Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists · 2024
Rituximab Treatment as Second-Line Therapy in Glucocorticoid Nonresponsive Graves' Orbitopathy: A Nonrandomized, Controlled, Interventional Study.
СтатьяКонтролируемое клиническое исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Manousou Sofia, Holmberg Mats, Ekdahl Elin, Malmgren Helge, Filipsson Nyström Helena
Аннотация
OBJECTIVE: In moderate-to-severe Graves' orbitopathy, rituximab is recommended as second-line therapy in patients nonresponsive to intravenous glucocorticoids. We aimed to evaluate rituximab as early second-line therapy, as data are scarce and contradictory.
METHODS: In this nonrandomized, controlled, interventional study, patients with Graves' orbitopathy started on intravenous glucocorticoids. After 4 weeks, patients with < 2 points improvement in clinical activity score (CAS) were switched to rituximab [Non-Responders Rituximab (NR-RTX) group] and were compared to the remaining patients who continued with intravenous glucocorticoids for 12 weeks [Responders-Glucocorticoid (R-GC) group]. A retrospective group of non-responsive patients who were provided regular care with intravenous glucocorticoids for 12 weeks was used as control [Non-Responders-Regular Care group]. Background data and CAS were recorded for all groups at 0, 4, 12, 18, and 68 weeks. Quality of life (QoL) and safety data were collected from the NR-RTX and R-GC groups.
RESULTS: The NR-RTX group (n = 12) was similar to the others at baseline except for a 1-point lower median CAS compared to the NR-RC group (n = 12) (P = .03), and for having twice as many men compared to the R-GC group (n = 13) (P = .03). At 4 weeks, a linear mixed model indicated that the R-GC group had a 1.21-point (95% CI: -2.40 to -0.02) lower value for CAS compared to the NR-RTX group. CAS for all groups converged over time. Similar models for QoL revealed no treatment or time effects.
CONCLUSION: Switch to RTX early in the treatment course did not result in better CAS or QoL, compared to continuous intravenous glucocorticoids.
METHODS: In this nonrandomized, controlled, interventional study, patients with Graves' orbitopathy started on intravenous glucocorticoids. After 4 weeks, patients with < 2 points improvement in clinical activity score (CAS) were switched to rituximab [Non-Responders Rituximab (NR-RTX) group] and were compared to the remaining patients who continued with intravenous glucocorticoids for 12 weeks [Responders-Glucocorticoid (R-GC) group]. A retrospective group of non-responsive patients who were provided regular care with intravenous glucocorticoids for 12 weeks was used as control [Non-Responders-Regular Care group]. Background data and CAS were recorded for all groups at 0, 4, 12, 18, and 68 weeks. Quality of life (QoL) and safety data were collected from the NR-RTX and R-GC groups.
RESULTS: The NR-RTX group (n = 12) was similar to the others at baseline except for a 1-point lower median CAS compared to the NR-RC group (n = 12) (P = .03), and for having twice as many men compared to the R-GC group (n = 13) (P = .03). At 4 weeks, a linear mixed model indicated that the R-GC group had a 1.21-point (95% CI: -2.40 to -0.02) lower value for CAS compared to the NR-RTX group. CAS for all groups converged over time. Similar models for QoL revealed no treatment or time effects.
CONCLUSION: Switch to RTX early in the treatment course did not result in better CAS or QoL, compared to continuous intravenous glucocorticoids.