Can Xolair injection be used for allergies?

Yes, Xolair can be used for food allergies. Xolair injection was approved on February 16, 2024 to reduce the risk of allergic reactions (including anaphylaxis) in adults and children aged 1 year and older with one or more Ig-E-mediated food allergies. It is not currently approved to treat other types of allergy, such as to medications, bee stings, or pollen.

Xolair is also approved to treat allergic asthma, nasal polyps, and chronic urticaria. There is also some evidence to show that it may be helpful for allergic rhinitis. In Japan, Xolair is also approved to treat severe Japanese cedar pollinosis (JC) a form of seasonal allergic rhinitis that affects 38.8% of the Japanese population.

Is Xolair effective for food allergies?

Xolair has shown to be effective at preventing allergic reactions in people with IgE-mediated food allergies.

• In the OUtMATCH study 68% of patients with Ig-E-mediated food allergies treated with Xolair for 16 to 20 weeks tolerated at least 600 mg of peanut protein (2.5 peanuts or half a teaspoon of peanut butter) without moderate to severe allergic symptoms, compared to 5% of those treated with placebo (p<0.0001).
• In addition, 66% tolerated at least 1,000 mg of protein from milk (vs. 11%; p<0.0001), 67% egg (vs. 0%; p<0.0001) and 42% cashew (vs. 3%; p<0.0001) without moderate to severe allergic symptoms. This amount is equivalent to approximately two tablespoons of 1% milk, one-quarter of an egg or three and a half cashews.
• Before the study, all participants were unable to tolerate up to 100 mg of peanut protein (equivalent to about one third of a peanut), and up to 300 mg each of milk, egg and cashew protein.
• Xolair should be used in patients with Ig-E-mediated food allergies with continued food allergen avoidance.

Xolair for Allergic Rhinitis

There is good evidence to support the use of omalizumab for allergic rhinitis. An RCT evaluated 536 ragweed-allergic patients with different dosages of omalizumab (50, 150, and 300 mg) or placebo (an inactive treatment) every 3–4 weeks just before and during ragweed season. Patients treated with 300 mg of omalizumab had fewer rhinitis symptoms better quality of life scores than the other groups and did not decline during the peak ragweed season. A follow-up study reported that the therapy is well tolerated without any significant immunologic reactions. Further studies have reported omalizumab to be effective at reducing symptoms and rescue medication usage in patients with allergic rhinitis to ragweed, birch, cedar, and perennial allergens.
A meta-analysis published evaluated 2,870 patients treated for seasonal or perennial allergic rhinitis and reported omalizumab significantly reduced both daily nasal symptoms and daily nasal rescue medication usage. No significant adverse events were reported.

Xolair for Allergen immunotherapy (inhalants)

There is good evidence to support the use of omalizumab in people undergoing allergen immunotherapy in addition to standard maintenance-dose immunotherapy. In 221 pediatric patients sensitized to birch and grass pollen, the addition of omalizumab reduced symptoms by 48% compared to birch immunotherapy alone. Similar results were seen in grass season, with a 57% decrease in symptoms and significantly reduced rescue medication with the addition of Xolair to grass immunotherapy compared to grass immunotherapy alone. In another study looking at patients allergic to ragweed, the combination of omalizumab and immunotherapy showed a significant improvement in severity scores during the ragweed season compared with those receiving immunotherapy alone after rush immunotherapy build-up. Combined treatment with omalizumab and immunotherapy is more effective than omalizumab or immunotherapy alone.

In addition, the addition of omalizumab to immunotherapy decreased the risk of anaphylaxis caused by immunotherapy five-fold and resulted in fewer systemic reactions in asthma patients.

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Xolair for Atopic Dermatitis

Several case series have investigated using omalizumab for atopic dermatitis (AD) but results have been mixed and evidence is considered fair to support its use. One small case series of 7 patients noted clinical improvement 3 to 6 months after starting therapy and all patients had improvement after 12 months of therapy. An RCT randomized 20 atopic dermatitis patients to omalizumab or placebo for 16 weeks. Although some laboratory markers, such as free IgE, surface IgE, and FceRI expression were reduced, no significant improvement was noted in AD symptoms. Results were similar in another study of patients with severe AD. A meta-analysis reported no concrete evidence that omalizumab was effective in treating AD, although 43% of patients improved clinically with omalizumab. There may be some patients who are more responsive than others.

Xolair for Eosinophilic Gastrointestinal Diseases

There is weak evidence to suggest that omalizumab may be effective for eosinophilic esophagitis. In two case studies of patients with eosinophilic esophagitis and multiple food allergies, the addition of omalizumab to the patient’s standard therapy reduced symptoms of eosinophilic esophagitis but did not improve endoscopic and histologic changes. In a randomized prospective trial in 30 patients who were either refractory to or had relapsed after topical corticosteroids, Xolair for 16 weeks did not improve either esophageal eosinophil counts or symptom scores. In an open-label study, only 5 out of 15 patients with eosinophilic esophagitis had histological and clinical improvement after 3 months of treatment. In nine patients treated with omalizumab every 2 weeks for 16 weeks, symptom scores were decreased by 70% although there was a non-significant decrease in eosinophils present in the duodenum and stomach. No effect on T-cell function was noted. Overall, omalizumab may be effective for select patients with eosinophilic-based GI diseases, especially those with low blood eosinophil counts.

Xolair for Allergic Bronchopulmonary Aspergillosis (ABA)

The evidence is too weak to recommend omalizumab for ABA. Treatment with omalizumab improved lung functions and reduced respiratory symptoms and systemic corticosteroid use in 8 children with allergic bronchopulmonary aspergillosis and cystic fibrosis. A retrospective analysis found omalizumab was steroid-sparing and reduced inflammatory markers and symptom scores, even with elevated IgE levels.

Why hasn’t Xolair been approved for other allergies?

It is unknown why Xolair has not been approved for other conditions. Reasons may include:
• The makers of Xolair, Genentech/Novartis have not sought further approval
• The evidence for using Xolair for other allergic conditions ranges from good to weak depending on the condition
• There is a risk of anaphylaxis with the first few doses of Xolair that require patients being administered Xolair to be monitored which may make it cumbersome or risky for widespread use
• Xolair needs to be given by subcutaneous injection regularly which may be difficult for some people
• Xolair costs approximately $1,500 per injection, and there are much cheaper alternatives.