Background It has been reported that anakinra, an anti IL-1 R antagonist, may be a safe alternative treatment during pregnancy in a series of patients with various autoinflammatory syndromes (1,2).
Objectives To assess the safety of anakinra in pregnant FMF patients and its effect on fetal and maternal outcomes.
Methods Four FMF patients who had to use anakinra during pregnancy because of recurrent febrile attacks despite prophylactic colchicine therapy in 3 and colchicine side effect in 1, were monitored closely for disease activity, side effects, fetal USG and pregnancy outcome.
Results Case 1: A 33-year old FMF patient with a previous diagnosis of multiple sclerosis, developed severe myalgia and high fever at her 21st gestational week (GW) while receiving colchicine 1.5 mg/d. She didn't respond neither to 30 mg/d prednisolone nor to steroid pulses of 500 mg. Anakinra 100 mg/d was initiated. After the 3rd injection, she was symptom-free. At her 36th GW due to vaginal bleeding, she underwent C-section and gave birth to a healthy baby. After the birth she continued with regular 1,5 mg/d of colchicine and anakinra was stopped. The 1st minute APGAR score of the baby was 8. The baby was breast fed and after 30 month of follow-up the mother and the baby are healthy. This case is among the 5 patients that has been previously reported by Lachmann H in 2013 (1).
Case 2: 28 year-old FMF patient on colchicine, experienced frequent febrile attacks of abdominal pain and myalgia after the 9th GW. She did not respond to 30 mg/d prednisolone. Anakinra 100 mg/day was started at the 12th GW. Her symptoms gradually decreased after the 2nd week of anakinra. Anti IL-1 treatment together with colchicine continued till delivery. The 1st minute APGAR score of the baby was 10. After the birth anakinra was stopped and she continued with colchicine (2 mg/d) without recurrence of the febrile attacks. The follow up is 18 months. The baby is breast fed and the development remains normal.
Case 3: 31-year old FMF patient has been treated with anakinra since 2012 with the indication of recurrent protracted febrile myalgia unresponsive to colchicine 2 mg/d. She conceived while on anakinra treatment. Because she was symptom-free, anakinra was stopped at 29th GW and continued only with colchicine. However she flared 4 weeks later and anakinra was reintroduced. She is now at 36th GW and the control fetal USGs are normal.
Case 4: 24 year-old FMF patient developed thrombocytopenia (39,000/mm3) at her 15th GW which we thought might be secondary to colchicine. Colchicine was stopped and anakinra 100 mg/d and prednisolone 10 mg/d were started at 15th GW. The initial improvement in the platelet count was lost when the steroid dose was tapered. Now she is at 37th GW and thrombocyte levels remain low but she is otherwise healthy.
Conclusions Our observation in 4 FMF patients provides additional data on the safety and outcome of pregnancies exposed to anakinra. IL-1 blockade seems to be a very effective approach in the treatment of protracted febrile myalgia, non-responsive to colchicine and corticosteroid therapy, even in pregnant FMF patients.
Lachman HJ, et al. Anti IL-1 therapies and pregnancy outcome. Pediatric Rheumatology 2013, 11(Suppl 1): A269
Chang Z, et al. Anakinra use during pregnancy in patients with cryopyrin-associated periodic syndromes (CAPS). Arthritis Rheumatol. 2014 Sep 15.
Disclosure of Interest None declared