Little is known about how the change from intravenous to subcutaneous vedolizumab in a real-life setting in inflammatory bowel disease patients on stable maintenance therapy affects clinical outcomes. We compared the data on vedolizumab serum trough concentration, efficacy, and safety prior to and six months after the switch from intravenous to subcutaneous vedolizumab. In total, 24 patients, 13 with ulcerative colitis (UC) and 11 with Crohn’s disease (CD), were included. Mean serum trough concentration of intravenous vedolizumab was significantly lower than mean serum trough concentration of subcutaneous vedolizumab (p = 0.002). There was no significant difference between C-reactive protein levels, fecal calprotectin levels or clinical scores (Harvey–Bradshaw index or Partial Mayo score) prior to transition to subcutaneous vedolizumab and after 6 months. In four (16.7%) patients, two CD and two UC, therapy was discontinued during the follow-up period with a median of 5 months (minimum–maximum: 4–6). In all patients, therapy was discontinued due to loss of response. In total, 13 adverse events were reported by 11 patients, and the most common adverse event was COVID-19. No serious adverse events were reported. In conclusion, subcutaneous vedolizumab has shown to be effective and safe in patients on previously established maintenance therapy with intravenous vedolizumab.
Background and objectives: Dreaming is a commonly reported side effect of propofol anesthesia. Materials and Methods: We investigated the inci-dence and character of dreams in patients undergoing intravenous propofol anesthesia and cor-related it with an observer rating scale of facial expression on the seven-point scale from pain to smile. A total of 124 patients undergoing gastrointestinal endoscopy were recruited in the pro-spective observational study. Bispectral index (BIS), blood pressure (BP), and pulse were moni-tored. Upon emergence from anesthesia, the patient’s facial expression was rated numerically. Thereafter, patients were asked whether they had dreams and to rate their dreams as pleasant or unpleasant. The mean age of participants was 53; body mass index, 26.17; duration of procedure, 20 min; and average propofol dose, 265 mg. Results: Dreaming was reported by 43% of patients. Dreams were pleasant in all but one patient. There was a significant correlation of the observer’s rating of facial expression with dreaming (r = 0.260; p = 0.004). Dreamers had higher scores of observer rating of facial expression (1 (0–2) vs. 0.5 (0–1), p = 0.006). Conclusions: BIS values were lower in the dreamers vs. non-dreamers 2 min after the endoscopy started (48 (43–62) vs. 59 (45–71), p = 0.038). Both BIS and observer ratings correlate with dreaming in patients undergoing gastrointestinal endos-copy. Trial registration number: NCT04235894.
Background
CT-P13 subcutaneous (SC) infliximab formulation showed comparable efficacy and safety with CT-P13 intravenous (IV) infliximab in inflammatory bowel disease (IBD)1 and rheumatoid arthritis2. This study aimed to demonstrate the superiority of CT-P13 SC over placebo as maintenance therapy after induction therapy of CT-P13 IV in patient with Crohn’s disease (CD).
Methods
Moderately to severely active CD patients with Crohn’s disease activity index (CDAI) score 220 to 450 and simplified endoscopic activity score for Crohn’s disease (SES-CD) of ≥6 points for ileal-colonic CD or ≥4 points including ulcer score from at least 1 segment for ileal CD or colonic CD were enrolled LIBERTY-CD study (NCT03945019) and treated with open-label CT-P13 IV 5 mg/kg at Weeks 0, 2 and 6 as induction therapy. At Week 10, patients who had a clinical response were randomised (2:1) to receive either CT-P13 SC 120 mg (CT-P13 SC) or placebo every 2 weeks up to Week 54. At Week 54, clinical remission and endoscopic response were assessed as co-primary endpoints. Clinical response, clinical remission (alternative definition), endoscopic remission, and corticosteroid-free remission were assessed at Week 54 as key secondary endpoint. Safety was evaluated up to Week 54.
Results
A total of 396 patients were enrolled and 343 patients (86.6%) were randomised (231 in CT-P13 SC arm and 112 in placebo arm) at Week 10. At Week 54, the clinical remission rate was greater in CT-P13 SC arm than placebo arm (62.3% and 32.1% respectively, with P <0.0001). The endoscopic response rate was also greater in CT-P13 arm than placebo arm (51.1% and 17.9% respectively, with P <0.0001). CT-P13 SC also had significantly greater efficacy on key secondary endpoints results compared to placebo arm (Table 1). Safety profiles were generally comparable between CT-P13 SC and placebo arms, but a single death was reported during the maintenance phase (Table 2).
Conclusion
CT-P13 SC was more effective than placebo in clinical remission, endoscopic response, clinical response, clinical remission (alternative definition), endoscopic remission, and corticosteroid-free remission at Week 54. No new safety concerns were found during treatment of CT-P13 SC. These results demonstrate that maintenance therapy with CT-P13 SC provides both a robust clinical benefit and the convenience of SC administration to moderately to severely active CD patients.
[1] Schreiber et al., 2021. Gastroenterology 2021;160:2340–23
[2] Westhovens et al., 2020. Rheumatology 2020;00:1
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