FOR US AUDIENCES ONLY
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
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.
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.
“With Otezla, my wardrobe was mine again. Clearer skin meant I could wear what I wanted.”
-Sarah, Actual Otezla patient
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.
You must not take Otezla if you are allergic to apremilast or to any of the ingredients in Otezla.
Otezla can cause allergic reactions, sometimes severe. Stop using Otezla and call your healthcare provider or seek emergency help right away if you develop any of the following symptoms of a serious allergic reaction: trouble breathing or swallowing, raised bumps (hives), rash or itching, swelling of the face, lips, tongue, throat or arms.
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 complications from having severe 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.
The most common side effects of Otezla include diarrhea, nausea, upper respiratory tract infection, 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.
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 the Full Prescribing Information for Otezla.
Otezla® (apremilast) is a prescription medicine used to treat adult patients with:
You must not take Otezla if you are allergic to apremilast or to any of the ingredients in Otezla.
Otezla can cause allergic reactions, sometimes severe. Stop using Otezla and call your healthcare provider or seek emergency help right away if you develop any of the following symptoms of a serious allergic reaction: trouble breathing or swallowing, raised bumps (hives), rash or itching, swelling of the face, lips, tongue, throat or arms.
