How safe it is to treat pregnant FMF patients with Anakinra?

British Society for Rheumatology guideline on prescribing drugs in pregnancy and breastfeeding: immunomodulatory anti-rheumatic drugs and corticosteroids

“…This limited evidence came from reports on five pregnancies in three studies/ reports, with no evidence of harm [50,367,368]. Subsequently, we identified four studies of 43 pregnancy exposures to anakinra [369][370][371][372], in addition to one exposure in the papers described above which reported combined outcomes of multiple biologic-exposed pregnancies (see 'Biologic DMARDs' above). These exposures were mostly in patients with periodic fevers and severe maternal disease.…”

A Systematic Review of the safety of non-TNF inhibitor biologic and targeted synthetic drugs in rheumatic disease in pregnancy

“…A total of 8 studies including 4 case reports [113][114][115][116], 4 case series [117][118][119][120] and 3 cohort studies [60,85,109] reported on 59 pregnancies exposed to anakinra. Pregnancy exposures occurred during preconception (n=1); to first trimester (n=5); to second trimester (n=2); to third trimester (n=4); preconception to post-partum/breastfeeding (n=20); started during pregnancy (n=13); and with unknown time-points (n=14).…”

“…Two infants exposed to rituximab experienced mild asthma [31] and multiple infections [59] respectively, whilst the remaining 32/34 infants followed-up had no complications reported [23,24,27,32,35,[37][38][39][40][41]43,46,51,58,59,125]. One infant exposed to anakinra had a low platelet count at birth, which was treated by three infusions of intravenous immunoglobulin and normalised at 2 months post-partum follow-up [119]. Overall, the long-term outcomes for all infants where follow-up details were available concluded that infants had normal developmental outcomes, with no adverse events reported.…”

How safe it is to treat pregnant FMF patients with Anakinra?

“…Background It has been reported that anakinra, an anti-IL-1R antagonist, may be a safe alternative during pregnancy in patients with various autoinflammatory syndromes (1,2).…”