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. 2022 Oct 11;11(12):e220303. doi: 10.1530/EC-22-0303

Table 1.

Characteristics of recent studies involving RTX in the treatment of GO.

Author Year Trial design Drug Dose Number of patients TRAb CAS CAS at 24 weeks DON Disease inactivation (at week 24) Improvement in composite ophthalmic index (at week 24) Recurrence SAE
Salvi 2015 Randomized and prospective RTX 2 × 1000 mg 15 10.7 ± 9.1 4.4 ± 0.7 0.6 ± 3 0 100% 9/15 (60%) improved 0 2
ivGCS 7.5 g cumulative 16 18.2 ± 21.7 4.7 ± 0.7 2.3 ± 0.5 1 68.70% 6/16 (37.5%) improved June 16 3
Stan 2015 Randomized, prospective, and double-blinded RTX 2 × 1000 mg 13 20 (9–60) 4.9 (1.0) 3.7 (1.9) 2 4/13 at week 24 No significant difference between groups in disease severity No data 5 moderate/severe
Placebo n.a. 12 19.5 (2.2–28.8) 5.3 (1.0) 3.8 (1.4) 0 2/12 at week 24 No data 1 moderate/severe
Karasek 2017 Prospective RTX 1 × 100 mg 10 5.7 (1.1–41.0) to 1.6 (1.0–6.9) 3.6 ± 0.9 0.8 ± 0.4 at month 6 2 100% Not reported October 1 0
Eid 2019 Retrospective RTX 2 × 1000 mg 15 4 3.0 (2.0–3.0) 0 50% Not reported 5/12 (41.7%) 0
Deltour 2020 Retrospective RTX 2 × 1000 mg 32 63% reduction 3.29 ± 1.16 1.59 ± 1.12 at week 24 0 20/31 Not reported No data 1 (cytokine release syndrome)
Bennedjai 2020 Retrospective Tocilizumab 8 mg/kg on weeks 0, 4, 8, and 12 7 11 ± 4 5 ± 0.5 1.2 ± 0.9 at week 24 0 July 7 Not reported July 1 0
RTX 2 × 1000 mg 14 10 ± 7 4 ± 1.2 1.9 ± 1.7 at week 24 0 September 14 Not reported April 14 0
Vannucchi 2021 Prospective, open-label, and no control group RTX 1 × 100 mg 17 Decreased (27.6 ± 42.8 (n.v. <1.5)) 4.56 ± 0.96 1.25 ± 1.14 at 24 weeks (P  = 0.001) 2 >90% at 24 weeks 58.30% 0 at 72 weeks 1 (cytokine release syndrome)

CAS, clinical activity score; DON, dysthyroid optic neuropathy; GO, Graves’ orbitopathy; ivGCs, i.v. glucocorticosteroids; RTX, rituximab; SAE, serious adverse events; TRAb, thyroid receptor antibodies.