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

Abstract

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...

Systematic literature review of the clinical, humanistic, and economic burden associated with asthma uncontrolled by GINA Steps 4 or 5 treatment

“…Our SLR identified 83 primary studies with epidemiology data relevant to SUA; all were observational studies. Three studies were international (involving multiple countries from different continents) [11][12][13] , and the remaining studies were from Asia [14][15][16][17][18][19] , Australia 20,21 , Germany 22,23 , France [24][25][26][27] , Italy [28][29][30][31][32][33][34][35] , Spain 36-40 , the UK 6,[41][42][43][44][45][46][47][48] , Europe (other) [49][50][51][52][53][54][55][56][57][58][59][60][61][62][63][64]…”

“…Omalizumab treatment was approved for the treatment of patients with severe asthma for a substantial period covered by this review. We identified 58 publications of reports of omalizumab from clinical trials and observational settings 15,19,21,22,27,[29][30][31]34,39,40,48,56,62,64,67,68,79,98,99,104,117,122,[124][125][126][127][128][129][130][131]134,136,138,139,146,149,152,153,[156][157][158][160][161][162][163][164][167][168][169]174,…”

The Long-Term Omalizumab Therapy in Children with Severe Persistent Uncontrolled Asthma: Evaluation of the Outcomes According to the Data of the Hospital Patient Registry

“…У всех пациентов эффективность терапии определялась в фиксированных точках (до начала терапии, через 1 год, 2 года и 5 лет) и по установленным параметрам (потребность в системных глюкокортикостероидах, обострения, уровень контроля над болезнью и ОФВ 1 ). У пациентов обеих групп отмечалось повышение уров-ня контроля над болезнью, выраженное повышение баллов по АСТ-тесту во всех точках (p<0,01), было зафиксировано уменьшение количества тяжелых обо-стрений в группе атопической бронхиальной астмы на 77% к 5 годам терапии, однако у 47% пациентов по-прежнему отмечалось как минимум 1 обострение в течение года [24].…”

“…Цель исследования -проанализировать эффективность и безопасность длительной таргетной терапии омализумабом (более 4 лет) у детей с тяжелой персистирующей неконтролируемой бронхиальной астмой по данным электронной информационной базы данных клинических слу-чаев (регистра). (Me 14 [12;17,5],24]; p=0,0017). Было зафиксировано уменьшение объема ежедневной базисной терапии: до начала терапии средняя доза ингаляционных глюкокорти-костероидов в пересчете на флутиказон составляла 575 мкг/сут (Me 500 [437,5; 750]), через 48 мес -492 мкг/ сут (Me 500 [250; 562,5]; p=0,066); сокращение количества обострений и потребности в применении короткодей-ствующих β 2 -агонистов -с 12 (Me 10,5 [9,75;13,25] [225; 375].…”

“…Было зафиксировано уменьшение объема ежедневной базисной терапии: до начала терапии средняя доза ингаляционных глюкокорти-костероидов в пересчете на флутиказон составляла 575 мкг/сут (Me 500 [437,5; 750]), через 48 мес -492 мкг/ сут (Me 500 [250; 562,5]; p=0,066); сокращение количества обострений и потребности в применении короткодей-ствующих β 2 -агонистов -с 12 (Me 10,5 [9,75;13,25] [225; 375]. Asthma control test (ACT) before the start of the treatment was 14 points (Me 14 [12;17,5],24]; p=0,0017). The decrease of the amount of the daily therapy was demonstrated.…”