Janssen Touts Encouraging Data From Two Ulcerative Colitis Treatments

  • Janssen Pharmaceutical, a unit of Johnson & Johnson JNJ, 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.
  • Price Action: JNJ shares are down 0.16% at $159.95 on the last check Monday.
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