Entry and Exit Criteria

ENTRY CRITERIA:
  1. Active disease defined as a SDAI score = 20. The swollen and tender joint count must be at least 6 each.
  2. A history of at least 3 DMARDs used serially or in combination at maximum tolerated doses. Methotrexate must be one of the DMARDs unless contra-indicated.
  3. DMARD use, as described, for at least 6 months.
EXIT CRITERIA:
  1. Failure to achieve adequate improvement in SDAI score; defined as an improvement of = 7 points from entry score, after 3 months of TNF-a blocker use.
  2. Failure to achieve a low disease state; defined as a SDAI score = 11 or a major SDAI response of = 17 points after 6 months of treatment.
  3. Intolerance to TNF-a blocker.
References:
  1. Assessment of rheumatoid arthritis activity in clinical trials and clinical practise. J.Smolen and D.Aletaha: Arthritis and Rheum 2006. Up to date.
  2. The definition and measurement of disease modification in inflammatory rheumatic diseases. Aletaha d, Smolen J: Rheum Dis Clin of North Am 2006;32:9-44.
  3. Remission and active disease in rheumatoid arthritis: defining criteria for disease activity states. Aletaha D. Arthritis Rheum 2005;52:2625-2636.
SARAA GUIDELINES ON TNF-a BLOCKER SWITCHING

SARAA follows the European (EULAR) guidelines and wishes to place no restriction on switching of TNF-a blockers.

Switches should however be based on: lack of efficacy: SDAI improvement score = 10-20 after 3 months of treatment, intolerance to current TNF-a inhibitor, affordability and practicality (change in patient circumstances).

Switching between Enbrel and Humira or Revellex or vice versa is clinically appropriate.

Reference: Ann Rheum Dis 2005;64:iv2-iv14.

SARAA GUIDELINES ON THE USE OF MABTHERA

Rheumatoid arthritis patients who have failed to achieve a low disease state SDAI =11 or who failed to show a 10-20 point SDAI improvement after 6 months of TNF-a blocker treatment are eligible for the use of MabThera.

Repeated treatments of MabThera should only be considered after 24 weeks if good improvement of 10-20 points in SDAI scores is seen at 16 weeks after the last treatment.

Reference: Consensus statement on the use of rituximab in patients with rheumatoid arthritis. Smolen J. Ann Rheum Dis :66,2: p143-150.