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Apremilast in plaque psoriasis, psoriatic arthritis: No added benefit can be derived

Date:
May 19, 2015
Source:
Institute for Quality and Efficiency in Health Care
Summary:
Reviewers report that the dossiers submitted regarding the use of Apremilast for psoriasis contained neither data from studies of direct comparisons nor indirect comparisons. The manufacturer itself also did not claim an added benefit for its new drug, they conclude.
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Apremilast (trade name: Otezla) has been available since January 2015 for the treatment of moderate to severe plaque psoriasis or active psoriatic arthritis in adult patients in whom certain pretreatments are not sufficiently effective or unsuitable. The German Institute for Quality and Efficiency in Health Care (IQWiG) examined in two dossier assessments whether this drug offers an added benefit over the respective appropriate comparator therapy. Such an added benefit cannot be derived from any of the dossiers however, because they contain no relevant data.

Manufacturer itself did not claim an added benefit

The drug manufacturer presented no studies in which apremilast was tested against the respective appropriate comparator therapy for any of the two therapeutic indications. It only described data from placebo-controlled studies, but did not use them for indirect comparisons.

There was also no systematic search for studies with the appropriate comparator therapy, which might be suitable for an indirect comparison with apremilast. It therefore remains unclear whether an indirect comparison would have been possible and whether this comparison would have shown an added benefit or lesser benefit of apremilast in comparison with the drugs already available. Consistently, the manufacturer itself did not claim an added benefit for the new drug in any of the two therapeutic indications.


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Materials provided by Institute for Quality and Efficiency in Health Care. Note: Content may be edited for style and length.


Cite This Page:

Institute for Quality and Efficiency in Health Care. "Apremilast in plaque psoriasis, psoriatic arthritis: No added benefit can be derived." ScienceDaily. ScienceDaily, 19 May 2015. <www.sciencedaily.com/releases/2015/05/150519105711.htm>.
Institute for Quality and Efficiency in Health Care. (2015, May 19). Apremilast in plaque psoriasis, psoriatic arthritis: No added benefit can be derived. ScienceDaily. Retrieved May 23, 2017 from www.sciencedaily.com/releases/2015/05/150519105711.htm
Institute for Quality and Efficiency in Health Care. "Apremilast in plaque psoriasis, psoriatic arthritis: No added benefit can be derived." ScienceDaily. www.sciencedaily.com/releases/2015/05/150519105711.htm (accessed May 23, 2017).

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