title: A phase 2, open-label, investigator-initiated study to evaluate the safety and efficacy of apremilast in subjects with recalcitrant allergic contact or atopic dermatitis.
abstract: OBJECTIVE
  Evaluate the efficacy and safety of apremilast, a novel phosphodiesterase 4 (PDE4) inhibitor, in subjects with recalcitrant moderate to severe atopic dermatitis (AD) or allergic contact dermatitis (ACD).
  
  
  METHODS
  This was a proof-of-concept, phase 2, open-label, single institution trial that evaluated the efficacy and safety of apremilast, 20 mg twice daily, for twelve weeks, in ten subjects with either AD and/or ACD. The primary endpoint was a ?2 point improvement in Investigator Global Assessment (IGA) score after 12 weeks of treatment. Secondary endpoints included a 75% reduction in the Eczema Assessment Severity Index (EASI-75), EASI-50, and the maximum EASI response.
  
  
  RESULTS
  The primary endpoint of improvement in IGA by two or more points was met by 20% of subjects. Ten percent of subjects achieved EASI-75 and another 10% reached EASI-50. All subjects tolerated apremilast well with no serious adverse events or withdrawal due to side effects. Common adverse events associated with apremilast included headache, nausea, and soft stool.
  
  
  CONCLUSIONS
  This study was limited by its small sample size and lack of a comparison group to serve as a control.
  
  
  CONCLUSIONS
  Apremilast was well tolerated in all subjects. Apremilast was minimally effective in AD and ACD and results were inferior to previous trials of apremilast in psoriasis.
authors.affiliation: Tufts University School of Medicine, Boston, MA, USA. evolf01@gmail.com
authors.forename: Eva M
authors.initials: EM
authors.lastname: Volf
authors.forename: Shiu-Chung
authors.initials: SC
authors.lastname: Au
authors.forename: Nicole
authors.initials: N
authors.lastname: Dumont
authors.forename: Pamela
authors.initials: P
authors.lastname: Scheinman
authors.forename: Alice B
authors.initials: AB
authors.lastname: Gottlieb
mesh_terms: D000328:Adult; D000368:Aged; D017449:Dermatitis, Allergic Contact / Q000188:drug therapy* / Q000473:pathology; D003876:Dermatitis, Atopic / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D058988:Phosphodiesterase 4 Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D012720:Severity of Illness Index; D013792:Thalidomide / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D058988:Phosphodiesterase 4 Inhibitors; D013792:Thalidomide; C505730:apremilast