This site is only for UK healthcare professionals and contains promotional information.
Introducing Skilarence® (dimethyl fumarate)

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

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

Skilarence® was superior to placebo and non-inferior to Fumaderm® in PASI 75 at Week 16. The coprimary endpoints were the percentage of patients achieving ≥75% improvement in PASI 75 and the percentage achieving a score of ‘clear’ or ‘almost clear’ in PGA at Week 16.2

The BRIDGE study was a Phase III, double blind, placebo controlled, 16 week trial. Patients were randomised to dimethyl fumarate, Fumaderm® or Placebo (2:2:1) and titrated from week 1 to 9.2

Skilarence® was superior to placebo and non-inferior to Fumaderm® in PASI 75 at Week 16.2

Adapted from Mrowietz et al., 2016.2

Skilarence® demonstrated significant improvement in DLQI vs. placebo at Week 162

Skilarence® led to a 52% reduction in DLQI vs. baseline at Week 16 (absolute difference 5.9)2

Adapted from van de Kerkhof et al., 2016.3

Skilarence® dosing flexibility may help you to find a balance between clinical response and tolerability

How to start Skilarence®:1

  • It is recommended to begin treatment with a low initial dose with subsequent gradual increases1
  • If treatment success is observed before the maximum dose is reached, no further increase of dose is necessary1
  • If a particular dose increase is not tolerated, it may be temporarily reduced to the last tolerated dose.
  • After clinically relevant improvement of skin lesions has been achieved, consideration should be given to gradual reduction of the daily dose of Skilarence® to the maintenance dose required by the individual.1

Monitoring helps to detect and address potential Adverse Events

Before and during treatment, a complete blood count with differential and a urine test to monitor renal and hepatic function should be performed periodically. Treatment should be adjusted or discontinued whenever certain values are reached.1

Treatment should not be initiated if leukopenia (<3.0×109/L), lymphopenia (<1.0×109/L) or other pathological results are identified.1

Every 3

months

If lab results correspond toAction
Lymphocytes≥0.7×109 cells/L and
<1.0×109/L
Monthly monitoring
(until values ≥1.0×109 cells/L for 2 consecutive tests)
<0.7×109 cells/LStop treatment
if lab result is confirmed in second test continue monitoring until levels return to normal
Leukocytes<3.0×109 cells/LStop treatment
Marked decreaseCareful monitoring
Hepatic EnzymesIf clinically relevant changes occurConsider dose reduction or treatment discontinuation
Renal function
& Urine status

Most adverse reactions with Skilarence® were considered mild and did not lead to discontinuation of study treatment1

  • Persistant moderate or severe lymphopenia during treatment with dimethyl fumarate is considered a risk factor for progressive multifocal leukoencephalopathy.
  • At the time of writing, 15 published cases of progressive multifocal leukoencephalopathy have been linked to the use of FAEs in the treatment of psoriasis4,5

Skilarence® is backed by long-term FAE efficacy experience1

In the future study (a multicentre, retrospective database analysis of 984 patients on Fumaderm® from 163 centres in Germany)6:

  • 76.2% of patients continuously achieved markedly improved or clear skin after 12 months of Fumaderm® therapy (n=936)6
  • 80% of patients were markedly improved or clear at the end of the documentation timeframe (24 months or >36 months)6

Skilarence® is the only fumaric acid ester licensed for adults with moderate-to-severe psoriasis in the UK:

  • Skilarence® is effective and improves patients’ QoL vs. placebo3
  • Skilarence® safety profile is comparable to Fumaderm®2
  • Skilarence® is backed by long-term FAE efficacy experience6

Bring balance to your psoriasis patients with Skilarence®

References:

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1. Skilarence® Summary of Product Characteristics. Almirall.

2. Mrowietz U, Szepietowski JC, Loewe R, 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.

3. Van de Kerkhof P, Szepietowski J, Loewe R, et al. Treatment with LAS41008 (dimethyl fumarate) improves health-related quality of life and has a positive impact on the patient benefit index in adults with moderate-to-severe chronic plaque psoriasis: results of the BRIDGE study. E-poster: P1998. Presented at the European Academy of Dermatology and Venereology, Vienna, 28th September – 2nd October 2016.

4. Gieselbach R-J, Muller-Hansma AH, Wijburg MT, et al. Progressive multifocal leukoencephalopathy in patients treated with fumaric acid esters: a review of 19 cases. J Neurol 2017; 264(6): 1155–64.

5. Elsner P. Insufficient laboratory monitoring and progressive multifocal leukoencephalopathy on fumaric acid ester therapy for psoriasis. Journal der Deutschen Dermatologischen Gesellschaft = Journal of the German Society of Dermatology: JDDG. 2020;18(4):367–368.

6. 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.

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UK-IEDMF-2100002

March 2021

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