Delayed-release prednisone improves fatigue and health-related quality of life: findings from the CAPRA-2 double-blind randomised study in rheumatoid arthritis

Alten, Rieke; Grahn, Amy; Holt, Robert J.; Rice, Patricia; Buttgereit, Frank

doi:10.1136/rmdopen-2015-000134

Cited by 19 publications

(14 citation statements)

References 46 publications

(52 reference statements)

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“…GC are considered a bridging therapy, with short-term symptomatic21 22 and structural effects. However, the GC risk/benefit balance has little evidence base, with most recent data provided by observational studies.…”

Section: Discussionmentioning

confidence: 99%

Seven-year tolerability profile of glucocorticoids use in early rheumatoid arthritis: data from the ESPOIR cohort

et al. 2017

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ObjectiveTo explore the 7-year tolerability profile of glucocorticoids (GC) for early rheumatoid arthritis (RA).MethodsWe examined data for 602 patients with RA from the early arthritis Etude et Suivi des POlyarthrites Indifférenciées Récentes (ESPOIR) cohort (<6 months disease duration) stratified into two groups: with or without GC treatment at least once during follow-up (median 7 years (IQR 0.038–7.65)). The main outcome was a composite of death, cardiovascular disease (including myocardial ischaemia, cerebrovascular accident and heart failure), severe infection and fracture.ResultsAmong the 602 patients with RA (476 women (79%), mean age 48±12 years), 386 with GC (64.1%) received low-dose prednisone (mean 3.1±2.9 mg/day for the entire follow-up): 263 started GC during the first 6 months (68%), and the mean duration of total GC treatment was 1057±876 days. As compared with patients without GC (216 (35.9%)), those with GC showed greater use of non-steroidal anti-inflammatory drugs, synthetic and biological disease-modifying antirheumatic drugs and had more active disease disability, higher C reactive protein and anticitrullinated protein antibody levels. Among 65 events (7 deaths, 14 cardiovascular diseases, 19 severe infections and 25 fractures), 44 and 21 occurred in patients with and without GC (p=0.520). Infections were more frequent, although not significantly, in patients with than without GC (p=0.09). On weighted Cox proportional-hazards analysis, with use of propensity score and inverse-probability-of-treatment weighting, and including age, gender, history of hypertension and GC treatment, outcomes did not differ with and without GC (p=0.520; HR=0.889; 95% CI 0.620 to 1.273).ConclusionsThis 7-year analysis of the ESPOIR cohort supports the good safety profile of very low-dose GC for early active RA.

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Section: Discussionmentioning

confidence: 99%

Seven-year tolerability profile of glucocorticoids use in early rheumatoid arthritis: data from the ESPOIR cohort

et al. 2017

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“…During the 12-week study, the RA-evaluated Functional Assessment of Chronic Illness Therapy-Fatigue score improved significantly in the MR prednisone group (least squares mean difference 2.2, P =0.0032) compared to placebo. 47 This improvement in Functional Assessment of Chronic Illness Therapy-Fatigue was associated with ACR20 responsiveness in both groups. Furthermore, other quality of life markers, such as the 36-item Short-Form health survey or the Health Assessment Questionnaire Disability Index, also showed a significant improvement in the MR prednisone group ( P =0.001 and <0.001, respectively).…”

Section: Quality Of Lifementioning

confidence: 85%

Efficacy and safety of modified-release prednisone in patients with rheumatoid arthritis

Krasselt¹,

Baerwald²

2016

DDDT

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The introduction of modified-release (MR) prednisone adds a drug with encouraging potential to the armamentarium of the rheumatologist. In particular, for patients experiencing a reduced quality of life due to prolonged morning stiffness, it is a promising therapeutic approach. Two clinical trials and one open-label observational study investigated the effectiveness of MR prednisone in reducing rheumatoid arthritis-related morning stiffness for both new and current users of corticosteroids. The efficacy and safety of MR prednisone use in rheumatoid arthritis patients are reviewed in this article. This includes pivotal trials as well as pathophysiological considerations and clinical implications.

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“…In the CAPRA-2 trial, a study of patients with established RA (disease duration approximately 8 years) and active disease, low-dose (5 mg/day) prednisone with a modified release formulation (chronotherapy) added to existing DMARDs significantly ameliorated disease activity at 12 weeks as compared with placebo (PBO) added to existing DMARDs 18 19. DMARDs were almost exclusively csDMARDs because only one patient in each group received a bDMARD.…”

Section: Glucocorticoids Efficacymentioning

confidence: 99%

Glucocorticoids in rheumatoid arthritis: current status and future studies

2020

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Since their first use for treating rheumatoid arthritis (RA) in the late 1940s, glucocorticoids (GCs) have been representing a substantial part of the therapeutic arsenal for RA. However, even if GCs are still widely prescribed drugs, their toxicity is discussed controversially, so obtaining consensus on their use in RA is difficult. Hence, the most recent European League Against Rheumatism and American College of Rheumatology recommendations on early arthritis and RA management advocate the use of GCs as adjunct treatment to conventional synthetic disease-modifying antirheumatic drugs, at the lowest dose possible and for the shortest time possible. However, the recommendations remain relatively vague on dose regimens and routes of administration. Here, we describe literature data on which the current recommendations are based as well as data from recent trials published since the drafting of the guidelines. Moreover, we make proposals for daily practice and provide suggestions for studies that could help clarifying the place of GCs in RA management. Indeed, numerous items, including the benefit/risk ratio of low-dose and very low-dose GCs and optimal duration of GCs as bridging therapy, remain on the research agenda, and future studies are needed to guide the next recommendations for RA.

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Delayed-release prednisone improves fatigue and health-related quality of life: findings from the CAPRA-2 double-blind randomised study in rheumatoid arthritis

Cited by 19 publications

References 46 publications

Seven-year tolerability profile of glucocorticoids use in early rheumatoid arthritis: data from the ESPOIR cohort

Seven-year tolerability profile of glucocorticoids use in early rheumatoid arthritis: data from the ESPOIR cohort

Efficacy and safety of modified-release prednisone in patients with rheumatoid arthritis

Glucocorticoids in rheumatoid arthritis: current status and future studies

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