Persistency of response to omalizumab therapy in severe allergic (IgE‐mediated) asthma

• Published in: Allergy (Copenhagen) 2011-05, Vol.66 (5), p.671-678
• Main Authors: Bousquet, J., Siergiejko, Z., Świebocka, E., Humbert, M., Rabe, K. F., Smith, N., Leo, J., Peckitt, C., Maykut, R., Peachey, G.
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Aged; Allergic asthma; Anti-Asthmatic Agents - therapeutic use; Antibodies, Anti-Idiotypic - therapeutic use; Antibodies, Monoclonal - therapeutic use; Antibodies, Monoclonal, Humanized; Asthma; Asthma - drug therapy; Biological and medical sciences; Child; Classification; Dermatology; Drug therapy; Effectiveness studies; Follow-Up Studies; Fundamental and applied biological sciences. Psychology; Fundamental immunology; Humans; Hypersensitivity; Immunoglobulin E; Inventories; Medical sciences; Middle Aged; Monoclonal antibodies; Omalizumab; omalizumab, persistency; response; Sarcoidosis. Granulomatous diseases of unproved etiology. Connective tissue diseases. Elastic tissue diseases. Vasculitis; Time Factors; Treatment Outcome
• ISSN: 0105-4538; 1398-9995
• DOI: 10.1111/j.1398-9995.2010.02522.x

To cite this article: Bousquet J, Siergiejko Z, Świebocka E, Humbert M, Rabe KF, Smith N, Leo J, Peckitt C, Maykut R, Peachey G. Persistency of response to omalizumab therapy in severe allergic (IgE‐mediated) asthma. Allergy 2011; 66: 671–678. Background:  The physician’s global evaluation of treatment effectiveness (GETE) at 16 weeks has been shown to be the most effective assessment of response to omalizumab (XOLAIR®). This randomized, open‐label, parallel‐group study evaluated the persistency of treatment responder classification in patients receiving omalizumab added to optimized asthma therapy (OAT). Methods:  Patients (12–75 years, n = 400) with severe allergic asthma, uncontrolled despite Global Initiative for Asthma 2004 Step 4 therapy, received OAT and omalizumab (n = 272) or OAT (n = 128) for 32 weeks. Response or nonresponse was evaluated at Weeks 16 and 32. Response was defined as an investigator’s (physician’s) GETE rating of excellent or good; nonresponse was defined as a rating of moderate, poor or worsening. Results:  Three hundred and forty‐nine patients had GETE ratings available at Weeks 16 and 32 (omalizumab n = 258, OAT n = 91). Omalizumab responders of about 171/187 (91.4%)and 44/71 (62.0%) omalizumab nonresponders at Week 16 persisted as responders or nonresponders at Week 32. The investigator’s GETE at Week 16 predicted persistency of response or nonresponse to omalizumab at Week 32 for 83.3% (215/258) of patients. OAT patients showed a lower persistency of response (18/28 [64.3%]) and a higher persistency of nonresponse (57/63 [90.5%]) than omalizumab patients. Excellent and good GETE ratings in omalizumab‐treated patients were reflected by improvements in exacerbation rates (P