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Abstract Number: 0138

Patients with Familial Mediterranean Fever (FMF) Under Canakinumab Treatment – Long-term Efficacy and Safety Interim Data of the RELIANCE Registry

Joerg Henes1, Jasmin B. Kuemmerle-Deschner2, Tobias Krickau3, Tilmann Kallinich4, Frank Dressler5, Gerd Horneff6, Florian Meier7, Ivan Foeldvari8, Frank Weller-Heinemann9, Birgit Kortus-Goetze10, Markus Hufnagel11, Juergen Rech12, Prasad T. Oommen13, Julia Weber-Arden14 and Norbert Blank15, 1Center for Interdisciplinary Clinical Immunology, Rheumatology and Auto-inflammatory Diseases (INDIRA), University Hospital Tübingen, Tübingen, Germany, 2Department of Pediatrics, Division of Pediatric Rheumatology, University Hospital Tübingen, Tübingen, Germany, 3Friedrich-Alexander Universität Erlangen-Nürnberg (FAU), Pediatrics, Erlangen, Germany, 4Charité - Universitätsmedizin Berlin, Nuremberg, Germany, 5Division of Pediatric Pneumology, Allergology and Neonatology, Hannover Medical School, Hannover, Germany, 6Pediatrics, Asklepios Klinik Sankt Augustin GmbH, Sankt Augustin, Germany, 7Division of Rheumatology, University Hospital Frankfurt, Goethe University, Frankfurt am Main, Germany, and Fraunhofer Institute for Molecular Biology and Applied Ecology IME, Project Group Translational Medicine and Pharmacology TMP, Frankfurt, Germany, 8Hamburger Zentrum für Kinder- und Jugendrheumatologie, Hamburg, Germany, 9Klinikum Bremen-Mitte, Prof. Hess Kinderklinik, Bremen, Germany, 10Division of Nephrology, University of Marburg, Marburg, Germany, 11Division of Pediatric Infectious Diseases and Rheumatology, Department of Pediatrics and Adolescent Medicine, University Hospital Medical Center Freiburg, Medical Faculty, University of Freiburg, Freiburg, Germany, 12University Clinic Erlangen, Erlangen, Germany, 13Clinic of Pediatric Hematology, Oncology and Clinical Immunology, Heinrich-Heine-University Duesseldorf, Duesseldorf, Germany, 14Novartis Pharma GmbH, Nuernberg, Germany, 15Rheumatology, University Hospital Heidelberg, Heidelberg, Germany

Meeting: ACR Convergence 2022

Keywords: Autoinflammatory diseases, Biologicals, FMF, Innate Immunity Rheumatic Disease, longitudinal studies

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Session Information

Date: Saturday, November 12, 2022

Session Title: Miscellaneous Rheumatic and Inflammatory Diseases Poster I

Session Type: Poster Session A

Session Time: 1:00PM-3:00PM

Background/Purpose: Familial Mediterranean fever (FMF) is a chronic disease characterized by recurrent episodes of fever and serositis, with a risk of severe complications (e. g. amyloidosis). Treatment of FMF according to EULAR recommendations aims to control acute relapses and subclinical inflammation and improve patients’ quality of life. Clinical data suggest that inhibition of interleukin-1β with canakinumab (CAN) is effective in controlling and preventing relapses in FMF patients.

The present study investigates the long-term efficacy and safety of CAN in routine clinical practice in pediatric (age ≥2 years) and adult FMF patients.

Methods: RELIANCE is a prospective, non-interventional, multicenter observational study in Germany with a follow-up period of up to seven years. Patients with a clinically confirmed diagnosis of FMF who routinely receive CAN will be enrolled in the study. At the time of study inclusion and at six-months intervals, the following parameters will be recorded: Disease activity (physician assessment), fatigue and impact on social life (patient assessment), inflammatory markers and the Auto-Inflammatory Diseases Activity Index (AIDAI) score.

Results: This interim analysis of FMF patients (N=74) enrolled through December 2021 includes data from baseline through the 24-months visit. The mean age in this cohort was 25 years (2-61 years). The proportion of female patients was 51% (N=38). At baseline, the median duration of prior CAN treatment was 1.0 years (0-6 years). Patients had been pre-treated with colchicine (71%), canakinumab (77%), anakinra (31%) and tocilizumab (5%). At month 24, approximately 63% of patients were in disease remission by physician assessment, and 67% of patients documented inactive disease in the AIDAI (Table 1).

Mutations were documented in a total of N=57 patients. Most common variants were M694V (9 homozygous [hoz], 10 compound heterozygous [hec], 12 heterozygous [hez],), V726A (1 hoz, 6 hec, 1 hez), and M680I (1 hoz, 6 hec, 1 hez).

At baseline, N=16 FMF patients were CAN-naive and received a starting dose of median 150 mg CAN (40 mg/kg – 150 mg every 4 weeks). In this subgroup, a total of 12 dose adjustments were made over the course of two years (9 dose increases, 3 dose reductions).

A total of 18 severe adverse events (SAE) were reported, of which 2 (tonsillectomy due to recurrent tonsillitis and tachycardia, patient age: 6 years each) were classified as drug-related.

Conclusion: Interim data from FMF patients in the RELIANCE study, the longest running canakinumab registry, confirm the efficacy and safety of long-term treatment with canakinumab. Dose adjustments during the course of therapy are possible.

Supporting image 1

Table 1: Evaluation of clinical disease activity and safety aspects of patients with FMF.


Disclosures: J. Henes, Boehringer Ingelheim; J. Kuemmerle-Deschner, AbbVie/Abbott, Novartis, SOBI; T. Krickau, Novartis; T. Kallinich, Roche; F. Dressler, Novartis, AbbVie/Abbott, Mylan, Pfizer; G. Horneff, Roche, Pfizer, Novartis, Merck/MSD, Eli Lilly, AbbVie/Abbott; F. Meier, Novartis; I. Foeldvari, None; F. Weller-Heinemann, None; B. Kortus-Goetze, Novartis; M. Hufnagel, Novartis; J. Rech, Novartis, SOBI, AbbVie/Abbott, Biogen, Bristol-Myers Squibb(BMS), Chugai, GlaxoSmithKlein(GSK), Janssen, Eli Lilly, Merck/MSD, Mylan, Roche, Sanofi, UCB; P. Oommen, Novartis; J. Weber-Arden, Novartis; N. Blank, Novartis, SOBI, Lilly, Pfizer, AbbVie/Abbott, Bristol-Myers Squibb(BMS), Merck/MSD, Actelion, UCB, Boehringer-Ingelheim, Roche.

To cite this abstract in AMA style:

Henes J, Kuemmerle-Deschner J, Krickau T, Kallinich T, Dressler F, Horneff G, Meier F, Foeldvari I, Weller-Heinemann F, Kortus-Goetze B, Hufnagel M, Rech J, Oommen P, Weber-Arden J, Blank N. Patients with Familial Mediterranean Fever (FMF) Under Canakinumab Treatment – Long-term Efficacy and Safety Interim Data of the RELIANCE Registry [abstract]. Arthritis Rheumatol. 2022; 74 (suppl 9). https://acrabstracts.org/abstract/patients-with-familial-mediterranean-fever-fmf-under-canakinumab-treatment-long-term-efficacy-and-safety-interim-data-of-the-reliance-registry/. Accessed May 27, 2023.
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