Immunotherapy Safety for the Primary Care ... - U.S. Coast Guard

J ALLERGY CLIN IMMUNOL
VOLUME 120, NUMBER 3
Cox et al S65
effective in many studies of adults and children with
allergic rhinitis and asthma, but a consistent relationship
among allergen dose, treatment duration, and clinical
efficacy has not been established. However, there is no
FDA-approved formulation for sublingual or oral immunotherapy
in the United States. Therefore sublingual and
oral immunotherapy should be considered investigational
at this time. B
Alternative routes of administration of allergen immunotherapy
are ‘‘a viable alternative to parenteral injection
therapy’’ in some cases. 106,296 Studies of oral immunotherapy
have provided conflicting results for ragweed, 297
birch, 298 and cat 299 immunotherapy. The present dosage of
oral immunotherapy extract is 20 to 200 times the parenteral
injected dosage, which requires a cost assessment for
this type of therapy. Furthermore, adverse effects have included
gastrointestinal and oral reactions (50% in 1 study)
that might preclude home therapy. Oral immunotherapy
should be considered investigational at this time.
Optimal-dose (high-dose) sublingual swallow immunotherapy
is effective in adults and children. 300-304 In a
study of 855 patients with grass pollen allergy and allergic
rhinitis randomized to placebo or one of 3 grass tablet
doses, there was a significant reduction in symptom and
medication scores in the highest-dose subgroup, who
were treated for at least 8 weeks before the grass pollen
season, compared with the placebo group (symptoms,
21%, P 5 .0020; medication use, 29%, P 5 .0120). 303
Sublingual allergen studies have evaluated house dust,
olive pollen, grass pollen, ragweed, birch, cat, latex,
Alternaria species, and Parietaria judaica. 305-313
Sublingual immunotherapy has been shown to be effective
in patients sensitized to 2 non–cross-reacting allergens,
grass and birch. 314 It has been noted that the allergen is
not degraded by saliva and that there is no direct sublingual
absorption of allergen. Radiolabeled allergen has
been detected after 48 hours in the sublingual region.
315,316 Alternative protocols, such as rush and ultrarush
(20 minutes) sublingual swallow 307,316,318 and no
induction (build-up) phase, 301,303,317,319,320 have been
studied. Several studies have suggested a relationship
between dose and efficacy with sublingual immunotherapy,
303,310,321 but a consistent relationship among allergen
dose, treatment duration, and clinical efficacy has not been
established. The majority of sublingual studies have demonstrated
some evidence of clinical efficacy in the form of
either improved symptom scores, medication scores, or
both, but approximately 35% of the randomized, doubleblind,
placebo-controlled studies did not demonstrate
efficacy in either parameter during the first year of treatment.
322 Further studies are needed to confirm the optimal
dose for sublingual immunotherapy.
One of the potential advantages of sublingual immunotherapy
is that it appears to be safe, even at very high
doses (up to 500 times the usual monthly subcutaneous
dose), and to be associated with a lower incidence of
serious side effects. 310,320,323 This appears to apply to
young children (