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55% of the children; allergic sensitisation to
at least 3 allergens in 66%; food allergies in
35%; allergic rhinitis in 84.5%.
Outcomewas assessedwith the same criteria
after 2 years of omalizumab treatment (
Eur
Resp J, in revision
). Seventy three of the 92
children (79.3%) were still under treatment.
Omalizumab was discontinued in 15 patients
during the second year: four because of lack
of health improvement, eight because of
adverse events attributed to omalizumab,
and three for personal reasons unrelated
to the treatment. Four patients were lost to
follow-up. The adverse events attributed to
omalizumab were: fatigue reported in six
patients and associated with erythema in
one, local reactions in another, and to an
unexpected weight gain in a third; system-
ic clinical signs in two patients consisting of
abdominal pain, headache and fever in one
and hematuria, hemoptysis, and arthralgia
in the other which resolved on discontinu-
ation of the drug. At the end of the second
year, we observed the persistence of the
benefits reported at one year in the children
still receiving omalizumab.The severe exac-
erbation rate continued to decrease to reach
We previously reported the French real-life
experience of one-year of treatment with
omalizumab in 101 severe allergic asthmat-
ic children (6-18 years), 92 of whom were
still receiving the treatment at the end of the
first year [1]. This study provided comple-
mentary data to the previous randomized
trials [2-6]. We showed a marked drop of
72% in the mean rate of severe exacerba-
tions (from 4.4 per patient during the pre-
ceding year to 1.25 during the year of treat-
ment) and of 88.5% for hospitalizations (44%
of the patients during the preceding year to
6.7% during the year of treatment); a large
improvement in asthma control (from 0% at
initiation to 67% of well-controlled patients
after 1 year); a decrease of 30% of the mean
inhaled corticosteroid (ICS) dose (from 703
at initiation to 488 µg fluticasone equivalent
per day after one year); and a forced expira-
tory volume in 1 s (FEV1) increase, from a
mean of 88% to 92.1% of the predicted val-
ue (PV). Treatment was discontinued in six
patients due to serious adverse events at-
tributed to omalizumab by the practitioner.
We finally described the characteristics of
the patients, highly atopic (IgE > 700 kIU/l in
La eficacia más allá de los ensayos
clínicos
Antoine Deschildre
Pediatric Pulmonology and Allergy Unit. Hôpital Jeanne de Flandre. Lille University Hospital. France