Food allergy, anaphylaxis, dermatology, and drug allergy
American Academy of Allergy, Asthma & Immunology/American College of Allergy, Asthma and Immunology Joint Task Force Report on omalizumab-associated anaphylaxis

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The American Academy of Allergy, Asthma & Immunology and the American College of Allergy, Asthma and Immunology Executive Committees formed the Omalizumab Joint Task Force with the purpose of reviewing the Genentech Xolair (omalizumab) clinical trials and postmarketing surveillance data on anaphylaxis and anaphylactoid reactions. Using the definition of anaphylaxis proposed at a 2005 multidisciplinary symposia, the Omalizumab Joint Task Force concluded that 35 patients had 41 episodes of anaphylaxis associated with Xolair (omalizumab) administration between June 1, 2003, and December 31, 2005. With 39,510 patients receiving Xolair (omalizumab) during the same period of time, this would correspond to an anaphylaxis-reporting rate of 0.09% of patients. Of those 36 events for which the time of reaction was known, 22 (61%) reactions occurred in the first 2 hours after one of the first 3 doses. Five (14%) of the events after the fourth or later doses occurred within 30 minutes. Considering the timing of these 36 events, an observation period of 2 hours for the first 3 injections and 30 minutes for subsequent injections would have captured 75% of the anaphylactic reactions. The OJTF report provides recommendations for physicians who prescribe Xolair (omalizumab) on (1) the suggested wait periods after administration and (2) patient education regarding anaphylaxis.

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Summary of AAAAI/ACAAI OJTF recommendations

  • 1.

    Informed consent should be obtained from the patient after discussing the risks, benefits, and alternatives to Xolair (omalizumab).

  • 2.

    The patient should be educated regarding the signs, symptoms, and treatment of anaphylaxis (Table I).1, 2

  • 3.

    Patients should be prescribed and educated on the proper use of the epinephrine autoinjector and advised to carry this before Xolair (omalizumab) administration and for the next 24 hours after Xolair (omalizumab) administration.

  • 4.

    An assessment of the patient's

Monoclonal antibodies and hypersensitivity reactions

Recombinant chimeric or fully humanized mAbs are increasingly part of medical treatment not only in chronic inflammatory and malignant disease but also in allergic disease. Hypersensitivity reactions to biologic agents, including anaphylaxis, have been well described.4, 5, 6 Anaphylaxis has been reported with several different mAbs, including omalizumab. However, the prevalence is low (ie, ≤0.2%) for Xolair (omalizumab).7 Such reactions, in general, are least to most common with human (100%

Incidence of potential Xolair (omalizumab) anaphylactic reactions

The OJTF reviewed a composite report provided by pharmaceutical firms that manufacture and market Xolair (omalizumab), Genentech and Novartis, dated May 3, 2006, that included the pivotal Xolair (omalizumab) clinical trials, as well as the postmarketing reports filed with the Food and Drug Administration between June 1, 2003, and December 31, 2005. Also reviewed was the information provided in the revised Xolair (omalizumab) package insert that included postmarketing reports from June 2003

OJTF conclusions and recommendations

Based on the data summarized above, the OJTF concluded that Xolair (omalizumab) should only be administered by a physician or other licensed health care provider who has been trained to recognize and treat anaphylaxis and who has available appropriate medications, equipment, and staff to respond to anaphylaxis.3 It would not be appropriate to administer Xolair (omalizumab) at home or in a facility that did not have appropriate staff and equipment to treat anaphylaxis. Direct observation for 2

Pre–Xolair (omalizumab) administration patient assessment

Before each Xolair (omalizumab) administration, an assessment of the patient's current health status should be made to determine whether there were any recent health changes that might require withholding treatment. The preinjection assessment should include measurement of vital signs, an assessment of asthma control, and some measurement of lung function (eg, peak expiratory flow rate or FEV1) at every visit (Fig 1). Prescribing physicians should provide guidelines on the actions staff should

Informed consent

The administration of Xolair (omalizumab) should be balanced with regard to the possibility of anaphylaxis, and the risk to a particular patient, as well as the benefit, should be discussed. Informed consent should be obtained before beginning Xolair (omalizumab), and this can be documented in the medical record or as a written consent form.

If the physician's recommendation differs from established guidelines (ie, practice parameters) or package insert information, this should be included in

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Disclosure of potential conflict of interest: I. Finegold is on the speakers' bureau for Novartis, Genentech, Alcon, Sanofi-Aventis, and Teva. L. B. Schwartz has consulting arrangements with GlaxoSmithKline, Genentech/Novartis, and Mast Cell Pharmaceuticals; has patent licensing arrangements with Phadia; has received grant support from the National Institutes of Health, the Philip Morris Foundation, GlaxoSmithKline, and Genentech/Novartis; and is on the speakers' bureau for Genentech/Novartis and Teva. T. A. E. Platts-Mills has consulting arrangements with Bristol-Meyers-Squibb. D. V. Wallace has declared that she has no conflict of interest.

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