Even before it received U.S. Food and Drug Administration (FDA) approval in September 2009, Stelara (ustekinumab) had considerable buzz in the psoriasis community. Imagine a treatment that (after two initial doses) you take just four times a year! But the early buzz was based on 12 week, and later 40 week, studies. That left two big questions for patients contemplating Stelara: would it work for years, not weeks; and would it be safe to take for the long-term?
Centocor Ortho Biotech, the company behind Stelara in the U.S., is funding ongoing studies to try to answer these questions, and the data is now in for patients on Stelara for three years. The news is good.
Can it work for years?
In one study, the investigators took patients who had maintained a 75% improvement in psoriasis symptoms after about 9 months of Stelara treatment, and kept them on treatment every 12 weeks thereafter. Patients under 220 pounds received 45 mg doses of Stelara, and patients over 220 pounds received 90 mg doses of Stelara (these are the current, standard doses.) After 2.8 years, 88% of patients in the under 220 pounds group, and 72% in the over 220 pounds group, maintained that 75% improvement (called PASI 75, this is the benchmark used by the FDA in evaluating psoriasis treatments). Also noteworthy, 48% and 44% of those groups, respectively, achieved a “PASI 90″ response, a 90% improvement in their psoriasis symptoms. These are impressive numbers.
In short, it says that if Stelara is working for you after 9 months, it is likely still to be working for you after 2.8 years, and almost half of patients will be enjoying a 90% improvement as their third anniversary of Stelara treatment approaches. The study is continuing, with its five year data to be collected in October 2011. (This means we should get four year data announced in 2011, and the five year analysis published in 2012.)
Two cautionary notes. First, this study only included those who had achieved success with Stelara at 9 months of treatment. Of course, most of those who were not doing well on Stelara would switch treatments long before 9 months, but it’s worth noting that these success figures at 2.8 years had already screened out those ‘failing’ on Stelara.
Second, among those weighing more than 220 pounds (a significant proportion of American adults), almost 3 in 10 had slipped below the 75% threshold of success by 2.8 years. [This is particularly relevant right now with the news about golf star Phil Mickelson and his battle with psoriatic arthritis. Much of the early media coverage seemed to suggest that he would just take his biologic and his problems would be solved for good. We quickly issued a press statement to note that (among other things) for many psoriasis and psoriatic arthritis patients, treatments lose effectiveness over time.] We’ll have to see how the five-year data plays out for this group of patients.
Is it safe to take for the long-term?
The company also noted data that included patients taking Stelara for up to 3 years. It reported that rates of serious infections, non-cutaneous malignancies and major cardiovascular events “remained stable over time and were consistent with expected rates in both general or psoriasis populations.” More good news. But again, a pair of cautionary notes.
In the 2.8 year study, noted above, 6% of patients in the study dropped out due to “adverse events,” typically negative health issues that lead someone to quit a study. The company summary of the study does not detail these; when we find out more about these we will update this post.
Also, the study included just a few hundred patients for the 2.8 years. A related study they reported on included 3,000+ patients who averaged treatment of just roughly 1.5 years. Compare that to another biologic, Remicade (infliximab), made by the same company. More than one million patients have used Remicade worldwide for a variety of diseases, and Remicade has been around for more than a decade. Also, Stelara is the first and only anti-IL12/23 treatment that is FDA approved. We simply do not yet know whether Stelara can maintain this safety record over the long haul.
Bottom line? Stelara continues to add to its clinical trial successes with more good news regarding its effectiveness and safety over periods of up to three years. But the total patient population exposed to Stelara is still quite small compared to those of three other psoriasis biologics, Remicade, Enbrel (etanercept), and Humira (adalimumab).