Secukinumab

Author: Prof. Dr. med. Peter Altmeyer

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Last updated on: 29.10.2020

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Definition
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Secukinumab is a fully humanized monoclonal antibody against the cytokine IL-17A (see interleukins below), which is overexpressed in the pathogenesis of psoriatic inflammation (see psoriasis below) and plays a central role (see Th17 cell). The active ingredient is used in the treatment of various rheumatological diseases - also in psoriatic arthritis. The antibody secukinumab (AIN457) selectively binds to IL-17 and neutralises this cytokine.

Field of application/use
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Secukinumab was approved by the European Medicines Agency (EMA) in January 2015 for the primary systemic treatment of moderate to severe plaque psoriasis in adult patients requiring systemic treatment. An expanded indication for psoriatic arthritis and ankylosing spondylitis (ankylosing spondylitis) followed in 2016.

Secukinumab has been shown to be successful in several large studies in the treatment of psoriasis. In the ERASURE1 trial, 738 patients with moderate to severe psoriasis received either 300 or 150 mg of secukinumab or placebo subcutaneously at weeks 1, 2, 3, 4 and 8. 81.6 percent (300 mg) and 71.6 percent (150 mg) of secukinumab patients respectively at week 12 met the PASI 75 criteria, but only 4.5 percent of control patients met the PASI 75 criteria. 65.3 vs. 51.2 vs. 2.4% of the participants were clinically largely free of symptoms, > 40% of the study participants achieved PASI-100 (complete clinical freedom of appearance). The effect of secukinumab peaked after 16 weeks and remained constant until week 52.

A follow-up study (A2304E1) to the pivotal SCULPTURE study, which included a treatment period of 260 weeks, demonstrated that the initial response rate (69% PASI-90 response) was maintained during this 5-year observation period.

Complication(s)
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Side effects observed with Secukinumab include nasopharyngitis, upper respiratory tract infections and headaches. Also herpes simplex labialis, oral candidiasis, urticarial exanthema, dyslipidemia (increase in cholesterol/triglycerides) and headaches. In rare cases (1-2% of patients) a (transient) neutropenia may occur (Altenburg A et al. 2018).

Dosage and method of use
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The recommended dose is 300 mg by subcutaneous injection. Each 300 mg dose is administered in the form of two injections of 150 mg each. After the first dose, further weekly injections are initially given in weeks 1, 2 and 3, and from week 4 onwards the injections are given at monthly intervals. The total dose injected is always divided into 2 single doses of 150 mg each.

Preparations
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Cosentyx®

Note(s)
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Secukinumab has been approved by Novartis for the treatment of psoriasis under the trade name Cosentyx® since mid-2015.

Good therapeutic successes have been described in psoriasis capitis (which is very difficult to treat topically) (Bagel J et al. 2017)

Literature
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  1. Adami S (2014) The Role of Interleukin-17A in Psoriatic Disease. BioDrugs 28:487-497
  2. Altenburg A et al (2018) Biologic side effects in psoriasis. Dermatologist 69: 290-297
  3. Bagel J et al (2017) The effect of secukinumab on moderate to severe scalp psoriasis: Results of a24-week
    , randomized, double-blind, placebo-controlled phase 3b study. J Am Acad Dermatol 77:667-674.
  4. Blauvelt A et al (2014) the FEATURE Study Group. Secukinumab administration by pre-filled syringe: efficacy, safety and usability results from a randomized controlled trial in psoriasis (FEATURE). Br J Dermatol 172: 484-492.
  5. Böhner A et al (2016) Acute Generalized Pustular Psoriasis Treated With the IL-17A Antibody Secukinumab. JAMA Dermatol 152:482-484.
  6. Chiricozzi A (2014) Pathogenic role of IL-17 in psoriasis and psoriatic arthritis Actas Dermosifiliogr 105 Suppl 1:9-20
  7. Lønnberg AS et al (2014) Targeting of interleukin-17 in the treatment of psoriasis. Clin Cosmet Invest Dermatol 15:251-259
  8. Ohtsuki M et al (2014) ERASURE Study Japanese subgroup. Secukinumab efficacy and safety in Japanese patients with moderate to severe plaque psoriasis: Subanalysis from ERASURE, a randomized, placebo-controlled, phase 3 study. J Dermatol 41:1039-1046
  9. Paul C et al (2014) the JUNCTURE study group. Efficacy, safety and usability of secukinumab administration by autoinjector/pen in psoriasis: a randomized, controlled trial (JUNCTURE). J Eur Acad Dermatol Venereol doi:10.1111/jdv.12751.
  10. Sobell JM et al (2014) Therapeutic development in psoriasis. Seminar Cutan Med Surg 33 (4 Suppl): 69-72

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Last updated on: 29.10.2020