Treatment of Systemic Complications in Sjogren's Syndrome
Treatment of Systemic Complications in Sjogren's Syndrome
Systemic therapy should be tailored to the organ involved and the severity, and includes hydroxychloroquine, glucocorticoids and immunosuppressive agents, although no controlled trials in primary Sjögren's syndrome guide their use. In contrast, the amount and quality of evidence on biologic agents are greater. Random controlled trials (RCTs) have demonstrated the lack of efficacy of antitumor necrosis factor agents and promising results for B-cell depleting agents. Four recent studies evaluated the use of rituximab in primary Sjögren's syndrome patients. Gottenberg et al. studied the use of rituximab in 78 Sjögren's syndrome patients with systemic involvement and found an overall efficacy of 60%, with a reduction in the mean ESSDAI score and the mean corticosteroid dosage, whereas Carubbi et al. found a faster and more pronounced ESSDAI reduction in patients treated with rituximab than in those treated with conventional therapy. In contrast, the successful use of rituximab in the most prominent triad of symptoms (dryness, fatigue and pain) is not so clear. St Clair et al. found only modest improvements in a small open-label trial of 12 patients treated with rituximab, although recent data from a French RCT of 120 patients found no significant changes in the primary outcome (subjective intensity scored by the patient with respect to overall disease activity, pain, fatigue and dryness); the results of a second large RCT using rituximab are awaited.
Several studies have supported a role for BLyS in the pathogenesis of primary Sjögren's syndrome, suggesting BLyS blocking may be a potential therapeutic approach. Mariette et al. were the first to use belimumab (10 mg/kg at 0, 2 and 4 weeks, and then every 4 weeks to week 24) in 30 patients with primary Sjögren's syndrome with either early disease (< 5 years), severe salivary gland enlargement, current systemic complications, or positive biomarkers of B-cell activation. The primary endpoint was defined as an improvement in at least two items (dryness, fatigue, pain, systemic activity and B-cell biomarkers) and was achieved in 18 (60%) patients, together with a significant reduction in the ESSDAI score.
Biological Agents as Key Therapeutic Players
Systemic therapy should be tailored to the organ involved and the severity, and includes hydroxychloroquine, glucocorticoids and immunosuppressive agents, although no controlled trials in primary Sjögren's syndrome guide their use. In contrast, the amount and quality of evidence on biologic agents are greater. Random controlled trials (RCTs) have demonstrated the lack of efficacy of antitumor necrosis factor agents and promising results for B-cell depleting agents. Four recent studies evaluated the use of rituximab in primary Sjögren's syndrome patients. Gottenberg et al. studied the use of rituximab in 78 Sjögren's syndrome patients with systemic involvement and found an overall efficacy of 60%, with a reduction in the mean ESSDAI score and the mean corticosteroid dosage, whereas Carubbi et al. found a faster and more pronounced ESSDAI reduction in patients treated with rituximab than in those treated with conventional therapy. In contrast, the successful use of rituximab in the most prominent triad of symptoms (dryness, fatigue and pain) is not so clear. St Clair et al. found only modest improvements in a small open-label trial of 12 patients treated with rituximab, although recent data from a French RCT of 120 patients found no significant changes in the primary outcome (subjective intensity scored by the patient with respect to overall disease activity, pain, fatigue and dryness); the results of a second large RCT using rituximab are awaited.
Several studies have supported a role for BLyS in the pathogenesis of primary Sjögren's syndrome, suggesting BLyS blocking may be a potential therapeutic approach. Mariette et al. were the first to use belimumab (10 mg/kg at 0, 2 and 4 weeks, and then every 4 weeks to week 24) in 30 patients with primary Sjögren's syndrome with either early disease (< 5 years), severe salivary gland enlargement, current systemic complications, or positive biomarkers of B-cell activation. The primary endpoint was defined as an improvement in at least two items (dryness, fatigue, pain, systemic activity and B-cell biomarkers) and was achieved in 18 (60%) patients, together with a significant reduction in the ESSDAI score.
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