Efficacy and Safety of CT-P13 in Inflammatory Bowel Disease after Switching from Originator Infliximab: Exploratory Analyses from the NOR-SWITCH Main and Extension Trials.

BACKGROUND: The NOR-SWITCH main and extension trials demonstrated that switching from originator to biosimilar infliximab (CT-P13) is efficacious and safe across six diseases. However, a subgroup analysis of Crohn's disease (CD) in the main trial displayed a close to significant difference favouring originator infliximab, and more scientific data have therefore been requested. OBJECTIVE: The aim was to assess treatment efficacy, safety, and immunogenicity in an explorative subgroup analysis in CD and ulcerative colitis (UC) in the NOR-SWITCH trials. PATIENTS AND METHODS: The 52-week, randomised, non-inferiority, double-blind, multicentre, phase 4 NOR-SWITCH study was followed by a 26-week open extension trial where all patients received treatment with CT-P13. Treatment efficacy, safety, and immunogenicity in CD and UC were assessed throughout the 78-week study period. RESULTS: The main and extension trials included 155 and 93 patients with CD and 93 and 80 patients with UC, respectively. Demographic and baseline characteristics were comparable in both treatment arms within patient groups. There were no differences in the main and extension trials regarding changes in activity indices, C-reactive protein, faecal calprotectin, patient's and physician's global assessment of disease activity and patient-reported outcome measures in CD and UC. Moreover, comparable results were also demonstrated for trough serum levels, presence of anti-drug antibodies, and reported adverse events. CONCLUSION: Efficacy, safety, and immunogenicity of both the originator and biosimilar infliximab were comparable in CD and UC in the NOR-SWITCH main and extension trials. These explorative subgroup analyses confirm that there are no significant concerns related to switching from originator infliximab to CT-P13 in CD and UC. TRIAL REGISTRATION: ClinicalTrials.gov, number NCT02148640.

Routine vs. on-demand analgesia in colonoscopy: a randomized clinical trial.

BACKGROUND AND STUDY AIMS: Colonoscopy is frequently performed with opioid analgesia, but the impact of drug delivery timing has not been studied in detail. Low-dose opioids administered before the procedure may provide better pain control than on-demand administration when the patient experiences pain. PATIENTS AND METHODS: A total of 119 outpatients were randomized to receive 50 µg of fentanyl either before colonoscopy (routine group) or on demand if needed during the colonoscopy (on-demand group). Additional fentanyl or midazolam was allowed in both groups if required. The primary outcome was pain measured on both a 100-mm visual analog scale (VAS; 0 = no pain, 100 = worst possible pain) and a four-point Likert scale (no, slight, moderate, or severe pain) immediately after the procedure. RESULTS: A total of 61 patients in the routine group and 58 patients in the on-demand group were included in the study. Mean VAS pain scores were 27.4 mm in the routine group and 30.5 mm in the on-demand group (mean difference - 3.2 mm; 95 % confidence interval - 11.9 to 5.5; P = 0.5). On the Likert scale, moderate or severe pain was experienced by 25.0 % and 31.5 % of patients in the routine and on-demand groups, respectively (p = 0.5). Cecal intubation rate and time to reach the cecum were similar between the groups. More patients in the on-demand group (81.0 %) than in the routine group (62.3 %) were able to leave the clinic without the need for recovery time (P = 0.03). CONCLUSION: Routine administration of fentanyl did not provide better analgesia during colonoscopy than on-demand fentanyl, and more patients needed time for recovery. TRIAL REGISTRATION: ClinicalTrials.gov (NCT01786434).

[The development of BMI in 4-year-olds in Tromsø 1980 to 2005]. / Utviklingen i kroppsmasseindeks hos fireåringer i Tromsø 1980-2005.

BACKGROUND: Studies indicate that the number of overweight adults and children in Norway is increasing. The aim of this study was to find out whether the epidemic of obesity has reached 4-year olds in Tromsø. MATERIAL AND METHOD: The study is retrospective and compares cross-sectional surveys to find trends. Age in months, height and weight of 4-year olds were collected from child health care centre records in Tromsø, Norway. Data from 1645 children born in 1976, 1981, 1986, 1991 and 2001 were collected. The body mass index (BMI) was calculated and adjusted for age with standard deviation scores. The children were classified as normal or overweight based on the recommendations from the International Obesity Task Force. RESULTS: Mean BMI was 15.9 kg/m2 for boys and 15.8 kg/m2 for girls born in 2001. BMI had not changed significantly from that for children born in 1976. The prevalence of overweight in girls has increased significantly from 7.2 % to 16.8 % in the same period (p = 0.02). The prevalence of overweight in boys born in 2001 was 8.8 %; this is not significantly different from those born in 1976. At the two most recent measurements the prevalence of overweight in girls was significantly higher than the prevalence of overweight in boys. INTERPRETATION: The increasing prevalence of overweight in girls may indicate that the epidemic of obesity is starting to affect 4-year-old girls in Tromsø. The development is worrying and should be further monitored and followed up.