Real-Life Clinical Experience With SQ Grass, Tree, Ragweed, and House Dust Mite Sublingual Immunotherapy Tablets: A Review of Evidence From Non-Interventional Studies

Abstract

This review evaluates data from > 12,000 children, adolescents and adults (≥ 4 years) in non-interventional studies to assess the real-life effectiveness and safety of SQ sublingual immunotherapy (SLIT)-tablets for allergic rhinitis (AR). Non-interventional studies of SQ grass, tree, ragweed, and house dust mite (HDM) SLIT tablets were identified from PubMed (1 January 2006 to 11 February 2025) and supplemented by manual searches. Effectiveness was captured as patient-reported change in AR symptoms; AR and/or asthma medication use, safety and treatment satisfaction were also evaluated. In total, 12,136 participants were enrolled across 22 SQ SLIT tablet studies (grass: n = 6744; HDM: n = 4323; tree: n = 1069; ragweed: n = 102). Across studies, a high proportion of participants reported improvements from baseline or the previous season across nasal (up to 87%), ocular (up to 81%), and bronchial symptoms (up to 78%) with SQ SLIT tablets. Compared to baseline, a lower proportion of patients reported use of symptom-relieving medication, consistent across key drug classes including oral antihistamine, intranasal corticosteroids, short-acting beta-agonist, and inhaled corticosteroids. Discontinuations due to adverse events were low (0%-14.5%). Among studies reporting treatment satisfaction, 73%-96% of participants were found to be 'satisfied' or 'very satisfied' with this treatment. SQ SLIT tablets showed consistent effectiveness for AR, were well-tolerated, and were associated with a high degree of patient satisfaction. These real-life data from clinical practice are a valuable and important source of complementary evidence to the well established efficacy and safety from randomised clinical trials.

Keywords: allergen immunotherapy; allergic rhinitis; non‐interventional; real‐life effectiveness; sublingual immunotherapy (SLIT)‐tablet.

FIGURE 1

Literature searching conducted to identify publications of non‐interventional studies of SQ SLIT‐tablets. ^aFor each of the SQ grass SLIT‐tablet and SQ HDM SLIT‐tablet, two publications reported data from the same study (grass: Suárez‐Fueyo et al. [2014] and Varona et al. [2019]; HDM: Demoly et al. [2022] and Jaffuel et al. [2024]). ^bOne publication reported data for the co‐administration of grass and ragweed SQ SLIT‐tablets and has, therefore, been included in both categories (grass and ragweed). HDM, house dust mite; RCT, randomised controlled trial; RWE, real‐world evidence; SLIT, sublingual immunotherapy.

FIGURE 2

Effect of SQ SLIT‐tablets on: (A) AR, lower airway, and skin symptoms and (B) patient‐reported outcomes. Data were obtained from: ^aHorn et al. (2016); ^bSchwab et al. (2013); ^cSchwab et al. (2018); ^dVitzthum et al. (2014); ^eGronke et al. (2013); ^fTjan et al. (2017); ^gReiber et al. (2021); ^hSidenius et al. (2021); ⁱPfaar et al. (2024) (Europe = Denmark, Finland, Germany, the Netherlands, Norway and Sweden); ^jWessel et al. (2012); ^kTempels‐Pavlica et al. (2024). Data are missing for some non‐interventional studies due to heterogeneity in the reporting of data among the publications. AT, Austria; DE, Germany; DK, Denmark; FR, France; HDM, house dust mite; NL, the Netherlands; SE, Sweden; SLIT, sublingual immunotherapy.

FIGURE 3

Reduction in symptom‐relieving medication following treatment with SQ SLIT‐tablets. Data were obtained from: ^aHorn et al. (2016); ^bSchwab et al. (2013); ^cSchwab et al. (2018); ^dGronke et al. (2013); ^eReiber et al. (2021); ^fTempels‐Pavlica et al. (2024); ^gPfaar et al. (2024) (Europe = Denmark, Finland, Germany, the Netherlands, Norway and Sweden). Data are missing for some non‐interventional studies due to heterogeneity in the reporting of data among the publications. AT, Austria; DE, Germany; HDM, house dust mite; NL, the Netherlands; SLIT, sublingual immunotherapy.

FIGURE 4

Most frequently reported AEs/ADRs with SQ SLIT‐tablet treatment. Publications reported data for AEs that occurred after treatment initiation and/or for AEs that were considered related to study treatment (i.e., ADRs). Data were obtained from: ^aWessel et al. (2012); ^bSchwab et al. (2018); ^cReiber et al. (2016); ^dArmentia et al. (2012); ^eTjan et al. (2017); ^fDemoly et al. (2022); ^gReiber et al. (2021); ^hSidenius et al. (2021); ⁱKajiume (2022); ^jPfaar et al. (2024) (Europe = Denmark, Finland, Germany, the Netherlands, Norway and Sweden). Data are missing for some non‐interventional studies due to heterogeneity in the reporting of data among the publications. ADR, adverse drug reaction; AE, adverse event; DE, Germany; DK, Denmark; ES, Spain; FR, France; HDM, house dust mite; JP, Japan.