The efficacy, tolerability and safety of a new oral formulation of Sandimmun®-Sandimmun Neoral® in severe refractory atopic dermatitis

Aim To investigate the efficacy, tolerability and safety of a new oral formulation of Sandimmun(R)-Sandimmun Neoral(R) in severe refractory atopic dermatitis in an open, multicenter study. Methods The study was conducted in three parts. After 2 weeks of screening, Sandimmun Neoral(R) was commenced at a dose of 3 mg/kg per day and continued until remission or for a maximum of 8 weeks, after which the dose was reduced by half and continued for another 2 weeks and then discontinued. After the treatment period, patients were followed up first for 8 weeks and then until relapse or for a maximum of 24 weeks. Subjects Twenty-three patients with severe refractory atopic dermatitis (15 females, eight males) mean age 27.2 +/- 14.6 years (range 13-70 years) entered and 22 patients completed the study (one drop-out due to withdrawal of consent). Results After the end of the full-dose (mean duration 6.5 weeks) and half dose treatment periods, the SCORAD index decreased by 82 and 90%, respectively. Improvement started as early as at 2 and 4 weeks of treatment (mean reduction in SCORAD: 37.5 and 71.7%). At the end of the treatment phase, reductions in EDS, intensity of disease, DSS, pruritus, and sleep loss were 85, 88, 79, 85 and 96%, respectively. The overall efficacy was assessed as very good or good in 96 and 100% of the patients at the end of treatment and after 8 weeks follow-up, respectively. During the follow-up of 24 weeks alter treatment, 73% of the patients had a relapse, whereas 27% were still in remission at the end of 24 weeks. In the 22 patients who completed the study, no adverse events were noted which would have necessitated dose reduction or drug withdrawal. Tolerability was assessed as very good or good in 91 and 96% of the patients, at the end of treatment and after 8 weeks follow-up, respectively. Adverse events observed were: nausea (18%), hirsutism (9%), headache (4.5%), epigastric pain (4.5%), paresthesia (4.5%), furuncle (4.5%), and herpes labialis (4.5%). No significant changes in vital signs, hematological and biochemical parameters and serum creatinine were observed during the study except eosinophilia which was reduced by 40% towards the end of treatment. Conclusions Our results suggested that short-term (8 weeks), low dose (3 mg/kg per day) Sandimmun Neoral(R) treatment is an effective, safe, and well-tolerated treatment for atopic dermatitis refractory to conventional treatment modalities and can lead to long-term remission of the disease in some patients. However,a double-blind, placebo controlled, long-term follow-up study would be necessary to confirm these results. (C) 1998 Elsevier Science B.V. All rights reserved.