Background/Purpose:

The colchicine-resistant FMF (crFMF) is defined as 6 or more polyserositis attacks in the last year despite the regular usage of colchicine in the highest tolerable dose. IL-1 receptor antagonists have been shown to be efficient in crFMF. We tried to define the efficacy of opocalcium colchicine (OC), anakinra and canakinumab by FMF50 scores, complete and partial clinical responses.

Methods:

Patients who were under OC, anakinra and canakinumab are considered to be resistant to standard colchicine treatment. The FMF50 score is used to define the response to treatment. Complete clinic and laboratory response is characterized by an absence of clinical features and normal laboratory findings. The partial clinical and laboratory response include 30 % improvement in clinical and laboratory features.

Results:

A total of 839 FMF patients has been assessed and 49/839(5,8%) of them has been considered colchicine resistant. FMF50 response has been obtained in 4/49(8.2%) patients under standard colchicine treatment; in 14/30 (46.7%) patients treated with OC, in 5/6 (83.3%) with anakinra and in 12/13(92.3%) patients with canakinumab. The FMF50 response significantly differed according to treatment modality (p<0.005). Clinical remission has been achieved in 10/30(33.3%), 5/6(83.3%) and in 11/13(84.6%) patients treated with OC, anakinra and canakinumab, respectively. Patients treated with OC significantly differed from those treated with anti IL-1 according to complete clinical remission (p<0.002). Laboratory remission has been obtained in 7/30(23.3%), 4/6(66.7%) and 11/13(84.6%) patients treated with OC, anakinra and canakinumab, respectively. The laboratory remission was significantly different between patients treated with OC and with anti IL-1 (p<0.0001).

The most common adverse effect was diarrhea in 17/49(34.6%), transaminases elevation in 3/49(6%) patients and leukopenia in 1 patient. Diarrhea was seen in 3/30(10%) patients under OC treatment. Local allergic reactions were seen in 3/6(50%) anakinra patients. One patient developed pneumonia while on canakinumab treatment; upper respiratory tract infection has been registered in 3/13(23%) patients and acute gastroenteritis in one patient. None of the patients developed severe adverse effect.

Conclusion:

The FMF50 response has not been achieved in majority of patients under OC treatment, although their drug compliance was better comparing to standard colchicine compound in our country. Complete clinical remission has been obtained in minority of patients treated with OC. In contrary, FMF50 response, complete clinical and laboratory response have been detected in most of patients treated with anakinra and canakinumab. Both of anti IL-1 agents were safe and effective in crFMF patients.

References

1. Ozen S, Demirkaya E, Duzova A, et al. FMF50: a score for assessing outcome in familial Mediterranean fever. Ann Rheum Dis 2014;73:897-901.
2. Gul A, Ozdogan H, Erer B, Ugurlu S, Kasapcopur O, Davis N, Sevgi S. Efficacy and safety of canakinumab in adolescents and adults with colchicine-resistant familial Mediterranean fever. Arthritis research & therapy 2015;17:243.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/evaluation-of-efficacy-and-safety-of-opocalcium-colchicine-and-anti-il1-treatment-in-childhood-colchicine-resistant-familial-mediterranean-fever/