Eli Lilly and Company plans to announce positive findings from its Phase IIIb/IV SPIRIT-Head-to-Head (H2H) clinical trial comparing its Taltz (ixekizumab) to AbbVie’s Humira (adalimumab) in active psoriatic arthritis (PsA) at the European Congress of Rheumatology (EULAR) being held in Madrid, Spain.
The primary endpoint of the study was to show that Taltz was superior to Humira in treating PsA.
Psoriatic arthritis is a type of arthritis that affects people with psoriasis, which is marked by red patches of skin with silvery scales. Usually people develop psoriasis first and then psoriatic arthritis later, but sometimes the joint issues begin first. The primary symptoms are joint pain, stiffness and swelling. They can affect any part of the body, including fingertips and the spine, and have a broad range of severity. The disease affects up to 50 million people worldwide.
The disease is an autoimmune disease, where the body’s immune system attacks healthy cells and tissues. This immune response stimulates inflammation in the joints in addition to overproduction of skin cells.
Topline data from the trial was announced in December 2018.
“In the SPIRIT-H2H trial, Taltz demonstrated effectiveness in improving the signs and symptoms of active psoriatic arthritis,” stated Philip Mease, with the Swedish Medical Center/Provide St. Joseph Health and University of Washington. “Head-to-head data like these are significant and help inform treatment decisions. This study underscores that Taltz is an important option for healthcare providers to consider for their patients.”
The SPIRIT-H2H trial enrolled 566 patients with active PsA. They were split up randomly to receive Taltz or Humira at the approved dose for a total of 52 weeks. Primary analysis was performed at 24 weeks. In addition, PsA patients who also met the same criteria for moderate- to severe plaque psoriasis also received Taltz or Humira at the approved dose for psoriasis.
At 24 weeks, the patients who achieved both a reduction in disease activity by at least 50%, were observed, and for the patients receiving Taltz, 36% hit that mark compared to 28% in the Humira cohort. Taltz also hit the key secondary endpoints, which included non-inferiority compared to Humira for proportion of patients achieving 50% disease activity (51% versus 47%), and superiority compared to Humira for proportion of patients showing complete skin clearance, PASI 100, with 60% of the Taltz group hitting the mark compared to 47% of the Humira group.
Earlier this week, Novartis presented data from its FUTURE 5 clinical trial of Cosentyx (secukinumab) in PsA at the EULAR meeting. In that trial, patients receiving Cosentyx showed no radiographic progression in almost 90% of PsA patients over two years. Of the patients receiving the drug at 150 mg, 66.3% had rapid and significant improvements in symptoms of the disease with axial manifestations at week 12.
Many companies are chasing AbbVie’s Humira, hoping to gain a piece of the company’s astonishing profits. In 2018, sales of Humira hit $19.9 billion, an increase of 8.2% from 2017. Although the results of this head-to-head study provide a compelling rationale for switching patients from Humira to Taltz, convincing doctors to do so may be hard, and Lilly is aware of this.
Lilly also presented Taltz data in plaque psoriasis earlier this week at the World Congress of Dermatology (WCD) meeting in Milan, Italy.
“Of the patients who continued to take Taltz through five years in the extension period of this study, more than 90% maintained significant skin clearance as measured by PASA 75 and almost half of patients maintained completely clear skin,” stated Craig Leonard, lead investigator and professor of dermatology at St. Louis University School of Medicine. “These results demonstrate that patients taking Taltz can achieve sustained skin clearance over the five-year treatment period.”
