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Statement by Michael Paranzino, president, Psoriasis Cure Now, to the FDA’s Arthritis Drugs Advisory Committee, regarding the biologics license application for abatacept (trade name ORENCIA)


September 6, 2005

Psoriasis Cure Now, a nonprofit patient advocacy group, appreciates this opportunity to address the Food and Drug Administration’s Arthritis Drugs Advisory Committee on behalf of the as many as 7.5 million Americans with psoriasis and/or psoriatic arthritis.

Psoriasis is an incurable, recurring, non-contagious disease of the immune system that can first strike at any age, causing painful skin lesions, and often, arthritic symptoms (psoriatic arthritis). A 1999 study found that psoriasis causes reductions in physical and mental functioning comparable to that seen in diabetes, heart disease, hypertension, depression and other diseases. Psoriasis costs the U.S. economy billions annually.

While for many psoriasis patients, the disease will remain mild throughout life, for millions of others it is a daily impediment, and can be debilitating, both physically and psychologically.

While today’s application concerns rheumatoid arthritis (RA) patients, it is no secret that many of the same drugs that benefit RA patients also benefit patients with psoriasis and psoriatic arthritis (and drugs that help treat psoriasis and psoriatic arthritis also often help RA patients). So millions of Americans who do not have RA still have a significant interest in seeing additional treatment options for RA, as these drugs might one day also help psoriasis patients.

As psoriasis patients know all too well, a treatment that works wonderfully for one patient may have little or no effect for a different patient. In addition, many patients find that a treatment that has previously proven effective for them sometimes loses effectiveness over time. This is why psoriasis patients clamor for additional treatment options. Even those patients whose disease is presently well-controlled may one day need a different option. We hope that abatacept proves to be one of those options for psoriasis and psoriatic arthritis patients, but it is unlikely to become available for psoriasis patients in the future if it is not approved for RA first.

Finally, in this post-Vioxx world, it is worth repeating that millions of Americans continue to believe that they have the ability—working in conjunction with their physicians—to make sensible decisions about balancing risks and benefits in deciding whether to pursue a particular treatment option. Please add this drug to the treatment arsenal for those who believe it makes sense for them. People are suffering, and the more options out there to bring relief, the better off we are.

Thank you for all you do on behalf of arthritis patients.


 
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