METHODS: The RQLQ was included in three randomized, double-blinded, placebo-controlled clinical trials (P001, P003 and MT-06) evaluating the efficacy and safety of SQ HDM SLIT-tablet in North American and European subjects with HDM induced AR, with or without allergic asthma. The RQLQ was assessed and recorded at multiple time points throughout the trials.
RESULTS: QoL measured by the RQLQ consistently improved across all three trials. The groups receiving SQ HDM SLIT-tablet had larger increases in their QoL as compared to the placebo groups. The differences in improvement from baseline between the placebo and active groups were statistically significant in all three studies; P001: 0.28 (1.84 vs. 1.56), p<0.001, P003: 0.56 (2.47 vs. 1.91), p=0.010 and MT-06: 0.19 (1.58 vs. 1.38), p=0.031. Consistent results were also seen across the individual domains of RQLQ. In P001 the difference in improvement from baseline for all domains reached statistical significance for SQ HDM SLIT-tablet compared to placebo. This was also the case for all domains but "eye symptoms" in P003, whereas MT-06 showed statistically significant differences in four domains: "nasal symptoms", “non-nose/non-eye symptoms", "practical problems" and "sleep" domains.
CONCLUSIONS: The RQLQ results from three randomized, double-blinded, placebo-controlled clinical trials show that SQ HDM SLIT-tablet consistently improves the QoL of people suffering from HDM induced AR across slightly different populations and in different settings.