Lilly's Taltz shows promise for patients with active psoriatic arthritis

Demonstrated significant improvements in disease signs and symptoms at 24 weeks among patients with active psoriatic arthritis who had prior inadequate response or intolerance to TNF inhibitors.

"Psoriatic arthritis is a chronic, progressive disease that affects more than 37 million people worldwide, and can cause a range of signs and symptoms, including pain, swelling and stiffness of the joints that can lead to impaired physical function, as well as itchy and painful skin plaques," said Dr. Lotus Mallbris, global brand development leader, Taltz, Eli Lilly and Company. "We are pleased this data will be presented at the Annual European Congress of Rheumatology (EULAR) 2017, as it represents an invaluable opportunity to foster discussion among experts from around the world on the importance of new treatments for this debilitating disease."

The SPIRIT-P2 study evaluated the safety and efficacy of Taltz (80 mg every 4 weeks or every 2 weeks, following a 160-mg starting dose) compared to placebo after 24 weeks in patients with active PsA who were previously treated with TNF inhibitors and had an inadequate response to one or two TNF inhibitors or were intolerant to TNF inhibitors. Patients were required to have a diagnosis of active PsA for at least 6 months and at least three tender and three swollen joints.

In this study, the primary endpoint was the percentage of patients achieving at least a 20% reduction in a composite measure of disease activity, as defined by the American College of Rheumatology (ACR20). This study also evaluated secondary endpoints including ACR50 and ACR70, which represent 50% and 70% reductions in disease activity; improvement in physical function as assessed using the Health Assessment Questionnaire Disability Index (HAQ-DI); and improved skin clearance as measured by the Psoriasis Area Severity Index (PASI).

Patients treated with either dosing regimen of Taltz demonstrated significant improvements at 24 weeks compared with placebo in disease activity of PsA.

At 24 weeks, patients achieved the following response rates:

Patients treated with either dosing regimen of Taltz also experienced significant improvements compared with placebo in other key secondary measures, including physical function as assessed by the HAQ-DI and skin clearance in patients with at least 3% body surface area of skin involvement as measured by PASI 75, PASI 90 and PASI 100 at 12 weeks and 24 weeks. A PASI 75 score indicates at least a 75% reduction in a patient's plaque psoriasis from the patient's baseline assessment, while PASI 90 reflects a 90% reduction. PASI 100 represents a 100% reduction and reflects complete skin clearance.

"Many patients with psoriatic arthritis have tried a variety of therapies and have either lost response over time, had an inadequate response or been intolerant of therapy," said Associate Professor Peter Nash, lead author, University of Queensland, Queensland, Australia. "If approved, ixekizumab may provide physicians with a new option in this difficult-to-treat patient population."