DÄ internationalArchive35-36/2015Marginal Effect and Little Clinical Relevance

Correspondence

Marginal Effect and Little Clinical Relevance

Dtsch Arztebl Int 2015; 112: 601. DOI: 10.3238/arztebl.2015.0601a

Mühlbauer, B; Sybrecht, G W

LNSLNS

Although the review by Lommatzsch and Virchow (1) may appear somewhat unsystematic, it at least provides a balanced overview of the basic aspects of the diagnosis and treatment of severe asthma. Therefore, the authors’ extremely positive description of the role of omalizumab in severe IgE-mediated asthma that remains inadequately controlled despite treatment with high-dose inhaled corticosteroids (ICS) plus LABA is even more surprising. According to the authors, omalizumab reduces the number of severe exacerbations by 50% while improving the quality of life on top of dramatically reducing the need for corticosteroids and having almost no side effects. An indispensable drug?

A thorough literature search focused on well-designed RCTs tells a different story—a story that is in line with the rather disappointing experiences pulmonologists have made with this drug in clinical practice where treatment with omalizumab showed only a marginal effect and was of little clinical relevance (2). In some studies, the effects were not even statistically significant compared with placebo (3). It is difficult to see why these recent studies from respected research organizations were not included in this review, and why it is not mentioned that in the cited, presumably pivotal study of Humbert et al.(4) the exacerbation rate reduction by just 26% (relative!) became statistically significant only after a statistical adjustment exercise. The authors’ advice that treatment with omalizumab is worth a try is difficult to comprehend given the information from the available data and the unpleasant (common and occasional) side effects listed in the prescribing information (Xolair®, July 2014 MS 08/14 V 002), including headache, upper abdominal pain, pharyngitis, syncope, paresthesia, sleepiness, dizziness, orthostatic hypotension, flushes, allergic bronchospasm, cough, dyspepsia, diarrhea, nausea, urticaria, and photosensitivity).

DOI: 10.3238/arztebl.2015.0601a

Prof. Dr. med. B. Mühlbauer

Institut für Pharmakologie, Klinikum Bremen Mitte

b.muehlbauer@pharmakologie-bremen.de

Prof. Dr. med. G. W. Sybrecht

Emeritus, Universitätsklinikum des Saarlandes

Conflict of interest statement
The authors declare that no conflict of interest exists.

1.
Lommatzsch M, Virchow JC: Severe asthma: definition, diagnosis and treatment. Dtsch Arztebl Int 2014; 111: 847–55 VOLLTEXT
2.
Hanania NA, Alpan O, Hamilos DL, et al.: Omalizumab in severe allergic asthma inadequately controlled with standard therapy: a randomized trial. Ann Intern Med 2011; 154: 573–82 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.
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
1.Lommatzsch M, Virchow JC: Severe asthma: definition, diagnosis and treatment. Dtsch Arztebl Int 2014; 111: 847–55 VOLLTEXT
2.Hanania NA, Alpan O, Hamilos DL, et al.: Omalizumab in severe allergic asthma inadequately controlled with standard therapy: a randomized trial. Ann Intern Med 2011; 154: 573–82 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.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

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