Tofacitinib in Chronic Plaque Psoriasis

In a 12-week phase 3 trial, tofacitinib,10 mg twice a day, was non-inferior to etanercept, 50 mg twice a week. Tofacitinib, 5 mg twice a day, was inferior to etanercept.

Bachelez H, van de Kerkhof PCM, Strohal R, et al. Tofacitinib versus etanercept or placebo in moderate-to-severe chronic plaque psoriasis: a phase 3 randomised non-inferiority trial.The Lancet. Online: 04 June 2015 DOI: 10.1016/S0140-6736(14)62113-9

Lebwohl M. Comment: Do we need more psoriasis therapies?The Lancet. Online: 4 June 2015 DOI: 10.1016/S0140-6736(15)60205-7

Tofacitinib, 10 mg twice a day was non-inferior to etanercept 50 mg twice a week. Tofacitinib 5 mg twice a day was inferior to etanercept.

Adverseeffects were similar, but a commentary says, “We do not know the real risk of any drug until it has been used in thousands of patients for many years.”

However, the risks of psoriasis drugs must be weighed against the comorbidities of psoriasis itself.

This Pfizer-sponsored phase 3, placebo-controlled, 12-week non-inferiority trial compared 1,106 patients with moderate to severe psoriasis on two doses of tofacitinib with etanercept and placebo. End points were Psoriasis Area and Severity Index (PASI) score reduction of at least 75% by week 12 (PASI75), and percent of patients achieving a Physician’s Global Assessment (PGA) of “clear” or “almost clear.”

Tofacitinib
5 mg 2x/day

Tofacitinib
10 mg 2x/day

Etanercept 50 mg 2x/wk

PASI75

39.5%

63.6%*

58.8%

PGA score of clear

11.2%

25.4%*

19.4%