Safety and Effectiveness of Ustekinumab for Treatment of Moderate to Severe Psoriasis: A Prospective Study in a Clinical Setting
August 2014 | Volume 13 | Issue 8 | Original Article | 971 | Copyright © August 2014
Alejandro Molina-Leyva MD, Husein Husein-Elahmed MD, Ramon Naranjo-Sintes PhD,
and Jose Carlos Ruiz-Carrascosa MD
Department of Dermatology, Hospital Universitario San Cecilio, Granada, Spain
BACKGROUND: There are few studies analyzing the behavior of ustekinumab in the complex management of psoriasis within diary clinical
OBJECTIVE: To assess the utility of ustekinumab in a psoriasis unit.
METHODS: Analysis of the prospective data gathered during the follow-up of 30 consecutive psoriasis patients treated with ustekinumab at
a single referral centre. Three effectiveness endpoints were defined 12 weeks, 28 and “long-term treatment”. The main outcome measure
was improvement from baseline PASI at week 28 and at a point of adjustment of prolonged treatment signed as “long-term treatment”.
RESULTS: Overall 82.1% and 42.8% patients achieved respectively PASI75 and PASI90 response rates at week 28. Long-term treatment
maintained efficacy outcomes 81.5% and 40.7% PASI75 and PASI90, respectively were observed. At week 28, patients naïve to TNFα-
blockers agents and patients with a baseline PASI >10 had better PASI75 and PASI90 response rates than previously treated patients.
CONCLUSIONS: In clinical practice, the efficacy and patient adherence to ustekinumab are excellent and even better to the data obtained
in clinical trials. Clinical indicators of psoriasis severity: previous treatments with tumor necrosis factor α blockers agents and active
treatment beside small increases in PASI determine a delayed maximal response. J Drugs Dermatol
Psoriasis is a chronic immune-mediated skin disorder that
affects 2% of the population. Moderate to severe forms of
psoriasis require systemic treatment. The management of
this condition with classic systemic agents such as methotrexate,
acitretin, and cyclosporine have been associated with organ toxicity
in long-term use. The new biologic agents show a superior
response rate and are suggested to be absent of accumulative
toxicity. Ustekinumab is a human monoclonal antibody against
the shared p40 subunit of interleukins 12 and 23. Three phase III
clinical trials (PHOENIX 1, PHOENIX 2, and ACCEPT) have shown
high levels of effectiveness of this agent in patients with psoriasis.
However clinical trials provide a poor perspective in the complex
management of psoriasis within diary clinical practice setting due
to the strict conditions and criteria associated to those types of researches.
The aim of this study is to assess the utility of this agent
in a diary clinical setting: The Psoriasis Unit of our clinic.
MATERIAL AND METHODS
In our unit, 286 patients with moderate-to-severe psoriasis are
attended. This prospective study involved 30 consecutive patients
treated with ustekinumab from February 2009 to August
2012. Biometric data, history of psoriasis, previous therapies,
comorbidities, effectiveness of the treatment measured by
the psoriasis area and severity index (PASI), side effects and
the results from complementary tests performed during the treatment were collected in each follow-up visit. The Ethic Committee
of XX approved the study.
All the patients underwent pretreatment screening protocol according
to the guidelines from the consensus document of the Academia Española de Dermatología.1 These pretreatment
screening comprises test for latent tuberculosis, hepatitis B or C
infection, HIV infection and a blood test including counter blood
counts and basic serum chemistry. All the patients fulfil both the
Spanish and American guidelines criteria for biological therapies
and were treated with standard dose 45mg (at week 0, 4, and every
12 weeks). For patients >100kg 90mg dose was administered.
A washout period was not given prior to the initiation of
ustekinumab in patients with unsatisfactory response to other
Definition of Effectiveness
The percentage of improvement in PASI score was defined as
primary effectiveness outcome: PASI90, PASI75, and PASI50 reflect
respectively an improvement of 90%, 75%, and 50% of the
baseline PASI. Responders were defined as >PASI 75. Three effectiveness
time endpoints were defined: at 12 week, 28 week,
and long-term treatment. Long-term treatment included all the
patients treated with ustekinumab who reached at least week