Alopecia areata causes hair loss on the scalp or other body parts such as the eyebrows. New treatments like Olumiant offer hope for some people. This FDA-approved medicine works in unique ways to help improve hair regrowth. Olumiant provides people with alopecia areata another option in their treatment journey.
How Does Olumiant Work for Alopecia?
Alopecia areata is a condition in which the body’s immune system mistakenly attacks its own hair follicles. This can cause hair to fall out on the scalp or other parts of the body. The most common areas where people with alopecia areata lose hair are the scalp and beard. Hair loss with alopecia areata does not leave scars, so hair can grow back over time.
Aside from hair loss, some people may get burning or itching where the hair falls out. Changes to the nail, like tiny dents (called pits), may also happen.
Experts suggest that chemicals in the immune system called cytokines may become overactive, attack hair follicles, and cause hair loss. These pathways have allowed health care providers to identify medicines that can work to treat alopecia areata.
Olumiant contains the medicine baricitinib, which helps calm the overactive cytokines in the immune system. Specifically, baricitinib blocks a chemical called Janus kinase, which blocks the activity of the specific cytokines interferon-γ and interleukin-15.
How Do I Take Olumiant?
Olumiant comes as a tablet that you take by mouth with or without food. Your health care provider may prescribe the 2-milligram (mg) tablet once daily when you start. If this dosage does not work well for you, your health care provider may increase your dosage to 4 mg once daily.
For people with complete or almost complete hair loss, your starting dosage may be 4 mg once daily. When your condition improves with Olumiant, your health care provider may lower your dose to 2 mg once daily.
For people who cannot swallow Olumiant, the tablets can be placed in 5-10 milliliters (about 1-2 teaspoons) of room-temperature water in a drinking glass. The tablets will break apart when the glass is gently swirled. The liquid should be consumed right away.
Afterward, the glass should be rinsed with another 5-10 milliliters of room temperature water. The contents should also be consumed right away to ensure the full dose is taken.
How Was Olumiant Studied for Alopecia Areata?
Two clinical trials tested if Olumiant was effective and safe for people with alopecia areata. The trials included 1,200 people who had severe alopecia areata for more than six months. Most of the people in the study were female (61%) and White (52%). Asian participants made up 36% of the study population, Black participants made up 8%, and other racial groups accounted for the remaining 4%. At the start of the study, more than half of participants (53%) had at least 95% scalp hair loss.
In each clinical trial, people were given either a placebo or Olumiant at a dosage of 2 mg or 4 mg, taken once daily.
The Severity of Alopecia Tool (SALT) measured how well Olumiant worked at week 36. SALT is a common tool that some dermatologists use to score how much hair loss is on the scalp. How severe it is depends on the percentage of the scalp with hair loss. Mild alopecia areata ranges from 0% to 20%, moderate is from 21% to 49%, and severe is from 50% to 100%. A SALT score of 20 or less is recognized as a meaningful improvement for people with alopecia areata.
What were the benefits?
Hair regrowth: In clinical trials, Olumiant improved hair regrowth by week 36. More people in the higher-dose group achieved a SALT score of 20 or less, which shows greater regrowth. At week 36, 17% to 22% of people who took 2 mg of Olumiant and 32% to 35% of those who took 4 mg of Olumiant reached this score. Only 3% to 5% of people had a SALT score of less than 20 in the placebo group. Similarly, 11% to 13% of people who took 2 mg and 24% to 26% of those who took 4 mg had a SALT score of 10 or less. Only 4% to 5% in the placebo group achieved this result.
Perception of hair regrowth: Another tool used in the trials was the Scalp Hair Assessment PRO score, which measures a person’s perception of hair regrowth on the scalp during treatment. The scale ranges from 0 (full satisfaction) to 4 (no satisfaction). By week 36, 16% of people taking 2 mg of Olumiant achieved a score of 0 or 1. For those taking 4 mg, 24% to 33% reached a score of 0 or 1. Among those who took a placebo, about 4% to 5% had a Scalp Hair Assessment PRO score of 0 or 1.
How Long Does It Take for It to Work?
Olumiant calms the immune system as soon as you begin your treatment. You may only notice benefits of the treatment after several months. Talk to your health care provider if you do not notice improvements in hair regrowth with Olumiant.
How Can I Prevent and Manage Side Effects?
Common side effects reported from people who took Olumiant for alopecia areata included infections, headaches, acne, and high cholesterol.
The most common infections reported by people taking Olumiant were upper respiratory tract infections, including sinus, throat, and ear infections. Proper handwashing techniques can help reduce the risk of these infections.
In clinical studies, people taking higher doses of Olumiant were more likely to get headaches. Ask your doctor or pharmacist for tips on managing headaches while on Olumiant. If your headache becomes severe or does not go away, contact your doctor right away.
Some people in the clinical studies developed acne while taking Olumiant. Acne caused by medication may improve or disappear after you stop taking the drug. But do not stop taking Olumiant without first consulting your doctor. If acne persists while on Olumiant, your doctor may recommend treatments to help manage it.
Your doctor will check your cholesterol levels in your blood 12 weeks after you start treatment with Olumiant. If needed, your health care provider may check your blood tests regularly after the first 12 months. Your health care provider may need to treat high cholesterol if your levels rise too high.
What Kinds of Drug Interactions May Happen?
Olumiant interacts with a specific type of medicine that blocks a protein in the body called organic anion transporter 3 (OAT3). OAT3 is found in the kidneys. It helps move substances, like medicines and toxins, out of the body into the urine. When OAT3 is blocked, certain medicines, like Olumiant, may build up in the body.
Probenecid is a medicine that blocks OAT3. If you need to take probenecid and Olumiant at the same time, your health care provider will cut your Olumiant dose in half.
This is not a complete list of interactions. Tell your pharmacist or doctor about all the prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, or other supplements you take or have recently taken.
What Are Other Things to Keep in Mind?
If you take other Janus kinase inhibitors, biologic medicines, or cyclosporine, Olumiant may not be right for you. Medicines that calm down the immune system combined with Olumiant may further lower the activity of the immune system. This can increase the risk of severe side effects, such as serious infections.
Serious infections can happen in rare situations with Olumiant. These may include infections caused by bacteria, viruses, or fungi. The most common serious infections include pneumonia, shingles, and urinary tract infections.
Tuberculosis is a severe infection caused by bacteria that may happen with Olumiant. Your health care provider will check for tuberculosis before you start the medication. If you get a serious infection like tuberculosis, your treatment may need to be paused or stopped by your health care provider.
Before your health care provider prescribes Olumiant, they may also check you for a serious liver condition called viral hepatitis.
If you get an infection while taking Olumiant, tell your health care provider right away. Symptoms of an infection may include a fever, sweating, a hard time breathing, low energy, muscle pain, diarrhea, coughing, weight loss, or a burning sensation when you urinate.
Olumiant may also cause heart problems. In a clinical trial for a similar medicine, a higher risk of death and major heart problems were seen in people with certain risk factors for heart disease. If you have heart problems or are a current or past smoker, ask your health care provider if Olumiant is safe for you.
Go to the nearest emergency room if you have any of the following symptoms with Olumiant: pain in the chest, arms, back, neck, jaw, or stomach; a hard time breathing; nausea; vomiting; weakness on one side of the body; or slurred speech.
Certain cancers, such as lymphoma, were also seen in clinical trials of Olumiant. Lung cancer was seen mostly in current or past smokers. Be sure to tell your health care provider if you have cancer or a history of cancer before you start Olumiant.
Olumiant may increase the risk of blood clots, which can block blood flow to the legs or lungs and cause serious emergencies. Tell your health care provider if you have a history of blood clots or if you take blood-thinning medicine before you start Olumiant. If you get symptoms of a blood clot, such as sudden chest pain, a hard time breathing, swelling, pain, or tenderness in the leg, go to the nearest emergency room.
If you have a history of stomach or intestine issues, such as diverticulitis, Olumiant may not be the right choice for you. Rarely, Olumiant can cause tears (ruptures) in the stomach or intestines.
Olumiant may also cause changes in specific blood tests. Your health care provider may pause your treatment until your test results improve.
If you have kidney or liver problems, your health care provider may prescribe a lower dose of Olumiant. For severe kidney or liver problems, Olumiant may not be safe.
Olumiant may be harmful during pregnancy. Tell your health care provider if you are pregnant or planning to become pregnant. If you become pregnant while taking Olumiant, contact Eli Lilly and Company to report your pregnancy at 800-545-5979.
Avoid breastfeeding while taking Olumiant and for four days after the last dose, as its safety during breastfeeding is unknown.
Is There Any Cost Assistance Available?
You can find a savings card from the maker of Olumiant. The savings card may allow you to pay as little as $5 for your prescription if your private drug insurance plan covers Olumiant. If your drug insurance does not cover Olumiant, you may be eligible to pay as little at $25. You can read more about the savings coupon at https://olumiant.lilly.com/savings-support.
