Volume 10 Supplement 2
The efficacy and safety of the short ragweed sublingual immunotherapy tablet MK-3641 is similar in asthmatic and nonasthmatic subjects treated for allergic rhinitis with/without conjunctivitis
© Maloney et al; licensee BioMed Central Ltd. 2014
Published: 18 December 2014
We conducted a post-hoc analysis of two short-ragweed sublingual immunotherapy tablet (SLIT-T) trials to investigate whether the subjects with allergic rhinitis with/without conjunctivitis (AR/C) and comorbid asthma reported different efficacy or safety events than those with AR/C and no asthma.
Data from two trials evaluating the short-ragweed SLIT-T MK-3641 (Ambrosia artemisiifolia; Merck/ALK-Abelló) were pooled. Subjects with ragweed-pollen–induced AR/C were randomized to once-daily MK-3641 (6 or 12 Amb a 1-U doses) or placebo for approximately 52 weeks. Subjects with AR/C and stable asthma not requiring medium- or high-dose inhaled corticosteroids and ≥70% predicted FEV1 were eligible. Efficacy and safety outcomes were assessed in subjects with AR/C with/without reported asthma. Efficacy measurements included AR/C total combined score (TCS; combined symptom+medication scores); safety was assessed by reported adverse events (AEs).
Among subjects with AR/C and asthma receiving MK-3641 6 or 12 Amb a 1-U, TCS was reduced by 17% (−1.27; 95% CI: −3.48, 0.93; n=56) and 22% (−1.68; 95% CI: −3.69, 0.33; n=64), respectively, versus placebo (mean TCS=7.65; n=64) over the 15-day peak season. Among subjects without asthma receiving MK-3641 6 or 12 Amb a 1-U, TCS was reduced by 21% (−1.83; 95% CI: −2.84, −0.82; n=261) and 27% (−2.34; 95% CI: −3.33, −1.35; n=247), respectively, versus placebo (mean TCS=8.73; n=269). At least one treatment-related AE was experienced by 33%, 63%, and 65% of placebo and MK-3641 6 and 12 Amb a 1-U subjects with asthma, respectively, versus 24%, 54%, and 60% of subjects without asthma. No treatment-related serious or life-threatening AEs or hypersensitivity or systemic reactions were observed.
The overall number of subjects with asthma was low and the data must be interpreted with caution. However, the SLIT-T treatment MK-3641 appeared to demonstrate similar efficacy and safety results in subjects with ragweed AR/C with or without asthma.
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.
This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.