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Rituximab in relapsing Graves' disease, a phase II study

Departments of¹ , Endocrinology² Rheumatology, Leiden University Medical Centre, Leiden, The Netherlands³ Department of Internal Medicine, Medical Centre Alkmaar, Alkmaar, The Netherlands

(Correspondence should be addressed to J W Smit who is now at Department of Endocrinology and Metabolic Diseases, Leiden University Medical Centre, PO Box 9600, 2300 RC Leiden, The Netherlands; Email: j.w.a.smit{at}lumc.nl)

Objective: Conventional therapies for Graves' disease, consisting of medical therapy or radioiodine are unsatisfactory, because of limited efficacy and adverse events. Interventions aimed at the underlying autoimmune pathogenesis of Graves' disease may be worthwhile to explore. We therefore performed a prospective, 26-week phase II study with open-ended observational extension to assess the efficacy of rituximab in patients with recurrent Graves' disease.

Design: We performed a prospective, 26-week phase II study with open-ended observations.

Methods: Thirteen patients with relapsing Graves' disease (9 females and 4 males, age 39.5±9.5 years) received 2 dosages of rituximab 1000 mg i.v. with a 2-week interval. Before administration and on several periods after the administration of TSH, free thyroxine (FT₄), thyrotropin binding inhibitory immunoglobulins (TBII) and the proportion of CD19 and MS4A1 positive peripheral blood mononuclear cells were measured.

Results: The proportion of MS4A1 positive lymphocytes decreased in all patients from 5.8% at baseline to 1.4% at 26 weeks (P=0.007). Four patients with high initial FT₄ levels did not respond to treatment. All remaining patients had a decrease in FT₄ levels at 26 weeks (P=0.001) and an increase in TSH levels (P=0.011). TBII decreased in all remaining patients (P=0.003). At a follow-up time of 14–27 months, nine of these patients were still euthyroid with normal FT₄ (P<0.001) and TSH levels (P=0.008).

Conclusions: The present study results suggest a beneficial role of rituximab in mild relapsing Graves' disease. A subsequent randomized controlled trial with rituximab is recommended.