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Janssen reports positive results from Stelara studies

Janssen pharmaceuticals' telara (Ustekinumab) has demonstrated effectiveness and was well-tolerated in patients with moderate to severe plaque psoriasis.

Ustekinumab demonstrated effectiveness and was tolerated in patients inadequately responsive to methotrexate, and improved quality of life outcomes in patients transitioned from methotrexate in the 52-week TRANSIT study.

High levels of clinical responses were achieved and maintained through up to five years of ustekinumab treatment in the PHOENIX 2 study.

University of Munich professor Jorg Prinz said the findings from the studies support 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."

No dose-response or cumulative effect of increasing duration of exposure to ustekinumab on the rates of overall and targeted adverse events after up to five years of treatment was observed from 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.