Phase 3 Study of Simponi for Ulcerative Colitis

New Phase 3 study findings show that subcutaneous induction regimens of Simponi (golimumab; Janssen Biotech, Inc.) induced clinical response in a majority of patients with moderately to severely active ulcerative colitis (UC) who had previously failed or were intolerant to conventional agents. 

PURSUIT was a multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of subcutaneous Simponi in adults with moderately to severely active UC. All trial patients had failed to respond to or tolerate treatment with 6-mercaptopurine (6-MP), azathioprine (AZA), corticosteroids and/or 5-aminosalicylate (5-ASA), or were corticosteroid dependent.  Study participants were naive to treatment with tumor necrosis factor (TNF) inhibitors and had a baseline Mayo score between 6 and 12 and endoscopic subscore ≥2.  The Mayo score is a 12-point clinical assessment and colonoscopy-based measure of disease activity, which assesses improvement in symptoms based on rectal bleeding, endoscopic findings, stool frequency and a physician’s global assessment.

The trial had an adaptive design with Phase 2 dose ranging followed by a confirmatory Phase 3 component. Patients were randomized to receive Simponi 100mg/50mg (prior to dose selection only), placebo or Simponi 200mg/100mg or 400mg/200mg at Weeks 0 and 2.  The primary endpoint was clinical response at Week 6. Secondary endpoints at Week 6 included clinical remission, mucosal healing and a change from baseline in IBDQ scores. Overall, 1065 patients were treated in the study; 774 of these patients were randomized into the Phase 3 component of the study. Patients responding to induction treatment with Simponi were eligible to continue in the Phase 3 PURSUIT maintenance study. 

A significantly higher proportion of patients receiving induction treatment with subcutaneous administrations of Simponi 200mg at Week 0 and Simponi 100mg at Week 2 or Simponi 400mg at Week 0 and Simponi 200mg at Week 2 met the primary endpoint of clinical response at Week 6 compared with the placebo [51.8%, 55% and 29.7% of patients achieving clinical response, respectively (P<0.0001)]. Clinical response at Week 6 was defined as a decrease in the Mayo score of at least 30% and 3 points compared to baseline score, with either a decrease from baseline in the rectal bleeding subscore of at least 1 or a rectal bleeding subscore of 0 or 1. 

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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