From investor.lilly.com - April 22, 2015 2:09 PM

NDIANAPOLIS, April 20, 2015 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that the investigational medicine ixekizumab was statistically superior to placebo in the treatment of patients with active psoriatic arthritis (PsA), as demonstrated by the proportion of patients achieving an ACR 20 response. ACR 20 is a standard assessment that represents a 20 percent reduction in disease signs and symptoms as defined by the American College of Rheumatologyresponse criteria. During the 24-week, Phase 3 study, titled SPIRIT-P1, patients who were naïve to biologic disease-modifying antirheumatic drugs (bDMARD) were treated with one of two different ixekizumab dosing regimens or placebo. In both dosing regimens, ixekizumab-treated patients demonstrated significant improvements versus placebo in signs and symptoms of active PsA.

 

SPIRIT-P1 is a Phase 3 randomized, active- and placebo-controlled study examining the effect of ixekizumab compared with placebo in patients with active PsA who are bDMARD-naïve. Patients were required to have an established diagnosis of PsA and active disease for at least six months. During the study, ixekizumab-treated patients received a starting dose of 160 mg administered subcutaneously (SC), followed by one of two dosing regimens: either 80 mg administered SC once every two weeks or 80 mg administered SC once every four weeks. Adalimumab at the approved dose of 40 mg SC and regimen of every other week was selected as the active control for comparison with placebo. The SPIRIT-P1 study will also evaluate the long-term efficacy and safety of ixekizumab in PsA for up to three years.


Via Krishan Maggon