How long does it take for Otezla to work?

Otezla (apremilast) is approved to treat plaque psoriasis in adults and children 6 years and older (and weighing at least 20 kg), as well as psoriatic arthritis and Behçet’s Disease in adults. Patients may start to feel an improvement within the first few weeks, but symptoms can further improve over 12 to 16 weeks.

Otezla is meant to be taken long-term for these chronic conditions.

Otezla clinical studies

Adults

• 32% to 41% of adults with psoriatic arthritis had at least a 20% improvement after 16 weeks (compared to 18% to 19% of the inactive placebo group).

• 28.8% to 33.1% of adults with plaque psoriasis saw at least a 75% improvement after 16 weeks (compared to 5.3% to 5.8% of the inactive placebo group).

• 52.9% of adults with Behçet’s Disease were free of oral ulcers at 12 weeks (compared to 22.3% in the inactive placebo group). Of this group, 30% of patients taking Otezla were ulcer-free at 6 weeks. Pain relief began as early as 2 weeks.

Improvements in physical functioning and ability to perform daily activities (like dressing, walking, eating, grip and personal hygiene) were also improved in patients with psoriatic arthritis.

Patients were allowed to use additional medications, such as NSAIDS and DMARDS for psoriatic arthritis, or topical creams for psoriasis, to control their symptoms during the studies. However, patients with Behçet’s Disease did not use additional treatments.

Children

Otezla was studied in 245 children 6 to 17 years of age (and weighing at least 20 kg) with plaque psoriasis (PSOR-6 study).

sPGA

At week 16, 33.1% children treated with Otezla (n=163) achieved an sPGA (static Physician's Global Assessment) response, the primary endpoint of the study, compared to 10.8% in the inactive placebo group (n=82).

sPGA was defined by the researchers as a score of clear skin (0) or almost clear skin (1) with at least a 2-point reduction in severity from the start of the study.

PASI-75

At week 16, 45.7% of pediatric patients treated with Otezla (n=163) saw at least a 75% improvement (PASI-75 score) from the start of the study, compared to 16% of the inactive placebo group (n=82).

PASI (Psoriasis Area and Severity Index)-75 score is a score used by doctors to determine the effectiveness of psoriasis treatments. PASI-75 indicates a 75% reduction in disease severity and a significant improvement in psoriasis (extent of skin coverage of the psoriasis, discoloration, thickness, and scaling).

Remember, each patient is unique and the results you or your child see with Otezla may not be similar to other patients. If you have questions or concerns about how well your treatment is working, speak with your healthcare provider.

Key facts about Otezla

• Otezla is a small molecule phosphodiesterase 4 (PDE4) inhibitor approved by the FDA for the treatment of plaque psoriasis, psoriatic arthritis, and oral ulcers associated with Behçet’s Disease.

• Otezla is taken as an oral tablet twice a day. Your doctor will start your dose slowly to help lessen side effects like stomach upset or diarrhea. Doses in children are based on their weight. If you have severe kidney disease, you will need a lower dose of Otezla.

• Otezla’s generic name is apremilast. A generic has been approved but may not yet be available for this drug. Amgen is the manufacturer for Otezla and it was first approved by the FDA in 2014.

• Otezla works in your immune system by blocking the phosphodiesterase type 4 (PDE4) enzyme in the cell to lower inflammation in the body. The PDE4 enzyme is a type of immune system protein that can be overactive in some people, leading to symptoms.

Related questions

• What does psoriasis look like?
• How do you get psoriasis and is it contagious?
• How does Tremfya work to treat plaque and psoriatic arthritis?

Otezla side effects you should know about

The most common side effects that can occur with Otezla are diarrhea, nausea and vomiting, upper respiratory tract infections, weight loss, headache, and stomach pain. Over time, many of these side effects will subside or go away. Your doctor will slowly increase your Otezla dose over the first 5 days to lessen side effects.

In most patients, diarrhea and nausea occurred within the first 2 weeks of treatment and tended to go away over time without stopping Otezla.

*In plaque psoriasis studies; data from manufacturer.

Severe diarrhea, nausea, and vomiting can occur within the first few weeks of starting Otezla, and in some cases, patients were hospitalized. Older patients may be at a greater risk, especially if they are at risk of low blood pressure or dehydration, or taking medications that can worsen these effects.

If you develop severe diarrhea, nausea or vomiting, tell your doctor immediately. Side effects of severe diarrhea or vomiting typically improve quickly with dose reduction or discontinuation of Otezla. Do not stop taking Otezla unless recommended by your doctor.

If you notice that you are having signs or symptoms of depression or worsened depression, suicidal thoughts, or other mood changes while taking Otezla, contact your doctor immediately. Your family members should also help to monitor you for these changes. Before starting treatment with Otezla, tell your doctor if you have ever had problems with mood or depression.

Weight loss can be a significant side effect with Otezla. Your doctor will monitor your or your child's body weight regularly, and decide if it is safe to remain on Otezla.

In clinical studies, about 4.6% to 6.1% of patients stopped treatment due to any side effect, compared to 1.2% to 4.9% for placebo-treated patients.

Have your pharmacist or doctor review for drug interactions, as some medications may lower the effectiveness of Otezla.

Bottom Line

• Otezla (apremilast) is a phosphodiesterase 4 (PDE4) inhibitor available as an oral tablet used to treat adults plaque psoriasis, psoriatic arthritis, and oral ulcers associated with Behçet’s Disease. It is approved for use in children 6 to 17 years of age (and weighing at least 20 kg) for plaque psoriasis.
• Otezla can start working in the first few weeks of treatment and patients usually see therapeutic results within 12 to 16 weeks.
• Your initial dose of Otezla is started gradually to help minimize stomach side effects like diarrhea and nausea. Doses in children are based on weight.