2016 Section 5 Green Book

SUBLINGUAL IMMUNOTHERAPY FOR RHINOCONJUNCTIVITIS AND ASTHMA

SafetyOutcomes. The studies did not uniformly or consistently report safety information, although 47 studies (75%)

sive description and subanalysis of the pediatric studies are available in the full Agency for Healthcare Research and

Quality report on effectiveness of spe- cific immunotherapy for allergic rhini- tis and asthma.

Table 1. Sublingual Immunotherapy Evidence Summary (continued)

Strength of the Evidence Moderate

No. of Participants

No. of Studies

Summary of Grading Data

Outcome

Allergens

Comparators

Findings

Sublingual immunotherapy vs placebo 10,12,14-17,19, 22,24-32,35,37-39,43-45,50, 52,54-56,58,64,65 vs pharmacotherapy 23,46, 61,66 vs 5 placebo-controlled trials of sublingual immunotherapy 11,41,57, 60,62

Ten studies with low risk of bias 11,14,25,30, 32,38,56,57,60,64 ; 2 of these had strong magnitude of effect 11,25 ; 2 had weak magnitude. 14,60 Twenty-two studies 7 of these had strong magnitude, 12,23, 24,45,46,52,61 ; 6 of these had weak magnitude of effect. 10,15,50,54,62,65 Six studies with high risk of bias 22,27,29,31, 55,58 ; 3 of these had strong magnitude. 22,55,58 Ten studies with insufficient data to determine magnitude of Four studies with low risk of bias 14,57,64,67 ; 1 of these had strong magnitude 57 ; 2 had low magnitude. 14,64 Eleven studies with medium risk of bias 8,15,23,34,50,52-54, 63,65,69 ; 5 of these had strong magnitude. 8,43,52,63,69 Four studies with high risk of bias. 22,31,68,70 Eight studies with insufficient data to determine magnitude of effect. 2,23,31,53,54,65,67,70 bias 14,54,65,68 ; 2 of these had strong magnitude. 14,65 Two studies with low risk of bias and insufficient data to determine magnitude of effect. 2,67 Five studies with insufficient data to determine magnitude of effect. 29,32,51,65,67 with medium risk of bias 10,12,15-17,19, 23,24,26,28,35,37,39,41, 45,46,50,52,54,61,63,65 ; Four studies with medium risk of

Sublingual

Medication use scores

2162

41 Grass

immunotherapy did better than comparator in all but 1 study. 32 change could not be determined in 1 study. 30

mix 11,12,16,17,19,31,32, 43,46,50 Dust mite 15,25-29,35,37,62 Parietaria 30,38,52,64 Cedar 54,55,65 Alternaria 22,45 Tree mix 23,41 Timothy grass 56,60 Ragweed 10,57 Birch 58,61 Olive 39 Rye 44 Multiple allergens 14,24,63

The direction of

There was a strong magnitude of effect in 16

studies. 11,12,22,23,25,27, 37,44-46,52,55,57,58,61,63

effect. 16,17,25,29-32,35,39,56

Sublingual immunotherapy vs placebo 14,15,22,43,50, 53,54,64,65,67-70 vs pharmacotherapy 23,52 vs no treatment 31,34 vs sublingual immunotherapy (1 placebo-controlled trial, 57 1 pharmacotherapy- controlled trial, 63 and 1 trial vs no treatment 8 )

All studies but one 67 (in which direction of change could not be determined) showed greater improvement

Moderate

Medication use plus symptom scores

1669

20 Cedar 53,54,65,67,68 Grass mix 31,43,50,69 Parietaria 52,64,70

Dust mite 15 Alternaria 22 Ragweed 57 Tree mix 23 Multiple

with sublingual immunotherapy than comparator. demonstrated a stong magnitude of effect. 8,34,52,57, 63,69

allergens 8,14,34,63

Six studies

Sublingual immunotherapy vs placebo 14,29,32,51,54, 65,67,68

Four studies reported significant improvement in disease-specific quality of life vs placebo. 54,65,67,68 Two studies reported significant improvement with sublingual

Moderate

Disease-specific quality of life

819

8 Cedar 54,65,67,68 Dust mite 29,51 Grass mix 32

Multiple allergens 14

immunotherapy when comparing the initial with the final quality-of-life scores. 14,51

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JAMA, March 27, 2013—Vol 309, No. 12 Corrected on July 29, 2013

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