Effectiveness and safety of tofacitinib for ulcerative colitis: two-year results of the ICC Registry.

BACKGROUND: Tofacitinib is an oral Janus kinase (JAK) inhibitor and is registered for the treatment of ulcerative colitis (UC). The effectiveness of tofacitinib has been evaluated up to 12 months of treatment. AIM: The aim of this study was to assess the effectiveness and safety of 24 months of tofacitinib use in UC patients in the Netherlands. METHODS: Patients initiating tofacitinib treatment were included in the ICC Registry, a nationwide, observational registry. Patients were prospectively evaluated for up to 24 months. The primary outcome was corticosteroid-free clinical remission (CSFR, Simple Clinical Colitis Activity Index [SCCAI] ≤2) at week 104. Secondary outcomes included biochemical remission (C-reactive protein (CRP) ≤5 mg/L and faecal calprotectin (FC) ≤250 µg/g), safety, and discontinuation rate. RESULTS: We included 110 patients of whom 104 (94.5%) were anti-TNF experienced. After 104 weeks of tofacitinib, 31.8% (34/107) were in CSFR, 23.4% (25/107) in biochemical remission and 18.7% (20/107) in combined clinical and biochemical remission. Of the patients in CSFR at week 52, 76.5% (26/34) remained so after 104 weeks of treatment. Sixty-one patients (55.5%) discontinued tofacitinib after a median duration of 13 weeks (IQR 7-34). The main reasons for discontinuation were non-response (59%), loss of response (14.8%), and adverse events (18%). There were 33.9 possible tofacitinib-related adverse events per 100 patient-years during follow-up. Adverse events most probably related to tofacitinib were skin reactions and headaches. There were 6.4 herpes zoster infections per 100 patient-years. CONCLUSION: Tofacitinib was effective in 31.8% of patients after 24 months of treatment.

Severe COVID-19 in inflammatory bowel disease patients in a population-based setting.

OBJECTIVE: Data on the course of severe COVID-19 in inflammatory bowel disease (IBD) patients remains limited. We aimed to determine the incidence rate and clinical course of severe COVID-19 in the heavily affected South-Limburg region in the Netherlands. METHODS: All COVID-19 patients admitted to the only two hospitals covering the whole South-Limburg region between February 27, 2020 and January 4, 2021 were included. Incidence rates for hospitalization due to COVID-19 were determined for the IBD (n = 4980) and general population (n = 597,184) in South-Limburg. RESULTS: During a follow-up of 4254 and 510,120 person-years, 20 IBD patients (0.40%; 11 ulcerative colitis (UC), 9 Crohn's disease (CD)) and 1425 (0.24%) patients from the general population were hospitalized due to proven COVID-19 corresponding to an incidence rate of 4.7 (95% Confidence interval (CI) 3.0-7.1) and 2.8 (95% CI 2.6-2.9) per 1000 patient years, respectively (Incidence rate ratio: 1.68, 95% CI 1.08-2.62, p = 0.019). Median age (IBD: 63.0 (IQR 58.0-75.8) years vs. general population: 72.0 (IQR 62.0-80.0) years, p = 0.10) and mean BMI (IBD: 24.4 (SD 3.3) kg/m2 vs. general population 24.1 (SD 4.9) kg/m2, p = 0.79) at admission were comparable in both populations. As for course of severe COVID-19, similar rates of ICU admission (IBD: 12.5% vs. general population: 15.7%, p = 1.00), mechanical ventilation (6.3% vs. 11.2%, p = 1.00) and death were observed (6.3% vs. 21.8%, p = 0.22). CONCLUSION: We found a statistically significant higher rate of hospitalization due to COVID-19 in IBD patients in a population-based setting in a heavily impacted Dutch region. This finding reflects previous research that showed IBD patients using systemic medication were at an increased risk of serious infection. However, although at an increased risk of hospitalization, clinical course of severe COVID-19 was comparable to hospitalized patients without IBD.

Poor nutritional status, risk of sarcopenia and nutrition related complaints are prevalent in COVID-19 patients during and after hospital admission.

BACKGROUND AND AIMS: Patients with COVID-19 infection presents with a broad clinical spectrum of symptoms and complications. As a consequence nutritional requirements are not met, resulting in weight- and muscle loss, and malnutrition. The aim of the present study is to delineate nutritional complaints, the (course of the) nutritional status and risk of sarcopenia of COVID-19 patients, during hospitalisation and after discharge. METHODS: In this prospective observational study in 407 hospital admitted COVID-19 patients in four university and peripheral hospitals, data were collected during dietetic consultations. Presence of nutrition related complaints (decreased appetite, loss of smell, changed taste, loss of taste, chewing and swallowing problems, nausea, vomiting, feeling of being full, stool frequency and consistency, gastric retention, need for help with food intake due to weakness and shortness of breath and nutritional status (weight loss, BMI, risk of sarcopenia with SARC-F ≥4 points) before, during hospital stay and after discharge were, where possible, collected. RESULTS: Included patients were most men (69%), median age of 64.8 ± 12.4 years, 60% were admitted to ICU at any time point during hospitalisation with a median LOS of 15 days and an in-hospital mortality rate of 21%. The most commonly reported complaints were: decreased appetite (58%), feeling of being full (49%) and shortness of breath (43%). One in three patients experienced changed taste, loss of taste and/or loss of smell. Prior to hospital admission, 67% of the patients was overweight (BMI >25 kg/m2), 35% of the patients was characterised as malnourished, mainly caused by considerable weight loss. Serious acute weight loss (>5 kg) was showed in 22% of the patents during the hospital stay; most of these patients (85%) were admitted to the ICU at any point in time. A high risk of sarcopenia (SARC-F ≥ 4 points) was scored in 73% of the patients during hospital admission. CONCLUSION: In conclusion, one in five hospital admitted COVID-19 patients suffered from serious acute weight loss and 73% had a high risk of sarcopenia. Moreover, almost all patients had one or more nutritional complaints. Of these complaints, decreased appetite, feeling of being full, shortness of breath and changed taste and loss of taste were the most predominant nutrition related complaints. These symptoms have serious repercussions on nutritional status. Although nutritional complaints persisted a long time after discharge, only a small group of patients received dietetic treatment after hospital discharge in recovery phase. Clinicians should consider the risks of acute malnutrition and sarcopenia in COVID-19 patients and investigate multidisciplinary treatment including dietetics during hospital stay and after discharge.