Janssen Pharmaceutical, a unit of Johnson & JohnsonJNJ, announced data from an ongoing analysis of a Phase 2a trial of guselkumab and golimumab combo therapy for ulcerative colitis.
The results showed that 12 weeks of combination induction therapy with guselkumab and golimumab, followed by a transition to guselkumab alone for maintenance, achieved a clinical remission rate at week 38 of 47.9%, a higher rate than induction and maintenance treatment with either guselkumab alone (31%) or golimumab alone (20.8%).
Endoscopic improvements and the composite histologic-endoscopic endpoints & remission were higher in patients who received combination therapy followed by treatment with guselkumab than those who received guselkumab or golimumab alone.
Patients receiving combination therapy followed by maintenance treatment with guselkumab and patients receiving only guselkumab monotherapy achieved the same rate of symptomatic remission of 69%, which was greater than the golimumab monotherapy group of 59.7%.
Janssen also announced final data from the long-term extension (LTE) of the Phase 3 UNIFI study demonstrating the efficacy and safety of STELARA (ustekinumab) through four years of treatment for moderately to severely active ulcerative colitis (UC).
Among all patients who had achieved clinical response with STELARA during induction, 64.9% were in symptomatic remission after 44 weeks of maintenance.
At week 200 (four years), this proportion of patients was 55.2%; most were not receiving corticosteroids.
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