A Randomized, blinded assessor study to Evaluate the efFIcacy and safety of etanercept 50 mg once weekly plus as Needed topical agent vs. Etanercept 50 mg twice weekly in patients with moderate to severe plaque psoriasis (REFINE).
Bottom Line: PASI response rates were similar between groups.Difference (95% CI) between groups in change in affected BSA from week 12 to week 24 was 4.9% (-23.4%, 33.2%).Patients who received etanercept 50 mg QW at week 12 plus as-needed topical therapy and those who stayed on etanercept 50 mg BIW maintained clinical response through week 24 with no notable differences in PASI responses.
Affiliation: Probity Medical Research, Waterloo, ON, Canada.Show MeSH
Related in: MedlinePlus
Mentions: Of 310 patients enrolled, 144 were randomized to etanercept, 143 to etanercept+topical, and 23 discontinued prior to week 12 and were not randomized. Forty-three (13.9%) patients discontinued because of withdrawn consent (n = 10), loss to follow-up (n = 10), AE (n = 7), non-compliance (n = 5), protocol violation (n = 2), disease progression (n = 2), requirement for alternative therapy (n = 2), administrative decision (n = 2), pregnancy (n = 2) and other reasons (n = 1) (Fig. 1).