Apremilast medac: Uses, Dosage & Side Effects
A selective PDE4 inhibitor for the treatment of moderate to severe plaque psoriasis, active psoriatic arthritis, and oral ulcers associated with Behçet’s disease
Apremilast medac is a selective phosphodiesterase 4 (PDE4) inhibitor used for the treatment of moderate to severe plaque psoriasis, active psoriatic arthritis, and oral ulcers associated with Behçet’s disease. Unlike biologic therapies that target specific cytokines, apremilast works intracellularly by modulating the inflammatory network through PDE4 inhibition, reducing pro-inflammatory mediators while increasing anti-inflammatory signals. It is taken orally as a film-coated tablet, making it a convenient option compared to injectable biologics. Apremilast medac is a generic version of the original apremilast product, offering the same active substance, efficacy, and safety profile at a more accessible price point.
Quick Facts: Apremilast medac
Key Takeaways
- Apremilast medac is an oral PDE4 inhibitor that modulates the immune response by increasing intracellular cAMP, thereby reducing pro-inflammatory cytokines (TNF-α, IL-17, IL-23) and increasing anti-inflammatory mediators (IL-10).
- It is approved for moderate to severe plaque psoriasis in adults who are candidates for systemic therapy, active psoriatic arthritis after inadequate response to a DMARD, and oral ulcers in Behçet’s disease.
- Treatment begins with a 5-day dose titration from 10 mg once daily up to the maintenance dose of 30 mg twice daily, which significantly reduces gastrointestinal side effects such as nausea and diarrhea.
- Depression and suicidal ideation have been reported; patients should be carefully assessed for psychiatric symptoms before and during treatment, and treatment should be reassessed if new or worsening symptoms occur.
- No routine laboratory monitoring is required, but patients with severe renal impairment need a dose adjustment to 30 mg once daily; strong CYP3A4 inducers such as rifampicin should be avoided.
What Is Apremilast medac and What Is It Used For?
Apremilast medac contains the active substance apremilast, a small molecule that belongs to the class of phosphodiesterase 4 (PDE4) inhibitors. PDE4 is an intracellular enzyme predominantly found in inflammatory and immune cells, including monocytes, macrophages, T cells, neutrophils, dendritic cells, and keratinocytes. By selectively inhibiting PDE4, apremilast prevents the breakdown of cyclic adenosine monophosphate (cAMP), a key intracellular signaling molecule. Elevated cAMP levels activate protein kinase A (PKA), which in turn modulates the expression of numerous genes involved in the inflammatory response.
The downstream effects of PDE4 inhibition are broad and clinically meaningful. Apremilast reduces the production of several pro-inflammatory cytokines that are central to the pathogenesis of psoriasis and psoriatic arthritis, including tumor necrosis factor-alpha (TNF-α), interleukin-17 (IL-17), interleukin-23 (IL-23), and interferon-gamma (IFN-γ). Simultaneously, it increases the production of anti-inflammatory mediators, particularly interleukin-10 (IL-10). This dual action—suppressing inflammation while promoting regulatory pathways—results in a rebalancing of the immune response rather than broad immunosuppression. This distinguishes apremilast from many conventional immunosuppressants and biologic agents.
Unlike biologic therapies, which are large protein molecules that must be injected or infused and target specific extracellular cytokines or their receptors, apremilast is a small molecule that is taken orally and works inside the cell. This intracellular mechanism of action means it modulates a network of inflammatory pathways simultaneously rather than blocking a single target. For patients, this translates to the convenience of oral administration without the need for injections, infusion appointments, or cold-chain storage.
Apremilast medac is approved by the European Medicines Agency (EMA) and other regulatory authorities for the following therapeutic indications:
- Moderate to severe plaque psoriasis: Apremilast is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who have failed to respond to, have a contraindication to, or are intolerant of other systemic therapies, including cyclosporine, methotrexate, or psoralen plus ultraviolet A (PUVA). The pivotal ESTEEM 1 and ESTEEM 2 trials demonstrated statistically significant improvements in the Psoriasis Area and Severity Index (PASI) compared with placebo, with durable responses maintained over long-term treatment.
- Active psoriatic arthritis: Apremilast is indicated, alone or in combination with disease-modifying antirheumatic drugs (DMARDs), for the treatment of active psoriatic arthritis in adult patients who have had an inadequate response or have been intolerant to a prior DMARD therapy. The PALACE 1, 2, and 3 trials demonstrated significant improvements in ACR20 response rates, physical function, and enthesitis and dactylitis resolution compared with placebo.
- Oral ulcers associated with Behçet’s disease: Apremilast is approved for the treatment of adult patients with oral ulcers associated with Behçet’s disease who are candidates for systemic therapy. The BCT-002 trial demonstrated significant reductions in the number and pain of oral ulcers compared with placebo.
Psoriasis is a chronic, immune-mediated inflammatory skin disease affecting approximately 2–3% of the global population. It is characterized by well-demarcated, erythematous plaques with silvery-white scales, most commonly on the elbows, knees, scalp, and lower back. Beyond skin involvement, psoriasis is associated with significant comorbidities including cardiovascular disease, metabolic syndrome, depression, and psoriatic arthritis. Psoriatic arthritis affects up to 30% of patients with psoriasis and involves inflammation of the joints, entheses (where tendons and ligaments attach to bone), and sometimes the spine, leading to pain, stiffness, and potential joint damage if untreated.
Unlike many treatments for moderate to severe psoriasis and psoriatic arthritis, which require injections or intravenous infusions, apremilast is taken as a simple tablet twice daily. This can be particularly advantageous for patients who prefer to avoid needles, have difficulty traveling to infusion centers, or do not have access to cold-chain storage required by many biologic therapies.
What Should You Know Before Taking Apremilast medac?
Before beginning treatment with apremilast medac, it is essential that your healthcare provider conducts a thorough medical evaluation. This includes a review of your complete medical history, current medications, and any known allergies. While apremilast does not require the routine pre-treatment laboratory screening typical of many immunosuppressant therapies (such as tuberculosis testing or hepatitis serology), several important considerations must be addressed before initiating treatment.
Contraindications
Apremilast medac is contraindicated in patients with known hypersensitivity to apremilast or any of the excipients in the formulation. It is also contraindicated during pregnancy. Apremilast has been shown to be embryotoxic in animal studies, and there are no adequate or well-controlled studies in pregnant women. Women of childbearing potential must use effective contraception during treatment, and pregnancy should be excluded before initiating therapy.
Warnings and Precautions
Several important warnings and precautions apply to apremilast therapy. Perhaps the most clinically significant is the association with psychiatric adverse events. Clinical trials and post-marketing surveillance have reported cases of depression, depressed mood, and, rarely, suicidal ideation and behavior in patients treated with apremilast. Although a causal relationship has not been definitively established, the temporal association warrants caution. Patients and caregivers should be instructed to watch for the emergence or worsening of depression, suicidal thoughts, or unusual changes in mood or behavior. If such symptoms develop, treatment should be reassessed, and the patient should be promptly evaluated by a qualified mental health professional.
Weight loss is another noteworthy effect observed during apremilast treatment. In clinical trials, approximately 10% of patients experienced weight loss of 5–10% of body weight, and about 2% lost more than 10%. While this may be welcomed by some patients, unexplained or significant weight loss should be monitored, and treatment should be reassessed if clinically significant weight loss occurs. Body weight should be measured regularly, and underweight patients at baseline should be monitored with particular attention.
Patients with severe renal impairment (creatinine clearance less than 30 mL/min) require a dose adjustment. The recommended maintenance dose in this population is 30 mg once daily instead of the standard 30 mg twice daily. No dose adjustment is necessary for patients with mild or moderate renal impairment or hepatic impairment.
Apremilast contains lactose as an excipient. Patients with rare hereditary conditions of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this medication.
Depression and suicidal ideation have been reported with apremilast. Carefully weigh the risks and benefits of treatment in patients with a history of depression and/or suicidal thoughts or behavior. Patients, caregivers, and families should be advised to be alert for the emergence or worsening of depression, suicidal thoughts, or other mood changes. If such reactions occur, patients should be instructed to contact their healthcare provider immediately.
Pregnancy and Breastfeeding
Apremilast is contraindicated during pregnancy. Animal studies have demonstrated embryofetal toxicity, including reduced fetal weight, delayed ossification, and increased post-implantation loss at clinically relevant exposures. Women of childbearing potential must use effective contraception during treatment. Pregnancy should be excluded before starting therapy, and patients should be counseled about the importance of avoiding pregnancy throughout the course of treatment.
It is not known whether apremilast or its metabolites are excreted in human breast milk. Because many drugs are excreted in human milk and because of the potential for adverse reactions in nursing infants, a decision should be made whether to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.
In animal studies, apremilast showed no effects on male or female fertility at exposures up to approximately 3 times the maximum recommended human dose. However, patients planning to conceive should discuss timing with their healthcare provider.
How Does Apremilast medac Interact with Other Drugs?
Apremilast is metabolized extensively through multiple pathways, including both cytochrome P450 (CYP)-mediated oxidation (primarily CYP3A4, with minor contributions from CYP1A2 and CYP2A6) and non-CYP-mediated pathways including glucuronidation, hydrolysis, and oxidation. The metabolic pathway primarily involves CYP3A4-mediated oxidative metabolism followed by glucuronide conjugation. Although apremilast is a substrate of CYP3A4, it is not an inhibitor or inducer of CYP enzymes, and it does not inhibit or induce P-glycoprotein transport at clinically relevant concentrations.
The clinical pharmacokinetic interaction profile of apremilast is relatively straightforward. The primary concern involves strong inducers of CYP3A4, which can accelerate the metabolism of apremilast and reduce its plasma concentrations to subtherapeutic levels. Conversely, CYP3A4 inhibitors do not cause clinically significant increases in apremilast exposure, as apremilast undergoes multiple metabolic pathways, and inhibition of a single pathway does not lead to a dangerous accumulation.
Major Interactions
| Drug | Effect | Recommendation |
|---|---|---|
| Rifampicin | Reduces apremilast AUC by approximately 72%; strong CYP3A4 inducer | Co-administration is not recommended; apremilast efficacy may be substantially reduced |
| Phenobarbital | Strong CYP3A4 inducer; expected to significantly reduce apremilast exposure | Co-administration is not recommended |
| Carbamazepine | Strong CYP3A4 inducer; expected to significantly reduce apremilast exposure | Co-administration is not recommended |
| Phenytoin | Strong CYP3A4 inducer; expected to significantly reduce apremilast exposure | Co-administration is not recommended |
| St. John’s Wort | Herbal CYP3A4 inducer; may reduce apremilast levels | Avoid concomitant use |
Minor Interactions and No Significant Interactions
Apremilast has been studied in combination with several commonly used medications without evidence of clinically significant pharmacokinetic interactions. This is clinically important because many patients with psoriasis and psoriatic arthritis take multiple medications concurrently.
| Drug | Finding | Clinical Implication |
|---|---|---|
| Methotrexate | No clinically significant pharmacokinetic interaction in either direction | Can be safely co-administered; studied in PALACE clinical trials |
| Oral contraceptives | No effect on pharmacokinetics of ethinyl estradiol or norgestimate | Hormonal contraceptives remain effective during apremilast use |
| Ketoconazole | Increased apremilast AUC by ~36% (strong CYP3A4 inhibitor) | No dose adjustment needed; increase is not clinically significant |
| Warfarin | No clinically relevant interaction expected based on metabolic profile | Standard INR monitoring is sufficient |
Apremilast does not interact with methotrexate, which is particularly relevant because many patients with psoriatic arthritis receive concomitant methotrexate therapy. In the PALACE clinical trials, apremilast was used in combination with small molecule DMARDs (including methotrexate, leflunomide, and sulfasalazine) without unexpected safety findings. Apremilast also does not affect the pharmacokinetics of oral contraceptives, which is important for women of childbearing potential who are required to use effective contraception during treatment.
Unlike some other systemic therapies for psoriasis and psoriatic arthritis (such as methotrexate, cyclosporine, or certain biologics), apremilast does not require routine laboratory monitoring for liver function, complete blood counts, or lipid profiles. This can simplify treatment management and reduce the burden of frequent blood tests on patients.
What Is the Correct Dosage of Apremilast medac?
The dosing of apremilast follows a carefully designed titration protocol that has been shown to significantly reduce the incidence and severity of gastrointestinal side effects, particularly nausea and diarrhea, which are the most common adverse events reported during the initial weeks of treatment. This gradual dose escalation allows the body to adapt to the medication and is a key component of the treatment regimen.
Initial Dose Titration (Days 1–5)
| Day | Morning Dose | Evening Dose |
|---|---|---|
| Day 1 | 10 mg | — |
| Day 2 | 10 mg | 10 mg |
| Day 3 | 10 mg | 20 mg |
| Day 4 | 20 mg | 20 mg |
| Day 5 | 20 mg | 30 mg |
| Day 6 onward | 30 mg | 30 mg |
Adults
Standard Adult Dosage
After completing the initial 5-day titration, the recommended maintenance dose is 30 mg twice daily, taken approximately 12 hours apart. The tablets can be taken with or without food. Each dose should be swallowed whole and not crushed, split, or chewed. Treatment should be continued for the duration recommended by the prescribing physician. In clinical trials for psoriasis, some patients who did not achieve a PASI 75 response at week 16 were still able to achieve meaningful improvements by week 24 and beyond, suggesting that at least 24 weeks of treatment may be needed to fully assess efficacy.
Children
Pediatric Use
The safety and efficacy of apremilast in children and adolescents under 18 years of age have not been established. Apremilast is not currently recommended for use in the pediatric population. Clinical trials evaluating apremilast in pediatric patients are ongoing, and future data may inform potential use in this age group.
Elderly
Elderly Patients (≥65 years)
No dose adjustment is required for elderly patients based on age alone. However, elderly patients may be more susceptible to gastrointestinal side effects and weight loss. Clinical experience in patients aged 75 years and older is limited. As with all medications in the elderly, careful monitoring and individualized treatment decisions are recommended, taking into account overall health status, renal function, and concomitant medications.
Renal Impairment
Dose Adjustment for Severe Renal Impairment
In patients with severe renal impairment (creatinine clearance <30 mL/min, estimated by the Cockcroft-Gault equation), the recommended maintenance dose is 30 mg once daily. The initial titration should use only the morning doses from the standard schedule. No dose adjustment is needed for patients with mild or moderate renal impairment.
Missed Dose
If a dose is missed, it should be taken as soon as the patient remembers. However, if it is close to the time of the next scheduled dose, the missed dose should be skipped and the next dose taken at the regular time. Patients should not take a double dose to make up for a missed dose. Consistent adherence to the twice-daily dosing schedule is important for maintaining therapeutic drug levels and optimal clinical response.
Overdose
Apremilast has been studied at doses up to 100 mg daily (50 mg twice daily) in healthy volunteers without dose-limiting toxicities being identified. In the event of an overdose, patients should be monitored for signs and symptoms of adverse effects, and standard supportive care should be provided. There is no specific antidote for apremilast. Due to the high plasma protein binding of apremilast (approximately 68%), dialysis is unlikely to be an effective method of drug removal.
Always follow the 5-day titration schedule when starting apremilast. Starting directly at the full maintenance dose of 30 mg twice daily significantly increases the risk of gastrointestinal side effects, particularly nausea and diarrhea. If treatment is interrupted for a prolonged period, re-titration may be advisable; discuss this with your healthcare provider.
What Are the Side Effects of Apremilast medac?
Like all medicines, apremilast can cause side effects, although not everyone experiences them. The safety profile of apremilast has been extensively characterized through the ESTEEM (psoriasis) and PALACE (psoriatic arthritis) clinical trial programs, as well as through post-marketing surveillance data. The overall safety profile is considered favorable compared with many conventional systemic therapies and biologics, with no requirement for routine laboratory monitoring for organ toxicity.
The most frequently reported adverse reactions are gastrointestinal in nature and are most pronounced during the initial weeks of treatment. The dose titration schedule described above was specifically designed to mitigate these effects. In most patients, gastrointestinal symptoms are self-limiting and resolve within the first four weeks of treatment without the need for dose adjustment or treatment discontinuation.
The following side effect frequencies are based on data from the pivotal clinical trials and the Summary of Product Characteristics:
Very Common
Affects more than 1 in 10 patients
- Diarrhea
- Nausea
- Upper respiratory tract infections (nasopharyngitis, common cold)
- Headache, including tension headache
Common
Affects 1 in 10 to 1 in 100 patients
- Vomiting (especially during first two weeks)
- Decreased appetite
- Abdominal pain (upper)
- Frequent bowel movements
- Dyspepsia (indigestion)
- Back pain
- Cough
- Fatigue
- Insomnia
- Weight loss
- Migraine
- Bronchitis
Uncommon
Affects 1 in 100 to 1 in 1,000 patients
- Depression
- Rash
- Urticaria (hives)
- Gastrointestinal hemorrhage (GI bleeding)
- Suicidal ideation and behavior
Rare
Affects fewer than 1 in 1,000 patients
- Hypersensitivity reactions (angioedema)
- Severe skin reactions
Not Known
Frequency cannot be estimated from available data
- Drug reaction with eosinophilia and systemic symptoms (DRESS)
Gastrointestinal side effects deserve particular attention because they are the most common reason patients discontinue apremilast during the initial weeks of therapy. In the ESTEEM trials, diarrhea occurred in approximately 17% of patients (compared with 6% in the placebo group), and nausea occurred in approximately 17% of patients (compared with 7% with placebo). The vast majority of these events were mild to moderate in severity, occurred within the first two weeks of treatment, and resolved within one month. Fewer than 2% of patients discontinued treatment due to diarrhea or nausea.
Weight loss associated with apremilast treatment is typically modest. In clinical trials, the mean weight change from baseline was approximately −1.5 to −2 kg over the first year of treatment. However, some patients may experience more significant weight loss. Patients who are underweight at baseline or who experience unexplained or significant weight loss during treatment should have their body weight monitored regularly, and the continuation of treatment should be reassessed if clinically meaningful weight loss occurs.
The psychiatric adverse effects, while uncommon, are among the most important to monitor. In the pooled clinical trial data, depression (including depressed mood) was reported in approximately 1% of apremilast-treated patients compared with 0.8% of placebo-treated patients. Cases of suicidal ideation and completed suicide have been reported in post-marketing experience, though a causal relationship with apremilast has not been established. Patients with a history of depression or suicidal ideation should be carefully assessed before starting treatment, and all patients should be monitored for the emergence or worsening of psychiatric symptoms during therapy.
Contact your healthcare provider immediately if you experience: severe or persistent diarrhea with dehydration, new or worsening depression or suicidal thoughts, signs of a severe allergic reaction (difficulty breathing, swelling of the face/throat, severe rash), or unexplained significant weight loss. These symptoms may require treatment reassessment or discontinuation.
How Should You Store Apremilast medac?
Proper storage of apremilast medac is important to maintain the stability, efficacy, and safety of the medication. Film-coated tablets should be stored at temperatures not exceeding 30°C (86°F). There is no need for refrigeration, which is an advantage over many biologic therapies that require cold-chain storage.
The tablets should be kept in the original packaging (blister pack or bottle, depending on the presentation) to protect from light and moisture. The packaging is designed to maintain the integrity of the tablets throughout their shelf life. Do not transfer tablets to other containers unless specifically instructed to do so by your pharmacist.
As with all medications, apremilast medac should be kept out of the sight and reach of children. Do not use the tablets after the expiry date stated on the carton and blister or bottle. The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.
If you notice any change in the appearance of the tablets (such as discoloration, crumbling, or unusual odor), do not take them. Contact your pharmacist for advice on whether the medication should be replaced.
What Does Apremilast medac Contain?
Active Ingredient
The active ingredient is apremilast. Each film-coated tablet contains either 10 mg, 20 mg, or 30 mg of apremilast. Apremilast is a racemic mixture with the chemical name (±)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-4-acetylaminoisoindoline-1,3-dione. It has a molecular weight of 460.5 g/mol and appears as a white to pale yellow, non-hygroscopic powder.
Inactive Ingredients (Excipients)
The tablet core contains:
- Lactose monohydrate
- Microcrystalline cellulose
- Croscarmellose sodium
- Magnesium stearate
The film-coating contains:
- Polyvinyl alcohol
- Titanium dioxide (E171)
- Macrogol (polyethylene glycol)
- Talc
- Iron oxide red (E172) – 10 mg and 20 mg tablets
- Iron oxide yellow (E172) – 20 mg tablets
Appearance
Apremilast medac film-coated tablets are distinguished by their strength-specific appearance. The 10 mg tablets are pink, diamond-shaped tablets. The 20 mg tablets are brown, diamond-shaped tablets. The 30 mg tablets are beige, round tablets. All tablets are marked with the strength on one side. The starter pack contains tablets of all three strengths arranged according to the titration schedule, making it easy for patients to follow the correct dosing regimen during the first week of treatment.
Manufacturer
Apremilast medac is manufactured and marketed by medac Gesellschaft für klinische Spezialpräparate mbH, a pharmaceutical company based in Germany. As a generic product, it contains the same active substance and has demonstrated bioequivalence to the reference product, meaning it delivers the same clinical efficacy and safety profile.
Frequently Asked Questions About Apremilast medac
Apremilast medac is used to treat three conditions: moderate to severe plaque psoriasis in adults who are candidates for systemic therapy, active psoriatic arthritis in adults who have had an inadequate response or intolerance to a prior DMARD therapy (used alone or in combination with DMARDs), and oral ulcers associated with Behçet’s disease. It works by inhibiting PDE4, which modulates the immune response and reduces inflammation.
The onset of action varies by indication. For psoriasis, some patients may begin to notice improvement in skin symptoms within the first few weeks, but the full effect is typically assessed at 16 weeks, with additional improvements possible up to 24–32 weeks. For psoriatic arthritis, ACR20 responses were statistically significant at week 16 in clinical trials. For Behçet’s disease oral ulcers, improvements were observed as early as week 6. It is important to give the medication adequate time to work before concluding it is ineffective.
Yes, apremilast can be taken with or without food. Food does not significantly affect the absorption of the medication. However, some patients find that taking the medication with food may help reduce gastrointestinal side effects such as nausea, particularly during the initial titration period. The tablets should be swallowed whole and should not be crushed, split, or chewed.
Apremilast modulates the immune response rather than broadly suppressing it. Unlike traditional immunosuppressants, it works by rebalancing pro-inflammatory and anti-inflammatory mediators through PDE4 inhibition. Clinical trial data show that apremilast does not increase the risk of serious infections, opportunistic infections, or malignancies to the degree seen with some conventional immunosuppressants and biologic therapies. No routine laboratory monitoring for immunosuppression-related complications (such as TB screening or hepatitis screening) is required before or during treatment.
Apremilast has not been extensively studied in combination with biologic therapies in large clinical trials. Its approved use in psoriatic arthritis includes combination with conventional DMARDs such as methotrexate, leflunomide, and sulfasalazine, but not with biologics. The combination of apremilast with biologic agents is generally not recommended in current treatment guidelines, as the safety of such combinations has not been established. Always consult your dermatologist or rheumatologist before combining treatments.
Apremilast medac contains the same active substance (apremilast) as Otezla, the originator product. As a generic medicine, Apremilast medac has demonstrated bioequivalence to Otezla, meaning it delivers the same amount of active substance to the body at the same rate. This ensures equivalent clinical efficacy and safety. The inactive ingredients (excipients) may differ slightly between generic and originator products, but these differences do not affect how the medicine works. Apremilast medac may be available at a lower cost, improving access for patients.
References
- European Medicines Agency (EMA). Otezla (apremilast) – Summary of Product Characteristics. Last updated 2025. Available from: EMA EPAR.
- U.S. Food and Drug Administration (FDA). Otezla (apremilast) Prescribing Information. Revised 2024. Available from: FDA Drug Label.
- Papp K, Reich K, Leonardi CL, et al. Apremilast, an oral phosphodiesterase 4 (PDE4) inhibitor, in patients with moderate to severe plaque psoriasis: Results of a phase III, randomized, controlled trial (Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis [ESTEEM] 1). J Am Acad Dermatol. 2015;73(1):37–49. doi:10.1016/j.jaad.2015.03.049.
- Paul C, Cather J, Gooderham M, et al. Efficacy and safety of apremilast, an oral phosphodiesterase 4 inhibitor, in patients with moderate-to-severe plaque psoriasis over 52 weeks: a phase III, randomized controlled trial (ESTEEM 2). Br J Dermatol. 2015;173(6):1387–1399. doi:10.1111/bjd.14164.
- Kavanaugh A, Mease PJ, Gomez-Reino JJ, et al. Treatment of psoriatic arthritis in a phase 3 randomised, placebo-controlled trial with apremilast, an oral phosphodiesterase 4 inhibitor (PALACE 1). Ann Rheum Dis. 2014;73(6):1020–1026. doi:10.1136/annrheumdis-2013-205056.
- Cutolo M, Myerson GE, Genovese MC, et al. A phase III, randomized, controlled trial of apremilast in patients with psoriatic arthritis: Results of the PALACE 2 trial. J Rheumatol. 2016;43(9):1724–1734. doi:10.3899/jrheum.151376.
- Hatemi G, Mahr A, Ishigatsubo Y, et al. Trial of apremilast for oral ulcers in Behçet’s syndrome (BCT-002). N Engl J Med. 2019;381(20):1918–1928. doi:10.1056/NEJMoa1816594.
- Menter A, Strober BE, Kaplan DH, et al. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics. J Am Acad Dermatol. 2019;80(4):1029–1072. doi:10.1016/j.jaad.2018.11.057.
- Gossec L, Baraliakos X, Kerschbaumer A, et al. EULAR recommendations for the management of psoriatic arthritis with pharmacological therapies: 2023 update. Ann Rheum Dis. 2024;83(6):706–719. doi:10.1136/ard-2024-225531.
- World Health Organization (WHO). WHO Model List of Essential Medicines – 23rd List. Geneva: WHO; 2023.
Editorial Team
This article was written and reviewed by the iMedic Medical Editorial Team, comprising licensed specialist physicians with expertise in dermatology, rheumatology, and clinical pharmacology.
Medical Content
iMedic Dermatology Editorial Team – specialist physicians in dermatology and rheumatology with clinical experience in psoriasis and psoriatic arthritis treatment
Medical Review
iMedic Medical Review Board – independent panel verifying accuracy against EMA SmPC, FDA label, AAD-NPF, and EULAR guidelines
Pharmacology Review
iMedic Clinical Pharmacology Team – specialists in drug interactions, pharmacokinetics, and medication safety
Accessibility & SEO
iMedic Digital Health Team – ensuring WCAG 2.2 AAA compliance and optimal search visibility
All content follows the GRADE evidence framework and is reviewed according to international medical guidelines. iMedic receives no commercial funding from pharmaceutical companies.