ABSTRACT
BACKGROUND: The GEMINI trials established the efficacy of vedolizumab in moderate-to-severe inflammatory bowel disease (IBD) and demonstrated a favorable safety profile, suggesting it may be advantageous in older patients at greater risk of treatment-related complications. However, there is a paucity of data exploring the outcomes of vedolizumab in this group. Our objective was to determine the clinical effectiveness and safety of vedolizumab in older IBD patients within a real-world multicenter UK cohort. METHODS: A retrospective review of electronic records across 6 UK hospitals was undertaken to evaluate the clinical effectiveness and safety outcomes of vedolizumab in IBD patients aged ≥60 at start of therapy. Rates of clinical response, remission and corticosteroid-free remission were assessed at weeks 14 and 52, using validated clinical indices, and were compared to historical controls from real-world vedolizumab-treated cohorts unstratified by age. RESULTS: Of 74 patients aged 60 years or above (median 66 years), 48 were included in our effectiveness analysis (29 ulcerative colitis, 19 Crohn's disease). Rates of clinical response, remission and corticosteroid-free remission at week 14 were 64%, 48% and 30%, respectively. By week 52, the rates of clinical response, remission, and corticosteroid-free remission were 52%, 38%, and 32%, respectively. Six (8%) patients experienced adverse effects. Effectiveness and safety outcomes were comparable to those of age-unstratified vedolizumab-treated cohorts. CONCLUSION: Our 1-year outcome data suggests that vedolizumab is safe and effective in older IBD patients and broadly comparable to cohorts unselected by age.
ABSTRACT
BACKGROUND: Abdominal pain following percutaneous endoscopic gastrostomy (PEG) placement is a recognized complication. However, the prevalence and degree of severity of pain are poorly characterized. We assessed abdominal pain and anxiety levels associated with PEG placement in communicative and noncommunicative patients. METHODS: A prospective questionnaire assessed patients' anxiety and abdominal pain 1 hour before, 1 hour after, and 24 hours after PEG placement using 11-point Likert-type scales. Patients were followed up until pain had resolved. Procedural data, analgesia requirements, and complications were recorded. For analysis, patients were divided into 2 groups: communicative (able to self-assess) and noncommunicative (clinician assessed). RESULTS: Seventy consecutive patients were assessed. Of the 49 self-assessed patients, 11 (22%) reported immediate pain, 32 (65%) reported pain at 1 hour (24 mild, 5 moderate, 3 severe), and 40 (82%) reported pain at 24 hours. Pain most commonly lasted between 24 and 48 hours (25 patients). Of the 21 clinician-assessed patients, only 1 was deemed to have pain, and this was at 24 hours. Four (6%) patients were admitted with pain. There was no relationship between preplacement anxiety scores and postplacement pain scores. DISCUSSION: Abdominal pain after PEG placement pain is common but resolved by 48 hours in most patients. In patients able to communicate, clinicians scored pain lower compared with patients' scores. It is likely that pain is not identified in patients unable to communicate. Patients need to be better informed about the possibility of postprocedural pain and routinely offered access to appropriate analgesia.
