TY - JOUR T1 - HDM sublingual AIT tablet is well-tolerated and effective in partly and uncontrolled allergic asthma JF - European Respiratory Journal JO - Eur Respir J VL - 44 IS - Suppl 58 SP - P298 AU - Vibeke Backer AU - Johan Christian Virchow AU - Hanne H. Villesen AU - Peter A. Fejerskov AU - Bente Riis AU - Frederic De Blay Y1 - 2014/09/01 UR - http://erj.ersjournals.com/content/44/Suppl_58/P298.abstract N2 - Background: Use of allergy immunotherapy (AIT) in allergic asthma (AA) is complicated by a general contraindication of AIT in "severe asthma". We investigated SQ house dust mite (HDM) sublingual tablet (ALK, Denmark) in subjects with HDM AA.Methods: The trial (EudraCT 2010-018621-19) was a DBPC trial, including 834 subjects from 13 European countries with >1 year history of AA and positive tests of HDM sensitisation. At enrolment, subjects were not well-controlled (ACQ score >1) by inhaled corticosteroid (ICS; budesonide 400-1200µg or equivalent). Subjects were randomised 1:1:1 to daily treatment for up to 18 months with placebo, 6 or 12 SQ-HDM. Subjects received ICS during for 7-12 months; before ICS was reduced by 50% for 3 months and by 100% for 3 months.Results: By GINA criteria, 28% of subjects were uncontrolled at randomisation and 72% were partly controlled (equally between treatment groups). No safety concerns were observed. At randomisation all subjects had FEV1≥70% of predicted, but during the trial 129 subjects had at least 1 FEV1 record <70%, with no safety signals in active versus placebo. Asthma control was significantly improved as shown by reduced risk for an asthma exacerbation during ICS reduction (risk reduction with 12 SQ-HDM: 31%, HR=0.69, p=0.027).Conclusions: This is the first trial demonstrating a clinically relevant reduced risk of asthma exacerbation with SQ HDM SLIT-tablet. Treatment was well-tolerated in a population with partly or uncontrolled AA (GINA definition) and in subjects with occasional FEV1 values below 70% of predicted. This suggests a possibility for treatment of uncontrolled AA patients with occasional lung function below 70% of predicted. ER -