Article Text

THU0176 12 Week Period May be too Short to Evaluate Clinical Response to Etanercept in RA Patients
  1. A. Pchelintseva1,
  2. E. Panasyuk1,
  3. L. Denisov1,
  4. E. Nasonov2
  1. 1Department of Clinical Trials
  2. 2director, Federal state budgetary Institution “Scientific Research Institute of Rheumatology” RAMS Moscow Russia, Moscow, Russian Federation


Background Etanercept (ETN) is a fully human TNF-α receptor that is approved for the treatment of rheumatoid arthritis (RA). Several double-blind, placebo-controlled studies demonstrated that ETN was efficacious and safe in treatment RA patients who had an inadequate response to disease-modifying antirheumatic drugs (DMARDs). In some countries guidelines for the antiTNF treatment consider 12 weeks as timepoint to stop or continue therapy.

Objectives to evaluate time of clinical response to ETN treatment in the patients with RA and optimal timepoint to make a decision to continue or change ETN therapy.

Methods 188 subjects aging ≥18 years with moderate-to-severe RA despite stable doses of conventional DMARDs received ETN 50 mg weekly subcutaneously for 24 weeks. The mean age was 47,9±13,3; 80,3% (151) were females; the median disease duration was 8,5±7,7 years; 64,9% (122) used methotrexate, 19,1% (36)-leflunomide, 16% (30)-other DMARDs. 44,7% (84) administred low dose of corticosteroids (≤10 mg/day). 31,9% (60) had used another biologics prior to start of ETN.Baseline disease characteristics were (M±SD) : patient pain, VAS (mm): 60,1±18,2; patient disease activity, VAS (mm) : 59,6±18,1; physician disease activity, VAS (mm) : 57,6±13,5; tender joint count 68: 20,7±9,5; swollen joint count 66: 11,9±5,5; tender joint count 28: 13,9±5,5; swollen joint count 28: 9,7±4,1; HAQ: 1,50±0,60; ESR, MM/h: 43,04±22,83; DAS28: 6,26±0,89; CR-P, Mg/l: (Md [Q25-75]) 21,3[9,8-37,9]; Disease characteristics evaluated were swollen/tender joint counts (68/66 joints), patient pain and disease activity visual analog scale (VAS), physician disease activity VAS, Health Assessment Questionnarie (HAQ), erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) at weeks 0,2,4,12,25. Response was defined as achievement of low disease activity (DAS28≤3.2) or remission (DAS28<2.6) at week 12 and 25; the rate of ACR 20/50/70 responders at weeks 12 and 25 was determined.

Results Response according to ACR 20/50/70 and EULAR to weeks 12 and 25

Conclusions some RA patients had delayed clinical response; they became responders after 3 months of ETN treatment. Although clinicians usually expect rapid effect with biologics, 12 week period may be too short to make a treatment decision about continue or change therapy of ETN.

Disclosure of Interest None Declared

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