Lodotra® [Modified Release (MR) prednisone] is licensed for the treatment of moderate to severe rheumatoid arthritis in adults particularly when accompanied by morning stiffness.
Lodotra® is formulated to release prednisone with a delay of 4-6 hours. Release of Lodotra, when taken at night is intended to coincide with the early morning peak of pro-inflammatory cytokines.
The initial dose is usually 10mg at night which is tapered to lowest effective dose for long-term treatment.
MR prednisone has been shown to be beneficial compared to placebo and immediate release (IR) prednisone, in reducing morning stiffness and compared to IR prednisone in reducing levels of interleukin-6 in two controlled trials. No other significant differences in RA parameters or quality of life measures were seen between IR and MR prednisone.
Clinical trials were limited to a maximum of 12 months; data on continued benefit of use for longer than 12 months is limited.
Side effects appear to be similar to equivalent doses of IR glucocorticoids.
No change in the suppression of the hypothalamic-pituitary-adrenal (HPA) axis was seen when patients were switched from IR to MR prednisone.
Patients need to be counselled to take Lodotra® at night, with a light meal or snack.
28 days treatment with 5mg Lodotra® is more than 20 times the cost of uncoated IR prednisolone 5mg.