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Fecal calprotectin, intestinal ultrasound, and their combination for the diagnosis of inflammatory bowel disease
No full textInternational audienceBackground: We aimed to evaluate the diagnostic accuracy of fecal calprotectin (FC) and intestinal ultrasound (IUS), independently and in combination, as screening tools for adults with suspected IBD to reduce the number of unnecessary endoscopic procedures.Methods: We conducted a retrospective monocentric study that included consecutive adult patients with (i) ileocolonoscopy for suspected IBD between January 2021 and June 2023 who had either (ii) IUS and/or (iii) a FC test within 6 weeks. Bowel wall thickness (BWT) and the color Doppler signal (CDS) were evaluated for all segments. The presence of lymphadenopathy, loss of stratification, stricture, and fistula were also recorded.Results: In total, 119 patients with a median age of 32 years (IQR, 24.0-41.0) were included. The most common symptoms were abdominal pain (n=88, 75%) and chronic diarrhea (n=89, 75%). Among the 119 patients, 74 (62%) had IUS, 101 (82%) had a FC test, and 56 (47%) had both. Forty patients (34%) had a diagnosis of IBD, including 31 (26%) with CD and 9 (8%) with UC. By ROC curve analysis, the best threshold of FC to diagnose IBD was 117 ug/g (Se 97%, Sp 73%, PPV 67%, NPV 98%, AUC 0.88, 95%CI [0.81; 0.94], p=0.006). Using this threshold, only 3% of patients were misclassified as non-IBD. Screening by measuring FC levels would result in a 48% reduction in the number of adults requiring endoscopy. Abnomal IUS was significantly associated with a diagnosis of IBD (OR 5.6, 95%IC [2.1;16.2], P=0.0008). The association of a BWT>3 mm and a positive CDS was associated with a Se, Sp, PPV, and NPV of 48%, 100%, 100%, and 75%, respectively, but 52% of patients were misclassified as non-IBD. The combination of a BWT>3 mm, CDS, and FC>117 ug/g had a Se, Sp, PPV, and NPV of 44%, 100%, 100%, and 69%, respectively. For patients with a normal IUS and FC<117 ug/g, 4% were misclassified as non-IBD.Conclusions: The combination of FC and IUS is a useful screening strategy to identify patients who truly require endoscopy for suspected IBD. Calprotectin is a highly effective test for ruling out IBD. Conversely, relying solely on IUS lacks the discriminative power to safely rule out IBD. However, it shows a high PPV and is a potent tool for diagnosing IBD
Nivolumab and hypofractionated radiotherapy in patients with advanced melanoma: A phase 2 trial
No full textInternational audienceBackground: Radiotherapy is thought to enhance anti-tumor immunity, particularly when delivered in a hypofractionated and multisite manner. Therefore, we investigated the effects of combining radiotherapy with nivolumab in patients with advanced melanoma.Methods: This was a multicenter, non-randomized, phase 2 trial that enrolled patients with treatment-naïve metastatic melanoma. They received nivolumab (240 mg / 2 weeks) plus radiotherapy (day 15, 6 Gy × 3). When feasible, one target from each organ was irradiated (no irradiation of all targets). The primary endpoint was 1-year overall survival (OS).Results: This trial included 64 patients between March 2017 and July 2019. The median follow-up was 23.5 (2.3-43.8) months. The median age was 68 (35-95) years, patients were mostly male (67 %) with an Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score of 0 (72 %), stage IV-M1c disease (47 %), and were BRAF-wild-type (67 %). The 2-year OS and 1-year PFS rates were 65.2 % and 56 %, respectively (P = 0.22 and P = 0.03, vs. 58 % and 43 %, respectively, in the Checkmate 066 study). Thirty-seven (58 %) and twenty-seven (42 %) patients were irradiated at one and multiple targets, respectively. The ECOG-PS (1 vs. 0; HR = 3.5; P = 0.005) was an independent prognostic factor for OS. Irradiating more than one site and irradiating a smaller cumulative tumor volume tended to correlate with better outcome. Grade 3-4 treatment-related adverse events occurred in 21.9 % of the patients (no grade 5).Conclusions: Combined immunotherapy and hypofractionated radiotherapy did not improve survival compared to historical cohorts. The radiotherapy schedule needs to be optimized in order to improve these results
Impact and risk factors of anti-rituximab antibodies in small-vessel vasculitis: a multicenter retrospective study
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Efficacy and safety of capsaicin 8% patches: The experience of a rheumatology department
No full textInternational audienceBackground: Capsaicin 8% patches are recommended for the treatment of localized neuropathic pain, which is a frequent reason for rheumatology consultations. Objectives: This study aimed to evaluate the efficacy and safety of capsaicin 8% used in our Rheumatology Department. Design: Single-center retrospective study. Methods: Patients treated by capsaicin 8% between October 03, 2019 and December 31, 2023 were included. Their age, sex, pain duration, DN4 score, pain intensity, and the cause of the neuropathic pain were collected. Patch safety was assessed on the day of application and after 15 days. The patient was asked about improvement, pain intensity, and the occurrence of burning sensations. Results: One hundred twelve patients (mean age 62, 70% female) were included. The causes of neuropathic pain were especially scar ( n = 31), digital osteoarthritis ( n = 26), or radiculalgia ( n = 22). Sixty patients reported improvement (54%) at day 15, with a mean percentage of improvement of 59%. Mean pain intensity decreased from 6.4 ± 1.9 to 4.5 ± 2.7 ( p < 0.001). This improvement in pain was significant regardless of etiology. There was no difference in age, sex, and pain duration between improved and unimproved patients. Fifty-eight patients (58/106: 54.7%) experienced burning sensations after patching, mainly of moderate to high intensity (32/52: 61.5%), with an average duration of 2 days. Of the eight unimproved after the first patch, six reported a 50% improvement after the second patch. Conclusion: Capsaicin 8% appeared to be an effective treatment in localized neuropathic pain, whatever the cause. It seemed beneficial to repeat the application after the 1st one had failed. Burning sensations after placement were fairly frequent, usually moderate to high, but lasting only a short time
Influence of Socio-Demographic, Occupational and Lifestyle Variables on Sleep Time
No full textInternational audienceBackground: Socio-demographic, occupational and lifestyle variables influence total sleep time. Therefore, we aimed to evaluate the influence of those variables on sleep time, and to study risk factors of being a short sleeper.Methods: The COVISTRESS international study is an online questionnaire using the secure REDCap® software. Total sleep time was evaluated using declared bedtime and time of awakening and was analyzed as a quantitative variable and as a qualitative variable.Results: We included 549 respondents to the questionnaire, divided into 10-year age groups ranging from <30yo to ≥60yo. The mean quantity of sleep was 7.11±1.43 hours per night. Factors that reduce total sleep time were age (coefficient -0.19, 95CI -0.33 to 0.06), being an employee (-0.46, -0.85 to -0.06), working time (-0.18, -0.31 to 0.05), smoking ≥5 cigarettes/day (-0.5, -0.95 to -0.20), high stress at work (-0.64, -0.96 to -0.32) and at home (-0.66, -0.97 to -0.35). Being a student (0.61, 0.02 to 1.19), working less than 25h per week (0.57, 0.17 to 0.97) and telework (0.46, 0.02 to 0.89) increased total sleep time. The risk factors of being a short sleeper were age (odds ratio 1.27, 95CI 1.07 to 1.51), being an employee (2.58, 1.36 to 4.89), smoking ≥5 cigarettes/day (2.73, 1.54 to 4.84) and a high level of stress at work (2.64, 1.45 to 4.82) and at home (3.89, 2.25 to 6.63). Physical activity ≥2.5 hours/week tended to decrease the risk of being a short sleeper by 35%.Conclusion: We demonstrated the concomitant impact of sociodemographic, occupational and lifestyle behavior on sleep, which may help to build efficient preventive strategy
Daratumumab can lead to long-lasting remissions in patients with refractory immune thrombocytopenia but with a high incidence of severe infections
No full textMeeting abstractInternational audienceIntroduction Despite the increasing number of therapeutic options for immune thrombocytopenia (ITP), refractory disease remains an unmet need in clinical practice. Anti-CD38 monoclonal antibodies such as daratumumab have recently been shown to be a promising treatment in ITP. The aim of this study was to assess safety and efficacy of daratumumab given for refractory ITP. Patients and methods We conducted an observational, retrospective, multicenter study throughout the network of the French reference center for adult' immune cytopenias including patients receiving compassionate off-label treatment by daratumumab for ITP (either primary or secondary) between 01/01/2020 and 01/06/2025. ITP was diagnosed according to international guidelines. Patients were excluded if daratumumab was given to treat plasma cell malignancy. Complete response (CR) was defined by platelet count >100x109/L and response (R) by platelet count 30 to 100x109/L with at least a 2-fold increase from baseline. Patients who required any other treatment including rescue therapy more than six weeks after first daratumumab infusion were considered non-responders regardless of platelet counts. All patients were informed and gave consent to ‘off-label’ use of daratumumab. The study received institutional review board approval (00011558, UPEC University, AP-HP). Results Twenty-one patients (43% females) with a median age at first daratumumab infusion of 67 years [range 21-88] were included in the study. Eight had secondary ITP (38%; Evans syndrome, n=6, and/or antiphospholipid syndrome (APLS), n=2, or rheumatoid arthritis, n=1). In addition, 2 patients had antibodies against GPIIb-IIIa (acquired Glanzmann syndrome, n=1) and GPVI (n=1) responsible for chronic bleeding symptoms. Median ITP duration was 78 months [range 4-594], and patients had previously received a median number of 8 [range, 3-12] treatment lines for ITP, including corticosteroids (100%), rituximab (100%), intravenous immunoglobulin (95%), thrombopoietin receptor agonists (95%; including eltrombopag [90%] and romiplostim [86%]), mycophenolate mofetil (81%), splenectomy (71%), fostamatinib (48%), and one or more other immunosuppressive drug (43%). Fifteen patients (71%) had bleeding symptoms despite treatment in the previous month. Patients received a median number of 6 [range 3-20] infusions of daratumumab either at 16mg/kg of body weight intravenously (n=10) or at a fixed dose of 1800 mg subcutaneously (n=11) with dexamethasone premedication. Daratumumab was given with other ITP treatments in 15 patients (71%). Median follow up after daratumumab was 16 months [range 1-60]. Ten (48%) patients had adverse events imputable to daratumumab, including 5 patients (24%) with infectious events requiring hospitalization (sepsis, n=2, bacterial pneumonia, n=2, acute tonsillitis, n=1), 2 patients with transient neutropenia (but without infection), and 3 patients with immediate reaction after infusion. During follow-up, 4 patients (19%) died (1 splenectomized patient had campylobacter sepsis 1 month after daratumumab initiation, 1 patient with stroke and APLS had sepsis 23 months after daratumumab, 1 patient died from refractory ITP, and 1 patient with metastatic cancer died from cardiac failure). In the 6 months following daratumumab, among the 10 patients with available gammaglobulin assessment without intravenous immunoglobulin administration, 8 (80%) had concentrations below 6g/L. Overall response (CR+PR) was achieved in 11 patients (52%), including 9 CR (43%), and 2 PR (10%), with a median time to response of 35 days [range 7-84]. Relapses occurred in 3/7 (43%) of responders that had a follow-up >6 months after daratumumab. Four patients had long-lasting CR without any other ITP treatment, with relapses in 2 (50%) after 10 and 32 months, respectively. Two patients with initial CR and experiencing a relapse had a second course of daratumumab, resulting in 2 new initial CR but eventually with relapses in both patients. Discussion Overall, these results suggest that daratumumab has the potential to induce durable remissions even in multirefractory ITP patients, although response appears transient in most responders. However, this came at the cost of a high rate of severe infections in this particular group of heavily treated, frequently splenectomized, immunocompromised and fragile patients. Careful assessment of benefit/risk balance is therefore warranted before daratumumab administration
Development and characterization of an amphotericin B vaginal ovule for the local treatment of recrurrent vulvovaginal candidiasis
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