Pfizer Announces Tofacitinib Met Endpoints In Phase III Study

Pfizer announced in a press release that tofacitinib met two primary efficacy endpoints in a Phase III study. Tofacitinib, brand name Xeljanz in the U.S., is under investigation for adult patients with moderate-to-severe chronic plaque psoriasis. Pfizer presented the results on the Janus kinase (JAK) inhibitor at the 11th European Academy of Dermatology and Venereology (EADV) Spring Symposium in Belgrade, Serbia. Pfizer will submit a supplemental New Drug Application (sNDA) to the Food and Drug Administration (FDA) for Xeljanz in psoriasis treatment by early 2015.

Lead investigator Robert Bissonnette of Innovaderm Research in Montreal, said, “The OPT Retreatment data showed that patients who stayed on therapy with tofacitinib maintained their rates of response and for those who stopped therapy, a proportion of patients were able to regain their original clinical response when retreated with tofacitinib.”

Xeljanz

Xeljanz (tofacitinib citrate) is approved in several countries for rheumatoid arthritis. In the U.S., it is approved for adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or demonstrated intolerance to methotrexate. Xeljanz is a Janus-associated kinase (JAK) inhibitor that reduces the symptoms of joint pain, swelling, and stiffness associated with RA by disrupting cytokine signaling. In development for the treatment of moderate-to-severe plaque psoriasis, Xeljanz proved safe and effective in trials.

Phase III Xeljanz Trials

In the Oral treatment Psoriasis Trial (OPT) Retreatment study (A3921111), Xeljanz met the primary endpoint of maintained clinical response for patients that continued on tofacitinib after the initial treatment phase, compared to patients who switched to placebo. The second endpoint evaluated those patients that switched to a placebo, losing half of the original clinical response, and those that restarted tofacitinib, regaining the clinical response. Efficacy was measured by the Physician’s Global Assessment (PGA).

• 44 percent of patients who received tofacitinib 5 mg twice daily and 68 percent of the patients who received a 10 mg dose twice daily achieved at least a 75 percent reduction in the Psoriasis Area and Severity Index (PASI75).
• 42 percent of the 5 mg tofacitinib dose group and 63 percent of the 10 mg group achieved a clear or almost clear skin response.
• Patients who stopped and started tofacitinib maintained clinical responses compared to patients who switched to placebo.

Nasopharyngitis and upper respiratory tract infection were the most common adverse events — similar in earlier trials. One cardiac death occurred at the 5 mg dose, but investigators concluded that it was not related to tofacitinib.