Apremilast

(Otezla®)

Apremilast

Drug updated on 7/25/2024

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

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Summary
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  • 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 is derived from 24 systematic reviews and meta-analyses.
  • In treating moderate-to-severe plaque psoriasis, biologics like infliximab, bimekizumab, ixekizumab, and risankizumab were significantly more effective than apremilast in achieving PASI 90 responses.
  • For palmoplantar psoriasis/pustulosis specifically, apremilast showed superior improvement compared to placebo but had comparable efficacy to methotrexate.
  • Oral TYK2 inhibitors such as deucravacitinib demonstrated superior efficacy over apremilast in treating plaque psoriasis; however, their safety profiles were similar.
  • Long-term studies indicate that newer agents like brodalumab and secukinumab outperform apremilast at achieving significant PASI responses after one year of treatment.
  • Real-world evidence supports the safe use of apremilast in patients with serious baseline comorbidities without an increased incidence of severe adverse events.
  • Meta-analysis data show significant improvements in mucocutaneous symptoms, including a reduction in oral ulcers for Behçet's disease when treated with apremilast.

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
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