Anti-tumour necrosis factor discontinuation in inflammatory bowel disease patients in remission: study protocol of a prospective, multicentre, randomized clinical trial

Background: Patients with inflammatory bowel disease who achieve remission with anti-tumour necrosis factor (anti-TNF) drugs may have treatment withdrawn due to safety concerns and cost considerations, but there is a lack of prospective, controlled data investigating this strategy. The primary study aim is to compare the rates of clinical remission at 1?year in patients who discontinue anti-TNF treatment versus those who continue treatment. Methods: This is an ongoing, prospective, double-blind, multicentre, randomized, placebo-controlled study in patients with Crohn?s disease or ulcerative colitis who have achieved clinical remission for ?6?months with an anti-TNF treatment and an immunosuppressant. Patients are being randomized 1:1 to discontinue anti-TNF therapy or continue therapy. Randomization stratifies patients by the type of inflammatory bowel disease and drug (infliximab versus adalimumab) at study inclusion. The primary endpoint of the study is sustained clinical remission at 1?year. Other endpoints include endoscopic and radiological activity, patient-reported outcomes (quality of life, work productivity), safety and predictive factors for relapse. The required sample size is 194 patients. In addition to the main analysis (discontinuation versus continuation), subanalyses will include stratification by type of inflammatory bowel disease, phenotype and previous treatment. Biological samples will be obtained to identify factors predictive of relapse after treatment withdrawal. Results: Enrolment began in 2016, and the study is expected to end in 2020. Conclusions: This study will contribute prospective, controlled data on outcomes and predictors of relapse in patients with inflammatory bowel disease after withdrawal of anti-TNF agents following achievement of clinical remission. Clinical trial reference number: EudraCT 2015-001410-1

Gender, living arrangements and social circumstances as determinants of entry into and exit from long-term institutional care at older ages: a six-year follow-up study of older Finns

Purpose: Due to population ageing, the need for long-term institutional care is increasing. We study the potentially modifiable sociodemographic factors that affect the rate of entry into and exit from long-term care. Design and Methods: A 40% sample from the population registration data of Finns aged 65 and older living in private households at the end of 1997 (n = 280,722) was followed for first entry into (n = 35,926) and subsequent exit—due to death or return to the community—from long-term institutional care until the end of 2003. Results: Being female, old, living alone, and of low socioeconomic status increased the risk for entering long-term care. Exit was affected by the same factors, but the associations were weaker and, with the exception of age, in the opposite direction. Women's higher risk for entry was due to older age and greater likelihood of living alone. The effects of living arrangements and socioeconomic factors on entry were stronger among men and were attenuated after adjustment for each other and for health status. The mean duration of care was 1,064 days among women and 686 among men. Implications: Gender, age, living arrangements, and socioeconomic status are major determinants of institutional residence. Women and certain other population groups, e.g., those living alone, are likely to spend a longer time in institutional care because of higher rates of entry and lower rates of exit. These results have implications for the financing of long-term care and for targeting of interventions aimed at delaying it

Search for heavy Higgs bosons decaying to a top quark pair in proton-proton collisions at root s = 13 TeV (vol 04, 171, 2020)

Erratum to: JHEP04(2020)17