MSD has presented a first look at findings from a post-marketing study of its biologic Simponi showing significant improvements in quality of life in patients with ulcerative colitis taking the drug.
The UK GO-COLITIS study looked at the efficacy of Simponi (golimumab) in inducing and maintaining clinical response and quality of life in 205 patients with moderate to severe forms of the disease not previously treated with anti-TNF therapy.
The first data reported from the trial show a significant clinical response in those treated with the drug (69 percent, n=141), and clinical remission at week six in 38.5 percent of patients.
Further findings show that, at the end of the induction phase, patients reported significant improvements in both disease-specific and generic quality of life following treatment with Simponi.
Improvements in disease-specific quality of life were analysed using the Inflammatory Bowel Disease Questionnaire (IBDQ), which asks patients to record their quality of life across a range of measures including feelings of depression, fatigue and low energy, as well as experience of pain, irregular bowel movements and ability to attend work or social engagements.
In a separate observational study to identify cut-off values for patient-defined remission, an IBDQ increase of _20 points was identified as an objective and clinically meaningful endpoint; in GO-COLITIS, the degree of improvement greatly exceeded this with an IBDQ total score of 45.2 points, the firm said.
Adverse events occurred in 18 percent of patients and were consistent with previous observations. Serious AEs were reported in 8 percent of patients: UC flare/worsening (n=11), accidental overdose (n=2), anaphylaxis (n=1), constipation (n=1), rectal fissure (n=1), and respiratory tract infection (n=1). Eight patients (4%) discontinued due to serious AEs.
“GO-COLITIS has shown us that golimumab may offer patients significant improvements in quality of life in the induction phase. We hope that this response in the UK is continued in the maintenance phase of the study,” noted Mark Toms, executive director, Medical Affairs, MSD UK and Ireland.
The ongoing maintenance phase of the study that will evaluate response to Simponi over 48 weeks.