Clinical Trials

Date: 2017-06-15

Type of information: Presentation of results at a congress

phase: 3

Announcement: presentation of results at the European League Against Rheumatism Annual Congress (EULAR 2017)

Company: Eli Lilly (USA - IN)

Product: Taltz® (ixekizumab)

Action mechanism:

• monoclonal antibody. Ixekizumab is a monoclonal antibody with high affinity and specificity that binds to and neutralizes the pro-inflammatory cytokine interleukin-17A (IL-17A). In psoriasis, IL-17A plays a major role in driving excess keratinocyte (skin cell) proliferation and activation. Ixekizumab does not bind to cytokines IL-17B, IL-17C, IL-17D, IL-17E or IL-17F. Ixekizumab is administered via subcutaneous injection.
• Taltz® (ixekizumab) is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

Disease: active psoriatic arthritis

Therapeutic area: Autoimmune diseases – Inflammatory diseases - Rheumatic diseases

Country:

Trial details:

Latest news:

• • On June 15, 2017, Eli Lilly announced that patients with active psoriatic arthritis  who had inadequate response to one or two TNF inhibitors or were intolerant of TNF inhibitors treated with Taltz® (ixekizumab) achieved significant improvement in signs and symptoms of their disease at 24 weeks when compared to placebo. 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).
• 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. ¤ 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. ¤ 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).
• 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.
• Lilly has filed a supplemental Biologics License Application (sBLA) with the 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.

Is general: Yes