Drug updated on 4/17/2024
| 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.
Summary
- Apremilast (Otezla) is indicated for the treatment of adult patients with active psoriatic arthritis, moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, and oral ulcers associated with Behçet’s disease.
- The information was derived from 24 systematic reviews/meta-analyses focusing on apremilast's indications, efficacies, and safety profile compared to other therapies in conditions like psoriatic arthritis, plaque psoriasis, and Behçet’s disease.
- In terms of efficacy in achieving substantial clinical outcomes such as PASI 75 (75% reduction in Psoriasis Area and Severity Index score) and significant improvements in psoriatic arthritis symptoms, Otezla shows commendable efficacy but is generally outperformed by certain biologics targeting IL-17 and IL-23 pathways.
- Treatments like infliximab, ixekizumab, secukinumab have a higher efficacy than Otezla in achieving PASI 90 response rates among patients suffering from Psoriasis. However, due to its preferable safety profile with a low incidence of serious adverse events (SAEs), it remains a viable option for long-term management of these diseases.
- For treating oral ulcers associated with Behçet's disease along with specific dermatological conditions like palmoplantar pustulosis & palmoplantar psoriasis, Otezla has shown significant improvement over placebo while demonstrating comparable effectiveness against methotrexate, thus providing an alternative treatment option for challenging patient cases.
- Across all studies reviewed, Otezla exhibits a favorable safety profile, especially noteworthy amongst populations having serious comorbidities or those contraindicated for biological therapies, making it an appealing choice requiring systemic therapy without the additional burden of managing SAEs linked to some biological therapies.
- Often less effective than some biologics & TYK2 inhibitors specifically in achieving higher thresholds of PASI responses among psoriasis patients, Otezla stands out for its safety and ease of use.
- The efficacy and appropriateness of Otezla may differ based on patient subgroups; it might offer a particularly suitable option for patients with contraindications for biologics or those seeking oral treatments with a favorable safety profile.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Otezla (apremilast) prescribing information. | 2023 | Amgen Inc., Thousand Oaks, CA |