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Trial drug stays effective for psoriasis, even after a break

Melissa Leavitt

If you've ever taken a break from your psoriasis medication, you may wonder how well it will work when you start it again.

A Phase III trial for tofacitinib, an oral drug in development, tested the effects of restarting treatment after stopping for several months.

Almost two-thirds of patients whose skin significantly improved during their first course of treatment achieved similar results the second time around, according to findings presented by the drug manufacturer on May 23.

The trial involved 674 patients and lasted 14 months. For the first six months, patients were randomly assigned to take either a placebo or 5- or 10-milligram (mg) doses of the pill. Results showed that 68 percent of patients in the 10-mg group, and 44 percent in the 5-mg group, experienced a 75 percent reduction in psoriasis severity (or PASI 75, as measured by the Psoriasis Area and Severity Index). In addition, 63 percent of patients taking the 10-mg dose, and 42 percent taking the 5-mg dose, were assessed as having "clear" or "almost clear" skin.

Next, half of the patients who achieved these results were switched to a placebo until their psoriasis significantly worsened, or until four months had passed, whichever came first. At that point, they began taking tofacitnib again at their original dose for another four months.

After this second treatment period, 61 percent of patients taking the 10-mg dose, and almost 37 percent taking the 5-mg dose, regained PASI 75. More than 57 percent in the 10-mg group, and almost 45 percent in the 5-mg group, achieved "clear" or "almost clear" skin.

Tofacitinib targets Janus kinase, an enzyme linked to psoriasis inflammation. It is currently available in the U.S. under the brand name of Xeljanz for the treatment of rheumatoid arthritis.

Pfizer, the manufacturer of tofacitinib, plans to submit these results to the U.S. Food and Drug Administration, along with data from four other trials, by early 2015. Results from two other Phase III trials were released last month.

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