Tamara Perry, MD and Robert A. Wood, MD
Baltimore, MD
Purpose to the Study. The role of leukotrienes in the pathogenesis of atopic dermatitis (AD) is uncertain. This double-blind, placebo-controlled crossover study addressed the efficacy of the leukotriene receptor antagonist montelukast in moderate to severe AD.
Study Population. Fifteen patients (ages 6–16) with moderate to severe AD despite conventional therapy consisting of at least a class II steroid, soap substitutes, and emollients.
Methods. Disease severity was evaluated by grading 8 areas of the body (head/neck, front of the trunk, the back, genitalia, and 4 limbs) on a scale of 0 to 3. A score of at least 40 was required to be enrolled in the study. The extent of disease was calculated by estimating the percentage of the body surface involvement. Patients were examined by the same physician on a biweekly basis and completed questionnaires to assess the impact of AD on daily life, as well as the effect of disease on relationships with family members and social life. There was a 2-week run-in period during which standardized topical treatment was initiated. Patients were randomized to receive either 5 mg montelukast or placebo daily for 4 weeks. There was a 2-week washout period before crossover for the second phase.
Results. Eleven patients completed the study with 6 in group A (placebo first) and 5 in group B (drug first). Despite randomization, the baseline median disease severity score between groups was significantly different, group A 52 and group B 78 (P = .018). Group B had a significant decrease in the disease severity (P = .05) during the drug phase. There was also an increase in disease severity during the placebo phase, however, severity scores did not return to baseline. Group A had improvement during both the placebo and drug phase (P = .075 and .029, respectively). Patient index scores and extent of disease did not change significantly for either group.
Conclusion. This pilot study shows that leukotrienes may be important mediators in AD and leukotriene receptor antagonists (LRAs) may be suitable adjuvant therapy in those patients with severe disease.
Reviewers’ Comments. Although leukotrienes are important chemical mediators in asthma and allergic rhinitis, their role in the pathogenesis of AD is not as clear. This study suggests that they may have a role in AD and that LRAs may provide some clinical benefit. In practice, some patients do seem to improve although the responses have not been overwhelming, which is consistent with the results of this study. It may be worth a try in patients with severe disease and, in addition, patients who are started on an LRA for their asthma may experience some improvement in their AD.
REFERENCES
Pei A, Chan H, Leung T. Pediatr Allergy Immunol.2001; 12 :154 –158[CrossRef][ISI][Medline]
PEDIATRICS (ISSN 1098-4275). ©2002 by the American Academy of Pediatrics
Showing posts with label Atopic Dermatitis And LCZ-Mont. Show all posts
Showing posts with label Atopic Dermatitis And LCZ-Mont. Show all posts
Monday, June 22, 2009
Montelukast is efffective in Atopic Dermatitis ?
Montelukast treatment of moderate to severe atopic dermatitis in adults: a randomized, double-blind, placebo-controlled trial
Journal of Drugs in Dermatology , Sept-Oct, 2005
The authors present a two-center, randomized, double-blind, placebo-controlled trial to evaluate the efficacy of montelukast in the treatment of moderate to severe atopic dermatitis. Fifty-nine patients were recruited for the study and randomly assigned to 1 of 2 treatment arms: 10 mg of montelukast once daily or placebo for 4 weeks. No statistically significant differences in disease activity were noted in the 2 groups at baseline. Patients were required to undergo a wash-out period of 2 weeks and no systemic or topical treatment, with the exception of emollients, was allowed during the study. The primary outcome was the modified eczema area and severity index (EASI) score. This score is the sum of a score for pruritus and the EASI score. A secondary outcome was the pruritus score alone. Patients were assessed at baseline, after the wash-out period, and at weeks 1, 2, and 4 of treatment. Six patients dropped out of the study before beginning treatment. Drop-out occurred in 6 patients during the study secondary to either worsening of their atopic dermatitis or not returning for follow-up visits. As the intention-to-treat analysis was used, these latter 6 patients were included in the analysis giving a total of 53 patients. No statistically significant difference was noted between the montelukast and placebo groups. No adverse events were reported.
Comment
The authors present a well-designed study to evaluate the efficacy of montelukast in the treatment of moderate to severe atopic dermatitis. Rationale for the use of montelukast in atopic dermatitis is based on anecdotal reports as well as prior studies. As leukotrienes are important in the pathogenesis of atopic disorders such as asthma and allergic rhinitis, it is possible they also play a role in atopic dermatitis. Synthesis of leukotrienes, determined by urinary excretion of leukotriene E4, was studied in 8 patients with atopic dermatitis compared with 8 healthy controls. (1) Patients with atopic dermatitis were found to have a statistically significant increase (4.5-fold) in leukotriene E4 excretion in comparison to controls. Hence it is theoretically possible that a leukotriene antagonist such as montelukast would improve atopic dermatitis. This study fails to demonstrate such efficacy. One reason may be that the investigators considered a 60% reduction in scoring as significant. Prior studies have shown efficacy. (2,3) These studies involved fewer patients and considered smaller reductions as significant. For example in Yanase et al, a 30% reduction in scoring was considered significant. This study confirms that the efficacy of montelukast in the treatment of atopic dermatitis is in no way dramatic. It may improve atopic dermatitis modestly at best and is certainly not suitable as a monotherapy. However, it may be useful in combination with a topical or systemic agent in a subset of patients.
References
1. Fauler J, et al. Enhanced synthesis of cysteinyl leukotrienes in atopic dermatitis. British Journal of Dermatology. 1993;128(6):627-630.
2. Eustachio N, et al. Efficacy and tolerability of montelukast as a therapeutic agent for severe atopic dermatitis in adults. Acta Derm Venereol. 2002; 82:297-320.
3. Yanase DJ, et al. The leukotriene antagonist montelukast as a therapeutic agent for atopic dermatitis. Journal of the American Academy of Dermatology. 2001; 44(1):89-93.
Washington Whispers provides a summary and critical evaluation of the latest drug trials, studies, and reactions available to the medical community, as collated from a wealth of industry sources.
Journal of Drugs in Dermatology , Sept-Oct, 2005
The authors present a two-center, randomized, double-blind, placebo-controlled trial to evaluate the efficacy of montelukast in the treatment of moderate to severe atopic dermatitis. Fifty-nine patients were recruited for the study and randomly assigned to 1 of 2 treatment arms: 10 mg of montelukast once daily or placebo for 4 weeks. No statistically significant differences in disease activity were noted in the 2 groups at baseline. Patients were required to undergo a wash-out period of 2 weeks and no systemic or topical treatment, with the exception of emollients, was allowed during the study. The primary outcome was the modified eczema area and severity index (EASI) score. This score is the sum of a score for pruritus and the EASI score. A secondary outcome was the pruritus score alone. Patients were assessed at baseline, after the wash-out period, and at weeks 1, 2, and 4 of treatment. Six patients dropped out of the study before beginning treatment. Drop-out occurred in 6 patients during the study secondary to either worsening of their atopic dermatitis or not returning for follow-up visits. As the intention-to-treat analysis was used, these latter 6 patients were included in the analysis giving a total of 53 patients. No statistically significant difference was noted between the montelukast and placebo groups. No adverse events were reported.
Comment
The authors present a well-designed study to evaluate the efficacy of montelukast in the treatment of moderate to severe atopic dermatitis. Rationale for the use of montelukast in atopic dermatitis is based on anecdotal reports as well as prior studies. As leukotrienes are important in the pathogenesis of atopic disorders such as asthma and allergic rhinitis, it is possible they also play a role in atopic dermatitis. Synthesis of leukotrienes, determined by urinary excretion of leukotriene E4, was studied in 8 patients with atopic dermatitis compared with 8 healthy controls. (1) Patients with atopic dermatitis were found to have a statistically significant increase (4.5-fold) in leukotriene E4 excretion in comparison to controls. Hence it is theoretically possible that a leukotriene antagonist such as montelukast would improve atopic dermatitis. This study fails to demonstrate such efficacy. One reason may be that the investigators considered a 60% reduction in scoring as significant. Prior studies have shown efficacy. (2,3) These studies involved fewer patients and considered smaller reductions as significant. For example in Yanase et al, a 30% reduction in scoring was considered significant. This study confirms that the efficacy of montelukast in the treatment of atopic dermatitis is in no way dramatic. It may improve atopic dermatitis modestly at best and is certainly not suitable as a monotherapy. However, it may be useful in combination with a topical or systemic agent in a subset of patients.
References
1. Fauler J, et al. Enhanced synthesis of cysteinyl leukotrienes in atopic dermatitis. British Journal of Dermatology. 1993;128(6):627-630.
2. Eustachio N, et al. Efficacy and tolerability of montelukast as a therapeutic agent for severe atopic dermatitis in adults. Acta Derm Venereol. 2002; 82:297-320.
3. Yanase DJ, et al. The leukotriene antagonist montelukast as a therapeutic agent for atopic dermatitis. Journal of the American Academy of Dermatology. 2001; 44(1):89-93.
Washington Whispers provides a summary and critical evaluation of the latest drug trials, studies, and reactions available to the medical community, as collated from a wealth of industry sources.
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