This protocol addresses a specific clinical step in systemic Sjögren syndrome: patients with objective joint inflammation and active systemic disease who did not achieve the required response on a prior rituximab-based regimen.

Clinical Scenario

The patient has confirmed Sjögren syndrome presenting with arthritis — objective inflammation of one or more joints, evidenced by heat, redness, and swelling on examination, and supported by ultrasound when findings are equivocal. Systemic disease activity is confirmed by a clinESSDAI score of ≥1. ESSDAI severity of arthritis is graded by the number of joints involved.

Escalation Trigger — Prior Line Did Not Reach Target

This step is reached when a previous course of Rituximab (used for systemic articular involvement) failed to produce a reduction of ≥3 points in the global ESSDAI score — the defined criterion for therapeutic response in systemic Sjögren syndrome. Failure to meet this target is the trigger for the next structured treatment step.

Next-Line Approach

The protocol for this situation involves Belimumab, a targeted biologic therapy given intravenously. The complete administration schedule, sequencing, and full treatment algorithm are detailed in the structured protocol. The treatment goal remains a reduction of ≥3 points in the global ESSDAI score.

References

DOI: 10.1136/annrheumdis-2019-216114

Arthritis is clinically diagnosed on the basis of objective inflammation of ≥1 joints (heat, redness and swelling in the physical examination of the affected joint) supported by ultrasound studies when in doubt, and the ESSDAI score classifies the severity of arthritis according to the number of joints involved (moderate <5 joints, high >5).
BLM: belimumab; 10 mg/kg (0, 2 and 4 weeks and then every 4 weeks).
With respect to the definition of the therapeutic response in systemic SjS, the TF recommends using a reduction of ≥3 points in the global ESSDAI score.

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Sjögren Syndrome with Active Arthritis: Next-Line Treatment When Rituximab Has Not Reached the Therapeutic Target

References