Safety and effectiveness of tofacitinib in ulcerative colitis: Data from TOFA-UC, a SN-IBD study.

BACKGROUND: Real-world evidence is needed to determine the value of tofacitinib (TOFA) for the treatment of ulcerative colitis (UC). AIM: To assess the safety and effectiveness of TOFA in clinical practice. METHODS: TOFA-UC is a multicenter, observational study performed among the Sicilian Network for Inflammatory Bowel Disease (SN-IBD). All consecutive patients with UC starting TOFA from its introduction in Sicily (July 2021) to July 2022 were included. RESULTS: 111 patients were included (mean follow-up: 31.7 ± 14.9 weeks; biologic-experienced: 92.8%). Nineteen adverse events were reported (17.1%; incidence rate: 28.2 per 100 patient years), including 11 cases of hypercholesterolemia and 3 infections (no cases of herpes zoster reactivation. At week 8, the rates of clinical response, steroid free clinical remission, and CRP normalization were 74.8%, 45.0%, and 56.9%, respectively, and 68.5%, 51.4%, and 65.2%, respectively, at the end of follow-up. Eighteen patients experienced a loss of response after successful induction (21.7%; incidence rate: 33.2 per 100 patient years). Twenty-six patients (23.4%) discontinued TOFA over time, of whom 3 due to AEs, and 23 to non response or loss of response. CONCLUSIONS: TOFA is safe and effective in patients with UC, including those with history of multiple failures to biological therapies.

Ustekinumab is a promising option for the treatment of postoperative recurrence of Crohn's disease.

BACKGROUND AND AIM: Postoperative recurrence (POR) following ileocolonic resection is a major concern in patients with Crohn's disease (CD). The role of ustekinumab (UST) in this setting is poorly known. METHODS: All consecutive CD patients with a baseline colonoscopy at 6-12 months from ileocolonic resection showing POR (Rutgeerts score ≥ i2) who were treated with UST after the baseline colonoscopy and with an available post-treatment endoscopy, were extracted from the cohort of the Sicilian Network for Inflammatory Bowel Diseases (SN-IBD). The primary outcome was endoscopic success, defined as reduction of at least one point of Rutgeerts score. The secondary outcome was clinical success, assessed at the end of follow-up. Reasons for clinical failure included mild clinical relapse (Harvey-Bradshaw index 5-7), clinically relevant relapse (Harvey-Bradshaw index > 7), and need for new resection. RESULTS: Forty-four patients were included (mean follow-up: 17.8 ± 8.4 months). The baseline postoperative colonoscopy showed severe POR (Rutgeerts score i3 or i4) in 75.0% of patients. The post-treatment colonoscopy was performed after a mean of 14.5 ± 5.5 months following initiation of UST. Endoscopic success was reported in 22 out of 44 (50.0%) patients, of whom 12 (27.3%) achieved a Rutgeerts score i0 or i1. Clinical success at the end of follow-up was reported in 32 out of 44 patients (72.7%); none of the 12 patients with clinical failure had achieved endoscopic success at post-treatment colonoscopy. CONCLUSIONS: Ustekinumab could be a promising option for the treatment of POR of CD.

Association among Disorders of Gut-Brain Interaction (DGBI) and Fibromyalgia: A Prospective Study.

The disorders of gut-brain interaction (DGBI) have been associated with Fibromyalgia (FM). However, there are no data about the relationship between FM and DGBI using Rome IV criteria. This study aimed to evaluate the prevalence of FM in patients with Irritable Bowel Syndrome (IBS) and/or Functional Dyspepsia (FD) and the prevalence of IBS and FD in FM patients using Rome IV criteria. DGBI patients and FM patients were recruited from two outpatient clinics devoted to DGBI and FM. All patients underwent a standardized gastrointestinal (GI) symptoms questionnaire. FM symptoms in DGBI patients were assessed through Fibromyalgia Rapid Screening Tool (FiRST) and Fibromyalgia Impact Questionnaire. Thereafter, the rheumatologists evaluated them. 49.0% of FM patients fulfilled the diagnostic criteria for IBS, 81.6% for FD with an overlap for both IBS/FD in 44.9%. IBS-C was the most prevalent IBS-subtype in DGBI patients, whereas IBS-M was the most prevalent in FM patients (p = 0.01). 45.3% of DGBI patients reported pathological FiRST scores. DGBI patients with FM showed the highest score at the standardized GI questionnaire followed by FM patients with DGBI and DGBI without FM. In conclusion DGBI are common in FM patients and vice versa. The presence of FD is extremely frequent in FM patients. A multidisciplinary approach should be routinely used for the management of these patients.

Impact of COVID-19 lockdown on symptoms in patients with functional gastrointestinal disorders: Relationship with anxiety and perceived stress.

BACKGROUND: Psychological stress and anxiety, such those generated by forced quarantine, affect gastrointestinal symptoms course in patients with functional gastrointestinal disorders. Thus, our aim was to assess, in a cohort of patients regularly followed up in a devoted outpatient clinic of Southern Italy, the association between their gastrointestinal symptoms changes, stress, and anxiety reported during the Italian lockdown. METHODS: We recruited patients from the outpatient clinic of the University of Salerno, devoted to functional gastrointestinal disorders, selecting only patients for whom an evaluation was available in the last 6 months before the lockdown. Gastrointestinal symptoms were evaluated at each visit through standardized questionnaire and pooled in a database. On 45th days from the beginning of the lockdown, patients were re-assessed by phone with the same questionnaire. Anxiety and stress levels were assessed through a self-administered online questionnaire based on Generalized Anxiety Disorder 7 test and Perceived Stress Scale 10 test. KEY RESULTS: The intensity-frequency scores of several upper gastrointestinal symptoms improved (Wilcoxon test <0.05). Higher anxiety levels had a higher risk of worsening chest pain (OR 1.3 [1.1-1.7]), waterbrash (OR 1.3 [1.0-1.7]), epigastric burning (OR 1.3 [1.0-1.6]), and abdominal pain (OR 1.6 [1.0-2.3]). When compared to the interval preceding the outbreak, half of the patients declared their symptoms remained unchanged, 13.6% worsened, and 36.4% improved. CONCLUSIONS AND INFERENCES: During the COVID-19 quarantine, there was an improvement of the majority of upper gastrointestinal symptoms in our patients, and anxiety seems an important risk of worsening few of them.