ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 942

A Nationwide Experience with the Off Label Use of Interleukin 1 Targeting Treatment in Familial Mediterranean Fever Patients

Servet Akar1, Pınar Cetin2, Umut Kalyoncu3, Omer Karadag4, Ismail Sari5, Muhammed Cinar6, Sedat Yılmaz7, Ahmet Mesut Onat8, Bunyamin Kisacik9, Abdulsamet Erden3, Ayşe Balkarli10, Orhan Kucuksahin11, Sibel Yilmaz Oner12, Soner Senel13, Abdurrahman Tufan13, Haner Direskeneli12, Mustafa Ferhat Oksuz14, Yavuz Pehlivan14, Ozun Bayndır15, Gokhan Keser16, Kenan Aksu17, Ahmet Omma18, Timucin Kasifoglu19, Ali Ugur Unal20, Fatih Yildiz21, Mehmet Ali Balci22, Sule Yavuz13, Sukran Erten23, Metin Ozgen24, Mehmet Sayarlioglu25, Atalay Dogru26, Gozde Yildirim Cetin27, Fatma Alibaz-Oner20, Mehmet Engin Tezcan28, Omer Nuri Pamuk29 and Fatos Onen30, 1Department of Internal Medicine, Division of Rheumatology, Izmir Katip Celebi University School of Medicine, Izmir, Turkey, 2Dokuz Eylul University, izmir, Turkey, 3Hacettepe University, Ankara, Turkey, 4Rheumatology, Hacettepe University Faculty of Medicine, Ankara, Turkey, 5Rheumatology, Toronto Western Hospital, University of Toronto, Spondylitis Clinic, Toronto, ON, Canada, 6GATA, Ankara, Turkey, 7Division of Rheumatology, Gülhane Military Medical Academy, School of Medicine, Ankara, Turkey, 8Gaziantep University School of Medicine, Ankara, Turkey, 9Rheumatology, Gaziantep University School of Medicine, Gaziantep, Turkey, 10Antalya EAH, Antalya, Turkey, 11Internal Medicine-Rheumatology, Yildirim Beyazit University Faculty of Medicine, Ankara, Turkey, 12Rheumatology, Marmara University, School of Medicine, Istanbul, Turkey, 13PsART study group, Ankara, Turkey, 14Rheumatology, Uludag University Medcal Faculty, Bursa, Turkey, 15İnternal Medicine Division of Rheumatology, Ege University Medical Faculty, Izmir, Turkey, 16Rheumatology, Ege University Medical Faculty, Izmir, Turkey, 17Ege University, İzmir, Turkey, 18Department of Internal Medicine, Rheumatology Division, Ankara Numune Hospital, Ankara, Turkey, 19İnternal Medicine Division of Rheumatology, Osmangazi University, Faculty of Medicine, Eskisehir, Turkey, 20Marmara University, School of Medicine, Rheumatology, Istanbul, Turkey, 21Rheumatology, Van EAH, Adana, Turkey, 22Rheumatology, Trakya University Medical Faculty, Edirne, Turkey, 23Rheumatology, Yildirim Beyazit University Faculty Of Medicine, Ankara, Turkey, 24Department of Internal Medicine Division of Rheumatology, Ondokuz Mayıs University, Faculty of Medicine, Samsun, Turkey, 25Rheumatology, Ondokuz Mayis University Faculty of Medicine, Samsun, Turkey, 26Suleyman Demirel University, Isparta, Turkey, 27Deparment of Rheumatology, Sutcu Imam University, School of Medicine, Department of Internal Medicine, Division of Rheumatology, Kahramanmaras, Turkey, 28Internal Medicine-Rheumatology, Gazi University Medical School, Ankara, Turkey, 29Rheumatology, Department of Rheumatology, Trakya University Medical Faculty, Edirne, Turkey, Edirne, Turkey, 30Rheumatology, Dokuz Eylul University Faculty of Medicine, Izmir, Turkey

Meeting: 2016 ACR/ARHP Annual Meeting

Date of first publication: September 28, 2016

Keywords: ,

Session Information

Date: Sunday, November 13, 2016

Title: Miscellaneous Rheumatic and Inflammatory Diseases I

Session Type: ACR Concurrent Abstract Session

Session Time: 2:30PM-4:00PM

Background/Purpose: Familial Mediterranean fever (FMF) is the most common autoinflammatory disease and colchicine is the mainstay of treatment. Around 30-45% of FMF patients were reported to have attacks despite the colchicine treatment. Currently the data regarding the treatment of colchicine unresponsive or intolerant FMF patients is limited and the most promising alternatives seem to be anti-interleukin-1 (IL1) agents. Herein we report our experience in the off-label use of anti-IL1 agents in a large group of FMF patients.

Methods: This study was conducted by the means of Turkish Multi-centered Investigations Platform in Rheumatology (TULIP). Twenty-one centers from different geographical regions of Turkey were included in the study. Medical records of all FMF patients who used anti-IL1 treatment for at least 6 months were reviewed. Demographics, disease related clinical and laboratory data were collected by a web based structured questionnaire.

Results: In total 135 FMF patients (69 [51%] male, mean age 34.1 [range; 18-67] years) were included in the analysis. In our FMF patients the mean age at symptom onset was 12.3 (range; 1-45) and at diagnosis was 20.1 (3-60) years. 98 patients were carrying M694V mutation. The mean colchicine dose was 1.8 (1.0-4.0) mg/day and attack frequency was reported to be decreased from a mean of 26/years (3-96) to 13.9/years (0-96). 116 out of 135 patients were put on anakinra and 19 on canakinumab treatment due to colchicine resistance in 114 patients, amyloidosis in 15 and other reasons in 4 patients. During the median 14.5 (6-69) months of treatment period; yearly attack frequency was significantly reduced (P<0.001), and 74 (54%) patients reported no FMF attacks. Besides serum levels of C-reactive protein, erythrocyte sedimentation rate, and 24 hours urinary protein excretion were significantly reduced, as shown in table. Although serum creatinine levels were also improved with anti-IL1 treatment, it was not reached to statistical significance.

Conclusion:  The results of this large study showed that anti-IL1 treatment is an effective alternative for not only controlling the attacks but also decreasing the proteinuria in quite challenging FMF patients.

 

Before treatment

After treatment

P

Attacks/year, mean (range)

16.8 (0-96)

2.1 (0-24)

<0.001

CRP level (mg/L), mean (range)

34.5 (0.14-220)

6.6 (0-52)

<0.001

ESR (mm/h), mean (range)

45.2 (2-129)

15.6 (0-154)

<0.001

24 hour urinary protein (mg), mean (range)

2746.7

(20-19610)

1769.6

(0-18500)

<0.001

Serum creatinine (mg/dL), mean (range)

1.68 (0.3-10.2)

1.18 (0.4-7.7)

0.907

Disclosure: S. Akar, None; P. Cetin, None; U. Kalyoncu, None; O. Karadag, Pfizer Inc, 2,Abbvie, 2,Abbvie, 5,BMS, 5,MSD, 5,Pfizer Inc, 5,Roche Pharmaceuticals, 5,UCB, 5,Sanofi-Aventis Pharmaceutical, 5; I. Sari, None; M. Cinar, None; S. Yılmaz, None; A. M. Onat, BMS, 8,MSD, 8,Pfizer Inc, 8,UCB, 8,Roche Pharmaceuticals, 8; B. Kisacik, None; A. Erden, None; A. Balkarli, None; O. Kucuksahin, None; S. Y. Oner, None; S. Senel, None; A. Tufan, None; H. Direskeneli, None; M. F. Oksuz, None; Y. Pehlivan, None; O. Bayndır, None; G. Keser, None; K. Aksu, None; A. Omma, None; T. Kasifoglu, None; A. U. Unal, None; F. Yildiz, None; M. A. Balci, None; S. Yavuz, None; S. Erten, Pfizer Inc, 8,Novartis Pharmaceutical Corporation, 8; M. Ozgen, None; M. Sayarlioglu, Pfizer Inc, 8,Abbvie, 8,MSD, 8,BMS, 8,UCB, 8,Celtrion, 8; A. Dogru, None; G. Yildirim Cetin, None; F. Alibaz-Oner, None; M. E. Tezcan, None; O. N. Pamuk, None; F. Onen, None.

To cite this abstract in AMA style:

Akar S, Cetin P, Kalyoncu U, Karadag O, Sari I, Cinar M, Yılmaz S, Onat AM, Kisacik B, Erden A, Balkarli A, Kucuksahin O, Oner SY, Senel S, Tufan A, Direskeneli H, Oksuz MF, Pehlivan Y, Bayndır O, Keser G, Aksu K, Omma A, Kasifoglu T, Unal AU, Yildiz F, Balci MA, Yavuz S, Erten S, Ozgen M, Sayarlioglu M, Dogru A, Yildirim Cetin G, Alibaz-Oner F, Tezcan ME, Pamuk ON, Onen F. A Nationwide Experience with the Off Label Use of Interleukin 1 Targeting Treatment in Familial Mediterranean Fever Patients [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/a-nationwide-experience-with-the-off-label-use-of-interleukin-1-targeting-treatment-in-familial-mediterranean-fever-patients/. Accessed .

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