Psoriasis, which affects an estimated 7.5 million Americans, occurs when the immune system sends out faulty signals, ultimately accelerating skin cells’ growth cycles. The result is raised, ruby patches of skin, or silvery colored scales from dead skin pile-up. One in four people with the lesions is also at risk for joint pain, inflammation and bone destruction from psoriatic arthritis, which sometimes takes many years to develop.
Ritchlin was tapped to help lead a multi-site, multi-investigator trial sponsored by Janssen Research & Development, LLC, testing effectiveness of the injectable drug (STELARA, or ustekinumab) for psoriatic arthritis patients. Of note, in the past, Ritchlin has received consulting honoraria from Janssen; the particular data discussed at the meeting stems from a trial that was collaboratively designed, conducted and analyzed by Ritchlin, co-investigators from Janssen, and scientists at other U.S. medical centers.
The trial – dubbed PSUMMIT II – analyzed the ability of STELARA to improve symptoms of 312 adults with psoriatic arthritis who had tender and swollen joints and fingers. All patients enrolled had some history seeking symptom relief with other drugs, including disease-modifying arthritis drugs (DMARDS), like methotrexate, or anti-TNF “biologicals” – newer, more targeted drugs that pinpoint chemical messengers at the root of inflammation, minimizing side-effects. (Of note, the study comes on the heels of a similar phase-3 trial organized by Janssen – PSUMMIT I, which examined STELARA’s effectiveness for patients who had never tried anti-TNF drugs.)
“As helpful as anti-TNF therapies are, 30 to 40 percent of patients don’t respond well to them,” said Ritchlin. “Having a drug that works by a different mechanism could one day flesh out rheumatologists’ treatment portfolio.”
STELARA works against P-40 chains – key ingredients in the chemical messengers (specifically, interleukin-12 and interleukin-23) which, in psoriasis patients, run rampant. Having too many such messengers begets an overproduction of immune cells, culminating in an ironic attack of the very skin and joints they were meant to protect.
But by homing in on P-40 chains, STELARA works “upstream” of the process, helping to minimize disease activity.
Administered about every three months, the trial showed that STELARA holds promise for individuals who have failed conventional and anti-TNF drugs. Twenty-four weeks in, about 43 percent of patients treated with the drug, regardless of dose, achieved ACR 20 (a standard measure of dwindling disease activity), compared with only about 20 percent of persons receiving placebo.
Other measures of disease improvement were noted as well. For instance, for patients with at least 3 percent of their body surface affected by psoriasis at the trial’s start, 51.3 to 55.6 percent of patients receiving STELARA (depending on dose) saw at least a 75 percent improvement in psoriasis, as measured by the Psoriasis Area Severity Index (PASI 75). Just five percent of patients receiving placebo saw similar progress.
“The findings are certainly exciting for the rheumatology community,” Ritchlin said.
The findings were formally unveiled at an oral presentation Tuesday, Nov. 13, at the American College of Rheumatology’s annual meeting in Washington, D.C.
URMC’s Novel Approach to Psoriasis Care, Treatment
Given the complex and systemic nature of psoriatic disease, in 2009 URMC opened a dedicated Psoriasis Center – one of the few recognized multidisciplinary psoriasis centers in the country. The Center tackles the disease from a 360-degree perspective that not only focuses on skin lesions, but also the attendant joint pain, psychological components, and more. In fact, the Center is thought to be the only clinic in the country where patients are seen simultaneously by a dermatologist, psychiatrist and rheumatologist. All team care discussions take place in front of the patient.
The Center also folds clinical research activities into the care mix, giving patients access to cutting-edge investigational therapies, as well as the chance to contribute to scientists’ collective knowledge of the disease. To that end, Ritchlin heads up one of the six sites comprising the International Psoriatic Arthritis (IPART) database – a registry funded by the Canadian Institutes of Health Research, pooling data from nearly 4,000 psoriasis patients across Canada and the U.S. He’s also conducting clinical trials through the Center, exploring DC-STAMP and molecule CD-16, both thought to be potential biomarkers that might bear clues into the psoriasis-arthritis connection. Ritchlin hopes the research will one day help clinicians forecast which psoriasis patients are most at risk for joint damage, and consequently, might be candidates for more aggressive therapies.
In addition to conducting research and caring for patients, Ritchlin serves on the Scientific Committee for the National Psoriasis Foundation and is a member of the Education Committee of the American College of Rheumatology.
For more information on the Psoriasis Center (located at 400 Red Creek Drive, off Calkins Road in Henrietta), please call (585) 487-1403 or visit http://www.urmc.rochester.edu/dermatology/psoriasis/.
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