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The fi rst clinical studies used lefl unomide at a loading dose of 100 mg/day for 3 days followed by a maintenance dose of 20 mg/day. This regimen was based on pharmakocinetics data to achieve the target serum concentration as soon as possible. However, the use of the loading dose was associated with a higher risk of side effects leading to consider as recommended the starting dose of 20 mg/day without a loading dose for RA patients.