Italian real-life experience of omalizumab

Abstract

Omalizumab is a humanized murine monoclonal antibody directed toward a portion of the IgE indicated in Europe for the treatment of severe persistent allergic asthma, inadequately controlled despite high-dose of ICS (mean BDP equivalent dose of inhaled corticosteroid 2224.68microg/die) in association with long-acting beta(2) agonists. Our aim was to describe the experience, efficacy and safety in a cohort of Italian patients treated with omalizumab in a real-life clinical setting. One hundred and forty two patients from 13 Italian Centers were observed and analysed. The dosage of omalizumab was established according to the labelling indication, with a median dose of IgE of 297.38IU/ml or kU/l. During the previous year, all patients experienced frequent exacerbations (mean=4.87), emergency visits (mean=4.45) and hospitalisation (mean=1.53). Following treatment with omalizumab, the annual rate of exacerbations, emergency visits and hospitalisation decreased by 79%, 88% and 95%, respectively. The proportion of patients without exacerbation, not needing emergency visits and hospitalization increased by 610%, 154% and 28%, respectively. The response to omalizumab measured with the GETE (global evaluation of treatment effectiveness) scale rated as good to excellent in 77% of patients. Overall, 9.6% (n=9) of the patients experienced one single adverse effect. Only one patient reported a serious adverse event (local reaction at the site of injection) leading to interruption of treatment. The observed reduction of asthma-related events in particularly poorly controlled patients in this Italian real-life setting is consistent with the results of other observational studies.

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

“…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.…”

Effectiveness of Omalizumab in Severe Allergic Asthma: A Retrospective UK Real-World Study

“…There was a reduction in the number of asthma exacerbations requiring OCS following OMB therapy with a similar effect size to RCT data (2) and previous international observational studies (10,28,30,31). As all exacerbations were treated with OCS, the reduction in exacerbations may be a contributing factor in the reduction also seen in the number of patients requiring OCS and the reduction in total quantity and mean daily OCS dose.…”

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

“…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]. Unlike the aforementioned projects, the Spanish register helped not only to evaluate omalizumab's effectiveness and safety in patients with atopic persistent uncontrollable asthma, but also to compare this group of patients with a group of patients with non-atopic BA in respect of the drug's effect [35].…”

“…Long-term observation performed thanks to the data register confirmed safety of the therapeutic interventions [37]. Moreover, data of the multicenter observation correspond with the results of the previously performed clinical trials [27,30,32]. Thus, registers have become an important instrument of determining effectiveness and safety of long-term therapy and observation, a methodological means for healthcare quality analysis, as well as determination and assessment of impact of one or another medical technology on healthcare [38].…”