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. 2021 Nov 30:13:100275.
doi: 10.1016/j.lanepe.2021.100275. eCollection 2022 Feb.

Long-term real-world effectiveness of allergy immunotherapy in patients with allergic rhinitis and asthma: Results from the REACT study, a retrospective cohort study

Benedikt Fritzsching  1 , Marco Contoli  2 , Celeste Porsbjerg  3 , Sarah Buchs  4 , Julie Rask Larsen  5 , Lisa Elliott  4 , Mercedes Romano Rodriguez  4 , Nick Freemantle  6
Affiliations

Long-term real-world effectiveness of allergy immunotherapy in patients with allergic rhinitis and asthma: Results from the REACT study, a retrospective cohort study

Benedikt Fritzsching et al. Lancet Reg Health Eur. .

Abstract

Background: Allergen immunotherapy (AIT) is the only causal treatment for respiratory allergy. Long-term real-life effectiveness of AIT remains to be demonstrated beyond the evidence from randomised controlled trials (RCTs).

Methods: REACT (Real world effectiveness in allergy immunotherapy) is a retrospective cohort study using claims data between 2007 and 2017. Study eligibility was a confirmed diagnosis of allergic rhinitis (AR), with or without asthma, and AIT. To ensure comparable groups, AIT-treated subjects were propensity score matched 1:1 with control subjects, using characteristic and potential confounding variables. Outcomes were analysed as within (pre vs post AIT) and between (AIT vs control) group differences across 9 years of follow-up (ClinicalTrial.gov: NCT04125888).

Findings: 46,024 AIT-treated subjects were matched with control subjects and 14,614 were included in the pre-existing asthma cohort. AIT-treated subjects were 29·5 (16·3) years and 53% were male. Compared to pre-index year, AIT was consistently associated with greater reductions compared to control subjects in AR and asthma prescriptions, including both asthma controller and reliever prescriptions. Additionally, the AIT group had significantly greater likelihood of stepping down asthma treatment (P <0·0001). In addition to the reduction in asthma treatment in the AIT group, a greater reduction in severe asthma exacerbations was demonstrated (P<0·05). Reductions in pneumonia with antibiotic prescriptions, hospitalisations, and duration of inpatients stays were all in favour of AIT.

Interpretation: The study extends the existing RCT evidence for AIT by demonstrating longer-term and sustained effectiveness of AIT in the real world. Additionally, in patients with concurrent asthma, AIT was associated with reduced likelihood of asthma exacerbations and pneumonia.

Funding: The study was funded by ALK A/S.

Keywords: AIT, allergy immunotherapy; AR, allergic rhinitis; Allergic rhinitis; Allergy; Allergy immunotherapy; Asthma; Effectiveness; FU, follow-up; HDM, house dust mite; HRU, health care resource utilisation; ICS, inhaled corticosteroids; INCS, intranasal corticosteroids; LABA, long-acting beta2-agonists; PSM, propensity score matching; RCT, randomised clinical trial; RWE, real world evidence; Real-world evidence; Retrospective cohort study; Rx, prescription; SABA, short-acting beta2-agonists; SCIT, subcutaneous immunotherapy; SLIT, sublingual immunotherapy.

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Conflict of interest statement

Dr. Fritzsching reports personal fees (pertaining travelling to study meeting) from ALK during the conduct of the study; and speaker honorarium from Novartis and from Merck Sharp & Dohme, outside the submitted work. Dr. Contoli reports personal fees from Alk-Abello, during the conduct of the study; grants, personal fees and non-financial support from Chiesi, personal fees and non-financial support from AstraZeneca, personal fees and non-financial support from Boehringer Ingelheim, grants, personal fees and non-financial support from GlaxoSmithKline, personal fees and non-financial support from Novartis, personal fees and non-financial support from Zambon, grants from University of Ferrara - Italy, outside the submitted work. Dr. Porsbjerg reports grants from ALK, grants and personal fees from Astra Zeneca, grants and personal fees from GSK, grants and personal fees from Novartis, grants, and personal fees from Chiesi, grants and personal fees from Sanofi, grants and personal fees from TEVA, outside the submitted work. Sarah Buchs reports to be employed at ALK-Abello. Dr. Rask Larsen reports being an employee at ALK. Dr. Elliott has nothing to disclose. Ms. Romano Rodriguez reports she is an ALK employee. Dr. Freemantle reports personal fees from Astrazeneca, personal fees from Ipsen, personal fees from Sanofi Aventis, personal fees from Grifols, personal fees from Novatis, personal fees from Aimmune, personal fees from Vertex, personal fees from MSD, personal fees from Allergan, outside the submitted work.

Figures

Fig. 1
Fig. 1
Change from pre-index year in average Rx/subjects per follow-up year. AR prescriptions includes symptom-relieving allergic rhinitis medication, e.g. antihistamine and INCS.
Fig. 2
Fig. 2
a and b): Odds ratio for stepping down asthma treatment (a) and severe asthma exacerbations (b) in pre-existing asthma cohort. Panel a): Odds ratio and 95%CI of stepping down in asthma treatment step compared to pre-index year per follow-up year. Panel b): Odds ratio and 95%CI of severe asthma exacerbation per follow-up year. Asthma treatment step [change]: The definition of improvement or worsening in asthma treatment step was met, if subjects with pre-existing asthma changed asthma treatment step compared to the pre-index year. The asthma treatment steps were pre-defined categories based on asthma diagnoses codes and asthma medication prescriptions during pre-index and post-index years. Treatment step 1: Asthma diagnosis in the absence of controller asthma medication; Treatment step 2: Monotherapy with either low dose ICS or LTRA; Treatment step 3: Dual therapy or therapy with medium-high ICS, LABA or methylxanthine; Treatment step 4: Triple therapy or therapy with anti-IgE or anti-IL-5; Severe asthma exacerbation: 3-point composite of either new systemic corticosteroid prescription, status asthmaticus recorded in ambulatory care or hospitalisation for asthma. AIT: allergen immunotherapy; CI: confidence interval; OR: odds ratio; IL: interleukin; SABA: short-acting beta2-agonists, ICS: inhaled corticosteroids; LABA: long-acting beta2-agonists; LTRA: leukotriene receptor antagonists.
Fig. 3
Fig. 3
a) and b): Odds ratios for pneumonia diagnosis (a) and inpatient hospitalisations (b) in pre-existing asthma cohort. Panel a) Odds ratio and 95%CI of pneumonia diagnosis per follow-up year. Panel b) Odds ratio and 95%CI of inpatient hospitalisations per follow-up year. AIT: allergen immunotherapy; CI: confidence interval; OR: odds ratio.
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