The efficacy and safety of ustekinumab for the long-term treatment of moderate to severe plaque psoriasis found support in study data published in Dermatologic Therapy.
Investigators conducted an observational, retrospective study at a tertiary referral center in Turkey from 2010 to 2019. Adult patients with moderate to severe chronic plaque psoriasis were enrolled. Patients were treated with ustekinumab for a minimum period of 28 weeks. Ustekinumab was administered as a subcutaneous injection at a standard weight-dosing regimen. Treatment response was assessed using the Psoriasis Area and Severity Index (PASI). The primary outcome was the percentage of patients achieving a 50% (PASI50), 75% (PASI75), 90% (PASI90), or 100% (PASI100) reduction in baseline PASI score. Patients were followed-up until treatment discontinuation or conclusion of study period. Logistic regression models were used to identify correlates of treatment response.
A total of 52 patients were enrolled, of whom 36 were men and 16 were women. Mean age at baseline was 42.9 ± 12.6 years; mean disease duration was 15.8 ± 9.9 years. Average duration of ustekinumab treatment was 33.5 ± 21.1 months, with a range of 28 weeks to 105 months. Overall, 86.5%, 63.5%, 32.7%, 21.2%, 9.6%, and 3.8% of patients completed 1, 2, 3, 4, 5, and 8 years of ustekinumab treatment, respectively. In total, 32.7% discontinued ustekinumab after a median duration of 25.0 ± 33.5 months. The most common reasons for discontinuation were secondary failure and loss to follow-up.
After 1 year of treatment, the PASI50, PASI75, PASI90, and PASI100 response rates were 97.8%, 88.9%, 53.3%, and 35.5%, respectively. At year 5, the rates were 100%, 80.0%, 60.0%, and 40.0%. A raw PASI score of 3 or lower was achieved by 82.2% and 80.0% of the patients at years 1 and 5, respectively. In logistic regression models, non-obesity was associated with greater likelihood of PASI90 response at year 2 (P =.043). Patients without prior biologic agent exposure were more likely to obtain PASI90 response at year 2 (P =.047) and year 3 (P =.021). There were 9 patients who underwent ustekinumab dose escalation when response lagged. Also, 9 patients received adjuvant therapy to improve clinical response. Ustekinumab was generally well tolerated; no new safety signals were observed.
The primary study limitations were the small study cohort and loss to follow-up of several patients.
Based on these results, ustekinumab is an effective and safe long-term treatment option for plaque psoriasis, the investigators believe. During 5 years of follow-up, ustekinumab lowered PASI scores and resulted in few adverse events, they noted. A small percentage of patients required dose escalation or secondary treatment. “Further real-life studies are warranted to improve our understanding of the long-term efficacy and safety profile of biologic therapies for psoriasis in actual clinical practice,” the study authors wrote.
Babuna Kobaner G, Polat Ekinci A, Kutlay A. Long-term efficacy and safety of ustekinumab for moderate-to-severe psoriasis: a 9-year real-life experience from a tertiary referral center in Turkey. Dermatol Ther. Published online June 23, 2021. doi:10.1111/dth.15042