J&J Reports Participants Rank Dry Mouth First for Sjögren’s Symptom Improvement

Johnson & Johnson said interviews with participants in a midstage study of nipocalimab identified dry mouth as the symptom they most wanted improved, offering a view of patient priorities as two Phase 3 studies continue.

Participants ranked eye dryness next, followed by fatigue and joint pain. The interviews included people who received nipocalimab and people who received a placebo, so they cannot establish whether the drug improves symptoms.

In earlier trial results, 33% of patients in the higher-dose group had at least a 50% increase in saliva production, compared with 16% in the placebo group. The saliva measure was exploratory.

Two Phase 3 studies are underway, assessing disease activity, dryness, pain, fatigue and quality of life. Nipocalimab has received FDA breakthrough therapy and fast track designations; neither designation is an approval.