Background Ustekinumab is indicated for moderate to severe psoriasis (msPs) in patients who have had an inadequate response to systemic treatments.
Purpose To assess the effectiveness and safety of ustekinumab in our hospital patients with msPs refractory to tumour necrosis factor inhibitors (anti-TNFα).
Material and methods Descriptive retrospective study from January 2010 to September 2018 was developed. Patients with msPs had previously been treated with ≥2 anti-TNFα and received ustekinumab were selected. Farmatools application and digital clinical history were used to record variables: age, gender, previous treatment, therapy duration, treatment regimen and Psoriasis Area and Severity Index (PASI). Patients with weight ≤100 kg received subcutaneous ustekinumab 45 mg at week 0, 4 and 16, followed by 45 mg every 12 weeks, and patients with weight >100 kg received ustekinumab 90 mg. Effectiveness endpoint was PASI90 (≥90% reduction from baseline in PASI) and PASI75 (≥75% reduction from baseline in PASI) at 24, 48 and 96 weeks. Adverse reactions (AR) were collected to analyse safety.
Results In the study period, 36 patients with mean age 47.2 (24–78) years were included: 22 (61.1%) men and 14 (38.9%) women. Previous anti-TNFα treatments were: 28 (77.7%) patients with etanercept+adalimumab, four (11.1%) infliximab+etanercept+adalimumab, two (5.6%) infliximab+adalimumab, one (2.8%) infliximab+etanercept and one (2.8%) efalizumab+infliximab. Mean therapy duration was 30.7 (6–85) months. Thirty-four (94.4%) patients received ustekinumab 45 mg and two (5.6%) ustekinumab 90 mg. At baseline: 29 (80.5%) patients had PASI ≥12, two (5.6%) PASI=6, two (5.6%) PASI=4 and three (8.3%) PASI=2. At week 24 and 48: 24 (66.7%) patients achieved PASI90 and seven (19.4%) PASI75. At week 96, 35 patients were assessed (one withdrew from treatment for pregnancy): 20 (57.1%) patients achieved PASI90 and seven (20%) PASI75. No AR were reported.
Conclusion Ustekinumab was an effective treatment in more than half of our study patients with msPs refractory to ≥2 anti-TNFα, showing a response maintained for long periods of time (96 weeks). No patients recorded AR, so ustekinumab was safe in our hospital patients. Studies with a larger sample size and duration are necessary to assess the effectiveness and security of ustekinumab. The main limitation of our research was the limited number of patients.
References and/or acknowledgements None.
No conflict of interest.
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