Observational studyJournal of the European Academy of Dermatology and Venereology : JEADV2018
Long-term real-life safety profile and effectiveness of fumaric acid esters in psoriasis patients: a single-centre, retrospective, observational study.
Observational study in Journal of the European Academy of Dermatology and Venereology : JEADV, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
8 citing papers in PubMed, 1 synthesis or guideline pooled it, 25 citations in OpenAlex.
- Persistence and effectiveness of nonbiologic systemic therapies for moderate-to-severe psoriasis in adults: a systematic review.The British journal of dermatology · 2019Pooled it
- The Intersection of Psoriasis and Neoplasia: Risk Factors, Therapeutic Approaches, and Management Strategies.Cancers · 2024Review
- Short-term Safety of Dimethyl Fumarate for Psoriasis in Korea.Annals of dermatology · 2024Article
- Real-world use of dimethyl fumarate in patients with plaque psoriasis: a Delphi-based expert consensus.Dermatology reports · 2023Article
- Skin Cancer Correlations in Psoriatic Patients.Cancers · 2023Review
- Dimethyl Fumarate Treatment in Patients with Moderate-to-Severe Psoriasis: A 52-week Real-life Study.Acta dermato-venereologica · 2023Article
- Long-term Safety of Oral Systemic Therapies for Psoriasis: A Comprehensive Review of the Literature.Dermatology and therapy · 2020Review
- Fumaric acid ester-induced T-cell lymphopenia in the real-life treatment of psoriasis.Journal of the European Academy of Dermatology and Venereology : JEADV · 2019Observational
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 2 institutions in 1 country.
Funding
Abstract
backgroundFumaric acid esters (FAEs) are an established systemic treatment for moderate-to-severe psoriasis. However, the long-term clinical safety and effectiveness of continuous FAE monotherapy and combination therapy have not been established.
objectiveTo examine the long-term safety and effectiveness of FAEs as monotherapy and in combination with phototherapy or methotrexate in patients with psoriasis treated at a single centre in Germany.
methodsThis monocentric, retrospective observational study, with a follow-up period of up to 32.5 years, included 859 patients: 626 received FAE monotherapy, 123 received FAEs with concomitant phototherapy and 110 received FAEs with methotrexate.
resultsApproximately half of patients (49.0%) reported adverse events (566 total events), most of which involved the gastrointestinal tract. Serious adverse events were reported in 2.3% of patients, but none were deemed to have a causal relationship with any of the treatment regimens. Adverse events leading to treatment discontinuation were observed in 12.9% of patients. A median duration of 1 year was observed in all three treatment subcohorts (P = 0.70) from initiation of FAE treatment to a 50% response rate, where response was defined as achieving a cumulative static Physician's Global Assessment (PGA) score of 'light' and at least a 2-point reduction in baseline PGA. A 50% response rate for the cumulative Psoriasis Area and Severity Index 75 was achieved in the FAE monotherapy subcohort after a median of 3 years of treatment, in the FAEs + phototherapy subcohort after 6.7 years and in the FAEs + methotrexate subcohort after 8.1 years (P = 0.001).
conclusionAccording to our data, FAEs as monotherapy or in combination with phototherapy or methotrexate are safe and beneficial for long-term clinical use. However, multicentre, randomized controlled trials are required to establish the clinical value of monotherapy versus combination therapy and the optimal treatment duration.
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Registered trials
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