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Monday, April 28, 2008

Raptiva maintains effectiveness for psoriasis for three years with continuous therapy

A newly-released study funded by the companies that market Raptiva (efalizumab) has found that with continued treatment, Raptiva continues to maintain major improvement in psoriasis symptoms for many patients, even at the three year point. The study authors call this the "longest continuous study using a biologic therapy for psoriasis." The study was fairly complex and we won't try to summarize all its nuances, but we'd like to highlight a few points.

First, we are pleased to see multi-year studies of these new therapies. Major clinical trials are usually based on safety and efficacy performance after a number of weeks. But psoriasis lasts a lifetime, and treatment is typically needed for decades. A 36-month trial is valuable, particularly with respect to safety concerns.

Second, the good news is that the Raptiva study found no new safety concerns other than those previously identified. The study underscored that Raptiva (and other biologics) are serious treatments -- and some patients develop serious (though usually reversible) side-effects from these treatments -- but the vast majority of patients who see a benefit from Raptiva appear to manage it well for the 36 months studied.

Third, for those who benefit from Raptiva, the significant improvement they see can be maintained for 36 months (and certainly longer). An even longer study is in progress, so in the future we should see data for even longer periods of use.

Finally, we should note that we support trying to get new treatments to patients as quickly as possible, which typically means before these types of long studies can be completed. That underscores the importance of longer studies like this, conducted after a treatment is made available to the public. Of course, what physicians see from the actual use of treatments in tens of thousands of patients worldwide is also a critically important way to assess safety and effectiveness in the real world.

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