Long-term efficacy and safety of cyclosporin in severe adult atopic dermatitis

Abstract

A prospective, open, multicentre study was performed to investigate the efficacy and safety of long-term treatment with cyclosporin in adults with severe atopic dermatitis. Subjects were treated for a maximum of 48 weeks. For the first 8 weeks, cyclosporin was administered at 2.5 mg/kg per day. The dose was then adjusted according to response. Disease activity was monitored using the six-area, six-sign score and the proportion of skin involved. Pruritus and sleep disturbance were assessed using four-point scales. Response was further evaluated on a five-point scale. Adverse events, blood pressure and serum biochemistry were monitored. Tolerability was assessed on a five-point scale. One hundred subjects were enrolled and 65 completed 48 weeks of treatment. Withdrawals occurred due to remission (three), inadequate response (seven), protocol violations (11) and adverse events (14, of which seven were probably treatment related). Cyclosporin produced rapid and highly significant improvements in all indices of disease activity. Sixty-five subjects considered that they had shown a considerable improvement or complete clearance of disease. Most patients relapsed after cessation of treatment, but neither signs nor symptoms had returned to baseline severity 8 weeks later. Blood pressure and serum creatinine levels increased slightly, and in one subject renal impairment was a major factor contributing to withdrawal of the drug. Overall, 85 subjects rated the tolerability of cyclosporin as good or very good. The results indicate that cyclosporin has a place in the long-term treatment of severe atopic dermatitis provided that appropriate patients are selected and careful monitoring is performed.

Health Outcome Measures in Atopic Dermatitis: A Systematic Review of Trends in Disease Severity and Quality-of-Life Instruments 1985–2010

“…SASSAD does not assess subjective symptoms. The SASSAD is sensitive to changes in topical steroid requirements, pruritus, and sleep loss [30], [31], [32], [33], [34]. In a small reliability study involving 6 patients, there was interobserver variation for dryness and lichenification [35].…”

Efficacy and tolerability of three different doses of oral pimecrolimus in the treatment of moderate to severe atopic dermatitis: a randomized controlled trial

“…Further studies will be required to confirm the absence of long-term nephrotoxicity and to allow comparisons with ciclosporin. 17,18 While statistical significance was not achieved at week 13, the sample size at this time point was not sufficiently large to draw firm conclusions. The apparent reduction in the efficacy of oral pimecrolimus treatment is further weakened by the fact that data from 13 patients were censored at week 7 due to an IVR system error.…”

Treatment of moderate-to-severe atopic eczema in adults within the U.K.: results of a national survey of dermatologists

“…It should be used only for a limited period (the British National Formulary recommends 2 months maximum) because prolonged use is associated with hypertension, renal impairment and risk of cancer. [6][7][8][9][10][11] In 2000 a systematic review 12 highlighted the lack of therapeutic options for patients with refractory atopic eczema and underscored the need for robust testing of a range of treatments for the disease. Investigators responded with clinical trials assessing a variety of modalities of phototherapy and a number of systemic agents, often adapted from use in other autoimmune and inflammatory conditions.…”