Long-Term Use of Lilly's Taltz Shows Efficacy Improvements in PsA for Patients with Prior Inadequate Response or Intolerance to TNF Inhibitors

Patients with active psoriatic arthritis (PsA) treated with Taltz (ixekizumab), who were previously intolerant or had inadequate responses to TNF inhibitors, showed improvements in the signs and symptoms of PsA across treatment groups for up to 52 weeks, according to Eli Lilly and Company. Interim results from the extension period of the Phase 3 SPIRIT-P2 study are being presented  in an oral presentation at the American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals (ARHP) Annual Meeting in San Diego, CA.

Over the 52-week extension period, 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 (ACR 20), the primary endpoint of the study extension. Patients also maintained improvements in key secondary endpoints, including skin clearance and physical function, as measured by the Psoriasis Area Severity Index (PASI) and the Health Assessment Questionnaire Disability Index (HAQ-DI) respectively.

"These data are promising for the more than 37 million people worldwide who suffer from joint and skin symptoms of psoriatic arthritis," said Dr. Lotus Mallbris, vice president, immunology platform team leader, Lilly Bio-Medicines. "In addition to the efficacy of Taltz for people with skin symptoms, we are pleased to share new data suggesting that Taltz, if approved, may provide an option for those with joint symptoms of PsA."

Full SPIRIT-P2 Extension Results
During the extension period of the SPIRIT-P2 study, the majority of patients treated with Taltz showed improvements at 52 weeks in disease activity of PsA. Patients were required to have a diagnosis of PsA for at least six months, at least three tender and swollen joints and a previous intolerant or inadequate response to TNF inhibitors.

Patients who received treatment with Taltz during the initial double-blind treatment period of the SPIRIT-P2 study continued the same dosing regimen (either 80mg of Taltz once every two weeks or 80mg of Taltz once every four weeks) during the extension period. At 52 weeks, patients who continued treatment with Taltz achieved the following response rates:

ACR 20: 68 percent of patients treated with Taltz every four weeks, 59 percent of patients treated with Taltz every two weeks.
ACR 50: 46 percent of patients treated with Taltz every four weeks, 38 percent of patients treated with Taltz every two weeks.
ACR 70: 29 percent of patients treated with Taltz every four weeks, 21 percent of patients treated with Taltz every two weeks.

Patients treated with placebo during the initial double-blind treatment period of the SPIRIT-P2 study were re-randomized during the extension period at week 16 or 24 to receive either 80mg of Taltz once every two weeks or 80-mg of Taltz once every four weeks, following a 160-mg starting dose. At 52 weeks, patients re-randomized to Taltz achieving the following response rates:

ACR 20: 61 percent of patients treated with Taltz every four weeks and 50 percent of patients treated with Taltz every two weeks.
ACR 50: 44 percent of patients treated with Taltz every four weeks and 35 percent of patients treated with Taltz every two weeks.
ACR 70: 24 percent of patients treated with Taltz every four weeks and 15 percent of patients treated with Taltz every two weeks.

"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 Mark C. Genovese, MD, presenting author and professor and director of the Rheumatology Clinic in the Division of Immunology and Rheumatology, Stanford University. "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.  

Lilly has filed a supplemental Biologics License Application (sBLA) with the FDA for Taltz as a treatment of adult patients with active PsA. Lilly also submitted Taltz to the European Medicines Agency (EMA) for the treatment for adult patients with active PsA. Taltz is approved for adult patients with active PsA in Japan. Submissions to other regulatory agencies around the world are expected later this year.