Halobetasol 0.01%/Tazarotene 0.045% Lotion in the Treatment of Moderate-to-Severe Plaque Psoriasis: Maintenance of Therapeutic Effect After Cessation of Therapy
August 2019 | Volume 18 | Issue 8 | Original Article | 815 | Copyright © August 2019
Linda Stein Gold MD,ª Edward Lain MD,b Lawrence J. Green MD,c Tina Lin PharmD,d Robert Israel MDe
ªHenry Ford Hospital, Detroit, MI bAustin Institute for Clinical Research, Pflugerville, TX cTemple University School, Philadelphia, PA dOrtho Dermatologics, Bridgewater, NJ eBausch Health, Bridgewater, NJ
Objective: To investigate the maintenance of effect posttreatment with a once-daily application of halobetasol propionate 0.01%/tazarotene 0.045% (HP/TAZ) lotion in comparison with vehicle in patients with moderate or severe plaque psoriasis.
Methods: Two multicenter, randomized, double-blind, vehicle-controlled Phase 3 studies in moderate or severe psoriasis (N=418). Patients randomized (2:1) to receive HP/TAZ lotion or vehicle, once-daily for 8 weeks with a 4 week posttreatment follow-up. Efficacy assessments included treatment success (defined as at least a 2-grade improvement from baseline in the IGA score, and ‘clear’ or ‘almost clear’), impact on individual signs of psoriasis (erythema, plaque elevation, and scaling) at the target lesion, and maintenance of improvements in Body Surface Area (BSA), IGAxBSA and clinically meaningful benefit (IGAxBSA-75).
Results: At week 8, 40.7% of patients achieved treatment success with HP/TAZ lotion, compared with 9.9% treated with vehicle (P<0.001). Four weeks posttreatment, 33.3% of patients achieved treatment success. Two thirds of patients (63%) who were treatment successes at week 8 remained treatment successes posttreatment. In addition, up to 20% of patients who were not treatment successes at week 8 became treatment successes by the end of the study. Three-quarters of patients maintained BSA improvements or reported further reductions in BSA that seemed to be unrelated to baseline BSA severity. At the end of the 4 week posttreatment period, patients who had been treated with HP/TAZ lotion achieved a 46.6% reduction in IGAxBSA, compared with 7.9% on vehicle. 41.7% of patients achieved a clinically meaningful effect at week 8 and this was maintained posttreatment.
Limitations: The studies only had a 4 week follow-up period.
Conclusions: In conclusion, HP 0.01%/TAZ 0.045% lotion provides effective maintenance of efficacy over a 4 week posttreatment period.
J Drugs Dermatol. 2019;18(8):815-820.