Otezla (apremilast) is an oral tablet commonly used to treat plaque psoriasis in adults and children. Plaque psoriasis is an inflammatory skin condition that causes itchy, painful patches on the skin. These patches, or plaques, can appear anywhere on your body, but they most commonly affect the scalp, elbows, knees, and back. People may refer to plaque psoriasis as psoriasis vulgaris or simply psoriasis.
The FDA approved Otezla in 2014. It belongs to a class of medicines called phosphodiesterase-4 (PDE-4) inhibitors. Otezla is the first PDE-4 inhibitor approved to treat psoriasis.
Otezla is also FDA-approved to treat psoriatic arthritis in adults and mouth ulcers in adults with Behçet’s disease. Otezla may also be used for other conditions as determined by your health care provider.
Keep in mind that while Otezla helps manage the symptoms of psoriasis, it does not cure the condition.
Below are common questions and answers about Otezla for psoriasis and whether it may be right for you.
Is Otezla Right for My Psoriasis?
Otezla treats psoriasis in adults and children. More specifically, this medicine is approved for the following people.
- Adults with plaque psoriasis who are eligible to receive light therapy or systemic treatment (medicine that affects your whole body).
- Children ages 6 years and older with moderate to severe plaque psoriasis who weigh at least 20 kilograms (kg) and are eligible to receive light therapy or systemic treatment.
Otezla can be used to treat plaque psoriasis of any severity in adults. Clinical studies show that Otezla is an effective treatment for adults with mild, moderate, or severe plaque psoriasis.
A health care professional can help find out how severe your psoriasis is by measuring how much of your body surface is affected by plaques.
Studies show that Otezla is an effective treatment for children with moderate to severe plaque psoriasis. Otezla is not approved to treat mild psoriasis in children. Topical treatments (medicines that you apply to the skin) usually work to manage the symptoms of mild psoriasis in kids.
This medicine has not been proven safe or effective for psoriasis treatment in children younger than 6 or weighing less than 20 kg.
How Does Otezla Work for Psoriasis?
Otezla is thought to manage psoriasis symptoms by reducing inflammation in the body. Psoriasis is a condition in which the immune system attacks skin tissue. This leads to inflammation and changes in skin cell growth, resulting in the formation of plaques (itchy, painful patches on the skin).
Otezla is a PDE-4 inhibitor. It works by blocking a protein called phosphodiesterase-4 (PDE-4). This increases a substance in your body called cyclic adenosine monophosphate (cAMP). cAMP signals your immune system to stop releasing substances that promote inflammation. It also tells your body to release more substances that reduce inflammation.
How Do I Take Otezla?
Most people take Otezla twice per day. This medicine comes as an oral tablet that you swallow whole. You can take it with or without food. Otezla is available in three strengths: 10 milligrams (mg), 20 mg, and 30 mg.
The typical adult dosage for psoriasis is 30 mg twice daily. Your health care provider may recommend a different dosage depending on your age, weight, and kidney health.
Your health care provider will prescribe a lower starting dosage when you begin Otezla treatment. You will follow a titration schedule that gradually increases your dosage over the first 5 days of treatment. This helps to lessen the digestive side effects from Otezla.
The typical titration schedule for Otezla for psoriasis is shown below.
Titration Schedule (Adults and Children 50 kg or more)
| Day 1 | 10 mg in the morning |
| Day 2 | 10 mg in the morning and 10 mg in the evening |
| Day 3 | 10 mg in the morning and 20 mg in the evening |
| Day 4 | 20 mg in the morning and 20 mg in the evening |
| Day 5 | 20 mg in the morning and 30 mg in the evening |
| Day 6 and on | 30 mg in the morning and 30 mg in the evening |
Children ages 6 years and older with moderate to severe psoriasis who weigh 50 kg or more will follow the adult titration schedule, shown just above. Children who weigh at least 20 kg to less than 50 kg typically follow the schedule shown below.
Titration Schedule (Children 20 kg to less than 50 kg)
| Day 1 | 10 mg in the morning |
| Day 2 | 10 mg in the morning and 10 mg in the evening |
| Day 3 | 10 mg in the morning and 20 mg in the evening |
| Day 4 and on | 20 mg in the morning and 20 mg in the evening |
Your health care provider may recommend a different titration schedule, depending on your age, weight, and kidney health.
What Happens if I Stop Taking Otezla?
If you are taking Otezla for psoriasis and stop taking it, the symptoms of plaque psoriasis will eventually return.
In one study, people had a loss of response about 5 weeks after stopping Otezla. This means that their plaques returned or worsened. In another trial that defined response to Otezla slightly differently, the time to loss of response after stopping Otezla was about 12 weeks.
Rarely, some people may have severe worsening of their psoriasis after stopping Otezla.
How Was Otezla Studied for the Treatment of Plaque Psoriasis?
Six clinical studies were done to see if Otezla is a safe and effective treatment for plaque psoriasis. All of the studies compared Otezla to a placebo (a treatment that contains no medicine) to see how well Otezla works. Researchers also studied Otezla’s safety by collecting information about side effects. Across all six studies, people who took Otezla for psoriasis had better results than people who took a placebo.
The DISCREET study evaluated Otezla in adults with moderate to severe psoriasis. Everyone in this study had plaque psoriasis for at least 6 months before the study began and had symptoms affecting the genitals. The average age was 45 years old, and most of the people were male (about 70%). To measure response, the researchers used a psoriasis rating scale to assess symptoms. Effectiveness was determined based on the proportion of people who achieved a score of 0, meaning clear, or 1, meaning almost clear, with at least a 2-point reduction on the rating scale by week 16.
Another trial, STYLE, studied the use of Otezla in adults with moderate to severe plaque psoriasis of the scalp. Everyone in this study already tried at least one topical treatment for scalp psoriasis, but it did not help. The average age of the people in the study was 47 years, and 62% were male. Most of the study participants were White (about 75%). Similar to the DISCREET study, this trial mainly looked at the proportion of people who had a response of clear or almost clear, with at least a 2-point reduction by week 16.
A study called ADVANCE examined the efficacy and safety of Otezla in adults with mild to moderate plaque psoriasis. Like the other studies, this study primarily looked at efficacy using an assessment to rate how severe symptoms were. Researchers looked for response to the drug based on a score of 0, meaning plaque psoriasis had cleared, or 1, meaning psoriasis was almost clear, and a reduction of 2 or more points by week 16. The average age of people in the study was 49 years, and more than half were male.
Three other clinical trials evaluated the safety and efficacy of Otezla in people with moderate to severe plaque psoriasis. These trials were called ESTEEM 1, ESTEEM 2, and LIBERATE.
The ESTEEM studies looked at the proportion of adults achieving a 75% or greater reduction on a symptom rating scale at week 16 with Otezla vs. a placebo. These trials had a different design, in which some people were switched from Otezla to a placebo. Then they restarted Otezla after their psoriasis symptoms returned, which was considered a loss of response to the medicine. In these studies, the average ages were 45-47 years, and most people in the study were male. Around 90% of the people in the ESTEEM study were White.
The LIBERATE trial looked at the use of Otezla compared to a placebo in people with moderate to severe plaque psoriasis. This study also looked at the safety of switching from another medicine called etanercept to Otezla. The primary endpoint to evaluate efficacy was the proportion of people receiving Otezla or a placebo who achieved a 75% or greater reduction on a symptom rating scale at week 16. This study did not find any new safety concerns linked to switching from etanercept to apremilast.
How Well Does Otezla Work for Psoriasis?
To understand how well Otezla works, it is helpful to look at its clinical trial results. In six clinical trials of Otezla, scores on the psoriasis symptom rating scales decreased, showing that Otezla helped to make plaques go away or become less noticeable. These trials showed that Otezla worked better than a placebo in people with psoriasis.
Some of these clinical trial results are shown in the tables below. Your results may be different from what was seen in studies.
Percentage of people with reductions in symptoms of moderate to severe psoriasis
| Otezla (apremilast) | Placebo | |
| ESTEEM 1 Study | 33.1% | 5.3% |
| ESTEEM 2 Study | 28.8% | 5.8% |
Percentage of people with reductions in symptoms of mild to moderate psoriasis
| Otezla (apremilast) | Placebo | |
| ADVANCE Study | 21.6% | 4.1% |
Percentage of people with reductions in symptoms of psoriasis affecting the genitals
| Otezla (apremilast) | Placebo | |
| DISCREET Study | 39.6% | 19.5% |
Percentage of people with reductions in symptoms of scalp psoriasis
| Otezla (apremilast) | Placebo | |
| STYLE Study | 43.3% | 21.1% |
How Long Does It Take for Otezla to Work?
In studies of Otezla for plaque psoriasis, significant improvements were seen within 4 months of starting treatment. But you may start to see improvement in symptoms sooner than this.
You can tell the medicine is working if you have less swelling and pain in your joints. If you feel that Otezla is not working after 4 months, contact your health care provider for advice.
What Are the Possible Side Effects of Otezla, and How Can I Prevent or Manage Them?
The most common side effects of Otezla in people with plaque psoriasis include the following.
- Diarrhea
- Nausea
- Upper respiratory infection
- Headache, including tension headache
Other side effects may occur. The side effects that most often led people to stop Otezla in studies were diarrhea, nausea, and vomiting. These side effects mainly happen during the first few weeks of treatment.
If you develop severe diarrhea, nausea, or vomiting while taking Otezla, contact your health care provider. They will recommend ways to manage these side effects, which may include reducing your dosage.
In many cases, you can prevent headaches, including tension headaches, by getting enough sleep and drinking plenty of water. Diet changes may also help. Over-the-counter pain relievers, such as acetaminophen, are an option to ease headache pain.
Otezla also has the potential to cause depression and weight loss. Contact your health care provider if you have new or worsening depression, suicidal thoughts, or other mood changes. Monitor your weight regularly while taking Otezla and notify your prescriber of unexplained weight loss. If you have unexplained or concerning weight loss, they may recommend stopping this medicine.
Also, Otezla may cause allergic reactions, which could involve swelling and trouble breathing. If you think you are having an allergic reaction to Otezla, stop the medicine and seek medical care right away.
What Interactions Can Happen With Otezla?
Some medicines may interact with Otezla. Certain medicines that induce (speed up) the CYP450 enzymes can decrease the level of Otezla in your body. This can make Otezla less effective for treating your psoriasis. Ideally, you will not take Otezla with strong inducers of CYP450 enzymes. One example of such an inducer is rifampin.
Always tell your health care provider about everything you take, including medicines and supplements. Sharing this information can help prevent drug interactions. If you take Otezla with other medicines or supplements, tell your health care provider if you think that Otezla is not working well.
How Can I Get Otezla?
Otezla requires a prescription from a health care provider. Your prescriber may provide you with a starter pack of Otezla, which includes enough medicine for the first 4 weeks of treatment. To continue treatment, a specialty pharmacy will fill your prescription and ship the medicine to your home.
Is There Any Cost Assistance Available for Otezla?
A cost assistance program is available from the drugmaker that may allow you to pay $0 for your Otezla prescription. Whether you qualify to enroll may depend on what type of insurance you have or if you are uninsured. Visit this website from the drugmaker for more information about Otezla costs and copay savings.
You can also contact the drugmaker at 844-468-3952 to connect with a representative for financial support information and other resources.
