In a recent trial, treatment with ixekizumab was more effective in active psoriatic arthritis (PsA) patients than adalimumab.
The findings come from Eli Lilly & Company’s SPIRIT-H2H (head-to-head) trial, which compared the safety and efficacy of its drug, Taltz (ixekizumab), with that of Humira (adalimumab). According to Lilly, their open-label, randomized, controlled trial was the first H2H study to use on-label dosing for both drugs and include concomitant conventional disease-modifying anti-rheumatic drugs (DMARDs).
Take it from our patients! They felt confident in their ability to use the Taltz device.
— Taltz® ixekizumab US (@taltz) August 15, 2018
The study included 566 patients with active PsA. Active PsA patients were randomized to receive, for 52 weeks, either an initial 160-mg dose of Taltz followed by 80 mg every four weeks, or 40 mg of Humira every two weeks. Primary analysis took place at 24 weeks. Moderate-to-severe psoriasis patients were also randomized to receive either drug, with the Taltz group receiving an initial 160-mg dose, followed by 80 mg every two weeks from week two to week 12 and every four weeks subsequently, and the Humira cohort receiving an initial 80-mg dose followed one week later by 40 mg every two weeks.
— Reuters Top News (@Reuters) December 17, 2018
The primary endpoint for patients treated with ixekizumab was achieving both ACR50 (at least a 50% reduction in disease activity as defined by the American College of Rheumatology) and PASI100 (complete skin clearance as defined by the Psoriasis Area and Severity Index) and demonstrating superiority over adalimumab in improving signs and symptoms.
— Joel M Gelfand MD MSCE (@DrJoelGelfand) December 17, 2018
Ixekizumab met the primary and secondary endpoints of the study. It was noninferior to adalimumab in treating PsA symptoms. However, ixekizumab patients were more likely to achieve clearer skin, and to achieve ACR50 and PASI100 simultaneously.
The company will submit the study’s findings for disclosure at scientific meetings and in peer-reviewed journals sometime in 2019, according to a press release.
“The positive results from the SPIRIT-H2H trial reinforce that Taltz effectively treats the debilitating joint signs and symptoms of active psoriatic arthritis, while also providing skin clearance,” said Lotus Mallbris, MD, PhD, vice president of immunology development at Lilly. “These results provide evidence that Taltz can be used as a first-line biologic treatment for patients with active psoriatic arthritis.”
Sources: Lilly, Reuters