The Addition of Montelukast for the Treatment of Chronic Idiopathic Urticaria

PubMed Central: Published: July, 2021

Urticaria is a frequent, mast cell–driven disease that presents with wheals, angioedema, or both. The lifetime prevalence for acute urticaria is approximately 20%.

Chronic idiopathic urticaria (CIU) is a common skin condition characterized by the appearance of recurrent wheals and/or angioedema for duration of at least six weeks without an identifiable trigger. The wheals usually resolve in less than 24 hours. It has been estimated that up to 1% of the general population experiences chronic urticaria (CU).

Although all age groups can be affected the peak incidence is between 20 and 40 years of age and women are more commonly affected than men (2:1).

The discomfort experienced with CIU along with the lack of adequate symptoms control can significantly affect patients’ sleep, productivity and quality of life and can be very frustrating for both patients and health care providers.


The pathogenesis of CU is complex. Although histamine plays a significant role in CU, prostaglandins and leukotrienes lengthen the inflammatory activity.

The international EAACI/GA²LEN/EuroGuiDerm/APAAACI updated guideline for the diagnosis and management of urticaria. The guidelines include a treatment approach, which involves:

(A) Identification and elimination of underlying causes and avoidance of eliciting factors and (B) Symptomatic pharmacological treatment

The avoidance method outlines the removal of identifiable causes, avoid physical triggers, and minimize aggravating factors.

The second approach is interfering with mast cell mediators with the use of non-sedating second-generation H1-antihistamines such as cetirizine, desloratadine, ebastine, fexofenadine, levocetirizine, loratadine, and rupatadine.

Guidelines recommend the use of a standard-dosed modern 2nd generation H1-antihistamines as the first-line symptomatic treatment for urticaria, and recommend up dosing of a 2nd generation H1-antihistamine up to fourfold in patients with chronic urticaria unresponsive to a standard-dosed as second-line treatment before other treatments are considered.

It is strongly recommended not to use 1st generation H1-antihistamines any longer in allergy both for adults and especially in children. This view is shared by the WHO guideline ARIA.

Based on strong evidence regarding potentially serious side effects of 1st generation H1-antihistamines (lethal overdoses have been reported), authors recommend against their use for the routine management of CU as first-line agents.

The addition of H2-antihistamine to conventional H1-antihistamines may be helpful although the evidence of combining H1 and H2 is still poor.

Omalizumab is the other treatment in urticaria for patients who do not show sufficient benefit from treatment with a 2nd generation H1-antihistamine.

Guidelines suggest considering a short course of rescue systemic glucocorticosteroids in patients with an acute exacerbation of CU.

Montelukast for the Treatment of Chronic Idiopathic Urticaria:

Montelukast is an active Leukotriene receptor antagonist (LTRA) for the maintenance therapy of asthma and symptoms control of allergic rhinitis. Consensus guidelines suggest the use of LTRA (e.g. montelukast) in patients with CIU resistant to antihistamines.

Montelukast 10mg once daily has been used either as monotherapy or in combination with H1 and/or H2-antihistamines to treat various forms of CU, including chronic autoimmune urticaria, delayed-pressure urticaria, cold urticaria, urticaria related to food and CIU.

Some systematic clinical trials or case series suggest that some patients with chronic resistant idiopathic urticaria report a good response to leukotriene inhibition.


Addition of LTRA, such as montelukast, plus anti-H1/H2 antihistamines therapy was effective in most of the patient population. This case series shows that montelukast can be a successful treatment option for patients with CIU who are not adequately controlled with antihistamines and can significantly improve a patient’s condition.

Moreover, the excellent safety profile without the need for regular blood monitoring is the reason why LTRAs are considered the preferred additional agents in patient population.

The European Academy of Allergology and Clinical Immunology (EAACI), the Global Allergy and Asthma European Network (GA²LEN) and its Urticaria and Angioedema Centers of Reference and Excellence (UCAREs and ACAREs), the European Dermatology Forum (EDF), and the Asia Pacific Association of Allergy, Asthma, and Clinical Immunology (APAAACI).

Doctors Liked to Read More


Chronic urticaria (CU) is a common disorder that can significantly affect the quality of life. The goal of treatment is complete symptomatic relief. Conventional therapy, with antihistamines, is not always effective in all patients. Leukotrienes are believed to be involved in the pathogenesis of urticaria. Leukotriene receptor antagonists (LTRAs), such as montelukast, have been suggested as useful agents in patients with chronic idiopathic urticaria. Our objective is to document the efficacy of montelukast in our patients.

Materials and methods

Patients who received montelukast were identified from clinic letters. Data including clinical features were collected and analyzed. The main endpoint was adequate disease control.


A total of nine patients who met the inclusion criteria were included in this study. Four patients reported having a good response to montelukast and three patients reported full control of the disease.


These findings suggest that leukotriene antagonists, such as montelukast, are effective as an add-on therapy to anti-histamines and their use in histamine resistant patients is justifiable.

Read In Details

This is for informational purposes only. You should consult your clinical textbook for advising your patients.