Lodotra: new prednisone formulation for rheumatoid arthritis

Lodotra is a modified-release preparation of prednisone licensed for the treatment of moderate to severe active rheumatoid arthritis (RA), particularly with morning stiffness.

Lodotra is specifically indicated for the treatment of rheumatoid arthritis
Lodotra is specifically indicated for the treatment of rheumatoid arthritis

Lodotra (prednisone) features a unique hydrophilic shell that delivers low-dose prednisone 4 to 6 hours after administration.

It is recommended that Lodotra be taken at bedtime (around 10pm) with or after the evening meal. If more than 2 to 3 hours have passed since the meal a light snack should be eaten.

Tablets should be swallowed whole as they consist of a prednisone-containing core and an inert coating.1

The delayed release of prednisone coincides with the circadian rhythms of endogenous cortisol and disease symptoms, both of which peak in the early morning hours, to improve the benefit-risk ratio of glucocorticoid therapy in RA.2

In a 12-week, double-blind trial patients with active RA (n=288) were randomised to receive either a modified-release prednisone tablet administered at bedtime or an immediate-release prednisone tablet administered in the morning.

The mean relative change in duration of morning stiffness of the joints from baseline to end of treatment was significantly higher in the modified-release group compared with the immediate-release group (p=0.045).

The absolute difference between the two groups was 29.2 minutes in favour of the modified-release prednisone group (p=0.072).

There were no differences in the safety profiles for the two treatments.2

View Lodotra drug record

REFERENCES

  1. Lodotra Summary of product characteristics, March 2010.
  2. Buttgereit F et al. Lancet 2008; 371:205-14.

Further information: Napp

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