Abstract:Our data confirm that CSA is efficacious and acts rapidly in the majority of children with severe AD. CSA therapy can provide sustained remission in some patients. CSA seems to be well tolerated in children, but strict monitoring is mandatory.
“…Zaki used the highest dosing of the pediatric trials, at 5‐6 mg/kg, followed by Harper and Berth‐Jones with 5 mg/kg daily, titrated to clinical response. Hernandez‐Martin used a mean initial dose of 4.3 mg/kg. Sarıcaoğlu and Bunikowski used 2.5‐5 mg/kg daily and 2.5 mg/kg, respectively, initially, also titrated to clinical response, and Garrido Colmenero used weekend dosing—5 mg/kg given Saturday and Sunday only.…”
Section: Resultsmentioning
confidence: 99%
“…Berth‐Jones, Sarıcaoğlu, and Garrido Colmenero all reported no incidence of clinically significant creatinine rise, while Harper, Yee, and Zaki reported 9.3%, 7%, and 5%, respectively. El‐Khalawany reported that 15% of participants developed renal dysfunction; Bunikowski reported 10% had a rise in creatinine (not otherwise defined); and in Hernandez‐Martin's cohort, 3% had a transient rise in urea nitrogen.…”
Section: Resultsmentioning
confidence: 99%
“…The nephrotoxic effects of cyclosporine have been reported to occur less frequently in children; in ten trials assessing pediatric atopic dermatitis, there were only 16 cases of renal dysfunction in 318 patients (5%) . There is limited evidence regarding long‐term use of cyclosporine in pediatric populations, with the mean duration of treatment in most of these trials ranging from 6 to 20 weeks.…”
Section: Introductionmentioning
confidence: 99%
“…There is limited evidence regarding long‐term use of cyclosporine in pediatric populations, with the mean duration of treatment in most of these trials ranging from 6 to 20 weeks. Three trials extended this to 15, 21.6, and 37.6 months; however, the number of patients with prolonged follow‐up was limited and mean duration of treatment in Sibbald and Yee was 10.2 and 10.4 months, respectively. Hernandez‐Martin reported a median treatment period of 4.6 months.…”
Section: Introductionmentioning
confidence: 99%
“…To date, there have been no published systematic reviews that examine cyclosporine trough level monitoring in the pediatric atopic dermatitis. In ten trials assessing cyclosporine use in pediatric atopic dermatitis patients, only two performed serological cyclosporine levels . A previous systematic review on the short‐term use of cyclosporine in adult psoriasis patients suggested no monitoring was required for dosing at or below 3 mg/kg daily .…”
Background
Cyclosporine is a useful immunosuppressive agent for achieving disease control in moderate to severe atopic dermatitis in children and adults. However, it carries the potential for nephrotoxicity. Monitoring of drug levels is performed in other patient groups, such as transplant recipients, but is not commonplace in the management of atopic dermatitis.
Objectives
To investigate levels of nephrotoxicity associated with cyclosporine use in atopic dermatitis and assess potential correlation with trough levels of cyclosporine.
Methods
An electronic search was conducted on MEDLINE, EMBASE, and Cochrane databases for randomized controlled trials and cohort studies assessing the safety profile of cyclosporine compared to placebo or other atopic dermatitis treatments, in adult and pediatric atopic dermatitis patients from 1966 to May 2019. Studies that did not assess renal toxicity were excluded from analysis.
Results
Thirty‐eight trials were included for analysis, excluding 11 that did not assess renal toxicity. Descriptive statistical analysis only was performed, due to the high heterogeneity between study methodologies. Significant renal toxicity was seen in 0%‐9% of pediatric participants. Monitoring of trough cyclosporine levels was performed in only 10 of the studies, and their correlation to toxicity or disease activity was not explored.
Conclusion
There is limited evidence in atopic dermatitis regarding trough level monitoring of cyclosporine. Currently, the practice is not commonplace, particularly in pediatrics, and this is reflected in trial methodology. Monitoring may be useful in specific pediatric groups, such as those on multiple concurrent medications, patients with hepatic or renal dysfunction and non‐responders to therapy.
“…Zaki used the highest dosing of the pediatric trials, at 5‐6 mg/kg, followed by Harper and Berth‐Jones with 5 mg/kg daily, titrated to clinical response. Hernandez‐Martin used a mean initial dose of 4.3 mg/kg. Sarıcaoğlu and Bunikowski used 2.5‐5 mg/kg daily and 2.5 mg/kg, respectively, initially, also titrated to clinical response, and Garrido Colmenero used weekend dosing—5 mg/kg given Saturday and Sunday only.…”
Section: Resultsmentioning
confidence: 99%
“…Berth‐Jones, Sarıcaoğlu, and Garrido Colmenero all reported no incidence of clinically significant creatinine rise, while Harper, Yee, and Zaki reported 9.3%, 7%, and 5%, respectively. El‐Khalawany reported that 15% of participants developed renal dysfunction; Bunikowski reported 10% had a rise in creatinine (not otherwise defined); and in Hernandez‐Martin's cohort, 3% had a transient rise in urea nitrogen.…”
Section: Resultsmentioning
confidence: 99%
“…The nephrotoxic effects of cyclosporine have been reported to occur less frequently in children; in ten trials assessing pediatric atopic dermatitis, there were only 16 cases of renal dysfunction in 318 patients (5%) . There is limited evidence regarding long‐term use of cyclosporine in pediatric populations, with the mean duration of treatment in most of these trials ranging from 6 to 20 weeks.…”
Section: Introductionmentioning
confidence: 99%
“…There is limited evidence regarding long‐term use of cyclosporine in pediatric populations, with the mean duration of treatment in most of these trials ranging from 6 to 20 weeks. Three trials extended this to 15, 21.6, and 37.6 months; however, the number of patients with prolonged follow‐up was limited and mean duration of treatment in Sibbald and Yee was 10.2 and 10.4 months, respectively. Hernandez‐Martin reported a median treatment period of 4.6 months.…”
Section: Introductionmentioning
confidence: 99%
“…To date, there have been no published systematic reviews that examine cyclosporine trough level monitoring in the pediatric atopic dermatitis. In ten trials assessing cyclosporine use in pediatric atopic dermatitis patients, only two performed serological cyclosporine levels . A previous systematic review on the short‐term use of cyclosporine in adult psoriasis patients suggested no monitoring was required for dosing at or below 3 mg/kg daily .…”
Background
Cyclosporine is a useful immunosuppressive agent for achieving disease control in moderate to severe atopic dermatitis in children and adults. However, it carries the potential for nephrotoxicity. Monitoring of drug levels is performed in other patient groups, such as transplant recipients, but is not commonplace in the management of atopic dermatitis.
Objectives
To investigate levels of nephrotoxicity associated with cyclosporine use in atopic dermatitis and assess potential correlation with trough levels of cyclosporine.
Methods
An electronic search was conducted on MEDLINE, EMBASE, and Cochrane databases for randomized controlled trials and cohort studies assessing the safety profile of cyclosporine compared to placebo or other atopic dermatitis treatments, in adult and pediatric atopic dermatitis patients from 1966 to May 2019. Studies that did not assess renal toxicity were excluded from analysis.
Results
Thirty‐eight trials were included for analysis, excluding 11 that did not assess renal toxicity. Descriptive statistical analysis only was performed, due to the high heterogeneity between study methodologies. Significant renal toxicity was seen in 0%‐9% of pediatric participants. Monitoring of trough cyclosporine levels was performed in only 10 of the studies, and their correlation to toxicity or disease activity was not explored.
Conclusion
There is limited evidence in atopic dermatitis regarding trough level monitoring of cyclosporine. Currently, the practice is not commonplace, particularly in pediatrics, and this is reflected in trial methodology. Monitoring may be useful in specific pediatric groups, such as those on multiple concurrent medications, patients with hepatic or renal dysfunction and non‐responders to therapy.
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