posted on 2021-01-20, 01:17authored byArnold Lee, Hannah A. Blair
Declarations
Funding The preparation of this review was not supported
by any external funding.
Authorship and Conflict of interest A. Lee and H.A. Blair are salaried employees of Adis International Ltd/Springer
Nature, and declare no relevant conflicts of interest. All authors contributed
to the review and are responsible for the article content.
Ethics
approval, Consent to participate, Consent to publish, Availability of data and
material, Code availability Not applicable.
Abstract
The list of approved indications for anakinra (Kineret®), an
anti-interleukin (IL)-1 biological, has been expanded in the EU to include Familial
Mediterranean fever (FMF). The pathology of FMF is associated with excess
production of IL-1, thus IL-1 blockade with anakinra was investigated as a
treatment for FMF. Results from a phase 3 clinical trial and real-world
experience in patients with FMF demonstrated reductions in FMF attack frequency,
improvements in quality of life and reductions in serum amyloid A (SAA) and
C-reactive protein (CRP) levels. Efficacy was also observed in patients with
FMF and amyloidosis in the real-world setting; nevertheless, concurrent use of
colchicine with anti-IL-1 biologicals is recommended to prevent and/or halt the
progression of amyloidosis. Anakinra was generally well tolerated during the phase
3 clinical trial, with comparable proportions of patients with adverse
reactions in the anakinra and placebo groups. Furthermore, the safety profile of
anakinra in FMF was consistent with that established in other indications,
based on all available evidence.
Additional
information about this Adis Drug Review can be found here