Patients with rheumatoid arthritis who received Lodotra (prednisone) for up to 12 months experienced sustained relief of morning stiffness, the CAPRA-1 study has shown.
Lodotra, due to be launched in September, is a delayed-release formulation of low-dose prednisone. Taken at bedtime, it releases the steroid whilst patients sleep. In this way, levels of the drug in patients’ blood reach a peak at the same time as the circadian peak in inflammation.
CAPRA-1 investigators randomised 288 patients with active rheumatoid arthritis to undergo double-blind treatment with either:
- Lodotra, taken at bedtime, or
- the same dose of immediate-release prednisolone, taken in the morning.
After 12 weeks, patients switched to open-label treatment with Lodotra.
Assessment at 12 months showed that the duration of stiffness on waking had fallen by 55% in patients who had taken Lodotra continuously, compared with 45% in those who had initially received conventional prednisolone.
Furthermore, circulating levels of interleukin-6 were half as high in the Lodotra group as in the conventional prednisolone group. This cytokine is a key marker of inflammation.
Approximately half the patients in the open-label phase of Lodotra treatment (51%) reported adverse events, with 5% leaving the study as a result.
The long-term results of CAPRA-1 are consistent with the initial findings of the study. Assessment at 12 weeks showed that patients receiving Lodotra, compared with those on conventional prednisolone, had:
- a greater decrease in the duration of morning stiffness (–22.7% versus –0.4%; p=0.045)
- a greater decrease in serum interleukin-6 levels (p=0.0322)
- similar rates of adverse events.
NICE guidance recommends a combination of glucocorticoids and DMARDs for patients with newly diagnosed active RA.