Table 9. Clinical trials of sublingual immunotherapy.

Design & reference	Sample: size & age	Protocol: duration & daily maintenance dose	Outcome (by ITT) and other significant findings	Notable adverse events
Hazelnut SLIT vs placebo, RCT	12 active 11 placebo	8 to 12 weeks	Hazelnut SLIT induced desensitization in 50% of active subjects tolerating 20 g hazelnut after therapy, vs 9% placebo, with good safety profile	Mild reactions in 7.4% of doses; systemic reactions in 0.2% (N=3), all during build-up. No EAI
Enrique et al. 2005	18–60 years	13 mg
Peanut SLIT vs placebo, RCT	11 active 7 placebo	12 to 18 months	Peanut SLIT induces desensitization, with active group ingesting 20-fold more protein than placebo (P=0.011), with good safety profile	Symptoms with 11.5% of active doses, vs 8.6% placebo. 1 home dose required albuterol. No EAI
Kim et al. 2011	1–11 years	2 mg
Peanut SLIT vs placebo, RCT	20 active 20 placebo	11 months	Peanut SLIT induces desensitization in a majority: 70% of active tolerated 5 g or ingested 10-fold more than at baseline, vs 15% of placebo (P<0.001), with good safety profile	Symptoms with 37% of doses; 2.9% of doses require treatment, with 1 administration of albuterol and 1 EAI, during build-up
Fleischer et al. 2013	12–37 years	165 to 1,385 μg
Peanut SLIT, long-term follow-up of Fleisher et al. 2013	37 active	3 years	With 3 years peanut SLIT, only a portion (11%) of subjects achieved desensitization and 8-wk SU to 10 g, with good safety profile, but high (>50%) drop-out rate	2% of doses with symptoms; no severe AE, no EAI. 2 AE-related withdrawals
Burks et al. 2015		dose as above

AE, adverse event; EAI, epinephrine auto-injector; ITT, intention to treat; OFC, oral food challenge; OIT, oral immunotherapy; RCT, randomized controlled trial; SLIT, sublingual immunotherapy.