Oral Dimethyl Fumarate’s Effect on Psoriasis Patients Meeting Upgrade Criteria

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Oral dimethyl fumarate (DMF) treatment may lead to significant improvements in the upgrade criteria for moderate-to-severe psoriasis classification, according to recent findings, even when it is discontinued prior to the 52-week mark.¹

These findings and others were the result of new research led by Sascha Gerdes, of the University Medical Center Schleswig-Holstein Campus Kiel Psoriasis Center in Kiel, Germany. The investigators sought to assess quality of life (QoL), effectiveness, and tolerability of DMF during routine clinical practice in a patient population with plaque psoriasis meeting the upgrade criteria for moderate-to-severe disease.

This is related to the fact that consideration of systemic treatment has been established within certain national guidelines for individuals with mild somatic plaque psoriasis.²

“While inclusion into the SKILL study was restricted to patients with moderate-to-severe disease, the present study evaluated the effect of (dimethyl fumarate) on patients with a low BSA/PASI but with moderate-to-severe plaque psoriasis due to the presence of upgrade criteria,” Gerdes and colleagues wrote.¹

Background and Design

The study was titled UPSKIL and had a prospective, non-interventional, open-label, observational trial design. The research team conducted their work in Germany from July 2019 - February 2022, with each participant being observed by the team for a total of 52 weeks and assessments carried out at the point by baseline and then at the 3, 6, 9, and 12-month marks.

Subjects were given permission to exit the study at any point for any given reason. The investigators adhered to the ICH-GCP guidelines whenever it was feasible. There were not any additional therapeutic or diagnostic measures needed beyond what was already required.

The study included adult patients who had recorded diagnoses of psoriasis, with Psoriasis Area and Severity Index (PASI) and body surface area (BSA) values of 10 or less. These individuals would be qualified for moderate-to-severe disease and were selected by dermatologists in either practice-based or hospital-based settings if therapy with dimethyl fumarate was highlighted as an indication.

The move to use DMF for treatment was made independently of the team’s research. Previous fumaric acid esters utilization, any contraindications or warnings covered within the dimethyl fumarate’s summary of characteristics, and insufficient treatment response as determined by clinicians, were exclusion criteria used by the investigators.

The research team decided upon selection and treatment regimens, including duration and dose of dimethyl fumarate, through the participating investigators in line with the aforementioned summary of characteristics. Given their research’s non-interventional nature, there were no restrictions on concomitant medications.

BSA, PASI, DLQI, Physician's Global Assessment (PGA) using a 5-point scale, and the Itchy Quality of Life (ItchyQoL) questionnaire at the point of baseline and at the 12, 24, 36, and 52-week marks were all used in the team’s assessments.

Findings

Overall, there were 180 participants and there was an average age among these subjects of 43.4 years, with 60.3% being identified as male. The investigators found that 86.1% of the participants were shown to have visible area involvement, 81.1% had itch which led to scratching, 83.9% had single recalcitrant plaques, and 71.1% were shown to have major scalp involvement.

The research team reported that, after using the last observation carried forward method, their finding that the proportion of subjects with PASI scores below 3 had risen from 7.9% at the initiation of the research to 55.3% by the 52-week mark. Additionally, the proportion of subjects reporting a DLQI score of 5 or less was found to have grown from 17.4% up to 52.1%.

The team added that PGA score improvements had been visible across all of the included subgroups. They noted that an increasing number of individuals with a PGA score of 0 or 1 had been reported, suggesting skin which was clear or almost clear.

The investigators concluded that a total of 51.2% of the study subjects were found to have experienced at least a single adverse drug reaction.

“Taken together, the real-world data collected in this non-interventional study provided additional insights on patients receiving (dimethyl fumarate) due to upgrade criteria,” they wrote. “While patients showed low PASI values at baseline, they still suffered greatly from highly impaired quality of life. Treatment with (dimethyl fumarate) led to relevant improvement of all upgrade criteria, even when discontinued before Week 52, and was mostly well tolerated.”

References

1. ^{Gerdes S, Ghazal PA, Diemert S, Termeer C. Effect of dimethyl fumarate in patients with plaque psoriasis meeting the upgrade criteria required for moderate-to-severe disease classification. JEADV Clin Pract. 2024; 1–11. https://doi.org/10.1002/jvc2.504.}
2. ^{Nast A, Altenburg A, Augustin M, Boehncke WH, Härle P, Klaus J, et al. German S3-guideline on the treatment of psoriasis vulgaris, adapted from EuroGuiDerm—part 1: treatment goals and treatment recommendations. J Deutsch Dermatol Ges. 2021; 19(6):934-150. https://doi.org/10.1111/ddg.14508}