Efficacy and safety of infliximab vs. XXXX in @entity1 with moderate-to-severe @entity1569 : results of an open-label, active-controlled, randomized trial (RESTORE1).

@entity1 @entity6987 @entity1569 @entity1500 @entity1499
BACKGROUND: Infliximab is indicated for treatment of moderate-to-severe @entity1569 in adults whose disease cannot be controlled with other systemic therapies, including @entity1499 ( @entity1500 ). To date, no studies have directly compared the efficacy and safety of infliximab and @entity1500 . OBJECTIVES: To compare the efficacy and safety of infliximab vs. @entity1500 in adults with moderate-to-severe @entity1569 . METHODS: @entity1500 -na  ve @entity1 (n = 868) were randomized 3:1 to receive infliximab 5 mg kg      at weeks 0, 2, 6, 14 and 22 or @entity1500 15 mg weekly with a dose increase to 20 mg weekly at week 6 if the Psoriasis Area and Severity Index (PASI) response was < 25%. At week 16, @entity1 with <   PASI 50 response could switch treatment groups. The primary efficacy endpoint was PASI 75 response at week 16. Major secondary efficacy endpoints were PASI 75 response at week 26, and the proportion of @entity1 achieving a Physician's Global Assessment (PGA) score of cleared (0) or minimal (1) at weeks 16 and 26. Others included Dermatology Life Quality Index, 36-Item Short Form Health Survey, and @entity6987 , PASI 50, PASI 75 and PASI 90 responses over time. RESULTS: The primary endpoint was achieved by a significantly greater proportion of infliximab-treated @entity1 (508/653, 78%) than @entity1500 -treated @entity1 (90/215, 42%; P < 0  001). Key secondary endpoints also were achieved by a greater proportion of infliximab-treated @entity1 . Similar responses were observed at week 26 in @entity1 who switched from @entity1500 to infliximab at week 16. Overall adverse event (AE) incidence was comparable between groups, but incidence of serious and severe AEs was slightly higher in the infliximab group. CONCLUSIONS: Infliximab was well tolerated and more efficacious than @entity1500 in @entity1 with moderate-to-severe @entity1569 . Infliximab also was efficacious in @entity1 who failed @entity1500 and switched to infliximab.
