This site is only for UK healthcare professionals and contains promotional information.

Prescribing Information can be found at the bottom of this page.

Skilarence® is indicated for the treatment of moderate-to-severe plaque psoriasis in adults in need of systemic treatment.1

1. Skilarence® Summary of Product Characteristics. Almirall.

 Skilarence® information

See the clinical evidence, efficacy and safety profile, and more information on Skilarence®.

Product information 

Skilarence® is an oral treatment option for moderate-to-severe plaque psoriasis in adults in need of systemic treatment.1

Introducing Skilarence®

Here you will find the key information regarding Skilarence®, reviewing efficacy, posology, precautions for use and the long-term experience with other fumaric acid esters in psoriasis.

1. Skilarence® Summary of Product Characteristics. Almirall.

How to use Skilarence®

Review Skilarence® information that may be useful in your daily practice, including how to identify psoriasis patients who may benefit from this treatment.

Guidance for use

You will find more information detailing Skilarence® posology, precautions for use and the management of adverse events. This information will allow you to adapt the dose for each psoriasis patient according to their response to therapy and the occurrence of any side effects.

Patient support materials

Find information that can help you guide your psoriasis patients during treatment with Skilarence®, thus helping to maintain patient compliance.

Skilarence® patient website

psoderm.co.uk is a dedicated and exclusive website for patients that have been prescribed Skilarence®, where they can find detailed and useful information about Skilarence® that may help them during their treatment.

Learn more about fumarates

FAEs* are the most frequently prescribed first-line systemic therapy for moderate-to-severe plaque psoriasis in Germany, where they have been used for the last 20 years, 1,2 with overall treatment experience comprising more than 180,000 patient-years.3 

BADBIR reported in 2015 that 7.6% of patients receiving conventional systemic therapy were receiving FAEs.4

Mechanism of action 

The main activity of dimethyl fumarate (DMF) and its main metabolite monomethyl fumarate (MMF) has not been elucidated but is considered to be immunomodulatory and anti-inflammatory.6

DMF results in shift in T helper cells from Th1 and Th17 profile to Th2 phenotype and reduction of inflammatory cytokine production by inducing proapoptotic events, inhibition of keratinocytic proliferation and diminished inflammatory infiltrate within plaque. 6
 

The effect of DMF on dendritic cells is of central importance. Experimental studies show that DMF suppresses the production of proinflammatory cytokines such as IL-12 and IL-23 in dendritic cells by interaction with the intracellular glutathione system. This affects the central inflammatory processes underlying psoriasis and shifts the proinflammatory Th17 and Th1 immune responses into a Th2 profile.6,7

Efficacy of FAEs* for the long-term treatment of psoriais

FAEs have proven clinical efficacy in the long-term treatment of moderate-to-severe psoriasis. The FUTURE study was a multicentre, retrospective and cross-sectional study including 984 patients from 163 dermatology centres in Germany. It was designed to investigate the efficacy and safety of Fumaderm® for the long-term treatment of psoriasis. The results show that 76.2% of patients continuously achieved ‘markedly improved’ or ‘clear’ skin after 12 months of therapy. The majority of patients were able to continue treatment beyond 36 months. Among those, 83.6% had markedly improved or clear skin.8
In a retrospective database analysis study 80% of patients were markedly improved or clear at the end of the documentation timeframe (24 months or >36 months*)8
Adapted from Reich et. al. 20098

Global assessment of psoriasis severity at baseline performed using the five-step PGA categories: mild, moderate, moderate-to-severe, severe and very severe.

Long-term safety

Clinical studies have also been carried out on the long-term safety of fumaric acid esters (FAEs*) in patients with psoriasis. The adverse events present after long-term use of FAEs in a study with 66 patients were mostly mild, with the most prevalent being flushing, tiredness and gastrointestinal adverse events.9

A German registry observational study showed that the rate of serious adverse events (such as severe infections, malignancies, major adverse cardiac events and other severe cardiovascular events) with FAE* treatment did not differ from that with other systemic therapies for psoriasis in the long term.10 Other studies have reconfirmed the efficacy and good safety profile of FAEs in patients with psoriasis treated for long periods.11,12

References

1. Mrowietz U, Szepietowski JC, Loewe R, van de Kerkhof P, Lamarca R, Ocker WG, et al. Efficacy and safety of LAS41008 (dimethyl fumarate) in adults with moderate-to-severe chronic plaque psoriasis: a randomized, double-blind, Fumaderm® – and placebo-controlled trial (BRIDGE). Br J Dermatol. 2017;176(3):645-723. 2. Mrowietz U, Rostami-Yazdi M, Neureither M, Reich K. [15 years of fumaderm: fumaric acid esters for the systemic treatment of moderately severe and severe psoriasis vulgaris]. Journal der Deutschen Dermatologischen Gesellschaft = Journal of the German Society of Dermatology : JDDG. 2009;7 Suppl 2:S3-S16. 3. Ruggieri S, Tortorella C, Gasperini C. Pharmacology and clinical efficacy of dimethyl fumarate (BG-12) for treatment of relapsing-remitting multiple sclerosis. Ther Clin Risk Manag. 2014;10:229-239. 4. Iskandar IY, Ashcroft DM, Warren RB, Yiu ZZ, McElhone K, Lunt M, et al. Demographics and disease characteristics of patients with psoriasis enrolled in the British Association of Dermatologists Biologic Interventions Register. Br J Dermatol. 2015;173(2):510-8. 5. Nast A, Gisondi P, Ormerod AD, Saiag P, Smith C, Spuls PI, et al. European S3-Guidelines on the systemic treatment of psoriasis vulgaris–Update 2015–EDF in cooperation with EADV and IPC. European Dermatology Forum Guidelines [Online] 2015. 6. Skilarence® Summary of Product Characteristics. Almirall. 7. Ghoreschi K, Bruck J, Kellerer C, et al. Fumarates improve psoriasis and multiple sclerosis by inducing type II dendritic cells. J Exp Med. 2011;208(11):2291-2303. 8. Reich K, Thaci D, Mrowietz U, Kamps A, Neureither M, Luger T. Efficacy and safety of fumaric acid esters in the long-term treatment of psoriasis–a retrospective study (FUTURE). Journal der Deutschen Dermatologischen Gesellschaft = Journal of the German Society of Dermatology : JDDG. 2009;7(7):603-711. 9. Hoefnagel JJ, Thio HB, Willemze R, Bouwes Bavinck JN. Long-term safety aspects of systemic therapy with fumaric acid esters in severe psoriasis. Br J Dermatol. 2003;149(2):363-369. 10. Reich K, Mrowietz U, Radtke MA, Thaci D, Rustenbach SJ, Spehr C, et al. Drug safety of systemic treatments for psoriasis: results from The German Psoriasis Registry PsoBest. Arch Dermatol Res. 2015;307(10):875-883. 11. Brewer L, Rogers S. Fumaric acid esters in the management of severe psoriasis. Clin Exp Dermatol. 2007;32(3):246-249. 12. Harries MJ, Chalmers RJG, Griffiths CEM. Fumaric acid esters for severe psoriasis: a retrospective review of 58 cases. Br J Dermatol. 2005;153(3):549-551.
*These guidelines do not include Skilarence®. FAE used in study was Fumaderm®(DMF with 3 salts of MEF) not approved in the UK.

 

 

Job code: UK-IEDMF-2100002

March 2021

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