title: Combined treatment with low-dose cyclosporine and calcipotriol/betamethasone dipropionate ointment for moderate-to-severe plaque psoriasis: a randomized controlled open-label study.
abstract: Combination therapy is a common approach to psoriasis, aimed at improving clinical response and minimizing the risk of side effects. The aim of this pilot randomized open-label study was to evaluate the efficacy and safety of the combination of low-dose cyclosporine (CsA) with calcipotriol-betamethasone dipropionate (CBD) ointment in the treatment of psoriasis. Sixty patients with moderate-to-severe plaque psoriasis were randomized to receive CsA, 2 mg/kg/day, combined with CBD ointment (n = 30) or CsA, at the same daily dosage, in combination with an emollient (n = 30), for 8 weeks. The primary efficacy parameter was the Psoriasis Area and Severity Index (PASI) 75 response rate at 8 weeks. Combination therapy with CsA and CBD ointment was more effective than CsA and emollient treatment, with statistically significant results, particularly less itching after 4 and 8 weeks and PASI reduction at all post-baseline visits. Significantly more patients treated with CsA + CBD achieved the PASI 75 at 8th week (87% vs 37% in the CsA-emollient group; p = 0.0001). The efficacy results were paralleled by the investigator and patient's global assessment of disease severity at the end of study. Our results suggest that the addition of CBD ointment to low-dose CsA enhances clinical response and improves the risk/benefit ratio.
authors.affiliation: 2nd Dermatology Clinic, University of Bari, Bari, Italy. g.vena@dermatologia.uniba.it
authors.forename: Gino A
authors.initials: GA
authors.lastname: Vena
authors.forename: Antonia
authors.initials: A
authors.lastname: Galluccio
authors.forename: Michele
authors.initials: M
authors.lastname: Pezza
authors.forename: Michelangelo
authors.initials: M
authors.lastname: Vestita
authors.forename: Nicoletta
authors.initials: N
authors.lastname: Cassano
mesh_terms: D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use*; D001623:Betamethasone / Q000031:analogs & derivatives* / Q000627:therapeutic use; D002117:Calcitriol / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016572:Cyclosporine / Q000627:therapeutic use*; D003879:Dermatologic Agents / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009824:Ointments / Q000627:therapeutic use; D010865:Pilot Projects; D011565:Psoriasis / Q000188:drug therapy*; D012720:Severity of Illness Index; D055815:Young Adult
chemical_list: D000893:Anti-Inflammatory Agents; D003879:Dermatologic Agents; D009824:Ointments; C055085:calcipotriene; C011175:betamethasone-17,21-dipropionate; D016572:Cyclosporine; D001623:Betamethasone; D002117:Calcitriol