Intraorbital injection of rituximab versus high dose of systemic glucocorticoids in the treatment of thyroid-associated orbitopathy

Abstract

The aim of the study was to compare, in a randomized prospective study, the efficacy and safety of intraorbital administration of low doses of RTX versus intravenous glucocorticoids (GCs) to treat patients affected by moderately severe thyroid-associated active orbitopathy. Twenty patients with active, moderately severe TAO, whose mean age was 56.7 years±10.2 SD participated in the study. Patients were randomly selected and treated with intraorbital injections of RTX or with i.v. GCs. Disease activity and severity were assessed by the Clinical Activity Score (CAS) and the NOSPECS. Computed tomography or magnetic resonance scans were performed in all patients. In the RTX group, full blood cell count and flow cytometric analysis on peripheral blood lymphocytes were done. The patients were followed for 20 months. In both groups, CAS and NOSPECS indexes were significantly reduced (p<0.005). In particular, CAS reduction was evident since the first follow-up with both treatments. Proptosis decreased significantly only in group B and diplopia showed no significant changes during follow-up times in both groups. Neither of the treatments affected the peripheral TRab. In group A, 5 weeks after the first injection, the CD20+ peripheral lymphocytes value was nearly zero. One patient treated with rituximab progressed to severe TAO (optic neuropathy) following the second injection so the treatment was discontinued. The data confirm the therapeutic efficacy of RTX in active TAO, even in low doses and locally administered. The efficacy on the inflammatory component of the disease is comparable to that of steroids and seems to be related with the reduction of peripheral CD20+ lymphocytes. Caution should be given to an accurate patient selection.

Efficacy and Safety of Rituximab for the Treatment of Graves' Orbitopathy: A Meta‐analysis of Randomized Controlled Trials

“…Of those, 19 were not RCTs, 21 were reviews, eight evaluated different comparisons, four were animal studies, and one was a clinical practice guideline. Thus, four trials were eligible for inclusion in this meta‐analysis …”

“…The methodologic quality of the included trials is summarized in Table . All four studies reported acceptable methods of randomization . Two studies did not describe the blinding of patients and outcome assessors .…”

“…RTX has been successfully used for treating autoimmune disorders such as rheumatoid arthritis and systemic lupus erythematosus . Several randomized controlled trials (RCTs) have recently investigated the efficacy of RTX for the treatment of GO . However, the outcomes of these trials varied and are thus inconclusive.…”

The Efficacy of Rituximab Combined with ¹³¹I for Ophthalmic Outcomes of Graves' Ophthalmopathy Patients

“…Savino et al [16], using intraorbital RTX in a randomized prospective study versus MP, reported that the effect could be associated with the sharp reduction of the peripheral CD20+ lymphocytes after a 12-week administration. Gess et al [21] reported about patients who were treated with intravenous RTX, presenting the depletion of CD20+ lymphocytes, even after a clinical deterioration.…”

“…Previous studies have suggested that RTX can prevent Graves' disease and improve thyroid dysfunction in GD but cannot cure the disease [11,14,15]. In the treatment of GO, RTX reduces the activity and severity of GO more effectively, and it has lower GO relapse rates and less adverse events [11,16]. Another study showed that orbital radiation therapy could be used as a supplement to corticosteroid therapy for patients with GO in minimizing the dose and duration of corticosteroid [17].…”