FIRST SYSTEMIC TREATMENT FOR ALOPECIA AREATA (PATCHY HAIR LOSS), APPROVED BY FDA

Alopecia areata is an autoimmune disorder in which one or more circular patches of baldness develops due to sudden hairloss which occurs as a result of the body's immune system attacking its own hair follicles.

Genetics and stress have major influence over alopecia areata. Patients having certain autoimmune disorders and the close relatives often tend to develop alopecia areata.

Patchy hair loss is the most prominent symptom and hair may regrow if the inflammation subsides in certain individuals.

The US FDA approved Olumiant (Baricitinib) on June 13, 2022 to treat severe alopecia areata in adult patients. Olumiant is approved as a systemic oral dosage form; tablets, meant to treat alopecia areata in the entire body. 

Olumiant interferes an inflammatory pathway by blocking the activity of Janus kinase enzymes. It is a JAK-inhibitor.

Trial AA-1 & Trial AA-2 were two randomized, double-blind, placebo-controlled trials through which the safety and efficacy of Olumiant was studied. The subjects of the study were patients measured by the Severity of Alopecia Tool to have at least 50% hair loss for more than 6 months.

The subjects included in the trial were given 2 or 4 milligrams of Olumiant or a placebo. Efficacy was measured as the proportion of patients who had atleast 80% hair re-growth by the 36th week.

22% of the184 patients recieving 2 milligrams and 35% of the 281 patients recieving 4 milligrams of Olumiant had sufficient hair growth compared to the 5% of 189 patients recieving a placebo in Trial AA-1.  

Among the 156 patients recieving 2 milligrams of Olumiant, 17% patients had sufficient hair growth and 234 patients recieving 4 milligrams of Olumiant, 32% patients had sufficient hair growth, in comparison with the 3% of the 156 patients recieving a placebo in Trial AA-2.

Eli Lilly and Company was granted the approval for Olumiant by the FDA as a breakthrough therapy for this indication (Alopecia areata). While Olumiant was already approved for use in Moderate to severe active rheumatoid arthritis and COVID-19.

Acne, headache, respiratory tract infections, hyperlipidemia, urinary tract infections, anemia, neutropenia, abdominal pain, candidia and herpes zoster infections, increase in weight and liver enzymes, etc. are the side-effects associated with the use of Olumiant.

Olumiant should not be used along with potent  biologic immunomodulators, immunosuppressants, or other JAK inhibitors. Olumiant contains boxed warning for thrombosis, cardiovascular events, malignancy, mortality and most importantly, the risk for serious infections, for which frequent monitoring is recommended.