title: Drug safety evaluation of apremilast for treating psoriatic arthritis.
abstract: BACKGROUND
  Apremilast is an orally available small molecule that targets PDE4. PDE4 modulates intracellular signaling and thereby can impact various proinflammatory and anti-inflammatory mediators. Apremilast has been approved by the USA FDA for the treatment of active psoriatic arthritis (PsA) and moderate-to-severe psoriasis (PsO). Although there are several therapies approved and used for the treatment of PsA, there is still an unmet need for additional effective and well-tolerated therapeutic options. In PsA clinical trials, apremilast has been shown to be efficacious and to have an acceptable safety profile.
  
  
  METHODS
  This review article covers the mechanism of action of apremilast, its efficacy in clinical trials and a detailed focus on its safety profile, mainly from Phase III clinical trials.
  
  
  CONCLUSIONS
  Based on the available literature, apremilast has proven to be an efficacious therapy for PsA and PsO. It may offer some advantage as compared to other therapeutic options given its favorable safety profile, including a lack of need for routine laboratory monitoring.
authors.affiliation: University of California San Diego, Division of Rheumatology, Allergy and Immunology , La Jolla, CA , USA sbusa@ucsd.edu.
authors.forename: Swapna
authors.initials: S
authors.lastname: Busa
authors.forename: Arthur
authors.initials: A
authors.lastname: Kavanaugh
mesh_terms: D000284:Administration, Oral; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D018501:Antirheumatic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D015535:Arthritis, Psoriatic / Q000188:drug therapy* / Q000473:pathology; D017326:Clinical Trials, Phase III as Topic; D016903:Drug Monitoring; D006801:Humans; D058988:Phosphodiesterase 4 Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011565:Psoriasis / Q000188:drug therapy / Q000473:pathology; D012720:Severity of Illness Index; D013792:Thalidomide / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D018501:Antirheumatic Agents; D058988:Phosphodiesterase 4 Inhibitors; D013792:Thalidomide; C505730:apremilast
keywords: PDE4 inhibitor; apremilast; efficacy; psoriatic arthritis; safety