We like to thank our colleagues Mühlbauer, Sybrecht and Tasci for reading our article (1). In view of the available literature and clinical experience, the role of omalizumab in the treatment of severe asthma has been correctly represented in our article (1). The opinion held by our colleague Mühlbauer that omalizumab is of no pharmacological value is not comprehensible. Likewise, the ‘disappointing experiences’ our colleague Sybrecht has made with omalizumab cannot be generalized. Frequently, omalizumab treatment achieves better than expected improvements in clinically relevant parameters, such as exacerbation rate, in carefully phenotyped patients with severe, IgE-mediated asthma. Data from the available studies, which are only superficially cited by our colleagues Mühlbauer and Sybrecht, reflect this situation: In the pivotal study by Humbert et al. published in 2005, a 50% reduction of the incidence of severe exacerbations was observed in patients treated with omalizumab—and that without any “statistical adjustment exercise“ (2). For this reason, we mentioned this result in our article (1). In contrast, the study by Bardelas et al. did not have exacerbations, but, among other parameters, an unvalidated, vague 5-point scale, reflecting the impression of the examiner regarding treatment success (IGETE), as an endpoint (3). However, the primary aim of omalizumab treatment is to reduce the incidence of severe exacerbations which is of high clinical relevance especially in patients with severe asthma (4). The commentators’ opinion that treatment with omalizumab is “not even worth a try” in these patients does neither do justice to the scientific evidence, nor is it in line with clinical experience. In addition, it does not reflect the clinical reality of treating patients with omalizumab. To simply provide a list of side effects from the summary of product characteristics is actually misleading: Even the RCTs cited by the authors reported side effects a tplacebo level (3). We think that the concerns of Mühlbauer and Sybrecht are proven unfounded by the very studies they have cited. Therefore, we encourage an approach which is not limited to the pharmacological perspective but also draws from clinical experience and insights from real-life studies. Consequently, we continue to recommend to try omalizumab treatment in patients with severe IgE-mediated asthma, as this approach is well supported by both scientific evidence and clinical experience.
We welcome our colleague Tasci’s reference to sleep-related breathing disorder as a comorbidity in patients with asthma and like to point out that this association is highlighted in our article in the “Adherence, triggers, and comorbidities“ section (1).
Prof. Dr. med. Marek Lommatzsch
Prof. Dr. med. Johann Christian Virchow
Abteilung für Pneumologie/interdisziplinäre internistische Intensivstation
Conflict of interest statement
Prof. Lommatzsch has received consultancy and lecture fees and reimbursement of travel and participation costs from Allergopharma, Astra Zeneca, Bencard, Berlin-Chemie, Boehringer-Ingelheim, Chiesi, GSK, Janssen-Cilag, MSD, Mundipharma, Novartis, Nycomed/Takeda, TEVA, and UCB. He has also received fees for commissioned clinical trials from Astra Zeneca and research funding from GSK.
Prof. Virchow has received consultancy and lecture fees and reimbursement of travel and participation costs from Allergopharma, Astra Zeneca, Avontec, Bayer, Bencard, Berlin-Chemie, Bionorica, Boehringer-Ingelheim, Chiesi, Essex/Schering-Plough, GSK, Janssen-Cilag, Leti, MEDA, Merck, MSD, Mundipharma, Novartis, Nycomed/Takeda, Pfizer, Revotar, Roche, Sanofi-Aventis, Sandoz-Hexal, Stallergens, TEVA, UCB, and Zydus/Cadila. He has also received research funding from GSK and MSD.
|1.||Lommatzsch M, Virchow JC: Severe asthma: definition, diagnosis and treatment. Dtsch Arztebl Int 2014; 111: 847–55 VOLLTEXT|
|2.||Humbert M, Beasley R, Ayres J, et al.: Benefits of omalizumab as add-on therapy in patients with severe persistent asthma who are inadequately controlled despite best available therapy (GINA 2002 step 4 treatment): INNOVATE. Allergy 2005; 60: 309–16 CrossRef MEDLINE|
|3.||Bardelas J, Figliomeni M, Kianifard F, Meng X: A 26-week, randomized, double-blind, placebo-controlled, multicenter study to evaluate the effect of omalizumab on asthma control in patients with persistent allergic asthma. J Asthma 2012; 49: 144–52 CrossRef MEDLINE|
|4.||Lommatzsch M, Korn S, Buhl R, Virchow JC: Against all odds: anti-IgE for intrinsic asthma? Thorax 2014; 69: 94–6 CrossRef MEDLINE PubMed Central|