Take a Breath of Real-World Evidence

Abstract

Allergen immunotherapy (AIT) in the form of subcutaneous or sublingual immunotherapy (SCIT/SLIT) is the only treatment for allergic rhinitis (AR) and/or allergic asthma with long-term efficacy. Dr Fox considered the benefits for using real-world (RW) evidence in AIT. RW evidence provides the opportunity to explore a wide range of patients, estimate evolving risk benefits, and obtain data on clinical and economic value, as well as allowing comparisons of multiple alternative interventions. In clinical settings, such information allows doctors to provide allergy patients with the best advice, because most patients do not fit the narrow inclusion/exclusion criteria of clinical trials. The benefits of RW research can be illustrated by two studies that are part of the Bringing Real-World Evidence to Allergy Treatment for Health (BREATH) programme, which was launched by Stallergenes Greer. Prof Zielen provided an overview of the design of the German Birch AIT and French Grass SLIT Tablets RW studies. The studies are retrospective cohort studies based on IQVIA™ longitudinal prescription databases allowing patient follow-up. Follow-up was up to 9 years in Germany. Both studies share three objectives: looking at progression of AR after treatment cessation, initiation of new asthma medication in patients with AR (not asthma) at baseline, and progression of asthma medication use in patients with asthma (with or without AR at baseline). Exploring the studies in greater detail, Prof Demoly presented the French Grass SLIT Tablets RW study, which compared 1,099 patients treated with SLIT with 24,475 controls not treated with SLIT. The results for the SLIT cohort versus the control cohort demonstrated long-term benefits for AIT (up to 2 years after treatment cessation), significantly reduced AR medication intake (p<0.001), significantly reduced asthma medication intake (p=0.003), and significantly decreased initiation of asthma medication (p=0.0013). Prof Wahn presented the German Birch AIT RW study, which compared 9,001 AIT patients with 45,005 control patients not taking AIT. The results showed that AIT patients were significantly more likely to be AR medication-free (p<0.001), had reduced risk for initiation of asthma medication during the study (p=0.001), and were more likely to be asthma medication-free during 6 years of follow-up (p<0.001). Notably, when different types of AIT were compared to control, SLIT was not found to be any less effective than SCIT, opening the way for wider use of sublingual treatments.