A patient-oriented approach to long-term use of omalizumab in chronic spontaneous urticaria

Abstract

Background

Omalizumab is an effective and safe treatment for antihistamine resistant chronic spontaneous urticaria (CSU), however, long-term efficacy and safety remains unclear.

Objective

To evaluate the efficacy and safety of omalizumab in CSU patients treated for long term and to identify long-term management strategies.

Methods

We retrospectively analyzed demographic characteristics, clinical features, laboratory parameters and treatment outcomes of 41 CSU patients who received omalizumab for at least 3 years. Treatment responses were evaluated with urticaria control test (UCT). Treatment safety was evaluated by comparing laboratory findings before and three years after omalizumab initiation as well as considering patients’ adverse event reports.

Results

The patients (mean age 40.46 years; 63.4% women) received omalizumab for an average of 41.93 months (mean 31.68 injections/patient). The mean baseline UCT score was 5.56 and average number of injections to reach UCT score ≥12 was 3.3. Nine patients (22%) responded insufficiently to 300 mg/4 weeks omalizumab and required updosing. Thirty-eight patients (92.7%) could tolerate longer dose intervals (>4 weeks) and the dose interval was increased after a mean of 11.53 injections. There was no loss of efficacy of omalizumab. Sixteen patients (39%) had been retreated with omalizumab after a mean discontinuation time of 24 weeks. Five patients (12.2%) reported mild and transient adverse effects. Liver and renal function tests as well as full blood count before and after omalizumab were in normal ranges.

Conclusion

For the long-term management of CSU, omalizumab is a safe and effective treatment which can be tailored according to patients’ disease activity.

Keywords:

• Adverse events
• efficacy
• omalizumab
• treatment
• urticaria
• long term
• safety

Disclosure statement

Dr Emek Kocaturk reports advisory board fees from Novartis, and has served as a medical advisor for Bayer and Sanofi. The other author has no conflict of interest to declare.