Lilly's Taltz Shows Superiority Over J&J's Tremfya In Psoriasis Study
In a Phase IV post-marketing study, Indianapolis-based Eli Lilly said Taltz (ixekizumab) met the primary and secondary endpoints at 12 weeks in the comparison study using the Psoriasis Area Severity Index 100 (PASI 100). At 12 weeks, Taltz demonstrated superiority over Tremfya (guselkumab) in people living with moderate to severe plaque psoriasis. Patients who took Taltz in the post-marketing study achieved higher rates of “complete skin clearance” in comparison to Tremfya as measured by PASI 100, Eli Lilly said this morning. Taltz also met all major secondary endpoints by hitting certain key measures on the PASI scale throughout the trial period, Eli Lilly said. The study, IXORA-R, is the first Phase IV head-to-head study comparing the efficacy between an IL-17A inhibitor and an IL-23/p19 inhibitor using PASI 100 as the primary endpoint.
In IXORA-R, the safety profile of Taltz was consistent with previously reported results. No new safety signals were detected. Lilly said it plans to submit detailed data from the IXORA-R study at future scientific meetings and in peer-reviewed journals.
Lotus Mallbris, head of immunology development at Eli Lilly, said the goal of her division is to “raise the treatment bar” for people who live with psoriasis, the most common inflammatory disease in the United States. For people who live with psoriasis, Mallbris said research shows they want rapid improvements in having clear skin. The Phase IV data shows that Taltz is hitting the mark in being able to meet those demands, she added.
“We're pleased to see that Taltz helped more people achieve 100 percent skin clearance compared to Tremfya at week 12. These positive results reinforce that Taltz is an important treatment option for people with this disease,” Mallbris said in a statement.
Taltz was first approved for treating psoriasis in 2016. In December 2017, Taltz was approved for the treatment of adults with psoriatic arthritis, a type of arthritis that attacks adults who have psoriasis. Earlier this year, Taltz beat AbbVie’s Humira in a head-to-head study in active psoriatic arthritis. Data from the Phase IIIb/IV SPIRIT-Head-to-Head trial showed that Taltz was superior to Humira in treating active psoriatic arthritis.
In June, Eli Lilly presented five-year data for Taltz as a treatment for plaque psoriasis. Phase III data presented at the World Congress of Dermatology in Italy showed that patients with moderate- to severe plaque psoriasis who continued to receive Taltz maintained high levels of skin clearance. More than 90 percent maintained significant skin clearance as measured by PASI 75 and almost half of the patients maintained completely clear skin, Eli Lilly said in June.
The Phase IV IXORA-R study included 1,027 patients with moderate to severe plaque psoriasis. Participants were randomized to receive Taltz or Tremfya for 24 weeks. The primary analysis was conducted at 12 weeks.
Andrew Blauvelt, dermatologist and president of Oregon Medical Research Center in Portland, Oregon, spoke on behalf of the trial data and called the head-to-head data important in order to help inform physicians and their patients when making individual treatment decisions.
"Completely clear skin and rapid relief of symptoms are possible for many people living with moderate to severe plaque psoriasis, and should be two topics dermatologists discuss with their patients," Blauvelt said in a statement.