Eli Lilly and Company announced that Taltz (ixekizumab) injection 80 mg/mL for the treatment of moderate-to-severe plaque psoriasis is now available by prescription order through a contracted network of specialty pharmacies in the United States. Lilly is also offering patient support programmes to help ensure eligible patients have access to Taltz and available resources.
Taltz was approved by the US FDA in March 2016 for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systematic therapy or phototherapy. Taltz should not be used in patients with previous hypersensitivity reaction, such as anaphylaxis, to ixekizumab or to any of the excipients. Taltz is designed to specifically target IL-17A, a protein that plays a role in driving underlying inflammation in psoriasis.
In three pivotal studies, at 12 weeks, 87 to 90 per cent of patients treated with Taltz saw a significant improvement of their psoriasis plaques (PASI 75). In addition, 81 to 83 per cent of patients treated with Taltz achieved sPGA 0 or 1. The majority of patients treated with Taltz, 68 to 71 per cent, achieved virtually clear skin (PASI 90) and 35 to 42 per cent of patients saw complete resolution of their psoriasis plaques (PASI 100, sPGA 0). Among those patients treated with placebo, 7 per cent or fewer achieved PASI 75, 7 per cent or fewer achieved sPGA 0 or 1, 3 per cent or fewer achieved PASI 90 and 1 per cent or fewer achieved PASI 100 and sPGA 0.
Taltz may increase the risk of infection. In trials, the rate of infection in the Taltz group was 27 per cent vs. 23 per cent in the placebo group. Serious infections have occurred. Instruct patients to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur. If a serious infection develops, monitor the patient closely and discontinue Taltz until the infection resolves.
"Many people with moderate-to-severe plaque psoriasis are searching for a treatment that will help them achieve high levels of clear skin. With Taltz now available, physicians and patients have a new treatment option that may help patients experience virtually or completely clear skin," said Alex Azar, president, Lilly USA, LLC. "Lilly is committed to providing education and resources to help make Taltz accessible to people with moderate-to-severe plaque psoriasis."
The Taltz Together programme will provide interested patients with injection training, guidance on navigating insurance benefits, and working with a contracted network of specialty pharmacies to help fill Taltz prescriptions. Patients will also have access to a Companion in Care, a personal patient representative to answer questions and concerns, with each patient receiving attention from the same specialist during each call.
"The availability of new treatments like Taltz is vitally important for patients with moderate-to-severe plaque psoriasis," said Randy Beranek, president of the National Psoriasis Foundation. "The effects of psoriasis can vary among patients and what works for one patient may not work for another. We are happy to see more options available so patients can continue treating this very difficult disease."
The clinical programme for Taltz included three double-blind, multicenter, phase 3 studies—UNCOVER-1, UNCOVER-2 and UNCOVER-3—which demonstrated the safety and efficacy of Taltz in patients with moderate-to-severe plaque psoriasis. All three studies 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 US-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 per cent 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. PASI measures the extent and severity of psoriasis by assessing average redness, thickness and scaliness of skin lesions (each graded on a zero to four scale), weighted by the body surface area of involved skin, while the sPGA is the physician's assessment of severity of a patient's psoriasis lesions overall at a specific point in time and is a required measure the FDA uses to evaluate effectiveness.
Taltz was also statistically superior to US-approved etanercept at all skin clearance levels, including PASI 75 and sPGA 0 or 1 at 12 weeks. In an integrated analysis of the US sites in the two active comparator studies—UNCOVER-2 and UNCOVER-3—the respective response rates for Taltz vs. US-approved etanercept were 87 per cent vs. 41 per cent for PASI 75 and 73 per cent vs. 27 per cent for sPGA 0 or 1.
Taltz (ixekizumab) is a humanized IgG4 monoclonal antibody that selectively binds with 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. Taltz inhibits the release of pro-inflammatory cytokines and chemokines.