A practical guide to the sublingual immunotherapy tablet adverse event profile: implications for clinical practice

ABSTRACT

Objectives: 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.

KEYWORDS:

• Adverse events
• allergy immunotherapy
• clinical practice
• safety
• sublingual immunotherapy
• tablets

Declaration of interest

A Kaur is an employee of Merck & Co., Inc. H Nolte and Z Li were employees of Merck & Co., Inc. at the time of this work. JA Bardelas has served as a clinical investigator for Merck. BS Fogh and H Nolte are employees of ALK, Horsholm, Denmark. DI Bernstein has received consultancy fees from Merck & Co, Inc., Kenilworth, NJ, USA, Circassia, TEVA, Proctor Gamble, Sanofi Aventis, and Stallergenes Greer; grants from Merck & Co, Inc., Kenilworth, NJ, USA, Circassia, Stallergenes Greer, TEVA, GlaxoSmithKline, Pfizer, Amgen, Pearl, Genentech, Allergy Therapy, Boehringer Ingelheim, and AstraZeneca; and lecture fees from Merck & Co, Inc., Kenilworth, NJ, USA and AstraZeneca. Medical writing and editorial assistance was provided by Erin P. Scott, PhD, of Scott Medical Communications, LLC. This assistance was funded by Merck & Co., Inc., Kenilworth, NJ, USA. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Additional information

Funding

Funding for this research was provided by Merck & Co., Inc., Kenilworth, NJ, USA and ALK, Horsholm, Denmark.