The open-label follow-up phase lasted nine months, and was the continuation of a three month Phase III double blind controlled trial. This study had demonstrated that Lodotra was more effective than immediate release prednisone at reducing morning stiffness.
Following this trial, 249 patients who had finished the three months trial started open-label treatment with Lodotra for a further nine months. Patients recorded the duration of their morning stiffness for the entire treatment period of 12 months. Compared to immediate release prednisone, after three months the study population showed a mean relative reduction in the duration of morning stiffness of 22.7% versus 0.4%.
After six months of treatment with Lodotra, the reduction of morning stiffness amounted to 55.0% (96 minutes) compared to baseline. This effect was sustained until the end of the 12 month treatment period (mean reduction 46.1 %, 84 minutes).
Dr Anders Harfstrand, CEO of Nitec, said: “We are delighted to have such positive 12 month results confirming the results of the double-blind period of the Phase III trial. Reducing morning stiffness by about 50% will deliver tangible benefit to people with rheumatoid arthritis.”