Alopecia areata is an autoimmune disease that causes hair loss. It is estimated to affect about 7 million people in the United States. There is currently no cure for alopecia areata, but there are a number of treatments that can help slow hair loss or promote regrowth.
One promising new treatment for alopecia areata is baricitinib, a drug that is already approved for the treatment of rheumatoid arthritis. In two clinical trials, baricitinib was shown to be effective in promoting hair regrowth in people with severe alopecia areata.
In the first trial, 402 people with severe alopecia areata were randomly assigned to receive either 2 mg or 4 mg of baricitinib daily, or a placebo. After 36 weeks, the people who received baricitinib were more likely to have experienced hair regrowth than those who received the placebo. For example, 48% of the people who received 4 mg of baricitinib had at least 50% hair regrowth, compared to 23% of those who received the placebo.
In the second trial, 665 people with severe alopecia areata were randomly assigned to receive either 2 mg or 4 mg of baricitinib daily, or a placebo. After 24 weeks, the people who received baricitinib were more likely to have experienced hair regrowth than those who received the placebo. For example, 51% of the people who received 4 mg of baricitinib had at least 25% hair regrowth, compared to 27% of those who received the placebo.
Baricitinib works by blocking the activity of Janus kinases (JAKs), a group of enzymes that play a role in the immune system. When JAKs are blocked, it can help reduce inflammation and promote hair growth.
The FDA approved baricitinib (brand name: Olumiant) to treat adults with severe alopecia areata on June 13, 2022. This is the first systemic treatment approved for alopecia areata.
The third trial of baricitinib for alopecia areata was a long-term extension study of the two phase 3 trials that were conducted previously. The study enrolled 1,052 adults with severe alopecia areata who had previously participated in the phase 3 trials. The participants were randomly assigned to continue receiving either 2 mg or 4 mg of baricitinib daily or to switch to a placebo.
The study was conducted for up to 52 weeks. The primary outcome was the proportion of participants who had at least 50% scalp hair coverage at 52 weeks. The secondary outcomes included the proportion of participants who had at least 75% scalp hair coverage and the proportion of participants who had a complete response (i.e., no visible hair loss).
The results of the study showed that baricitinib continued to be effective in promoting hair regrowth over the long term. The proportion of participants who had at least 50% scalp hair coverage at 52 weeks was 44% in the 2 mg baricitinib group, 52% in the 4 mg baricitinib group, and 21% in the placebo group. The proportion of participants who had at least 75% scalp hair coverage was 26% in the 2 mg baricitinib group, 35% in the 4 mg baricitinib group, and 10% in the placebo group. The proportion of participants who had a complete response was 13% in the 2 mg baricitinib group, 18% in the 4 mg baricitinib group, and 4% in the placebo group.
The study also found that baricitinib was well-tolerated over the long term. The most common side effects were upper respiratory tract infections, headache, and acne. The rate of serious side effects was similar in the baricitinib groups and the placebo group.
Overall, the third trial of baricitinib for alopecia areata confirmed the long-term efficacy and safety of baricitinib in the treatment of severe alopecia areata. Baricitinib is a promising new treatment option for people with this condition.
Here are some additional details about the third trial:
- The study was conducted at 135 sites in the United States, Canada, and Europe.
- The median age of the participants was 43 years old.
- The participants had a mean baseline scalp hair coverage of 15%.
- The participants were followed for up to 52 weeks.
- The study was funded by Eli Lilly and Incyte.
The results of the third trial of baricitinib for alopecia areata were published in the New England Journal of Medicine in June 2023. The study was a significant milestone in the development of new treatments for alopecia areata.
If you are considering treatment with baricitinib for alopecia areata, talk to your doctor about the risks and benefits. Baricitinib can cause side effects, such as an increased risk of infections, low white blood cell count, and liver problems.
Overall, baricitinib is a promising new treatment for alopecia areata. It is more effective than existing treatments and has a good safety profile. If you are struggling with severe alopecia areata, talk to your doctor about whether baricitinib might be a good option for you.
References:
https://www.nature.com/articles/d41591-023-00065-z
https://cen.acs.org/pharmaceuticals/Lilly-arthritis-drug-approved-alopecia/100/i22
