title: Treatment of chronic idiopathic urticaria and positive autologous serum skin test with cyclosporine: clinical and immunological evaluation.
abstract: This study evaluates the effectiveness and safety of cyclosporine (CsA) in the treatment of patients with chronic idiopathic urticaria with a positive autologous serum skin test (ASST), who fail to respond to conventional therapy, and requiring long-term oral steroid treatment. In a double-blind study, 40 adults were assigned randomly to receive CsA (5 mg/kg per day for 8 weeks and then 4 mg/kg per day for 8 weeks) or cetirizine (10 mg/day) and then they were followed up for 9 months. After 2 weeks, the study was opened because 16 patients (40%) had daily severe relapses requiring systemic steroids treatment. All of these patients had been receiving antihistamines and, therefore, all patients also were assigned to the CsA treatment regimen (5 mg/kg per day for 8 weeks and then 4 mg/kg per day for 8 weeks). The ASST and clinical severity score were evaluated before and after treatment. All of the 40 patients completed the 16-week CsA course without dropping out because of relevant side effects. In three patients, CsA was reduced by 0.5 mg/kg per day after the 1st month of treatment for a mild and reversible increase in serum creatinine. During CsA treatment, 20 patients had relapses resolving spontaneously (8 patients) or with antihistamines (12 patients). During the 9-month follow-up period, 22 patients had relapses resolving spontaneously (10 patients) or with antihistamines (12 patients). Only two patients failed to complete the study because of severe symptoms occurring after 4 and 7 days of follow-up and requiring long-term steroid treatment. After 9 months of follow-up, 16 patients were still in full remission. The clinical severity score of chronic idiopathic urticaria dropped significantly by the end of the 4th month of treatment (p = 0.002) as well as by the completion of follow-up (p = 0.007). The ASST was negative in 13 patients and positive in 3 of 16 patients, with total remission of symptoms. Significant score reduction also was observed in patients experiencing relapses that resolved spontaneously (p = 0.005) or with antihistamines (p = 0.03). These results show the long-term efficacy and tolerability of CsA in patients with severe chronic idiopathic urticaria, unresponsive to conventional treatments.
authors.affiliation: IRCCS San Gallicano, Roma, Italy.
authors.forename: Mario
authors.initials: M
authors.lastname: Di Gioacchino
authors.forename: Fabio
authors.initials: F
authors.lastname: Di Stefano
authors.forename: Enrico
authors.initials: E
authors.lastname: Cavallucci
authors.forename: Nicola
authors.initials: N
authors.lastname: Verna
authors.forename: Stefania
authors.initials: S
authors.lastname: Ramondo
authors.forename: Franco
authors.initials: F
authors.lastname: Paolini
authors.forename: Riccardo
authors.initials: R
authors.lastname: Caruso
authors.forename: Cosima
authors.initials: C
authors.lastname: Schiavone
authors.forename: Silvio
authors.initials: S
authors.lastname: Masci
authors.forename: Bartolomeo
authors.initials: B
authors.lastname: Santucci
authors.forename: Roberto
authors.initials: R
authors.lastname: Paganelli
authors.forename: Pio
authors.initials: P
authors.lastname: Conti
mesh_terms: D000328:Adult; D002908:Chronic Disease; D016572:Cyclosporine / Q000009:adverse effects / Q000627:therapeutic use*; D003879:Dermatologic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D012882:Skin Tests; D014581:Urticaria / Q000097:blood / Q000188:drug therapy*
chemical_list: D003879:Dermatologic Agents; D016572:Cyclosporine