Centre of Evidence of Dermatology Best practice guidelines

Guidelines chronic spontaneous urticaria Updated on december 2019


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Adult and adolescent > 12 years old
Stage 3

Back to decision-making tree Print last updated on 18/09/2020

In case of failure with second-generation anti-H1 antihistamines at quadruple dose

The WG recommends treatment by omalizumab or cyclosporine, in addition to the quadruple dose of anti-H1 antihistamines.

The WG considers that in the absence of comparative data between omalizumab and cyclosporine, both can be prescribed in the treatment of refractory CSU, in addition to anti-H1 antihistamines, if there are no contraindications. Data on omalizumab are more numerous and have a higher level of evidence.

The majority of experts prefer omalizumab over cyclosporine, in combination with a quadruple dose of anti-H1 antihistamines, to treat CSU resistant to anti-H1 antihistamines alone.


In addition to anti-H1 antihistamines, omalizumab is more effective than placebo in adult patients with CSU who have an inadequate response to anti-H1 antihistamines at variable doses.

The recommended (MA) dose of omalizumab is 300 mg/4 weeks.

There are no data in the literature enabling us to determine the interval between the failure of anti-H1 antihistamines and the initiation of omalizumab.

This interval varies between 1 and 6 months, depending on experts.

There are no long-term follow-up data on their efficacy.

The most common adverse reactions reported in trials were:

  • respiratory infections,
  • headaches,
  • and diarrhoea.

Regarding tolerance, there are no long-term data on CSU, but data on higher doses are available from asthma patients.


Cyclosporine is the immunosuppressant most widely used after failure of anti-H1 drugs. The dose of cyclosporine is 4 or 5 mg/kg/day initially, followed by a gradual decrease in 15-day increments, according to the literature. The maximum study period was 6 months. Cyclosporine was prescribed in addition to conventional or double-dose anti-H1 antihistamines.

The most common adverse effects reported in trials were:

  • headaches,
  • digestive problems,
  • paraesthesia,
  • high blood pressure,
  • hypertrichosis.

The WG does not recommend the use of other immunosuppressants in CSU due to lack of studies with a sufficient level of evidence, or due to negative studies (methotrexate).

The following are not recommended due to lack of sufficient evidence:

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