A comparison of tazarotene 0.1% gel once daily plus mometasone furoate 0.1% cream once daily versus calcipotriene 0.005% ointment twice daily in the treatment of plaque psoriasis

Background: Both tazarotene (a retinoid prodrug) and calcipotriene (a synth etic analog of vitamin D-3) are effective in the treatment of plaque psoria sis, but no reports in the literature directly compare the efficacy and tol erability of these 2 drugs. Tazarotene is commonly used in conjunction with a topical corticosteroid. In this study, tazarotene was used with mometaso ne furoate (a synthetic corticosteroid), and the 2-drug regimen was compare d with calcipotriene monotherapy. Objective: This study was conducted to compare the efficacy and tolerabilit y of tazarotene 0.1% gel once daily plus mometasone furoate 0.1% cream once daily with those of calcipotriene 0.005% ointment twice daily in the treat ment of plaque psoriasis. Methods: In this multicenter, investigator-blinded, parallel-group study, a dult patients with chronic, stable plaque psoriasis affecting 5% to 20% of their body surface area were randomly allocated to receive up to 8 weeks of treatment with either tazarotene 0.1% gel once daily (in the evening) plus mometasone furoate 0.1% cream once daily (in the morning) or calcipotriene 0.005% ointment twice daily. Patients were assessed at baseline and at wee ks 2, 4, and 8 of treatment. Patients who demonstrated complete clearance o f plaque psoriasis after 2 or 4 weeks of treatment and those whose psoriasi s had improved greater than or equal to 50% after 8 weeks of treatment ente red a 12-week posttreatment follow-up phase during which they applied only moisturizer. Patients were reassessed after 4, 8, and 12 weeks of posttreat ment follow-up. Physician-rated measures of efficacy included global improv ement, plaque elevation, scaling, erythema, and percentage of body surface area involvement. Patient-rated assessments included efficacy of study trea tment compared with previous therapies, comfort of treated skin, outlook fo r long-term control of psoriasis, and overall impression of treatment. Results: Of 120 patients with moderate to severe psoriasis enrolled from 3 centers, 106 (88%) completed the study. No significant differences in basel ine clinical variables were observed between the 2 groups. Twenty-seven pat ients (45%) in the tazarotene plus corticosteroid group achieved marked imp rovement (greater than or equal to 75% global improvement) after 2 weeks of treatment compared with 15 patients (26%) in the calcipotriene group (P le ss than or equal to 0.05). Between-group comparisons of the percentage of p atients achieving complete or almost complete clearance (greater than or eq ual to 90% global improvement) did not reach statistical significance at an y time point. When compared with the calcipotriene regimen, the tazarotene plus corticosteroid regimen resulted in significantly greater efficacy on t runk lesions in reducing plaque elevation (at the end of treatment and at w eek 4 of the posttreatment phase, P less than or equal to 0.05), scaling (w eek 4 of treatment and week 4 of the posttreatment phase, P less than or eq ual to 0.05), erythema (week 4 of treatment and at the end of treatment, P less than or equal to 0.05), and percentage of body surface area involvemen t (weeks 2 and 4 of treatment, P less than or equal to 0.01). In addition, the tazarotene plus corticosteroid regimen was significantly more effective in reducing the percentage of body surface area involvement in upper limb lesions (weeks 2 [P less than or equal to 0.05] and 4 [P less than or equal to 0.01] of treatment). Forty-two of 55 patients (76%) in the tazarotene p lus corticosteroid group rated their medication as more or much more effect ive than previous therapies compared with 30 of 52 patients (58%) in the ca lcipotriene group (P less than or equal to 0.05). Although adverse events ( burning, pruritus, irritation, and erythema) occurred in a significantly gr eater proportion of patients who received tazarotene plus corticosteroid th an in those who received calcipotriene (P less than or equal to 0.05), 47 o f 55 patients (85%) in both groups rated the comfort of their treated skin as "somewhat comfortable" or better and both groups had similar discontinua tion rates due to treatment-related adverse events (3% and 5%, respectively ). Conclusion: Tazarotene 0.1% gel once daily plus mometasone furoate 0.1% cre am once daily appears to be more efficacious than calcipotriene 0.005% oint ment twice daily in the treatment of plaque psoriasis of the trunk.