Apremilast (Otezla)
At the 2018 meeting of the American Academy of Dermatology, Dr. Kavanaugh presented 5-year outcomes of the open-label extension of the 504-patient, phase 3 PALACE-1 trial. In an as-observed analysis, patients on apremilast 30 mg b.i.d. up to week 260 had a 71.7% ACR20 response rate, a 48.6% ACR50 response rate, and a 28.4% ACR70 response. Eighty percent of patients on the oral phosphodiesterase-4 (PDE-4) inhibitor had a dactylitis count of 0, and 54.5% had a Maastricht Ankylosing Spondylitis Enthesitis Score of 0.
In a report from the 219-patient, phase 3B ACTIVE trial, investigators showed that biologic-naive patients randomized to apremilast at 30 mg b.i.d. had a significantly greater ACR20 response as early as week 2, which was the first assessment. At that point, the ACR20 rate was 16.4% with apremilast, compared with 6.4% in placebo-treated controls. The apremilast group also demonstrated significant early improvements in patient-reported outcomes, including the Health Assessment Questionnaire-Disability Index, morning stiffness, and enthesitis severity.
The primary outcome, the ACR20 rate at week 16, was 38.2% with active treatment versus 20.2% in controls (Ann Rheum Dis. 2018 Jan 17. doi: 10.1136/annrheumdis-2017-211568).