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Canakinumab improves patient-reported outcomes in children and adults with autoinflammatory recurrent fever syndromes: results from the CLUSTER trial

1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12


  1. University College London Division of Medicine and Royal Free Hospital, London, UK.
  2. Department of Rheumatology, Cliniques Universitaires Saint-Luc & Institut de Recherche Expérimentale et Clinique, Université Catholique de Louvain, Brussels, Belgium.
  3. Department of Paediatric Rheumatology, Alberta Children's Hospital, Calgary, Canada.
  4. Department of Pneumology and Immunology, Charité Medical University of Berlin, Germany.
  5. Department of Rheumatology and Immunology, Dr. von Hauner Children’s Hospital, University Hospital, LMU, Munich, Germany.
  6. Department of Rheumatology, Bnai Zion Medical Center, Haifa, Israel.
  7. Department of Internal Medicine and Autoinflammatory Diseases, Fondazione Policlinico Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy.
  8. Paediatric Rheumatology Unit, University Hospital La Paz, Madrid, Spain.
  9. Department of Clinical Immunology and Allergy, St James’s University Hospital, Leeds, and Musculoskelatal Biomedical Research Unit, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, UK.
  10. Immunology, Hepatology and Dermatology Franchise, Novartis Pharma B.V., Arnhem, the Netherlands.
  11. Division of Rheumatology, Ospedale Pediatrico Bambino Gesú, Rome, Italy.
  12. Department of Internal Medicine, Radboud University Medical Centre, Nijmegen, The Netherlands.

2021 Vol.39, N°5 ,Suppl.132
PI 0051, PF 0058
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PMID: 34622762 [PubMed]

Received: 23/11/2020
Accepted : 17/05/2021
In Press: 06/10/2021
Published: 06/10/2021


To evaluate the effect of canakinumab on health-related quality of life (HRQoL), work/school and social life of patients with autoinflammatory recurrent fever syndromes, including colchicine-resistant familial Mediterranean fever, mevalonate kinase deficiency, and tumour necrosis factor receptor-associated periodic syndrome, in the CLUSTER trial.
HRQoL of patients who received canakinumab 150 mg or 300 mg every four weeks in the CLUSTER trial (n=173) was assessed at baseline and Weeks 17 and 41. For children we used the Child Health Questionnaire - Parent Form 50 (CHQ-PF50), including psychosocial (PsS) and physical (PhS) component summary scores. For adults, the Short-Form-12 (SF-12) Health Survey was used, including physical (PFS) and mental (PCS) component summary scores. The Sheehan Disability Scale (SDS) was used to determine the impact of treatment on work/school, social and family life.
The results obtained were remarkably consistent in both paediatric and adult patients across the three disease cohorts. At baseline, median scores for physical components were relatively low (26–29 for PhS and 34–38 for PFS); they improved to values similar to those expected in the general population by Week 17, and this improvement was sustained at Week 41, when median PhS scores were 47–50 and PFS 44–54. Psychosocial and mental scores also improved from baseline to Week 17 and 41, with scores comparable to the general population. Notable improvements were also observed in the SDS scale.
Patients with three inherited autoinflammatory syndromes experienced sustained improvements on their HRQoL, work/school, and social life on treatment with canakinumab.

Rheumatology Article