<p>Clinical Determinants of Successful Omalizumab Therapy in Severe Allergic Asthma Patients: 4-Year-Long, Real-Life Observation</p>

Abstract

Introduction Omalizumab is a high-cost therapy recommended for the treatment of severe allergic asthma. Objective To find clinical parameters that are related to the sustained response to omalizumab. Patients and Methods This retrospective, real-life, 4-year follow-up was provided in Poland between March 2013 and May 2019. The success of omalizumab was assessed based on composed subjective and objective criteria. Simple/multiple regression analyses were performed to search for predictors of the response to omalizumab. Results A total of 989 severe allergic asthma patients were referred for omalizumab therapy, of whom 854 patients were considered eligible for treatment. At weeks 16 and 52, omalizumab was successful in 84% and 91% of patients, respectively. Treatment effectiveness was maintained up to the 4-year follow-up. Four predictors of the response to omalizumab were found at week 16 and two at week 52. The results at week 16 may be used as predictors of success at week 52 based on the model including baseline FEV1% and change in ACQ-7 and miniAQLQ score at week 16: the area under the ROC curve equals 0.746 [95% CI: 0.672–0.820]. Conclusion Omalizumab therapy is very effective, with this efficacy sustained after 4 years of treatment. Success of the therapy can be predicted from the baseline FEV1% and clinical improvement (based on ACQ-7 and miniAQLQ scores) at week 16.

Oral Corticosteroids Dependence and Biologic Drugs in Severe Asthma: Myths or Facts? A Systematic Review of Real-World Evidence

“…The only very large study [85] on reslizumab also confirmed that mAb therapy is able to halve the percentage of patients requiring maintenance OCS, although reslizumab reduced the daily dose of OCS slightly less than omalizumab and mepolizumab among the patients that continued to need OCS. However, we have to highlight that the daily dose of OCS at baseline in the very large studies on omalizumab [74,78,82] and mepolizumab studies [42,50,56] were generally lower than that of the very large study on reslizumab [85]. Only one large real-world study [34] has been carried out on benralizumab, which permitted OCS consumption to be abolished in all the observed patients.…”

“…Regardless of the disease characteristics reported for each study, omalizumab seems to be the mAb characterized by the largest amount of evidence resulting from very large and long-term real-world investigations [74,78,82], which, consistently, indicated that this drug may be effective in suspending the use of OCS in more than 50% of severe asthmatic patients, and reducing the daily dose of OCS in more than 50% of the remaining patients. Indeed, the large real-world evidence on omalizumab may be related to the fact that this mAb has been present on the market for a longer time than the other mAbs included in this systematic review.…”

“…Several national real-world studies have been carried out on omalizumab [59,60,62,65,[67][68][69]78,82,84]. In a very large and long-term national study performed in Poland [78] on severe asthmatic patients, the OCS dose decreased from 10.8 mg/day to 2.7 mg/day after 4 years of treatment with omalizumab, with a significant reduction observed at week 16, when 56% of patients had not used OCS at all.…”

“…Several national real-world studies have been carried out on omalizumab [59,60,62,65,[67][68][69]78,82,84]. In a very large and long-term national study performed in Poland [78] on severe asthmatic patients, the OCS dose decreased from 10.8 mg/day to 2.7 mg/day after 4 years of treatment with omalizumab, with a significant reduction observed at week 16, when 56% of patients had not used OCS at all. A very large national study [59] from a national pharmaceutical agency in Japan showed that treatment with omalizumab reduced the OCS dose of 10.4% at week 16 and 50.3% at week 52, when more than 80% of patients had a ≥50% OCS dose reduction and 13.3% had a ≥90% reduction.…”

Long-term safety, durability of response, cessation and switching of biologics

“…Though long-term studies evaluating omalizumab vary in sample size (8 to >800 patients), duration (5-16 years) and study design [38][39][40][41][42][43], they have convincingly validated its efficacy (e.g. lung function, exacerbations, quality of life (QoL) and background medication withdrawal) and safety.…”