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Giménez Arnau AM, et al.
J Investig Allergol Clin Immunol 2019; Vol. 29(5): 338-348 © 2019 Esmon Publicidad
doi: 10.18176/jiaci.0323
4.3. Good Responders
Patients with a sustained UAS7 score ranging from 1 to
6 points are considered good responders (Table 2). In these
patients, the standard dose and treatment frequency should
continue until the 6-month follow-up assessment. If the disease
remains controlled, then the strategy could be modified in
an attempt to identify the minimum effective dose for good
disease control. In these cases, the 3 possible strategies are as
follows: (1) dose reduction at the same treatment interval, ( 2)
increased treatment interval with the same dose, and (3) no
change in dose or treatment interval.
If either the dose or the treatment interval is modified, then
the patient should be re-evaluated after 3 and 6 months. If this
assessment shows a deterioration in the patient’s health, then
the patient should be returned to the previous standard dose
and frequency and re-evaluated after a further 3 and 6 months.
Similarly, when no change is made to standard therapy,
the patient should be re-evaluated at a maximum of 6 months.
4.4. Complete Responders
Patients considered complete responders are those with
sustained UAS7 scores of 0 and no signs or symptoms of
urticaria while on the standard omalizumab dose.
Cons i de r i ng add - on t r ea tmen t , t he comp l e t e
responder profile also includes patients who require
neither H1antihistamines nor salvage medications (Table 2).
In fact, we recommend reducing the dose or even complete
withdrawal of H1 antihistamines in these patients.
Prolongation of the standard prescription of omalizumab
beyond 6 months is not recommended in complete responders.
However, a change in the therapeutic approach may be
considered 3 months after initiation of omalizumab in complete
responders. In these cases, the change in strategy would involve
a dose reduction while maintaining the treatment interval;
alternatively, the treatment interval could be increased while
maintaining the dose in order to find the minimum effective
dose. If possible, treatment should be withdrawn.
If the patient's condition has worsened at the 3- or
6-month re-evaluation following the modification in strategy,
a return to the standard dose and frequency (300 mg/4 wk)
is recommended, followed by re-evaluation 3 to 6 months
later. Discontinuation of omalizumab should be considered in
patients who maintain a sustained response lasting ≥8 weeks to
determine whether the patient has achieved disease remission.
Although implementation of the therapeutic strategies for
omalizumab suggested may involve an increase in costs, these
may be compensated by a decrease in concomitant medication
use, improvement in patients’ quality of life, and reduced
disease-related health care costs [42].
5. Conclusion
European guidelines support the use of omalizumab as a
third-line treatment for patients with CSU. Patients typically
respond to omalizumab within the first 4-8 weeks of treatment,
and the response is often evident within the first week.
Importantly, even patients who do not initially respond to
treatment (nonresponders) can obtain a significant reduction
in disease activity and achieve “good control” (UAS7≤6) or
“complete control” (UAS7=0) if treatment is continued for
up to 24 weeks.
The therapeutic algorithm presented here is intended to
facilitate the clinical management of omalizumab and to help
clinicians determine the most appropriate therapeutic strategy
based on the 4 different patient response profiles described in
this study.
Acknowledgments
We are grateful to Novartis Pharmaceutical S.A. for
sponsoring the meetings organized to prepare this article.
Funding
The meetings were financed by Novartis Farmacéutica S.A.
Conflicts of Interest
Ana M Giménez-Arnau declares the following, real or
perceived conflicts of interest: medical advisor for Uriach
Pharma, Genentech, Novartis, FAES, GSK; research grants
supported by Uriach Pharma, Novartis, grants from Instituto
Carlos III-FEDER; educational activities for Uriach Pharma,
Novartis, Genentech, Menarini, LEO- PHARMA, GSK, MSD,
Almirall.
Antonio Valero belongs to the Spanish advisory group in
chronic urticaria sponsored by Novartis. He has participated in
several observational studies sponsored by Novartis involving
chronic urticaria patients. He has also accepted invitations to
international meetings and travel grants from Novartis and
other companies.
Joan Bartra reports having served as a consultant to
Novartis, FAES FARMA, Hal Allergy, and UCB and having
been paid lecture fees by Novartis, Stallergenes, Hal Allergy,
FAES FARMA, and Thermo Fisher.
Ignacio Jáuregui belongs to the Spanish advisory group in
chronic urticaria sponsored by Novartis. He has participated
in several observational studies sponsored by Novartis and
Circassia. He has accepted invitations to international meetings
and travel grants from Novartis, Leti, and Roxall. He has
received advisory, speaking, and medical writing fees from
Novartis, Sanofi, MSD, FAES FARMA, and Roxall. He reports
no other conflicts of interest related to this paper.
Moises Labrador has received speaker and consulting fees
from Novartis.
Francisco Javier Miquel Miquel belongs to the Spanish
advisory group in chronic urticaria sponsored by Novartis.
He has participated as a paid speaker in training activities
and meetings organized by the following companies: Novartis
Pharmaceutical S.A., Leo Pharma, Astellas, Janssen, and
Almirall. He has participated in several observational studies
sponsored by Novartis involving chronic urticaria patients and
has accepted invitations to meetings and travel grants from
Novartis, Leo Pharma, Astellas, Janssen, andAlmirall. He has
also participated in advisory boards from Novartis.
Javier Ortiz de Frutos has served as a consultant to
Novartis, Uriach, Astellas, Sanofi, Viñas, BDF, and GSK and
has been paid lecture fees by Sanofi, Novartis, BDF, GSK,
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