title: Clobetasol propionate spray 0.05% add-on therapy to a stable regimen of biologic treatment in patients with moderate to very severe plaque psoriasis.
abstract: Moderate to severe psoriasis often requires systemic treatment, but even biologic medications do not always induce complete clearing in patients. In many instances, physicians supplement biologic treatment with topical agents as adjunctive therapy to obtain additional clearing of plaques. To evaluate the effectiveness of the addition of a superpotent corticosteroid--clobetasol propionate spray 0.05%--to various psoriasis treatments, a phase 4, multicenter, open-label, community-based trial was conducted. In this study, clobetasol propionate spray 0.05% applied twice daily was added on to a variety of existing stable treatments including systemic biologic agents in participants with moderate, severe, or very severe plaque psoriasis. The decision to add clobetasol propionate spray 0.05% to stable psoriasis therapy was determined by each investigator based on his/her evaluation of a participant's needs. A total of 159 participants from the trial adhered to stable (> or = 3 months' duration) therapeutic regimens that included a biologic treatment. In this population, at the end of the study period, 81.0% of participants with moderate disease at baseline, 79.5% of participants with severe disease at baseline, and 58.8% of participants with very severe disease at baseline were rated as clear or almost clear (target plaque severity [TPS]). Worst skin tolerability response was assessed postbaseline and included erythema (20.3% mild, 8.9% moderate, 1.9% severe), peeling (26.6% mild, 7.0% moderate, 1.3% severe), dryness (34.8% mild, 8.9% moderate, 1.3% severe), and stinging (25.3% mild, 3.8% moderate, 0.6% severe). Telangiectasia and skin atrophy were reported in 1.3% of participants each at some point during the study (postbaseline). Pruritus was reported in 7.6% of participants and folliculitis was reported in 1.9% of participants. Eight participants experienced adverse events (AEs) that were regarded as probably related to the study medication (clobetasol propionate spray 0.05%). Because those participants who entered the study already were receiving one medication (the biologic agent), it is believed that most of the reported AEs were due to the addition of clobetasol propionate spray 0.05%, and those AEs associated with the biologic agent and/or the combination of the two may be underreported. Although the results of this study are intriguing, further research is needed to evaluate if the addition of topical therapies, such as superpotent corticosteroids, are effective and safe options for treating psoriasis plaques when control with biologic therapy is not fully effective on its own.
authors.affiliation: Center for Dermatology Research, Department of Dermatology, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA.
authors.forename: Steven R
authors.initials: SR
authors.lastname: Feldman
authors.forename: John Y M
authors.initials: JY
authors.lastname: Koo
authors.forename: Lori A
authors.initials: LA
authors.lastname: Johnson
authors.forename: Norman J
authors.initials: NJ
authors.lastname: Preston
mesh_terms: D000279:Administration, Cutaneous; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001688:Biological Products / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002990:Clobetasol / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011565:Psoriasis / Q000188:drug therapy* / Q000503:physiopathology; D011788:Quality of Life; D012720:Severity of Illness Index; D055815:Young Adult
chemical_list: D000893:Anti-Inflammatory Agents; D001688:Biological Products; D002990:Clobetasol