On June 13, 2022, the US Food and Drug Administration (FDA) announced that Olumiant (baricitinib) has been approved for the treatment of adult patients with severe alopecia areata. When clinically tested, Olumiant, a Janus kinase (JAK) inhibitor, successfully regrew hair in patients with alopecia areata who had at least 50% scalp hair loss as measured by the Severity of Alopecia Tool for more than 6 months. FDA approval was granted upon reviewing the results of two pivotal Phase III studies which included a total of 1200 adults with severe alopecia areata.
Olumiant (baricitinib), a Janus kinase (JAK) inhibitor, has become the first FDA-approved JAK inhibitor to treat adults with severe alopecia areata.
Olumiant is the first FDA-approved JAK inhibitor to treat adults with severe alopecia areata. The characteristic hair loss associated with this disease has a significant impact on the patient’s quality of life. Baricitinib is an oral therapy that is administered once daily. It is not recommended to use Olumiant concomitantly with other JAK inhibitors, potent immunosuppressants, or biologic immunomodulators.
Alopecia areata is a disease that causes hair loss and currently affects as many as 6.8 million people in the United States.
Alopecia areata is a disease that causes non-scarringl hair loss and affects as many as 6.8 million people in the United States. Alopecia areata is a form of hair loss that can affect both men and women. This autoimmune condition occurs when the immune system mistakenly targets its hair follicles, resulting in hair loss. The course of treatment will vary depending on disease severity, but it is important to note that there is currently no cure for alopecia areata.
Alopecia areata can manifest as alopecia totalis, when there is loss of scalp hair, and alopecia universalis, when there is complete loss of all scalp and body hair.
In pivotal clinical trials, Olumiant was able to regrow hair in patients with severe alopecia areata.
Olumiant was developed by Eli Lilly and Company in collaboration with Incyte, and a trademark for BARICITINIB was granted to Eli Lilly in March 2022. The company purchased the rights to commercialize Olumiant from Incyte in 2009 and has agreed to pay Incyte up to 20% of royalties collected from global net sales of this drug.
The approval was based on the results of two pivotal phase III studies which included a total of 1200 adults with severe alopecia areata.
In both phase III studies, patients were randomized to receive either 2 mg or 4 mg of Olumiant, or placebo once daily for 36 weeks.
Adverse events (AEs) and serious adverse events (SAEs) were collected throughout the clinical trial. Patients’ response to treatment was clinically assessed on a scale from 0% (no hair loss) to 100% (complete regrowth).
Olumiant is an oral therapy taken once daily.
Olumiant is an oral therapy taken once daily. It should be taken at the same time every day, with or without food. If you miss a dose, take it as soon as you remember and continue with your regular schedule. Do not take two doses within one day to make up for missed doses.
If you are unable to swallow tablets or capsules because of difficulty swallowing or other reasons, consult your doctor about potentially switching to another form (such as a liquid) of this medication for your alopecia areata treatment.
Olumiant does not work for all patients and may cause side effects in some people who use it. Tell your doctor if any of the following side effects occur or begin to interfere with your daily life: nausea; dizziness; diarrhea; constipation; headache; sore throat/fever/infection around mouth area (oral thrush); skin rash/redness on face (rosacea); trouble breathing while sleeping (sleep apnea). Immediately seek emergency help if you experience the following symptoms: chest pain or shortness of breath with exertion; swelling in feet/ankles accompanied by coldness or numbness in toes when exposed to cold temperatures.
All patients taking Olumiant will receive a Medication Guide and Boxed Warning, which provide additional label information and potential risks associated with its use.
A Medication Guide is a layperson’s guide to the patient’s medication. Drug companies are required to provide these plain-language guides with their drugs to allow patients to review them on their own time with family or caregivers.
A boxed warning is a prominent warning issued by the FDA about an approved drug. It contains important information regarding serious side effects associated with the use of a medication, as well as risks which may occur after it is discontinued.
Medication Guides educate consumers on proper drug administration to optimize safety and drug efficacy. Boxed warnings are intended to alert consumers about potentially serious adverse reactions if they take certain medications without proper medical supervision.
Consult a medical professional to find out whether this new treatment may be right for your alopecia areata.
If you have been diagnosed with severe alopecia areata, consult your doctor about whether Olumiant may be right for you. It is important to note that JAK inhibitor therapies are associated with various side effects, which may not be suitable for all individuals. Before starting JAK inhibitor therapy, ensure the Medication Guide and Boxed Warning have been thoroughly reviewed. Immediately follow up with your physician if you develop any of the following symptoms upon starting Olumiant: weight gain, diarrhea, nausea, or vomiting; swelling of ankles; sore throat; low white blood cell count (neutropenia); muscle pain or weakness; increased thirst or urination (polydipsia/polyuria); joint pain or tenderness; light-headedness.
Olumiant (baricitinib) is the first FDA-approved JAK inhibitor for adults with severe alopecia areata. If you have been diagnosed with severe alopecia areata, speak with your physician to determine whether Olumiant is a good option for you.
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