Combination therapy with etanercept in psoriasis: Retrospective analysis of efficacy and safety outcomes from real-life practice
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Combination therapy with etanercept in psoriasis: Retrospective analysis of efficacy and safety outcomes from real-life practice
Graziella Babino 1
Alessandro Giunta 1
Manuela Ruzzetti 1
Maria Sole Chimenti 0
Sergio Chimenti 1
Maria Esposito 1
0 Rheumatology, Allergology and Clinical Immunology, Department of Systemic Medicine, University of Tor Vergata , Rome , Italy
1 Department of Dermatology, University of Rome Tor Vergata , Rome , Italy
Objective: To investigate the efficacy and safety outcomes of combination therapy used to optimize etanercept treatment in patients with psoriasis treated in real-life clinical practice. Methods: Data from patients presenting with psoriasis, treated initially with etanercept monotherapy, were analysed retrospectively. Patients subsequently treated with combination therapy were further analysed. The Psoriasis Area and Severity Index (PASI) score was recorded for all patients receiving comedication; a subjective pain score was recorded in those with psoriatic arthritis receiving comedication after 12, 24 and 48 weeks' treatment and thereafter at 6-month intervals. Results: From the database of 400 patients treated with etanercept, 37 patients (18 male; 19 female; mean age 59.43 years) underwent combination therapy due to lack of efficacy. Patients received mostly short-term (range 4-34 weeks) comedication with corticosteroids, cyclosporine, methotrexate, nonsteroidal anti-inflammatory drugs, acitretin or sulphasalazine. There were significant reductions in the mean PASI score from baseline at all timepoints. There were also significant reductions in the mean pain VAS score from baseline at all timepoints in patients with psoriatic arthritis. The drug survival rate was 59.6% over a mean duration of 323 weeks of etanercept treatment. The safety profile of combination therapy was satisfactory. Conclusions: Short-term comedication in combination with etanercept may optimize treatment options and improve long-term drug survival in patients with psoriasis.
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Several therapeutic options are available for
the treatment of psoriasis; however,
traditional systemic therapies are often unable to
meet desired treatment goals and their
highdose and/or long-term use is associated with
organ toxicity.1–3 Over the past two decades,
the introduction of biological agents has
dramatically improved treatment outcomes,
although they are not effective in all
individuals with psoriasis.2 According to current
guidelines,4 there is no approved indication
for any combination of a biological agent
with a conventional systemic treatment in
psoriasis, although comedication has been
shown to be a frequent dermatological
practice in up to 30% of patients receiving
a tumour necrosis factor-a antagonist.5–8
Combination treatment may provide
improved therapeutic results for patients
who inadequately respond to a single drug;
moreover, combination therapy may reduce
safety concerns and cumulative toxicity, as a
lower dose of two single agents may offer a
better safety and efficacy profile when used
in combination.5–8 The present retrospective
study aimed to describe experience of a
combination treatment strategy used in
real-life clinical practice to optimize
etanercept efficacy and drug survival in patients
with plaque-type psoriasis or psoriatic
arthritis.
Patients and methods
A retrospective analysis was conducted on a
clinical database at the Department of
Dermatology, University of Rome Tor
Vergata, Rome, Italy, of adult patients
with plaque-type psoriasis and/or psoriatic
arthritis, initially treated with etanercept
monotherapy for a minimum of 6 months
in the period between January 2004 and
December 2008. Those treated with a
combination treatment at baseline and/or a
history of active infectious disorders
(including active tuberculosis), or a history
of serious chronic, recurrent, opportunistic
infective diseases, demyelinating diseases or
recent neoplasms, were excluded from the
study. Pregnant or breastfeeding women
were also excluded. Patients were originally
eligible for etanercept treatment if they
presented with moderate-to-severe psoriasis
defined by a Psoriasis Area and Severity
Index (PASI) score9 10 and an affected
body surface area > 10%, were resistant
and/or intolerant to at least two traditional
systemic treatments and/or had
contraindications to such therapies.4 Coexistence of a
joint impairment was diagnosed according
to the CASPAR (Classification Criteria (...truncated)