Apremilast with Add-On Calcipotriene/Betamethasone Dipropionate for Treating Moderate to Severe Plaque Psoriasis

J Drugs Dermatol. 2020 Dec 1;19(12):1149-1155. doi: 10.36849/JDD.2020.5435.

Abstract

Background: About 20% of patients taking apremilast alone obtain PASI 75 by week 8. This single-center, pilot study aimed to determine whether add-on topical therapy with calcipotriene/betamethasone dipropionate (C/BD) could improve responses of partial apremilast responders by week 12.

Methods: Adults (≥18 years of age) with moderate to severe plaque psoriasis (baseline PGA ≥3, BSA affected ≥10%, PASI ≥12) took oral apremilast (30 mg twice daily) for 8 weeks. Patients who achieved between PASI 25–74 at week 8 used add-on, daily topical C/BD (.005%/.064%) foam up to week 12; those with <PASI 25 at week 8 were discontinued.

Results: Of 50 patients enrolled, 26 achieved PASI 25−74 and 8 PASI 75 at week 8. At week 12, 29 achieved PASI 75, and 24 at week 16. Of the week-8 partial responders, 21/26 achieved PASI 75 at week 12 on combination therapy and 15 maintained PASI 75 through week 16 on apremilast alone (4 did not maintain; 2 lost to follow up). In partial responders, mean PGA and BSA affected improved by 30% and 33% on apremilast, respectively, and by 67% and 86% at week 12 on the combination therapy, respectively. The most commonly reported adverse events (AEs; >5% occurrence) were headache (14%), diarrhea (10%), and nausea (8%); majority were mild. No related serious AEs occurred.

Conclusion: We show that most week-8 partial apremilast responders can achieve PASI 75 at week 12 with combination C/BD topical therapy, and maintain PASI 75 through week 16 with apremilast monotherapy. J Drugs Dermatol. 2020;19(12): doi:10.36849/JDD.2020.5435.

Publication types

  • Clinical Trial

MeSH terms

  • Administration, Cutaneous
  • Adult
  • Aerosols
  • Aged
  • Betamethasone / administration & dosage
  • Betamethasone / adverse effects
  • Betamethasone / analogs & derivatives*
  • Calcitriol / administration & dosage
  • Calcitriol / adverse effects
  • Calcitriol / analogs & derivatives*
  • Diarrhea / chemically induced
  • Diarrhea / diagnosis
  • Diarrhea / epidemiology
  • Drug Combinations
  • Drug Therapy, Combination / adverse effects
  • Drug Therapy, Combination / methods
  • Female
  • Headache / chemically induced
  • Headache / diagnosis
  • Headache / epidemiology
  • Humans
  • Male
  • Middle Aged
  • Nausea / chemically induced
  • Nausea / diagnosis
  • Nausea / epidemiology
  • Pilot Projects
  • Psoriasis / diagnosis
  • Psoriasis / drug therapy*
  • Severity of Illness Index
  • Thalidomide / administration & dosage
  • Thalidomide / adverse effects
  • Thalidomide / analogs & derivatives*
  • Treatment Outcome
  • Young Adult

Substances

  • Aerosols
  • Drug Combinations
  • calcipotriene
  • Thalidomide
  • betamethasone-17,21-dipropionate
  • Betamethasone
  • Calcitriol
  • apremilast