Treatment with omalizumab

Back to decision-making tree Print last updated on 21/02/2024

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.

The most common adverse reactions reported in the trials were:

• respiratory infections
• headaches
• and diarrhoea.

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

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

The WG considers that in the absence of comparative data on omalizumab and cyclosporine, both can be prescribed in the treatment of refractory CSU with the addition of anti-H1 antihistamines.

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

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.

Omalizumab and drug interaction

There are no drug interactions, apart from a reduction in the effectiveness of anti-helminthics.

Omalizumab, pregnancy and breastfeeding

Omalizumab must be avoided during pregnancy, and its long elimination half-life (26 days) makes it advisable to stop it before conception.

In the absence of breastfeeding risk data, the WG can neither recommend nor contraindicate omalizumab at this time.

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