title: Combination Therapy of Etanercept and Fumarates versus Etanercept Monotherapy in Psoriasis: A Randomized Exploratory Study.
abstract: BACKGROUND
  Biologics are a safe and efficacious therapy for psoriasis. The drug survival of biologics may be disappointing, primarily due to loss of efficacy. Therefore, safe combination treatments are sought to improve their clinical response.
  
  
  OBJECTIVE
  To assess the efficacy, safety and tolerability of the combination therapy of etanercept with fumarates versus etanercept monotherapy.
  
  
  METHODS
  Thirty-three patients with psoriasis were randomized 1:1 to receive etanercept combined with fumarates or etanercept monotherapy. The primary outcome measure was the difference in PASI-75 response after 24 weeks; additionally, a longitudinal analysis was performed. An important secondary outcome measure was the proportion of patients with a Physician Global Assessment (PGA) of clear or almost clear. Adverse events were collected throughout the study.
  
  
  RESULTS
  In the combination therapy group, 78% (14 out of 18 patients) reached PASI-75 at week 24 versus 57% (8 out of 14 patients) in the monotherapy group (p = 0.27). The longitudinal analysis showed a PASI reduction of 5.97% per week for the combination therapy group and of 4.76% for the monotherapy group (p = 0.11). In the combination therapy group, 94% (17 out of 18 patients) of patients had a PGA of clear/almost clear versus 64% (9 out of 14 patients) in the monotherapy group (p = 0.064). The incidence of mild gastrointestinal complaints was higher in the combination group than in the monotherapy group.
  
  
  CONCLUSIONS
  Using the PGA, combination therapy showed a trend towards faster improvement in the first 24 weeks. The difference in the PASI score between the two groups was not statistically significant. Addition of fumarates to etanercept for 48 weeks appeared safe with an acceptable tolerability.
authors: Department of Dermatology, Erasmus MC, Rotterdam, The Netherlands.
authors: Ji Sun
authors: JS
authors: van Bezooijen
authors: Deepak M W
authors: DM
authors: Balak
authors: Martijn B A
authors: MB
authors: van Doorn
authors: Caspar W N
authors: CW
authors: Looman
authors: Marco W J
authors: MW
authors: Schreurs
authors: Birgit C P
authors: BC
authors: Koch
authors: Teun
authors: T
authors: van Gelder
authors: Errol P
authors: EP
authors: Prens
mesh_terms: D000328:Adult; D001706:Biopsy; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D000068800:Etanercept / Q000008:administration & dosage*; D005260:Female; D005500:Follow-Up Studies; D005650:Fumarates / Q000008:administration & dosage*; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D011565:Psoriasis / Q000175:diagnosis / Q000188:drug therapy*; D012720:Severity of Illness Index; D012867:Skin / Q000473:pathology; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D005650:Fumarates; D007166:Immunosuppressive Agents; D000068800:Etanercept