Phase 3 Trial Update of Simponi for Ulcerative Colitis

Janssen Biotech announced new Phase 3 study findings which showed significantly more patients with moderately to severely active ulcerative colitis (UC) who responded to induction therapy with subcutaneously administered Simponi (golimumab) maintained clinical response through Week 54, the primary endpoint of the study, compared with patients receiving placebo. 

In the PURSUIT-Maintenance trial, patients in response to Simponi induction therapy were randomized to treatment with subcutaneous Simponi 50mg, Simponi 100mg or placebo every four weeks.  The primary endpoint was clinical response through Week 54.  All patients were assessed for UC disease activity using the Mayo score at Week 30 and at Week 54 and by partial Mayo score every four weeks (loss of response was confirmed by endoscopy).  Patients not in response at any point in the study were treated as non-responders.  Therefore, a patient who maintained response was in a state of continuous clinical response through Week 54.  

Investigators reported that 47% of patients receiving Simponi 50mg and 51% of patients receiving Simponi 100mg demonstrated maintenance of clinical response through Week 54 vs. 31% of patients receiving placebo (P=0.01 and P<0.001, respectively).  Clinical response was defined using the Mayo score, a 12-point clinical assessment and colonoscopy-based measure of disease activity, which assesses improvement in symptoms based on rectal bleeding, stool frequency, endoscopic findings and a physician's global assessment.

Secondary endpoints included clinical remission and mucosal healing at both Weeks 30 and 54 among patients who were in clinical response at Week 0 of the maintenance study; maintained clinical remission at both Weeks 30 and 54 among patients who were in clinical remission at Week 0 of the maintenance trial; and, clinical remission with corticosteroid discontinuation at Week 54 among patients in response to induction therapy and receiving corticosteroids at Week 0 of the maintenance study.  A significantly higher proportion of patients in response to Simponi induction therapy who received Simponi 100mg achieved clinical remission (29%) and mucosal healing (44%) at both Week 30 and Week 54 compared with patients receiving placebo (15% [P=0.003]; 27% [P=0.001], respectively).  Improvements in the SIMPONI 50mg group for clinical remission (24%) and mucosal healing (42%) at both Weeks 30 and 54 were greater, though not significantly, compared with the placebo group (15%; 27%, respectively).  Among the study patients who had achieved clinical remission at Week 0, the proportions of patients in clinical remission at both Week 30 and Week 54 were greater, though not significantly, in the Simponi 50mg and Simponi 100mg groups (37% and 40%, respectively) compared with the placebo group (24%).  Corticosteroid-free remission at Week 54 among patients in response to induction therapy and receiving corticosteroids at Week 0 was reported in 28% of patients receiving Simponi 50mg and 23% of patients receiving Simponi 100mg compared with 18% of patients receiving placebo, these results were not statistically significant.

Simponi is a human monoclonal antibody that targets and neutralizes excess TNF-α, a protein that when overproduced in the body due to chronic inflammatory diseases can cause inflammation and damage to bones, cartilage and tissue. Simponi is approved for the treatment of moderately to severely active RA with methotrexate, active psoriatic arthritis alone or with methotrexate and active ankylosing spondylitis.

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