Long-term efficacy of ustekinumab in patients with moderate-to-severe psoriasis: results from the PHOENIX 1 trial through up to 3 years

Abstract

Overall, 79·8% of the ustekinumab-treated patients remained in the study for 3 years. PASI 75 response rates (45 mg: 61·2%; 90 mg: 72·4%) at week 76 were maintained through year 3 (45 mg: 62·7%; 90 mg: 72·2%); PGA response was similarly durable. At year 3, 80·9% (45 mg) and 82·7% (90 mg) of week 40 responders continuing treatment every 12 weeks achieved a PASI 75 response, while 42·6% (45 mg) and 58·0% (90 mg) achieved a PASI 90 response. Among partial responders adjusted to dosing every 8 weeks, 50·9% (45 mg) and 52·0% (90 mg) had a PASI 75 response at year 3. DLQI responses paralleled the PASI responses. Through year 3, no dose response was observed in rates of adverse events (AEs), overall infections, serious AEs, or AEs leading to discontinuation; nor was there evidence of cumulative organ toxicity. CONCLUSIONS; Continuous, stable, maintenance dosing with ustekinumab was generally well tolerated and sustained durable efficacy for up to 3 years of treatment.

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

“…The efficacy results in our patients are consistent with those of a multicenter retrospective case cohort study from the UK and Ireland [5], with a PASI75 response rate of 63% at 16 weeks, and confirm those in a previous preliminary report [6], when 86% of patients achieved a PASI75 response at week 36. Our long-term results appear to be better than those in an Italian multicenter cohort of 79 patients, with a PASI75 response rate of 58% at 7 months [7], but are consistent with those of the open label extension of the PHOENIX trials up to 3 years [1], when PASI75 response rates were maintained through year 3 (45-mg group: 63%; 90-mg group: 72%). Interestingly, partial responders (week 28: PASI50-74; week 40: <PASI75) in this study switched to dosing every 8 weeks, an approach similar to ours.…”

“…Reports concerning the long-term (up to 5 years) efficacy and safety of the open label extension phase of the PHOENIX 1 and PHOENIX 2 clinical trials of ustekinumab for the treatment of moderate to severe psoriasis vulgaris have been published recently [1,2,3]. Patients in real life do differ from those enrolled in clinical trials [4], and cohort studies and registries are required to provide efficacy and safety data in clinical practice.…”

A Retrospective Study of Patients with Psoriasis Treated with Biologics: Relation to Body Mass Index and Gender

“…A treatment round consists of a baseline (-3 months) and several consecutive values at 3 months (± 1 month), 6 months (± 2 months), 12 months (± 2 months), 18 months (± 2 months) and 24 months (± 3 months). Any interruption of treatment longer than 4 months was considered a new treatment round, as patients on biologics, even those with a long half-life, such as ustekinumab, were noted to have a mean relapse time of 16 weeks (12). A single patient could have several treatment rounds in different periods with different biologics.…”

Established and experimental medical therapy of pulmonary sarcoidosis

“…Ustekinumab is an anti-interleukin 12 and interleukin 23 monoclonal antibody which has been shown to be safe and effective for psoriasis for up to 3 years [164]. Since these cytokines are important in chronic sarcoidosis [165], there is a rationale for study of this drug in sarcoidosis.…”