For patients with plaque psoriasis, topical therapies such as creams or ointments sometimes are not enough. Plaque psoriasis is a lifelong illness, consisting of cycles with flare-ups and remission. Many patients who have plaque psoriasis can also go on to develop psoriatic arthritis, which causes pain, swelling, and inflammation around the joints.
In 2014, a medication called Otezla, became approved by the United States Food and Drug Administration (FDA) for both plaque psoriasis and psoriatic arthritis. In 2019, Otezla received additional FDA approval for a condition called Behçet’s disease, an autoimmune disorder that can cause oral ulcers, genital ulcers, and inflammation in parts of the body.
In this article, we will explore the mechanism of action, efficacy, and safety profile of Otezla, as well as its potential side effects, drug interactions, and patient considerations.
What Is Otezla?
Otezla is a prescription medication approved by the FDA to treat plaque psoriasis, psoriatic arthritis, and oral ulcers associated with Behçet’s disease.
It belongs to a group of drugs called phosphodiesterase-4 (PDE4) inhibitors and works by suppressing inflammation in the body. Otezla is the brand name for the generic drug, apremilast.
Since its approval in 2014, Otezla has gained popularity among patients and healthcare professionals as a safe and effective treatment option for psoriatic arthritis, all stages of plaque psoriasis, and oral ulcers associated with Behçet’s disease.
One of the main advantages of Otezla is that it is a non-biologic medication, meaning it does not contain living cells or proteins. This makes it a safer option for patients who cannot tolerate biologics or have a higher infection risk.
Biologics are medications that can be made from living cells or proteins and are often used as a treatment option for those with psoriasis and psoriatic arthritis. However, biologics can increase the risk of infections, especially in patients with weakened immune systems.
Keep in mind that Otezla is not suitable for everyone.
- It is not recommended in patients with a history of depression, suicidal thoughts, or behavior, as it may exacerbate symptoms.
- It can also interact with other medications, such as rifampin, St. John’s Wort, and carbamazepine, and should not be taken with these drugs.
Hence, you should always inform your doctor about your health history and any medications that you might be taking.
What Is Otezla Used For?
Otezla is approved by the U.S. Food and Drug Administration (FDA) for the treatment of:
- Plaque psoriasis: Otezla is used to treat moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
- Psoriatic arthritis: Otezla treats active psoriatic arthritis in adults, either alone or in combination with other medications.
- Oral ulcers associated with Behçet’s Disease: Otezla is used to treat oral ulcers associated with Behçet’s Disease in adults.
How Is Otezla Used?
Otezla is taken orally, in tablet form. You should swallow it with water without crushing, chewing, or breaking the tablet.
It’s important to follow your doctor’s instructions for taking this medication and not to change your dosage or stop taking the medication without consulting your doctor first. It may take several weeks for Otezla to start working, and it should be taken continuously to maintain its effects.
If you miss a dose, you should take it as soon as you remember unless it’s close to the time for your next dose, in which case you should skip the missed dose and continue with your regular dosing schedule.
How Does It Work?
Inflammatory conditions occur when the immune system overreacts and produces too many inflammatory cells and proteins. PDE4 is an enzyme that breaks down a molecule called cyclic adenosine monophosphate (cAMP), which controls inflammation in the body. The more PDE4 circulates in the body, the more it breaks down cAMP, leading to an increase in inflammation.
By inhibiting PDE4, Otezla increases the levels of cAMP, reducing the production of inflammatory cells and proteins. This helps to control inflammation and reduce symptoms such as joint pain, swelling, and skin inflammation.
It’s important to note that Otezla is not a cure for inflammatory conditions, but can help manage them.
Side Effects
Like all medications, Otezla can cause side effects. Here are some of the most common side effects:
- Nausea
- Diarrhea
- Headache
- Upper respiratory tract infection
- Tension headache
- Weight loss
Less common side effects include:
- Depression
- Suicidal thoughts or behavior
- Worsening depression or anxiety
- Angioedema (swelling of the lips, tongue or face)
- Severe allergic reaction
- Severe diarrhea
- Severe vomiting
If you experience any of these side effects or any other unusual symptoms after taking Otezla, don’t hesitate to contact your healthcare provider immediately. Your healthcare provider can help determine the best course of action to manage any side effects you may experience.
Drug Dosage
Otezla should be titrated to a recommended dose of 30 mg twice daily. A titration schedule is used to decrease the possibility of gastrointestinal (GI) symptoms. The schedule is as follows:
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 ongoing: 30 mg in the morning and 30 mg in the evening
Your healthcare provider may change your drug dose if you have severe kidney damage.
Precautions
There are several precautions that you should take before and after using Otezla.
Before using the medication:
- Tell your doctor if you have any allergies or medical conditions or are taking other medications.
- Let your doctor know if you are pregnant or planning to become pregnant, as Otezla may not be safe during pregnancy.
- Inform your doctor if you have a history of depression or suicidal thoughts, as Otezla can increase the risk of depression or suicidal behavior.
After using the medication:
- Follow your doctor’s instructions regarding dosage and frequency of use.
- Keep track of any side effects you may experience and report them to your doctor.
- Avoid drinking alcohol while taking Otezla, as it may increase the risk of liver damage.
- Only stop taking Otezla after consulting your doctor, as sudden discontinuation can cause rebound symptoms.
- Store Otezla at room temperature and away from direct sunlight.
Cost
The cost of Otezla may vary depending on several factors, such as your country, insurance coverage, and dosage.
In the United States, the average wholesale price (AWP) of Otezla is approximately $153 per pill, with a recommended dosage of two pills per day. This means that the cost can be around $4,600 for a 60-pill supply, equivalent to a one-month treatment.
It is essential to note that this price is only an estimate and may not reflect the actual cost patients will pay for Otezla. Patients should consult their healthcare provider or pharmacist for more accurate and up-to-date pricing information.
Additionally, patients may be able to receive discounts or enroll in financial assistance programs to help offset the cost.
