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.