Ixekizumab (Taltz) - Biotech, Pharma and Life Science Channel

21:39 EDT 23rd October 2016 | BioPortfolio

Ixekizumab (Taltz) is a humanised IgG4 monoclonal antibody that selectively binds with high affinity to the interleukin 17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor.iii IL-17A is a naturally occurring cytokine that is involved in normal inflammatory and immune responses, and elevated levels of IL-17A have been implicated in the pathogenesis of a variety of autoimmune diseases such as psoriasis.iii  Neutralisation of IL-17A by ixekizumab inhibits these pro-inflammatory actions.iii

Ixekizumab is administered by subcutaneous injection, either via auto-injector or prefilled syringe.iii

In UNCOVER-1 the results show that when treated every two weeks with ixekizumab for 12 weeks following a starting dose, approximately 9 of 10 patients achieved a PASI 75 score.iiiIn both UNCOVER-2 and UNCOVER-3 etanercept was used as an active comparator. The results show that approximately 9 of 10 patients treated with ixekizumab every two weeks achieved a PASI 75 score at week 12, and approximately 8 of 10 patients achieved clear or almost clear skin as defined by sPGA 0 or 1 respectively.iii,

Numerous secondary end points were also collected from the UNCOVER series of trials, including higher levels of clearance, (PASI 90, 100 and sPGA 0). The impact of psoriasis on patient's lives was assessed using patient reported outcome measures, including the DLQI. Across UNCOVER-1 and UNCOVER 2&3, 35.3 percent and 39 percent of patients, respectively achieved PASI 100 (clear skin) after 12 weeks of treatment with ixekizumab.iii

The approved dosing regimen for ixekizumab is a 160-mg starting dose by subcutaneous injection (two 80-mg injections) at Week 0, followed by 80 mg (one injection) every two weeks through 12 weeks, then maintenance dosing of 80 mg (one injection) every four weeks.iii

Lilly received a positive opinion from the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) on February 25, 2016.v

Safety information

The very common (≥1/10 patients) adverse events in clinical trials were injection site reactions and upper respiratory tract infections (most frequently nasopharyngitis).iii

About the UNCOVER Studies

The UNCOVER-1, UNCOVER-2 and UNCOVER-3 studies are double-blind, multicentre, Phase III studies evaluating more than 3,800 patients with moderate-to-severe plaque psoriasis from 21 countries.iii

All three studies evaluated the safety and efficacy of different dosing regimens of ixekizumab (80 mg every two or four weeks, following a 160-mg starting dose) compared to placebo after 12 weeks.iii

·       UNCOVER-2 and UNCOVER-3 included an additional comparator arm in which patients received etanercept (50 mg twice a week) for 12 weeks.iv

·       UNCOVER-1, UNCOVER-2 and UNCOVER-3 also evaluated response rates with ixekizumab during the maintenance period through 60 weeks, with UNCOVER-1 and UNCOVER-2 employing a randomized withdrawal design.iii,iv

·       In these studies, the co-primary efficacy endpoints at 12 weeks were Psoriasis Area Severity Index (PASI) 75 and static Physician’s Global Assessment (sPGA) 0 or 1.iiiPASI 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 Both assessment tools (PASI and sPGA) are in line with CHMP guidelines to assess the effectiveness of treatments for psoriasis.vii


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Medical and Biotech [MESH] Definitions

A common genetically determined, chronic, inflammatory skin disease characterized by rounded erythematous, dry, scaling patches. The lesions have a predilection for nails, scalp, genitalia, extensor surfaces, and the lumbosacral region. Accelerated epidermopoiesis is considered to be the fundamental pathologic feature in psoriasis.

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An oral retinoid used in the treatment of keratotic genodermatosis, lichen planus, and psoriasis. Beneficial effects have also been claimed in the prophylaxis of epithelial neoplasia. The compound may be teratogenic.

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