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.
- Copyright © 2002 by the American Academy of Pediatrics