ABSTRACT
Objective: To explore the impact of adding apremilast to a regimen of topical corticosteroids in patients with moderate plaque-type psoriasis. Research Design and Methods: This was an open label, 16-week study of apremilast in combination with topical steroids with a 4-week follow up off-treatment. Twenty qualified subjects were enrolled. Assessments included investigators assessments: sPGA, PASI, BSA; and subject assessments: DLQI, pruritis, and TSQM-2 (treatment satisfaction questionnaire). The primary efficacy measure was mean change and mean percent change in product of BSA (%) x sPGA at week 16 compared to baseline. Assessments were made at baseline (week 0), week 4, week 8, week 16, and week 20. Results: There was a statistically significant improvement in the mean change and mean percent change from baseline in product of sPGA x BSA at week 16, compared to baseline. Mean and median reductions in BSA achieved statistical significance by week 8. By week 16, there was a 36% improvement in median BSA from baseline (P=.006). The proportion of patients achieving PASI-50 at weeks 8 and 16 was 15% and 40%, respectively. Thirty percent of subjects achieved PASI-75 at week 16. Subject quality of life was statistically significantly improved from baseline at weeks 8 and 16, as evidenced by deceases in DLQI scores. Reductions in pruritus were evident at week 4 and achieved statistical significance at week 8. Two of the four domains of the TSQM domains achieved statistical significance by week 4 and through week 20. A total of 34 adverse events were reported in 17 subjects, the majority of the events were related to the gastrointestinal system and determined to be related to the study medication. Conclusion: The addition of apremilast for subjects with moderate plaque-type psoriasis, who are not satisfied by topical treatment alone, produced a statistically significant improvement in the improvement of their disease despite experienced adverse events. J Drugs Dermatol. 2019;18(4):336-340.
