Raphaël Lijnen1, Elsemieke Otters2, Deepak Balak3, Bing Thio3. 1. a Department of Dermatology , Laurentius Hospital , Roermond , The Netherlands . 2. b Department of Dermatology , Radboud University Medical Center , The Netherlands , and. 3. c Department of Dermatology , Erasmus Medical Centre , Rotterdam , The Netherlands.
Abstract
BACKGROUND: Mixtures of fumaric acid esters (FAE) are used as an oral systemic treatment for moderate to severe psoriasis. Large clinical studies with dimethylfumarate (DMF) monotherapy are scarce. OBJECTIVES: The objective of this study is to assess the effectiveness and long-term safety of high-dose DMF monotherapy in moderate to severe psoriasis. METHODS: A prospective single-blinded follow-up study was performed in a cohort of patients treated with DMF. Patients were followed-up at fixed intervals. Assessment of consecutive photographs was performed by two observers. Primary outcome was a change in static physician global assessment (PGA) score. Safety outcome was defined as incidences of (serious) adverse events. RESULTS: A total of 176 patients with moderate to severe psoriasis were treated with DMF for a median duration of 28 months. The median daily maintenance dosage of 480 mg was reached after a median of 8 months. Psoriasis activity decreased significantly by 1.7 out of five points. A total of 152 patients reported one or more adverse events, such as gastrointestinal complaints and flushing. CONCLUSIONS:High-dose DMF monotherapy is an effective and safe treatment option in moderate to severe psoriasis. It can be suggested that 50% of all patients may benefit from high-dose DMF monotherapy.
RCT Entities:
BACKGROUND: Mixtures of fumaric acid esters (FAE) are used as an oral systemic treatment for moderate to severe psoriasis. Large clinical studies with dimethylfumarate (DMF) monotherapy are scarce. OBJECTIVES: The objective of this study is to assess the effectiveness and long-term safety of high-dose DMF monotherapy in moderate to severe psoriasis. METHODS: A prospective single-blinded follow-up study was performed in a cohort of patients treated with DMF. Patients were followed-up at fixed intervals. Assessment of consecutive photographs was performed by two observers. Primary outcome was a change in static physician global assessment (PGA) score. Safety outcome was defined as incidences of (serious) adverse events. RESULTS: A total of 176 patients with moderate to severe psoriasis were treated with DMF for a median duration of 28 months. The median daily maintenance dosage of 480 mg was reached after a median of 8 months. Psoriasis activity decreased significantly by 1.7 out of five points. A total of 152 patients reported one or more adverse events, such as gastrointestinal complaints and flushing. CONCLUSIONS: High-dose DMF monotherapy is an effective and safe treatment option in moderate to severe psoriasis. It can be suggested that 50% of all patients may benefit from high-dose DMF monotherapy.
Entities:
Keywords:
Dimethylfumurate; high dose; monotherapy; prospective study; psoriasis
Authors: G E van der Kraaij; D M W Balak; C I Busard; O D van Cranenburgh; Y Chung; R J B Driessen; M de Groot; E M G J de Jong; P M J H Kemperman; W J A de Kort; S A Karsch; A Lamberts; L L A Lecluse; P P M van Lümig; S P Menting; E P Prens; J M P A van den Reek; M M B Seyger; H B Thio; W R Veldkamp; M Wakkee; A Nast; A Jacobs; S Rosumeck; P I Spuls Chair Journal: Br J Dermatol Date: 2019-01 Impact factor: 9.302