- |||||||||| Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche, Lemtrada (alemtuzumab) / Sanofi
[VIRTUAL] Propensity-matched comparison of early intensive and escalation treatment strategy in Finnish MS patients () - Dec 8, 2020 - Abstract #AECF2020AECF_157;
A total of 127 MS patients who initiated infusion therapy as first disease modifying therapy (DMT) within 3 years of relapsing MS diagnosis (EIT group) and 1620 patients initially treated with injectable therapies, teriflunomide or dimethylfumarate (ESC group), were identified from four hospital districts...In the EIT group, 43 patients were treated with natalizumab, 3 with rituximab and 9 with alemtuzumab... EIT resulted in lower risk and longer time to disability progression than ESC strategy.
- |||||||||| dimethyl fumarate / Generic mfg.
[VIRTUAL] Comorbidity and persistence of disease-modifying therapy use for relapsing remitting multiple sclerosis () - Dec 8, 2020 - Abstract #AECF2020AECF_142;
We identified individuals with relapsing remitting multiple sclerosis (RRMS) or clinically isolated syndrome (CIS) starting a platform DMT (interferon-b, glatiramer acetate, teriflunomide, dimethyl fumarate) as initial therapy in the province of Nova Scotia, Canada from 2001 to 2016.Cases were identified using a database maintained at the only clinic providing specialty MS care in a province with universal publicly-funded healthcare...Comorbidity was not associated with DMT discontinuation for lack of efficacy. Individuals with higher comorbidity burden, and particularly mental health comorbidity should be monitored for barriers to continuing DMT after treatment initiation.
- |||||||||| Kesimpta (ofatumumab subcutaneous) / Novartis, Genmab
[VIRTUAL] Serum Immunoglobulin Levels and Infections in Relapsing Multiple Sclerosis () - Dec 8, 2020 - Abstract #AECF2020AECF_127;
More information, especially longer follow-up, is needed to understand the association of risk of infections with IgM/IgG<LLN. This study was funded by Novartis Pharma AG, Basel, Switzerland.A detailed disclosure from each author will be included in the poster presentation.Data have been previously presented at the 8th Joint ACTRIMS-ECTRIMS Meeting, MSVirtual2020, September 11-13, 2020.
- |||||||||| teriflunomide / Generic mfg.
Clinical, Journal: Slowing of brain atrophy with teriflunomide and delayed conversion to clinically definite MS. (Pubmed Central) - Nov 28, 2020
In patients with the least (bottom quartile) versus most (top quartile) atrophy during years 1-2, risk of CDMS conversion was reduced by 58% (CGM; p = 0.0024) and 58% (WB; p = 0.0028) during years 1-2, and 42% (CGM; p = 0.0138) and 29% (WB; p = 0.1912) during years 1-5. These findings support the clinical relevance of CGM and WB atrophy and early intervention with teriflunomide in CIS.
- |||||||||| dimethyl fumarate / Generic mfg.
Journal: Exit strategies for "needle fatigue" in multiple sclerosis: a propensity score-matched comparison study. (Pubmed Central) - Nov 25, 2020
In this independent, multicentre post-marketing study, we sought to directly compare switching to either teriflunomide (TFN), dimethyl fumarate (DMF), or pegylated interferon (PEG) on treatment persistence and time to first relapse over a 12-month follow-up...The low number of patients who relapsed over the 12-month follow-up (25 out of 621, approximately 4%) prevented any analysis on the short-term risk of relapse. This real-world study suggests that oral drugs are a better switching option than low-frequency interferon for promoting the short-term treatment persistence in stable patients who do not tolerate injectable drugs.
- |||||||||| Leustatin (cladribine) / J&J
Journal: MSCOVID19: Using social media to achieve rapid dissemination of health information. (Pubmed Central) - Nov 2, 2020
The cases shared present the earliest reported data on outcomes of COVID-19 infection in pwMS. Whilst limited, the cautiously reassuring nature of these early cases assisted in clinical management by allowing neurologists to continuously reassess their approach to DMT management.
- |||||||||| Leustatin (cladribine) / J&J, Lemtrada (alemtuzumab) / Sanofi
Review, Journal: Effects of MS disease-modifying therapies on responses to vaccinations: A review. (Pubmed Central) - Nov 1, 2020
Responses to any vaccination depend on the vaccine type, the type of response (recall versus response to a novel antigen), and the impact of the individual disease-modifying therapy on humoral and cellular immunity in response to that vaccine type. When considering a given therapy, clinicians should weigh its efficacy against MS for the individual patient versus potential impact on responses to vaccinations that may be needed in the future.
- |||||||||| dimethyl fumarate / Generic mfg.
Retrospective data, Review, Journal, HEOR, Real-World Evidence: Real-world adherence to, and persistence with, once- and twice-daily oral disease-modifying drugs in patients with multiple sclerosis: a systematic review and meta-analysis. (Pubmed Central) - Oct 24, 2020
Opportunities to improve adherence and ultimately patient outcomes, such as patient education, medication support/reminders, simplified dosing regimens, and reducing administration or monitoring requirements, remain. Implementation of efforts to improve adherence are essential to improving care of patients with MS.
- |||||||||| Leustatin (cladribine) / J&J, Lemtrada (alemtuzumab) / Sanofi
Review, Journal: Immunological Aspects of Approved MS Therapeutics. (Pubmed Central) - Oct 22, 2020
Currently, more than a dozen drugs representing 1 substances with different mechanisms of action have been approved (interferon beta preparations, glatiramer acetate, fingolimod, siponimod, mitoxantrone, teriflunomide, dimethyl fumarate, cladribine, alemtuzumab, ocrelizumab, and natalizumab)...The objective of this review is to present the modes of action of these drugs and their effects on the immunopathogenesis of MS. Each agent's clinical development and potential side effects are discussed.
- |||||||||| teriflunomide / Generic mfg.
Trial completion date: Teriflunomide Concentration in Serum and Cerebrospinal Fluid From Patients With Multiple Sclerosis (clinicaltrials.gov) - Oct 21, 2020
P4, N=20, Recruiting,
In a large cohort of U.S. adults with MS, controlling for key baseline characteristics, fingolimod was associated with significantly longer time to treatment failure and lower risk of treatment failure compared with teriflunomide. Trial completion date: Dec 2020 --> Jun 2021
- |||||||||| teriflunomide / Generic mfg.
Trial completion date, Trial primary completion date: An Observational Study on Teriflunomide-exposed Pregnancies (clinicaltrials.gov) - Oct 20, 2020
P=N/A, N=325, Recruiting,
Trial completion date: Dec 2020 --> Jun 2021 Trial completion date: Feb 2022 --> Dec 2022 | Trial primary completion date: Feb 2022 --> Dec 2022
- |||||||||| glatiramer acetate / Generic mfg., dimethyl fumarate / Generic mfg., teriflunomide / Generic mfg.
Enrollment open, Trial initiation date, HEOR, Cost effectiveness: Discontinuing Disease-modifying Therapies in Stable Relapsing - Onset Multiple Sclerosis (DOT-MS). (clinicaltrials.gov) - Oct 19, 2020
P=N/A, N=130, Recruiting,
Trial completion date: Feb 2022 --> Dec 2022 | Trial primary completion date: Feb 2022 --> Dec 2022 Not yet recruiting --> Recruiting | Initiation date: Feb 2020 --> Jul 2020
- |||||||||| Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Clinical, Journal, Real-World Evidence: Real-world effectiveness of initial disease-modifying therapies in pediatric MS. (Pubmed Central) - Oct 15, 2020
Initial treatment of pediatric MS/CIS with newer DMTs led to better disease activity control compared to injectables, supporting greater effectiveness of newer therapies. Long-term safety data for newer DMTs are required.
- |||||||||| teriflunomide / Generic mfg.
Enrollment closed, Enrollment change, Trial completion date: TERIS: Randomized, Double-blinded Study of Treatment:Teriflunomide, in Radiologically Isolated Syndrome (clinicaltrials.gov) - Oct 13, 2020
P3, N=125, Active, not recruiting,
Long-term safety data for newer DMTs are required. Recruiting --> Active, not recruiting | N=200 --> 125 | Trial completion date: Sep 2021 --> Oct 2022
- |||||||||| dimethyl fumarate / Generic mfg., Ocrevus (ocrelizumab) / Roche, Biogen
[VIRTUAL] Multiple Sclerosis in Portugal - Clinical and Economic IMPACT of Ocrelizumab () - Oct 3, 2020 - Abstract #ISPOREU2020ISPOR-EU_1845;
METHODS Previously validated discrete-time Markov models for MS were adapted to model the impact of ocrelizumab versus current clinical practise across three populations: treatment naïve RRMS (versus IFNB-1a, dimethyl fumarate, glatiramer acetate and teriflunomide), treatment experienced RRMS (versus fingolimod, natalizumab) and PPMS (versus best supportive care)...Subpopulation analysis demonstrates a higher effectiveness for the treatment of naïve RRMS patients (1.05 incremental QALY) and a dominant (cost-saving) scenario for experienced RRMS patients. CONCLUSIONS Ocrelizumab has demonstrated to be an efficient alternative for the treatment of MS in Portugal, being expected to provide a clear clinical benefit and overall savings for the National Health Service.
- |||||||||| [VIRTUAL] Rwe Use of Cladribine Tablets in Portugal- Snapshot of a Cohort Database () - Oct 3, 2020 - Abstract #ISPOREU2020ISPOR-EU_1505;
Characterization of RWE data is possible and should be pursued in order to properly verify real world outcomes. Further analysis should be carried-out over time to properly characterize this patient population and the long-term outcomes resulting from this specific treatment option, such as the time on treatment.
- |||||||||| [VIRTUAL] Cladribine Tablets (CT) Versus Other Disease-Modifying Therapies in the Treatment of Relapsing-Remitting Multiple Sclerosis (RRMS) - Cost-Effectiveness Analysis. () - Oct 3, 2020 - Abstract #ISPOREU2020ISPOR-EU_1255;
OBJECTIVES To assess the cost-effectiveness of CT (Mavenclad®) as a treatment of high disease activity (HDA) RRMS, compared with alternative 1st line therapies in Poland: interferon beta-1a (IFN-b1a), interferon beta-1b (IFN-b1b), peginterferon beta-1a (pegIFN), dimethyl fumarate (DMF), glatiramer acetate (GA) and teriflunomide (TER)...CONCLUSIONS CT appears as cost-effective MS therapy in Poland, offering good value for money in the Polish healthcare system. Therefore the recent positive reimbursement decision for Mavenclad® issued for restricted population should be reconsidered in the future, so that more patients with HDA RRMS could benefit from CT use, that is firmly grounded in clinical evidence and supported by the financial estimates.
- |||||||||| [VIRTUAL] Optimal Treatment Sequence for Relapsing Remitting Multiple Sclerosis- Results from a Health Economic Modelling Study () - Oct 3, 2020 - Abstract #ISPOREU2020ISPOR-EU_1168;
Sequences were limited to treatments in the Dutch MS clinical guidelines with first line (interferons, glatiramer acetate, dimethyl fumarate and teriflunomide), second line (fingolimod, ocrelizumab, cladribine and natalizumab) and third line (alemtuzumab)...Treatments that were dominated in the fully incremental analysis ranked high in a net health benefit analysis. Limitations of the study include the lack of treatment effect on imaging results, which are an important driver in clinical decision making, and issues inherent to the use of NMA, such as confounders due to trial design.
- |||||||||| teriflunomide / Generic mfg.
[VIRTUAL] Cost-Utility Analysis of Teriflunomide in Naïve VS. Previously Treated Patients with Relapsing-Remitting Multiple Sclerosis in Italy () - Oct 3, 2020 - Abstract #ISPOREU2020ISPOR-EU_713;
Univariate and probabilistic sensitivity analyses tested the robustness of the baseline findings.RESULTS When compared to patients who have been previously treated with different DMTs, teriflunomide in RRMS naÏve patients is strongly dominant in baseline CUA, both from the healthcare sector (-€1,042.68 and +0.480 QALYs) and societal perspectives (-€6,782.81 and +0.480 QALYs). Cost-effectiveness acceptability curve shows that, for a willingness to pay of €40,000, the probability that teriflunomide is cost-effective in RRMS naÏve patients is 95.37% (healthcare sector perspective) and 95.89% (societal perspective).CONCLUSIONS Teriflunomide in RRMS naÏve patients is cost-effective and possibly strongly dominant from both the healthcare sector and the society viewpoints in Italy.
- |||||||||| dimethyl fumarate / Generic mfg., teriflunomide / Generic mfg., Fumaderm (dimethyl fumarate) / Biogen
[VIRTUAL] Cost-Effectiveness of Dimethyl-Fumarate Compared to Teriflunomide for Relapsing Remitting Multiple Sclerosis Patients in Italy () - Oct 3, 2020 - Abstract #ISPOREU2020ISPOR-EU_592;
Cost-effectiveness acceptability curve shows that, for a willingness to pay of €40,000, the probability that teriflunomide is cost-effective in RRMS naÏve patients is 95.37% (healthcare sector perspective) and 95.89% (societal perspective).CONCLUSIONS Teriflunomide in RRMS naÏve patients is cost-effective and possibly strongly dominant from both the healthcare sector and the society viewpoints in Italy. Dimethyl-fumarate is cost-effective or dominant (more effective and less costly) vs teriflunomide for the first-line treatment of relapsing-remitting multiple sclerosis in Italian setting.
- |||||||||| teriflunomide / Generic mfg., ponesimod (ACT-128800) / J&J
[VIRTUAL] Patient Preferences for Multiple Sclerosis Treatment during a Phase 3 Trial () - Oct 3, 2020 - Abstract #ISPOREU2020ISPOR-EU_556;
P3
CONCLUSIONS : Trial subjects cared most about disability due to disease progression and their preferences were stable throughout the trial. MACBETH technique was able to capture treatment preferences accurately and Dirichlet regression was appropriate for quantifying observable preference heterogeneity.
- |||||||||| dimethyl fumarate / Generic mfg.
[VIRTUAL] Cost-Consequence Analysis of Dimethyl Fumarate Versus Other Disease-Modifying Therapies in Multiple Sclerosis- A French Cohort Study with Snds National Claims Database in France () - Oct 3, 2020 - Abstract #ISPOREU2020ISPOR-EU_468;
OBJECTIVES Recently, dimethyl fumarate (DMF) was added to the therapeutic arsenal against Multiple Sclerosis (MS), but the cost-consequence of this drug versus other first-line disease-modifying therapies (i.e. injectable immunomodulatory drugs (IID) and two other oral drugs: fingolimod (FTY) and teriflunomide (TERI)) has never been studied in real world settings using data of a national claims database METHODS A cost–consequence analysis was performed for all patients identified in the French national claims database (SNDS), who initiated DMF, IID, TERI or FTY between 2015 and 2017, with 1 to 3.5 years of follow-up...In comparison to FTY, overall costs were significantly lower for DMF (15575€ vs. 24206€). CONCLUSIONS Compared to TERI and IID, DMF is an effective treatment strategy in reducing relapse occurrence in MS patients, which nevertheless entails an additional cost for the French healthcare system.
- |||||||||| teriflunomide / Generic mfg., FTY720, fingolimod / Generic mfg., Novus Therap
[VIRTUAL] Real World Evidence in Argentina- Treatment of Patients with Multiple Sclerosis in the Social Security System (2013-2017) () - Oct 3, 2020 - Abstract #ISPOREU2020ISPOR-EU_176;
The pharmacotherapy cost for MS increased in 2016-2019 as the trend is predicted to be the same for the next 3 years. The real world evidence data of patients treated for multiple sclerosis during the period 2013-2017 shows a strong tendency of switch the type of administration of the drug from injectable to oral ones, representing a 74% in the period, while the change from injectable to another type of injectable was 18% and the switch inside oral ones was 8%.CONCLUSIONS
- |||||||||| acyclovir / Generic mfg., leflunomide / Generic mfg.
Journal: Leflunomide increased the renal exposure of acyclovir by inhibiting OAT1/3 and MRP2. (Pubmed Central) - Oct 3, 2020
Here we used a specific MRP inhibitor MK571 and probenecid (OAT1/3 and MRP2 inhibitor) to assess the effects of MRP2 and OAT1/3 on the pharmacokinetics and tissue distribution of acyclovir in rats...These results suggest that LEF/TER increased the kidney accumulation of acyclovir by inhibiting the efflux transporter MRP2, which increased its kidney/plasma ratio and renal injury risk. However, the inhibitory effects of LEF/TER on OAT1/3 reduced the tubular cells' uptake of acyclovir and increased the plasma concentration.
- |||||||||| Actemra IV (tocilizumab) / Roche, JW Pharma, Humira (adalimumab) / Eisai, AbbVie
Preclinical, Journal: The in vitro effect of antirheumatic drugs on platelet function. (Pubmed Central) - Oct 2, 2020
Results indicate that teriflunomide, prednisolone, and tocilizumab inhibit, and adalimumab increases platelet aggregation. The study suggests that the majority of antirheumatic drugs mainly reduced cardiovascular risk through indirect effects (e.g., reducing inflammation).
- |||||||||| teriflunomide / Generic mfg.
Clinical, Journal: Teriflunomide-exposed pregnancies in a French cohort of patients with multiple sclerosis. (Pubmed Central) - Sep 30, 2020
Despite specific TERIF guidelines for pregnancy-related issues and the availability of alternative therapies, some pregnancies exposed to TERIF were identified. Most of the cases were because of the absence of the recommended accelerated elimination procedure and appeared to be mostly unplanned pregnancies that probably reflect a lack of effective contraception.
- |||||||||| teriflunomide / Generic mfg.
Clinical, Journal: COVID-19 in teriflunomide-treated patients with multiple sclerosis. (Pubmed Central) - Sep 27, 2020
The patients continued teriflunomide therapy and had self-limiting infection, without relapse of their MS. These observations have implications for the management of MS in the setting of the COVID-19 pandemic.
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