Journal of Allergy and Clinical Immunology
Efficacy Of Short Ragweed Sublingual Immunotherapy Tablet (SLIT-T) In Mono-Sensitized and Poly-Sensitized Subjects
Section snippets
Rationale
Immunotherapy may be less effective in allergic rhinitis with/without conjunctivitis (AR/C) patients with multiple sensitizations. However, this was not observed in recent trials with standardized timothy-grass sublingual immunotherapy tablet (SLIT-T), MK-7243 (Merck/ALK; 2800 BAU Phleum pratense). The relevance of multiple sensitizations to treatment effect of short ragweed SLIT-T, MK-3641 (Merck/ALK; 12 Amb a 1-U Ambrosia artemisiifolia) is not known.
Methods
A prospective subpopulation efficacy analysis between mono- and poly-sensitized ragweed-pollen–induced AR/C was performed in subjects treated with MK-3641. Pooled data from 2 randomized controlled trials investigating MK-3641 (6 and 12 Amb a 1-U doses) were used. Efficacy outcomes included the total combined score (TCS=symptom+medication scores) during the 15-day peak season.
Results
For the whole population, peak TCS improvements from placebo for the pooled MK-3641 6 and 12 Amb a 1-U groups were 20% (−1.70; 95%CI, −2.55 to −0.86) and 23% (−2.02; 95%CI, −2.87 to −1.17), respectively (P<0.0001 for both). Differences vs placebo in the mono-sensitized ragweed MK-3641 pool (n=175) were 15% (-1.34; 95%CI, -3.40 to 0.73) and 19% (-1.72; 95%CI, -3.63 to 0.20) for 6 and 12 Amb a 1-U, respectively. In the poly-sensitized MK-3641 pool (n=784) differences vs placebo were 21% (-1.78;
Conclusions
In the whole study population, treatment with MK-3641 6 and 12 Amb a 1-U for ragweed-induced AR/C was superior to placebo. In the subpopulations, numerical trends suggest a greater treatment effect in poly-sensitized subjects.