L Bartalena1, G Veronesi2, G E Krassas3, W M Wiersinga4, C Marcocci5, M Marinò5, M Salvi6, C Daumerie7, C Bournaud8, M Stahl9, L Sassi2, C Azzolini2, K G Boboridis10, M P Mourits4, M R Soeters4, L Baldeschi7, M Nardi5, N Currò6, A Boschi7, M Bernard8, G von Arx11, P Perros12, G J Kahaly13. 1. Department of medicine and surgery, University of Insubria, Endocrine Unit, ASST dei Sette Laghi, Viale Borri, 57, 21100, Varese, Italy. luigi.bartalena@uninsubria.it. 2. Department of medicine and surgery, University of Insubria, Endocrine Unit, ASST dei Sette Laghi, Viale Borri, 57, 21100, Varese, Italy. 3. IASIO Medical Center, Thessaloniki, Greece. 4. Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands. 5. University of Pisa, Pisa, Italy. 6. Fondazione Policlinico, University of Milan, Milan, Italy. 7. CatholicUniversity of Louvain, Brussels, Belgium. 8. Lyon 1 University, Lyon, France. 9. Kantonsspital Baselland, University Clinic of Internal Medicine, Bruderholz, Switzerland. 10. University Department of Ophthalmology, AHEPA Hospital, Thessaloniki, Greece. 11. Admedico Orbital Center, Olten, Switzerland. 12. Newcastle upon Tyne Hospitals NHS Trust, Newcastle upon Tyne, UK. 13. Gutenberg University Medical Center, Mainz, Germany.
Abstract
PURPOSE: Intravenous glucocorticoids (ivGCs) given as 12-weekly infusions are the first-line treatment for moderate-to-severe and active Graves' orbitopathy (GO), but they are not always effective. In this study, we evaluated whether response at 6 weeks correlated with outcomes at 12 (end of intervention) and 24 (follow-up) weeks, particularly in patients initially unresponsive. METHODS: Our database (Bartalena et al. J Clin Endocrinol Metab 97:4454-4463, 10), comprising 159 patients given three different cumulative doses of methylprednisolone (2.25, 4.98, 7.47 g) was analyzed, pooling data for analyses. Responses at 6 weeks were compared with those at 12 and 24 weeks using three outcomes: overall ophthalmic involvement [composite index (CI)]; quality of life (QoL); Clinical Activity Score (CAS). Responses were classified as "Improved", "Unchanged", "Deteriorated", compared to baseline. RESULTS: Deteriorated patients at 6 weeks for CI (n = 8) remained in the same category at 12 weeks and 7/8 at 24 weeks. Improved patients at 6 weeks for CI (n = 51) remained in the same category in 63% and 53% of cases at 12 and 24 weeks, respectively. Unchanged patients at 6 weeks (n = 100) eventually improved in 28% of cases (CI), 58% (CAS), 32% (QoL). There was no glucocorticoid dose-dependent difference in the influence of early response on later outcomes. CONCLUSIONS: Patients who deteriorate at 6 weeks after ivGCs are unlikely to benefit from continuing ivGCs. Patients unresponsive at 6 weeks still have a significant possibility of improvement later. Accordingly, they may continue ivGC treatment, or, alternatively, possibly stop ivGCs and be switched to a second-line treatment.
PURPOSE: Intravenous glucocorticoids (ivGCs) given as 12-weekly infusions are the first-line treatment for moderate-to-severe and active Graves' orbitopathy (GO), but they are not always effective. In this study, we evaluated whether response at 6 weeks correlated with outcomes at 12 (end of intervention) and 24 (follow-up) weeks, particularly in patients initially unresponsive. METHODS: Our database (Bartalena et al. J Clin Endocrinol Metab 97:4454-4463, 10), comprising 159 patients given three different cumulative doses of methylprednisolone (2.25, 4.98, 7.47 g) was analyzed, pooling data for analyses. Responses at 6 weeks were compared with those at 12 and 24 weeks using three outcomes: overall ophthalmic involvement [composite index (CI)]; quality of life (QoL); Clinical Activity Score (CAS). Responses were classified as "Improved", "Unchanged", "Deteriorated", compared to baseline. RESULTS: Deteriorated patients at 6 weeks for CI (n = 8) remained in the same category at 12 weeks and 7/8 at 24 weeks. Improved patients at 6 weeks for CI (n = 51) remained in the same category in 63% and 53% of cases at 12 and 24 weeks, respectively. Unchanged patients at 6 weeks (n = 100) eventually improved in 28% of cases (CI), 58% (CAS), 32% (QoL). There was no glucocorticoid dose-dependent difference in the influence of early response on later outcomes. CONCLUSIONS:Patients who deteriorate at 6 weeks after ivGCs are unlikely to benefit from continuing ivGCs. Patients unresponsive at 6 weeks still have a significant possibility of improvement later. Accordingly, they may continue ivGC treatment, or, alternatively, possibly stop ivGCs and be switched to a second-line treatment.
Entities:
Keywords:
Clinical Activity Score; Cyclosporine; Graves’ orbitopathy or ophthalmopathy; Intravenous glucocorticoids; Orbital radiotherapy; Shared decision-making
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