Taltz (ixekizumab)

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Taltz (ixekizumab)

Taltz (ixekizumab) is a medication used for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis.

How to buy Taltz (ixekizumab): You can order Taltz (ixekizumab) from TheSocialMedwork if the drug has not been approved or is not available in your country.

Dermatology Psoriasis
Marketing Authorisation Holder Eli Lilly Nederland B.V.
Mode of Action Humanised interleukin-17A antagonist
Administration subcutaneous
Regulatory agency approval European Medical Agency (EMA), European Union, Food and Drug Administration (FDA), USA, Therapeutic Goods Administration (TGA), Australia
Strength 80 milligram

What is Taltz (ixekizumab) for?

Taltz (ixekizumab) is a monoclonal antibody indicated for the treatment of people with:

  • moderate to severe plaque psoriasis2,3,4 who are candidates for systemic therapy2,3,4 or phototherapy2,3

  • Active psoriatic arthritis2,4 in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drug (DMARD) therapies4.

How does Taltz (ixekizumab) work?

The active ingredient in Taltz, ixekizumab, is a humanised interleukin-17A antagonist2; 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 psoriasis1 and psoriatic arthritis. By attaching to interleukin 17A, ixekizumab blocks its action and reduces the activity of the immune system, thereby reducing the symptoms of psoriasis1 and psoriatic arthritis.

Where has Taltz (ixekizumab) been approved?

Taltz (ixekizumab) was approved by:

  • Food and Drug Administration (FDA), USA:

    • March 22, 2016, for plaque psoriasis2

    • December 1, 2017, for psoriatic arthritis8

  • European Medical Agency (EMA), European Union:

    • May 2, 2016, for plaque psoriasis1

    • January 11, 2018, for psoriatic arthritis1

  • Therapeutic Goods Administration (TGA), Australia, September 6, 2016, for plaque psoriasis3

Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.

How is Taltz (ixekizumab) taken?

The standard dosage for plaque psoriasis is:

  • first dose of 160 mg (two subcutaneous injections)

  • for the first 12 weeks: a subcutaneous injection of 80 mg every 2 weeks

  • thereafter a subcutaneous injection of 80 mg every 4 weeks.

The standard dosage for psoriatic arthritis is:

  • first dose of 160 mg (two subcutaneous injections)

  • thereafter a subcutaneous injection of 80 mg every 4 weeks.

Taltz (ixekizumab) is provided as a prefilled syringe or a prefilled pen. Instruction for the use of the prefilled syringe and the prefilled pen can be found in our resources section5,6.

Complete information about Taltz (ixekizumab) dosage and administration can be found in the official prescribing information listed in our resources section2,3,4.

Please consult with your treating doctor for personalised dosing.

Are there any known side effects of Taltz (ixekizumab)?

Common side effects

The most common side effects listed in the prescribing information include2,3,4:

  • injection site reactions

  • upper respiratory tract infections

  • nausea (feeling sick)

  • tinea infections (superficial fungal infection of the skin)

Serious side effects

The serious side effects listed in the prescribing information include2,3,4:

  • serious infections

  • hypersensitivity (serious allergic reaction)

  • inflammatory Bowel Disease

Use in a specific population

Taltz (ixekizumab) must not be given to patients with active tuberculosis (TB). Anti-TB therapy should be considered in patients with latent TB prior to initiation of treatment.

There is a limited knowledge about the use of ixekizumab in pregnant women. As a precautionary measure, it is preferable to avoid the use of Taltz during pregnancy and use of effective contraception during treatment and for at least 10 weeks after treatment is recommended.

Breast-feeding should be avoided during treatment.

For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information2,3,4.

More Information
Working ingredient ixekizumab
Shipping method Cold chain (temperature controlled)
Therapeutic Area Dermatology
Dermatology Psoriasis
Indication Plaque psoriasis
Administration subcutaneous
Mode of Action Humanised interleukin-17A antagonist
Regulatory agency approval European Medical Agency (EMA), European Union, Food and Drug Administration (FDA), USA, Therapeutic Goods Administration (TGA), Australia
Marketing Authorisation Holder Eli Lilly Nederland B.V.

Plaque psoriasis

The Food and Drug Administration (FDA), USA, European Medical Agency (EMA), European Union, and Therapeutic Goods Administration (TGA), Australia, approvals of Taltz (ixekizumab) for plaque psoriasis were based on 3 double-blind trials that tested Taltz (ixekizumab) against placebo and an active comparator (UNCOVER-1,2,3). These studies involved a total of 3,866 patients with moderate to severe plaque psoriasis who were candidates for phototherapy or systemic therapy2,3,4.

Results

The major efficacy outcome measures were the static Physician Global Assessment (sPGA) and the Psoriasis Area and Severity Index (PASI)2,4.

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 lesions7.

The results presented here are the average across the 3 studies, the complete results can be found in our resources section2,4. After 12 weeks Taltz (ixekizumab) administered every 2 weeks resulted as superior in all the measured parameters to all other tested conditions.

The sPGA after 12 weeks was:

  • sPGA =0 (=clear) or 1 (=almost clear) in 81.8% of patients treated with Taltz (ixekizumab) every 2 weeks4
  • sPGA =1 in 39.7% of the patients4
  • sPGA =0 or 1 in 
    • 74.9% of the patients treated with Taltz (ixekizumab) every 4 weeks
    • 38.8% of those treated with etanercept 
    • 4.1 % in the placebo cohort4.

The PASI after 12 weeks was:

  • reduced by 100% in 37.8% of patients treated with Taltz (ixekizumab)every 2 weeks4
  • reduced by 75% in4:
    • almost 89% of those treated every 2 weeks with Taltz (ixekizumab)
    • 82.5% of the patients on Taltz (ixekizumab) every 4 weeks
    • 47.5% of patients on etanercept
    • 4.5% of those given placebo.

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 Taltz (ixekizumab) (both those on the biweekly plan and those on the monthly plan). These patients were randomly assigned to a maintenance dosage of Taltz (ixekizumab) every 4 weeks or to placebo. The best results were obtained in patients who took Taltz (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 14, meaning that most of them relapsed after interruption of the treatment with Taltz (ixekizumab).

Psoriatic arthritis

The Food and Drug Administration (FDA), USA, and European Medical Agency (EMA), European Union, approvals of Taltz (ixekizumab) for psoriatic arthritis were based on 2 placebo-controlled studies (SPIRIT-P1/PsA1 and SPIRIT -P2/PsA2). These studies involved a total of 780 patients with active psoriatic arthritis2,4.

Results

The major efficacy outcomes were the ACR 20, 50 and 70. In both studies, patients treated with Taltz (ixekizumab) 80 mg demonstrated a greater clinical response compared to placebo at Week 242,4.

An important measure in patients with rheumatoid arthritis is the ACR 20, 50 or 70 which is a criteria to measure the improvement of patients of 20%, 50% or 70% based on measures as swollen joint count, tender joint count, patient assessment of global status, acute phase reactant (dramatic increase in hepatic synthesis of plasma proteins which accompanies acute phases of tissue injury and inflammation), health professional assessment of global status, physical function, and pain9.

The ACR20 response at week 24 was2,4:

  • 58% with Taltz every 4 weeks vs. 30% with placebo in study SPIRIT-P1/PsA1

    • Difference from placebo 28% [95% CI: 15, 41].

  • 53% with Taltz every 4 weeks vs. 20% with placebo in study SPIRIT-P2/PsA2

    • Difference from placebo 34% [95% CI: 22, 45].

The ACR50 response at week 24 was2,4:

  • 40% with Taltz every 4 weeks vs. 15% with placebo in study SPIRIT-P1/PsA1

    • Difference from placebo 25% [95% CI: 14, 37].

  • 35% with Taltz every 4 weeks vs. 5% with placebo in study SPIRIT-P2/PsA2

    • Difference from placebo 30% [95% CI: 21, 40].

The ACR70 response at week 24 was2,4:

  • 23% with Taltz every 4 weeks vs. 6% with placebo in study SPIRIT-P1/PsA1

    • Difference from placebo 18% [95% CI: 9, 27].

  • 22% with Taltz every 4 weeks vs. 0% with placebo in study SPIRIT-P2/PsA2

    • Difference from placebo 22% [95% CI: 15, 30].

1. EMA. Human Medicines: Taltz (ixekizumab)
    cited March 2017 

2. Summary of Product Characteristics [FDA]: Taltz (ixekizumab) [PDF]
    Eli Lilly and Co., Dec. 2017.

3. Summary of Product Characteristics [TGA]: Taltz (ixekizumab) [PDF]
    Eli Lilly Australia Pty. Ltd., Apr. 2017.

4. Summary of Product Characteristics [EMA]: Taltz (ixekizumab), [PDF]
    Eli Lilly Nederland B.V., Feb. 2018.

5. Instructions for use: Taltz (ixekizumab) prefilled syringe [PDF]

6. Instructions for use: Taltz (ixekizumab) prefilled pen [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.

8. Drugs@FDA: FDA Approved Drug Products: Taltz (ixekizumab)
    cited on 16/02/2018

9. Pincus T. The American College of Rheumatology (ACR) Core Data Set and derivative “patient only” indices to assess rheumatoid arthritis
    Clin Exp Rheumatol 2005; 23(39):109–113. 


Shipping Type Cold Chain
Shipping method Cold chain (temperature controlled)
Dynamic Weight No
This content has been reviewed by our medical doctor Jan de Witt.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Medicine information contained herein may be time sensitive. The absence of a warning for a given medicine or combination thereof in no way should be construed to indicate that the medicine or combination is safe, effective or appropriate for any given patient. Always consult your treating physician before starting a course of treatment.