Add‐on omalizumab improves day‐to‐day symptoms in inadequately controlled severe persistent allergic asthma

Abstract

In patients with inadequately controlled severe persistent asthma, day-to-day symptoms correlate well with QoL. Add-on omalizumab significantly improves day-to-day symptoms compared with placebo. Further improvement in responders confirms the physician's assessment as a response measure.

Patient-reported outcomes in moderate-to-severe allergic asthmatics treated with omalizumab: a systematic literature review of randomized controlled trials

“…Across the 48 weeks of follow-up, omalizumab-treated patients had significantly fewer mean days (per 2-week interval) of wheezing, interference with activities, and night-time sleep disruptions compared to placebo-treated patients (p .02) 32 . In a separate study, the percentages of symptom-free days and symptom-controlled days over each 2-week interval were significantly higher in patients who were considered responders to omalizumab therapy compared with those who were treated with omalizumab and placebo over 26-28 weeks (p < .001) 18 . However, when the number of days with asthma symptoms, nights with awakening, and days with impairment in daily activities were counted over a 1-week period on a patient diary card, the change from baseline to 16 weeks between omalizumab and placebo was not significant 28 .…”

“…The majority of the studies were either double-blind placebo-controlled (13 of 19) trials or randomized open-label studies (three of 19). In addition, there was one post-hoc analysis of the INNOVATE study 18 and two subgroup analyses of previously conducted studies 20,21 . All of the studies that reported symptom-related PROs varied by the time period over which the symptoms were measured (range ¼ 4-52 weeks) and by the type of assessment used to capture asthma symptoms.…”

“…Four studies had no placebo control group and evaluated omalizumab plus standard of care compared to standard therapy alone 13,16,20,26 . Analyses in two studies isolated a group of patients designated as "responders" to omalizumab, and included them as a third comparator, along with the placebo arm and either all omalizumab patients or those not responding to omalizumab therapy 18,25 . Overall, the risk of bias in the 26 RCTs reviewed was low across the evaluated domains (e.g., blinding of study personnel and participants, complete outcome assessment, and selective reporting) ( Table 2).…”

“…The studies had a broad global representation, with 10 multi-national RCTs included [13][14][15][16][17][18][19][20][21][22] . The majority of included analyses evaluated patients aged 12 years and older (15 of 26 studies) [13][14][15][16][17][18]20,[22][23][24][25][26][27] ; five trials included adults, aged 18 years and older, only 21,[28][29][30][31] , and two trials included children aged 6 to <12 years 19,32 . The majority of RCTs were large (69% had n > 300 patients).…”

Eosinophilic Esophagitis: Asthma of the Esophagus?

“…While asthma has been shown to respond to anti-IgE treatment in a number of studies which showed a reduction in the number of exacerbations [27], the response of EoE to this form of treatment has not been systematically investigated, and positive responses are limited to case reports [28]. While there was some symptomatic improvement in these patients, the number of eosinophils did not change.…”