Alopecia areata is an autoimmune condition where the body attacks its own hair follicles. It results in hair loss that typically appears in small, round patches about the size of a coin. The severity varies from person to person; some people may only have a few bare spots, while others experience extensive hair loss. Some people may also notice that hair is falling out in certain areas while simultaneously growing back in others. In some instances, significant hair loss happens very quickly over a short period. Although several variations of the condition exist, patchy alopecia areata is the most common type.
Litfulo (ritlecitinib) is a medicine used for the treatment of severe alopecia areata in adults and adolescents who are aged 12 years or older.
How Does Litfulo Treat Alopecia Areata?
Litfulo is a medicine that works by blocking certain enzymes in the body called kinases to help calm an overactive immune system. The active ingredient, ritlecitinib, stops two types of kinases from working: JAK3 and TEC. These enzymes normally help send signals in the immune system. By blocking the spot where energy attaches, Litfulo reduces signals that can cause inflammation and affect how the immune system responds. Scientists are still learning exactly how blocking these enzymes helps improve symptoms.
How Do I Take Litfulo?
Before you start taking Litfulo, your health care provider needs to do some tests to make sure it is safe for you:
- Tuberculosis (TB) check. You need a TB test before starting Litfulo. You should not use Litfulo if you have active TB. If you have inactive (latent) TB or are at high risk for it, you must start treatment for TB before starting Litfulo.
- Hepatitis screening. You need to be checked for viral hepatitis. You should not start Litfulo if you have hepatitis B or hepatitis C.
- Blood tests. Your doctor will check your blood cell counts. You should not start this medicine if your white blood cell (lymphocyte) count or platelet count is too low.
- Vaccines. Make sure you are up to date on all of your recommended vaccines before you begin treatment. Your health care provider can help determine which vaccines you may need and when to get them before starting Litfulo.
Litfulo comes as a capsule that you take by mouth once daily. You can take it with or without food. The recommended dosage is 50 milligrams (mg) once a day.
It is important to swallow the capsules whole. Do not crush, split, or chew them.
How Can I Prevent and Manage Side Effects?
If you think Litfulo is causing a side effect, tell your health care provider right away. They may adjust your dose, have you stop taking it for a while, or stop it completelyif needed to keep you safe.
Litfulo can affect your immune system, which may lower its ability to fight infections. You should watch for symptoms of an infection, such as fever, sweating, chills, muscle aches, weight loss, or cough. If you develop any signs of an infection, call your health care provider right away.
Headaches were a frequent side effect in clinical studies. If you have headaches that are severe or do not go away, contact your health care provider.
Some people got acne or inflamed hair pores (folliculitis) while taking Litfulo. If you experience skin issues that do not go away, your doctor may suggest treatments to help manage them.
Litfulo may also cause heart problems. In a clinical trial for a similar medicine, a higher risk of death and major heart problems was 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 Litfulo is safe for you. Go to the nearest emergency room if you have any of the following symptoms with Litfulo: pain in the chest, arms, back, neck, jaw, or stomach; trouble breathing; nausea; vomiting; weakness on one side of the body; or slurred speech.
Certain cancers, such as skin cancer and lymphoma, were seen in clinical trials of Litfulo or similar medicines. 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 starting Litfulo. They may suggest regular screenings, such as having your skin checked, while taking Litfulo.
Litfulo 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 Litfulo. 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.
Your doctor will perform blood tests before you start and during your treatment. These tests check for low lymphocyte (white blood cell) counts, low platelet counts, and increased liver enzymes. They will also check if you have increased levels of creatine phosphokinase in your blood, which is a common side effect. Your health care provider may need to stop your treatment for a certain period if your blood test results show these changes.
What Kinds of Drug Interactions May Happen?
Litfulo interacts with certain medicines that affect how your body processes medicines. Specifically, it interacts with medicines that affect certain cytochrome P450 (CYP) enzymes in your body. These medicines can cause (induce) your body to get rid of Litfulo too quickly, which lowers the amount of the medicine in your system and may cause it to not work as well. Rifampin is an example of a medicine that does this. It is recommended that you do not take strong CYP3A inducers with Litfulo.
Litfulo can also affect how other medicines work. It blocks certain enzymes (CYP3A and CYP1A2) that help break down other medicines. If you take medicines that rely on these enzymes, Litfulo might cause them to build up in your body, potentially increasing the risk of side effects. Your health care provider may need to adjust your dosage of these other medicines.
Also, Litfulo is not recommended for use in combination with other Janus kinase (JAK) inhibitors, biologic immunomodulators, cyclosporine, or other strong immunosuppressants.
This is not a complete list of interactions. Tell your health care provider about all the prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, or other supplements you take or have recently taken.
How Was Litfulo Studied for the Treatment of Alopecia Areata?
The safety and effectiveness of Litfulo were studied in a trial done at 118 sites across 18 countries. The trial included 718 people with alopecia areata who were 12 years or older and had at least 50% scalp hair loss. Hair loss was measured using the Severity of Alopecia Tool (SALT), which is a score that shows how much scalp hair is missing. The scale ranges from 0, meaning no hair loss, to 100, meaning complete hair loss.
About 62% of participants were female, and the rest were male. The average age was 34 years. Most (68%) were White, 26% were Asian, 4% were Black or African American, and 2% were from other racial groups. Before the study treatment began, almost half of the participants (46%) had complete scalp hair loss (alopecia totalis or alopecia universalis), and the starting SALT score ranged from 88 to 93.
In the study, people were given either a placebo (containing no medicine) or Litfulo at different doses, both taken once daily. Some groups started with a higher “loading dose” for four weeks before switching to a lower daily dose. The main goal was to see how many people had significant hair regrowth, defined as having 20% or less scalp hair loss (SALT score of 20 or less) after 24 weeks. A SALT score of 20 or less means a person has most of their scalp hair back.
What Were the benefits?
Hair regrowth. At week 24, 31% of people who took the highest dose of Litfulo reached a SALT score of 20 or less. For other doses, 14%-23% of people reached this score. Only 2% of people in the placebo group had this result. Also, more people taking Litfulo reached a stricter goal of 10% or less scalp hair loss compared to those on placebo.
Of the people who took the recommended dosage of Litfulo (50 mg once daily), 23% achieved a SALT score of 20 or less, and 13% achieved a SALT score of 10 or less.
Safety. Most side effects were mild or moderate. The most common side effects seen were upper respiratory infections, stuffy nose, and headaches. Serious side effects were uncommon, and no deaths were reported.
Your results may differ from what was seen in clinical studies.
How Long Does It Take for Litfulo to Work?
Litfulo calms the immune system as soon as you begin your treatment. But it may take several months before you notice the benefits of the treatment. Talk to your health care provider if you do not notice improvements in hair regrowth with Litfulo.
Are There Any Special Steps Required to Get Litfulo?
Litfulo is a “specialty” medicine. This means that you can only get it from a specialty pharmacy, and that it may require prior authorization from your insurance company.
Is There Any Cost Assistance Available?
You can find a savings card from the maker of Litfulo. Whether you are eligible depends on whether you have prescription insurance and what type of insurance you have. You can find out more at www.litfulo.com/savings-and-support/overview or by calling 833-956-3376.
