- |||||||||| A real-world study of Alemtuzumab in a cohort of Italian patients (Poster Exhibition) - Aug 28, 2019 - Abstract #ECTRIMS2019ECTRIMS_1043;
Alemtuzumab decreases ARR independent of previous therapy, including patients with disease activity during Natalizumab. Relapses between treatment courses are associated with higher disease activity during follow-up.
- |||||||||| Tecfidera (dimethyl fumarate) / Biogen
Cumulative DMT exposure influence on the immune system in patients under oral DMT (Poster Exhibition) - Aug 28, 2019 - Abstract #ECTRIMS2019ECTRIMS_1028;
Our results suggest that for a given oral DMT, the lymphocyte count depends mostly on the current treatment. Although the contribution of total cumulative DMT on lymphocyte depletion was mild, it should be taken into account in patients under oral DMT, particularly in cases of high cumulative DMT exposure.
- |||||||||| teriflunomide / Generic Mfg.
Title:miRNA profiling in Teriflunomide treated multiple sclerosis (MS) patients (Poster Exhibition) - Aug 28, 2019 - Abstract #ECTRIMS2019ECTRIMS_744;
We obtained serum miRNA profiles in MS patients initiating teriflunomide treatment. Our analysis identified a number of miRNAs that were differentially expressed in pre-treatment vs. on treatment serum samples from MS patients on teriflunomide treatment.
- |||||||||| Tysabri (natalizumab) / Biogen, Tecfidera (dimethyl fumarate) / Biogen
Natalizumab usage in Denmark - report from the Danish National Multiple Sclerosis Registry (Poster Exhibition) - Aug 28, 2019 - Abstract #ECTRIMS2019ECTRIMS_713;
Natalizumab treatment termination typically results from JC virus status or anti-natalizumab antibodies and very infrequently due to lack of efficacy and adverse events. Most treatment switches from natalizumab are to other high-efficacy therapies.
- |||||||||| A Danish nationwide pharmacoepidemiological study of treatment with teriflumonide (Poster Exhibition) - Aug 28, 2019 - Abstract #ECTRIMS2019ECTRIMS_704;
This study provides timely and meaningful information on TFL treatment patterns from the entire Danish MS population treated with TFL. Although observational studies are weaker methodologically than randomized trials, they have a number of distinct advantages, particularly in examining the frequency of events in real-life settings and not on selected sub-groups of patients.
- |||||||||| The Burden of Treatment Monitoring for Patients and Physicians in Multiple Sclerosis (MS) in Europe and The United States (Poster Exhibition) - Aug 28, 2019 - Abstract #ECTRIMS2019ECTRIMS_649;
57% of HCPs in 5EU and 57% in US, associated platform injectables (Interferons and glatiramer acetate) with low monitoring burden compared to 11% (5EU) and 11% (US) who associate this with the mAbs (alemtuzumab, natalizumab, ocrelizumab) and 19% (5EU) and 23% (US) with the orals (fingolimod, dimethyl fumarate, teriflunomide, cladribine (5EU only))...However, for patients, monitoring is a reassurance. This highlights a potential disconnect between HCP and patient perceptions that could be impacting treatment choice and, as such, warrants further investigation.
- |||||||||| Tecfidera (dimethyl fumarate) / Biogen, Lemtrada (alemtuzumab) / Sanofi
Do real world studies include real world patients in MS? (Poster Exhibition) - Aug 28, 2019 - Abstract #ECTRIMS2019ECTRIMS_488;
We did not observe significant differences in clinical and demographic aspects of included patients in RCCT and RWS. More studies that include all the diversity of the spectrum of MS patients followed in clinical practice are needed to better understand the effectiveness and safety profile of old and new MS treatments in patients different from the ones that entered to RCCT
- |||||||||| Tysabri (natalizumab) / Biogen, Tecfidera (dimethyl fumarate) / Biogen
Treatment choice after Natalizumab discontinuation: results from an Italian multicenter retrospective study (Poster Exhibition) - Aug 28, 2019 - Abstract #ECTRIMS2019ECTRIMS_440;
Out of them, 2,483 (45.3%) discontinued NTZ treatment; 1000 (40.3%) were then treated with fingolimod, 483 (19.5%) with glatiramer acetate, 308 (12.4%) with interferons, 224 (9.0%) with other immunosuppressive drugs, 224 (9.0%) with dimethyl fumarate, 137 (5.5%) with alemtuzumab, and 107 (4.3%) with teriflunomide. Stratifying according to the age at NTZ initiation, we found that patients older than 40 years and patients with EDSS higher than 4.0, were treated more frequently with interferons compared to patients younger than 40 and to patients with EDSS lower than 4.0 (227 [17.8%] versus 81 [6.7%], p< 0.05; 253 [21.7] versus 55 [4.2], p< 0.05, respectively).
- |||||||||| Tecfidera (dimethyl fumarate) / Biogen, Lemtrada (alemtuzumab) / Sanofi
DMTs Drop out analysis: 10 years follow-up in a cohort of relapsing-remitting multiple sclerosis patients in Argentina (Poster Exhibition) - Aug 28, 2019 - Abstract #ECTRIMS2019ECTRIMS_354;
352 DMS patients treated with at least one of the available DMTs:Interferons(IFNs),GlatiramerAcetate(GA),Fingolimod(FTY),Teriflunomide(TRF),Dimethylfumarate(DMF),Alemtuzumab(ALZ),Natalizumab(NTZ)... After 10years of F-U,59% patients remain on their first therapy.41% stopped treatment.LoE and SAE were the main reasons of discontinuation.97% had LTFU.These results confirm that efficacy, tolerability and close LTFU have strong influence in adherence to treatment.
- |||||||||| Tecfidera (dimethyl fumarate) / Biogen, Lemtrada (alemtuzumab) / Sanofi
TREAT-MS study of real-world effectiveness of alemtuzumab in RRMS patients in Germany: subgroup analysis by number of prior disease-modifying therapies (Poster Exhibition) - Aug 28, 2019 - Abstract #ECTRIMS2019ECTRIMS_335;
Treatments immediately prior to enrolment were fingolimod (21.6%), natalizumab (14.9%), IFNB preparations (9.0%), dimethyl fumarate (8.2%), glatiramer acetate (5.8%), teriflunomide (2.2%), other/unknown (23.6%), or none (14.8%)... These interim analyses show stable EDSS scores and reduced relapses with alemtuzumab regardless of number of prior DMTs, and support registration trial findings in real-world patients with longer disease duration and varied treatment history.
- |||||||||| Lemtrada (alemtuzumab) / Sanofi
Safety and efficacy of various DMTs in MS patients who failed Alemtuzumab Therapy (Poster Exhibition) - Aug 28, 2019 - Abstract #ECTRIMS2019ECTRIMS_334;
Limitations: Our study represents real world data with a small number of subjects and variable duration of treatment. The results of the study suggests that patients who demonstrate evidence of disease activity on Alemtuzumab therapy can be safely transitioned to Ocrelizumab therapy with acceptable efficacy and safety profile.
- |||||||||| Tecfidera (dimethyl fumarate) / Biogen
Therapeutic lag in relapsing multiple sclerosis (Poster Exhibition) - Aug 28, 2019 - Abstract #ECTRIMS2019ECTRIMS_316;
Time to full effect (the 'therapeutic lag') varies among therapies. This method will be applied in studies that will evaluate the effect of patient and disease characteristics on therapeutic lag.
- |||||||||| Tecfidera (dimethyl fumarate) / Biogen, Lemtrada (alemtuzumab) / Sanofi
Clinical and patient reported outcomes in multiple sclerosis patients on disease modifying therapies (Poster Exhibition) - Aug 28, 2019 - Abstract #ECTRIMS2019ECTRIMS_289;
This study shows that low efficacy treatment can be effective for some patients with no significant increase in EDSS or worsening of patient reported outcomes over 10 years. The higher efficacy treatments produce a greater reduction in EDSS and GNDS, as well as an increase in LMSQoL scores demonstrating an improvement in patient reported well-being.
- |||||||||| Tecfidera (dimethyl fumarate) / Biogen
The management of RIS (Hall E) - Aug 28, 2019 - Abstract #ECTRIMS2019ECTRIMS_228;
Many experts groups in the USA, Europe and South America have proposed guidelines to follow the RIS subjects. The recommendation is not to treat off label these subjects as 2 phases 3 studies are on going in USA and Europe with dimethylfumarate and teriflunomide.
- |||||||||| Tecfidera (dimethyl fumarate) / Biogen
Against (Hall C) - Aug 28, 2019 - Abstract #ECTRIMS2019ECTRIMS_94;
First line therapies (interferon-beta, glatiramer acetate, teriflunomide, and dimethyl fumarate ) are often prescribed when newly diagnosed active multiple sclerosis (MS) patients have good prognostic signs and are early in the window of opportunity...As regards long term benefit, the results of the largest, prospective, long term(10 years), observational UK trial showed that first line injectables had a clinically significant effect on the expanded disability status scale (EDSS) progression. Perhaps, the main problem is the convenience, compliance and adherence, nevertheless, there are many clinical situations in which the first line injectables are the best choice of all first line therapies.
- |||||||||| teriflunomide / Generic Mfg.
Journal: Mom Controls the Thermostat: Mitochondria Influence the Neuronal Firing Set Point. (Pubmed Central) - Aug 27, 2019
In vivo, teriflunomide decreased CA3-CA1 synaptic transmission and CA1 mean firing rate and attenuated susceptibility to seizures, even in the intractable Dravet syndrome epilepsy model. Our results uncover mitochondria as a key regulator of activity set points, demonstrate the differential regulation of set points and compensatory mechanisms, and propose a new strategy to treat epilepsy.
- |||||||||| Tecfidera (dimethyl fumarate) / Biogen, Plegridy (PEG-interferon β-1a) / Biogen
Reimbursement, Journal, Medicare: Trends in Prices, Market Share, and Spending on Self-administered Disease-Modifying Therapies for Multiple Sclerosis in Medicare Part D. (Pubmed Central) - Aug 27, 2019
...All prescription claims for self-administered DMTs for MS (glatiramer acetate, interferon beta-1a, interferon beta-1b, fingolimod hydrochloride, teriflunomide, dimethyl fumarate, and peginterferon beta-1a) were extracted throughout the study period...Platform therapies experienced a substantial drop from 2006 to 2016 in favor of newer therapies, with decreases in the market shares of brand-name glatiramers (per 1000 Medicare beneficiaries: $2861 of $7794 [36.7%] to $25 552 of $79 411 [32.2%]), interferon beta-1a (30 µg; per 1000 Medicare beneficiaries: $2521 of $7794 [32.3%] to $11 298 of $79 411 [14.2%]), interferon beta-1b (Betaseron; per 1000 Medicare beneficiaries: $1460 of $7794 [18.7%] to $3588 of $79 411 [4.5%]), and interferon beta-1a (8.8/22/44 µg; per 1000 Medicare beneficiaries: $951 of $7794 [12.2%] to $6588 of $79 411 [8.3%]) and increases in fingolimod (to $6311 of $79 411 per 1000 Medicare beneficiaries [7.9%]), teriflunomide (to $7177 of $79 411 per 1000 Medicare beneficiaries [9.0%]), and dimethyl fumarate (to $15 262 of $79 411 per 1000 Medicare beneficiaries [19.2%])...Per this analysis, prices of self-administered DMTs for MS increased dramatically between 2006 and 2016. This resulted in a 7.2-fold increase in patient out-of-pocket costs.
- |||||||||| Tecfidera (dimethyl fumarate) / Biogen, Zinbryta (daclizumab) / Biogen, AbbVie, Lemtrada (alemtuzumab) / Sanofi
Clinical, Review, Journal: Preapproval and postapproval evidence on drugs for multiple sclerosis. (Pubmed Central) - Aug 15, 2019
These results suggest that TEF W/O microemulsion can be used as a promising preparation to play an anti-inflammatory role while significantly reducing hepatotoxicity. The lack of comparative evidence and data on clinical effectiveness hamper the assessment of therapeutic value and place in therapy of drugs approved for MS.
- |||||||||| Ponvory (ponesimod) / Juvise Pharma, Vanda
Trial completion, Head-to-Head: OPTIMUM: Oral Ponesimod Versus Teriflunomide In Relapsing MUltiple Sclerosis (clinicaltrials.gov) - Aug 14, 2019
P3, N=1133, Completed,
The lack of comparative evidence and data on clinical effectiveness hamper the assessment of therapeutic value and place in therapy of drugs approved for MS. Active, not recruiting --> Completed
- |||||||||| cladribine / Generic mfg., Mavenclad (cladribine) / EMD Serono, Lemtrada (alemtuzumab) / Sanofi
Biomarker, Clinical, Review, Journal, IO biomarker: Comprehensive systematic review summary: Disease-modifying therapies for adults with multiple sclerosis: Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology. (Pubmed Central) - Aug 7, 2019
For people with primary progressive MS, ocrelizumab is probably more effective than placebo (in-study disease progression)...Cladribine, immunoglobulins, IFN-β-1a 30 μg intramuscular weekly, IFN-β-1b subcutaneous alternate day, and teriflunomide are probably more effective than placebo in decreasing risk of conversion to MS. Suggestions for future research include studies considering comparative effectiveness, usefulness of high-efficacy treatment vs stepped-care protocols, and research into predictive biomarkers.
- |||||||||| teriflunomide / generics
Journal: Teriflunomide Modulates Vascular Permeability and Microglial Activation after Experimental Traumatic Brain Injury. (Pubmed Central) - Aug 7, 2019
Our results show that teriflunomide restores blood-brain barrier integrity, decreases inflammation, and increases neurogenesis in the subgranular zone of the hippocampus. While we were unable to detect neurocognitive effects of treatment on memory and special learning abilities after treatment, a 2-week treatment following injury was sufficient to reduce neuroinflammation up to 120 days later.
- |||||||||| Azulfidine (sulfasalazine) / Generic Mfg.
Journal: Correlation Analysis of Potential BCRP Probes in Different Monolayer Systems. (Pubmed Central) - Aug 7, 2019
In this paper the in vitro performance of five possible alternatives is evaluated: atorvastatin (AVS), chlorothiazide (CHT), dantrolene (DAN), topotecan (TPT), and teriflunomide (TRF), and benchmarked against SSZ and RVS in reference in vitro assays for BCRP DDI testing. Based on the results TRF is proposed as an alternate in vitro BCRP probe.
- |||||||||| teriflunomide / generics
Review, Journal: Teriflunomide: A Review in Relapsing-Remitting Multiple Sclerosis. (Pubmed Central) - Jul 26, 2019
In pivotal RCTs in this patient population, teriflunomide provided significantly better efficacy than placebo (TEMSO and TOWER) and was as effective as interferon β-1a (TENERE) in terms of improvements in clinical outcomes (such as reduced annualized relapse rates, prevention of disability progression) and/or MRI-assessed disease activity measures. Albeit head-to-head trials would definitively establish the relative efficacy of oral disease-modifying therapies, given its convenient oral regimen and beneficial effects in reducing relapses and disease activity, teriflunomide remains an effective option for the management of relapsing-remitting MS (RRMS).
- |||||||||| Tecfidera (dimethyl fumarate) / Biogen
Clinical, Journal: Real life use of oral disease modifying treatments in Austria. (Pubmed Central) - Jul 19, 2019
Hence it can be inferred that the nose-to-brain delivery of TFM-MNLC can be considered as effective and safe delivery for brain disorders. In the AMSTR, there was no difference concerning ARR, probability for a relapse, EDSS change, treatment interruption, EDSS progression or regression between oral DMTs, except regarding less sustained EDSS progression for 12 weeks concerning DMF vs fingolimod.
- |||||||||| Jynarque (tolvaptan) / Otsuka, Daliresp (roflumilast) / Allergan, AstraZeneca, Takeda
FDA event, Journal: Unveiling some FDA-approved drugs as inhibitors of the store-operated Ca(2+) entry pathway. (Pubmed Central) - Jul 1, 2019
Of these drugs, leflunomide and teriflunomide could suppress SOCE significantly at clinically-relevant doses and this provides for an additional mechanism towards the therapeutic utility of these drugs as immunosuppressants. The other three drugs namely lansoprazole, tolvaptan and roflumilast, were less potent in suppressing SOCE but were more selective and thus they may serve as novel scaffolds for future development of new, more efficacious SOCE inhibitors.
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