From the Guidelines
Urticaria evaluation should begin with a thorough history, physical examination, and basic tests, following the 7 Cs approach: confirmation, cofactors, comorbidities, consequences, components, course, and history, as outlined in the recent guidelines 1. The diagnostic workup for urticaria, particularly chronic spontaneous urticaria (CSU), has been refined to include a comprehensive set of steps to ensure accurate diagnosis and effective management.
Key Steps in Urticaria Evaluation
- History: Includes a review of patient photo documentation to understand the pattern and duration of urticaria.
- Physical Examination: A thorough examination to assess the distribution and appearance of hives, looking for signs of angioedema and systemic involvement.
- Basic Tests: Differential blood count, C-reactive protein level/erythrocyte sedimentation rate, IgG–anti-TPO level, and total IgE level for patients with special care, as these can help identify underlying causes such as autoallergic or autoimmune-mediated skin mast cell activation 1.
Additional Diagnostic Considerations
- Consequences and Comorbidities: Checking for potential triggers and aggravators, and identifying comorbid conditions that could impact disease activity and treatment outcomes.
- Components and Course: Assessing the impact of urticaria on quality of life, including sleep, distress, sexual health, and social performance, and monitoring disease activity and response to treatment. Given the complexity of urticaria and the potential for autoimmune or autoallergic causes, a targeted approach to laboratory testing and diagnostic procedures is recommended, based on clinical suspicion and the results of initial evaluations 1.
From the FDA Drug Label
The safety and efficacy of XOLAIR for the treatment of chronic spontaneous urticaria (CSU), previously referred to as chronic idiopathic urticaria (CIU) was assessed in two placebo-controlled, multiple-dose clinical trials of 24 weeks' duration (CSU Trial 1; n= 319, [NCT01287117]) and 12 weeks' duration (CSU Trial 2; n=322, [NCT01292473]). Patients received XOLAIR 75 mg, 150 mg, or 300 mg or placebo by SC injection every 4 weeks in addition to their baseline level of H1 antihistamine therapy for 24 or 12 weeks, followed by a 16-week washout observation period. In both CSU Trials 1 and 2, patients who received XOLAIR 150 mg or 300 mg had greater decreases from baseline in weekly itch severity scores and weekly hive count scores than placebo at Week 12.
Urticaria Evaluation: Omalizumab (XOLAIR) is effective in treating chronic spontaneous urticaria (CSU) in patients 12 years of age and older who continue to have hives that are not controlled with H1 antihistamine treatment. The recommended dose is 150 mg or 300 mg by SC injection every 4 weeks.
- Key findings:
- Patients who received XOLAIR 150 mg or 300 mg had greater decreases from baseline in weekly itch severity scores and weekly hive count scores than placebo at Week 12.
- A larger proportion of patients treated with XOLAIR 300 mg (36%) reported no itch and no hives (UAS7=0) at Week 12 compared to patients treated with XOLAIR 150 mg (15%), XOLAIR 75 mg (12%), and placebo group (9%).
- Clinical decision: Omalizumab (XOLAIR) can be considered as a treatment option for patients with CSU who have not responded to H1 antihistamine therapy. However, the decision to use XOLAIR should be made on a case-by-case basis, taking into account the individual patient's medical history, severity of symptoms, and potential risks and benefits of treatment 2.
From the Research
Urticaria Evaluation
Urticaria is a common condition characterized by intensely pruritic wheals, sometimes with edema of the subcutaneous or interstitial tissue, with a lifetime prevalence of about 20% 3, 4. The diagnosis of urticaria is made clinically, and anaphylaxis must be ruled out 3, 4.
Causes and Pathogenesis
Urticaria is caused by immunoglobulin E- and non-immunoglobulin E-mediated release of histamine and other inflammatory mediators from mast cells and basophils 3, 4. Chronic urticaria is idiopathic in 80% to 90% of cases, and only a limited nonspecific laboratory workup should be considered unless elements of the history or physical examination suggest specific underlying conditions 3, 4.
Treatment
The mainstay of treatment is avoidance of triggers, if identified 3, 4. The first-line pharmacotherapy is second-generation H1 antihistamines, which can be titrated to greater than standard doses 3, 4, 5. Other treatment options include:
- First-generation H1 antihistamines, H2 antihistamines, leukotriene receptor antagonists, and brief corticosteroid bursts as adjunctive treatment 3, 4
- Omalizumab, a humanized monoclonal anti-immunoglobulin E, for the treatment of chronic urticaria that is unresponsive to H1 antagonists 5
- Cyclosporine for refractory chronic urticaria 3, 6
Prognosis
More than one-half of patients with chronic urticaria will have resolution or improvement of symptoms within a year 3, 4.
Key Points
- Urticaria is a common condition with a lifetime prevalence of about 20% 3, 4
- The diagnosis of urticaria is made clinically, and anaphylaxis must be ruled out 3, 4
- Second-generation H1 antihistamines are the first-line pharmacotherapy for urticaria 3, 4, 5
- More than one-half of patients with chronic urticaria will have resolution or improvement of symptoms within a year 3, 4