eISSN: 2299-0046
ISSN: 1642-395X
Advances in Dermatology and Allergology/Postępy Dermatologii i Alergologii
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1/2023
vol. 40
 
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abstract:
Original paper

The "real-world" effectiveness and safety of omalizumab in patients with uncontrolled persistent allergic asthma in Slovakia: a subgroup analysis of the eXpeRience study

Simona Siracká
1
,
Lenka Dzivá Tinková
1
,
Luděk Hochmuth
2
,
Helena Leščišinová
3
,
Martin Hrubiško
4
,
Katarína Dostálová
5
,
Miloš Jeseňák
6

  1. Novartis Slovakia s.r.o., Bratislava, Slovakia
  2. F.D. Roosevelt Hospital, Banská Bystrica, Slovakia
  3. NsP Sv. Jakuba, Bardejov, Slovakia
  4. Department of Clinical Immunology and Allergy, Oncology Institute of St. Elisabeth, Bratislava, Slovakia
  5. Outpatient pulmonology Clinic Rockmed s.r.o., Bratislava, Slovakia
  6. Department of Paediatrics, Department of Pulmonology and Phthisiology, Comenius University in Bratislava, Jessenius Faculty of Medicine in Martin, University Teaching Hospital, Martin, Slovakia
Adv Dermatol Allergol 2023; XL (1): 134-141
DOI: https://doi.org/10.5114/ada.2022.116532
Online publish date: 2022/06/01
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Introduction:
Omalizumab was proven to be effective and safe in patients with moderate-to-severe allergic asthma. However, there is no direct evidence of the benefits of add-on omalizumab in real-life practice in the Slovakian population.

Aim:
This subgroup analysis assessed the real-life effectiveness and safety of omalizumab in Slovakian patients with severe allergic asthma enrolled in the eXpeRience registry.

Material and methods:
Patients who commenced omalizumab 15 weeks prior to inclusion were assessed for the physicians’ global evaluation of treatment effectiveness (GETE), exacerbation rate, asthma symptoms, lung function, oral corticosteroid (OCS) use, rescue medication, hospitalizations, and school/work absenteeism at 16 weeks and 12 and 24 months.

Results:
Of 204 patients, 159 (77.9%) completed 2-year follow-up. As per GETE, 69.5% of patients treated with omalizumab achieved excellent/good response at 16 (±1) weeks. The proportion of patients with no severe clinically significant asthma exacerbations increased from 17.3% at pre-treatment to 82.4% and 92.0% at months 12 and 24, respectively. Maintenance OCS use was reduced to 17.0% and 15.3% of patients at 12 and 24 months, respectively, compared with 34.7% at baseline (BL). From BL until month 24, asthma control test scores improved from 11.6 to 20.3; rescue medication use/week decreased from 5.5 to 1.6 days; mean total number of days of asthma-related medical healthcare use decreased from 7.7 to 0.3 days and missed workdays decreased from 16.8 to 0.3 days. No new safety signals were observed.

Conclusions:
Add-on omalizumab was effective and well-tolerated in Slovakian patients, complementing the results observed in the overall population of eXpeRience.

keywords:

asthma exacerbations, global evaluation of treatment effectiveness, lung function, omalizumab, real-world evidence, severe allergic asthma
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