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Efficacy of Modified-Release Prednisone in Rheumatoid Arthritis


Modified-release prednisone was well tolerated and reduced morning stiffness of joints in patients with rheumatoid arthritis (RA), according to the results of a double-blind, randomized controlled trial reported in the January 19 issue of The Lancet.

In this 12-week, multicenter trial, 288 patients with active RA were randomized to receive either a modified-release prednisone tablet at bedtime or an immediate-release prednisone tablet in the morning. With the modified-release tablet, prednisone was released 4 hours after ingestion. The main endpoint was duration of morning stiffness of the joints, and analysis was by intent-to-treat.

From baseline to end of treatment, the mean relative change in duration of morning stiffness of the joints was higher with modified-release prednisone than with immediate-release prednisone (–22.7% vs. –0.4%; difference, 22·4%; 95% confidence interval [CI], 0.49 - 44.30; P = .045). In the prednisone modified-release group, mean reduction from baseline in duration of morning stiffness was 44.0 ± 136.6 minutes. The absolute difference between the groups was 29.2 minutes (95% CI –2.59 to 61.9) favoring modified-release prednisone (P = .072).

Both treatments had a similar safety profile. Modified-release prednisone is well tolerated, convenient to administer, and produces a clinically relevant reduction of morning stiffness of the joints in addition to all known therapeutic effects of immediate-release prednisone. Interleukin 6 serum concentrations were also significantly reduced by modified-release prednisone after 3 months but were unchanged by immediate-release prednisone. Study limitations include that it was not designed to evaluate IL-6 in statistical confirmatory tests.

Modified-release prednisone provides an improvement with respect to conventional glucocorticoids for the treatment of rheumatoid arthritis. This new prednisone tablet might also be an option for the treatment of other diseases such as polymyalgia rheumatica or even asthma.

Source: Medscape Medical News / Lancet. 2008;371:183-184, 205-214