Omalizumab for severe allergic asthma in clinical trials and real-life studies: What we know and what we should address

Caminati, Marco; Senna, Gianenrico; Guerriero, Massimo; Dama, Annarita; Chieco-Bianchi, Fulvia; Stefanizzi, G; Montagni, Marcello; Ridolo, Erminia

doi:10.1016/j.pupt.2015.01.006

Cited by 28 publications

(22 citation statements)

References 62 publications

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“…In terms of efficacy, our findings were consistent with literature (10)(11)(12)(13)(14). While only 11.1% of our patients did not benefit from the treatment, 88.9% were benefited.…”

Section: Discussionsupporting

confidence: 92%

“…This study showed that long-term omalizumab administration was well tolerated in our patients, and it was safe and effective. In earlier studies and reviews, omalizumab treatment has proven to be effective and safe in severe allergic asthmatic cases (10)(11)(12). However, there were few studies on this subject in Turkey (13,14).…”

Section: Discussionmentioning

confidence: 99%

“…A literature review, which analyzed seven randomized clinical trials and 18 real-world data on omalizumab treatment in severe allergic asthma, showed that the duration of follow-ups was longer in studies reflecting the daily clinical practice better and real-life data than randomized clinical trials (18.29 vs 8.57 months) (12). From this point of view, the mean omalizumab treatment duration was 34.8±20.2 months in our study, which was relatively good compared to other studies.…”

Section: Discussionmentioning

confidence: 99%

See 2 more Smart Citations

Omalizumab Treatment in Patients with Severe Allergic Asthma

Tat¹,

Çilli²

2017

Istanbul Med J

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“…In terms of efficacy, our findings were consistent with literature (10)(11)(12)(13)(14). While only 11.1% of our patients did not benefit from the treatment, 88.9% were benefited.…”

Section: Discussionsupporting

confidence: 92%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Omalizumab Treatment in Patients with Severe Allergic Asthma

Tat¹,

Çilli²

2017

Istanbul Med J

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“…In fact, Omalizumab (Xolair®) is a recombinant DNA-derived humanized monoclonal antibody indicated as an add-on therapy in patients aged ≥ 6 years with severe persistent allergic asthma uncontrolled at treatment step 4 or 5 according to guidelines GINA (2). Omalizumab demonstrated to be efficacious both in adults and children (3)(4)(5). In particular, in real-life studies, anti-IgE therapy showed short-and long-term benefits in terms of improving lung function and quality of life, achieving asthma control and reducing symptomatology, severe exacerbations, healthcare resource utilizations, hospitalizations, emergency department visits and reducing or discontinuing other asthma medications thus confirming, complementing, and extending evidence from randomized trials (3,5).…”

Section: Introductionmentioning

confidence: 71%

Effects of omalizumab in severe asthmatics across ages: A real life Italian experience

Sposato

Scalese

Latorre

et al. 2016

Respiratory Medicine

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“…The results are consistent with the efficacy and safety profile of omalizumab as observed in RCTs. However, the comparative analysis between RCTs and real-life studies highlighted the need for further research, particularly into the long-term effects of omalizumab [30], since most previous real-life studies reflect a clinical observation lasting < 2 years in a relatively limited number of patients [11-29]. …”

Section: Introductionmentioning

confidence: 99%

Long-Term Omalizumab Treatment: A Multicenter, Real-Life, 5-Year Trial

Yorgancıoğlu

Erkekol²,

Mungan

et al. 2018

Int Arch Allergy Immunol

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Background: Omalizumab has demonstrated therapeutic benefits both in controlled clinical trials and real-life studies. However, research concerning the long-term effects and tolerability of omalizumab is needed. The main objective of this study was to evaluate the effectiveness and tolerability of treatment with omalizumab for up to 5 years. Methods: A multicenter, retrospective, chart-based study was carried out to compare documented exacerbations, hospitalizations, systemic steroid requirement, FEV₁, and asthma control test (ACT) results during 1 year prior to omalizumab treatment versus at 1, 3, and 5 years of treatment. Adverse events and reasons for discontinuation were also recorded at each time point. Results: Four hundred and sixty-five patients were enrolled in the study. Outcome variables had improved after the 1st year and were sustained after the 3rd and 5th years of treatment with omalizumab. Omalizumab treatment reduced the asthma exacerbation rate by 71.3% (p < 0.001) at 1 year, 64.3% (p < 0.001) at 3 years, and 54.8% (p = 0.002) at 5 years. The hospitalization rate also decreased; by the 5th year of the treatment no patients were hospitalized. ACT results had also improved significantly: 12 (p < 0.001) at 1 year, 12 (p < 0.001) at 3 years, and 12 (p = 0.002) at 5 years. Overall, 12.7% of patients reported adverse events (most of these were mild-to-moderate) and the overall dropout rate was 9.0%. Conclusion: Omalizumab had a significant effect on asthma outcomes and this effect was maintained over 5 years. The drug was found to be generally safe and treatment compliance was good.

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Omalizumab for severe allergic asthma in clinical trials and real-life studies: What we know and what we should address

Cited by 28 publications

References 62 publications

Omalizumab Treatment in Patients with Severe Allergic Asthma

Omalizumab Treatment in Patients with Severe Allergic Asthma

Effects of omalizumab in severe asthmatics across ages: A real life Italian experience

Long-Term Omalizumab Treatment: A Multicenter, Real-Life, 5-Year Trial

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