Stelara, a much-anticipated new biologic treatment for patients 18 years or older with moderate to severe plaque psoriasis, was approved by the US Food and Drug Administration (FDA) in September 2009 and is now available to patients. Stelara (ustekinumab) is the first of a new type of biologic for moderate to severe psoriasis that combines powerful psoriasis relief with very infrequent dosing. Stelara is given twice in the first month, followed by dosing just four times per year.
The big question is whether it will prove safe and effective for long-term use. It is too new to know at this point. Stelara is also approved for use in Canada and the U.K. Another important question is how it will fare in treating psoriatic arthritis. Many people with moderate or severe psoriasis also have psoriatic arthritis. Trials in psoriatic arthritis are ongoing.
Developed by Centocor, Stelara will be marketed by Centocor Ortho Biotech in the United States and by Janssen-Cilag in other countries. Both companies are subsidiaries of Johnson & Johnson.
How is it administered? Stelara (often misspelled Stelera) is administered by injection under the skin. Patients receive two initial doses four weeks apart and then maintenance doses every twelve weeks thereafter. So far, Stelara has not been approved for patient self-injection; it must be administered by a health care provider in a doctor’s office.
Advantages Stelara has proven very effective for moderate to severe psoriasis in clinical trials. Approximately 75% of patients in a pivotal trial saw at least a 75% improvement in skin psoriasis symptoms after 12 weeks of treatment, and that improvement has been sustained by most for periods exceeding a year. In addition, of those patients who enjoyed a 75% improvement after 9 months, 72%-88% of them maintained that 75% improvement after 2.8 years, and nearly half of those had achieved a 90% improvement at 2.8 years. The very infrequent dosing will be welcomed by many psoriasis patients. Also, Stelara has a different molecular target than other psoriasis biologics, so it may work for some patients where other biologics have failed. Finally, Stelara’s safety profile, in studies conducted to date, has been impressive.
Drawbacks Stelara’s long-term safety is unknown. Unlike some of the other biologics (Remicade and Enbrel) that have been around for a decade or longer (some rheumatoid arthritis patients have been on Enbrel for more than 10 years continuously, for example), Stelara has been tested in psoriasis patients for only three years, and most patients have taken it for much less time that that. Stelara, like other biologics, suppresses the immune system, which can increase the risk of serious infections or cancer. Three years is just not enough time to see if, for example, it later causes cancer rates to rise. [Raptiva, a biologic for psoriasis that led to several fatalities, was not pulled from the market until almost six years after its FDA approval.] Given that the average psoriasis patient will battle the disease for 50 years, long-term safety is critically important.
Currently patients are not permitted to self-inject Stelara at home, so they must travel to a doctor’s office to receive the medication, offsetting some of the convenience of infrequent dosing.
How does it work? Stelara (ustekinumab) blocks interleukin-12 and interleukin-23, immune-system molecules that are believed to be inappropriately active in the skin and joints of people with psoriasis.
The company that markets this treatment is among those that have programs to help people afford their treatments. Learn more here: Psoriasis Prescription Payment Assistance Programs.
In the summer of 2008, a U.S. Food and Drug Administration (FDA) panel of outside experts voted unanimously to approve Stelara (then an experimental biologic called ustekinumab) for the treatment of moderate to severe plaque psoriasis. As Reuters reported at the time:
An experimental Johnson & Johnson drug should be approved for treating adults with moderate or severe psoriasis, an advisory panel unanimously ruled Tuesday.
The ability of the drug, ustekinumab, to relieve symptoms of the skin disorder outweighed concerns treatment might increase the risk of cancer, the outside experts that advise the Food and Drug Administration said.
“It’s quite striking how well it works compared to other things that we have available,” said panel chairman Michael Bigby, associate professor of dermatology at Beth Israel Deaconess Medical Center in Boston.
But the panel said the manufacturer’s post-approval monitoring plans were insufficient to gauge long-term risks. Members also voted 7-4 that the drug should be injected by prescribers rather than patients themselves.
The FDA will consider the advice before making a final decision. The agency usually follows panel recommendations.
… [Most existing biologics for psoriasis] work by blocking an inflammation-causing protein called tumor necrosis factor (TNF).
Ustekinumab blocks interleukin-12 and interleukin-23, two other immune-system proteins linked to inflammation.
FDA reviewers said animal studies showed blocking those proteins increased the chances of developing cancer, which raised concern about the effect in people. …
Panel members said doctors and patients should be informed of the cancer concern, but it was not enough to keep the drug off the market.
“We don’t know if it’s going to hurt them … I think ethically we have to make this available” in light of the drug’s effectiveness, said Lynn Drake, a dermatologist at Massachusetts General Hospital.
Officials with J&J unit Centocor said no increase in cancer was seen in people studied as long as 18 months and the company would monitor cancer cases after approval.
The prescribing information for the TNF-blocking drugs come with a warning about a possible risk of cancer.
Michael Paranzino, president of Psoriasis Cure Now, appeared at the hearing and spoke to the Committee about the seriousness of psoriasis and the need for additional treatment options. He read excerpts from patient emails testifying to the debilitating nature of psoriasis, and on behalf of Psoriasis Cure Now he urged approval of ustekinumab (Stelara). He also urged the FDA to allow patients to be given the option to inject the medication at home, rather than requiring the patient to receive the injections at a physician’s office.
Paranzino also expressed disappointment with the FDA for failing to address, in its briefing materials for the committee, the profoundly negative impact that psoriasis can have on a patient’s quality of life. Finally, he urged the FDA and Centocor to agree on a robust, long-term study of the potential safety issues surrounding Stelara/ustekinumab and for Centocor to see the study through to completion and publication.
Additional studies must be undertaken to help us understand the benefits and risks of IL-12/IL-23 inhibitors as psoriasis treatments for the long-term; and certainly, patients should carefully evaluate with their physician any new treatment before using it.
Abbott is also working on an IL-12/IL-23 inhibitor, Briakinumab (ABT-874), but media reports suggest it is still a year away from seeking its own FDA approval.
“This new treatment option is exciting news for psoriasis patients,” said Paranzino. “We psoriasis patients need more options, and this expands the treatment arsenal.”
Visit Psoriasis.Name to discuss Stelara with other psoriasis patients. [Note: some patients incorrectly spell it Stelera.] While the patient response has been mostly very favorable, it has not worked for all psoriasis patients, and anecdotal reports on psoriatic arthritis are more mixed. Are you on Stelara? Thinking about it? Share your story at the social network for psoriasis patients, Psoriasis.Name.
Click here to visit the Stelara company website.