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Background: Transmural healing (TH) is being increasingly recognized for reflecting deep remission in Crohn's disease (CD). The long-term clinical significance of achieving TH is still not fully known. We aimed to evaluate TH as a predictor of long-term positive outcomes using intestinal ultrasonography (US), with comparison with the established endpoint mucosal healing (MH). Methods: CD patients were consecutively recruited from September 2015 to August 2018 at a single tertiary hospital. All patients were evaluated at baseline and followed up at 6 months prospectively with a guideline-based treatment regimen. Achieving TH/MH or not was evaluated by US/colonoscopy at the first follow-up. Long-term outcomes including steroid-free clinical remission (CR), drug escalation, hospitalization, and surgery, were recorded after at least another 12 months. Results: We identified 77 patients with a median age of 30 years (range, 12–73 years). Twenty-five (32%) patients achieved TH, and 31 (40%) patients achieved MH. TH and MH were poorly correlated (Cohen's κ = 0.387; p < 0.05). Univariate analysis showed that both MH and TH were associated with better long-term outcomes. In multivariate analysis, TH was an independent predictor of steroid-free CR [odds ratio (OR), 52.6; p < 0.001], drug escalation (OR, 0.1; p = 0.002), and hospitalization (OR, 0.05; p = 0.005), while MH was an independent predictor of drug escalation (OR, 0.3; p = 0.05). Smoking habit was the only predictor of surgery (OR, 6.6; p = 0.02). Conclusion: TH is an independent predictor of more favorable long-term outcomes than MH, suggesting that TH could become the potential treatment endpoint in CD. Plain language summary: Transmural healing predicts good prognosis in Crohn's disease The therapeutic endpoints of Crohn's disease keep evolving. The long-term clinical significance of achieving transmural healing is not fully discovered. Transmural healing is an independent predictor of more favorable long-term outcomes than mucosal healing. Transmural healing could become the potential treatment endpoint in Crohn's disease. [ABSTRACT FROM AUTHOR]

Treat-to-target strategies have changed the approach to management of many chronic conditions, with improvements in patient outcomes. The key to success of treat to target is the availability of validated treatment endpoints, which have been difficult to derive for SLE, a condition notorious for its heterogeneity. This review will focus on the development and validation of the definitions of remission in SLE framework and the lupus low disease activity state. Lupus low disease activity state is more attainable than remission, with a stepwise concentric relationship between the target states indicating increasing stringency. Both lupus low disease activity state and definitions of remission in SLE remission have been proven to be associated with reduction in disease flares, reduced risk of accrual of irreversible end organ damage, and improvement in patient reported outcomes. These endpoints have therefore provided the key for the development of a treat-to-target approach in clinical practice in SLE and for the design of future clinical trials. [ABSTRACT FROM AUTHOR]

Summary Chronic hepatitis delta represents the most severe form of chronic viral hepatitis. The current treatment of hepatitis delta virus (HDV) infection consists of the use of interferons and is largely unsatisfactory. Several new compounds are currently in development for the treatment of HDV infection. However, surrogate markers that can be used to develop clinical endpoints in HDV infection are not well defined. In the current manuscript, we aimed to evaluate the existing data on treatment of HDV infection and to suggest treatment goals (possible "trial endpoints") that could be used across different clinical trials. [ABSTRACT FROM AUTHOR]

Objectives A survey of the Ovarian Cancer National Alliance revealed a communication gap between physicians and survivors. This qualitative study explored the space between perceptions in hopes of better defining treatment endpoints meaningful to treating physicians and their patients. Methods A focus group of ovarian cancer survivors (n = 22) was assembled via the survivor support network SHARE. A physician-guided session explored expectations of treatment, perceived outcomes, toxicity thresholds and decision making. The session was recorded, transcribed and coded. Common themes were identified and used to perform intra-case analysis by two independent reviewers. Results The main themes identified were barriers to communication, importance of frequent communication between patient and physician regarding goals, and expectations of treatment changing with position along the treatment continuum. One hundred percent of participants identified communication with their physician as an essential element in determining treatment course. However, only 14% reported having a discussion about goals, values and perceptions with their physician preceding treatment decisions. Participants reported that the terms progression free and overall survival held minimal significance for them and instead they preferred an individualized approach to care focusing on quality of life. Many women underreported side effects with reasons ranging from fear of dose reductions and additional tests to forgetting about symptoms due to anxiety. Conclusions An objective measure of treatment success meaningful to survivors, physicians and regulators is, at present, elusive and may not exist. Ideally, future trial design would place equal weight on quantitative and qualitative measures and include information about goals of treatment. [ABSTRACT FROM AUTHOR]