Taltz (ixekizumab)

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Taltz (ixekizumab)

How to buy Taltz: You can order Taltz (ixekizumab) via TheSocialMedwork if the drug has not been approved and/or is not available in the patient's country. TheSocialMedwork - helping patients and doctors access the latest approved medicines and at the lowest price possible worldwide.

Manufacturer Eli Lilly and Co.
Disease Psoriasis
Indication Plaque psoriasis
Mode of Action Humanised interleukin-17A antagonist
Approval Status EMA approved (EU); FDA approved (USA); TGA approved (AUS)
Strength 80 mg/mL

Who is ixekizumab for?

Taltz (ixekizumab) is indicated for the treatment of patients with moderate to severe plaque psoriasis [1]who are candidates for systemic therapy or phototherapy [2][3].

Recommended dose

Complete information about Taltz (ixekizumab) dosage and administration can be found here: [4][2][3].
The standard dosage is:
  • first dose of 160 mg (two injections)
  • for the first 12 weeks: an injection of 80 mg every 2 weeks
  • thereafter an injection of 80 mg every 4 weeks.
Instruction for the use of the prefilled syringe can be found here [5], whilst instructions for the use of the prefilled pen can be found here [6].

Consult your treating doctor for personalised dosing.

What is ixekizumab and how does it work?

Taltz (ixekizumab) is a monoclonal antibody used to treat adults with moderate to severe plaque psoriasis [1][2][3]

The active ingredient in Taltz, ixekizumab, is a humanised interleukin-17A antagonist [2]; a protein designed to attach to interleukin 17A, a messenger molecule in the immune system. Interleukin 17A is involved in immune system effects, including inflammation, that cause psoriasis. By attaching to interleukin 17A, ixekizumab blocks its action and reduces the activity of the immune system, thereby reducing the symptoms of psoriasis [1].

What is ixekizumab's approval status?

Ixekizumab was approved by:
  • FDA (USA) on March 22, 2016 [2]
  • EMA (EU) on May 2, 2016 [1]
  • TGA (AUS) on September 6, 2016 [3]
for the treatment of adults with moderate to severe plaque psoriasis.

The approvals were based on 3 main clinical trials (UNCOVER-1,2,3) involving 3,866 patients with psoriasis [2][3][4]. All 3 studies compared ixekizumab administered at a dosage of 80 mg (after an initial injection of 160 mg) every 2 (N = 1169) or every 4 weeks (N= 1165), with placebo (N= 792). Two trials compared ixekizumab also to etanercept (N = 740). The parameters used for the comparison were the static Physician Global Assessment (sPGA)  and the Psoriasis Area and Severity Index (PASI) [4][2]. The sPGA is a measure of the status of the psoriatic lesions of a patient (i.e., plaque thickness/induration, erythema, scaling) on a severity scale from 0 (=clear) to 5 (=severe) [5]. The PASI additionally to the severity of the lesions takes into account the body surface area covered with psoriatic lesions [7]. The results presented here are the average across the 3 studies, the complete results can be found here: [4][2].

After 12 weeks ixekizumab administered every 2 weeks resulted as superior in all the measured parameters to all other tested conditions. The sPGA was equal to 0 (=clear) or 1 (=almost clear) in 81.8 % of the patients treated with ixekizumab every 2 weeks and almost 40 % of these had clear skin (sPGA =1 in 39.7 % of the patients and 37.8 % had a reduction of 100 % in PASI). On the other hand the sPGA was equal to 0 or 1 in 74.9 % of the patients treated with ixekizumab every 4 weeks, 38.8 % of those treated with etanercept and 4.1 % in the placebo cohort [4]. Almost 89 % of those treated every two weeks with ixekizumab attained a 75 % reduction in the PASI after 12 weeks, which compares with 82.5 % of the patients on ixekizumab every 4 weeks, 47.5 % of patients on etanercept, and 4.5 % of those given placebo [4].

To evaluate the maintenance and durability of the response, two studies continued for an additional 48 weeks in patients who at week 12 had responded to ixekizumab (both those on the biweekly plan and those on the monthly plan). These patients were randomly assigned to a maintenance dosage of ixekizumab every 4 weeks or to placebo. The best results were obtained in patients who took ixekizumab every 2 weeks for the first 12 weeks and every 4 weeks for the following 48 weeks. In this cohort, 78.3 % of the patients maintained a sPGA of 0 or 1, and about 58 % of these had maintained or achieved clear skin (sPGA = 0 in 58.8 % and 100 % reduction in PASI in 57.5 %). On the other hand, only about 7 % of the initial responders that switched to placebo had a sPGA of 0 or 1 [4], meaning that most of them relapsed after interruption of the treatment with ixekizumab.

The most common side effects are pain and redness at the injection site, and nose, throat or chest infections. It must not be given to patients who have potentially serious infections such as tuberculosis [1].
References
[1] EMA. Human Medicines: Taltx (ixekizumab), 02/05/2016 (last update: 15/12/2016), cited on 16/03/2017.
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003943/human_med_001977.jsp&mid=WC0b01ac058001d124
[2] Summary of Product Characteristics [FDA]: Taltz (ixekizumab), Eli Lilly and Co., Mar. 2016.
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125521s000lbl.pdf
[3] Summary of Product Characteristics [TGA]: Taltz (ixekizumab), Eli Lilly Australia Pty. Ltd., Apr. 2017.
https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2016-PI-02453-1&d=2017031316114622483
[4] Summary of Product Characteristics [EMA]: Taltz (ixekizumab), Eli Lilly Nederland B.V., Dec. 2016.
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/003943/WC500205804.pdf
[5] Instructions for use: Taltz (ixekizumab) prefilled syringe. Mar. 2016.
http://pi.lilly.com/us/taltz-pfs-us-ifu.pdf
[6] Instructions for use: Taltz (ixekizumab) prefilled pen
https://www.medicines.org.uk/emc/PIL.32045.latest.pdf
[7] Chow C., et al. Comparison of three methods for measuring psoriasis severity in clinical studies (Part 1 of 2): change during therapy in Psoriasis Area and Severity Index, Static Physician's Global Assessment and Lattice System Physician's Global Assessment. J Eur Acad Dermatol Venereol. 2015 Jul.; 29 (7):1406–1414.
http://onlinelibrary.wiley.com/wol1/doi/10.1111/jdv.13132/full









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