Real-world effectiveness and safety of omalizumab in patients with uncontrolled severe allergic asthma from the Czech Republic

Kirchnerová, Olga; Valena, Tomáš; Novosad, Jakub; Teřl, Milan

doi:10.5114/ada.2018.76606

Cited by 13 publications

(20 citation statements)

References 32 publications

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“…Some real-world international studies have been carried out on omalizumab [74,77,80]. A very large study [74] on an international registry database showed that of the 49.8% of uncontrolled persistent allergic asthmatic patients receiving OCS at baseline, the proportion of those receiving OCS was reduced to 16.1% and 14.2% after 1 year and 2 years of treatment with omalizumab, respectively.…”

Section: Omalizumabmentioning

confidence: 99%

See 1 more Smart Citation

Oral Corticosteroids Dependence and Biologic Drugs in Severe Asthma: Myths or Facts? A Systematic Review of Real-World Evidence

Calzetta

Aiello

Frizzelli

et al. 2021

IJMS

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Airway inflammation represents an important characteristic in asthma, modulating airflow limitation and symptom control, and triggering the risk of asthma exacerbation. Thus, although corticosteroids represent the cornerstone for the treatment of asthma, severe patients may be dependent on oral corticosteroids (OCSs). Fortunately, the current humanised monoclonal antibodies (mAbs) benralizumab, dupilumab, mepolizumab, omalizumab, and reslizumab have been proven to induce an OCS-sparing effect in randomized controlled trials (RCTs), thus overcoming the problem of OCS dependence in severe asthma. Nevertheless, a large discrepancy has been recognized between selected patients enrolled in RCTs and non-selected asthmatic populations in real-world settings. It is not possible to exclude that the OCS-sparing effect of mAbs resulting from the RCTs could be different than the real effect resulting in clinical practice. Therefore, we performed a systematic review and correlation analysis to assess whether mAbs are effective in eliciting an OCS-sparing effect and overcoming the OCS dependence in severe asthmatic patients in real-world settings. Overall, real-world studies support the evidence that OCS dependence is a real condition that, however, can be found only in a small number of really severe asthmatic patients. In most patients, the dependence on OCS can be related to modifying factors that, when adequately modulated, may lead to a significant reduction or suspension of OCS maintenance. Conversely, in severe asthmatics in whom OCS resistance is proved by a high daily dose intake, mAbs allow reversion of the OCS dependence, leading to the suspension of OCS therapy in most patients or >50% reduction in the daily OCS dose.

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Section: Omalizumabmentioning

confidence: 99%

“…Data from a large international registry database showed that in severe uncontrolled allergic asthmatic patients observed for 2 years, omalizumab decreased by 52.6% the proportion of subjects on OCS. The dose of OCS was reduced from 11.6 mg/day to 6.4 mg/day [80].…”

Section: Omalizumabmentioning

confidence: 99%

Oral Corticosteroids Dependence and Biologic Drugs in Severe Asthma: Myths or Facts? A Systematic Review of Real-World Evidence

Calzetta

Aiello

Frizzelli

et al. 2021

IJMS

View full text Add to dashboard Cite

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“…Only these centers are eligible to indicate biological treatment with anti-IgE antibody (omalizumab) in the CR [7,47]. This careful approach may contribute to the higher number of responders (according to GETE) in the eXpeRience registry (88.9%) [15] than in data from other countries (69.9%) [48]. Extensive supervision of patients in the NCTA centers can result in better treatment outcomes with respect to some parameters in all groups of patients.…”

Section: Discussionmentioning

confidence: 99%

“…Currently, the Global Initiative for Asthma (GINA) recommends targeted biological therapy before the administration of systemic corticosteroids (SCSs) in step 5 of the integrated treatment strategy, wherever possible. The broad clinical effects of omalizumab have been extensively documented in controlled studies [9,10] and real-world studies [11][12][13][14][15].…”

Section: Introductionmentioning

confidence: 99%

Effect of individual allergen sensitization on omalizumab treatment outcomes in patients with severe allergic asthma determined using data from the Czech Anti-IgE Registry

Vanik

Novosad

Kirchnerová

et al. 2020

Allergy Asthma Clin Immunol

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Background Omalizumab is an efficient drug for patients with uncontrolled severe allergic asthma (SAA). However, little is known about the differences in omalizumab treatment outcomes among patients with different types of atopic sensitization. Here, we assessed the effect of sensitization to individual allergens or their combinations on the outcomes of anti-IgE therapy in patients with SAA. Methods We performed a post hoc analysis of data of subgroups of patients enrolled in the Czech Anti-IgE Registry (CAR). The patients were evaluated at baseline and 16 weeks and 12 months after omalizumab treatment initiation. We analyzed the dependence of primary treatment outcomes [global evaluation of treatment effectiveness (GETE) after 16 weeks of treatment, a reduction in severe exacerbation rate (ER), and an improvement in the asthma control test (ACT) result during 12 months of treatment] and secondary outcomes [a reduction in systemic corticosteroid (SCS) use, an improvement in lung functions, and a fraction of exhaled nitric oxide] of patients with SAA treated with omalizumab for 12 months on sensitization to different perennial aeroallergens. We assessed sensitization to house dust mites, molds, and pets at baseline using skin prick tests and/or specific IgE measurement (semiquantitative evaluation). We compared polysensitized patients (sensitized to all tested allergens) with monosensitized (single positivity) or partially polysensitized patients (combined positivity but not to all allergens). Results We enrolled 279 patients (58.3% women, mean age 52.9 years). Omalizumab treatment presented an 82.8% response rate (according to GETE). It significantly reduced severe asthma exacerbations and SCS use, and improved the ACT result in 161 responders. We identified a subgroup of responders with distinct sensitization patterns (polysensitization to all tested perennial allergens) with higher odds of being responders (OR = 2.217, p = 0.02) and lower tendency to improve ACT result (OR 0.398, p = 0.023) and reduce ER (OR 0.431, p = 0.034) than non-polysensitized patients. Conclusions The clinical benefit of sensitization for patients with SAA receiving omalizumab may be particularly dependent on sensitization pattern. Polysensitized patients showed a higher tendency to be responders (GETE), but a lower tendency to improve the ACT result and reduce ER than non-polysensitized patients.

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“…It has been successfully used as a supplementary therapy to improve asthma control in children aged ≥ 6 years with severe persistent allergic asthma who experience frequent symptoms and have asthma exacerbation despite the use of high-dose inhaled corticosteroids (ICS) and long-acting β2-agonists (LABA) [ 4 ]. The efficacy and safety of anti-IgE therapy was documented in several studies [ 5 – 11 ], however the observational, real-life studies including asthma control after omalizumab discontinuation are still poor due to a relatively short period of anti-IgE therapy use.…”

Section: Introductionmentioning

confidence: 99%

Effectiveness of omalizumab in children and adolescents with uncontrolled allergic asthma: a case series from Poland

Sztafińska¹,

Gwardys²,

Podlecka³

et al. 2021

pdia

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Introduction Omalizumab has been successfully used as a supplementary therapy to improve asthma control in children aged ≥ 6 years with moderate or severe persistent allergic asthma. Aim To evaluate effectiveness ofomalizumab in children and adolescents with uncontrolled allergic asthma. Material and methods Seventeen children and adolescents aged 8–16, treated with omalizumab from 2011 until now, were enrolled into the retrospective, open, uncontrolled, observational study. The effectiveness of therapy, asthma control, quality of life, exacerbation rate, corticosteroid use, were assessed after 16, 52 and 104 weeks of treatment and after omalizumab cessation. Results The response to treatment was assessed as excellent (9 patients) and good (6 patients), according to global evaluation of treatment effectiveness (GETE). A statistically significant decrease in use of oral corticosteroids (OCS) and leukotriene receptor antagonists (LTRAs) was observed. The doses of inhaled corticosteroids (ICS) decreased significantly (the mean dose of ICS converted to a dose of budesonide before treatment was 1503.53 μg/day versus 903.53 μg after discontinuation). The mean asthma control questionnaire (ACQ) value decreased from 2.10 to 0.84 points and the mean mini asthma quality of life questionnaire (miniAQLQ) outcome increased from 4.37 to 6.1 points. The mean number of exacerbations decreased from 5.59 to 0.53 per year. Conclusions Our results are supportive of the existing evidence that omalizumab therapy improves asthma control, reduces OCS and ICS use, decreases exacerbations in children and adolescents with severe/moderate uncontrolled allergic asthma.

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Real-world effectiveness and safety of omalizumab in patients with uncontrolled severe allergic asthma from the Czech Republic

Cited by 13 publications

References 32 publications

Oral Corticosteroids Dependence and Biologic Drugs in Severe Asthma: Myths or Facts? A Systematic Review of Real-World Evidence

Oral Corticosteroids Dependence and Biologic Drugs in Severe Asthma: Myths or Facts? A Systematic Review of Real-World Evidence

Effect of individual allergen sensitization on omalizumab treatment outcomes in patients with severe allergic asthma determined using data from the Czech Anti-IgE Registry

Effectiveness of omalizumab in children and adolescents with uncontrolled allergic asthma: a case series from Poland

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