Delayed-release prednisone improves fatigue and health-related quality of life: findings from the CAPRA-2 double-blind randomised study in rheumatoid arthritis
Objectives Like morning stiffness, fatigue is a common, debilitating symptom of rheumatoid arthritis (RA). Delayed-release (DR) prednisone is designed for evening administration (approximately 22:00) and releases 4 h later to coincide with the rise of nocturnal inflammatory cytokines associated with...
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BMJ Publishing Group
2015-08-01
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| Series: | RMD Open |
| Online Access: | https://rmdopen.bmj.com/content/1/1/e000134.full |
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| author | Frank Buttgereit Rieke Alten Amy Grahn Robert J Holt Patricia Rice |
| author_facet | Frank Buttgereit Rieke Alten Amy Grahn Robert J Holt Patricia Rice |
| author_sort | Frank Buttgereit |
| collection | DOAJ |
| description | Objectives Like morning stiffness, fatigue is a common, debilitating symptom of rheumatoid arthritis (RA). Delayed-release (DR) prednisone is designed for evening administration (approximately 22:00) and releases 4 h later to coincide with the rise of nocturnal inflammatory cytokines associated with development of morning stiffness. The impact of DR prednisone on fatigue and other related patient-reported outcomes was analysed with data obtained from the Circadian Administration of Prednisone in Rheumatoid Arthritis (CAPRA) 2 study.Methods Patients with symptomatic RA (n=350) despite treatment with a disease-modifying antirheumatic drug (DMARD) were randomised 2:1 to receive additional therapy with DR prednisone 5 mg or placebo once daily for 12 weeks. Fatigue was assessed using validated instruments: the fatigue scale of the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) and the vitality domain of the Short Form-36 (SF-36). General quality of life was assessed using the general score and individual domains of Functional Assessment of Cancer Therapy-General (FACT-G) and SF-36.Results The change from baseline to week 12 in FACIT-F score was statistically significantly different with DR prednisone/DMARD (3.8) versus placebo/DMARD (1.6; difference 2.2, p=0.0032). Improvement in FACIT-F score correlated positively with clinical response. Compared with placebo/DMARD, DR prednisone/DMARD showed a significantly greater improvement in SF-36 vitality score (5.6, p=0.001), physical component of SF-36 (2.3, p=0.0003) and general score with FACT-G (2.6, p=0.0233).Conclusions DR prednisone in addition to a DMARD significantly improves fatigue and other aspects of health-related quality of life in patients with symptomatic RA compared with DMARD treatment alone.Trial registration number ClinicalTrials.gov NCT00650078. |
| format | Article |
| id | doaj-art-f5afc10b306c4905ad4b9a999b3e6a2b |
| institution | Kabale University |
| issn | 2056-5933 |
| language | English |
| publishDate | 2015-08-01 |
| publisher | BMJ Publishing Group |
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| series | RMD Open |
| spelling | doaj-art-f5afc10b306c4905ad4b9a999b3e6a2b2025-02-11T11:25:12ZengBMJ Publishing GroupRMD Open2056-59332015-08-011110.1136/rmdopen-2015-000134Delayed-release prednisone improves fatigue and health-related quality of life: findings from the CAPRA-2 double-blind randomised study in rheumatoid arthritisFrank Buttgereit0Rieke Alten1Amy Grahn2Robert J Holt3Patricia Rice44 Department of Rheumatology and Immunology, University Hospital Charité, Berlin, GermanyDepartment of Internal Medicine and Rheumatology, Schlosspark Klinik, University Medicine Berlin, Berlin, Germany2Horizon Pharma, Deerfield, Illinois, USA3University of Illinois-Chicago, Chicago, Illinois, USA4Premier Research, Naperville, Illinois, USAObjectives Like morning stiffness, fatigue is a common, debilitating symptom of rheumatoid arthritis (RA). Delayed-release (DR) prednisone is designed for evening administration (approximately 22:00) and releases 4 h later to coincide with the rise of nocturnal inflammatory cytokines associated with development of morning stiffness. The impact of DR prednisone on fatigue and other related patient-reported outcomes was analysed with data obtained from the Circadian Administration of Prednisone in Rheumatoid Arthritis (CAPRA) 2 study.Methods Patients with symptomatic RA (n=350) despite treatment with a disease-modifying antirheumatic drug (DMARD) were randomised 2:1 to receive additional therapy with DR prednisone 5 mg or placebo once daily for 12 weeks. Fatigue was assessed using validated instruments: the fatigue scale of the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) and the vitality domain of the Short Form-36 (SF-36). General quality of life was assessed using the general score and individual domains of Functional Assessment of Cancer Therapy-General (FACT-G) and SF-36.Results The change from baseline to week 12 in FACIT-F score was statistically significantly different with DR prednisone/DMARD (3.8) versus placebo/DMARD (1.6; difference 2.2, p=0.0032). Improvement in FACIT-F score correlated positively with clinical response. Compared with placebo/DMARD, DR prednisone/DMARD showed a significantly greater improvement in SF-36 vitality score (5.6, p=0.001), physical component of SF-36 (2.3, p=0.0003) and general score with FACT-G (2.6, p=0.0233).Conclusions DR prednisone in addition to a DMARD significantly improves fatigue and other aspects of health-related quality of life in patients with symptomatic RA compared with DMARD treatment alone.Trial registration number ClinicalTrials.gov NCT00650078.https://rmdopen.bmj.com/content/1/1/e000134.full |
| spellingShingle | Frank Buttgereit Rieke Alten Amy Grahn Robert J Holt Patricia Rice Delayed-release prednisone improves fatigue and health-related quality of life: findings from the CAPRA-2 double-blind randomised study in rheumatoid arthritis RMD Open |
| title | Delayed-release prednisone improves fatigue and health-related quality of life: findings from the CAPRA-2 double-blind randomised study in rheumatoid arthritis |
| title_full | Delayed-release prednisone improves fatigue and health-related quality of life: findings from the CAPRA-2 double-blind randomised study in rheumatoid arthritis |
| title_fullStr | Delayed-release prednisone improves fatigue and health-related quality of life: findings from the CAPRA-2 double-blind randomised study in rheumatoid arthritis |
| title_full_unstemmed | Delayed-release prednisone improves fatigue and health-related quality of life: findings from the CAPRA-2 double-blind randomised study in rheumatoid arthritis |
| title_short | Delayed-release prednisone improves fatigue and health-related quality of life: findings from the CAPRA-2 double-blind randomised study in rheumatoid arthritis |
| title_sort | delayed release prednisone improves fatigue and health related quality of life findings from the capra 2 double blind randomised study in rheumatoid arthritis |
| url | https://rmdopen.bmj.com/content/1/1/e000134.full |
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