Apremilast

(Otezla®)

Apremilast

Drug updated on 4/17/2024

Dosage FormTablet (oral; 10 mg, 20 mg, 30 mg)
Drug ClassPhosphodiesterase 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

loading GIF

Summary
This AI-generated content is provided without warranty, with no liability accepted for reliance on it. Learn more.

  • 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 TitleYearSource
Otezla (apremilast) prescribing information.2023Amgen Inc., Thousand Oaks, CA

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis. 2023Cochrane Database of Systematic Reviews
Apremilast in palmoplantar psoriasis and palmoplantar pustulosis: a systematic review and meta-analysis.2023Dermatology and Therapy
Oral small-molecule tyrosine kinase 2 and phosphodiesterase 4 inhibitors in plaque psoriasis: a network meta-analysis2023Frontiers in Immunology
The efficacy and safety of tyrosine kinase 2 inhibitor deucravacitinib in the treatment of plaque psoriasis: a systematic review and meta-analysis of randomized controlled trials2023Frontiers in Medicine
Time to relapse after discontinuing systemic treatment for psoriasis: a systematic review.2022American Journal of Clinical Dermatology
Targeted therapies for patients with moderate-to-severe psoriasis: a systematic review and network meta-analysis of PASI response at 1 year. 2022Journal of Dermatological Treatment
Biologics and small molecule inhibitors for treating hidradenitis suppurativa: a systematic review and meta-analysis.2022Biomedicines
Apremilast in psoriasis patients with serious comorbidities: a case series and systematic review of literature.2022Dermatology Practical & Conceptual
Combination therapy with apremilast and biologics for psoriasis: a systematic review.2022American Journal of Clinical Dermatology
Systematic review of newer agents for the management of alopecia areata in adults: Janus kinase inhibitors, biologics and phosphodiesterase-4 inhibitors.2022Journal of the European Academy of Dermatology & Venereology
Efficacy and safety of apremilast monotherapy in moderate-to-severe plaque psoriasis: a systematic review and meta-analysis.2022Dermatologic Therapy
Beneficial effects of apremilast on genital ulcers, skin lesions, and arthritis in patients with Behçet's disease: a systematic review and meta-analysis.2022Modern Rheumatology
Efficacy and safety profile of phosphodiesterase 4 inhibitor in the treatment of psoriasis: a systematic review and meta-analysis of randomized controlled trials.2022Frontiers in immunology
Effect of baseline disease severity on achievement of treatment target with apremilast: results from a pooled analysis. 2021Journal of the European Academy of Dermatology and Venereology
Assessment report: Otezla. 2020EMA
Therapeutic options for patients with rare rheumatic diseases: a systematic review and meta-analysis.2020Orphanet Journal of Rare Diseases
Comparability of European League Against Rheumatology-recommended pharmacological treatments of oral ulcers associated with Behçet’s disease: a systematic literature review of randomized controlled trials.2020Open Access Rheumatology: Research and Reviews
Biologics and small molecules in patients with scalp psoriasis: a systematic review.2020Journal of Dermatological Treatment
Efficacy and safety of biologics in psoriatic arthritis: a systematic literature review and network meta-analysis. 2020Rheumatic & Musculoskeletal Diseases Open
Systematic literature review of non-topical treatments for early, untreated (systemic therapy naïve) psoriatic disease: a GRAPPA initiative.2020Rheumatology Advances in Practice
Comparative efficacy and safety of targeted DMARDs for active psoriatic arthritis during induction therapy: a systematic review and network meta-analysis.2019Seminars in Arthritis and Rheumatism
Time until onset of action when treating psoriatic arthritis: meta-analysis and novel approach of generating confidence intervals.2019Rheumatology International
Long-term efficacy of novel therapies in moderate-to-severe plaque psoriasis: a systematic review and network meta-analysis of PASI response.2019Journal of the European Academy of Dermatology and Venereology
Comparison of the efficacy and safety of tofacitinib and apremilast in patients with active psoriatic arthritis: a Bayesian network meta-analysis of randomized controlled trials. 2019Clinical Drug Investigation
Comparative efficacy and safety of targeted DMARDs for active psoriatic arthritis during induction therapy: a systematic review and network meta-analysis.2019Seminars in Arthritis and Rheumatism

Clinical Practice Guidelines