Drug updated on 12/11/2024
| Dosage Form | Tablet (oral; 10 mg, 20 mg, 30 mg) |
| Drug Class | Phosphodiesterase 4 inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of adult patients with active psoriatic arthritis.
- Indicated for the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
- Indicated for the treatment of adult patients with oral ulcers associated with Behçet’s disease.
Latest News
Summary
- This summary is based on the review of 20 systematic review(s)/meta-analysis(es). [1-24]
- Palmoplantar Pustulosis (PPP): Excimer laser demonstrated 95.0% Palmoplantar Pustulosis Psoriasis Area and Severity Index (PPPASI)-75 in severe cases, while psoralen plus ultraviolet A therapy combined with retinoids or fumaric acid esters achieved PPPASI-90 rates of 90.0% and 81.8% in milder cases. Systemic therapies (guselkumab, brodalumab, apremilast) showed PPPASI-50 rates between 57.4% and 78.3% at week 16 across disease severities.
- Psoriatic Arthritis (PsA): Apremilast outperformed placebo in the American College of Rheumatology 20/50/70 Response Criteria (ACR20/50/70) ACR20 (relative risk (RR) = 1.92), ACR50 (RR = 2.34), ACR70 (RR = 2.89), and the Health Assessment Questionnaire Disability Index (HAQ-DI) (standardized mean difference (SMD) = -0.26).
- Plaque Psoriasis: Deucravacitinib surpassed apremilast and placebo in achieving PASI 75, Static Physician Global Assessment (sPGA) 0/1, PASI 90, PASI 100, and Dermatology Life Quality Index (DLQI) 0/1 by week 16. Infliximab, bimekizumab, ixekizumab, and risankizumab exhibited greater PASI 90 efficacy than non-biological systemic agents and small molecules, including apremilast.
- Palmoplantar Psoriasis (PP) and PPP: Apremilast was superior to placebo for PPPGA 0/1 and PPPASI 50 at week 16 and showed comparable PPPASI 50 outcomes to methotrexate.
- Psoriatic Arthritis (PsA): Apremilast was associated with a higher occurrence of gastrointestinal adverse events compared to placebo (RR = 1.21).
- General Psoriasis Patients with Serious Comorbidities: Real-world evidence indicated that apremilast did not increase the frequency or severity of adverse events, including among patients with chronic infections, malignancy, or serious liver, renal, psychiatric, or other diseases.
- There is no population type or subgroup information available in the reviewed studies.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Otezla (apremilast) prescribing information. | 2023 | Amgen Inc., Thousand Oaks, CA |