The effect of the ragweed sublingual immunotherapy tablet MK-3641 on rescue medication use
© Gawchik et al; licensee BioMed Central Ltd. 2014
Published: 18 December 2014
Allergic rhinitis with/without conjunctivitis (AR/C) sufferers often rely on pharmacotherapy to relieve symptoms. Although the main goal of immunotherapy is long-term disease modification, reducing or eliminating the need for pharmacotherapy is also an important and desirable treatment goal.
Data were pooled from two trials that evaluated the efficacy and safety of short-ragweed sublingual immunotherapy tablet (SLIT-T), MK-3641 (Ambrosia artemisiifolia; Merck/ALK-Abelló). Subjects with ragweed-pollen–induced AR/C were randomized ~16 weeks before the 2010 pollen season to once-daily MK-3641 (6 or 12 Amb a 1-U doses; one trial also included a no-effect dose of 1.5 Amb a 1-U) or placebo. During the trial, all subjects, whether taking MK-3641 or placebo, could use AR/C rescue medication, including oral/ocular antihistamines and intranasal/oral corticosteroids. We examined rescue medication use in all groups.
In pooled results from the two studies, 159 of 318 (50.0%) subjects receiving MK-3641 12 Amb a 1-U and 144 of 324 (44.4%) subjects receiving 6 Amb a 1-U used no rescue medication over the entire ragweed season, compared with 109 of 340 (32.1%) subjects receiving placebo. These differences represented 56% and 38% improvements over placebo. Similarly, during the peak ragweed season 173 of 311 (55.6%) subjects and 161 of 317 (50.8%) subjects in the 12 Amb a 1-U and 6 Amb 1-U groups, respectively, reported no rescue medication use, in contrast to 136 of 333 (40.8%) subjects receiving placebo. Fewer subjects taking 12 and 6 Amb a 1-U (28% and 19%, respectively) used oral antihistamine than those taking placebo; 35% and 28% fewer subjects used ocular antihistamine; and 43% and 27% fewer subjects used intranasal corticosteroid (oral corticosteroid was used by <5 subjects in any group, so rates were not calculated).
Compared with placebo, the SLIT-T treatment MK-3641 reduced rescue-medication use among subjects with ragweed-pollen–induced AR/C.
ClinicalTrials.gov Identifiers: NCT00783198; NCT00770315
Medical writing and editorial assistance was provided by Erin P. Scott, PhD. This assistance was funded by Merck & Co., Inc., Whitehouse Station, NJ, USA. Editorial assistance was also provided by Jorge Moreno-Cantu, PhD, Global Scientific and Medical Publications, Office of the Chief Medical Officer, Merck & Co., Inc., Whitehouse Station, NJ, USA.
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