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Development and validation of a score to assess transmural healing and response in patients with Crohn’s disease
No full textInternational audienceBecause transmural healing (TH) could be the best therapeutic target in Crohn's disease (CD), we aimed to build and validate a score to assess TH and transmural response (TR), and to confirm their association with favorable CD outcomes. Methods - DEVISE-CD project encompassed 2 retrospective cohorts (274 and 224 patients with CD for development and validation phase, retrospectively) and 1 multicenter prospective validation cohort (N = 46 patients). A step-by-step process was used to build the modified Clermont score (C-score). The primary end points were time to bowel damage progression, and steroid-free clinical remission with fecal calprotectin <250 at 1 year for retrospective and prospective validation cohorts, respectively. Results - Edema, ulcer, contrast enhancement, diffusion-weighted hyperintensity, fat wrapping, bowel thickening (>3 mm), and enlarged lymph nodes were associated to higher risk of bowel damage progression (P < .01). Edema, diffusion-weighted hyperintensity, post-gadolinium contrast enhancement, and bowel thickening were highly coexistent (>95%) and collinear (P < .0001). Bowel thickness had the highest sensitivity to change after treatment (standardized mean difference = 0.30 ± 1.0; P = .001). C-score was calculated as 0.2x(bowel thickness-3mm) + 1.5x enlarged lymph nodes + 2x ulcer. TH (C-score <0.5; hazard ratio [HR], 0.28 [0.13-0.63]; P = .002; adjusted HR [aHR], 0.15 [0.04-0.53]; P = .003), TR50 (50% decrease of C-score; HR, 0.30 [0.15-0.63]; P = .001; aHR, 0.36 [0.14-0.88]; P = .025), or TR25 (25% decrease of C-score; HR, 0.37 [0.19-0.71]; P = .003; aHR, 0.46 [0.23-0.94]; P = .034) prevented bowel damage progression in development and validation cohorts, respectively. In the prospective validation cohort, achieving TH (OR, 4.6 [1.3-15.6]; P = .016), TR50 (OR, 6.9 [1.8-26.0]; P = .008), or TR25 (OR, 6.0 [1.6-22.3]; P = .008) after 12 weeks of anti-tumor necrosis factor therapy led to higher rate of corticosteroid-free remission at 1 year. Conclusions - C-score is a validated, reliable, and easy-to-use tool to assess TH and TR in patients with CD
Clinical picture, outcomes and predictors of relapse in eosinophilia-associated coronary vasospasm: data from a European multicentric study.
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P927 Long-term outcomes of risankizumab in Crohn’s disease: a multicenter GETAID Study
No full textMeeting abstract du "19th Congress of ECCO", Stockholm, Suède, 21-24 février, 2024International audienceBackground Risankizumab is approved for moderate to severe Crohn’s disease (CD). The GETAID recently reported the real-world effectiveness of risankizumab as induction therapy for refractory CD. 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 CD. Methods From May 2021 to August 2023, all consecutive CD patients treated with risankizumab in 25 GETAID centers have been retrospectively included. Only patients who received risankizumab 600 mg IV at week 0,4 and 8 as induction and SC 360 mg every 8 weeks as maintenance treatment were included. The primary outcome measure was steroid-free clinical remission (Harvey Bradshaw Index (HBI) < 5) at week 52. Secondary outcomes included clinical response (≥ 3-point decrease of HB score and/or (HB) score < 5), endoscopic (no ulcers) and/or radiologic remission (normal intestinal ultra-sound or MRI), need for CD-related surgery, and adverse events. Results All patients had received at least three biologics and 108 (62%) had previous intestinal resection. Of the 174 patients included, 172 (99%), 162 (93%), and 167 (96%) had been previously exposed to anti-TNF, vedolizumab, and ustekinumab, respectively. Respectively 66 (38%) and 24 (14%) patients were on corticosteroids and immunosuppressants at risankizumab initiation. Median follow-up was 13.7 (10.0-18.1) months. The rates of steroid-free clinical remission and clinical remission at 52 weeks were 46% (60/131) and 50% (65/131), respectively. Absence/mild abdominal pain with normal stool frequency was observed in 48% (54/112) of patients at week 52. Among the 79 (45%) patients who had an endoscopic (n=67) and/or radiological (MRI, n=56 and IUS, n=15) evaluation during follow-up, response and remission were observed in 27 (34%) and 17 (22%) patients, 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. No factors were associated with steroid-free clinical remission at week 52. Twenty-five (14%) patients had an adverse event and 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. Half of the patients achieved steroid-free clinical remission after one year, and the safety profile was consistent with the literature
P1071 Patient preferences for adalimumab in inflammatory bowel disease: a nationwide study from the GETAID
No full textMeeting abstract du "19th Congress of ECCO", Stockholm, Suède, 21-24 février, 2024International audienceBackground Several adalimumab preparations are now available on the market for patients with inflammatory bowel disease. Comparative satisfaction and tolerability are unknown. The aim of this study was to investigate inflammatory bowel disease patient satisfaction with approved adalimumab biosimilars and their originator. Methods In this cross-sectional study, we included 941 consecutive adalimumab-treated patients with inflammatory bowel disease across 45 centres affiliated with the GETAID who completed a satisfaction questionnaire comprising four items each rated by a 10 points-scale. The differences in responses were performed using 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%). 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]) < 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]) (< 0.05). A total of 299 patients (31.8%) described injection site reactions. Two hundred twenty-three patients (23.7%) reported that they were 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 inflammatory bowel disease had a high level of satisfaction with adalimumab treatment, with some differences in terms of overall satisfaction and satisfaction with the injection device
Le déséquilibre effort–récompense durant la pandémie de COVID-19 en France
No full textInternational audienceContexteLes effets de la répétition des confinements sur le stress au travail, exprimé par le déséquilibre effort–récompense (ER), au cours de la pandémie de COVID-19 sont peu documentés. Le déséquilibre effort–récompense (ER) est l’un des modèles représentant le stress lié au travail, proposé par Siegrist en 1996. Sa composante extrinsèque (ER) est associée au stress au travail et à des complications somatiques, y compris la mortalité cardiovasculaire. Nous avons étudié l’effet de la répétition des confinements sur la balance ER chez les travailleurs français, ses différences entre les professions et l’évolution de ses facteurs prédicteurs dans le temps.MéthodesLes participants ont été inclus dans l’étude COVISTRESS, observationnelle transversale prospective, du 30 mars 2020 au 28 mai 2021. Le résultat principal était le score effort-récompense (ER, échelle visuelle analogique). Le score ER de la population a été examiné via des équations d’estimation généralisées. Pour chaque période, les facteurs influençant le score ER ont été étudiés par régression linéaire multivariée.RésultatsChez 8121 participants, le score ER a diminué au cours des 2 premiers confinements (53,2 ± 0,3, p < 0,001 ; 50,5 ± 0,7, p < 0,001) et après le deuxième confinement (54,8 ± 0,8, p = 0,004) par rapport à la période prépandémique (59 ± 0,4). Le score ER était plus élevé chez les médecins que chez les professionnels paramédicaux pendant la période prépandémique et les deux premiers confinements. Dans l’analyse par équations d’estimation généralisées, les classes d’âge 35–45 et 45–55, et le temps passé depuis le début de la pandémie étaient associés à une plus mauvaise balance effort–récompense, alors que la profession médicale et des charges de travail plus élevées étaient associées à une meilleure balance effort–récompense. Les facteurs associés avec le score ER dans la période prépandémique étaient de moins en moins influents à mesure l’avancée de la pandémie.ConclusionDans un large échantillon français, le déséquilibre effort–récompense s’est aggravé pendant la pandémie de COVID-19 jusqu’à la fin du deuxième confinement. Les professionnels paramédicaux ont subi une charge de stress plus importante que les professionnels médicaux
Chlorhexidine-alcohol compared with povidone-iodine-alcohol skin antisepsis protocols in major cardiac surgery: a randomized clinical trial
No full textInternational audiencePurpose: Whether skin disinfection of the surgical site using chlorhexidine-alcohol is superior to povidone-iodine-alcohol in reducing reoperation and surgical site infection rates after major cardiac surgery remains unclear.Methods: CLEAN 2 was a multicenter, open-label, randomized, two-arm, assessor-blind, superiority trial conducted in eight French hospitals. We randomly assigned adult patients undergoing major heart or aortic surgery via sternotomy, with or without saphenous vein or radial artery harvesting, to have all surgical sites disinfected with either 2% chlorhexidine-alcohol or 5% povidone-iodine-alcohol. The primary outcome was any resternotomy by day 90 or any reoperation at the peripheral surgical site by day 30.Results: Of 3242 patients (1621 in the chlorhexidine-alcohol group [median age, 69 years; 1276 (78.7%) men] and 1621 in the povidone-iodine-alcohol group [median age, 69 years; 1247 (76.9%) men], the percentage required reoperation within 90 days was similar (7.7% [125/1621] in the chlorhexidine-alcohol group vs 7.5% [121/1621] in the povidone-iodine-alcohol group; risk difference, 0.25 [95% confidence interval (CI), - 1.58-2.07], P = 0.79). The incidence of surgical site infections at the sternum or peripheral sites was similar (4% [65/1621] in the chlorhexidine-alcohol group vs 3.3% [53/1621] in the povidone-iodine-alcohol group; risk difference, 0.74 [95% CI - 0.55-2.03], P = 0.26). Length of hospital stay, intensive care unit or hospital readmission, mortality and surgical site adverse events were similar between the two groups.Conclusion: Among patients requiring sternotomy for major heart or aortic surgery, skin disinfection at the surgical site using chlorhexidine-alcohol was not superior to povidone-iodine-alcohol for reducing reoperation and surgical site infection rates
Prenatal exome sequencing, a powerful tool for improving the description of prenatal features associated with genetic disorders
No full textInternational audienceAbstract Objective Prenatal exome sequencing (pES) is now commonly used in clinical practice. It can be used to identifiy an additional diagnosis in around 30% of fetuses with structural defects and normal chromosomal microarray analysis (CMA). However, interpretation remains challenging due to the limited prenatal data for genetic disorders. Method We conducted an ancillary study including fetuses with pathogenic/likely pathogenic variants identified by trio‐pES from the “AnDDI‐Prenatome” study. The prenatal phenotype of each patient was categorized as typical, uncommon, or unreported based on the comparison of the prenatal findings with documented findings in the literature and public phenotype‐genotype databases (ClinVar, HGMD, OMIM, and Decipher). Results Prenatal phenotypes were typical for 38/56 fetuses (67.9%). For the others, genotype‐phenotype associations were challenging due to uncommon prenatal features (absence of recurrent hallmark, rare, or unreported). We report the first prenatal features associated with LINS1 and PGM1 variants. In addition, a double diagnosis was identified in three fetuses. Conclusion Standardizing the description of prenatal features, implementing longitudinal prenatal follow‐up, and large‐scale collection of prenatal features are essential steps to improving pES data interpretation
Apport de l’anesthésie générale et des outils numériques pour la réhabilitation esthétique et fonctionnelle d’une patiente avec un antécédent de carcinome épidermoïde symphysaire : cas clinique
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Anti-CD20 Therapies in Drug-Naive Patients With Primary Progressive Multiple Sclerosis
No full textInternational audienceBackground and objectives: Although rituximab failed to demonstrate a significant effect on disability progression in primary progressive multiple sclerosis (PPMS), ocrelizumab succeeded. Our main objective was to analyze confirmed disability progression (CDP) in a cohort of patients with PPMS treated with anti-CD20 therapies compared with a weighted untreated control cohort.Methods: This was a retrospective study using data from the French MS registry (Observatoire Français de la Sclérose En Plaques). We included patients with PPMS treated or never treated with anti-CD20 therapies from 2016 to 2021, with an Expanded Disability Status Scale score of ≤6.5 at baseline. The primary outcome was time to first CDP. The secondary outcomes were time to first relapse, MRI activity at 2 years, identification of risk factors associated with CDP, and serious infection incidence rates (IIRs). Each outcome was studied using an inverse probability of treatment weighting method. The outcomes were modeled using a weighted proportional Cox model for the time-to-event outcomes and by a logistic regression regarding the MRI activity.Results: A total of 1,184 patients (426 treated and 758 untreated) fulfilled the inclusion criteria. Median age (Q1-Q3) was 56 years (49.3-63.8), and 52.7% were female. Among treated patients, 295 received rituximab, whereas 131 received ocrelizumab. At baseline, anti-CD20-treated patients were younger (median 51.9 vs 58.6 years, Cohen d = 0.683) and had more active disease (54.5 vs 27.8%, Cohen d = 0.562). 91.6% were drug-naive at inclusion. In time to first CDP analysis, no statistical significance was observed (hazard ratio [HR], 1.13; 95% CI 0.93-1.36, p = 0.2113). In time to first relapse analysis, a nonsignificant trend toward fewer patients relapsing in the treated group was observed (HR 0.83; 95% CI 0.48-1.28, p = 0.0809). For MRI activity, no significant difference was found between the 2 groups. Risk factors associated with CDP in the treated group were male sex and MS duration. IIR was 6.67 (95% CI 3.12-14.25) per 100 person-years in the treated group vs 2.67 (95% CI 0.80-8.86) in the untreated group.Discussion: Time to first CDP was not different between anti-CD20 treated and untreated patients with PPMS. Although our study is retrospective and mainly included patients treated by rituximab, our results indicate that there should be a constant evaluation of all available data to ascertain the best risk/benefit ratio for patients with PPMS.Classification of evidence: This study provides Class III evidence that anti-CD20 therapy of previously untreated patients with PPMS was not superior to no therapy in delaying time to first CDP
Evaluation of a delayed liver transplantation strategy for patients with HCC receiving bridging therapy: the DELTA-HCC study
No full textInternational audienceBackground & AimsTo maximize utility and prevent premature liver transplantation (LT), a delayed LT strategy (DS) was adopted in France in 2015 in patients listed for any single HCC treated with resection or thermal ablation during the waiting phase. The DS involves postponing LT until recurrence. The purpose of this study was to evaluate the DS to make sure that it did not hamper pre- and post-LT outcomes.MethodsPatients listed for HCC in France between 2015 and 2018 were studied. After data extraction from the national LT database, 2,025 patients were identified and classified according to six groups: single tumor entering DS, single tumor not entering DS, multiple tumors, no curative treatment, untreatable HCC or T1 tumors. Kaplan-Meier estimates of the 18-month risk of dropout for death, too sick to be transplanted or tumor progression before LT, 5-year post-LT HCC recurrence and post-LT survival rates were compared.ResultsMedian waiting-time in the DS group was 910 days. Pre-LT dropout probability was significantly lower in the DS group compared to other groups (13% vs. 19%, p = 0.0043) and significantly higher in the T1 group (25.4%, p = 0.05). Post-LT HCC recurrence rate in the multiple nodules group was significantly higher (19.6%, p = 0.019), while 5-year post-LT survival did not differ among groups and was 74% in the DS group (p = 0.22).ConclusionThe DELTA-HCC study shows that DS does not negatively impact either pre- nor post-LT patient outcomes, and has the potential to allow for redistribution of organs to patients in more urgent need of LT. It can reasonably be proposed and pursued. The unexpectedly high risk of dropout in T1 patients seems related to the MELD-based offering rules underserving this subgroup