Higher Adalimumab Concentration is Associated with Complete Fistula Healing in Patients with Perianal Fistulizing Crohn's Disease.

Perianal fistulas can develop in around 30% of patients with Crohn's disease (CD) and are associated with impaired quality of life and worse outcomes including increased rates of hospitalizations and surgeries.1 The cornerstone of pharmacologic treatment for perianal fistulizing CD is anti-tumor necrosis factor therapy, mainly infliximab and adalimumab (ADM).2 Therapeutic drug monitoring (TDM) can be used to identify potential pharmacokinetic and pharmacodynamic issues and avoid or manage unwanted outcomes, such as primary nonresponse and secondary loss of response.3 There are several exposure-response relationship data demonstrating a positive correlation between serum infliximab concentrations and favorable objective therapeutic outcomes in patients with perianal fistulizing CD.4 Nevertheless, there are only limited data, which is mostly from small retrospective studies regarding the association of ADM concentration and outcomes in patients with perianal fistulizing CD.4-8 Furthermore, the optimal ADM concentration for fistula healing still remains to be elucidated. This is clinically important because drug concentration cutoffs are used in reactive and proactive TDM algorithms to define therapeutic drug concentrations. This study investigates the association of maintenance ADM concentrations with complete fistula healing (CFH) and identifies an optimal ADM concentration threshold for CFH.

Long-term Outcome of Risankizumab in Crohn's Disease: a Real-world GETAID Study.

BACKGROUND & AIMS: The aim of this study was to assess the long-term effectiveness and safety of risankizumab maintenance treatment in a large real-world cohort of patients with Crohn's Disease (CD). METHODS: From May 2021 to August 2023, all consecutive patients with CD treated with risankizumab in 25 GETAID centers have been retrospectively included. The primary endpoint was steroid-free clinical remission (Harvey Bradshaw Index [HBI] <5) at 52 weeks. RESULTS: Of the 174 patients included, 99%, 93%, and 96% had been previously exposed to anti-TNF, vedolizumab, and ustekinumab, respectively. All patients had received ≥3 biologics, and 108 (62%) had previous intestinal resection. Median follow-up was 13.7 months (interquartile range, 10.0-18.1 months). The rates of steroid-free clinical remission and clinical remission at week 26 were 47% (72/152) and 52% (79/152), and 46% (58/125), and 48% (60/125) at week 52, respectively. Risankizumab persistence rates were 94%, 89%, and 79% at weeks 12, 26, and 52, respectively. At the end of follow-up, 45 (45/174; 26%) patients had discontinued risankizumab (loss of response, 42%; primary failure, 37%; intolerance, 13%). Thirty-six patients (36/174; 20.9%) were hospitalized, and 22 (22/174; 12.6%) required intestinal resection. Fifty-one patients (29%) had an adverse event, including 26 (15%) serious adverse events (CD flare, n = 17). One death (myocardial infarction) and one cancer (papillary thyroid carcinoma) were observed. CONCLUSION: This is the first real-life study to report long-term outcomes in patients with refractory CD treated with risankizumab. One-half of the patients achieved steroid-free clinical remission after 1 year, and the safety profile was consistent with the literature.

Point-of-care ultrasound to assess left ventricular ejection fraction in heart failure in unselected patients in primary care: a systematic review.

BACKGROUND: Heart failure (HF) is the most frequent cardiovascular pathology in primary care. Echocardiography is the gold standard for diagnosis, follow-up, and prognosis of HF. Point-of-care ultrasound (POCUS) is of growing interest in daily practice. AIM: This study aimed to systematically review the literature to evaluate left ventricular ejection fraction (LVEF) assessment of unselected patients in primary care by non-expert physicians with cardiac POCUS (cPOCUS). METHODS: We searched in Medline, Embase, and Pubmed up to January 2024 for interventional and non-interventional studies assessing LVEF with cPOCUS in unselected patients with suspected or diagnosed HF in hospital or outpatient settings, performed by non-expert physicians. RESULTS: Forty-two studies were included, involving 6598 patients, of whom 60.2% were outpatients. LVEF was assessed by 351 non-expert physicians after an initial ultrasound training course. The LVEF was mainly assessed by visual estimation (90.2%). The most frequent views were parasternal long/short axis, and apical 4-chamber. The median time of cPOCUS was 8 minutes. A strong agreement was found (κ = 0.72 [0.63; 0.83]) compared to experts when using different types of ultrasound devices (hand-held and standard), and agreement was excellent (κ = 0.84 [0.71; 0.89]) with the same device. Training course combined a median of 4.5 hours for theory and 25 cPOCUS for practice. CONCLUSION: The use of cPOCUS by non-expert physicians after a short training course appears to be an accurate complementary tool for LVEF assessment in daily practice. Its diffusion in primary care could optimize patient management, without replacing specialist assessment.

Heart failure (HF) is the most frequent cardiovascular pathology in primary care. Echocardiography is the gold standard for its diagnosis, follow up and prognosis, especially for assessing left ventricular ejection fraction (LVEF), one of the essential hemodynamic cardiac markers. At a time when access to specialists is difficult, what if primary health care physicians had a tool that enabled them to sort and prioritize patients with suspected or diagnosed HF? Point-of-care ultrasound (POCUS) is already used in daily medical practice to provide optimum bedside diagnostics and tailored medical cares. Thus, we conduct a systematic review up to January 2024, including 42 studies, gathering 6598 patients with suspected or diagnosed HF, with 60% of outpatients. After a brief theoretical and practical training (a median of 4.5 hours and 25 cardiac POCUS), 351 physicians without expertise in cardiac ultrasound (defined as "non-experts") evaluated LVEF in unselected patients with cardiac POCUS, then compared with the experts' assessment. A strong to excellent agreement was found between the two groups, depending on the type of ultrasound device used. The LVEF assessment using cardiac POCUS after a short training course appears to be an accurate complementary tool for non-expert physicians. Its diffusion in primary care could optimize patient management, without replacing specialist assessment.

Patient preferences for adalimumab in inflammatory bowel disease: a nationwide study from the GETAID.

Background: Several adalimumab preparations are now available for patients with inflammatory bowel disease (IBD). Comparative satisfaction and tolerability are unknown. Objectives: This study investigated IBD patient satisfaction with approved adalimumab biosimilars and their originator. Design: In this cross-sectional study, we included 941 consecutive adalimumab-treated patients with IBD across 45 centres affiliated with the Groupe d'Etude Therapeutique des Affections Inflammatoires du tube Digestif who completed a satisfaction questionnaire comprising four items each rated by a 10-point scale. Methods: The differences in responses were performed using a one-way analysis of variance followed by Tukey's honest significant difference test. Results: The most commonly used drugs at inclusion were Humira® (436/941, 46.3%), Amgevita® (177/941, 18.8%) and Hulio® (105/941, 11.2%). The mean overall satisfaction rate with adalimumab was 8.5 (standard deviation 1.8). Overall satisfaction was significantly higher in patients treated with Humira (8.6 (1.5)), Hulio (8.6 (1.8)) or Amgevita (8.5 (1.4)) (p < 0.05). Satisfaction with the subcutaneous injection form was higher for patients treated with Yuflyma® (9.0 (1.4)), Humira (8.9 (1.3)) and Hulio (8.9 (1.7)) (p < 0.05). A total of 299 patients (31.8%) described injection site reactions. In all, 223 patients (23.7%) reported being previously treated with another adalimumab of which (32/223, 14.3%) discontinued treatment due to side effects. Conclusion: In this real-world setting, patients with IBD had a high level of satisfaction with adalimumab treatment, with some differences in terms of overall satisfaction and satisfaction with the injection device.