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A. I. Tabar1, L.
Fernández-Távora2, R. Alonso3, R.
Castillo4, A. Cisteró-Bahima3, F.
de la Torre-Morín5, J. Fernández6,
B. E. García-Figueroa1, S. Fernández7,
J. J. García-González7, J. C. García-Robaina5,
F. Moreno8, P. Lobatón8, I.
Sánchez-Machín5, F. de la Torre-Martínez9. |
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1 Hospital Virgen del Camino,
Pamplona, Spain
2 Ambulatorio Virgen de la Cinta, Huelva, Spain
3 Instituto Universitario Dexeus, UAB, Barcelona, Spain
4 Hospital Dr. Negrín, Las Palmas de Gran Canaria, Spain
5 Hospital Universitario Ntra Sra de la Candelaria,
Tenerife, Spain
6 Hospital general Universitario de Elche, Alicante,
Spain
7 Hospital regional Universitario Carlos Haya, Málaga,
Spain
8 Clínica Dr. Lobatón, Cádiz, Spain
9 ALK-ABELLÓ, S.A., Madrid, Spain |
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Abstract |
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Summary. The
standardisation of
allergenic extracts
in micrograms of the
major allergen has
encouraged the
search for new
treatment schedules,
with the purpose of
shortening the
number of visits and
doses required to
reach the
maintenance dose
without eliciting a
greater risk of
adverse reactions
for the patients.
With this objective,
a prospective
multicentre
pharmacovigilance
study was designed
that included 200
patients with
allergic
rhinoconjunctivitis
and/ or allergic
asthma sensitised to
mites (Dermatophagoides
pteronyssinus and/or
farinae). The dose
increment period was
carried out using a
cluster schedule,
where the optimal
dose was reached
after 4 visits,
administering two
doses in each visit.
The duration of the
study was 5 months
and a total of 1902
doses were
administered.
At the end of the
trial, 31 adverse
reactions in 23
patients were
recorded. Six of
these were systemic
(0.3% of the
administered doses)
recorded in 6
patients (3% of the
sample). One was an
immediate reaction
(grade 1) and 5
delayed (4 mild and
1 moderate). Two
were asthmatic
exacerbations, 2
cutaneous reactions,
1 rhinitis and 1 an
unspecific symptom (not
IgE-mediated). Two
appeared upon
administration of
the first vial and
the remaining 4
after administration
of the third
cluster.
Therefore, the
schedule tested
presents an adequate
tolerance profile,
suggesting savings (compared
to the conventional
schedule of 13 doses
per patient) of 1800
visits and 1000
treatment doses in
the whole study.
Keywords:
Rhinoconjunctivitis,
Asthma, Cluster
Immunotherapy,
Pharmacosurveillance,
Mites. |
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