Positive Results Reported for Golimumab (Simponi) in Patients With Ulcerative Colitis
Treatment induces clinical response in phase III trials (February 5)
The results of two pivotal clinical studies from the Program of Ulcerative Colitis Research Studies Utilizing an Investigational Treatment (PURSUIT) have been published in Gastroenterology.
The studies evaluated golimumab (Simponi, Janssen) induction and maintenance therapy in anti-tumor necrosis factor (TNF)-naïve adults with moderate-to-severe ulcerative colitis who had shown an inadequate response to or had failed to tolerate conventional treatments.
According to findings from the PURSUIT Induction and PURSUIT Maintenance studies, a greater proportion of patients who received subcutaneous (SC) golimumab at weeks 0 and 2 achieved a clinical response at week 61 and maintained that response with SC golimumab administered every 4 weeks through week 54 compared with the placebo group.
In the phase III portion of the PURSUIT Induction study, 51% of patients who received golimumab 200 mg/100 mg at weeks 0 and 2 and 55% of patients who received golimumab 400 mg/200 mg at weeks 0 and 2 met the primary endpoint of a clinical response at week 6 compared with 30% of patients in the placebo group.
In addition, according to results from the PURSUIT Maintenance study, 47% of patients who received golimumab 50 mg and 50% of patients who received golimumab 100 mg every 4 weeks maintained a continuous clinical response through week 54 compared with 31% of the placebo group, meeting the study’s endpoint.
At week 6 of the phase III portion of the PURSUIT Induction study, significantly greater results were achieved for the major secondary endpoints in the golimumab 200 mg/100 mg and golimumab 400 mg/200 mg treatment groups compared with the placebo group, including:
- Clinical remission: 18%, 18%, and 6%, respectively (P < 0.0001)
- Mucosal healing: 42% (P = 0.0014), 45% (P = 0.0001), and 29%, respectively
Source: CNW; February 5, 2014.