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SQ HDM SLIT-tablet safe, effective in adults with HDM-induced allergic rhinitis

SQ HDM SLIT-tablet reduced the effects of house dust mite-induced allergic rhinitis in adults compared with placebo, according to study results.

Pascal Demoly, MD, PhD, head of the department of pulmonology at University Hospital of Montpellier in Paris, and colleagues conducted a randomized placebo controlled, parallel-group, double blind phase 3 trial across 12 European countries to assess the efficacy and safety of SQ HDM SLIT-tablet (ALK; Hørsholm, Denmark) in adults with moderate to severe house dust mite-induced allergic rhinitis.

The analysis included 992 adults aged 18 to 65 years. Participants either received the tablet in doses of 6 SQ-HDM (n = 336) or 12 SQ-HDM (n = 318) or a daily placebo (n = 338) for approximately 1 year.

During the trial, participants recorded six allergic symptoms, four rhinitis symptoms and two conjunctivitis symptoms on a scale from 0 to 3 to indicate their response to the medication — labeled as total combined rhinitis score (TCRS).

Participants who received 6 SQ-HDM (1.18; P = .002) and 12 SQ-HDM (1.22; P = .001) each had an absolute reduction in TCRS compared with placebo from baseline results.

12 SQ-HDM effectively reduced allergic rhinitis symptoms (P = .003), pharmacotherapy use (P = .024) and improved patients’ responses on rhinitis quality of life questionnaire (P = .031).

Participants generally well tolerated the intervention medication. Participants who received 6 SQ-HDM reported 678 adverse events, 55% of them classified as mild. Participants who received 12 SQ-HDM reported 681 adverse events, 74% of which the participants identified as mild.

“It is clear from this trial that the SQ HDM SLIT-tablet reduces HDM-induced allergic rhinitis symptoms and medication use, and in addition, a more general effect on HDM-induced respiratory disease can be expected,” the researchers wrote. “The predefined clinical relevance was met for both doses. Onset of action after 14 weeks and a sustained year-round treatment effect were demonstrated.” – by Ryan McDonald

Disclosure: Demoly reports receiving consultancy fees from Allergopharma, ALK, DBV, Chiesi, Circassia, Pierre Fabre Medicaments, Stallergenes and Thermo Fisher Scientific. Please see the full study for the remainder of Demoly’s and all other researchers’ relevant financial disclosures.