To the Editor: We believe that the design of the FLIGHT trial has several methodologic flaws. First, since this was an open-label trial, the investigators would generally be more reluctant to shift medication in patients who were receiving mycophenolate mofetil than in those who were receiving glucocorticoids alone, even if the patient’s platelet count was less than 30×109 per liter ({sa2q2}the cutoff value for treatment failure), a factor that might have had an effect on the primary end point. Second, the trial lacks essential data to allow for interpretation of the results, including the number of patients who discontinued mycophenolate mofetil and the cumulative dose of glucocorticoids. Third, the results do not show whether mycophenolate mofetil had a “steroid- sparing” effect, which was the rationale for the trial. Fourth, randomization was not stratified according to the type of ITP that had been diagnosed at baseline,
as indicated.1 In addition, we cannot reproduce the power calculation. Finally, we are concerned by the use of a medication that may cause miscarriage and birth defects, since women of childbearing age represent 30 to 40% of patients with newly diagnosed ITP. We strongly believe that at this stage, mycophenolate mofetil should be considered only as a potential second-line option in patients with ITP rather than as first-line therapy.
