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GO-COLITIS: Simponi Induces Clinical Response in Patients With Ulcerative Colitis
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Simponi induced clinical response in more than two-thirds of patients with moderate-to-severe ulcerative colitis in the induction phase of the GO-COLITIS trial, according to interim results presented at the European Crohn’s and Colitis Organization’s Congress.
Simponi (golimumab, Janssen) “is a human monoclonal antibody that forms high-affinity, stable complexes with both the soluble and transmembrane bioactive forms of human tumor necrosis factor (TNF)-alpha,” according to a press release.
“We are delighted to be able to contribute real-world data to the growing clinical experience with golimumab,” Chris Probert, MD, of University of Liverpool, said in a press release. “This response rate shows the potential efficacy of golimumab in the management of moderately to severely active ulcerative colitis.”
Chris Probert
In this phase 4, multicenter, open-label trial, Probert and colleagues enrolled 205 patients with moderate-to-severe UC and administered 200 mg subcutaneous golimumab on day 0 and 100 mg on day 14 of the 6-week induction phase, followed by 50 mg or 100 mg every 4 weeks during the 48-week maintenance phase with 12-week follow-up. All patients were anti-TNF naive, received one or two induction doses, and 60% were men (mean age, 39.3 years; range, 18-79 years). Mean baseline partial Mayo score was 6.4 ± 1.4.
Clinical response occurred in 68.8% (95% CI, 62-75.1) of patients, and clinical remission occurred in 38.5% (95% CI, 31.8-45.6). The mean change from baseline in partial Mayo score was –3.2 ± 2.4. Adverse events occurred in 18% of patients and serious adverse events occurred in 8% of patients, including flare or worsening of UC in 11 patients, accidental overdose in two, as well as anaphylaxis, constipation, rectal fissure and respiratory tract infection in one patient each. Discontinuation of therapy due to serious adverse events occurred in 4% of patients. There were no fatal adverse events.
Patients with clinical response were eligible to continue to the maintenance phase, which is ongoing, and at the end of the induction phase, “patients reported significant improvements in generic quality of life (QoL) and disease-specific QoL, including bowel symptoms, emotional function, systemic symptoms and social function,” according to the press release. – by Adam Leitenberger
Referen ce:
Probert C, et al. Abstract DOP049. Presented at: ECCO Congress; March 16-19, 2016. Amsterdam.
Disclosure: Probert reports he served as a consultant for AbbVie, Napp and Takeda, and received lecture and/or other fees from AbbVie, Falk, Ferring, MSD, Napp, Shire and Takeda. Please see the ECCO disclosures database for all other researchers’ relevant financial disclosures.