Taltz (ixekizumab)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company:

Approval Status:

Approved March 2016

Specific Treatments:

plaque psoriasis and active psoriatic arthritis

General Information

Taltz (ixekizumab) a humanized interleukin-17A antagonist.

Taltz is specifically indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Taltz is also indicated for the treatment of active psoriatic arthritis.

Taltz is supplied as an injection for subcutaneous administration. The recommended dose is as follows:

Plaque psoriasis: The recommended dose is 160 mg (two 80 mg injections) at Week 0, followed by 80 mg at Weeks 2, 4, 6, 8, 10, and 12, then 80 mg every 4 weeks.

Active psoriatic arthritis: The recommended dose is 160 mg by subcutaneous injection (two 80 mg injections) at Week 0, followed by 80 mg every 4 weeks. For psoriatic arthritis patients with coexistent moderate-to-severe plaque psoriasis, use the dosing regimen for plaque psoriasis. Taltz may be administered alone or in combination with a conventional DMARD. 

Clinical Results

FDA Approval

Psoriasis:

The FDA approval of Taltz was based on three phase III trials conducted in over 3,800 subjects with moderate-to-severe plaque psoriasis from 21 countries. The three double-blind, multicenter studies, UNCOVER-1, UNCOVER-2 and UNCOVER-3, evaluated the safety and efficacy of Taltz (80 mg every two weeks, following a 160-mg starting dose) compared to placebo after 12 weeks. UNCOVER-2 and UNCOVER-3 included an additional comparator arm in which patients received U.S.-approved etanercept (50 mg twice a week) for 12 weeks. UNCOVER-1 and UNCOVER-2 also evaluated response rates with Taltz during the maintenance period through 60 weeks. In these studies, the co-primary efficacy endpoints at 12 weeks were a 75 percent improvement in the composite Psoriasis Area Severity Index (PASI) score and static Physician's Global Assessment (sPGA) 0 or 1 and at least a 2-point improvement from baseline. In all three studies, at 12 weeks, 87 to 90 percent of patients treated with Taltz saw a significant improvement of their psoriasis plaques (PASI 75). In addition, 81 to 83 percent of patients treated with Taltz achieved sPGA 0 or 1. The majority of patients treated with Taltz, 68 to 71 percent, achieved virtually clear skin (PASI 90) and 35 to 42 percent of patients saw complete resolution of their psoriasis plaques (PASI 100, sPGA 0). Among those patients treated with placebo, 7 percent or fewer achieved PASI 75, 7 percent or fewer achieved sPGA 0 or 1, 3 percent or fewer achieved PASI 90 and 1 percent or fewer achieved PASI 100 and sPGA 0. In UNCOVER-1 and UNCOVER-2, of patients who responded to Taltz (sPGA 0 or 1 and at least a 2-point improvement from baseline) at 12 weeks, 75 percent consistently maintained that response at the 60-week endpoint. Taltz was also statistically superior to etanercept at all skin clearance levels, including PASI 75 and sPGA 0 or 1 at 12 weeks. In an integrated analysis of the U.S. sites in the two active comparator studies, UNCOVER-2 and UNCOVER-3, the respective response rates for Taltz vs. etanercept were 87% vs. 41% for PASI 75 and 73% vs. 27% for sPGA 0 or 1.

Psoriatic arthritis:

The FDA approval of Taltz for psoriatic arthritis was based on two randomized, double-blind, placebo-controlled studies (PsA1 and PsA2) in adults, age 18 years and older with active psoriatic arthritis (at least 3 swollen and at least 3 tender joints) despite non-steroidal anti-inflammatory drug (NSAID), corticosteroid or disease modifying anti-rheumatic drug (DMARD) therapy. PsA1 evaluated 417 biologic-naive patients, who were treated with either Taltz 160 mg at Week 0 followed by 80 mg every 2 weeks (Q2W) or 4 weeks (Q4W), adalimumab 40 mg every 2 weeks, or placebo. PsA2 evaluated 363 anti-TNFα experienced patients, who were treated with Taltz 160 mg at Week 0 followed by 80 mg every 2 or 4 weeks, or placebo. Patients receiving placebo were re-randomized to receive Taltz (80 mg every 2 or 4 weeks) at Week 16 or Week 24 based on responder status. The primary endpoint was the percentage of patients achieving an ACR20 response at Week 24. In both studies, patients treated with Taltz 80 mg Q2W or 80 mg Q4W demonstrated a greater clinical response including ACR20, ACR50, and ACR70 compared to placebo at Week 24. In PsA2, responses were seen regardless of prior anti-TNFα exposure.

 

Side Effects

Adverse effects associated with the use of Taltz may include, but are not limited to, the following:

  • injection site reactions
  • upper respiratory tract infections
  • nausea
  • tinea infections

Serious infections have occurred with the use of Taltz. If signs or symptoms of clinically important chronic or acute infection occur, or if a serious infection develops, discontinue Taltz until the infection resolves.

Mechanism of Action

Taltz (ixekizumab) is a humanized IgG4 monoclonal antibody that selectively binds with the interleukin 17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor. IL-17A is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Ixekizumab inhibits the release of proinflammatory cytokines and chemokines. 

Additional Information

For additional information regarding the use of Taltz or plaque psoriasis, please visit https://www.taltz.com/