Apremilast

Behcet Syndrome, Psoriasis, Psoriasis Vulgaris + 3 more

Treatment

20 Active Studies for Apremilast

What is Apremilast

Apremilast

The Generic name of this drug

Treatment Summary

Apremilast, also known as Otezla, is a medication used to treat symptoms caused by certain autoimmune disorders such as Behcet’s disease. It works by blocking a certain enzyme called PDE4 and was first approved by the FDA in 2014. In 2019, it was given an additional approval for the treatment of oral ulcers associated with Behcet’s disease. Apremilast is part of a drug class that includes Roflumilast and Crisaborole.

Otezla

is the brand name

image of different drug pills on a surface

Apremilast Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Otezla

Apremilast

2014

9

Effectiveness

How Apremilast Affects Patients

Apremilast helps to reduce signs of psoriasis and Behcet's disease, like pain, by lowering the amount of inflammatory substances in the body. However, it can also cause weight loss and worsen depression, leading to suicidal thoughts or actions. People on apremilast should be monitored for signs of depression and have their weight loss evaluated. If depression or weight loss become serious, doctors may advise stopping the medication.

How Apremilast works in the body

Apremilast works by blocking an enzyme called phosphodiesterase 4 (PDE4). This enzyme helps regulate a molecule called cyclic adenosine monophosphate (cAMP) which is involved in inflammation. By blocking PDE4, apremilast increases cAMP levels, which helps reduce the levels of inflammatory molecules such as TNF-α, IL-17, and IL-23. This effect can reduce the symptoms of psoriasis, Behçet's disease, and other inflammatory conditions such as skin lesions and arthritis.

When to interrupt dosage

The proposed dosage of Apremilast is governed by the diagnosed condition, for instance Severe Plaque psoriasis, Psoriasis and Behcet's Syndrome. The quantity of dosage fluctuates as per the technique of administration (e.g. Tablet or Kit; Tablet, film coated) featured in the table below.

Condition

Dosage

Administration

Behcet Syndrome

30.0 mg, , 10.0 mg, 20.0 mg, 60.0 mg

, Oral, Tablet - Oral, Tablet, Kit; Tablet, Kit; Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral, Kit - Oral, Kit

Psoriasis

30.0 mg, , 10.0 mg, 20.0 mg, 60.0 mg

, Oral, Tablet - Oral, Tablet, Kit; Tablet, Kit; Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral, Kit - Oral, Kit

Psoriasis Vulgaris

30.0 mg, , 10.0 mg, 20.0 mg, 60.0 mg

, Oral, Tablet - Oral, Tablet, Kit; Tablet, Kit; Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral, Kit - Oral, Kit

Ulcer

30.0 mg, , 10.0 mg, 20.0 mg, 60.0 mg

, Oral, Tablet - Oral, Tablet, Kit; Tablet, Kit; Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral, Kit - Oral, Kit

candidates for phototherapy

30.0 mg, , 10.0 mg, 20.0 mg, 60.0 mg

, Oral, Tablet - Oral, Tablet, Kit; Tablet, Kit; Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral, Kit - Oral, Kit

candidate for systemic therapy

30.0 mg, , 10.0 mg, 20.0 mg, 60.0 mg

, Oral, Tablet - Oral, Tablet, Kit; Tablet, Kit; Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral, Kit - Oral, Kit

Warnings

Apremilast Contraindications

Condition

Risk Level

Notes

Severe Hypersensitivity Reactions

Do Not Combine

Apremilast may interact with Pulse Frequency

There are 20 known major drug interactions with Apremilast.

Common Apremilast Drug Interactions

Drug Name

Risk Level

Description

9-(N-methyl-L-isoleucine)-cyclosporin A

Major

The risk or severity of adverse effects can be increased when Apremilast is combined with 9-(N-methyl-L-isoleucine)-cyclosporin A.

Abemaciclib

Major

The metabolism of Abemaciclib can be increased when combined with Apremilast.

Abetimus

Major

The risk or severity of adverse effects can be increased when Apremilast is combined with Abetimus.

Acalabrutinib

Major

The metabolism of Acalabrutinib can be increased when combined with Apremilast.

Acenocoumarol

Major

The metabolism of Acenocoumarol can be increased when combined with Apremilast.

Apremilast Toxicity & Overdose Risk

The lowest toxic dose of apremilast in mice was found to be greater than 2000mg/kg, while in rats it was 2000mg/kg for males and 300mg/kg for females. People who take the maximum recommended dose of 100mg (50mg twice daily) for 5 days have not experienced significant toxicity. In case of an overdose, supportive and symptomatic treatment should be administered. Contact the local poison control center for guidance on how to manage an overdose of apremilast.

image of a doctor in a lab doing drug, clinical research

Apremilast Novel Uses: Which Conditions Have a Clinical Trial Featuring Apremilast?

Currently, 18 active clinical trials are examining the potential of Apremilast in treating patients who are candidates for phototherapy, Arthritis, Psoriatic and Psoriasis.

Condition

Clinical Trials

Trial Phases

Psoriasis

0 Actively Recruiting

candidates for phototherapy

0 Actively Recruiting

Ulcer

0 Actively Recruiting

Behcet Syndrome

0 Actively Recruiting

Psoriasis Vulgaris

23 Actively Recruiting

Early Phase 1, Phase 3, Not Applicable, Phase 2, Phase 4, Phase 1

candidate for systemic therapy

0 Actively Recruiting

Apremilast Reviews: What are patients saying about Apremilast?

4.7

Patient Review

6/16/2022

Apremilast for Moderate to Severe Plaque Psoriasis

I've been on Otezla for two months and, while it's done great things for my skin in terms of reducing redness and clearing up blemishes, I'm now experiencing hair thinning. This is a really frustrating side effect because the drug has otherwise worked so well. Has anyone else experienced this?

4.7

Patient Review

6/16/2022

Apremilast for Moderate to Severe Plaque Psoriasis

Otezla has worked great for me so far, clearing up most of my spots and redness. The only downside is that I'm experiencing hair thinning, which is a real bummer because I had such thick, luscious hair before. If anyone else is experiencing this side effect, please let me know!

4.3

Patient Review

2/7/2021

Apremilast for Moderate to Severe Plaque Psoriasis

I saw significant results within a month, which is amazing considering I hadn't had any success with other treatments. However, the side effects (GI issues and mental health problems) can be pretty severe. Worth it for me, though!

4.3

Patient Review

2/7/2021

Apremilast for Moderate to Severe Plaque Psoriasis

Though it comes with some intense side effects, this medication finally helped me after over a decade of searching. I'd recommend it to others in a similar situation.

3

Patient Review

9/27/2022

Apremilast for Psoriasis associated with Arthritis

I've been on the medication for two months now, taking 30mg every day. I had some mild nausea and headaches when I first started, but those have gone away. However, I really haven't seen any benefits to my scalp psoriasis.

3

Patient Review

9/27/2022

Apremilast for Psoriasis associated with Arthritis

I've been on 30 mg per day for two months now. I had mild nausea and headaches when I first started, but those have since subsided. I was told it would be five months before the full effect of the treatment would be known, but so far I haven't seen any benefits for my scalp psoriasis.

2.3

Patient Review

5/20/2022

Apremilast for Psoriasis associated with Arthritis

So far, I'm not really sure how well this is working. I'm on day two and it's made me nauseous the entire time. If this is the low dose, I can't imagine how bad the next few days will be. Fingers crossed that my body gets used to it.

2.3

Patient Review

5/8/2022

Apremilast for Psoriasis associated with Arthritis

I've been on this medication for four weeks now. No improvement as of yet. In fact I've had new spits show up on face face. Thank goodness it's paid by my gateway insurance.I was really hoping this medication would work. Maybe my Dr. Will put me back on an injectable

2.3

Patient Review

5/8/2022

Apremilast for Psoriasis associated with Arthritis

I'm four weeks in on this med and, so far, have seen no results—in fact, I've got new breakouts. Thank goodness my insurance is covering it. I was really hoping this would be the treatment that worked for me. Maybe my doctor will put me back on an injectable medication.

2.3

Patient Review

5/20/2022

Apremilast for Psoriasis associated with Arthritis

I'm not sure how effective this is yet. I've only been taking it for two days, but it's made me really sick. I'm on the graduated dose, so I can only imagine how bad the next few days will be. Hoping I get used to it.

2

Patient Review

1/3/2022

Apremilast for Psoriasis associated with Arthritis

I've been on Otezla for four months now, and I'm increasingly disappointed. There were some minor improvements at 60 days in skin and joint pain, but those started to decrease at 90 days. Now, at 120 days, there is no reason to continue taking this drug when the benefits don't outweigh the cost.

2

Patient Review

1/3/2022

Apremilast for Psoriasis associated with Arthritis

I've been on Otezla for four months now, and I'm increasingly disappointed. I saw some minor improvement at 60 days in both my skin and joint pain, but those effects have since dissipated. There's no reason to continue taking this drug when the benefits don't outweigh the cost.

1.7

Patient Review

4/17/2022

Apremilast for Moderate to Severe Plaque Psoriasis

I've been relatively lucky with side effects, but I do have to use the restroom more frequently than usual.

1.7

Patient Review

4/17/2022

Apremilast for Moderate to Severe Plaque Psoriasis

The only side effect I've experienced is needing to use the restroom more frequently, which happens about four or five times daily.

1.3

Patient Review

7/17/2021

Apremilast for Moderate to Severe Plaque Psoriasis

I've been taking otezla for two years now and, unfortunately, it doesn't seem to be helping. If anything, my psoriasis has gotten worse and I'm incredibly depressed. I don't think I'll be taking it anymore; hopefully my skin will start to improve on its own.

1.3

Patient Review

7/17/2021

Apremilast for Moderate to Severe Plaque Psoriasis

I've been taking otezla for two years now and, unfortunately, it seems to have made my psoriasis worse. I'm also incredibly depressed. So, I've decided to stop taking it and see if things improve on their own.

1

Patient Review

8/5/2022

Apremilast for Psoriasis associated with Arthritis

I'm really upset that Otezla is so expensive. It's hard enough to afford health care as it is, and this just makes it even more difficult for people who need this medication.

1

Patient Review

8/5/2022

Apremilast for Psoriasis associated with Arthritis

I'm really angry at Otezla for making a medication that could help me but is too expensive for most people to afford. It's terrible how our health care system works!
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about apremilast

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is apremilast a steroid?

"APREMILAST is a drug that belongs to a class of steroids called phosphodiesterase 4 (PDE4) inhibitors. It is used to treat plaque psoriasis, psoriasis arthritis, and oral ulcers."

Answered by AI

Can apremilast cure psoriasis?

"The treatment also helps with itching and redness.

In clinical trials, approximately 20% of patients saw a clearing or almost clearing of their plaque psoriasis by week 16, with about one third of patients seeing a 75% or greater improvement. The treatment also helps alleviate itching and redness."

Answered by AI

What kind of drug is apremilast?

"Apremilast is a medication used to treat ulcers in the mouth caused by Behcet's syndrome, a disorder characterized by swelling of blood vessels throughout the body. Apremilast works by inhibiting the action of certain natural substances in the body that lead to inflammation."

Answered by AI

Is apremilast an immunosuppressant?

"Since apremilast is not immunosuppressive, it may be the preferred option for immunocompromised patients. However, biologics are not contraindicated and may be used in these patients if they are monitored closely."

Answered by AI

Clinical Trials for Apremilast

Image of Exalt Clinical Research in Chula Vista, United States.

Zasocitinib for Plaque Psoriasis

4 - 17
All Sexes
Chula Vista, CA

The main aim of this study is to see how well the medicine zasocitinib works, how safe it is, and how children and teenagers aged 4 to under 18 with moderate-to-severe plaque psoriasis respond to it. The study will be done in 2 parts: Part A will include both children and teenagers, while part B will only include children. At first, only teenagers who meet the study rules can participate in this study. Children may only start to participate once enough information has been collected from other studies with zasocitinib. Participants in Part A will initially be assigned to receive either zasocitinib or placebo for the first 16 weeks of treatment, then all participants will receive zasocitinib through the end of the study. All participants in Part B will be assigned to receive treatment with zasocitinib throughout the study. Participants will be in the study for up to 4 years and 2 months (217 weeks), including up to 35 days for the screening period, 208 weeks of treatment (Part A and Part B) and a 4-week safety follow-up period. During the study, participants will visit their study site multiple times.

Phase 3
Recruiting

Exalt Clinical Research (+10 Sites)

Study Director

Takeda

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Image of Lynderm Research in Markham, Canada.

ESK-001 for Plaque Psoriasis

18+
All Sexes
Markham, Canada

The objective of the ESK-001-018 long term extension is to evaluate the safety and efficacy of ESK-001 over time. The scientific questions it aims to answer are: * How safe is taking ESK-001 long-term in people with moderate to severe plaque psoriasis? * Does taking ESK-001 long-term reduce the severity of people's plaque psoriasis? Patients will enter the long-term extension study following completion of one of the parent studies (ESK-001-016 or ESK-001-017) and will receive open-label ESK-001 twice daily for 24 weeks. After 24 weeks, the first 200 patients meeting at least PASI-75 clinical response will be randomly assigned to receive ESK-001 or placebo. At any point during this time, the patients losing the initial clinical response may return to the open-label ESK-001 treatment. Patients who complete Week 48 will return to open-label ESK-001 treatment and they will receive ESK-001 until the end of the study or discontinuation. All the remaining patients not meeting the entry criteria for the randomized withdrawal phase will continue to receive open-label ESK-001 for the remainder of the study. Patients taking part in the study must be men or women aged at least 18 years old and have completed a previous (parent) study of ESK-001 in moderate to severe plaque psoriasis. Patients must consent and agree to: * ensure drug daily compliance until end of study or discontinuation. * visit the clinic for checkups and assessments. * provide blood and urine samples.

Phase 3
Recruiting
Quick Reply

Lynderm Research (+35 Sites)

Alumis Inc

Have you considered Apremilast clinical trials?

We made a collection of clinical trials featuring Apremilast, we think they might fit your search criteria.
Go to Trials

Have you considered Apremilast clinical trials?

We made a collection of clinical trials featuring Apremilast, we think they might fit your search criteria.
Go to Trials