Lilly presents 52-week head-to-head (SPIRIT-H2H) data from Taltz v. Humira trial in psoriatic arthritis.

Eli Lilly and Company announced the 52-week results from the Phase IIIb/IV SPIRIT-Head-to-Head (H2H) study of Taltz (ixekizumab) versus Humira (adalimumab) in biologic-na�ve patients with active psoriatic arthritis (PsA). The results are being presented as a late-breaking oral presentation at the American College of Rheumatology (ACR)/Association of Rheumatology Professionals (ARP) Annual Meeting in Atlanta.

Taltz met the primary and all major secondary endpoints of the study. Taltz was superior to Humira at Week 24 as measured by the primary endpoint of simultaneous achievement of a reduction by at least 50 percent in disease activity as defined by the American College of Rheumatology (ACR50) and complete skin clearance as measured by the Psoriasis Area and Severity Index (PASI 100). At Week 52, 39 percent of patients treated with Taltz had sustained simultaneous joint and skin improvement (ACR50 and PASI 100), compared with 26 percent of patients treated with Humira.

A total of 566 patients with active PsA were enrolled in the SPIRIT-H2H study and were randomized to receive Taltz or Humira at the approved dose for PsA. PsA patients who also met the study criteria for moderate to severe plaque psoriasis received Taltz or Humira at the approved dose for psoriasis. Of the enrolled patients, 87 percent of patients treated with Taltz (N=246) and 84 percent of patients treated with Humira (N=237) participated in the study through 52 weeks. Taltz performed at least as well as Humira at Week 52 in other secondary endpoints, including: ACR50: 50 percent of patients treated with Taltz and 50 percent of patients treated with Humira achieved ACR50 at Week 52; ACR70: 35 percent of patients treated with Taltz and 34 percent of patients treated with Humira achieved ACR70 at Week 52; PASI 100: 64 percent of patients treated with Taltz and 41 percent of patients treated with Humira achieved PASI 100 at Week 52.

Taltz is the first and only IL-17A antagonist to demonstrate superiority over Humira in a head-to-head trial in psoriatic arthritis.