SAN ANTONIO, Texas—Ustekinumab (CNTO 1275), a new monoclonal antibody that blocks interleukin (IL)-12 and IL-23, may hold advantages over existing systemic therapies for chronic plaque psoriasis in terms of its convenience and potentially its safety, according to new research presented at the 66th annual meeting of the American Academy of Dermatology in San Antonio, Texas. Manufacturer Centocor, Inc recently announced that the Biologics License Application for ustekinumab was accepted for review by the US FDA for the treatment of chronic moderate-to-severe plaque psoriasis in adults.

"In terms of psoriasis, we have lots of patients who have failed anti-TNF drugs or who have chosen not to take anti-TNF drugs for a variety of reasons, so to have another option is a big advantage," said lead researcher Kenneth Gordon, MD, associate professor of dermatology at the Feinberg School of Medicine at Northwestern University in Chicago, and head of dermatology at Evanston Northwestern Healthcare in Skokie, Illinois. Dr. Gordon told MSKreport.com that he was "very optimistic" about the drug's future.

Compliance advantage is key

The new agent is given every 3 months. By contrast, other systemic therapies are given weekly or monthly. "There is no question that this is a major advantage to the medication as psoriasis patients would love the disease to go away and not have to worry about it," Dr. Gordon said.

In the phase III study, patients with moderate-to-severe plaque psoriasis who received the drug were more likely to achieve and sustain PASI 75 than their placebo counterparts. Study patients who received ustekinumab 45 mg or 90 mg and consistently achieved a 75% improvement from baseline were randomized at week 40 to continue treatment or switch to placebo. Their levels of response to maintenance therapy were measured at week 52.

Overall, 87% of maintenance therapy patients responding to the 45 mg regimen and 91% responding to the 90 mg regimen sustained PASI 75 at 1 year. By contrast, 64% of patients originally on the 45 mg dose and 62% originally on the 90 mg dose, but who were switched to placebo, maintained PASI 75 at 1 year.

At week 40, a total of 66% and 73% of patients achieved PASI 90 after receiving ustekinumab 45 mg or 90 mg, respectively. Moreover, response rates remained stable through week 52 with continued treatment, compared with 37% and 38% of patients who switched to placebo. "The PASI 75 results are outstanding and if look at data for 12 and 24 weeks, the responses are quite well-maintained," Dr. Gordon said.

No safety signals

The drug also appears safe, he said. "The safety record at least early on is clean, which is always encouraging. There is no increase in infection or malignancy. That said, we need longer term data to fully understand this agent's side effect profile."

When asked why this agent may be safer than existing systemic therapies, Dr. Gordon told MSKreport.com that "this may be because IL-23 is not as ubiquitous a cytokine as TNF." Going forward, researchers may use the drug in other autoimmune disease including Crohn's disease and inflammatory arthritis.

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