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Allergen immunotherapy effectiveness confirmed in long-term real-world study

3rd December 2021

Allergen immunotherapy in patients with allergic rhinitis and/or asthma was effective over a 9-year period in a real-world study

The effectiveness of allergen immunotherapy (AIT) in allergic rhinitis (AR) patients both with and without asthma has been confirmed in a 9-year retrospective analysis by researchers from the Paediatric Pulmonology and Allergy, Children’s Doctor Service, Heidelberg, Germany.

Allergies represent an abnormal immune system reaction to otherwise harmless allergens and in the UK, AR is estimated to affect 10-15% of children and 26% of adults. In addition, patients with AR can also suffer with asthma as a co-morbidity, with studies suggesting that 10% to 40% of AR patients have asthma. Furthermore, the presence of AR is associated with an incremental adverse impact on the disease-specific quality of life in patients with asthma and the level of asthma control.

Allergen immunotherapy (or desensitisation treatment) involves exposure to increasing doses of an allergen such as grass pollen, dust mite, or cat dander. AIT can be given via the subcutaneous or sublingual route, both of which have been shown to be effective treatment for patients with AR. Nevertheless, there is a recognised lack of information from studies on the effectiveness of AIT in real-world studies and over the longer term.

In order to address this gap in the evidence, the German researchers undertook the Real World effectiveness in allergy immunotherapy (REACT) study, primarily to assess the efficacy of AIT over a period of years. Using a retrospective, observational, propensity score matched cohort study, the team analysed health insurance claims from 2007 to 2017 and included AR patients with and without asthma and who had received an AIT prescription. These individuals were then propensity-score matched with AR individuals (also with or without asthma) but who had not been prescribed AIT. The primary outcome of the study was set as AR prescriptions in each follow-up year and secondary outcomes included asthma prescriptions, severe asthma exacerbations and any changes in the individual’s asthma treatment steps.

Findings

Between 2007 and 2017, 115,098 individuals had at least one AIT prescription, of whom, 46,024 with a mean age of 29.5 years (53% male) were propensity score matched. In addition, 14,614 AR patients with AR and co-existing asthma (mean age, 28.3 years, 54% male) were also matched with controls. However, over the 9 years, the study population declined, leaving 3692 individuals in the main cohort and 1142 with co-existent asthma.

When compared to control patients, AIT use was consistently associated with greater reductions in both AR and asthma prescriptions. In addition, there was a significantly greater likelihood that patients using AIT would have an asthma treatment step-down (p < 0.0001) and a reduction in severe asthma exacerbations (p < 0.05).

The authors concluded that their study had confirmed the real-world effectiveness of AIT as evidenced by sustained reductions in AR and asthma prescriptions, prevention of asthma exacerbations, and improved and sustained long-term asthma control.

Citation

Fritzching B et al. Long-term real-world effectiveness of allergy immunotherapy in patients with allergic rhinitis and asthma: Results from the REACT study, a retrospective cohort study. Lancet Regional Health Europe 2021

Dupilumab added to immunotherapy of no benefit in seasonal allergic rhinitis

20th August 2021

The addition of dupilumab to immunotherapy in patients with seasonal allergic rhinitis, did not further reduce post-allergen nasal symptoms.

Allergic rhinitis is characterised by several symptoms including sneezing, itching, nasal congestion and rhinorrhoea. It can be categorised as either seasonal allergic rhinitis, in which symptoms are evoked in response to season triggers such as pollen or perennial allergic rhinitis, where symptoms are continually present. Seasonal allergic rhinitis is a global health problem and has been reported to affect 15 to 25% of adults and children. Moreover, while localised symptoms are problematic for patients, the condition also has a more generalised effect upon sufferers leading to fatigue, mood changes and reduced cognitive function which can affect work and overall quality of life. Treatment involves the use of oral and intranasal antihistamines as well as intranasal corticosteroids. However, when such treatments fail to provide symptomatic relief, subcutaneous or sublingual allergen immunotherapy can be used with subcutaneous therapy appearing to be more effective. In fact, a recent review found that the benefits of allergen immunotherapy were sustained for at least 2 – 3 years after cessation of treatment.

The role of interleukins (IL) in the pathophysiology of seasonal allergic rhinitis is uncertain although some evidence observed a trend towards higher levels of both IL-4 and IL-13. The monoclonal antibody dupilumab targets the IL-4 and IL-13 receptor and been recently shown to improve asthma and perennial allergic rhinitis symptoms. This led a team from the Department of Medicine and Paediatrics, David Geffen School of Medicine, California, US, to examine whether addition of dupilumab to subcutaneous immunotherapy would provide an additional benefit to patients with seasonal allergic rhinitis. They undertook a phase 2a, randomised trial with four arms, comparing subcutaneous immunotherapy (SCIT) either alone or combined with dupilumab verses placebo in patients with seasonal allergic rhinitis. The study involved a 12-week screening period, a 16-week treatment phase and an 8-week post-treatment follow-up in adult patients (aged 18 years and over but less than 55 years) with seasonal grass pollen allergy. The four treatment arms were: SCIT + placebo; SCIT + dupilumab 300mg every 2 weeks; Dupilumab alone; SCIT alone. The primary outcome as the percentage change from pre-baseline in the area under the curve for peak total nasal symptom score (TNSS), a composite of rhinorrhoea, nasal congestion, nasal itching, and sneezing and measured 0 – 1 hour following a nasal allergen challenge.

Findings
A total of 103 patients were enrolled and randomised to one of the four arms. The mean age of participants assigned to SCIT and dupilumab was 33 years (30.8% male) and the mean age across the study ranged from 33 to 40.3 years. At week 17 and following a nasal allergen challenge, there was no difference between SCIT and SCIT + dupilumab (least squares mean – 56.76% vs 52.03%). Similarly, there was no significant difference in the absolute change in TNSS scores. There was however, a slight, but significant improvement in the peak TNSS scores when dupilumab was added to SCIT (p = 0.026), suggesting that addition of the drug may help improve SCIT tolerability. The authors concluded that there was no benefit from adding dupilumab to SCIT in terms of reducing the response to an allergen challenge.

Citation
Corren J et al. Short-term subcutaneous allergy immunotherapy and dupilumab are well tolerated in allergic rhinitis: a randomised trial. J Asthma Allergy 2021