Guy Peachey

The eXpeRience registry: The ‘real-world’ effectiveness of omalizumab in allergic asthma

Omalizumab has demonstrated therapeutic benefits in controlled clinical trials. Evaluation of outcomes in real-world clinical practice is needed to provide a complete understanding of the benefits of omalizumab treatment. eXpeRience was a 2-year, international, single-arm, open-label, observational registry that evaluated real-world effectiveness, safety and use of omalizumab therapy in 943 patients with uncontrolled persistent allergic asthma. Effectiveness variables (physicians Global Evaluation of Treatment Effectiveness [GETE], and change from baseline in exacerbation rate, symptoms, rescue medication use, and oral corticosteroid [OCS] use) were evaluated at pre-specified time-points. Safety data were also recorded. By physicians GETE, 69.9% of patients were responders to omalizumab after 16 (±1) weeks. The proportion of patients with no clinically significant exacerbations increased from 6.8% during the 12-month pre-treatment period to 54.1% and 67.3% at Months 12 and 24, respectively. Symptoms and rescue medication use at Month 24 were reduced by >50% from baseline. Maintenance OCS use was lower at Month 24 (14.2%) compared with Month 12 (16.1%) and baseline (28.6%). Overall, omalizumab had an acceptable safety profile. The results from eXpeRience indicate that omalizumab was associated with improvements in outcomes in patients with uncontrolled persistent allergic asthma; these improvements were consistent with the results of clinical trials.

Persistency of response to omalizumab therapy in severe allergic (IgE-mediated) asthma

To cite this article: Bousquet J, Siergiejko Z, Świebocka E, Humbert M, Rabe KF, Smith N, Leo J, Peckitt C, Maykut R, Peachey G. Persistency of response to omalizumab therapy in severe allergic (IgE‐mediated) asthma. Allergy 2011; 66: 671–678.

Oral corticosteroid sparing with omalizumab in severe allergic (IgE-mediated) asthma patients

Abstract Background: Long-term oral corticosteroid (OCS) therapy and related adverse events are associated with a significant burden on patients and healthcare resources. Methods: This subgroup analysis of a randomized, open-label, parallel-group study evaluated the OCS-sparing effect of omalizumab (OMA) added to optimized asthma therapy (OAT), compared with OAT alone. Patients (12–75 years) with severe allergic asthma, uncontrolled despite GINA 2004 Step 4 therapy, received OMA or OAT for 32 weeks. The change from baseline in OCS use by Week 32 in patients requiring maintenance OCS at baseline was assessed in terms of percent OCS dose change and numbers of patients with reduced/stopped or maintained/increased OCS. Results: Eighty-two patients were receiving maintenance OCS at baseline (OMA/OAT n = 59, OAT n = 23). Change from baseline in mean maintenance OCS dose at Week 32 was significantly greater in the OMA/OAT group compared with the OAT group (−45% vs. + 18.3%, p = 0.002). In the OMA/OAT group, 37 patients (62.7%) reduced/stopped OCS use at Week 32, compared with seven patients (30.4%) receiving OAT (p = 0.013). Improvements in other efficacy outcomes were seen at Week 32 in the OMA/OAT group, irrespective of OCS use. An investigator global evaluation of treatment effectiveness at Week 16 was an effective predictor of persistent treatment response at 32 weeks for the majority of OMA/OAT patients (93%), also irrespective of OCS use. Conclusion: In this open-label study of patients with severe allergic asthma, OMA/OAT therapy reduced maintenance OCS use, compared with OAT alone. Improvements in efficacy measures were observed in the OMA/OAT group, irrespective of OCS change. Clinicaltrials.gov identifier: NCT00264849.

Uncontrolled persistent allergic asthma in practice: eXpeRience registry baseline characteristics.

Abstract Background: Medical registries can be used to assess and monitor the effectiveness and safety of approved therapy, and provide insights into how quality of care can be optimized. Methods: The post-marketing, non-interventional, observational registry (eXpeRience) aims to collect data on the treatment effectiveness and safety of omalizumab in ‘real-world’ practice. The baseline characteristics of patients with uncontrolled allergic asthma receiving omalizumab therapy and included in the first interim analysis of this observational registry are reported. Results: A total of 294 patients were included in the first interim analysis. Of these patients, 271 (92.2%) were active in the registry at the time of reporting. At baseline, the mean duration of allergic asthma was approximately 19 years, with over 87% of patients testing positive for a perennial allergen. Mean % predicted FEV1 and serum total IgE levels were 62.4% and 316.7 IU/mL, respectively. Asthma was uncontrolled for approximately 62% of patients, while around 23% were partly controlled. The majority of patients were being treated with multiple asthma controller medications, including inhaled-corticosteroids, long-acting β2-agonists and leukotriene receptor antagonists, and 28% of patients were also receiving maintenance oral corticosteroids. Concomitant diseases were present in many patients, the most common being perennial allergic rhinitis (42.5%). Conclusions: Demographic and disease characteristics highlight the unmet clinical need in patients with uncontrolled allergic asthma. Future analyses from this study will further determine the real-life effectiveness and safety of omalizumab.

Immunogenicity and safety of omalizumab in pre-filled syringes in patients with allergic (IgE-mediated) asthma

Abstract Background: Omalizumab, a humanised anti-immunoglobulin E monoclonal antibody for treatment of uncontrolled moderate-to-severe or severe persistent allergic asthma, was developed as a lyophilised powder for reconstitution. A liquid formulation in pre-filled syringes has now been developed. The purpose of this study was to assess the immunogenicity and safety of this liquid formulation. Methods: In this multinational, open-label, single-arm study, patients (≥12 years) with moderate-to-severe allergic asthma were treated for 24 weeks with the liquid formulation of omalizumab (75 or 150 mg in a pre-filled syringe) at 2 or 4 week intervals. Immunogenicity was assessed by measurement of human anti-therapeutic antibody (ATA) levels. Safety was assessed by monitoring adverse events (AEs), haematology, blood chemistry, urine analysis and vital signs. Results: A total of 155 patients were enrolled in the study. No patient had a confirmed positive ATA test result. Most frequent individual AEs were asthma (17.4%), sinusitis (17.4%) and upper respiratory tract infection (11.6%). Fourteen patients (9.0%) had serious AEs and there was one death (not treatment related). There were no cases of anaphylaxis according to Sampson criteria. Most patients remained within normal ranges for haematology and biochemistry laboratory variables. Conclusions: Omalizumab in pre-filled syringes was not associated with immunogenicity. This novel formulation, which does not require reconstitution, had a safety profile consistent with the lyophilised formulation. A limitation of this study is that efficacy of omalizumab in the treatment of asthma was not specifically addressed herein. Clinicaltrials.gov identifier: NCT00500539.

Reduction in oral corticosteroid use in patients with severe allergic (IgE-mediated) asthma receiving omalizumab in a real-world setting

Background Patients with severe allergic asthma (SAA) are often inadequately controlled despite available treatments including high-dose inhaled corticosteroids and longacting b2-agonists. Use of oral corticosteroids (OCS) in SAA patients may not achieve full asthma control, and leads to significant long-term side effects. Omalizumab is a recombinant humanized monoclonal anti-immunoglobulin E (IgE) antibody approved in the European Union as an add-on therapy for patients with SAA. In clinical studies, omalizumab has been shown to reduce OCS use. Here we report the effect of omalizumab treatment on OCS maintenance use for up to 24 months in patients with SAA in the real-world eXpeRience registry.

Healthcare utilization and indirect cost of treatment associated with severe allergic asthma in a real-world setting

Background With an estimated 300 million individuals affected worldwide, asthma is associated with substantial social and economic burden. The cost of treating uncontrolled severe allergic asthma (SAA) is high encompassing a variety of direct medical costs and indirect costs. We present data on real-world healthcare utilization (direct) and school/ work absence (indirect) in uncontrolled SAA patients receiving omalizumab in the eXpeRience registry.