What Happened after the Clinical Trials: Long-Term Safety and Efficacy of Ustekinumab in Daily Clinical Practice

Abstract

Background: Ustekinumab has been investigated in patients with psoriasis by randomized clinical trials. There are few data on ustekinumab use under ‘real life' conditions outside long-term registries. Objective: The aim of our study was to evaluate the efficacy and safety of ustekinumab as a long-term therapy in real life. Methods: We retrospectively analyzed the data of 71 patients who had been treated with ustekinumab up to 2 years. Efficacy data were analyzed both by ‘as treated' and ‘intention to treat-last observation carried forward'. Results: A significant improvement in the Psoriasis Area and Severity Index score was observed at 4 weeks and further improvements were observed throughout the treatment. Adverse events were generally mild. Conclusions: In routine administration ustekinumab seems to be more efficient than reported by randomized clinical trials. Our results are encouraging and can answer the patients' biggest concern on whether ustekinumab is an effective and safe drug for long-term use.

Long-Term Efficacy, Safety and Drug Survival of Ustekinumab in a Spanish Cohort of Patients with Moderate to Severe Plaque Psoriasis

“…Interestingly, in no patients with a prior diagnosis of psoriatic arthritis was any worsening detected; since ustekinumab has been shown to be effective in the treatment of psoriatic arthritis [17], the appearance of arthritis in one of our patients, similar to what has been previously reported [18], might be considered an example of paradoxical arthritis, as described in the case of infliximab [19], for instance. Talamonti et al [20] have recently published their series with 71 patients treated with ustekinumab up to 2 years, without severe adverse events observed and showing the efficacy and safety of ustekinumab for long-term use, as our study. …”

Clinical factors predicting the therapeutic response to ustekinumab in patients with moderate to severe chronic plaque psoriasis

“…In addition, when compared with an anti‐tumor necrosis factor (TNF)‐α agent, it was shown to have a significantly longer drug survival . Despite these benefits, because of the variation in treatment response at an individual level, approximately 30% of patients are unable to achieve Psoriasis Area and Severity Index 75 (PASI75), defined as a 75% or more improvement from the baseline PASI score . However, the relationship between various clinical factors and the efficacy of ustekinumab in patients with psoriasis remains unclear.…”

Psoriasis Area and Severity Index response in moderate‐severe psoriatic patients switched to adalimumab: results from the OPPSA study

“…In cases of inadequate response, contraindication or intolerance to at least one DMARD, a therapy with a biologic drug such as tumour necrosis factor (TNF)‐alpha inhibitors (e.g. adalimumab, infliximab or etanercept) or anti‐interleukin therapies (ustekinumab, secukinumab, ixekizumab and brodalumab) is recommended . Although these treatments are effective in treating psoriasis (without severe adverse events), between 10% and 30% of patients show inadequate response, necessitating switching to a second‐line biologic .…”

“…adalimumab, infliximab or etanercept) or anti-interleukin therapies (ustekinumab, secukinumab, ixekizumab and brodalumab) is recommended. [5][6][7][8][9][10][11][12] Although these treatments are effective in treating psoriasis (without severe adverse events), between 10% and 30% of patients show inadequate response, necessitating switching to a second-line biologic. 13 In real-life clinical practice, switching is relatively common; however, few studies have evaluated the efficacy of secondary biologic treatment in these patients.…”