Janssen Pharmaceuticals has announced new data to demonstrate that Stelara (ustekinumab) is effective and well-tolerated in patients with moderate to severe plaque psoriasis.
Ustekinumab is for the treatment of plaque psoriasis in adults who failed to respond, have a contraindication, or are intolerant to other systemic therapies such as asciclosporin, methotrexate and psoralen plus UVA.
The drug targets interleukin-12 (IL-12) and interleukin-23 (IL-23), which are naturally occurring proteins that are vital in regulating immune responses, and are expected to be associated with immune-mediated inflammatory diseases.
University of Munich professor JorgPrinz said the findings from the studies supported a favourable benefit-to-risk profile for ustekinumab with up to five years of treatment.
"Importantly, results demonstrated in clinical trials are consistent with the real-world experience to date," Prinz added.
"These findings further advance our understanding of biologics, not just in terms of efficacy, safety and tolerability, but also health-related quality of life."
Ustekinumab was highly effective and well-tolerated in patients that were inadequately responsive to methotrexate, and improved quality of life outcomes in patients transitioned from methotrexate in the 52-week TRANSIT study.
The PHOENIX 2 study showed that high levels of clinical responses were achieved and maintained through up to five years of ustekinumab treatment.
No dose-response or cumulative effect of increasing duration of exposure to ustekinumab on the rates of overall and targeted adverse events from five years of treatment were observed in an integrated analysis of safety data from four randomised-controlled studies.
The PSOLAR Registry’s annual database extract described malignancy, infection and major adverse cardiovascular event rates in patients eligible for systemic therapies, including ustekinumab and infliximab, while no new safety signals were detected.