Aim: The aim of this retrospective study was to assess the efficacy of different doses of rituximab (RTX) in patients with active moderate-severe Graves Orbitopathy (GO).
Methods: Overall 40 patients, 5 M/35 F; mean age (± S.D.) 58±11 years were treated with RTX; 21 were smokers. The patients received the following treatment: 14 patients (group 1) a single 100 mg dose; 15 patients (group 2) a single 500 mg dose and 11 Patients (Group 3) 2 doses of 1000 mg.
|Nr||GO duration (months)||Patients age (years)||Nr. of pat. with previous steroid therapy||Baseline CAS*||12 weeks CAS*||24 weeks CAS*|
|*values are expressed as mean ±S.D.|
Results (2): - Serum TRAb levels were significantly reduced in the in the three groups at 24 weeks (P-value Group 1 0.002, P-value Group 2 0.001, P-value Group 3 0.05). At 12 weeks serum TRAb levels decreased significantly only in group 2 (P-value 0.002)
- 13/40 patients at baseline and 14/40 at 24 weeks were persistently hyperthyroid, despite the change in serum TRAb title throughout RTX therapy.
- 2 patients of group 1 (100 mg dose) developed optic neuropathy.
- 3 patients presented major adverse reaction after only 2575 mg of RTX: acute cytokine release syndrome, clinically manifesting with marked soft tissue edema associated with pain and transient decrease of vision.
Conclusions: 1. RTX induced persistent GO inactivation in all the patients, regardless of the doses used. The higher CAS value at 24 weeks in patients treated with 100 mg compared to those treated with higher doses may be due to a lesser degree of orbital lymphocytic depletion.
2. The analysis of the quality of life questionnaire shows only a minimal improvement of the appearance but not of ocular function score.
3. The decrease of serum TRAb at 24 weeks was observed in all three groups of patients and might be due to the ongoing anti-thyroid therapy rather than to an effect of RTX.
4. Finally, the use of low dose RTX does not seem to prevent the development of adverse effects. We suggest that RTX should not be used in patients with subclinical optic neuropathy.
18 May 2019 - 21 May 2019