|
A Armentia,1 F
Carballada,2 P Carretero,3 S de
Paz,4 T Lobera,5 C Marcos,6
JC Martínez,7 I Rodríguez,8 T
Soto,9 M Venturini,10 F de la
Torre11 |
|
1Allergy Service, Hospital
Rio Hortega, Valladolid, Spain
2Allergy Service, Hospital Lucus Augusti,
Lugo, Spain
3Allergy Service, Hospital General Yagüe,
Burgos, Spain
4Allergy Service, Hospital Santa Bárbara,
Soria, Spain
5Allergy Service, Centro de Alta Resolución
San Millán, Logroño, Spain
6Allergy Service, Complejo Hospitalario
Universitario de Vigo, Vigo, Spain
7Allergy Service, Hospital Virgen de la
Concha, Zamora, Spain
8Allergy Service, Hospital Arquitecto Marcide,
Ferrol, Spain
9Allergy Service, Complejo Hospitalario de
Pontevedra, Pontevedra, Spain
10Allergy Service, Fundación Hospital
Calahorra, Calahorra, Spain
11ALK-Abelló, S.A., Madrid, Spain |
|
Abstract |
|
Background and
Objective: Many
patients with grass
pollen allergy in
Spain have
concomitant
sensitization to
other allergens such
as profilin. Since
this type of
sensitization is
more common in
Mediterranean
countries than in
countries where most
patients were
enrolled in clinical
trials on GRAZAX (Phleum
pratense 75,000
SQ-T/2,800 BAU, ALK),
the aim of this
study was to analyze
tolerability to
GRAZAX under
clinical practice
conditions in
patients with grass
pollen allergy.
Methods: A
total of 155
patients were
enrolled
consecutively in a
prospective,
open-label,
observational study.
Adverse reactions
were recorded during
the fi rst month of
treatment at 3
different timepoints:
after the first
dose, when patients
were kept under
observation for 30
minutes, and on days
15 and 30 after
starting treatment
Results: With
the first dose, 117
adverse reactions
were recorded in 63
patients (40.7%).
The commonest
reactions (>10%
patients) were oral
pruritus (25.2%) and
throat irritation
(24.5%). Ear
pruritus was
recorded in 7.7%.
All reactions but 1
occurred within 30
minutes of
administration and
all were
mild-to-moderate. At
the end of
treatment, the
percentage of
patients with
adverse reactions
had decreased
significantly
(21.3%). Most
adverse reactions
(95.2%) were
mild-to-moderate and
only 3 (1.4%) were
severe. No serious
adverse reactions
were recorded.
Conclusion:
GRAZAX seems to be
well tolerated, and
most reactions were
mild-to-moderate.
Many of these
reactions occur with
the first dose.
Therefore, according
to the Summary of
Product
Characteristics, the
first dose has to be
administered under
medical supervision.
Key words:
Allergen
immunotherapy
tablets.
Rhinoconjunctivitis.
Tolerability.
Satisfaction. Grass
pollen allergy. |
|
|
|
| |
|
|
