Dry mouth emerged as the symptom patients most wanted improved in interviews from Johnson & Johnson’s Phase 2 Sjögren’s disease study, giving researchers a patient-reported priority measure as two Phase 3 trials continue.
Johnson & Johnson said 49 of 163 participants completed 60-minute exit interviews after the 24-week treatment period. The patient-experience findings were detailed in American College of Rheumatology (ACR) abstract No. 1366.
Among those asked which symptoms they wanted improved, mouth dryness ranked highest, followed by eye dryness, fatigue and joint pain. The company did not report separate response counts for each symptom.
The interview participants remained blinded to their treatment assignment, and responses from the nipocalimab and placebo groups were pooled. The interviews captured participants’ experiences and perceived changes, but cannot establish whether the drug caused them.
A separate measure from the DAHLIAS study tracked salivary flow. The trial publication in The Lancet reported that 33% of participants receiving nipocalimab at 15 mg/kg had at least a 50% increase in objective salivary flow at Week 24, compared with 16% of those receiving placebo. Johnson & Johnson classified the measure as exploratory.
The interview ranking and the salivary-flow result address different questions: one records patient priorities and perceived changes, while the other measures saliva production. Because interview responses were pooled across treatment arms, they cannot indicate whether nipocalimab recipients reported more symptom improvement than placebo recipients.
Johnson & Johnson said two Phase 3 studies are underway. The DAFFODIL study’s design includes assessments of disease activity, dryness, pain, fatigue, quality of life and patient-perceived improvement. The U.S. Food and Drug Administration (FDA) has granted nipocalimab Breakthrough Therapy and Fast Track designations for treating adults with moderate-to-severe Sjögren’s disease. The FDA describes these as programs intended to speed development and review; a designation does not grant marketing approval.
