You are here

Tofacitinib Shows Mixed Results in Adults With Plaque Psoriasis

Drug non-inferior to etanercept at 10 mg but not at 5 mg (October 9)

Mixed results have been reported from two phase III clinical trials of tofacitinib (Pfizer), an investigational oral Janus kinase (JAK) inhibitor that is being investigated for the treatment of adults with moderate-to-severe chronic plaque psoriasis.

OPT Compare and OPT Retreatment are the first two of five studies in the phase III Oral Psoriasis Treatment (OPT) global clinical trial program for tofacinitib.

OPT Compare is a 12-week, non-inferiority study comparing the efficacy and safety of tofacitinib 5 mg and 10 mg twice-daily (BID) with high-dose etanercept (Enbrel, Amgen/Pfizer) 50 mg twice-weekly (BIW) — the approved starting dose for etanercept — and with placebo for the treatment of adult patients with moderate-to-severe chronic plaque psoriasis.

Top-line results from this study showed that tofacitinib met the primary endpoint of non-inferiority to high-dose etanercept at the 10-mg BID dose. Tofacitinib did not meet the non-inferiority criteria to high-dose etanercept at the 5-mg BID dose.

OPT Retreatment is a 56-week study comparing the efficacy and safety of withdrawal and re-treatment with tofacitinib 5 mg and 10 mg BID with that of placebo for the treatment of adult patients with moderate-to-severe chronic plaque psoriasis.

The trial met its primary efficacy endpoints at the 5-mg and 10-mg BID doses by demonstrating that a greater proportion of patients continuing to facitinib treatment maintained their responses during the treatment-withdrawal phase compared with patients who switched to placebo. In addition, among patients who lost an adequate response, many were able to recapture their response after re-treatment with tofacitinib.

Source: Pfizer; October 9, 2013.

Recent Headlines

Despite older, sicker patients, mortality rate fell by a third in 10 years
Study finds fewer than half of trials followed the law
WHO to meet tomorrow to decide on international public heath emergency declaration
Study of posted prices finds wild variations and missing data
Potential contamination could lead to supply chain disruptions
Mortality nearly doubled when patients stopped using their drugs
Acasti reports disappointing results for a second Omega-3-based drug
Declining lung cancer mortality helped fuel the progress
Kinase inhibitor targets tumors with a PDGFRA exon 18 mutation