Improvement of patient-reported outcomes in severe allergic asthma by omalizumab treatment: the real life observational PROXIMA study

Canonica, Giorgio Walter; Rottoli, Paola; Bucca, Caterina; Zappa, Maria Cristina; Giovanni, Michetti; Macciocchi, B; Caruso, Cristiano; Santus, Pierachille; Bartezaghi, Marta; Rigoni, Laura

doi:10.1186/s40413-018-0214-3

Cited by 27 publications

(28 citation statements)

References 42 publications

(39 reference statements)

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“…The PROXIMA (Patient Reported Outcomes and Xolair ® In the Management of Asthma) study was an observational, non-controlled, multicenter, two-phase study in Italian severe allergic asthma (SAA) patients, aimed at assessing the prevalence of perennial environmental allergies (during the cross-sectional phase) and the rate of disease control after up to 12 months of omalizumab treatment (during the longitudinal phase). The secondary objectives of the study included the assessment of patients’ disease perception and level of asthma control during both the cross-sectional and longitudinal phases and patients’ compliance to and persistence with omalizumab, rate of exacerbations and patients’ QoL during the longitudinal phase [16, 17].…”

Section: Introductionmentioning

confidence: 99%

Gender differences in asthma perception and its impact on quality of life: a post hoc analysis of the PROXIMA (Patient Reported Outcomes and Xolair® In the Management of Asthma) study

Colombo

Zagni

Ferri³

et al. 2019

Allergy Asthma Clin Immunol

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Background: Gender differences in asthma perception and control have been reported. The PROXIMA observational study assessed these outcomes in a cohort of Italian severe allergic asthma (SAA) patients. This post hoc analysis of the PROXIMA results was aimed at assessing gender differences in SAA in a real-world setting, focusing on disease perception and impact on quality of life (QoL). Methods: The PROXIMA study was an observational, multicenter study, consisting of a cross-sectional and a prospective longitudinal phase, including adult outpatients diagnosed with SAA at step 4 requiring a therapeutic step-up. Patients on omalizumab treatment at baseline were included in the 12-month longitudinal phase. Disease control was assessed by the Asthma Control Questionnaire (ACQ) score, patients' disease perception by the Brief Illness Perception Questionnaire (BIPQ), and QoL by the EuroQoL five-dimensional three-level questionnaire (EQ-5D-3 L) at baseline and after 6 and 12 months. Two regression models were used to evaluate the association between gender and BIPQ total score and EQ-5D-3L score, respectively. Results: 357 patients (65% females) were analyzed for the cross-sectional phase and 99 (62.6% females) for the longitudinal phase. The prevalence of perennial and seasonal aeroallergens was similar between genders. ACQ score decreased similarly during omalizumab treatment at 6 and 12 months in both genders; no gender differences were observed in control rates. Asthma perception was worse among females at all study visits reaching statistical significance at 12 months (mean (SD) B-IPQ total score 41.8 (9.4) vs 35.6 (12.0); T test p-value (males vs females) < 0.05). Statistically significant gender differences were observed for some specific items, with males reporting less symptom experience, concern about the disease, and emotional impact at 12-months. The results of the multivariate regression model for repeated measures showed that overall treatment with omalizumab improved disease perception overtime regardless from gender. Males reported a significantly better QoL compared to females at both 6 and 12 months. Conclusions: In this real-world setting, females confirmed to have a worse perception of asthma, feel it as more symptomatic and suffer a greater impact on their QoL, even though having similar baseline severity and obtaining similar level of control.

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Section: Introductionmentioning

confidence: 99%

Gender differences in asthma perception and its impact on quality of life: a post hoc analysis of the PROXIMA (Patient Reported Outcomes and Xolair® In the Management of Asthma) study

Colombo

Zagni

Ferri³

et al. 2019

Allergy Asthma Clin Immunol

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“…Canonica et al demonstrated that the use of omalizumab in severe allergic asthma improves patient outcomes such as QoL and patients' FIGURE 4 | Total EE (estimated energy expenditure) variation at different follow-ups in the biologic therapy (BT) omalizumab group and in the BT mepolizumab group. illness perception (Canonica et al, 2018). PA levels are strictly related to QoL: PA levels are improved in populations with a high QoL (Mazzeo et al, 2016;Monda et al, 2017b;Wu et al, 2017;Cordova-Rivera et al, 2018a;Sessa et al, 2018a).…”

Section: Discussionmentioning

confidence: 99%

Physical Activity as a New Tool to Evaluate the Response to Omalizumab and Mepolizumab in Severe Asthmatic Patients: A Pilot Study

et al. 2020

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Asthma is a chronic inflammatory airway disease, representing one of the most severe pathologies in developed countries. Based on a report of the World Health Organization (WHO), it affects about 300 million people worldwide. Few studies have analyzed the effects of daily life physical activity (PA) levels in patients with asthma: moreover, little research has been carried out on PA levels in patients suffering from severe asthma (SA). This study aimed to investigate the PA levels in two groups of patients suffering from SA; in particular, this study analyzed the changes that occur in patients treated with biologic therapy (BT group) and patients who underwent traditional treatment (TT group) over 6 months. Moreover, this study represents a pilot study because, to the best of our knowledge, it is the first investigation that analyzed if the kind of biologic drug (omalizumab or mepolizumab) can produce differences in the PA levels of SA patients. Fifty SA patients were enrolled and PA parameters were monitored for 6 months. Subjects were divided into two treatment groups: TT (20 patients) and BT (30 patients), the BT group was further subdivided according to the drugs used (15, omalizumab; 15, mepolizumab). During drug treatment, all subjects improved their PA levels: indeed, considering the intragroup variation, the PA levels were significantly higher comparing the T6 levels to baseline (T0, p < 0.01). Considering the intragroup variation, it is very interesting to note that biologic therapy improved PA levels compared to the effects of traditional therapy; while at T0 there were no significant differences in the steps per day (SPD) values between the two groups (T0, p = 0.85), the differences become statistically significant at T1, T3, and T6 (T1, p = 0.019; T3, p = 3.48x10 −6 ; T6, p = 4.78x10 −10). As expected, the same differences were reported analyzing the energy expenditure data. In

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“…Detailed inclusion/exclusion criteria have been described previously. 16 The study consisted of a crosssectional phase and a 12-month longitudinal prospective phase. After screening, patients entered into the cross-sectional phase designed to estimate the pattern of allergic asthma (perennial versus seasonal).…”

Section: Study Design and Patientsmentioning

confidence: 99%

“…15 PROXIMA, an observational, multicenter twophase study (cross-sectional and longitudinal phase) conducted in patients with SAA showed that omalizumab reduced exacerbation rates by 87% and effectively controlled asthma after 6 and 12 months of treatment, improving quality of life of these patients. 16 A high proportion of the study population (longitudinal phase) responded to the omalizumab treatment with a response rate of 89%-96%.…”

Section: Introductionmentioning

confidence: 99%

Plasma Galectin-3 and urine proteomics predict FEV1 improvement in omalizumab-treated patients with severe allergic asthma: Results from the PROXIMA sub-study

Riccio

Mauri

Ferrari

et al. 2020

World Allergy Organization Journal

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Background: Patients with severe allergic asthma (SAA) when treated with omalizumab may exhibit different extent of response. Identifying biomarkers that can predict the extent of treatment effectiveness in patients can be useful in personalizing omalizumab treatment. Methods: Patients from the longitudinal phase of the PROXIMA study were selected for this ancillary study. After 12 months of omalizumab treatment, patients were categorized according to their response to treatment as: "clinical responder" (Asthma Control Questionnaire [ACQ] total score <1 at Month 12 and/or with a reduction in number of exacerbation versus the previous year); "functional responder" (an increment of !0.1 L in forced expiratory volume in 1 s [FEV 1 ] at Month 12 versus baseline); and "super responder" (among clinical responders group, who also showed a functional response). Plasma galectin-3 (GAL-3) levels were quantified using a micro titer platebased enzyme linked immunosorbent assay kit. Results: The Majority of patients (86.36%) in sub-study population were identified as clinical responders. Of the total patients identified as clinical responders, 64.86% were identified as super responders. A statistically significant difference in the baseline plasma GAL-3 levels between responders and non-responders was observed only in the functional responders group (P ¼ 0.0446). Patients with plasma GAL-3 level of !11 ng/mL had a greater probability of being a super responder (P ¼ 0.0118) or a functional responder (P ¼ 0.0032). Conclusion: Our findings support the use of plasma GAL-3 as a predictive marker to stratify responders and identify super responders and functional responders to omalizumab treatment in patients with severe allergic asthma using less invasive sample like plasma.

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Improvement of patient-reported outcomes in severe allergic asthma by omalizumab treatment: the real life observational PROXIMA study

Cited by 27 publications

References 42 publications

Gender differences in asthma perception and its impact on quality of life: a post hoc analysis of the PROXIMA (Patient Reported Outcomes and Xolair® In the Management of Asthma) study

Gender differences in asthma perception and its impact on quality of life: a post hoc analysis of the PROXIMA (Patient Reported Outcomes and Xolair® In the Management of Asthma) study

Physical Activity as a New Tool to Evaluate the Response to Omalizumab and Mepolizumab in Severe Asthmatic Patients: A Pilot Study

Plasma Galectin-3 and urine proteomics predict FEV1 improvement in omalizumab-treated patients with severe allergic asthma: Results from the PROXIMA sub-study

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