2018 Section 5 - Rhinology and Allergic Disorders

DURHAM AND PENAGOS

J ALLERGY CLIN IMMUNOL February 2016

Dropout rate

Y3: 54.7%

Y4: 59.5% Y5: 62%

Y1: 10.4%

Y2: 50.2%

57.3% PP

(Continued)

Season 2 2 0.89 6 4.37 Season 2 1 0.91 6 4.29 Season 2 2 0.08 6 11.69 P 5 .51 Season 2 2 0.93 6 2.69

Season 3 1 1.32 6 4.40 Season 3 2 0.28 6 11.55 P 5 .29 Season 3 2 0.92 6 2.47

SLIT change: Season 1 1 0.86 6 11.72 P 5 .35 Placebo change: Season 1 2 0.39 6 3.04

Reduction relative to placebo: Season 1 2 38% ( P < .0001) Season 2 2 45% ( P < .0001) Season 3 2 40% ( P < .001) Follow-up season 4 2 29% ( P 5 .022)

Follow-up season 5 2 20% ( P 5 .114)

cessation Symptom scores Medication scores

Placebo change: Season 1 1 1.49 6 4.57

5 3 2 2 Reduction relative to placebo: Season 1 2 31% ( P < .0001) Season 2 2 36% ( P < .0001) Season 3 2 29% ( P < .001) Follow-up season 4 2 26% ( P < .001)

Follow-up season 5 2 25% ( P 5 .004)

P 5 .036

P 5 .023

P 5 .0004

Season 3 -1.02 6 4.54

Season 1 2 0.03 6 4.19

4 3 1 1 SLIT change:

blinded after

Years

after

Years

cessation

duration (y)

therapy

Immuno-

duration (y)

Total

study

(1,500 m g

Cumulative dose

365-day

period

season

of group

5 major

allergen)

immunotherapy schedule Units

SQ-T 5.48 mg per

IR 22,000 IR per

Maintenance phase: Frequency : Daily Dose : 300 IR/mL (21 m g/mL Phl p 5)

Maintenance phase: Frequency : Daily Dose : 75,000 SQ-T (15 m g of Phl p 5)

Build-up phase: Frequency : 20-

Duration : 3 years

Dose : 30, 90, 150, and 300 IR Duration : 1 day

Study

methods and

Treatment started

16 weeks before

the expected start of the grass pollen

season. Treatment was continued

during 3 years.

Blind follow-up

was continued

2 years after

completion of the 3-year period of treatment.

Sublingual drops were

administered during 3

consecutive pollen seasons

(coseasonal). The fourth pollen season

during which

participants were not treated was the follow-up period.

minute intervals

(0, 20, 40, and 60 minutes)

P pratense Study description:

Build-up phase: No

Duration: 3 years

Study description:

Five-grass mix

Patients’

characteristics Allergen history of grass pollen–induced ARC

sIgE level and

SPT response to

Phleum pratense

Asthma: Patients with perennial asthma were excluded.

associated with grass pollen

sIgE level and

SPT response

to grass pollen

Asthma: 11% to 14%

Diagnosis: 2-y

Tests: Positive

Diagnosis: ARC

Tests: Positive

142 67 Age: 7-64 years

TABLE E1. Long-term efficacy of SLIT: Randomized, double-blind, placebo-controlled clinical trials Author, year, country SLIT Placebo Durham et al 6,15 and Dahl, 11 2006, 2010, 2012, United Kingdom 316 318 Age: 18-65 y Ott et al, 22 2009, Germany

167