An international team of Filipino and American scientists presented the results of clinical trials of a new type of drug – cenerimod. It is a drug developed for the treatment of systemic lupus erythematosus, especially in the acute form of this disease.
“It reduces the migration of T and B cells from the lymph nodes into the tissue circulation,” Dr. Navarra said at a lupus treatment conference in South Korea. S1P1 receptor antagonists are already approved for the treatment of multiple sclerosis, but cenerimod is the first therapy being investigated for the treatment of lupus.
The CARE Phase 2, international, randomized, placebo-controlled trial enrolled 427 patients with moderate to severe SLE.
Patients had to be diagnosed at least 6 months prior to screening, take stable lupus medications, and have anti-nuclear or bi-nuclear DNA antibodies. They were randomly assigned to receive 0.5 mg, 1 mg, 2 mg or 4 mg of cenerimod daily or placebo for 12 months. After 6 months, patients who were initially randomized to 4 mg/day were re-randomized to 2 mg/day or placebo .
The study showed that a 4 mg dose of cenerimod was associated with a reduction in disease activity from baseline to month 6 on the 2000 lupus erythematosus disease activity index (excluding leukopenia) compared to placebo.
The researchers also noted a greater response among those with high levels of type 1 gene expression at the start of the study, as well as those with high levels of anti-dsDNA and low levels of C4. According to Dr. Navarra, these are patients with a “more inflammatory, more active state.”
Patients with active lupus nephritis, severe central nervous system lupus or serious cardiovascular problems were excluded from the study.
These results are now being considered in the selection of patients for phase 3 trials, called OPUS-1 and OPUS-2, which are currently underway, said Dr. Navarra. The OPUS trial has revised eligibility criteria with an observation period of up to 60 days to ensure that only patients with moderate or severe SLE are enrolled.
Cenerimod was well tolerated and the rate of adverse events was similar in the treatment groups. Especially important adverse events – high blood pressure, infections and infestations, and eye problems – were mild and short-lived. There have been more reports of high blood pressure among those taking the 1mg and 4mg doses of cenerimod, but Dr. Navarra said monthly systolic or diastolic blood pressure tests showed no changes.
Explained by Marek Meissner