A practical guide to the sublingual immunotherapy tablet adverse event profile: implications for clinical practice.
OBJECTIVE
Treatment with allergy immunotherapy improves allergic rhinoconjunctivitis, but can also improve comorbidities associated with allergic rhinitis such as asthma. Sublingual immunotherapy (SLIT)-tablets are a convenient and efficacious method of allergy immunotherapy. They are self-administered after the first tablet has been provided under medical supervision. Therapy may elicit local reactions or, rarely, systemic allergic reactions. The objective of this report is to inform healthcare practitioners about the safety and tolerability profile of SLIT-tablets and use this information to provide practical guidance that may inform patients regarding potential adverse reactions and how to manage them.


METHODS
Pooled analyses of safety data from completed randomized, multicenter, double-blind, placebo-controlled phase 2 and phase 3 US and EU trials of timothy grass, short ragweed, and SQ house dust mite SLIT-tablets were conducted to characterize safety and tolerability.


RESULTS
SLIT-tablets are generally well tolerated. No life-threatening events, serious systemic allergic reactions, or events that compromised the airway have been reported. The most common treatment-related adverse events (AEs) are oral site reactions, most of which begin on day 1 of treatment, recur for less than 2 weeks, and resolve after approximately 30-60 minutes. Systemic allergic reactions have been managed with conventional pharmacotherapy. Reactions treated with epinephrine are uncommon, but have been reported. Treatment of AEs, treatment discontinuation considerations, and patient FAQs regarding SLIT-tablet safety/tolerability are discussed.


CONCLUSIONS
This report gives healthcare providers valuable information to educate patients regarding what to expect in terms of SLIT-tablet safety and tolerability. Practical guidance is also provided to ensure proper treatment of any adverse reactions.
a Bernstein Clinical Research Center and Department of Medicine and Environmental Health , University of Cincinnati , Cincinnati , OH , USA.
David I
DI
Bernstein
b Allergy and Asthma Center of North Carolina , High Point , NC , USA.
Jose A
JA
Bardelas
c ALK , Hørsholm , Denmark.
Bodil
B
Svanholm Fogh
d Merck & Co., Inc. , Kenilworth , NJ , USA.
Amarjot
A
Kaur
d Merck & Co., Inc. , Kenilworth , NJ , USA.
Ziliang
Z
Li
d Merck & Co., Inc. , Kenilworth , NJ , USA.
Hendrik
H
Nolte
D000293:Adolescent; D000328:Adult; D031164:Ambrosia; D000818:Animals; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D006109:Poaceae; D039981:Pyroglyphidae; D065631:Rhinitis, Allergic / Q000188:drug therapy* / Q000276:immunology*; D012648:Self Care; D063729:Sublingual Immunotherapy / Q000009:adverse effects*; D013607:Tablets; D016896:Treatment Outcome
D013607:Tablets
Adverse events; allergy immunotherapy; clinical practice; safety; sublingual immunotherapy; tablets