INDIANAPOLIS—Eli Lilly and Co. presented encouraging results from the extension period of its Phase 3 study involving patients with active psoriatic arthritis (PsA) treated with Taltz (ixekizumab) who previously experienced intolerance or inadequate response to TNF inhibitors. Participants in the study showed improvements in the signs and symptoms of PsA across treatment group for the extended time period (52 weeks) of the study, as presented at the American College of Rheumatology/Association of Rheumatology Health Professionals Annual Meeting in San Diego this fall.
During the extension period of the study—dubbed SPIRIT-P2—the majority of patients treated with Taltz achieved at least a 20-percent improvement in disease activity as defined by the American College of Rheumatology, which was the primary endpoint of the study extension. Secondary endpoints included skin clearance (measured by the Psoriasis Area Severity Index) and physical function (measured by the Health Assessment Questionnaire Disability Index). On these secondary endpoints, patients maintained the improvements through the 52-week extension period that the researchers noted during the study’s initial 24-week, double-blind treatment period.
“Insufficient response to TNF inhibitors is actually quite prevalent,” says Dr. Peter Salzmann, vice president of immunology at Eli Lilly. “TNF inhibitors were a step up from previous, non-biologic treatments, but there’s still a significant part of the patient population that doesn’t respond to the treatment initially, and TNF inhibitors also may demonstrate a loss of efficacy over time for many patients.”
Lilly’s SPIRIT-P2 study occurs in tandem with a second Phase 3 trial for Taltz—SPIRIT-P1—in which patients with active PsA who had never been treated previously with a biologic disease-modifying antirheumatic drug were treated with Taltz. In the double-blind P1 study, which measured progression of radiographic structural joint damage, researchers measured either no progression or minimal progression through 52 weeks of treatment with Taltz for the majority of patients. Results from the P1 study were presented in June during the Annual European Congress of Rheumatology 2017 in Madrid.
The two Phase 3 Taltz trials combined included approximately 670 patients and demonstrated efficacy on both skin and joint symptoms, with improvements in these primary endpoints maintained over 52 weeks.
“We’re excited about the fact that these trials are completed and have shown efficacy for patients both for joint and skin symptoms,” says Salzmann. “It’s important for patients to have both. These patients who have gotten insufficient response from the standard of care now have randomized, Phase 3 clinical trial results that can give them sufficient confidence to consider Taltz. It gives patients hope.”
“Many people living with PsA are seeking an effective treatment option that will address all of their symptoms including pain, swelling and stiffness of the joints, as well as painful skin plaques,” said Dr. Mark C. Genovese, presenting author and professor and director of the Rheumatology Clinic in the Division of Immunology and Rheumatology at Stanford University, in a media release about the presentation. “This new data shows the potential impact ixekizumab, if approved, could have for PsA patients.”
The observed safety profile was consistent with initial findings from the double-blind treatment period of the SPIRIT-P2 study. During the extension period, the majority of treatment-emergent adverse events were mild or moderate in severity, including injection site reaction, upper respiratory infection, nasopharyngitis and sinusitis. Serious adverse events occurred in 15 patients in the extension period, including one death.
Taltz is approved by the U.S. Food and Drug Administration (FDA) for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy, and is approved in Japan for adult patients with active PsA. The European Medicines Agency is currently reviewing Taltz as a treatment for adult patients with active psoriatic arthritis; the FDA granted approval for that indication in the United States on Dec. 1, making it the second approved U.S. indication for the drug.
“We hope to redefine what patients and their physicians can expect from therapy,” comments Salzmann. “We aim to have a broad portfolio of solutions to that end. Taltz simultaneously gives us a treatment option that fits into two different specialties: rheumatology and immunology.”
Taltz is one of the newest additions to Lilly’s portfolio. Also presented at the American College of Rheumatology/Association of Rheumatology Health Professionals Annual Meeting in San Diego was a new post-hoc analysis of the Phase 3 RA-BEAM conducted study by Eli Lilly and Incyte Corporation. The study involved patients with moderate-to-severe rheumatoid arthritis treated with baricitinib, and the presentation in November disclosed outcomes of patient-reported improvements in pain control when compared to Humira (adalimumab) or placebo.