Featured Research

from universities, journals, and other organizations

Dimethyl fumarate for multiple sclerosis: Added benefit not proven

Date:
August 7, 2014
Source:
Institute for Quality and Efficiency in Health Care
Summary:
No added benefit of dimethyl fumarate for multiple sclerosis can be determined, as no suitable data are available, neither for a direct nor for an indirect comparison, report researchers.

Dimethyl fumarate (trade name: Tecfidera) has been approved since January 2014 for adults with relapsing remitting multiple sclerosis (RRMS). 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) has examined whether this new drug for MS offers an added benefit over the appropriate comparator therapy specified by the Federal Joint Committee (G-BA). However, no added benefit can be determined, as no suitable data are available, neither for the direct nor for the indirect comparison.

Multiple sclerosis: New therapeutic indication for an old drug

MS is a chronic and incurable inflammatory disease of the central nervous system, which often has a relapsing course. If the symptoms disappear completely or at least largely after a relapse, the disease is referred to as "relapsing remitting" (RRMS).

Dimethyl fumarate is taken as a tablet. The exact mode of action in MS is not yet known. Fumaric acid (including dimethyl fumarate) has long been used for the treatment of moderately severe to severe types of psoriasis in patients who do not respond sufficiently to topical treatment.

Drug manufacturer restricts comparator therapy

The G-BA specified beta-interferon (1a or 1b) or glatiramer acetate as the appropriate comparator therapy. The manufacturer chose beta-interferon 1a as the comparator therapy; however, this was restricted to a specific compound with this active agent (Rebif). But according to the G-BA, all available beta-interferon 1a compounds and thus a further compound (Avonex) should have been considered for the comparison with dimethyl fumarate.

This has no consequences for the direct comparison with the appropriate comparator therapy, as no studies were available here anyway. However, this has far-ranging consequences for the indirect comparison, which is now incomplete, as some of the available data on beta-interferon 1a were not considered.

Approach for indirect comparison is unsuitable

The manufacturer presents a so-called network meta-analysis for the indirect comparison, which includes the results from a total of 14 studies. In two studies dimethyl fumarate was compared with glatiramer acetate or placebo. The other studies were also comparisons of beta-interferon (1a or 1b) and glatiramer acetate with each other or with placebo. In such a network it is possible to compare dimethyl fumarate with beta-interferon 1a without the two drugs having been investigated in a common study. The other drugs and placebo act as so-called intermediate comparators for the indirect comparison.

In principle, this approach can be used to derive an indirect comparison for dimethyl fumarate. However, for several reasons, the indirect comparison submitted by the manufacturer is not suitable to draw conclusions on the added benefit of dimethyl fumarate:

  • The data are incomplete, as the comparison with a further beta-interferon 1a (Avonex) is missing, even though this would have been possible, as the corresponding study data are available.
  • The statistical model used (network meta-analysis) is not suitable, as it can lead to an incorrect evaluation of treatment effects: Non-significant differences can incorrectly appear to be significant.
  • The similarity, homogeneity and consistency of the studies included as preconditions for a network meta-analysis were not adequately checked by the manufacturer. For instance, only studies investigating similar patients are allowed to be included in such a network. If, for example, the studies differ with regard to the type or severity of disease, no reliable conclusions are possible anymore. However, this basic precondition is not fulfilled in the network submitted.

An added benefit is not proven, as no suitable data are available, neither for the direct nor for the indirect comparison of dimethyl fumarate with the appropriate comparator therapy.


Story Source:

The above story is based on materials provided by Institute for Quality and Efficiency in Health Care. Note: Materials may be edited for content and length.


Cite This Page:

Institute for Quality and Efficiency in Health Care. "Dimethyl fumarate for multiple sclerosis: Added benefit not proven." ScienceDaily. ScienceDaily, 7 August 2014. <www.sciencedaily.com/releases/2014/08/140807121844.htm>.
Institute for Quality and Efficiency in Health Care. (2014, August 7). Dimethyl fumarate for multiple sclerosis: Added benefit not proven. ScienceDaily. Retrieved October 21, 2014 from www.sciencedaily.com/releases/2014/08/140807121844.htm
Institute for Quality and Efficiency in Health Care. "Dimethyl fumarate for multiple sclerosis: Added benefit not proven." ScienceDaily. www.sciencedaily.com/releases/2014/08/140807121844.htm (accessed October 21, 2014).

Share This



More Health & Medicine News

Tuesday, October 21, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

How Nigeria Beat Its Ebola Outbreak

How Nigeria Beat Its Ebola Outbreak

Newsy (Oct. 20, 2014) The World Health Organization has declared Nigeria free of Ebola. Health experts credit a bit of luck and the government's initial response. Video provided by Newsy
Powered by NewsLook.com
Another Study Suggests Viagra Is Good For The Heart

Another Study Suggests Viagra Is Good For The Heart

Newsy (Oct. 20, 2014) An ingredient in erectile-dysfunction medications such as Viagra could improve heart function. Perhaps not surprising, given Viagra's history. Video provided by Newsy
Powered by NewsLook.com
Ebola Worries End for Dozens on U.S. Watch Lists

Ebola Worries End for Dozens on U.S. Watch Lists

Reuters - US Online Video (Oct. 20, 2014) Forty-three people who had contact with Thomas Eric Duncan, the first person diagnosed with Ebola in the U.S., were cleared overnight of twice-daily monitoring after 21 days of showing no symptoms. Rough Cut (no reporter narration). Video provided by Reuters
Powered by NewsLook.com
CDC Calls for New Ebola Safety Guidelines

CDC Calls for New Ebola Safety Guidelines

AP (Oct. 20, 2014) Centers for Disease Control and Prevention Director Dr. Tom Frieden laid out new guidelines for health care workers when dealing with the deadly Ebola virus including new precautions when taking off personal protective equipment. (Oct. 20) Video provided by AP
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:

Breaking News:

Strange & Offbeat Stories


Health & Medicine

Mind & Brain

Living & Well

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile: iPhone Android Web
Follow: Facebook Twitter Google+
Subscribe: RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins