Drug updated on 9/4/2024
Dosage Form | Tablet (oral; 10 mg, 20 mg, 30 mg) |
Drug Class | Phosphodiesterase 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.
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Summary
- Otezla (apremilast) is indicated for the treatment of adult patients with active psoriatic arthritis, for the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, and for the treatment of adult patients with oral ulcers associated with Behçet’s disease.
- This summary is based on the review of 24 systematic review(s)/meta-analysis(es). [1-24]
- Apremilast showed significant efficacy in psoriasis treatment, with notable improvements in PASI 75, PASI 90, and PASI 100 scores compared to placebo, though it was less effective than biologics such as infliximab, bimekizumab, ixekizumab, and risankizumab.
- In palmoplantar psoriasis, apremilast demonstrated superior efficacy over placebo in achieving PPPGA 0/1 and PPPASI 50 at 16 weeks, with comparable outcomes to methotrexate.
- Comparative studies indicated that apremilast was less effective than deucravacitinib and ropsacitinib in terms of PASI and PGA response rates, with deucravacitinib showing higher efficacy in achieving PASI 75, sPGA 0/1, PASI 90, PASI 100, and DLQI 0/1.
- In Behçet's disease, apremilast significantly improved mucocutaneous and articular symptoms, particularly in oral ulcers, while in hidradenitis suppurativa, it did not show significant improvement in achieving HiSCR compared to placebo.
- Apremilast demonstrated a generally acceptable safety profile, with no significant increase in serious adverse events (SAEs) compared to placebo. However, the incidence of adverse events (AEs) was higher with apremilast 30 mg BID than placebo, with gastrointestinal issues being the most common, typically mild to moderate in severity.
- In a review of combination therapy with apremilast and biologics, one serious adverse event (hospitalization due to weight loss) was reported, though most adverse events were mild. No significant differences in the incidence of SAEs were observed between apremilast and other treatments like methotrexate and biologics.
- Apremilast was found to be safe in patients with serious baseline comorbidities, including chronic infections, history of malignancy, and severe hepatic or renal diseases, with no increased frequency or severity of adverse events or reduced drug efficacy noted.
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Otezla (apremilast) prescribing information. | 2023 | Amgen Inc., Thousand Oaks, CA |