Table 1 Summary of US SLIT trial findings

Nelson et al. 2010

Timothy grass tablet

439

35.9 (18–65)

76.9%

• Compared to placebo, the treatment group had at 20% improvement in TCS.

• The most common AEs were oral pruritus, throat irritation, ear pruritus, and upper respiratory tract infections.

• DSS improved by 18% and RQLQ by 17% in treatment group versus placebo. DMS improved by 26%.

• There were no serious AEs or anaphylactic reactions.

• There was 1 patient in the treatment group that received epinephrine from possible systemic reaction.

Blaiss et al. 2010

Timothy grass tablet

345

12.3 (5–17)

89%

• TCS improved 26% in treatment group versus placebo.

• Common AEs included oral pruritus, throat irritation, and mouth irritation.

• DSS improved 25%, DMS improved 81%, and RQLQ improved 18% over placebo.

• A moderate reaction of lip edema, dysphagia, and cough was reported by one patient, which responded to epinephrine. It was not considered systemic by the investigator.

Maloney et al. 2014

Timothy grass tablet MK-7243

1501

33 (5–65)

85%

• MK-7243 provided a 20% lower DSS during peak and entire GPS, 38% lower DMS during peak season, 35% lower DMS during entire GPS, and 32% lower TCS during entire GPS compared to placebo.

• The most common AEs were throat irritation, oral pruritus or paresthesias, mouth edema, and ear pruritus.

• Systemic reactions occurred in 2 MK-7243 patients, were moderate in severity, and resolved without treatment.

• There were no severe systemic reactions and no deaths.

Cox et al. 2012

5-grass tablet 300IR

473

37.2 (18–65)

77.9%

• Those in the treatment group had a significantly lower CS during the peak pollen season than the placebo group, with a relative decrease in 28.2%.

• Common AEs included oral itching, throat irritation, and nasopharyngitis.

• The benefit was most notable in those with baseline detectable serum IgE to timothy grass.

• There were no anaphylactic reactions and no serious treatment-related adverse events.

Nolte et al. 2013

Ragweed tablet

565

35.4 (18–50)

85%

• During the peak ragweed season, the 6- Amb a 1 unit group and 12-Amb a 1 unit group had a 21% and 27% reduction in TCS compared to placebo, respectively.

• The most common AEs were oral pruritus, throat irritation, swollen tongue, and ear pruritus.

• During the entire ragweed season, the 6- Amb a 1 unit group and 12-Amb a 1 unit group had a 16% and 26% reduction in TCS compared to placebo, respectively.

• There were no serious treatment-related AEs.

• One treatment patient received epinephrine for sensation of pharyngeal edema.

Creticos et al. 2013

Ragweed liquid

429

38.3 (18–55)

83.9%

• The treatment group had a 43% reduction in TCS during the entire ragweed season compared to placebo.

• The most frequently reported treatment-related AEs were oromucosal reactions, which occurred early and were transient.

• This was statistically significant after adjusting the 95% confidence interval to account for 20% clinically meaningful difference over placebo.

• There were no systemic reactions, anaphylaxis, or death in the treatment group.