The Effect of Rilonacept versus Placebo on Health-Related Quality of Life in Patients with Poorly Controlled Familial Mediterranean Fever

Objective. To examine the effect of rilonacept on the health-related quality of life (HRQoL) in patients with poorly controlled familial Mediterranean fever (FMF). Methods. As part of a randomized, double-blinded trial comparing rilonacept and placebo for the treatment of FMF, patients/parents compl...

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Published in:BioMed research international 2014-01, Vol.2014 (2014), p.1-8
Main Authors: Spalding, Steven J., Hashkes, Philip J., Hajj-Ali, Rula, Giannini, Edward H., Johnson, Anne, Barron, Karyl S., Weisman, Michael H., Pashinian, Noune, Reiff, Andreas O., Samuels, Jonathan, Wright, Dowain, Lovell, Daniel J., Huang, Bin
Format: Article
Language:English
Subjects:
Adult
Children & youth
Double-Blind Method
Drug therapy
Familial Mediterranean fever
Familial Mediterranean Fever - drug therapy
Female
Health aspects
Hospitals
Humans
Male
Patient outcomes
Quality of Life
Recombinant Fusion Proteins - therapeutic use
Rilonacept
Studies
Surveys and Questionnaires
Treatment Outcome
Young Adult
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Summary:Objective. To examine the effect of rilonacept on the health-related quality of life (HRQoL) in patients with poorly controlled familial Mediterranean fever (FMF). Methods. As part of a randomized, double-blinded trial comparing rilonacept and placebo for the treatment of FMF, patients/parents completed the modified Child Health Questionnaire (CHQ) at baseline, and at the start and end of each of 4 treatment courses, 2 each with rilonacept and placebo. Results. Fourteen subjects were randomized; mean age was 24.4 ± 11.8 years. At baseline the physical HRQoL score was significantly less (24.2 ± 49.5) but the psychosocial score was similar to the population norm (49.5 ± 10.0). There were significant improvements in most HRQoL concepts after rilonacept but not placebo. Significant differences between rilonacept and placebo were found in the physical (33.7 ± 16.4 versus 23.7 ± 14.5, P=0.021) but not psychosocial scores (51.4 ± 10.3 versus 49.8 ± 12.4, P=0.42). The physical HRQoL was significantly impacted by the treatment effect and patient global assessment. Conclusion. Treatment with rilonacept had a beneficial effect on the physical HRQoL in patients with poorly controlled FMF and was also significantly related to the patient global assessment. This trial is registered with ClinicalTrials.gov Identifier NCT00582907.
ISSN:2314-6133
2314-6141
DOI:10.1155/2014/854842