title: Comparison of joint destruction between standard- and low-dose etanercept in rheumatoid arthritis from the Prevention of Cartilage Destruction by Etanercept (PRECEPT) study.
abstract: OBJECTIVE
  To evaluate the prevention of joint destruction and clinical efficacy of low-dose etanercept (ETN) (25 mg/week) compared with standard-dose ETN (50 mg/week) in RA.
  
  
  METHODS
  In this prospective, randomized, open-label study, 70 patients were assigned to receive ETN at either 50 or 25 mg/week for 52 weeks. The primary endpoint was the variation in modified total Sharp score (mTSS), and secondary endpoints were variations in disease activity score in 28 joints (DAS-28), modified HAQ and adverse event rate. Values of mTSS were calculated at baseline and after 52 weeks. Non-progression was estimated as ΔmTSS ≤0.5, and the non-progression rate was compared between groups.
  
  
  RESULTS
  Mean values at baseline were as follows: disease duration 9.2 years; DAS-28 5.45; and annual progression of mTSS 26.1. No significant differences in background were seen between groups. At 52 weeks, the non-progression rate was significantly less in the 25 mg/week group (36.7%) than in the 50 mg/week group (67.7%) (P = 0.041). Mean ΔmTSS was higher at 25 mg/week (1.03) than at 50 mg/week (-0.13). DAS-28 was significantly improved at 4 weeks, and the effect of treatment lasted for 52 weeks in both groups. No differences in adverse event rates were seen between groups.
  
  
  CONCLUSIONS
  Low-dose ETN is not inferior to standard-dose ETN in terms of effects on clinical manifestations. However, in terms of the radiographic non-progression rate, the effects of low-dose ETN may be inferior to the effects of standard-dose ETN.
  
  
  BACKGROUND
  UMIN Clinical Trials Registry, http://www.umin.ac.jp/ctr/, UMIN000001798.
authors: Department of Rheumatosurgery, Osaka City University Medical School, Osaka, Japan.
authors: Masahiro
authors: M
authors: Tada
authors: Tatsuya
authors: T
authors: Koike
authors: Tadashi
authors: T
authors: Okano
authors: Yuko
authors: Y
authors: Sugioka
authors: Shigeyuki
authors: S
authors: Wakitani
authors: Kenzo
authors: K
authors: Fukushima
authors: Akira
authors: A
authors: Sakawa
authors: Kazunori
authors: K
authors: Uehara
authors: Kentaro
authors: K
authors: Inui
authors: Hiroaki
authors: H
authors: Nakamura
mesh_terms: D018501:Antirheumatic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001172:Arthritis, Rheumatoid / Q000188:drug therapy* / Q000473:pathology; D002357:Cartilage Diseases / Q000139:chemically induced / Q000473:pathology / Q000517:prevention & control*; D018450:Disease Progression; D004305:Dose-Response Relationship, Drug; D000068800:Etanercept; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011788:Quality of Life; D018124:Receptors, Tumor Necrosis Factor / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D018501:Antirheumatic Agents; D007074:Immunoglobulin G; D018124:Receptors, Tumor Necrosis Factor; D000068800:Etanercept