Ustekinumab (Stelara) versus Enbrel for psoriasis
An experimental psoriasis treatment that could be approved for use in psoriasis patients by the end of 2008 edged out the leading psoriasis biologic in a 12-week head-to-head clinical trial. Ustekinumab (likely brand name, Stelara), made by Johnson & Johnson's Centocor unit, helped more patients achieve 75% and 90% improvements in skin symptoms than did Amgen & Wyeth's Enbrel, which is currently used by more psoriasis patients than all the other biologics combined. As Dow Jones reported:
In addition, 36% of patients receiving the lower dose of ustekinumab and 45% of patients receiving the higher dose of ustekinumab achieved a 90% improvement at week 12, compared with 23% of patients receiving Enbrel.
Ustekinumab (Stelara) is also infrequently administered. During the study, patients received just 2 injections of Ustekinumab, and 24 of Enbrel.
This study is important for many reasons, and it points to some of the key issues facing patients seeking a psoriasis treatment.
* These two biologics are among the best psoriasis treatments we've ever had, and yet consider how many people do NOT achieve success with them. 26%, 32% and 43% of patients in the different treatment groups in this study failed to achieve a 75% improvement at week 12. So even if every psoriasis patient with moderate to severe psoriasis could access these expensive treatments, many people are still in need of additional options. (Note: Past studies have shown that some of those who do not reach the 75% improvement mark at week 12, do reach it with continued treatment after 12 weeks.)
*The study duration was 12 weeks. The average psoriasis patient will need psoriasis treatment for 50 YEARS. So while a useful data point, this study does not address whether these treatments can offer lasting relief for a lifelong disease.
* The 12-week duration also means this study does not address long-term safety. "Ustekinumab would be the first of a new class of anti-inflammatory drugs that target proteins called interleukins." It is an anti IL-12/IL-23 agent. Enbrel, meanwhile, is one of a class of biologics that target tumor necrosis factor alpha. These anti-TNFs have been around for more than a decade treating rheumatoid arthritis, psoriasis, Crohn's disease and other diseases. Enbrel has been used in nearly 500,000 patients worldwide over the last 15 years (and won its first U.S. approval, for RA, in 1998). When you add in Humira and Remicade (other anti-TNFs), the anti-TNFs have been used in more than one million people during this time. Ustekinumab, in contrast, has been tested for a year or two, in about 2,000 patients. We simply do not know how the anti-IL12/23 treatments (ustekinumab and another one in development by Abbott called ABT-874) will fare in the long term, either for safety or effectiveness.
* The study did not address psoriatic arthritis, which impacts up to one-third of those with moderate to severe psoriasis. Enbrel and the other anti-TNFs improve psoriatic arthritis and actually impede or stop the progressive damage psoriatic arthritis can cause. Let's hope the anti-IL12/23s also work on arthritis.
Competition by biotech and pharmaceutical companies helps psoriasis patients. This battle to find ever more effective and safer psoriasis treatments offers hope that one day, all psoriasis patients will be able to find and access a treatment that will work for them.
Psoriasis Cure Now spoke in support of approving ustekinumab at an FDA Advisory Committee hearing in June 2008, because its short-term safety and effectiveness are impressive, and because some of these long-term issues are best observed by having lots of informed patients choosing to use this treatment, so we can see how they fare over time in a real-world setting.
The FDA is expected to make its decision on ustekinumab by the end of 2008. In the meantime, you can learn more about biologics for psoriasis here.
In the 903-patient trial, participants with moderate to severe psoriasis received one of two dose levels of ustekinumab or Enbrel. The main goal was to track the proportion of patients in each group who achieved at least a 75% reduction in psoriasis at 12 weeks, as measured by an index assessing the surface area and severity of the disease, which causes skin lesions.
J&J said 68% of those taking the lower dose of ustekinumab and 74% taking the higher dose achieved at least a 75% reduction in disease, versus 57% of Enbrel users reaching that mark.
In addition, 36% of patients receiving the lower dose of ustekinumab and 45% of patients receiving the higher dose of ustekinumab achieved a 90% improvement at week 12, compared with 23% of patients receiving Enbrel.
Ustekinumab (Stelara) is also infrequently administered. During the study, patients received just 2 injections of Ustekinumab, and 24 of Enbrel.
This study is important for many reasons, and it points to some of the key issues facing patients seeking a psoriasis treatment.
* These two biologics are among the best psoriasis treatments we've ever had, and yet consider how many people do NOT achieve success with them. 26%, 32% and 43% of patients in the different treatment groups in this study failed to achieve a 75% improvement at week 12. So even if every psoriasis patient with moderate to severe psoriasis could access these expensive treatments, many people are still in need of additional options. (Note: Past studies have shown that some of those who do not reach the 75% improvement mark at week 12, do reach it with continued treatment after 12 weeks.)
*The study duration was 12 weeks. The average psoriasis patient will need psoriasis treatment for 50 YEARS. So while a useful data point, this study does not address whether these treatments can offer lasting relief for a lifelong disease.
* The 12-week duration also means this study does not address long-term safety. "Ustekinumab would be the first of a new class of anti-inflammatory drugs that target proteins called interleukins." It is an anti IL-12/IL-23 agent. Enbrel, meanwhile, is one of a class of biologics that target tumor necrosis factor alpha. These anti-TNFs have been around for more than a decade treating rheumatoid arthritis, psoriasis, Crohn's disease and other diseases. Enbrel has been used in nearly 500,000 patients worldwide over the last 15 years (and won its first U.S. approval, for RA, in 1998). When you add in Humira and Remicade (other anti-TNFs), the anti-TNFs have been used in more than one million people during this time. Ustekinumab, in contrast, has been tested for a year or two, in about 2,000 patients. We simply do not know how the anti-IL12/23 treatments (ustekinumab and another one in development by Abbott called ABT-874) will fare in the long term, either for safety or effectiveness.
* The study did not address psoriatic arthritis, which impacts up to one-third of those with moderate to severe psoriasis. Enbrel and the other anti-TNFs improve psoriatic arthritis and actually impede or stop the progressive damage psoriatic arthritis can cause. Let's hope the anti-IL12/23s also work on arthritis.
Competition by biotech and pharmaceutical companies helps psoriasis patients. This battle to find ever more effective and safer psoriasis treatments offers hope that one day, all psoriasis patients will be able to find and access a treatment that will work for them.
Psoriasis Cure Now spoke in support of approving ustekinumab at an FDA Advisory Committee hearing in June 2008, because its short-term safety and effectiveness are impressive, and because some of these long-term issues are best observed by having lots of informed patients choosing to use this treatment, so we can see how they fare over time in a real-world setting.
The FDA is expected to make its decision on ustekinumab by the end of 2008. In the meantime, you can learn more about biologics for psoriasis here.
posted by Psoriasis Cure Now at 12:26 PM
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