Postive Phase III Psoriasis Clinical Trial Results for Pfizer’s Xeljanz
Pfizer have announced positive Phase III clinical trial results for their JAK inhibitor, Xeljanz (tofacitinib).
The results from data taken from two Phase III clinical trials provide additional support for the drug’s use to treat moderate to severe psoriasis.
Pfizer commented that the results from the trials show that both tofacitinib 10mg and 5mg tablets twice daily were superior to placebo in achieving a Physician’s Global Assessment response of “clear” or “almost clear”, in addition to at least a 75% reduction in Psoriasis Area and Severity Index (PASI75).
Secondary endpoints, including the proportion of patients achieving at least a 90% reduction in PASI (PASI90) and the percent change from baseline in Body Surface Area, were also met. No additional safety signals were observed from the Phase III clinical trials, with the most common side effects reported being nasopharyngitis, upper respiratory infection and headache.
The lead investigator, Kim Papp of Probity Medical Research, commented that the data highlights “that if approved, tofacitinib may offer a clinically meaningful option in oral therapy as the first potential treatment in a new class of medicines for this chronic condition.”
Xeljanz has previously been approed by the US Food and Drug Administration (FDA) in 2012 as the first JAK inhibitor to treat rheumatoid arthritis. The US regulator is also currently considering the use of the treatment for adults with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.