppression for the Management of Active Relapsing-Remitting Multiple Sclerosis Patients? A Narrative Review. (Pubmed Central) - Apr 17, 2020 Among continuously applied regimens, interferons and glatiramer acetate act as immunomodulators, while dimethyl fumarate, fingolimod, ocrelizumab, natalizumab and teriflunomide are associated with continuous immunosuppression...A short treatment course of a pharmacologic agent hypothesized to act as an IRT, such as Cladribine Tablets 3.5 mg/kg or alemtuzumab, can provide long-term suppression of MS disease activity, without need for continuous treatment (the anti-CD20 mechanism of ocrelizumab has the potential to act as an IRT, but is administered continuously, at 6-monthly intervals)...The introduction of IRT-like disease-modifying drugs (DMDs) challenges the traditional maintenance/escalation mode of treatment and raises new questions about how disease activity is measured. In this review, we consider a modern classification of DMDs for MS and its implications for the care of patients in the IRT era.
- |||||||||| Arzerra (ofatumumab) / Novartis, Genmab
[VIRTUAL] Early Effect of Ofatumumab on B-cell Counts and MRI Activity in Relapsing Multiple Sclerosis Patients: Results from the APLIOS Study (Room Istanbul) - Apr 9, 2020 - Abstract #EAN2020EAN_2316; Background and aims: Ofatumumab, the 1 fully human anti-CD20 monoclonal antibody with a monthly 20mg subcutaneous (s.c.) dosing regimen, of gadolinium- enhancing (Gd+) lesions versus teriflunomide in the Phase 3 ASCLEPIOS I/II relapsing multiple sclerosis (RMS) trials. Ofatumumab treatment resulted in a rapid, close-to-complete and sustained B-cell depletion over 12 weeks, leading to a profound reduction of Gd+ lesions in RMS patients, consistent with the effects observed in the pooled Phase 3 ASCLEPIOS I/II population.
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