Methods: Data from 5 randomized trials of sublingual immunotherapy tablet (SLIT-T) treatment for subjects with allergic rhinitis with or without conjunctivitis (AR/C) were analyzed (3 trials including standardized timothy grass SLIT-T, MK-7243 [Merck/ALK; 2800 BAU of Phleum pratense] and placebo; 2 ragweed trials including short ragweed SLIT-T, MK-3641 [Merck/ALK; 6 and 12 Amb a 1-U of Ambrosia artemisiifolia] and placebo). Approval was obtained from appropriate IRBs and informed consent obtained from all research subjects. As per protocols, all trials scored daily rescue medication use as follows: oral antihistamine, up to 6 pts; ocular antihistamine, up to 6 pts; intranasal corticosteroid, up to 8 pts; oral steroid, up to 16 pts. We analyzed DMS with adjusted weighting based on WAO recommendations, but including the medications used in per-protocol DMS: oral antihistamine, up to 1 pt; ocular antihistamine, up to 1 pt; intranasal corticosteroid, up to 2 pts; oral steroid, up to 3 pts. The primary analysis period was entire pollen season in grass trials and peak season in ragweed trials.
Results: The Table shows DMS by per-protocol and adjusted scoring methods. DMS was consistently reduced by grass and ragweed SLIT-T, by differences ranging from 26% (P=.084) to 45% (P=.0001) by per-protocol scoring and 26% (P=.078) to 47% (P<.0001) by adjusted scoring.
Conclusions: Grass and ragweed SLIT-T were associated with lower medication use vs placebo. Analysis of DMS as per the adjusted scoring methods based on WAO recommendations showed results similar to the per-protocol weighting.
| Trial | DMS (Per Protocol) | Difference vs PBO in DMS (Per Protocol) | P | DMS (Adjusted) | Difference vs PBO in DMS (Adjusted) | P | |
| P05238 (grass) | PBO (n=207) | 1.70 | .27 | ||||
| 2800 BAU (n=184) | 1.25 | −.45 (−.96, .06); −26% | .084 | .20 | −.07 (−.15, .01); −26% | .078 | |
| P05239 (grass) | PBO (n=158) | 1.33 | .21 | ||||
| 2800 BAU (n=149) | .91 | −.42 (−.88, .03); −32% | .066 | .14 | −.07 (−.14, .00); −33% | .051 | |
| P08067 (grass) | PBO (n=672) | 1.36 | .29 | ||||
| 2800 BAU (n=629) | .88 | −.48 (−.73, −.22); −35% | .0003 | .18 | −.10 (−.17, .04); −36% | <.001 | |
| P05233 (ragweed) | PBO (n=164) | 2.87 | .53 | ||||
| 6 Amb a 1-U (n=150) | 1.89 | −.98 (−1.65, −.32); −34% | .0039 | .34 | −.19 (−.32, −.07); −36% | .0030 | |
| 12 Amb a 1-U (n=159) | 1.57 | −1.30 (−1.95, −.64); −45% | .0001 | .28 | −.25 (−.38, −.13); −47% | <.0001 | |
| P05234 (ragweed) | PBO (n=169) | 3.09 | .58 | ||||
| 6 Amb a 1-U (n=167) | 2.01 | −1.08 (−1.84, −.32); −35% | .0053 | .37 | −.21 (−.36, −.06); −37% | .0050 | |
| 12 Amb a 1-U (n=152) | 1.99 | −1.10 (−1.89, −.32); −36% | .0058 | .37 | −.21 (−.36, −.06); −36% | .0076 |