Table 1.
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.