Thirty-four patients (16 men and 18 women) with severe or refractory AA were enrolled in this study. Their mean age was 28.1 years (range: 6-54 years) and the duration of the disease ranged from 6 months to 16 years.
The extent of AA was evaluated in accordance with the National Alopecia Areata Foundation guidelines: S0: no hair loss, S1: <25% hair loss, S2: 26-50% hair loss, S3: 51-75% hair loss, S4: 76-99% hair loss, alopecia totalis (AT): total scalp hair loss and alopecia universalis (AU): total scalp and body hair loss. Of the 34 patients, eight had AU and seven had alopecia totalis/universalis (AT/ AU), which is defined as alopecia totalis with various degrees of body hair loss, 16 patients had patchy AA involving more than 50% of the scalp (S3: 8, S4: 7), one had involvement of less than 50% of the scalp (S2: 2) and two had ophiasis. None of the patients had previously responded to conventional treatments at least 6 months follow- up.
CsA was started at a dose of 2.5 to 5 mg/kg/day and methyl prednisone was started at a dose of 20 to 24 mg/day. The dose of methyl prednisone was subsequently tapered to 4 mg/day for 3 weeks, and then the methyl prednisone was maintained at a dose of 2 to 4 mg/day, according to the treatment response.
Evaluation of efficacy
All the patients were monitored on a monthly basis during the 24 weeks. Each patient was photographed at baseline and at 1, 3 and 6 months of treatment.
The responders were defined as the patients who recovered more than 50% of hair regrowth, while poor responders had less than 50% of regrowth. The responders were subclassified into cosmetically acceptable responders, and these were defined as patients with 75 to 100% hair regrowth, and satisfactory responders had 50 to 74% hair regrowth.
Monitoring of the trough CsA concentration and the laboratory data
To estimate the therapeutic concentration of CsA, blood samples were collected immediately before the oral administration of CsA and then they were analyzed. The initial trough concentration of CsA was measured 2 weeks after initiating the treatment, and the maintenance trough concentration was measured 1, 3 and 6 months after beginning the treatment. Blood pressure, complete blood counts, serum transaminase, blood urea nitrogen, creatinine, direct bilirubin and urinalysis were checked at 1, 3, and 6 months to evaluate the side effects associated with CsA and corticosteroid combination therapy. buy cialis soft tabs
Statistical analysis was performed using SAS version 9.1.3 (SAS Institute, Cary, NC, USA). The chi-square test was used to compare the trough concentrations of CsA between the responders and poor responders and between the groups with and without side effects.