Long-term efficacy and safety of biosimilar infliximab (CT-P13) after switching from originator infliximab: open-label extension of the NOR-SWITCH trial.

BACKGROUND AND OBJECTIVES: The 52-week, randomized, double-blind, noninferiority, government-funded NOR-SWITCH trial demonstrated that switching from infliximab originator to less expensive biosimilar CT-P13 was not inferior to continued treatment with infliximab originator. The NOR-SWITCH extension trial aimed to assess efficacy, safety and immunogenicity in patients on CT-P13 throughout the 78-week study period (maintenance group) versus patients switched to CT-P13 at week 52 (switch group). The primary outcome was disease worsening during follow-up based on disease-specific composite measures. METHODS: Patients were recruited from 24 Norwegian hospitals, 380 of 438 patients who completed the main study: 197 in the maintenance group and 183 in the switch group. In the full analysis set, 127 (33%) had Crohn's disease, 80 (21%) ulcerative colitis, 67 (18%) spondyloarthritis, 55 (15%) rheumatoid arthritis, 20 (5%) psoriatic arthritis and 31 (8%) chronic plaque psoriasis. RESULTS: Baseline characteristics were similar in the two groups at the time of switching (week 52). Disease worsening occurred in 32 (16.8%) patients in the maintenance group vs. 20 (11.6%) in the switch group (per-protocol set). Adjusted risk difference was 5.9% (95% CI -1.1 to 12.9). Frequency of adverse events, anti-drug antibodies, changes in generic disease variables and disease-specific composite measures were comparable between arms. The study was inadequately powered to detect noninferiority within individual diseases. CONCLUSION: The NOR-SWITCH extension showed no difference in safety and efficacy between patients who maintained CT-P13 and patients who switched from originator infliximab to CT-P13, supporting that switching from originator infliximab to CT-P13 is safe and efficacious.

Incontinence after colonoscopy--an unrecognized and preventable problem. A cross-sectional study from the Gastronet quality assurance program.

BACKGROUND: Colonoscopy requires insufflation of gas for visualization of the bowel wall. Worldwide, this is usually done using air. The aim of the present study was to assess the risk of postcolonoscopy incontinence, and to investigate whether insufflation of CO2 instead of air may reduce this risk, since it is easily absorbed through the bowel mucosa. METHODS: This is a prospective multicenter study of colonoscopy patients undergoing bowel insufflation using air or CO2. A successive series of colonoscopies were reported to a national quality assurance program in Norway between January and December 2009 from 21 endoscopy centers with varying insufflation practices. The study comprised 7812 patients aged 18 years or older who were referred for outpatient colonoscopy. Of these, 5015 underwent colonoscopy performed using air and 2797 colonoscopy using CO2 insufflation. RESULTS: Patient-reported incontinence up to 24 h after colonoscopy was compared using binary logistic regression analysis for the type of gas used for insufflation. The air and CO2 patient groups were comparable with regard to age, sex, indication for colonoscopy, and sedation practice. Incontinence was reported by 336 out of 7812 patients (4.3%). Incontinence was significantly less frequent in the CO2 group than in the air group [2.1% versus 5.5%; adjusted odds ratio (OR) 0.38; 95%CI 0.28-0.50; P < 0.001]. Female patients had a higher risk of incontinence than men (adjusted OR 1.77; 95% CI 1.39-2.24; P < 0.001). CONCLUSION: About every 20th patient undergoing colonoscopy using standard air insufflation experiences postexamination incontinence. This proportion can be reduced by 60% by converting from air insufflation to insufflation with the absorbable CO2.