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Endocrine Abstracts (2015) 37 GP27.05 | DOI: 10.1530/endoabs.37.GP.27.05


1Endocrine Unit, Fondazione IRCCS Cà Granda, Milan, Italy; 2Ophthalmology, Fondazione IRCCS Cà Granda, Milan, Italy; 3Neuroradiology, Fondazione IRCCS Cà Granda, Milan, Italy; 4Otolaryngology, Fondazione IRCCS Cà Granda, Milan, Italy; 5Internal Medicine, Ospedale di Fidenza, Fidenza, Italy.

Previous studies have shown that Rituximab (RTX) is effective as a disease modifying drug at doses of 500 mg or 1000×2 mg in active Graves’ orbitopathy (GO). We have conducted a pilot study (EUDRACT 2012-001980-53) in which patients with active moderate-severe GO were treated with a single infusion of low dose RTX (100 mg). Ten patients were enrolled of whom seven completed the study at 52 weeks. Five patients did not respond to a previous treatment with i.v. methylprednisolone, whereas five had newly diagnosed GO. Disease activity was assessed with the clinical activity score (CAS) and severity with NOSPECS score. The primary endpoint was the decrease of the CAS of 2 points or CAS ≤3.

Results: Of the seven patients who completed the study, six had inactive disease at 12 weeks (ANOVA, P=0.01); one was submitted to surgical orbital decompression because of signs of optic neuropathy (ON). Another patient, although who had disease inactivation at 12 weeks, underwent surgical orbital decompression at 22 weeks because of suspected subclinical ON. At 24 weeks four patients were inactive (ANOVA, P=0.001); one had a transient disease reactivation with stabilization at 40 weeks. The treatment was well tolerated with only minor infusion-related reactions.

Conclusion: Very low dose of RTX seems effective in disease inactivation but may not modify the natural course of disease as has been observed with higher therapeutic doses.

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