Nitec's Lodotra cuts RA morning stiffness

Swiss drugmaker Nitec Pharma AG's CAPRA-1 study showed a reduction of morning stiffness by more than 50% on average in patients with rheumatoid arthritis treated with Lodotra, a developmental circadian cytokine modulator, for up to 12 months, according to data presented at the annual meeting of the American College of Rheumatology, in Boston.

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% (p=0.0452, two sided). After six months of treatment with Lodotra the reduction of morning stiffness amounted to 55.0% (96 minutes, p<0.0001) compared to baseline. This effect was sustained until the end of the 12-month treatment period (mean reduction 46.1 %, 84 minutes, p<0.0001). The results also showed a statistically-significant reduction in serum levels of the pro-inflammatory cytokine interleukin-6 after three months of treatment with the drug versus prednisone (p=0.0322).

After 12 months of treatment with Lodotra, the relative change in IL-6 between start and end of open follow-ups was 40.1% (median). Elevated serum levels of IL-6 during the night are thought to be a contributing factor to the early morning stiffness of RA patients, Nitec noted.