Phase III data shows significant improvements for psoriatic arthritis patients on LY 2439821 (ixekizumab)- Eli Lilly

Eli Lilly announced that psoriatic arthritis (PsA) patients treated with LY 2439821 (ixekizumab) in a 24-week, double-blind period of a Phase III study achieved significant improvements in signs and symptoms of their disease when compared to placebo, while also experiencing significantly less progression of radiographic structural joint damage, reduced disability when performing certain physical functions and improved skin clearance of plaque psoriasis. In both dosing regimens (either 80 mg of ixekizumab once every two weeks or every four weeks), ixekizumab-treated patients demonstrated significant improvements compared with placebo in disease activity of PsA as demonstrated by the proportion of patients achieving an ACR20 response at 24 weeks, the study's primary objective. Improvements were experienced by ixekizumab-treated patients as early as one week after treatment initiation.

At 24 weeks, 62% of patients treated every two weeks and 58% of patients treated every four weeks with ixekizumab achieved ACR20 compared with 30% of placebo-treated patients. The proportions of ixekizumab-treated patients who achieved ACR50 when treated every two weeks or every four weeks were 47% and 40%, respectively, compared with 15% of patients treated with placebo. Furthermore, 34% of patients treated with ixekizumab every two weeks and 23% of those treated every four weeks experienced a 70% reduction in disease activity, while only 6% of patients treated with placebo achieved this level of improvement. Patients treated with ixekizumab at both dosing regimens also experienced significantly less radiographic progression of structural joint damage than those treated with placebo, as measured by the change from baseline in the van der Heijde modified total Sharp score for PsA at 24 weeks.

Patients in the ixekizumab treatment groups also experienced significant improvements compared with placebo in other key secondary measures, including physical function. The incidence of treatment-emergent adverse events was greater with ixekizumab treatment compared with placebo. The most common (≤4%) adverse events observed with ixekizumab treatment were injection site reaction, injection site erythema and nasopharyngitis. Data were presented during the American College of Rheumatology/Association of Rheumatology Health Professionals Annual Meeting.