title: Targeting tumour necrosis factor alleviates signs and symptoms of inflammatory osteoarthritis of the knee.
abstract: BACKGROUND
  Inflammation associated with synovial expression of TNFα is a recognised feature of osteoarthritis (OA), although no studies have yet reported beneficial effects of anti-TNFα therapy on clinical manifestations of inflammation in OA.
  
  
  METHODS
  We conducted an open-label evaluation of adalimumab over 12 weeks in 20 patients with OA of the knee and evidence of effusion clinically. Inclusion criteria included daily knee pain for the month preceding study enrolment and a summed pain score of 125 to 400 mm visual analogue scale on the Western Ontario and McMaster University Osteoarthritis Index (WOMAC) pain subscale. The primary outcome was the Osteoarthritis Research Society International/Outcome Measures in Rheumatology Clinical Trials (OARSI/OMERACT) response criterion at week 12. Secondary outcomes included the WOMAC pain score 20% and 50% improvement, WOMAC stiffness and function scores, patient and physician global visual analogue scale, as well as target joint swelling.
  
  
  RESULTS
  Treatment was well tolerated and completed by 17 patients with withdrawals unrelated to lack of efficacy or adverse events. By intention to treat, an OARSI/OMERACT response was recorded in 14 (70%) patients. WOMAC pain 20% and 50% responses were recorded in 14 (70%) patients and eight (40%) patients, respectively. Significant improvement was observed in mean WOMAC pain, stiffness, function, physician and patient global, as well as target joint swelling at 12 weeks (P < 0.0001 for all). After treatment discontinuation, 16 patients were available for assessment at 22 weeks and OARSI/OMERACT response compared with baseline was still evident in 10 (50%) patients.
  
  
  CONCLUSIONS
  Targeting TNFα may be of therapeutic benefit in OA and requires further evaluation in controlled trials.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT00686439.
authors.forename: Walter P
authors.initials: WP
authors.lastname: Maksymowych
authors.forename: Anthony S
authors.initials: AS
authors.lastname: Russell
authors.forename: Peter
authors.initials: P
authors.lastname: Chiu
authors.forename: Alex
authors.initials: A
authors.lastname: Yan
authors.forename: Niall
authors.initials: N
authors.lastname: Jones
authors.forename: Tracey
authors.initials: T
authors.lastname: Clare
authors.forename: Robert G W
authors.initials: RG
authors.lastname: Lambert
mesh_terms: D000068879:Adalimumab; D000368:Aged; D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D018501:Antirheumatic Agents / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D007249:Inflammation / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D020370:Osteoarthritis, Knee / Q000188:drug therapy*; D017063:Outcome Assessment, Health Care; D010147:Pain Measurement; D013997:Time Factors; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors* / Q000187:drug effects
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D018501:Antirheumatic Agents; D014409:Tumor Necrosis Factor-alpha; D000068879:Adalimumab