Long-term “real-life” safety of omalizumab in patients with severe uncontrolled asthma: A nine-year study

Abstract

Long-term treatment with omalizumab appears remarkably safe and well tolerated in real-life setting. Prolonged omalizumab treatment for many consecutive years did not increase the risk of side effects, particularly anaphylaxis.

Short- and long-term real-world effectiveness of omalizumab in severe allergic asthma: systematic review of 42 studies published 2008-2018

“…Our prior review provided strong evidence for the short-term (16 weeks to 1 year) effectiveness of omalizumab, and emergent yet still tentative evidence that the effectiveness may extend up to 2 to 4 years. This present review firmly establishes the short-term effectiveness of omalizumab at 16 weeks and 1 year, and provides strong evidence of its long-term effectiveness: seven studies reported outcomes at 2 years [37,39,43,45,60,70,76], seven studies at 3 years or more [36,47,58,63,64,66,70,73], one study at 4 years [36], and one study with a mean follow-up of 60.7 months followed patients for as long as 121 months [66]. Thus, our review provides strong evidence on the major outcomes of interest for up to 2 to 4 years; and emergent evidence reaching well beyond 4 years.…”

“…To minimize bias, non-significant results reported in the original publication were included in our pooled estimates. Table 1 summarizes the 42 studies stratified by 30 adult-only studies [24,26,27,[30][31][32][33][34][35][36][37][40][41][42][43][44][45][46][47][58][59][60][61][62][63][64][65][66][67][68] (n = 3558) and 12 adult/ adolescent studies [25,38,39,56,57,[69][70][71][72][73][74][75][76][77] (n = 5819). These 42 studies comprised a total of 9377 patients from 35 countries: 25 in Europe (incl.…”

Monoclonal antibodies for the treatment of severe asthma

“…To date, there appears to be no evidence of an increased risk of infection, although dupilumab may cause eosinophilia (<2% of patients vs 0.5% with placebo in clinical trials) . Clinical experience has been longest with omalizumab and small studies report generally good tolerability in patients who continue treatment for up to nine years (though others stopped treatment sooner due to adverse effects) . Anti‐drug antibodies may occur but do not appear to affect efficacy.…”

The use of biologics in children with allergic rhinitis and chronic rhinosinusitis: Current updates

“…Current recommendations include monitoring patients for 2 hours after each of the first 3 three doses, and a 30‐minute observation period after the administration of every subsequent doses . Omalizumab administration has also been associated with cardiovascular complications such as pulmonary embolism, deep vein thrombosis, myocardial infarction, and unstable angina, as well as malignancy . In addition to the need to be vigilantly aware of the potential complications and monitor the patient accordingly, there is a requirement for frequent monitoring of body weight and IgE levels, and appropriate adjustment of dosage and frequency based on those parameters.…”

“…1,21,23 Omalizumab administration has also been associated with cardiovascular complications such as pulmonary embolism, deep vein thrombosis, myocardial infarction, and unstable angina, as well as malignancy. 14,20,24 In addition to the need to be vigilantly aware of the potential complications and monitor the patient accordingly, there is a requirement for frequent monitoring of body weight and IgE levels, and appropriate adjustment of dosage and frequency based on those parameters. Frequent monitoring of IgE levels requires frequent blood taking, which may not be an easy task in children.…”