Skilarence (dimethyl fumarate) / Almirall - LARVOL DELTA

Protein profile following therapy with DMF in patients with plaque psoriasis (ESDR 2024) - "Th1 and Th17 related cytokines secreting cytotoxic type 17 CD8 T cells have been discovered that (Ortega et al 2009), CD5+T cells produce both IL17 and TNFa in psoriasis (Zhou et al 2022) and Itolizumab, targeting distal domain of CD6 has been clinically successful in patients who did not respond to any other therapy (Dogra et al 2020). Genes identified in this proteomics analysis may help us understand the mechanism of action of DMF in psoriasis patients. Grant reference: Almirall."

Clinical • Dermatology • Immunology • Psoriasis • CD5 • CD8 • IL10 • IL17A • IL3 • IL4 • TNFA

Dimethyl Fumarate in Adrenomyeloneuropathy (clinicaltrials.gov) - P2/3 | N=40 | Recruiting | Sponsor: Pujol, Aurora, M.D.

New P2/3 trial • Pain

Dimethyl Fumarate in Psoriasis (EADV 2023) - "CD2 is reported to stimulate Naïve T cells via keratinocytes (Orlik et al., 2020) and is a target for a biologic (Alefacept), which reduces infiltrating T cells while activating dendritic cells and inflammatory genes (Chamian et al., 2005)... Gene expression changes significantly from baseline by week 4 in patients taking DMF, with pathways relevant to the pathogenesis of psoriasis being dis-regulated. Preliminary data also indicate patients who achieve a higher level of response may have reduced CXCR3 at week 24 although this will require validation. Future analysis will be able to compare these signals in skin and blood and perform a multiomic assessment of response layering in analyses of DNA and the proteome."

IO biomarker • Dermatology • Immunology • Oncology • Psoriasis • CCL23 • CD2 • CXCR3 • GZMK • IDO1 • KIF5C • PI3K • STAT3 • TFF3

Efficacy and Safety of Dimethyl Fumarate in Patients with Moderate-to-Severe Plaque Psoriasis: Results from a 52-Week Open-Label Phase IV Clinical Trial (DIMESKIN 1). (PubMed, Dermatol Ther (Heidelb)) - "DMF significantly improves main severity and extension indexes and rates, as well as patient-reported outcomes such as pruritus and quality of life in patients with moderate-to-severe psoriasis after 24 weeks of treatment. These improvements are sustained through 52 weeks. The safety profile of DMF is similar to that previously described for fumarates."

Journal • P4 data • Dermatology • Gastroenterology • Gastrointestinal Disorder • Immunology • Pain • Pruritus • Psoriasis

Management of Nail Disease in Patients With Psoriatic Arthritis: An Updated Literature Review Informing the 2021 GRAPPA Treatment Recommendations. (PubMed, J Rheumatol) - "The highest strength of supporting evidence is for the recommendation of biologic agents including tumor necrosis factor inhibitors, and interleukin 12/23, 17, and 23 inhibitors."

Journal • Review • Dermatology • Immunology • Inflammatory Arthritis • Oncology • Psoriasis • Psoriatic Arthritis • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies • IL12A

Response to fumaric acid esters for plaque type psoriasis in real-world practice is largely independent of patient characteristics at baseline - a multivariable regression analysis from the German psoriasis registry PsoBest. (PubMed, J Dermatolog Treat) - "Neither sex, age, body weight, disease duration, comorbidity nor pre-treatment had an impact on the odds of response (p > 0.05). FAEs showed a favorable response at 12 months, largely independent of patient characteristics."

Journal • Real-world evidence • Dermatology • Immunology • Psoriasis

Long-Term Treatment with Dimethyl Fumarate for Plaque Psoriasis in Routine Practice: Good Overall Effectiveness and Positive Effect on Impactful Areas. (PubMed, Dermatol Ther (Heidelb)) - "Long-term treatment with DMF in routine practice showed good overall effectiveness and safety, and a positive effect on plaque-psoriasis-affected impactful areas."

Journal • Dermatology • Immunology • Pruritus • Psoriasis

"Absoluut niet. Ik bestelde enkele jaren achtereen via #deMagistraleBereider in Oud-Beijerland maar ik moest overstappen op #Skilarence, vermoedelijk omdat ik niet bij die apotheek ingeschreven stond oid." (@_Jet_NL)

Efficacy of dimethyl fumarate in Real-World Practice in Patients with Plaque Psoriasis Whose Disease Severity was upgraded on upgrade Criteria: Interim Analysis of the Upskil Study at Week 24 (FOBI 2022) - "88 patients were included in this analysis, 41 had discontinued the treatment prematurely, mainly due to intolerance. The Patient (60.9% Male) had an average Age of 43.1 Years and a body mass index [BMI] of 28.0 KG/M Despite a Comparativeely Low Pasi in BL, The Patients Suffered From A Severely Restricted Quality of Life. In this analysis, dmf what effective in Treating patients with plaque psoriasis whose disease severity was upgraded based on upgrade criteria."

Clinical • Real-world evidence • Dermatology • Immunology • Psoriasis

Efficacy of dimethyl fumarate in Real-World Practice in Patients with Plaque Psoriasis Whose Disease Severity was upgraded on upgrade Criteria: Interim Analysis of the Upskil Study at Week 24 (FOBI 2022) - "88 patients were included in this analysis, 41 had discontinued the treatment prematurely, mainly due to intolerance. The Patient (60.9% Male) had an average Age of 43.1 Years and a body mass index [BMI] of 28.0 KG/M Despite a Comparativeely Low Pasi in BL, The Patients Suffered From A Severely Restricted Quality of Life. In this analysis, dmf what effective in Treating patients with plaque psoriasis whose disease severity was upgraded based on upgrade criteria."

Clinical • Real-world evidence • Dermatology • Immunology • Psoriasis

Efficacy of dimethyl fumarate in Real-World Practice in Patients with Plaque Psoriasis Whose Disease Severity was upgraded on upgrade Criteria: Interim Analysis of the Upskil Study at Week 24 (FOBI 2022) - "88 patients were included in this analysis, 41 had discontinued the treatment prematurely, mainly due to intolerance. The Patient (60.9% Male) had an average Age of 43.1 Years and a body mass index [BMI] of 28.0 KG/M Despite a Comparativeely Low Pasi in BL, The Patients Suffered From A Severely Restricted Quality of Life. In this analysis, dmf what effective in Treating patients with plaque psoriasis whose disease severity was upgraded based on upgrade criteria."

Clinical • Real-world evidence • Dermatology • Immunology • Psoriasis

Efficacy of dimethyl fumarate in Real-World Practice in Patients with Plaque Psoriasis Whose Disease Severity was upgraded on upgrade Criteria: Interim Analysis of the Upskil Study at Week 24 (FOBI 2022) - "88 patients were included in this analysis, 41 had discontinued the treatment prematurely, mainly due to intolerance. The Patient (60.9% Male) had an average Age of 43.1 Years and a body mass index [BMI] of 28.0 KG/M Despite a Comparativeely Low Pasi in BL, The Patients Suffered From A Severely Restricted Quality of Life. In this analysis, dmf what effective in Treating patients with plaque psoriasis whose disease severity was upgraded based on upgrade criteria."

Clinical • Real-world evidence • Dermatology • Immunology • Psoriasis

TRANSITION: Efficacy and Safety of Tildrakizumab in Participants With Moderate-to-Severe Chronic Plaque Psoriasis Who Are Non-Responders to Dimethyl Fumarate Therapy (clinicaltrials.gov) - P4 | N=190 | Completed | Sponsor: Almirall, S.A. | Active, not recruiting ➔ Completed

Trial completion • Dermatology • Immunology • Psoriasis

Introducing a simplified titration scheme for dimethylfumarate (DMF) in patients with moderate-to-severe psoriasis: a case series. (PubMed, J Dermatolog Treat) - "In this case series, simplified DMF dosing was largely well-tolerated and provided similar efficacy to the current scheme. Higher doses were reached more quickly and the dosing regimen was simpler for patients (twice instead of three times daily)."

Clinical • Journal • Dermatology • Gastrointestinal Disorder • Immunology • Psoriasis

[VIRTUAL] GENOME-WIDE CRISPR/CAS9 KNOCKOUT SCREENING FOR THE IDENTIFICATION OF CRITICAL RESISTANCE DRIVERS IN DIMETHYL FUMARATE TREATED TUMORS (UEGW 2021) - "Introduction: Dimethyl fumarate (DMF), known as Skilarence® in Psoriasis treatment and Tecfidera in treatment of multibles sklerosis, has been shown to induce cell death in NF-kB-dependent T cell lines and primary T-cell lymphoma. CRISPR/Cas9-based knockout screening is a promising tool to identify genetic influences in drug treatment. Our experimental procedure was capable to generate a stable Cas9-expressing cell line. Furthermore, we were able to create high quality sequence data, which are expected to provide valid screening results to reveal potential driver genes in DMF resistance."

Colorectal Cancer • Dermatology • Gastrointestinal Cancer • Hematological Malignancies • Immunology • Lymphoma • Oncology • Psoriasis • Solid Tumor • T Cell Non-Hodgkin Lymphoma • FAS

[VIRTUAL] GENOME-WIDE CRISPR/CAS9 KNOCKOUT SCREENING FOR THE IDENTIFICATION OF CRITICAL RESISTANCE DRIVERS IN DIMETHYL FUMARATE TREATED TUMORS (UEGW 2021) - "Introduction: Dimethyl fumarate (DMF), known as Skilarence® in Psoriasis treatment and Tecfidera in treatment of multibles sklerosis, has been shown to induce cell death in NF-kB-dependent T cell lines and primary T-cell lymphoma. CRISPR/Cas9-based knockout screening is a promising tool to identify genetic influences in drug treatment. Our experimental procedure was capable to generate a stable Cas9-expressing cell line. Furthermore, we were able to create high quality sequence data, which are expected to provide valid screening results to reveal potential driver genes in DMF resistance."

Colorectal Cancer • Dermatology • Gastrointestinal Cancer • Hematological Malignancies • Immunology • Lymphoma • Oncology • Psoriasis • Solid Tumor • T Cell Non-Hodgkin Lymphoma • FAS

[VIRTUAL] GENOME-WIDE CRISPR/CAS9 KNOCKOUT SCREENING FOR THE IDENTIFICATION OF CRITICAL RESISTANCE DRIVERS IN DIMETHYL FUMARATE TREATED TUMORS (UEGW 2021) - "Introduction: Dimethyl fumarate (DMF), known as Skilarence® in Psoriasis treatment and Tecfidera in treatment of multibles sklerosis, has been shown to induce cell death in NF-kB-dependent T cell lines and primary T-cell lymphoma. CRISPR/Cas9-based knockout screening is a promising tool to identify genetic influences in drug treatment. Our experimental procedure was capable to generate a stable Cas9-expressing cell line. Furthermore, we were able to create high quality sequence data, which are expected to provide valid screening results to reveal potential driver genes in DMF resistance."

Colorectal Cancer • Dermatology • Gastrointestinal Cancer • Hematological Malignancies • Immunology • Lymphoma • Oncology • Psoriasis • Solid Tumor • T Cell Non-Hodgkin Lymphoma • FAS

Dimethyl fumarate treatment for psoriasis in a real-life setting: a multicentric retrospective study. (PubMed, Dermatol Ther) - "Our study shows the peculiarities of DMF in a real-world setting: effectiveness is often reached after 12 weeks of treatment and side effects could limit the continuation of the therapy but, at the same time, DMF has no major contraindications and, due to the wide range of dosage, it can allow both to manage side effects and to personalize the prescription for each patient."

Journal • Retrospective data • Dermatology • Immunology • Oncology • Psoriasis

Efficacy of dimethyl fumarate treatment for moderate-to-severe plaque psoriasis: presentation extracts from the 29 EADV virtual congress, 29-31 October 2020. (PubMed, Expert Rev Clin Immunol) - "The safety profile of DMF was similar to the previously described with fumaric acid esters. In summary, these results confirm the favorable efficacy and safety profile of DMF in long-term treatment."

Clinical • Journal • Dermatology • Immunology • Pruritus • Psoriasis

TRANSITION: Efficacy and Safety of Tildrakizumab in Participants With Moderate-to-Severe Chronic Plaque Psoriasis Who Are Non-Responders to Dimethyl Fumarate Therapy (clinicaltrials.gov) - P4; N=190; Active, not recruiting; Sponsor: Almirall, S.A.; Recruiting ➔ Active, not recruiting; Trial completion date: Feb 2021 ➔ Feb 2022; Trial primary completion date: Feb 2021 ➔ Feb 2022

Clinical • Enrollment closed • Trial completion date • Trial primary completion date • Dermatology • Immunology • Psoriasis

[VIRTUAL] Dimethyl Fumarate for the Treatment of First-LINE Moderate-to-Severe Plaque Psoriasis in Italy- A Budget-IMPACT Analysis (ISPOR-EU 2020) - "OBJECTIVES : Dimethyl fumarate (DMF, Skilarence®) is an oral formulation recommended for the first-line treatment of moderate-to-severe plaque psoriasis in adults in need of systemic medicinal therapy. The purpose of this study was to assess the budget impact of DMF in comparison with other commonly prescribed first-line therapies (methotrexate and cyclosporine) for the treatment of moderate-to-severe plaque psoriasis in Italy...After first-line treatment, patients were assumed to switch to second-line treatment (including apremilast and biologics) until the end of the time horizon...Cost savings were due to patients longer survival on DMF treatment and the consequent delay in initiation of second-line treatment. CONCLUSIONS : Results from this study indicate DMF generates significant savings as first-line treatment for patients with moderate-to-severe plaque psoriasis, due to the delay in use of second-line therapies given fumaric acid derivatives favorable stay on..."

Clinical • HEOR • Dermatology • Immunology • Psoriasis

TRANSITION: Efficacy and Safety of Tildrakizumab in Participants With Moderate-to-Severe Chronic Plaque Psoriasis Who Are Non-Responders to Dimethyl Fumarate Therapy (clinicaltrials.gov) - P4; N=250; Recruiting; Sponsor: Almirall, S.A.; Active, not recruiting ➔ Recruiting

Clinical • Enrollment open • Dermatology • Immunology • Psoriasis

[VIRTUAL] Outcomes of patients with psoriasis following fumaric acid ester switch from Fumaderm® to Skilarence®: a multicentre study (BAD 2020) - "Most common conventional treatments trialled were methotrexate and ciclosporin...Four patients found FAE treatment ineffective and switched to apremilast...Abnormal LFTs and lymphocytopenia were commonly observed in over half of patients; however, no serious adverse events were recorded. FAE continues to be a safe and effective treatment for severe psoriasis and is a more cost-effective option that should be considered prior to commencing biological therapy."

Clinical • Dermatology • Hematological Disorders • Immunology • Psoriasis

To evaluate the long-term efficacy and tolerability of treatment with dimethyl fumarate in adults with chronic plaque psoriasis. Valutare l’efficacia e la tollerabilità a lungo termine del trattamento con dimetilfumarato in adulti affetti da psoriasi cronica a placche . (clinicaltrialsregister.eu) - P3; N=300; Ongoing; Sponsor: ALMIRALL SPA

Clinical • New P3 trial • Dermatology • Dermatopathology • Immunology • Psoriasis

TRANSITION: Efficacy and Safety of Tildrakizumab in Participants With Moderate-to-Severe Chronic Plaque Psoriasis Who Are Non-Responders to Dimethyl Fumarate Therapy (clinicaltrials.gov) - P4; N=250; Active, not recruiting; Sponsor: Almirall, S.A.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Dermatology • Dermatopathology • Immunology • Psoriasis