Amyloidosis with Kineret (anakinra)

The FAERS Potential Signals of Serious Risks/New Safety Information listed Kineret (anakinra) with Amyloidosis as a potential signal on their January - March 2023 listing.

Analyzing the FAERS data up to 2023 Q3, the PRR for Amyloidosis is more than 2 when comparing anakinra within its ATC groups (ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS, IMMUNOSUPPRESSANTS, and INTERLEUKIN INHIBITORS).

ANAKINRA ATCs	PRR	MGPS	BCPN	ROR	CHISQ
ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS	9.78165	9.76989	48.40484	9.88913	78.83077
IMMUNOSUPPRESSANTS	8.62742	8.61721	47.00985	8.77052	67.48723
INTERLEUKIN INHIBITORS	8.79681	8.78637	40.48299	10.49177	70.44402

Amyloidosis is included in 1 SMQ (Immune-mediated/autoimmune disorders) under the narrow scope category. There is another adverse event reported for anakinra under the HLT Amyloidoses with PT (Secondary amyloidosis).  Amyloidosis is included in the EMA IME list. Further analysis is required to confirm the potential signal.