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Rupatadine is effective in the treatment of chronic spontaneous urticaria in children aged 2-11 years
Paul Potter1, Essack Mitha2, László Barkai3
1Allergy Diagnostic and Clinical Research Unit, Department of Medicine, University of Cape Town Lung Institute, Cape Town, South Africa.
Insights
Rupatadine effectively treats chronic spontaneous urticaria (CSU) in children, significantly reducing symptoms and improving quality of life compared to placebo. This H1 and PAF antagonist is well-tolerated in pediatric patients.
Area of Science:
- Pediatric Allergy and Immunology
- Dermatology
- Pharmacology
Background:
- Current chronic spontaneous urticaria (CSU) treatment guidelines for children often rely on adult data.
- Rupatadine, a dual H1 and PAF antagonist, is approved in Europe for allergic rhinitis and CSU in children.
- Pediatric-specific efficacy and safety data for CSU treatments are limited.
Purpose of the Study:
- To evaluate the efficacy and safety of rupatadine in pediatric patients with CSU.
- To compare rupatadine with desloratadine and placebo in treating childhood CSU.
- To assess the impact of treatment on children's quality of life.
Main Methods:
- A double-blind, randomized, multicenter trial in children aged 2-11 years with CSU.
- Comparison of rupatadine, desloratadine, and placebo over a 6-week treatment period.
- Primary endpoint: modified 7-day Urticaria Activity Score (UAS7) change.
Main Results:
- Both rupatadine and desloratadine showed statistically significant improvement in UAS7 compared to placebo (p < 0.001).
- Rupatadine demonstrated a 55.8% decrease in UAS7, significantly reducing pruritus compared to placebo.
- Active treatments improved children's quality of life; adverse events were rare and non-serious.
Conclusions:
- Rupatadine is an effective and well-tolerated treatment for pediatric CSU, enhancing quality of life.
- This study provides the first evidence using a modified UAS for CSU efficacy in children.
- Rupatadine offers a valuable therapeutic option for childhood CSU.
Background:
Recommendations in current guidelines for the treatment of chronic spontaneous urticaria (CSU) in infants and children are mostly based on extrapolation of data obtained in adults. This study reports the efficacy and safety of rupatadine, a modern H1 and PAF antagonist recently authorized in Europe for children with allergic rhinitis and CSU.
Methods:
A double-blind, randomized, parallel-group, multicentre, placebo-controlled compared study to desloratadine was carried out in children aged 2-11 years with CSU, with or without angio-oedema. Patients received either rupatadine (1 mg/ml), or desloratadine (0.5 mg/ml) or placebo once daily over 6 weeks. A modified 7-day cumulative Urticaria Activity Score (UAS7) was employed as the primary end-point.
Results:
The absolute change of UAS7 at 42 days showed statistically significant differences between active treatments vs. placebo (-5.5 ± 7.5 placebo, -11.8 ± 8.7 rupatadine and -10.6 ± 9.6 desloratadine; p < 0.001) and without differences between antihistamines compounds. There was a 55.8% decrease for rupatadine followed by desloratadine (-48.4%) and placebo (-30.3%). Rupatadine but not desloratadine was statistically superior to placebo in reduction of pruritus (-57%). Active treatments also showed a statistically better improvement in children's quality of life compared to placebo. Adverse events were uncommon and non-serious in both active groups.
Conclusion:
Rupatadine is effective and well tolerated in the relief of urticaria symptoms, improving quality of life over 6 weeks in children with CSU. This is the first study using a modified UAS to assess severity and efficacy outcome in CSU in children.
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