(Press-News.org) Contact information: Dr. Anna-Sabine Ernst
presse@iqwig.de
49-022-135-6850
Institute for Quality and Efficiency in Health Care
Teriflunomide in multiple sclerosis: Added benefit not proven
Regarding side effects, there are both positive and negative effects in comparison with beta interferon 1a
Teriflunomide (trade name: Aubagio) has been approved in Germany since August 2013 for adults with relapsing remitting multiple sclerosis. In an early benefit assessment pursuant to the Act on the Reform of the Market for Medicinal Products (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) examined whether this new drug offers an added benefit over the appropriate comparator therapy specified by the Federal Joint Committee (G-BA).
This is not the case, however: Although certain side effects occur less frequently under teriflunomide than under beta interferon 1a, others are more frequent. Overall, IQWiG does not regard an added benefit as proven.
Drug manufacturer limited itself to a certain beta interferon preparation
Multiple sclerosis (MS) is a chronic, incurable, inflammatory disease of the central nervous system, which often has a relapsing course. If there is a remission of all or most symptoms after a relapse, this type of MS is called relapsing-remitting (RRMS).
The Federal Joint Committee (G-BA) specified beta interferons (1a or 1b) or glatiramer acetate as appropriate comparator therapy. The drug manufacturer chose beta interferon 1a as comparator therapy, but limited itself to one certain preparation from this drug group (Rebif). This did not influence the result of the assessment, however. Teriflunomide is taken as a tablet, whereas beta interferon 1a has to be injected.
Only data from an approval study were used
In its dossier, the manufacturer presented results from an approval study (TENERE), which directly compared teriflunomide with Rebif. In this study, patients were treated for 48 to 115 weeks. The study was unblinded, i.e. both patients and doctors knew which drug was administered.
In addition, the manufacturer used an indirect comparison based on three studies, all of which tested teriflunomide or Rebif against placebo. The placebo was used as what is known as the "common comparator". The manufacturer then combined the results of this indirect comparison with the results from TENERE. However, the indirect comparison was unsuitable to support the results from the direct comparison (TENERE). IQWiG therefore only included the data on the direct comparison in the assessment.
No relevant differences in morbidity and quality of life
No conclusions can be drawn on mortality because no patients died during the study. The study was not long enough and did not have enough participants anyway to be able to reveal any differences in mortality.
Regarding disability progression and relapses such as vision disorders, there were no statistically significant differences between the teriflunomide and the interferon group.
No statistically significant difference was observed for the outcome "health-related quality of life", either.
Opposing results for side effects
There were also no important differences found with regards to serious adverse events and the outcome "treatment discontinuation due to side effects".
The picture is more complex for non-severe or non-serious side effects, however: Flu-like symptoms were less frequent under teriflunomide than under beta interferon 1a. This was also the case for reactions at the injection site, but this side effect cannot occur with a tablet (teriflunomide). In contrast, diarrhoea and hair loss (alopecia) were more frequent in the teriflunomide group.
Reliability of conclusions is limited
Overall, regarding side effects, IQWiG sees a hint of a positive and a negative effect, in each case with a considerable extent. IQWiG regards the reliability of the conclusions of the study to be limited, so that it sees hints, but no indications. One of the reasons is that the study was unblinded.
Balancing the positive and negative effects regarding side effects, the Institute does not regard an added benefit of teriflunomide in comparison with beta interferon 1a as proven.
G-BA decides on the extent of added benefit
The dossier assessment is part of the overall procedure for early benefit assessments supervised by the G-BA. After publication of the manufacturer's dossier and IQWiG's assessment, the G-BA conducts a commenting procedure, which may provide further information and result in a change to the benefit assessment. The G‑BA then decides on the extent of the added benefit, thus completing the early benefit assessment.
An overview of the results of IQWiG's benefit assessment is given by a German-language executive summary. In addition, the website gesundheitsinformation.de, published by IQWiG, provides easily understandable and brief German-language information on teriflunomide.
The G-BA website contains both general English-language information on benefit assessment pursuant to §35a Social Code Book (SGB) V and specific German-language information on the assessment of teriflunomide.
### END
Teriflunomide in multiple sclerosis: Added benefit not proven
Regarding side effects, there are both positive and negative effects in comparison with beta interferon 1a
2014-01-07
ELSE PRESS RELEASES FROM THIS DATE:
NREL finds a new cellulose digestion mechanism by a fast-eating enzyme
2014-01-07
NREL finds a new cellulose digestion mechanism by a fast-eating enzyme
CelA digests cellulose faster than enzymes from commercial preparations
Researchers at the Energy Department's National Renewable Energy Laboratory (NREL) have discovered ...
MU researcher's study of African forest elephants helps guide research efforts in the US
2014-01-07
MU researcher's study of African forest elephants helps guide research efforts in the US
Study finds that human occupation of an area may not contribute to population decline of an endangered species
COLUMBIA, Mo. – Conservation of a protected or endangered ...
Story tips from the Department of Energy's Oak Ridge National Laboratory, January 2014
2014-01-07
Story tips from the Department of Energy's Oak Ridge National Laboratory, January 2014
To arrange for an interview with a researcher, please contact the Communications staff member identified at the end of each tip. For more information on ORNL and its research ...
Might more ravens -- aided by humans -- mean 'nevermore' for sage-grouse?
2014-01-07
Might more ravens -- aided by humans -- mean 'nevermore' for sage-grouse?
BOZEMAN (January 7, 2014) – A new study by the Wildlife Conservation Society, Idaho State University and the U.S. Geological Survey suggests that habitat fragmentation and the addition of ...
On-demand vaccines possible with engineered nanoparticles
2014-01-07
On-demand vaccines possible with engineered nanoparticles
Vaccines combat diseases and protect populations from outbreaks, but the life-saving technology leaves room for improvement. Vaccines usually are made en masse in centralized locations far removed from where they ...
Newly discovered 3-star system to challenge Einstein's theory of General Relativity
2014-01-07
Newly discovered 3-star system to challenge Einstein's theory of General Relativity
A newly discovered system of two white dwarf stars and a superdense pulsar--all packed within a space smaller than the Earth's orbit around the sun -- is enabling astronomers to probe ...
Embargoed news from Jan. 6, 2014 Annals of Internal Medicine tip sheet
2014-01-07
Embargoed news from Jan. 6, 2014 Annals of Internal Medicine tip sheet
Mediterranean diet without weight loss helps prevent diabetes
1. Mediterranean diet reduces diabetes incidence without calorie restriction, exercise, or weight loss
Older patients at ...
New fossils shed light on the origins of lions, and tigers, and bears (oh my!)
2014-01-07
New fossils shed light on the origins of lions, and tigers, and bears (oh my!)
New fossils from Belgium have shed light on the origin of some of the most well-known, and well-loved, modern mammals. Cats and dogs, as well as other carnivorous mammals ...
People lacking insurance not likely to migrate to obtain Medicaid coverage
2014-01-07
People lacking insurance not likely to migrate to obtain Medicaid coverage
States choosing Medicaid expansion shouldn't expect costly influx of individuals from states not expanding coverage; other studies examine accountable care organizations and communication-and-resolution ...
1 in, 1 out: Oxford study shows how people put a limit on their social networks
2014-01-07
1 in, 1 out: Oxford study shows how people put a limit on their social networks
A new study shows that people put most effort into communicating with small numbers of close friends or family, operating unconscious 1-in, 1-out policies so that communication patterns ...
LAST 30 PRESS RELEASES:
Thirty-year mystery of dissonance in the “ringing” of black holes explained
Less intensive works best for agricultural soil
Arctic rivers project receives “national champion” designation from frontiers foundation
Computational biology paves the way for new ALS tests
Study offers new hope for babies born with opioid withdrawal syndrome
UT, Volkswagen Group of America celebrate research partnership
New Medicare program could dramatically improve affordability for cancer drugs – if patients enroll
Are ‘zombie’ skin cells harmful or helpful? The answer may be in their shapes
University of Cincinnati Cancer Center presents research at AACR 2025
Head and neck, breast, lung and survivorship studies headline Dana-Farber research at AACR Annual Meeting 2025
AACR: Researchers share promising results from MD Anderson clinical trials
New research explains why our waistlines expand in middle age
Advancements in muon detection: Taishan Antineutrino Observatory's innovative top veto tracker
Chips off the old block
Microvascular decompression combined with nerve combing for atypical trigeminal neuralgia
Cutting the complexity from digital carpentry
Lung immune cell type “quietly” controls inflammation in COVID-19
Fiscal impact of expanded Medicare coverage for GLP-1 receptor agonists to treat obesity
State and sociodemographic trends in US cigarette smoking with future projections
Young adults drive historic decline in smoking
NFCR congratulates Dr. Robert C. Bast, Jr. on receiving the AACR-Daniel D. Von Hoff Award for Outstanding Contributions to Education and Training in Cancer Research
Chimpanzee stem cells offer new insights into early embryonic development
This injected protein-like polymer helps tissues heal after a heart attack
FlexTech inaugural issue launches, pioneering interdisciplinary innovation in flexible technology
In Down syndrome mice, 40Hz light and sound improve cognition, neurogenesis, connectivity
Methyl eugenol: potential to inhibit oxidative stress, address related diseases, and its toxicological effects
A vascularized multilayer chip reveals shear stress-induced angiogenesis in diverse fluid conditions
AI helps unravel a cause of Alzheimer's disease and identify a therapeutic candidate
Coalition of Autism Scientists critiques US Department of Health and Human Services Autism Research Initiative
Structure dictates effectiveness, safety in nanomedicine
[Press-News.org] Teriflunomide in multiple sclerosis: Added benefit not provenRegarding side effects, there are both positive and negative effects in comparison with beta interferon 1a