Seza Özen1, Erdal Sag1, Eldad Ben-Chetrit2, Marco Gattorno3, Ahmet Gül4, Philip J Hashkes5, Isabelle Kone-Paut6, Helen J Lachmann7, Elena Tsitsami8, Marinka Twilt9, Fabrizio de Benedetti10, Jasmin B Kuemmerle-Deschner11. 1. Department of Pediatrics, Division of Pediatric Rheumatology, Hacettepe University, Ankara 06100, Turkey. 2. Department of Rheumatology, Hadassah-Hebrew University Medical Center, Jerusalem, Israel. 3. Center for Autoinflammatory Diseases and Immunodeficiencies, IRCCS, Genova, Italy. 4. Department of Internal Medicine, Division of Rheumatology, Istanbul University, Istanbul Faculty of Medicine, Istanbul, Turkey. 5. Pediatric Rheumatology Unit, Shaare-Zedek Medical Center, Jerusalem, Israel. 6. Pediatric Rheumatology Unit and CEREMAIA, Bicêtre Hospital, APHP, Université Paris-Sud Saclay, Paris, France. 7. National Amyloidosis Centre, Division of Medicine, The Royal Free Hospital & University College London, London, UK. 8. 1st Department of Pediatrics, School of Medicine, University of Athens, Athens, Greece. 9. Alberta Children's Hospital, Alberta Children's Hospital Research Institute and University of Calgary, Calgary, Alberta, Canada. 10. Division of Rheumatology, IRCCS Ospedale Pediatrico Bambino Gesù, Roma, Italy. 11. Division of Paediatric Rheumatology, Department of Paediatrics and Autoinflammation Reference Center Tuebingen, University Hospital Tuebingen, Tuebingen, Germany.
Abstract
OBJECTIVES: Colchicine is the main treatment for FMF. Although a number of individuals with FMF are intolerant/resistant to colchicine, there is no standard definition of colchicine resistance/intolerance. We developed a set of evidence-based core statements defining colchicine resistance/intolerance in patients with FMF that may serve as a guide for clinicians and health authorities. METHODS: A set of statements was identified using a modified-Delphi consensus-based approach. The process involved development of an initial colchicine resistance/intolerance-related questionnaire derived from a systematic literature review. The questionnaire, which was completed by an international panel of 11 adult and paediatric rheumatologists with expertise in FMF, was analysed anonymously. The results informed draft consensus statements that were discussed by a round-table expert panel, using a nominal group technique to agree on the selection and wording of the final statements. RESULTS: Consensus among the panel was achieved on eight core statements defining colchicine resistance/intolerance in patients with FMF. A definition of resistance was agreed upon that included recurrent clinical attacks (average one or more attacks per month over a 3-month period) or persistent laboratory inflammation in between attacks. Other core statements recognize the importance of assessing treatment adherence, and the impact of active disease and intolerance to colchicine on quality of life. CONCLUSION: Based on expert opinion, a set of evidence-based core statements defining colchicine resistance/intolerance in patients with FMF were identified to help guide clinicians and health authorities in the management of patients with FMF.
OBJECTIVES:Colchicine is the main treatment for FMF. Although a number of individuals with FMF are intolerant/resistant to colchicine, there is no standard definition of colchicine resistance/intolerance. We developed a set of evidence-based core statements defining colchicine resistance/intolerance in patients with FMF that may serve as a guide for clinicians and health authorities. METHODS: A set of statements was identified using a modified-Delphi consensus-based approach. The process involved development of an initial colchicine resistance/intolerance-related questionnaire derived from a systematic literature review. The questionnaire, which was completed by an international panel of 11 adult and paediatric rheumatologists with expertise in FMF, was analysed anonymously. The results informed draft consensus statements that were discussed by a round-table expert panel, using a nominal group technique to agree on the selection and wording of the final statements. RESULTS: Consensus among the panel was achieved on eight core statements defining colchicine resistance/intolerance in patients with FMF. A definition of resistance was agreed upon that included recurrent clinical attacks (average one or more attacks per month over a 3-month period) or persistent laboratory inflammation in between attacks. Other core statements recognize the importance of assessing treatment adherence, and the impact of active disease and intolerance to colchicine on quality of life. CONCLUSION: Based on expert opinion, a set of evidence-based core statements defining colchicine resistance/intolerance in patients with FMF were identified to help guide clinicians and health authorities in the management of patients with FMF.
Authors: Mikhail Kostik; Ummusen Akca Kaya; Olga V Zhogova; Erdal Sag; Evgeny N Suspitsin; Viktoriya I Nizhnik; Anastasiya V Tumakova; Sergey V Ivanovskiy; Natalia V Lagunova; Yelda Bilginer; Seza Ozen Journal: Turk Arch Pediatr Date: 2022-09