American Journal of Clinical Dermatology

, Volume 8, Issue 1, pp 37–42

Efficacy and Safety of Desloratadine in Adults with Chronic Idiopathic Urticaria

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial
  • Jean-Paul Ortonne
  • Jean-Jacques Grob
  • Pascal Auquier
  • Isabelle Dreyfus
Original Research Article


Background and objective: Chronic idiopathic urticaria (CIU), a condition characterized by pruritus and wheals, can cause patients physical and psychological distress. Desloratadine, a second-generation histamine H1 receptor antagonist (antihistamine), is a first-line treatment option for CIU. The objective of this study was to evaluate the efficacy and safety of once-daily desloratadine 5mg versus placebo for the treatment of CIU symptoms and disease severity in adults.

Methods: This was a randomized, placebo-controlled, multicenter trial of 137 adult patients with active CIU who received oral once-daily desloratadine 5mg or placebo for 6 weeks. Outcome measures included pruritus severity, number of wheals, and the size of the largest wheal. Patients assessed signs and symptoms on a four-point scale twice daily. The overall therapeutic response at the end of the 6-week treatment period was also rated.

Results: Desloratadine treatment was associated with significant improvements compared with placebo in pruritus scores and in the size of the largest wheals as early as day 1. These improvements continued through to the end of the trial. The mean score for the number of wheals was significantly lower in the desloratadine group than in the placebo group on days 14 and 42 (p ≤ 0.016). Overall improvement in CIU (complete, marked, or moderate therapeutic response) was also greater at the end of the study in the desloratadine group compared with placebo (p < 0.001). Adverse events occurred with similar frequency among desloratadine- and placebo-treated patients.

Conclusion: Once-daily desloratadine 5mg is well tolerated and superior to placebo in reducing pruritus and wheals associated with CIU. Desloratadine provided rapid and sustained relief of CIU symptoms as early as after the first dose and maintained this effect until the end of the 6-week treatment period.


  1. 1.
    Greaves MW.: Chronic urticaria. N Engl J Med 1995; 332(26): 1767–72PubMedCrossRefGoogle Scholar
  2. 2.
    O’Donnell BF, Lawlor F, Simpson J.: The impact of chronic urticaria on the quality of life. Br J Dermatol 1997; 136(2): 197–201PubMedCrossRefGoogle Scholar
  3. 3.
    Kozel MMA, Sabroe RA.: Chronic urticaria: aetiology, management and current and future treatment options. Drugs 2004; 64(22): 2515–36PubMedCrossRefGoogle Scholar
  4. 4.
    Ring J, Hein R, Gauger A. Desloratadine in the treatment of chronic idiopathic urticaria. Allergy 2001; 56 Suppl. 65: 28–32PubMedCrossRefGoogle Scholar
  5. 5.
    Sabroe RA, Greaves MW. The pathogenesis of chronic idiopathic urticaria. Arch Dermatol 1997; 133(8): 1003–8PubMedCrossRefGoogle Scholar
  6. 6.
    Kaplan AP, Horáková Z, Katz SI.: Assessment of tissue fluid histamine levels in patients with urticaria. J Allergy Clin Immunol 1978; 61(6): 350–4PubMedCrossRefGoogle Scholar
  7. 7.
    Monroe E, Finn A, Patel P.: Efficacy and safety of desloratadine 5mg once daily in the treatment of chronic idiopathic urticaria: a double-blind, randomized, placebo-controlled trial. J Am Acad Dermatol 2003; 48(4): 535–41PubMedCrossRefGoogle Scholar
  8. 8.
    Sabroe RA, Poon E, Orchard GE.: Cutaneous inflammatory cell infiltrate in chronic idiopathic urticaria: comparison of patients with and without anti-FceRI or anti-IgE autoantibodies. J Allergy Clin Immunol 1999; 103 (3 Pt 1): 484–93PubMedCrossRefGoogle Scholar
  9. 9.
    Gruber BL, Baeza ML, Marchese MJ.: Prevalence and functional role of anti-IgE autoantibodies in urticarial syndromes. J Invest Dermatol 1988; 90(2): 213–7PubMedCrossRefGoogle Scholar
  10. 10.
    Grattan CEH, Francis DM, Hide M.: Detection of circulating histamine releasing autoantibodies with functional properties of anti-IgE in chronic urticaria. Clin Exp Allergy 1991; 21(6): 695–704PubMedCrossRefGoogle Scholar
  11. 11.
    Hide M, Francis DM, Grattan C.: Autoantibodies against the high-affinity IgE receptor as a cause of histamine release in chronic urticaria. N Engl J Med 1993; 328(22): 1599–604PubMedCrossRefGoogle Scholar
  12. 12.
    Zweiman B, Valenzano M, Atkins PC.: Characteristics of histamine-releasing activity in the sera of patients with chronic idiopathic urticaria. J Allergy Clin Immunol 1996; 98(1): 89–98PubMedCrossRefGoogle Scholar
  13. 13.
    Tong LJ, Balakrishnan G, Kochan JP. Assessment of autoimmunity in patients with chronic urticaria. J Allergy Clin Immunol 1997; 99(4): 461–5PubMedCrossRefGoogle Scholar
  14. 14.
    Metzger H.: The high affinity receptor for IgE on mast cells. Clin Exp Allergy 1991; 21(3): 269–79PubMedCrossRefGoogle Scholar
  15. 15.
    Schwartz LB.: Mast cells and their role in urticaria. J Am Acad Dermatol 1991; 25 (sn1 Pt 2):190–204PubMedCrossRefGoogle Scholar
  16. 16.
    Maxwell DL, Atkinson BA, Spur BW.: Skin responses to intradermal histamine and leukotrienes C4, D4, and E4 in patients with chronic idiopathic urticaria and in normal subjects. J Allergy Clin Immunol 1990; 86(5): 759–65PubMedCrossRefGoogle Scholar
  17. 17.
    Zuberbier T, Bindslev-Jensen C, Canonica W.: EAACI/GA2LEN/EDF guideline: definition, classification and diagnosis of urticaria. Allergy 2006; 61(3): 316–20PubMedCrossRefGoogle Scholar
  18. 18.
    Zuberbier T, Bindslev-Jensen C, Canonica W.: EAACI/GA2LEN/EDF guideline: management of urticaria. Allergy 2006; 61(3): 321–31PubMedCrossRefGoogle Scholar
  19. 19.
    Yosipovitch G, Ansari N, Goon A.: Clinical characteristics of pruritus in chronic idiopathic urticaria. Br J Dermatol 2002; 147(1): 32–6PubMedCrossRefGoogle Scholar
  20. 20.
    Ring J, Brockow K, Ollert M.: Antihistamines in urticaria. Clin Exp Allergy 1999; 291: 31–7PubMedCrossRefGoogle Scholar
  21. 21.
    DuBuske LM.: Clinical comparison of histamine H1-receptor antagonist drugs. J Allergy Clin Immunol 1996; 98 (6 Pt 3): 307–18Google Scholar
  22. 22.
    Ng KH, Chong D, Wong CK.: Central nervous system side effects of first- and second-generation antihistamines in school children with perennial allergic rhinitis: a randomized, double-blind, placebo-controlled comparative study. Pediatrics 2004; 113(2): e116–21CrossRefGoogle Scholar
  23. 23.
    Simons FER.: Advances in H1-antihistamines. N Engl J Med 2004; 351(21): 2203–17PubMedCrossRefGoogle Scholar
  24. 24.
    Ring J, Hein R, Gauger A.: Once-daily desloratadine improves the signs and symptoms of chronic idiopathic urticaria: a randomized, double-blind, placebo-controlled study. Int J Dermatol 2001; 40 (1): 72–6PubMedCrossRefGoogle Scholar
  25. 25.
    Baiardini I, Pasquali M, Braido F.: A new tool to evaluate the impact of chronic urticaria on quality of life: chronic urticaria quality of life questionnaire (CU-QoL). Allergy 2005; 60(8): 1073–8PubMedCrossRefGoogle Scholar
  26. 26.
    Murdoch D, Goa KL, Keam SJ.: Desloratadine: an update of its efficacy in the management of allergic disorders. Drugs 2003; 63(19): 2051–77PubMedCrossRefGoogle Scholar
  27. 27.
    Di Lorenzo G, Pacor ML, Mansueto P.: Randomized placebo-controlled trial comparing desloratadine and montelukast in monotherapy and desloratadine plus montelukast in combined therapy for chronic idiopathic urticaria. J Allergy Clin Immunol 2004; 114(3): 619–25PubMedCrossRefGoogle Scholar
  28. 28.
    Nettis E, Colanardi MC, Paradiso MT.: Desloratadine in combination with montelukast in the treatment of chronic urticaria: a randomized, double-blind, placebo-controlled study. Clin Exp Allergy 2004; 34(9): 1401–7PubMedCrossRefGoogle Scholar

Copyright information

© Adis Data Information BV. 2007

Authors and Affiliations

  • Jean-Paul Ortonne
    • 1
  • Jean-Jacques Grob
    • 2
  • Pascal Auquier
    • 3
  • Isabelle Dreyfus
    • 4
  1. 1.Service de Dermatologie, Hôopital de l’ArchetNice Cedex 03France
  2. 2.Service de Dermatologie, Hôopital Ste MargueriteMarseilleFrance
  3. 3.Laboratoire de Santá PubliqueEA Évaluation Hospitalière et Santè Perçue, Facultè de Médicine MarseilleMarseilleFrance
  4. 4.Schering-PloughLevallois PerretFrance

Personalised recommendations