Methods: We conducted a double blind, randomized, trial (EUDRACT 2007–003910–33) to compare RTX to intravenous methylprednisolone (ivMP) in patients with active moderate-severe GO. Thirty-two patients were randomized to receive either ivMP (7.5 g) or RTX (2000 mg or 500 mg). Primary endpoint was the decrease of the CAS of 2 points or to <3 at week 24. Changes of proptosis, lid fissure, diplopia and eye muscle motility, quality of life score were secondary end points. The number of therapeutic responses, disease reactivation and surgical procedures required during follow-up and the patients’ quality of life, were also assessed.

Interpretation: The results of this trial confirm preliminary reports on a better therapeutic outcome of RTX in active moderate-severe GO, when compared to ivMP, even after a lower RTX dose. The better eye motility outcome, visual functioning of the quality of life assessment and the reduced number of surgical procedures in patients after RTX seem to suggest a disease modifying effect of the drug.

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