Three-year efficacy data on STELARA for psoriasis presented at American Academy of Dermatology meeting

Aug 10 2010

New study findings showed that a majority of patients with moderate to severe plaque psoriasis who had a previous response to STELARA® (ustekinumab) sustained a clinical response for up to three years with continued treatment regardless of their body weight. Investigators also presented findings from an integrated safety analysis that included data from one Phase 2 and three Phase 3 trials in which treatment with STELARA demonstrated a favorable benefit-risk profile for up to three years of treatment, consistent with previous analyses.  The data were presented at the Summer Academy Meeting of the American Academy of Dermatology in Chicago, and related findings were the subject of an article in the July issue of the Journal of the American Academy of Dermatology, entitled "Impact of weight on the efficacy and safety of ustekinumab in patients with moderate to severe psoriasis: Rationale for dosing recommendations."

In the PHOENIX 1 study, patients achieving at least a 75 percent improvement in their psoriasis as measured by the Psoriasis Area and Severity Index (PASI 75) at week 40 were randomized to continue treatment with every-12-week STELARA maintenance dosing based on body weight or to withdraw from treatment and only receive retreatment with loss of response. 

"Bringing about and sustaining skin clearance is a top priority for patients living with psoriasis and for their dermatologists," said Alexa Kimball, MD, MPH, Associate Professor, Harvard Medical School; Department of Dermatology, Massachusetts General Hospital and lead study investigator. "These data provide the dermatology community with new insights into the long-term efficacy of STELARA and the treatment of this chronic autoimmune disorder."

Findings from a separate pooled safety analysis of data for STELARA evaluating more than 3,000 patients for periods up to three years, which totaled 4,782 patient-years (PY), were consistent with results from previous STELARA studies.  The data, compiled from Phase 2 and Phase 3 clinical trials including the pivotal PHOENIX 1, PHOENIX 2 and ACCEPT studies, showed overall rates of AEs and serious AEs per 100 PY were comparable in the 45 mg and 90 mg STELARA patient groups.  The most commonly reported AEs (>5%) included nasopharyngitis, upper respiratory tract infection, arthralgia, sinusitis, headache and back pain.  Rates of serious infections (0.82 and 1.50 for 45 mg and 90 mg STELARA patient groups, respectively, per 100 PY), non-cutaneous malignancies (0.69; 0.46) and major cardiovascular events (0.41; 0.35) remained stable over time and were consistent with expected rates in both general or psoriasis populations.

"As with any medication, it is important for dermatologists to carefully monitor patients on biologic therapies to quickly and accurately identify and manage therapy-related safety concerns," said Craig Leonardi, MD, Clinical Professor of Dermatology, St. Louis University Medical School and study investigator.  "It is encouraging to see that the favorable benefit-to-risk profile seen in STELARA clinical trials has been maintained in patients who've received the treatment for several years.  Ongoing, five-year follow-up studies will allow us to continue to evaluate this treatment and the safety profile of STELARA."