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The aim of this report is to assess the added benefit of teriflunomide in comparison with the appropriate comparator therapy (ACT) in adult patients with relapsing remitting multiple sclerosis (RRMS).

Institute for Quality and Efficiency in Health Care (IQWiG).

Version: December 20, 2013

Teriflunomide was first used in rheumatoid arthritis, and is known to possess both anti‐proliferative (inhibiting cell growth) and anti‐inflammatory (counteracting a local response to cellular injury) actions. In 2012, its use was approved for these characteristics by the US Food and Drug Administration for people with relapsing (with recurrent exacerbations of neurological symptoms) forms of multiple sclerosis (MS) and in 2013 also by the European Medicines Agency.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2016

Bibliographic details: Canadian Agency for Drugs and Technologies in Health.  Teriflunomide (Aubagio) (14 mg film-coated tablet): teriflunomide is indicated as monotherapy for the treatment of patients with relapsing-remitting multiple sclerosis to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability. Ottawa (ON), Canada: Canadian Agency for Drugs and Technologies in Health. Common Drug Review. 201425411660

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2014

The objective of this systematic review is to examine the beneficial and harmful effects of teriflunomide for the treatment of relapsing-remitting form of MS (RRMS).

Common Drug Review - Canadian Agency for Drugs and Technologies in Health.

Version: October 2014

Purpose/Aim of the Study: Trials of dimethyl fumarate (DMF) and teriflunomide, two new oral therapies for relapsing-remitting multiple sclerosis (RRMS) were recently published [ 1, 2 , 3 ]. A comparison of their safety against glatiramer acetate-a prevalent injectable treatment-is relevant to inform therapy-switching decisions. The study objective was to conduct a systematic review and mixed treatment comparison of total AEs in RCTs of dimethyl fumarate 240 mg bid (DMF2) or tid (DMF3), glatiramer acetate 20 mg injectable daily (GA), and teriflunomide 7 mg (TERI7) or 14 mg (TERI14) daily in RRMS patients. Materials and Methods: Articles were selected following Cochrane guidelines. A network meta-analysis was used to compare the odds of patients experiencing at least one AE between drugs, using placebo as baseline. Drugs were compared using the odds ratio (OR), credible interval (CrI), and confidence in OR ≥1 (PrOR). The mean rank (best = 1) and corresponding Surface-Under-Cumulative-Ranking (SUCRA) (best = 100%) were reported. Results: 3737 patients from three RCTs were included for analysis. Patients receiving GA exhibited the lowest AEs (DMF2 [OR = 2.67, PrOR = 98.7%], DMF3 [OR = 1.92, PrOR = 95.3%], Teri7 [OR = 2.74, PrOR = 95.2%], Teri14 [OR = 3.03, PrOR = 96.4%]), and equivalent to PB (OR = 1.60; PrOR = 94.3%). No other significant differences were found. GA also ranked with the lowest AEs (rank = 1.2, SUCRA = 96.0%), whereas DMF2 and Teri14 ranked highest (rank = 4.8). Conclusions: RRMS patients treated with glatiramer have the lowest odds of experiencing AEs, while patients taking DMF or teriflunomide have similar, higher odds of developing AEs, suggesting that patients treated with glatiramer may have higher QoL than patients under DMF or teriflunomide.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2014

Sufficient data were available from 22 studies on the following drugs: cladribine (Movectro), glatiramer acetate (Copaxone), interferon beta‐1b (Betaferon), interferon beta‐1a (Rebif; Avonex), and teriflunomide (Aubagio).

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: April 25, 2017

Evidence-informed recommendations were developed by the Canadian Drug Expert Committee (CDEC) to address the following policy questions:

CADTH Therapeutic Review - Canadian Agency for Drugs and Technologies in Health.

Version: October 2013

Multiple sclerosis (MS) is a chronic inflammatory disorder of the central nervous system that is more common in women than in men, by a factor of approximately 3:1. Canada has the fifth-highest worldwide prevalence at 240 per 100,000 persons.

CADTH Therapeutic Review - Canadian Agency for Drugs and Technologies in Health.

Version: October 2013

The Canadian Agency for Drugs and Technologies in Health (CADTH) will undertake a systematic review to compare the efficacy and safety of disease-modifying agents for patients with relapsing-remitting multiple sclerosis (RRMS), and will examine their cost-effectiveness. The review will include disease-modifying agents that are currently available in Canada (interferon beta-1a and -1b, natalizumab, glatiramer acetate, fingolimod), and a number of agents that are newly emerging and not yet approved in Canada (teriflunomide, dimethyl fumarate, and alemtuzumab).

CADTH Therapeutic Review - Canadian Agency for Drugs and Technologies in Health.

Version: December 2012

Different therapeutic strategies are available for the treatment of people with relapsing‐remitting multiple sclerosis (RRMS), including immunomodulators, immunosuppressants, and biologics. Although there is consensus that these therapies may reduce the frequency of relapses, their relative benefit (effectiveness compared to each other) in delaying new relapses or disability worsening remains unclear due to the limited number of direct comparison studies (i.e. studies comparing two or more active agents with each other).

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2015

Disease‐modifying therapies (DMTs) for MS currently aim to specifically reduce inflammation in relapsing MS and promote protection and repair of the nervous system in progressive MS. Laquinimod is a new oral disease‐modifying drug (DMD) with dual properties of modulation of the immune system and protection of the nervous system. The authors of this review assessed the efficacy and safety of laquinimod in patients with MS. Concerning the outcomes, they considered relapse, disability progression, inflammatory lesion, and brain atrophy. Among the pertinent literature only one study met the inclusion criteria. The study involved a total of 1106 patients with relapsing‐remitting MS and evaluated the efficacy and safety of laquinimod as unique therapy versus placebo. As far as safety was concerned, common adverse events included headache, back pain, arthralgia, diarrhoea, cough, urinary tract infection, elevated alanine aminotransferase, insomnia, nausea, abdominal pain and sinusitis. The authors were unable to give any clear recommendations for the use of laquinimod as a DMD for MS because the study was poor quality and was funded by a pharmaceutical company. Future studies with higher methodological quality are needed to assess the potential benefits and the safety in a longer period of administration.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2013

This is an update of the Cochrane review "Rituximab for relapsing‐remitting multiple sclerosis" (first published in The Cochrane Library 2011, Issue 12).

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2014

Multiple sclerosis (MS) is an autoimmune, inflammatory, demyelinating disease of the central nervous system. It can result in a wide range of symptoms including sensory impairment, fatigue, walking or balance problems, visual impairment, vertigo and cognitive disabilities. At present, the most commonly used MS treatments are immunomodulating agents, such as beta interferon, glatiramer acetate, natalizumab, fingolimod, teriflunomide and dimethyl fumarate. Although these agents have all been shown to reduce relapse frequency, they have little effect on the disability that characterises the progressive forms of the disease. Animal studies show the sodium (Na+) accumulation leads to intracellular calcium (Ca2+) release, and the increased calcium levels can activate the release of harmful elements. These elements contribute to axonal injury exacerbating the neurological disability. If partial blockade of voltage‐gated sodium channels could result in neuroprotection in patients with MS, this would be of benefit in preventing the progression of disability in these patients. Neuroprotection is emerging as a potentially important strategy for preventing disability progression in MS.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2015

Dimethyl fumarate was approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency for adults with relapsing‐remitting multiple sclerosis (RRMS). It does not require that any other medication be tried before dimethyl fumarate is prescribed. Although data from non Cochrane reviews are available, it is important to systematically evaluate its efficacy and safety as monotherapy versus placebo.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2015

We conducted a systematic review to examine the long-term consequences of discontinuing disease-modifying treatment (DMT) for multiple sclerosis (MS) by examining the long-term benefits and harms, and the reasons for discontinuing treatment. We also examined the evidence for people's values, beliefs, and preferences regarding discontinuing DMT.

Comparative Effectiveness Reviews - Agency for Healthcare Research and Quality (US).

Version: April 2015

The study found that independent Evidence Review Groups frequently conduct exploratory analyses to test or improve the economic evaluations submitted to the National Institute for Health and Care Excellence (NICE) by companies as part of the single technology appraisal process. These analyses often influence the recommendations produced by NICE Technology Appraisal Committees.

Health Technology Assessment - NIHR Journals Library.

Version: April 2016

INTRODUCTION: A number of disease-modifying therapies have become available to treat multiple sclerosis (MS) in recent years. As the effects of these medications are unpredictable and they are generally used for a number of years, the selection of the most appropriate disease-modifying agent must be based on the long-term efficacy and toxicity profile, thus strategies to personalise treatment to optimise responses may be potentially very useful.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2014

BACKGROUND: Dimethyl fumarate (BG-12, Tecfidera®) is a new oral drug approved by FDA and EMA in March 2013 for relapsing - remitting multiple sclerosis (RRMS). The drug was much anticipated because of its possible superiority over currently available medications: fingolimod and teriflunomide as the only MS treatments currently available in oral form.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2014

Systematic Reviews in PubMed

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