Omalizumab in patients with severe asthma: the XCLUSIVE study

Schümann, Christian; Kropf, Cornelia; Wibmer, Thomas; Rüdiger, S; Stoiber, K; Thielen, A.; Rottbauer, Wolfgang; Kroegel, Claus

doi:10.1111/j.1752-699x.2011.00263.x

Cited by 74 publications

(54 citation statements)

References 31 publications

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“…Omalizumab add-on treatment in the Czech Republic sub-population resulted in considerable reductions in the daytime and nocturnal symptoms, limitations of activities, and rescue medication use, which was comparable with results seen in the overall population of the eXpeRience registry and other real-life studies [10,11,13,[25][26][27][28][29]. There was also a considerable reduction from baseline in the number of patients on OCS maintenance therapy (n = 38) to 24 months after the treatment (n = 18) along with a 44.8% reduction in the total daily dose from 11.6 mg at baseline (prednisolone equivalent) to 6.4 mg at month 24.…”

Section: Discussionsupporting

confidence: 66%

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

Kirchnerová¹,

Valena²,

Novosad³

et al. 2019

pdia

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A b s t r a c tIntroduction: This was a sub-group analysis of patients with uncontrolled persistent allergic asthma (AA) in the healthcare setting of the Czech Republic, from a global non-interventional, 2-year post-marketing, observational eXpeRience registry. Aim: To evaluate the real-life effectiveness and safety of omalizumab. Material and methods: Patients with uncontrolled persistent AA (currently defined by the Global Initiative for Asthma (GINA) as uncontrolled severe AA) who started omalizumab treatment 15 weeks before inclusion in the registry were analysed for physicians' global evaluation of treatment effectiveness (GETE), asthma symptoms, corticosteroid use, exacerbation rate, asthma control, quality of life, healthcare utilisation and safety during a 24-month observation period. Results: One hundred and fourteen patients from the Czech Republic were enrolled in the eXpeRience registry. A total of 88.9% of the patients were evaluated as responders to omalizumab according to the GETE assessment at week 16. From baseline to month 24: mean change in forced expiratory volume in 1 s (FEV 1 ) was 137 ml and the daily dose of OCS decreased (11.6 mg to 6.4 mg prednisolone equivalent); the percentage of patients with no severe clinically significant exacerbations increased (29.5% to 95.1%); Asthma Control Test scores improved (12.4 to 17.3) and mean total number of days of asthma-related medical healthcare use decreased (6.8 days to 0.4 days). Conclusions: The results of this subgroup analysis support the evidence that add-on omalizumab therapy is effective and well tolerated for management of patients with uncontrolled persistent AA in the Czech Republic. Global evaluation of treatment effectiveness assessment is a reliable predictor of long-term response to omalizumab treatment.

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Section: Discussionsupporting

confidence: 66%

“…Only 1 patient reported SAE that was considered to be study treatment related. The frequency of SAEs reported in the Czech Republic subgroup population (5.4%) was similar to that reported in the global eXpeRience registry (6.9%) and various clinical studies (3% to 6%) [25,36,37]. The single death reported was not related to omalizumab.…”

Section: Discussionsupporting

confidence: 65%

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

Kirchnerová¹,

Valena²,

Novosad³

et al. 2019

pdia

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“…All the subjects had a follow-up visit in the 16 th week; the researchers managed to monitor condition of 173 (88.7%) patients for 6 months. The obtained results are as follows: reduced number of exacerbations and need in adjunctive therapy, improved FEV 1 and asthma control parameters; this indicates effectiveness and high tolerance to the treatment and confirms the previously obtained positive data; this also allows extrapolating RCT results to the real clinical practice [30]. Moreover, projects of long-term clinical monitoring of patient populations with BA treated with omalizumab (in addition to the baseline treatment) were implemented in Mexico (52 15-67-years-old patients undergoing a 3-years-long therapy course) [31], Italy (142 patients; 1 year) [32], Portugal (15 adult patients; the trial was aimed at identifying short-and long-term [1-2 years] effects of the drug) [33] and Turkey (18 adult patients; course therapy duration varied from 1 to 29 months) [34].…”

Section: Registers Of Allergic Diseasessupporting

confidence: 70%

“…The results obtained by means of this register provide convincing proof that omalizumab's clinical effectiveness registered previously by means of RCTs is quite reproducible in the normal practice [29]. The clinical monitoring project implemented in Germany involved 195 over-12 patients from 85 centers (in total) [30]. All the subjects had a follow-up visit in the 16 th week; the researchers managed to monitor condition of 173 (88.7%) patients for 6 months.…”

Section: Registers Of Allergic Diseasesmentioning

confidence: 94%

Universal information structure as a tool of long-term follow-up monitoring in allergology

Вишнева¹,

Намазова-баранова²,

Antonova³

et al. 2014

PPh

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“…In the German registry real life study, omalizumab treatment decreased exacerbations by 75% at the 16 th week (19). Real-life data from 14 countries…”

Section: Discussionmentioning

confidence: 99%

Comparison of allergic asthma patients treated with omalizumab and non-allergic patients treated with continuous oral corticosteroids: results of five year follow-up therapies

Gemicioğlu¹,

Öztürk²,

Duman³

2016

Tuberk Toraks

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SUMMARY Comparison of allergic asthma patients treated with omalizumab and non-allergic patients treated with continuous oral corticosteroids: results of five year follow-up therapies Introduction: To assess the long-term (5 year) efficacy of omalizumab and systemic corticosteroid therapy in allergic and non-allergic asthma that could not be controlled by step 4 therapy, respectively. Patients and Methods:This single-center study was based on all consecutive step 4 patients with severe persistent uncontrolled allergic and non-allergic asthma who were given omalizumab and systemic corticosteroid (minimum: 4 mg, maximum: 12 mg, median: 8 mg methyl prednisone), respectively, in 2006-2014 and were Comparison of allergic asthma patients treated with omalizumab and non-allergic patients treated with continuous oral corticosteroids: results of five year follow-up therapies INTRODUCTIONThe great majority of patients with severe asthma are step 4 asthmatics, meaning that their asthma can be controlled with high doses of inhaled corticosteroids and long acting β2 agonists. However, the remaining patients with severe asthma are candidates for step 5 treatment, as their condition cannot be controlled with step 4 medications (1-3). Since these patients have severe asthma, require many medications, frequently visit emergency rooms, and are often hospitalized, this condition places a significant burden on both the patients and the health care system (4,5).Around 5-10% of patients with asthma have severe asthma. IgE-mediated immune mechanisms are thought to play a role in over 50% of these patients (6). Omalizumab is a recombinant humanized monoclonal antibody that complexes with free IgE, thereby preventing it from adhering to specific receptors on mast cells and basophils (FcRI). Omalizumab therefore acts as a potent antiinflammatory agent in patients with severe perennial allergic asthma (7). Three studies with follow-up periods of 0.5, 4 and 7 years found that omalizumab effectively decreases asthma exacerbations, lowers steroid doses, and imposes better asthma control (8-10). Four randomized controlled studies of omalizumab also showed that it decreases asthmarelated symptoms, reduces corticosteroid use, and improves quality of life (11-14).In recent years, case reports and a Spanish multicenter registry study showed that omalizumab is also effective in non-allergic asthma (15). Thereafter, research efforts turned to assessing the usefulness of omalizumab in patients with non-allergic asthma.However, at present, the guidelines state that when non-allergic asthma is even unresponsive to macrolide or tiotropium medications and another diagnosis cannot be made, oral corticosteroid or anticytokine treatments should be administered (16,17). However, the long-term outcomes of patients with non-allergic step 5 asthma who do not accept treatment with continuous oral steroids remain unclear.The present cohort study was performed to determine the outcomes over a 5 year follow-up period of patients whose severe persistent asthma w...

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Omalizumab in patients with severe asthma: the XCLUSIVE study

Cited by 74 publications

References 31 publications

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

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

Universal information structure as a tool of long-term follow-up monitoring in allergology

Comparison of allergic asthma patients treated with omalizumab and non-allergic patients treated with continuous oral corticosteroids: results of five year follow-up therapies

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