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Endocrine Abstracts (2021) 73 YI2 | DOI: 10.1530/endoabs.73.YI2

ECE2021 Oral Communications Young Investigator Awards (12 abstracts)

Efficacy of the Anti-BAFF monoclonal antibody belimumab vs methylprednisolone in active moderate-severe graves’ orbitopathy: Preliminary analysis of a randomized controlled trial

Vittoria Favero1, 2, Nicola Currò3, Irene Campi4, 5, Elisa Lazzaroni1, Danila Covelli1, Guia Vannucchi4, Davide Dazzi6, Ilaria Muller1, 2, Valeria Minorini3, Claudio Guastella7, Maura Arosio1, 2 & Mario Salvi1


1Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Endocrinology, Milan, Italy; 2University of Milan, Department of Clinical Sciences and Community Health, Milan, Italy; 3Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Ophthalmology, Milan, Italy; 4Istituto Auxologico Italiano IRCCS, Department of Endocrine and Metabolic Diseas, Milan, Italy; 5University of Milan, Department of Pathophysiology and Transplantation, Milan, Italy; 6Ospedale di Vaio, Internal Medicine, Fidenza, Italy; 7Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Otolaryngology, Milan, Italy


Serum B cell stimulating factor (BAFF) has been shown to be elevated in Graves’ disease (Vannucchi 2012). In addition, BAFF and its receptor have been shown to be expressed on lymphocytes infiltrating the thyroid in Graves’ disease and also on thyrocytes (Campi 2015).


We tested in a single-blind randomized controlled trial (EudraCT 2015–002127–26) whether the administration of the anti-BAFF monoclonal antibody belimumab (BMB), approved for therapy of SLE, is effective in active moderate-severe Graves’ Orbitopathy (GO) as compared to first line treatment iv methylprednisolone (MP).


We randomized 27 patients with active, moderate severe GO and detectable serum TSH receptor antibodies (TRAb), euthyroid for at least 3 months, whether untreated or previously treated with iv steroids (relapsing GO). 14 received iv belimumab at 0, 14, 28 days and then every four weeks for five cycles of infusion and 13 iv MP, 833 mg/ weekly for 6 cycles, followed by one cycle of 425 mg/week. The first dose of belimumab was associated to a full dose (833 mg) of MP (inception dose). Patient were studied at 12, 24 weeks (primary end point) and followed-up for 48 weeks. In addition to assessment of the CAS (primary end point), proptosis and the titers of TRAb (secondary end points) were also measured.


In both groups of patients the CAS decreased significantly at 24 weeks (P < 0.0001). At 12 weeks patients on MP had a significantly lower CAS than those on BMB (4.75 ± 0.3 1.5 ± 0.5 vs 4.15 ± 0.2 2.54 ± 0.5, P < 0.009). At 24 weeks 12/13 patients on MP (CAS 1.00 ± 0.4) and 13/14 on BMB (CAS 1.38 ± 0.3) had inactive disease. Proptosis improved in all patients (P < 0.05) and in MP patients more significantly than BMB (P < 0.04). Serum TRAb levels decreased significantly (P < 0.01) in both groups of patients. Two patients in each arm developed optic neuropathy. BMB treatment was very well tolerated, with 1 major and 4 minor side effects vs 2 and 3, when compared to MP.


BMB is as effective as iv MP in the treatment of active GO, inducing inactivation in more than 92% of subjects. While its effect is somewhat slower than that of MP, its tolerability is very good. BMB is suggested to be an excellent alternative to MP when this is contraindicated or not effective.


GLAXOSmithKline, Verona and Fondazione IRCCS Ca’ Granda, Milan, Italy.

Volume 73

European Congress of Endocrinology 2021

22 May 2021 - 26 May 2021

European Society of Endocrinology 

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