Tolerability of Omalizumab in Asthma as a Major Compliance Factor: 10-Year Follow Up

Abstract

BACKGROUND:There is a lack of data related to real life, long-term safety, tolerability and compliance of omalizumab treatment in asthma patients beyond 6 years.AIM:Study aimed to assess safety, tolerability, compliance and all reasons for treatment discontinuation during 10 years on omalizumab.SUBJECT AND METHODS:This is a retrospective, observational study of uncontrolled asthma patients receiving omalizumab for the last 10 years. All data were collected from patients’ files (demographics, adverse events, comorbidities, compliance index, reasons for discontinuation of omalizumab). Reactions to omalizumab were classified as local and systemic, and their severity as mild, moderate or severe. Reactions were either immediate (minutes to hours after drug administration) or delayed (after days). Compliance to omalizumab, defined as Compliance index (CI), was calculated by comparing milligrams of given to milligrams of prescribed dose/ per year.RESULTS:Out of 35 patients receiving omalizumab, 15 drop out at different time points mostly due to treatment efficacy or appearance of new comorbidities. Patients who continue for the next ten years had mild to moderate adverse events related to omalizumab. There was no increased risk of severe adverse events during 10 years on omalizumab. Patient’s treatment tolerability, despite mild to moderate adverse events, is in favour of compliance.CONCLUSION:Compliance with omalizumab mildly decreased over 10 years but was not affected by severe adverse events of treatment or new comorbidities. Although, omalizumab is safe medicine appearance of new comorbidities has to be closely followed up.

Influence of prolonged treatment with omalizumab on the development of solid epithelial cancer in patients with atopic asthma and chronic idiopathic urticaria: A systematic review and meta‐analysis

“…General characteristics of the twelve included studies that reported on study‐emergent solid epithelial cancer are summarized in Tables and . Additional details can be found in Appendix .…”

“…Collectively, these studies included a total of 11 758 participants and encompassed three study types. Three were RCTs, one was a comparative observational study (prospective cohort), and eight were non‐comparative observational studies . Their publication dates ranged from 2002 to 2018; however, 75% were published in the last 5 years.…”

“…Eight other observational studies were non‐comparative longitudinal studies that evaluated outcomes in a group of participants sampled on the basis of a single exposure (ie all subjects received omalizumab). Four studies (67%) were prospective, two were registry studies, and five were completed at a single centre.…”

“…Eight other observational studies were non‐comparative longitudinal studies that evaluated outcomes in a group of participants sampled on the basis of a single exposure (ie all subjects received omalizumab). Four studies (67%) were prospective, two were registry studies, and five were completed at a single centre. One study was funded by Novartis Pharmaceuticals, two studies were funded by both Genentech Inc and Novartis Pharmaceuticals, three declared no funding, and the others did not report on study funding.…”

“…Participants included in non‐comparative studies varied with respect to a variety of baseline characteristics. For example, five studies recruited patients with severe asthma only, while the other three included patients with moderate or severe asthma. One of these studies also enrolled participants with mild asthma, though the FEV1 per cent predicted values reported at baseline indicate that, on average, participants had moderate asthma (mean [SD]: 75.4 [20.6]).…”