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Omalizumab

A Review of its Use in the Management of Allergic Asthma

  • Adis Drug Evaluation
  • Published:
Treatments in Respiratory Medicine

Summary

Abstract

Omalizumab (Xolair®) is a humanized monoclonal antibody used in the treatment of adolescent and adult patients with moderate to severe allergic asthma inadequately controlled with inhaled corticosteroids (ICS). It selectively binds to circulating immunoglobulin E (IgE) and, thereby, prevents binding of IgE to mast cells and other effector cells. Without surface-bound IgE, these cells are unable to recognize allergens, thus preventing cellular activation by antigens and the subsequent allergic/asthmatic symptoms. Omalizumab decreases free serum IgE levels in a dose-dependent manner, reduces IgE receptor density on effector cells, and significantly improves airway inflammation parameters.

Omalizumab is slowly absorbed after subcutaneous administration, and mean elimination half-life is 26 days, thus allowing infrequent administration of the drug. Omalizumab dosage is determined by bodyweight and pretreatment serum total IgE levels. Patients treated with subcutaneous omalizumab in clinical trials received a dosage that was approximately equal to 0.016 mg/kg/IgE (IU/mL) per 4 weeks. Thus, patients received 150 or 300mg every 4 weeks, or 225, 300, or 375mg every 2 weeks.

In adults and adolescents (≥12 years of age) with moderate to severe allergic asthma, subcutaneous administration of omalizumab as add-on therapy with ICS improved the number of asthma exacerbations, rescue medication use, asthma symptom scores, and quality-of-life (QOL) scores compared with placebo during 28- and 32-week double-blind trials. In addition, concomitant ICS use was significantly decreased in patients receiving omalizumab, and in the two largest double-blind trials approximately 40% of omalizumab recipients completely withdrew from ICS therapy while maintaining effective asthma control. In general, results of extension studies showed that the beneficial effects of omalizumab were maintained over a total period of 52 weeks.

Omalizumab was well tolerated as add-on therapy with ICS during treatment for up to 52 weeks. Common adverse events in clinical trials included injection site reaction, viral infection, upper respiratory tract infection, sinusitis, headache, and pharyngitis, although the incidence of adverse events with omalizumab was similar to that with placebo.

Conclusion: Omalizumab, as add-on therapy with ICS, is an effective and well tolerated agent for the treatment of moderate to severe allergic asthma in adolescents and adults. In addition to its symptomatic and QOL benefits, omalizumab therapy allows ICS dosage reduction or discontinuation of ICS in many patients. Comparisons of omalizumab with other asthma therapies have yet to be conducted; however, clinical efficacy and tolerability data indicate that omalizumab is a valuable option in the treatment of allergic asthma.

Pharmacodynamic Properties

Omalizumab is a humanized recombinant immunoglobulin G (IgG) monoclonal antibody that selectively binds to the Cε3 domain of free IgE at the FcεR1 binding site. This, in turn, prevents IgE binding to mast cells and other effector cells, rendering them unable to detect allergens and, thereby, preventing the cellular activation by antigen and the associated allergic/asthmatic symptoms.

In patients with allergic asthma, omalizumab rapidly decreased serum free IgE levels in a dose-dependent manner. In clinical trials of 28 weeks’ duration, subcutaneous treatment with omalizumab resulted in median reductions in serum free IgE levels of 89–99%. After discontinuation of omalizumab therapy, serum free IgE levels slowly increased to the original level over a number of weeks to months.

In patients with allergic asthma, omalizumab decreased high-affinity IgE receptor expression by 2 log increments. Furthermore, median basophil FcεR1 density was decreased by ≈97% after 3 months of treatment with omalizumab in a study in patients with allergic rhinitis, with or without allergic asthma.

In patients with allergic asthma, treatment with omalizumab, but not placebo, significantly improved various mediators of airway inflammation. Sputum eosinophils were significantly reduced in patients treated with omalizumab when compared to placebo in a double-blind trial. In other studies, treatment with omalizumab decreased antigen-induced histamine release by 65–90% and cellular inflammatory late-asthmatic response by 80%. Statistically significant reductions were also observed in blood eosinophil counts, interleukin-13 levels, and skin-prick test reactivity with omalizumab versus placebo.

In well designed trials, treatment with omalizumab significantly attenuated the early- and late-phase asthmatic airway responses to an allergen challenge. Compared with baseline values in one study, the median concentration of allergen required to cause a fall in forced expiratory volume in 1 second (FEV1) of 15% (PC15) was increased by 2.7 doubling doses after 77 days of treatment with omalizumab.

Pharmacokinetic Properties

Subcutaneous omalizumab is slowly absorbed, with peak serum concentrations observed after an average of 7–8 days. Mean absolute bioavailability of omalizumab is 62% and the drug demonstrates linear pharmacokinetics at doses >0.5 mg/kg. The distribution volume of omalizumab is 78 mL/kg.

In patients with allergic asthma, the terminal elimination half-life averaged 26 days, with an apparent clearance of 2.4 mL/kg/day. On the basis of data from animal studies, urinary excretion appears to be the major route of elimination.

Therapeutic Efficacy

Subcutaneous omalizumab ≥0.016 mg/kg/IgE (IU/mL) per 4 weeks, as add-on therapy with inhaled corticosteroids (ICS), significantly reduced the mean number of asthma exacerbations per patient and the percentage of patients experiencing an acute exacerbation during 28 or 32 weeks of therapy. In the two largest, double-blind, randomized studies, 14.6% and 12.8% of omalizumab recipients experienced an asthma exacerbation during the 16-week stable-corticosteroid period compared with 23.3% and 30.5% of those in the placebo group. Corresponding values for the 12-week corticosteroid-reduction phase were 21.3% and 15.7% for omalizumab compared with 32.3% and 29.8% with placebo. All comparisons between omalizumab and placebo were statistically significant (p < 0.01).

In the two largest, double-blind, randomized trials, subcutaneous omalizumab significantly improved asthma scores and decreased rescue β2-agonist use when compared with placebo. In one of the trials, for example, mean asthma scores improved from 4.31 at baseline to 2.51 and 2.36 after 16 and 28 weeks of omalizumab therapy, and rescue medication use decreased by ≈30% at endpoint (28 weeks). Morning peak expiratory flow rate and/or FEV1 values were improved at various timepoints in patients receiving omalizumab, but not in those receiving placebo, during the stable-corticosteroid and corticosteroid-reduction phases of the two well designed studies. However, these results should be interpreted with caution, as absolute improvements in these parameters were small and may not have been clinically meaningful.

During the 12-week corticosteroid-reduction phase in the two large trials, the dosage of ICS was significantly reduced in patients receiving omalizumab compared with placebo, without a loss of asthma control. More than 50% of omalizumab recipients achieved a ≥50% reduction in ICS dosage. Median reductions in beclomethasone dipropionate (BDP) dosages of 75% and 80% were reported for omalizumab-treated patients compared with 50% and 47% in placebo recipients (all p < 0.001). In addition, approximately 40% of omalizumab recipients completely withdrew from ICS treatment during this period.

In several well designed studies evaluating patient quality of life (QOL), subcutaneous omalizumab for 28–32 weeks increased overall Asthma QOL Questionnaire (AQLQ) scores from baseline by 0.47–0.93 points and by 0.61–1.05 points during the stable-corticosteroid and corticosteroid-reduction phases, respectively. In comparison, increases of 0.26–0.66 and 0.24–0.7 points were reported for placebo recipients during the same time periods in these trials (p < 0.05 for all comparisons). In general, improved QOL scores were maintained throughout the corticosteroid-reduction phase of study in all trials, and, in some studies, a greater proportion of patients receiving omalizumab than placebo achieved clinically significant improvements of ≥0.5 points from baseline in AQLQ scores.

In general, extensions of double-blind randomized trials with omalizumab showed that the beneficial effects of the drug are maintained during therapy for 1 year.

Tolerability

Omalizumab was generally well tolerated in adolescents and adults with allergic asthma in clinical trials. Adverse effects following omalizumab administration for up to 52 weeks were mostly mild-to-moderate in severity and occurred at a similar frequency to those in placebo recipients. Common adverse events reported in adult and adolescent patients with allergic asthma who received omalizumab in controlled clinical trials were injection site reaction (45%), viral infection (23%), upper respiratory tract infection (20%), sinusitis (16%), headache (15%), and pharyngitis (11%). The most common local reactions with subcutaneous omalizumab include bruising, redness, warmth, and itching. Most injection site reactions occur within 1 hour of administration of omalizumab, and their frequency usually decreases with continued use of the drug.

Dosage and Administration

Omalizumab is indicated in the US for the treatment of moderate-to-severe persistent asthma in adults and adolescents (aged ≥12 years) who have a positive skin-prick test or in vitro reaction to a perennial aeroallergen and whose asthma is inadequately controlled with ICS. The drug is administered by subcutaneous injection at a dosage of 150 or 300mg every 4 weeks, or 225, 300, or 375 mg every 2 weeks based on patient bodyweight and pretreatment serum total IgE levels. Multiple delivery sites should be used for doses of >150mg. Corticosteroid dosage reduction should be attempted gradually over the course of several weeks under the direction of a physician.

Pretreatment rather than current serum total IgE levels should be used to determine dosage requirements if treatment has lapsed for a period of <12 months. Serum total IgE levels may be retested for dose determination if treatment has been stopped for ≥1 year. There is currently no commercially available test to monitor serum free IgE levels during omalizumab therapy.

Subcutaneous omalizumab has not been evaluated in patients with pretreatment serum total IgE levels above 700 IU/mL. Because of a lack of data in this patient population there are concerns regarding both efficacy and tolerability of omalizumab. Consequently, there are no dosage recommendations for omalizumab in patients with pretreatment serum total IgE levels >700 IU/mL, thus precluding its use in a proportion of patients with difficult to treat asthma.

Omalizumab is contraindicated in patients who have previously experienced a severe hypersensitivity reaction to the drug. Patients should be monitored after injection of omalizumab for possible anaphylaxis and medications for the treatment of hypersensitivity reactions, including anaphylaxis, should be available. The use of omalizumab in pregnant women has not been adequately evaluated and, as such, the drug should be used with caution in these patients.

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Notes

  1. 1 The use of trade names is for product identification purposes only and does not imply endorsement.

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Authors and Affiliations

  1. Adis International Inc., 770 Township Line Road, Suite 300, Yardley, Pennsylvania, 19067, USA

    Lynne M. Bang & Greg L. Plosker

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Additional information

Data Selection

Sources: Medical literature published in any language since 1980 on omalizumab, identified using Medline and EMBASE, supplemented by AdisBase (a proprietary database of Adis International). Additional references were identified from the reference lists of published articles. Bibliographical information, including contributory unpublished data, was also requested from the company developing the drug.

Search strategy: Medline search terms were ‘omalizumab’ or ‘monoclonal-antibody-E25’. EMBASE search terms were ‘omalizumab’ AdisBase search terms were ‘omalizumab’ or ‘monoclonal-antibody-E25’ or ‘rhuMAb-E25’. Searches were last updated 5 May, 2004.

Selection: Studies in patients with allergic asthma who received omalizumab. Inclusion of studies was based mainly on the methods section of the trials. When available, large, well controlled trials with appropriate statistical methodology were preferred. Relevant pharmacodynamic and pharmacokinetic data are also included.

Index terms: Omalizumab, asthma, monoclonal antibody, pharmacodynamics, pharmacokinetics, therapeutic use.

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Bang, L.M., Plosker, G.L. Omalizumab. Treat Respir Med 3, 183–199 (2004). https://doi.org/10.2165/00151829-200403030-00006

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