Apremilast

(Otezla®)

Otezla®

Drug updated on 9/4/2024

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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  • 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 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

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