IVIG Eases Nerve Pain in Sjögren Disease Trial
Adults with painful nerve symptoms from Sjögren disease saw pain and disability improve in a small controlled study.
Updated on Nov. 2, 2026 in Arthritis
A randomized placebo-controlled trial found that intravenous immunoglobulin (IVIG) reduced pain and disability in adults with Sjögren disease and painful sensory neuropathy, a nerve condition affecting some people with this autoimmune disorder. The results were presented at the International Symposium on Sjögren's Disease in Paris and point to a possible treatment option for patients with this specific complication.
Why it matters
Painful nerve involvement is a difficult complication of Sjögren disease, and until now evidence for IVIG came mostly from case reports, retrospective series, and expert opinion with mixed results. A controlled trial gives clinicians and patients a more reliable basis for weighing this option, though the study was small.
The TINISS trial was a randomized placebo-controlled study enrolling 22 adults aged 18 to 80 from 12 French university hospitals, with 12 assigned to IVIG and 10 to placebo. Six IVIG patients and one placebo patient met the primary endpoint, with a 96.5% probability of superiority for IVIG, but the small sample and unstated long-term follow-up leave the durability of benefit unresolved.
The players
CSL Behring
A global biopharmaceutical company that manufactures plasma-derived therapies, including immunoglobulin products used to treat immune and neurological conditions.
Gottenberg
A rheumatologist at Strasbourg University Hospital who leads research on Sjögren disease and autoimmune rheumatic conditions.
Johr
A clinician-researcher at a Philadelphia institution who commented on the trial's findings.
The details
Participants were randomly assigned to receive either IVIG, a concentrated antibody preparation drawn from donated plasma, or a placebo. Success was defined as at least a 20% improvement from baseline at week 11 on either the Rasch-built Overall Disability Scale or a 0-10 numerical pain rating scale. Two serious adverse events occurred in each arm, and none were considered treatment-related. The trial was funded by CSL Behring.
Timeline
Participants were assessed for pain and disability improvement at week 11 of the trial.
Results were presented on November 2, 2026, at the International Symposium on Sjögren's Disease in Paris.
Health Landscape
Before this trial, IVIG for Sjögren-related painful neuropathy rested on case reports, retrospective series, and expert opinion with mixed results. The TINISS trial is the first randomized placebo-controlled study of IVIG for this condition, moving the evidence closer to the standard used to guide treatment decisions.
If you have Sjögren disease with ongoing burning, tingling, or nerve pain, this trial is worth raising with your rheumatologist as a area of emerging evidence. Because the study was small and not yet a standard recommendation, any discussion about IVIG should happen with your physician, who can weigh its costs, risks, and fit for your situation.
The takeaway
A controlled trial now supports IVIG as a possible option for painful nerve involvement in Sjögren disease, though larger studies are still needed. If you notice persistent nerve pain alongside Sjögren symptoms, bring it up with your doctor so it can be evaluated early.
Further reading
For background on the autoimmune joint and connective-tissue conditions this trial sits within, explore our Arthritis coverage.
