PsA Patients Failing Anti-TNF Drugs May Do Well on Taltz

New data show that Taltz (ixekizumab) improved the signs and symptoms of active psoriatic arthritis (PsA) in patients who had inadequate response to one or two TNF inhibitors or were intolerant of TNF inhibitors treated.

Eli Lilly has filed a supplemental Biologics License Application (sBLA) with the U.S. Food and Drug Administration (FDA) for Taltz as a treatment of 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.

Detailed results of the SPIRIT-P2 study, a pivotal Phase 3 trial, will be presented in an oral presentation ar the Annual European Congress of Rheumatology (EULAR) 2017, taking place June 14-17, in Madrid. Results from the SPIRIT-P2 study were also recently published in The Lancet in May 2017.

The SPIRIT-P2 study evaluated the safety and efficacy of Taltz (80 mg every four weeks or every two 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 six 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 percent 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 percent and 70 percent 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:

• ACR 20: 53 percent of patients treated with Taltz every four weeks, 48 percent of patients treated with Taltz every two weeks and 19 percent of those treated with placebo (p<0.0001).

• ACR 50: 35 percent of patients treated with Taltz every four weeks, 33 percent of patients treated with Taltz every two weeks and 5 percent of those treated with placebo (p<0.0001).

• ACR 70: 22 percent of patients treated with Taltz every four weeks, 12 percent of patients treated with Taltz every two weeks and zero percent of those treated with placebo (p<0.0001).

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 percent 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 percent reduction in a patient's plaque psoriasis from the patient's baseline assessment, while PASI 90 reflects a 90 percent reduction. PASI 100 represents a 100 percent reduction and reflects complete skin clearance.

The incidence of treatment-emergent adverse events was greater with Taltz treatment compared with placebo. The most common (≥5 percent in Taltz groups combined) treatment-emergent adverse events observed with Taltz treatment were injection site reaction, upper respiratory infection, nasopharyngitis and sinusitis. Serious adverse events and discontinuation rates due to adverse events were not significantly different between treatment groups.

Other warnings and precautions for Taltz include pre-treatment evaluation for tuberculosis, hypersensitivity reactions, inflammatory bowel disease and immunizations.