New Stelara 5-Year Data Show Consistent Efficacy and Safety Profile in Treatment of Moderate to Severe Plaque Psoriasis


New efficacy and safety data from the Phase 3 PHOENIX 1 study, 1 of 2 pivotal registration trials, showed that maintenance treatment with Stelara (ustekinumab) for up to 5 years resulted in consistent, significant clinical response in adults with moderate to severe plaque psoriasis.

New efficacy and safety data from the Phase 3 PHOENIX 1 study, 1 of 2 pivotal registration trials, showed that maintenance treatment with Stelara receiving Stelara 45 mg or 90 mg and randomized to continue maintenance therapy through 5 years, 79% and 81% of patients, respectively, experienced at least a 75% improvement in psoriasis as measured by the Psoriasis Area and Severity Index (PASI 75) at the end of the treatment period. Investigators also reported a consistent benefit-to-risk profile for Stelara through 5 years and observed treatment with the biologic therapy to be generally well-tolerated with rates of adverse events (AEs), including infections, malignancies and cardiovascular events, remaining stable over time. The data were presented today at the 9th Annual European Academy of Dermatology and Venereology Spring Symposium in Verona, Italy.

"These data are important to the professional dermatology community as we now have 5-year data—the longest continuous study evaluating a biologic in the treatment of psoriasis—that reinforce our understanding of Stelara efficacy and safety as a therapeutic option," said Alexa Kimball, MD, MPH, associate professor, Harvard Medical School, department of dermatology, Massachusetts General Hospital and lead study investigator. "Stelara continues to be an important option for dermatologists in the treatment of moderate to severe plaque psoriasis, and these findings are reassuring for physicians and their patients living with this chronic disease who might be candidates for biologic therapy."

In the PHOENIX 1 study, patients were randomized to receive placebo or Stelara 45 mg or 90 mg at weeks 0 and 4. Following assessment of PASI 75 at week 12, the primary endpoint, Stelara-treated patients continued to receive treatment every 12 weeks. At week 40, PASI 75 responders were re-randomized to receive maintenance therapy with Stelara or to withdraw from treatment and only receive retreatment with loss of response. More than two-thirds (n=517) of all Stelara-treated patients (n=753) in PHOENIX 1 continued to receive Stelara through the last scheduled five-year dose. Among the responders who continued treatment from week 40 through the end of the study, 48 and 59 percent had PASI 90 in the Stelara 45 mg and 90 mg groups, respectively, with up to five years of treatment. Efficacy was similarly maintained in an overall analysis of the study population, with 63 and 72 percent of all PHOENIX 1 participants achieving PASI 75, and 40 and 49 percent achieving PASI 90, of those individuals receiving Stelara 45 mg or 90 mg, respectively.

Adverse events were evaluated in more than 753 ustekinumab-treated patients with a total 3104 patient-years (PY) of follow-up. Rates of AEs (221 and 209 per 100 PY), serious AEs (5.3 and 5.4 per 100 PY) and infections (84 and 82 per 100 PY) in the Stelara 45 mg and 90 mg treatment groups, respectively, remained stable over time. Rates of serious infection (1.03 per 100 PY), non-melanoma skin cancer (0.45 per 100 PY), malignancy other than non-melanoma skin cancer (0.48 per 100 PY), and major adverse cardiovascular events (0.35 per 100 PY) in combined Stelara groups were similarly consistent over the 5-year period. No new safety signals were reported with the increased duration of exposure.

As part of a post-marketing commitment with the FDA for safety surveillance of Stelara, Janssen Biotech, Inc is conducting the PSOriasis Longitudinal Assessment Registry (PSOLAR). PSOLAR is an international, multicenter, prospective, observational study evaluating long-term safety and clinical outcomes for patients receiving (or eligible to receive) treatment for psoriasis with biologics and/or conventional systemic agents in academic and community-based settings. Patients completing PHOENIX 1 are being transitioned into PSOLAR when possible to continue collection of long-term safety data.

About Psoriasis

Psoriasis, a chronic, immune-mediated disease that results from the overproduction of skin cells, affects 125 million people worldwide. Plaque psoriasis often results in patches of thick, red or inflamed skin covered with silvery scales known as plaques. These plaques can crack and bleed, and may occur anywhere on the body. The disease symptoms can range from mild, to moderate, to severe and disabling. It is estimated that nearly three percent of the world’s population is living with psoriasis and nearly one-quarter of those people have cases that are considered moderate to severe.


The Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial Evaluating the Efficacy and Safety of CNTO 1275 in the Treatment of Subjects with Moderate to Severe Plaque-type Psoriasis Followed by Long-term Extension (PHOENIX 1) evaluated the efficacy and safety of STELARA in the treatment of 766 patients with chronic plaque psoriasis for up to five years. Patients were randomized to receive subcutaneously administered STELARA or placebo. Patients randomized to receive STELARA received 45 mg or 90 mg doses at weeks 0 and 4 followed by the same dose every 12 weeks. Patients in the placebo group crossed over to receive either 45 mg or 90 mg doses of STELARA at weeks 12 and 16 and every 12 weeks thereafter. Some patients inadequately responding to STELARA at weeks 28 and 40 were eligible to switch to every 8 week dosing. The primary endpoint of the study was the proportion of patients achieving PASI 75 at week 12. Patients responding to STELARA through week 40 were randomized to continue maintenance treatment with their original dose of STELARA through the end of the study or to withdraw from treatment and only receive retreatment upon loss of response. After week 76, subjects continued on treatment in a long-term extension for up to 5 years.

About Stelara

Stelara, a human interleukin (IL)-12 and IL-23 antagonist, is approved for the treatment of adult patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. IL-12 and IL-23 are naturally occurring proteins that are believed to play a role in psoriasis.

In its 2012 Consensus Guidelines for the Management of chronic Plaque Psoriasis, the National Psoriasis Foundation supports the choice of Stelara as a first-line systemic therapy for moderate to severe plaque psoriasis. For more information about Stelara, visit

Janssen Biotech, Inc. discovered Stelara and has exclusive marketing rights to the product in the United States. The Janssen pharmaceutical companies maintain exclusive worldwide marketing rights to Stelara, which is currently approved for the treatment of moderate to severe plaque psoriasis in 65 countries.


Janssen Press Release

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