Modified-Release Prednisone: in Patients with Rheumatoid Arthritis
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ADIS DRUG EVALUATION
Modified-Release Prednisone: in Patients with Rheumatoid Arthritis Sheridan Henness • Lily P. H. Yang
Published online: 19 November 2013 Ó Springer International Publishing Switzerland 2013
Abstract Prednisone is a well-established treatment option in rheumatoid arthritis. Low-dose glucocorticoid therapy alleviates disease signs and symptoms, is better tolerated than high-dose therapy, and its addition to disease-modifying anti-rheumatic drugs (DMARDs) inhibits radiographic disease progression. A low-dose, modifiedrelease (MR) formulation of prednisone, administered in the evening, was developed to counter the circadian rise in pro-inflammatory cytokine levels that contributes to disease activity. In a 12-week, randomized trial (CAPRA-2) in adult patients with rheumatoid arthritis who were receiving stable DMARD therapy, the addition of MR prednisone reduced disease signs and symptoms by C20 % according to the American College of Rheumatology criteria (in 48 % of patients vs. 29 % with placebo; p \ 0.002 [primary endpoint]). In another 12-week trial (CAPRA-1), addition of evening MR prednisone to stable DMARD therapy reduced the mean duration of morning stiffness to a greater extent than addition of morning immediate-release (IR) prednisone (22.7 vs. 0.4 %; p = 0.045 [primary endpoint]). The improvement in morning stiffness with MR prednisone was maintained for 9–12 months during the open-label extension of CAPRA-1. These findings were supported by data from observational studies in various adult populations with rheumatoid arthritis. Treatment with evening
The manuscript was reviewed by: R. Alten, Department of Internal Medicine II, Rheumatology, Schlosspark-Klinik, Charite´ University Medicine, Berlin, Germany; M. Cutolo, Research Laboratory and Academic Division of Clinical Rheumatology, Department of Internal Medicine, University of Genoa, Genoa, Italy. S. Henness L. P. H. Yang (&) Adis, 41 Centorian Drive, Private Bag 65901, Mairangi Bay, North Shore 0754, Auckland, New Zealand e-mail: [email protected]
MR prednisone for up to 12 months was generally well tolerated, with an overall similar tolerability profile compared with evening placebo or morning IR prednisone, and no new safety concerns. MR prednisone was estimated to be cost effective relative to IR prednisone in patients with rheumatoid arthritis in a UK pharmacoeconomic model.
Modified-release prednisone in rheumatoid arthritis: a summary This formulation enables evening/bedtime drug administration that provides delayed drug release at the optimum time to counter the circadian, nocturnal rise in pro-inflammatory cytokine levels that contributes to disease activity The overall pharmacokinetic profile is essentially the same as that of immediate-release prednisone, with the exception of a &4-h lag period Effective in reducing morning stiffness and signs and symptoms of rheumatoid arthritis disease, as well as health-related quality of life Generally well tolerated, with no new safety concerns Estimated to be cost effective re
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