524
SHORT COMMUNICATION
Treatment of Refractory Chronic Spontaneous Urticaria with Adalimumab
Nannie BANGSGAARD, Lone SKOV and Claus ZACHARIAE
Department of Dermato-Allergology, Herlev and Gentofte Hospital, University of Copenhagen, DK-2900 Hellerup, Denmark. E-mail:
[email protected]
Accepted Nov 10, 2016; Epub ahead of print Nov 14, 2016
Chronic spontaneous urticaria (CSU) is defined by
the spontaneous appearance of wheals with or without
oedema that persist for more than 6 weeks (1). The di-
sease affects up to 1% of the general population at some
time in life (2) and can be very distressing, with severe
reduction in quality of life (3). Little is known about the
pathophysiology of CSU.
First-line treatment for CSU is based on non-sedating,
second-generation H1-antihistamine, given, if necessary,
in 4-fold licensed doses (1). A significant proportion
of patients with CSU remain poorly controlled on this
treatment and alternative therapeutic approaches have to
be considered. Several immune modulatory treatments
have been used with varying effect; prednisolone, aza-
thioprine, mycophenolate mofetil, cyclosporine, sulfa-
salazine and methotrexate (4).
Omalizumab, an anti-IgE monoclonal antibody
(anti-IgE mAb), has been approved recently by the US
Food and Drug Administration (FDA) and European
Medicines Agency (EMA) for the treatment of CSU,
with promising results (5).
Tumour necrosis factor alpha (TNF-α) is upregulated
in both skin and serum in patients with urticaria (6, 7),
and treatment with anti-TNF-α is hence expected to have
an effect on chronic urticaria. There is limited data on
the effect of anti-TNF-α treatment of urticaria. Wilson et
al. (8) reported the effect in 6 patients with recalcitrant
chronic urticaria treated with different TNF-α inhibitors,
and Magerl et al. (9) describe remission of delayed pres-
sure urticaria in one patient treated with etanercept.
The aim of this study was to investigate the effect of
adalimumab on antihistamine refractory CSU.
MATERIALS AND METHODS
This proof-of-concept study was performed at the Department of
Dermato-Allergology, Herlev and Gentofte Hospital in accordance
with the Declaration of Helsinki. The study was approved by the
local ethics committee (NO. H-3-2010-109) and The Danish Medi-
cines Agency (EUDRACT NO. 2010-022705-18). All subjects
gave written, informed consent prior to enrolment.
Nine patients with CSU refractory to H1-antihistamine in
4-fold licensed doses were included in the study. Baseline data
for enrolled patients are shown in Table I. Prior to enrollment
patients were screened for infectious diseases, including hepatitis,
HIV and tuberculosis. The protocol for adalimumab treatment of
psoriasis was followed.
The patients were treated subcutaneously with a loading dose
of 80 mg adalimumab (Humira ® ; R&D systems, Abington, UK),
followed by 40 mg every other week for 16 weeks. Patients were
evaluated at baseline,