Approved Uses

Otezla® (apremilast) is a prescription medicine approved for the treatment of patients with moderate to severe plaque psoriasis for whom phototherapy or systemic therapy is appropriate.

Otezla is a prescription medicine approved for the treatment of adult patients with active psoriatic arthritis.

Otezla is a prescription medicine approved for the treatment of adult patients with oral ulcers associated with Behçet’s Disease.

Otezla is a different kind of treatment Close
A pill that can help
you achieve clearer skin

Treat plaque psoriasis differently

Treat psoriatic arthritis differently

FOR US AUDIENCES ONLY
Otezla for moderate to severe
plaque psoriasis
Otezla for psoriatic arthritis
SEE MORE

*Certain restrictions apply. *Certain restrictions apply; eligibility not based on income.

APPROVED USES

Otezla® (apremilast) is a prescription medicine approved for the treatment of patients with moderate to severe plaque psoriasis for whom phototherapy or systemic therapy is appropriate.

Otezla is a prescription medicine approved for the treatment of adult patients with active psoriatic arthritis.

Otezla is a prescription medicine approved for the treatment of adult patients with oral ulcers associated with Behçet’s Disease.

IMPORTANT SAFETY INFORMATION

You must not take Otezla if you are allergic to apremilast or to any of the ingredients in Otezla.

Otezla can cause severe diarrhea, nausea, and vomiting, especially within the first few weeks of treatment. Use in elderly patients and the use of certain medications with Otezla appears to increase the risk of having diarrhea, nausea, or vomiting. Tell your doctor if any of these conditions occur.

Otezla is associated with an increase in depression. In clinical studies, some patients reported depression, or suicidal behavior while taking Otezla. Some patients stopped taking Otezla due to depression. Before starting Otezla, tell your doctor if you have had feelings of depression, or suicidal thoughts or behavior. Be sure to tell your doctor if any of these symptoms or other mood changes develop or worsen during treatment with Otezla.

Some patients taking Otezla lost body weight. Your doctor should monitor your weight regularly. If unexplained or significant weight loss occurs, your doctor will decide if you should continue taking Otezla.

Some medicines may make Otezla less effective, and should not be taken with Otezla. Tell your doctor about all the medicines you take, including prescription and nonprescription medicines.

Side effects of Otezla include diarrhea, nausea, vomiting, upper respiratory tract infection, runny nose, sneezing, or congestion, abdominal pain, tension headache, and headache. These are not all the possible side effects with Otezla. Ask your doctor about other potential side effects. Tell your doctor about any side effect that bothers you or does not go away.

Tell your doctor if you are pregnant, planning to become pregnant or planning to breastfeed. Otezla has not been studied in pregnant women or in women who are breastfeeding.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-332-1088.

Please click here for Full Prescribing Information.

Otezla clinical study results

Clearer skin (primary endpoint)

75% Clearer skin was achieved in some people with plaque psoriasis after just 4 months on Otezla, with reduced redness, thickness, and scaliness of plaques

How was skin clearance measured?

Skin clearance was the primary endpoint (or main focus) in clinical studies of Otezla for psoriasis, and it was assessed using the Psoriasis Area and Severity Index (PASI) score. PASI score is a measure of the level of redness, thickness, and scaliness of psoriasis plaques in addition to the percentage of the body covered by plaques.

Clearer skin as measured by PASI

The charts below show results of 75% skin clearance for people taking Otezla (562 people) and people taking placebo (sugar pill [282 people]) after 4 months.

Otezla

33% of people saw 75% clearer skin

Placebo

5% of people saw 75% clearer skin

Itch results (secondary endpoint)

Clinical studies of Otezla mainly focused on how well it cleared people’s skin (75% skin clearance measured by PASI). In addition, Otezla’s impact on itch was studied as a secondary endpoint—an additional measure to support or provide further information in a clinical study. The level of itch (itch score) was measured using a self-reported tool known as VAS (visual analog scale) in which people rate their itchiness based on how they feel. VAS measures itch on a 0-100 millimeter (mm) scale (0=no itch, 100=worst itch imaginable).

Average itch scores as measured by VAS
The charts below show itch score results for people taking Otezla and people taking placebo (sugar pill) over a 4-month clinical study period.

After taking Otezla for 4 months, people reported that their average itch scores decreased by 47%.

Although these are itch findings from the Otezla clinical trials, please keep in mind your experience may be different and your itch may not completely go away.

If you have questions about the charts shown here, or about how itch is measured, please discuss with your doctor.

SEE MORE

*Certain restrictions apply. *Certain restrictions apply; eligibility not based on income.

APPROVED USES

Otezla® (apremilast) is a prescription medicine approved for the treatment of patients with moderate to severe plaque psoriasis for whom phototherapy or systemic therapy is appropriate.

Otezla is a prescription medicine approved for the treatment of adult patients with active psoriatic arthritis.

Otezla is a prescription medicine approved for the treatment of adult patients with oral ulcers associated with Behçet’s Disease.

IMPORTANT SAFETY INFORMATION

You must not take Otezla if you are allergic to apremilast or to any of the ingredients in Otezla.

Otezla can cause severe diarrhea, nausea, and vomiting, especially within the first few weeks of treatment. Use in elderly patients and the use of certain medications with Otezla appears to increase the risk of having diarrhea, nausea, or vomiting. Tell your doctor if any of these conditions occur.

Otezla is associated with an increase in depression. In clinical studies, some patients reported depression, or suicidal behavior while taking Otezla. Some patients stopped taking Otezla due to depression. Before starting Otezla, tell your doctor if you have had feelings of depression, or suicidal thoughts or behavior. Be sure to tell your doctor if any of these symptoms or other mood changes develop or worsen during treatment with Otezla.

Some patients taking Otezla lost body weight. Your doctor should monitor your weight regularly. If unexplained or significant weight loss occurs, your doctor will decide if you should continue taking Otezla.

Some medicines may make Otezla less effective, and should not be taken with Otezla. Tell your doctor about all the medicines you take, including prescription and nonprescription medicines.

Side effects of Otezla include diarrhea, nausea, vomiting, upper respiratory tract infection, runny nose, sneezing, or congestion, abdominal pain, tension headache, and headache. These are not all the possible side effects with Otezla. Ask your doctor about other potential side effects. Tell your doctor about any side effect that bothers you or does not go away.

Tell your doctor if you are pregnant, planning to become pregnant or planning to breastfeed. Otezla has not been studied in pregnant women or in women who are breastfeeding.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-332-1088.

Please click here for Full Prescribing Information.

Important Safety Information

See more

You must not take Otezla if you are allergic to apremilast or to any of the ingredients in Otezla.

Otezla can cause severe diarrhea, nausea, and vomiting, especially within the first few weeks of treatment. Use in elderly patients and the use of certain medications with Otezla appears to increase the risk of having diarrhea, nausea, or vomiting. Tell your doctor if any of these conditions occur.

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