Table 2.
Double-blind, randomized studies (versus placebo, comparator) selected in this systematic review involving specific populations (either children or elderly).
| Ref* | Age† | Cohort size | Diagnosis | Allergen | Administration type | Study duration | Efficacyα | Safety |
|---|---|---|---|---|---|---|---|---|
| Children | ||||||||
| Valovirta et al.22 | 5–12 | 812 | RC | SQ-grass pollen | Continuous | 3 years of treatment + 2 years of follow-up | 22% reduction in DSS after 5 years 27% reduction in DMS after 5 years |
6 SAEs No Ax |
| Wahn et al.59 | 4–12 | 207 | R/RC | Grass pollen | Pre-/coseasonal | 8 months | Changes of −212.5 in AUC of TCS from baseline to first season Changes of −126.6/−85.9 in AUC of SS/MS (same period) |
No SAEs No Ax |
| Stelmach et al.61 | 6–18 | 60 | R | 5-grass pollen | Pre-/coseasonal versus continuous | 2 years | Reduction in TCS/TSS in pre-/coseasonal and continuous Pre-/coseasonal reduced more nasal symptoms than continuous |
No SAEs No Ax |
| Stelmach et al.76 | 6–17 | 50 | Asthma ± RC | 5-grass pollen | Pre-/coseasonal | 2 weeks (pre) until end of season 2 seasons |
25 and 41% improvement in nasal and asthma SS 10% improvement in use of rescue medication |
No SAEs No Ax |
| Bufe et al.77 | 5–16 | 253 | RC | SQ-grass pollen | Pre-/coseasonal | 8–23 weeks (pre) until end of season | 24 and 34% reduction in rhinoconjunctivitis SS and MS 64% reduction in asthma SS |
No SAEs No Ax |
| Wahn et al.80 | 5–17 | 278 | RC | 300 IR 5-grass pollen | Pre-/coseasonal | 4 months (pre) until end of season | 28.0% improvement in TSS −0.20 mean reduction in rescue MS |
17 SAEs No Ax |
| Röder et al.82 | 6–18 | 204 | RC | Grass pollen | Continuous | 2 years | No differences between groups in SS | - |
| Röder et al.92 | 6–18 | 204 | RC | 5-grass pollen | Continuous | 2 years | No differences between groups in TSS | - |
| Rolinck-Werninghaus et al.106 | 3–14 | 97 | RC | 5-grass pollen | Continuous | 32 months | TCS reduced by 77.3% of placebo group MS reduced by 67.3% of placebo group |
1 SAE No Ax |
| Wüthrich et al.113 | 4–11 | 28 | RC | 5-grass pollen | Continuous | 2 years | 70% improvement in MS in second year compared with first | No SAEs No Ax |
| Valovirta et al.99 | 5–15 | 88 | RC | Birch, alder, and hazel pollen | Continuous | Up to 18 months | Reduction in SS and MS with 24,000 and 200,000 SQ-U doses No differences between doses |
No SAEs No Ax |
| Pajno et al.118 | 8–15 | 24 | Asthma | House-dust mite | Continuous | 2 years | Reduced SS and MS after 2 years of treatment | No SAEs No Ax |
| de Bot et al.63 | 6–18 | 251 | R | House-dust mite | Continuous | 2 years | No significant effect in mean NSS after treatment | No SAEs No Ax |
| Yonekura et al.75 | 7–15 | 31 | R | House-dust mite | Continuous | 40 weeks | Reduction in mean NSS in week 32 and 35 Reduction in mean TSS in week 24 |
No SAEs No Ax |
| Pham-Thi et al.95 | 5–15 | 111 | Asthma ± R | House-dust mite | Continuous | 18 months | Decrease in rhinitis SS, but no difference with placebo | No SAEs No Ax |
| Hirsch et al.128 | 6–15 | 30 | Asthma ± R | House-dust mite | Continuous | 12 months | Reduction in mean NSS, but no difference with placebo | No SAEs No Ax |
| Pajno et al. 112 | 8–14 | 38 | Asthma ± RC | Parietaria Judaica pollen | Coseasonal | 13 months | Improvement in SS and MS in active and placebo groups | - |
| La Rosa et al.122 | 6–14 | 41 | RC | Parietaria judaica | Continuous | 2 years | Reduction in SS during the second season | No SAEs No Ax |
| Vourdas et al.125 | 7–17 | 66 | RC | Olive pollen | Pre-/coseasonal | 2 seasons | Decreased SS during first and second seasons | No SAEs No Ax |
| Elderly | ||||||||
| Bozek et al.25 | 66±5 | 47 | R | House-dust mite | Continuous | 3 years of treatment + 3 years of follow-up | 4.01 mean reduction in AASS after 3 years 3.17 mean reduction in AASS after 6 years Significant differences SLIT – placebo after 3 and 6 years |
- |
| Bozek et al.57 | 60–75 | 111 | R | House-dust mite | Continuous | 3 years | 44% decrease in TNSS at the end of treatment 51% decrease in TMS at the end of treatment |
No SAEs No Ax |
| Bozek et al.46 | 60–70 | 78 | R | 5-grass pollen | Preseasonal | 3 years | 64% decrease in nasal SS at the end of treatment 51% decrease in TMS at the end of treatment |
No SAEs No Ax |
Subanalyses (with redundant results), pooled studies, or references with not available full-text were not included in the table.
Age is shown as range (minimum–maximum) or mean ± standard deviation.
If not indicated, efficacy results are referred to the active treatment group. Comparisons are made with placebo. Only significant results are shown (p<0.05).
AASS, average adjusted symptoms score; AUC, area under the curve; Ax, anaphylactic reaction; DMS, daily medication score; DSS, daily symptom score; MS, medication score; NSS, nasal symptom score; R, rhinitis; RC, rhinoconjunctivitis; SAE, severe or serious adverse events (related to SLIT); SS, symptom score; TCS, total combined score; TMS, total medication score; TNSS, total nasal symptom score; TSS, total symptom score.