Background The safety of biologic agents for the treatment of psoriasis has been studied in long term clinical trials with up to 5 years of follow-up. However, observational studies provide the potential to identify safety signals in a real world setting.
Purpose To evaluate the safety and use of adalimumab, etanercept and ustekinumab in several lines of treatment in patients with psoriasis from a tertiary hospital.
Material and methods Retrospective observational longitudinal study of psoriasis patients followed from 1 January 2008 to 30 June 2015; there were no exit points. Variables included were: demographic (sex and age), pharmacological (biological drug used up to thirdline of treatment) and clinical (side effects reported).
Clinical databases used were PRISMA (prescribing electronic software) for patient selection and collection of pharmacological variables, and DIRAYA for collection of clinical variables.
Results 88 patients were included (mean age 66 years; 60% males).
40% of patients started treatment with adalimumab (35/88), 31% with etanercept (27/88) and 29% with ustekinumab (26/88).
42% of patients required a second biological drug (37/88). 9 patients received adalimumab (9/37; 24%), 6 patients received etanercept (6/37; 16%) and 22 patients received ustekinumab (22/37; 60%).
16% of patients required a third biological drug (14/88). 8 patients received adalimumab (8/14; 57%), 4 patients received etanercept (4/14; 29%) and 2 patients received ustekinumab (2/14; 14%).
Regarding safety, 4% of patients receiving adalimumab (2/53) experienced adverse effects (one patient presented fatigue and headaches and other increased transaminases).
14% of patients treated with etanercept (5/37) experienced side effects: 4 patients showed increased transaminases (1 with concomitant anxious depression and tonsillitis, and other with concomitant discomfort in the area of injection), and 1 patient showed herpes simplex reactivation.
6% of patients treated with ustekinumab experienced increased transaminases (3/50).
Conclusion The most used biological drug for psoriasis in our hospital was adalimumab (60%), followed by ustekinumab (56%) and etanercept (42%).
Adalimumab was the drug most commonly used in first and thirdline treatment, whereas ustekinumab was the most commonly used secondline drug.
The highest percentage of adverse effects was found in etanercept patients, whereas adalimumab treatment presented a lower occurrence of adverse events. The most common adverse effect was increased transaminases for any biological therapy.
No conflict of interest.
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