Taltz superior to Humira in head to head phase IIIb/IV SPIRIT-H2H study for psoriatic arthritis. Eli Lilly

Eli Lilly and Company announced Taltz (ixekizumab) met the primary and all major secondary endpoints in the Phase IIIb/IV SPIRIT-H2H study, which evaluated the efficacy and safety of Taltz versus Humira (adalimumab) in patients with active psoriatic arthritis (PsA) who are biologic disease-modifying anti-rheumatic drug (DMARD)-naive.

The SPIRIT-H2H trial is the first completed large head-to-head (H2H) superiority study in active PsA. This open-label, randomized, controlled trial is the first and only H2H study that utilizes on-label dosing for both Taltz and Humira and includes concomitant conventional DMARDs. At 24 weeks, patients treated with Taltz met the primary endpoint by demonstrating superiority in improving the signs and symptoms of active PsA compared to Humira as measured by the proportion of patients simultaneously achieving at least a 50-percent reduction in disease activity, as defined by the American College of Rheumatology (ACR50), as well as complete skin clearance as measured by the Psoriasis Area and Severity Index (PASI100). In addition, Taltz met the major secondary endpoints.

A total of 566 active PsA patients were enrolled in the study to evaluate the efficacy and safety of Taltz compared to Humira. Patients with active PsA were randomized to receive Taltz at the approved dose (160-mg starting dose followed by 80 mg every four weeks), or Humira (40 mg every two weeks) for a total of 52 weeks, with the primary analysis conducted at 24 weeks. Patients meeting criteria for moderate-to-severe plaque psoriasis received the approved dose of Taltz (160-mg starting dose followed by 80 mg every two weeks from Week 2 to Week 12 and every four weeks thereafter) or Humira (80-mg starting dose followed by 40 mg every two weeks, one week after the initial dose) In SPIRIT-H2H, the safety profile of Taltz was consistent with previously reported results. No new safety signals were detected. Lilly plans to submit detailed data from the SPIRIT-H2H study for disclosure at scientific meetings and in peer-reviewed journals in 2019.