NEW YORK (Reuters Health)—The oral Janus kinase inhibitor tofacitinib (Xeljanz, Pfizer) shows long-term efficacy against chronic plaque psoriasis, according to findings from two randomized studies and an extension trial.
The outcome, Dr. Svitlana Tatulych told Reuters Health by email, “demonstrated that oral tofacitinib, at both the 10 mg and 5 mg twice-daily doses, provided sustained efficacy in patients with moderate to severe chronic plaque psoriasis out to two years.”
In a Feb. 20 online paper in the Journal of the American Academy of Dermatology, Dr. Tatulych, of Pfizer, Groton, Conn., and colleagues noted that previous studies have shown the efficacy and safety of continuous tofacitinib treatment vs. placebo over 16 weeks.
To extend these findings, the researchers conducted two identical placebo-controlled Phase 3 studies in more than 1,800 patients with a diagnosis of plaque-type psoriasis for at least 12 months.
At week 16, all placebo patients were rerandomized to tofacitinib and followed up to 52 weeks. Eligible patients then entered an ongoing long-term extension study.
After 28 weeks, 55.6% of the patients in the 5 mg active treatment group and 68.8% of those in the 10 mg group had a 75% or greater reduction in Psoriasis Area and Severity Index score from baseline. Corresponding proportions for Physician Global Assessment of clear or almost clear were 54.7% and 65.9%.
There were no unexpected safety findings. Rates of serious adverse events (SAEs) and discontinuations because of adverse events (AEs) were low (less than 6%) and similar between tofacitinib doses through week 52.
“The most common AEs,” continued Dr. Tatulych, “were nasopharyngitis and upper respiratory tract infection. Safety events were also reported for the total tofacitinib exposure to describe the longer-term safety profile.”
“Over 33 months,” she said, “10.1% of patients experienced SAEs and 10.7% of patients discontinued because of AEs. The most common AEs remained nasopharyngitis and upper respiratory tract infection.”
These data, the investigators concluded, “support the continued evaluation of tofacitinib as a potential new, long-term, oral treatment option for plaque psoriasis.”
Pfizer sponsored this research. Dr. Tatulych and a number of other authors are employed by or have relationships with the company.