Results from a Phase 2 clinical trial comparing the effects of baricitinib to a placebo in patients with systemic lupus erythematosus (SLE) have been announced. For more detailed information, please read the source article, which can be found here at PR Newswire.
About Systemic Lupus Erythematosus (SLE)
SLE, also known as lupus, is a long-term autoimmune condition that causes inflammation. People are affected by lupus differently, and the condition can be milder or more severe. Over time, many people affected by lupus find that the condition follows a cycle, where it flares up and causes more severe symptoms, and then settles down (goes into remission).
The inflammation can affect many tissues, including the skin, joints, lungs, heart, brain, and kidneys. Severe inflammation can damage organs, and in some cases becomes life-threatening.
About the Study
314 patients took part in the Phase 2 clinical trial and were randomly assigned to one of three groups. These were (1) a placebo group, (2) a group receiving 2mg of baricitinib, and (3) a group receiving 4mg of baricitinib. The patients were followed for 24 weeks.
The group that was treated with 2mg of baricitinib was not found to have statistically significant different outcomes, as measured by the study’s endpoints. However, the group treated with 4mg of baricitinib showed improvements compared to the placebo group.
More patients in the 4mg group had improvements in overall disease activity and pain than in the placebo group over the 24 week period. According to the article, 67.3% of participants who were treated with 4mg of baricitinib and standard of care reached the resolution of SLE-related arthritis or rash. In comparison, this was true for 53.3% of the placebo group. Serious adverse events were recorded in 5% of the placebo group, compared to 10.5% of the 2mg group and 9.6% of the 4mg group.
The safety of baricitinib was also evaluated. The percentage of patients that stopped treatment during the 24-week trial was 21% of the placebo group, 18% of the group taking 2mg, and 17% of the 4mg group.
There are plans to begin Phase 3 trials to further investigate the use of baricitinib as a possible treatment for SLE. These are expected to begin in the second half of 2018.