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Graves' ophthalmopathy (GO) is a potentially vision-threatening disease that cannot be successfully treated with existing drugs
Threatening eyesight
Objective: To study the efficacy of rituximab (RTX) in the treatment of GO
Purpose:
Method : This is a prospective, randomized, double-blind, placebo case-control trial
Method :
Intervention: Two intravenous RTX infusions (1000 mg each time) or two saline infusions every 2 weeks
Intervention:
MAIN OUTCOME MEASURE: The primary endpoint is the continuous decline of the clinical activity score (CAS), and the improvement was ≥2 points at 24 weeks
MAIN OUTCOME MEASURE: The clinical activity score (CAS) decreased continuously and improved by ≥2 points at 24 weeks
Secondary endpoints : including success rate and failure rate, the proportion of clinically significant improvement of prominent symptoms, eye cleft width, diplopia score, exophthalmos and disease severity, as well as changes in these parameters, periorbital fat/muscle volume, and quality of life
Secondary endpoint :
Results: All parameters in the treatment group were similar at baseline
result:
Figure 1 Changes in CAS and TRAb levels during the study.
Figure 1 Changes in CAS and TRAb levels during the study.
(C) The average CAS±SD of each group; (D) The median level of TRAb in each group
(5 patients stopped before or after the 24th week) or 52 weeks (individual patients stopped the trial after 24 weeks) for final evaluation
Table 1 Changes in disease parameters; Abbreviations: TOV, total eyeball volume; TMV, total muscle volume; TFV, total fat
Table 1 Changes in disease parameters; Abbreviations: TOV, total eyeball volume; TMV, total muscle volume; TFV, total fat
Figure 2 In each study group, the proportion of patients with clinically significant improvement from baseline to 24 weeks (A and B) or from baseline to 52 weeks (C and D)
Figure 2 In each study group, the proportion of patients with clinically significant improvement from baseline to 24 weeks (A and B) or from baseline to 52 weeks (C and D)
Exophthalmos ≥2mm; diplopia score from 3 or 4 to 0, 1 or 2; eye cleft width ≥3mm; NOSPECS is classified according to 1 or 2 categories (A and C)
No need for additional treatment (success) or CAS reduction <2 points or need for additional treatment (failure)
.
There was no significant difference between any parameter group at any time point in each study group
.
Table 2 Side effects; bold numbers indicate moderate/severe side effects
Table 2 Side effects; bold numbers indicate moderate/severe side effectsConclusion: Compared with placebo, RTX on activity and moderate to severe GO patients without extra good at, and there are not able to ignore visual adverse reactions
.
.
Original source
Stan MN, Garrity JA, Carranza Leon BG, Randomized controlled trial of rituximab in patients with Graves' orbitopathy .
J Clin Endocrinol Metab 2015 Feb;100(2)
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