Ustekinumab in clinical practice: response depends on dose and previous treatment

Objectives To evaluate the efficacy of ustekinumab in a series of patients with moderate to severe psoriasis treated according to the European Medicines Agency (EMA) label and to identify factors such as dose, baseline PASI or previous treatment potentially related to therapeutic outcome. Methods Retrospective review of the clinical records from 36 consecutive patients treated with ustekinumab during at least 36 weeks at a single referral center. Candidates for treatment had a PASI 10 or a BSA 10 and either failure to respond to, or a contraindication to, or intolerance to some systemic or another biologic treatment. The main outcome measures were PASI improvement with respect to baseline at weeks 12 and 24 (prior to the third injection of ustekinumab). Results Overall 75%, 69%, and 86% patients achieved PASI75 response rates at weeks 12, 24 and 36, respectively. Patients weighing <= 100 kg and treated with 45 mg doses had better PASI 50, PASI75 and PASI90 response rates than heavier patients (treated with 90 mg) at every point in time, and the differences were statistically significant at week 24. PASI75 response rates at week 24 were significantly better in patients with no prior exposure to TNFa blocking agents (85% vs. 50%, P = 0.0235). Conclusions In clinical practice, ustekinumab is effective both in biologic-nay ve patients and as salvage therapy when other biological treatments have failed. The response rates prior to the third injection in our series were better in patients weighing <= 100 kg and in those without previous exposure to biologics.