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 synthetic analog of vitamin D-3) are effective in the treatment of plaque psoriasis, but no reports in the literature directly compare the efficacy and tolerability of these 2 drugs. Tazarotene is commonly used in conjunction with a topical corticosteroid. In this study, tazarotene was used with mometasone furoate (a synthetic corticosteroid), and the 2-drug regimen was compared with calcipotriene monotherapy. Objective: This study was conducted to compare the efficacy and tolerability 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 treatment of plaque psoriasis. Methods: In this multicenter, investigator-blinded, parallel-group study, adult 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 weeks 2, 4, and 8 of treatment. Patients who demonstrated complete clearance of plaque psoriasis after 2 or 4 weeks of treatment and those whose psoriasis had improved greater than or equal to 50% after 8 weeks of treatment entered a 12-week posttreatment follow-up phase during which they applied only moisturizer. Patients were reassessed after 4, 8, and 12 weeks of posttreatment follow-up. Physician-rated measures of efficacy included global improvement, plaque elevation, scaling, erythema, and percentage of body surface area involvement. Patient-rated assessments included efficacy of study treatment compared with previous therapies, comfort of treated skin, outlook for 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 baseline clinical variables were observed between the 2 groups. Twenty-seven patients (45%) in the tazarotene plus corticosteroid group achieved marked improvement (greater than or equal to 75% global improvement) after 2 weeks of treatment compared with 15 patients (26%) in the calcipotriene group (P less than or equal to 0.05). Between-group comparisons of the percentage of patients achieving complete or almost complete clearance (greater than or equal to 90% global improvement) did not reach statistical significance at any time point. When compared with the calcipotriene regimen, the tazarotene plus corticosteroid regimen resulted in significantly greater efficacy on trunk lesions in reducing plaque elevation (at the end of treatment and at week 4 of the posttreatment phase, P less than or equal to 0.05), scaling (week 4 of treatment and week 4 of the posttreatment phase, P less than or equal 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 involvement (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 plus corticosteroid group rated their medication as more or much more effective than previous therapies compared with 30 of 52 patients (58%) in the calcipotriene group (P less than or equal to 0.05). Although adverse events (burning, pruritus, irritation, and erythema) occurred in a significantly greater proportion of patients who received tazarotene plus corticosteroid than in those who received calcipotriene (P less than or equal to 0.05), 47 of 55 patients (85%) in both groups rated the comfort of their treated skin as somewhat comfortable or better and both groups had similar discontinuation rates due to treatment-related adverse events (3% and 5%, respectively). Conclusion: Tazarotene 0.1% gel once daily plus mometasone furoate 0.1% cream once daily appears to be more efficacious than calcipotriene 0.005% ointment twice daily in the treatment of plaque psoriasis of the trunk.