Cédric Baumann

Cumulative incidence of, risk factors for, and outcome of dermatological complications of anti-TNF therapy in inflammatory bowel disease: a 14-year experience.

Objectives:The broader and prolonged use of anti-tumor necrosis factor (TNF) agents in inflammatory bowel disease (IBD) could expose patients to an increased risk of adverse reactions, including dermatological complications. We assessed the cumulative incidence of anti-TNF-induced cutaneous adverse reactions in IBD patients, their risk factors, their dermatological management, and their outcome in a large cohort of IBD patients.Methods:In a single-center observational retrospective study, including all consecutive adult IBD patients treated with an anti-TNF agent between 2001 and 2014, all patients with dermatological complications under anti-TNF therapy were identified in a well-defined cohort of IBD patients. We conducted a survival analysis to determine the cumulative incidence of dermatological complications and risk factors for developing any dermatological complications, cutaneous infections, and psoriasiform lesions. Survival curves were estimated by the Kaplan–Meier method, and we used a Cox proportional hazards model to test the association between parameters and time to each event: any dermatological complication, cutaneous infections, and psoriasis lesions.Results:Among 583 IBD patients, 176 dermatological complications occurred, involving 20.5% of patients. Median duration of follow-up was 38.2 months (range: 1–179). Psoriasiform lesions (10.1%; 59/583) and cutaneous infections (11.6%, 68/583) were the most frequently observed, with a cumulative incidence of, respectively, 28.9% and 17.6% at 10 years. They led to anti-TNF discontinuation, respectively, in 18.6% and 2.9% of patients. In case of switching to another anti-TNF agent for psoriasiform lesions, recurrence occurred in 57% of patients. Ulcerative colitis was associated with a lower risk of developing cutaneous infections than Crohn’s disease (hazard ratio (HR)=0.25; 95% confidence interval (CI)=0.09–0.68; P=0.007). Higher dosing of anti-TNF agent was associated with a higher risk of developing cutaneous infections (HR=1.99; 95% CI=1.09–3.64; P=0.025). A younger age at time of anti-TNF initiation was associated with a higher risk of dermatological complications (HR=2.25; 95% CI=1.39–3.62; P<0.001).Conclusions:Dermatological complications involve one of five patients treated with anti-TNF therapy after a 14-year follow-up. Association of cutaneous infections with higher anti-TNF dosing suggests a dose-dependent effect. Discontinuation of anti-TNF therapy due to dermatological complications is required in one out of five patients with psoriasiform lesions, but specific dermatological treatment allows to continue anti-TNF therapy in half of them.

An endoscopic Mayo score of 0 is associated with a lower risk of colectomy than a score of 1 in ulcerative colitis

Dear Sir, In a recent article1 we showed that correlation between histological indexes is strong for ulcerative colitis (UC). Due to the lack of intervention studies and the absence of a validated histological index, histological healing cannot be considered as a treatment goal in clinical practice for these patients. Pending these studies, we need to define the therapeutic goal for patients with UC. In the ACT 1 and 2 clinical trials,2 early mucosal healing defined by an endoscopic Mayo score (EMS) of 0–1 was associated with a lower risk of colectomy through 54 weeks of follow-up evaluation and better long-term outcomes related to symptomatic remission, corticosteroid-free symptomatic remission and corticosteroid use, and subsequent mucosal healing at weeks 30 and 54. With the exception of colectomy …

Effect of gender on the association between weight status and health-related quality of life in adolescents.

BackgroundSome studies have investigated the association between body mass index (BMI) and health-related quality of life (HRQoL) among adolescents, but their results have been discrepant and few paid attention to the role of gender. The present investigation aimed to assess the relationship between weight status and HRQoL in adolescents and to verify whether it was similar in boys and girls.MethodsFive thousand two hundred and twenty six adolescents aged 14 to 18 years were included in the PRomotion de l’ALIMentation et de l’Activité Physique (PRALIMAP) trial, a 2x2x2 factorial cluster randomized trial performed in 24 high schools in France. Sociodemographic, anthropometric and HRQoL data were collected. BMI was categorized in four classes (thin, normal-weight, overweight, obese). Linear regression models were used to estimate the association between weight status and HRQoL, adjusting for confounders.ResultsThe mean age of adolescents was 15.7±0.6 years and their mean BMI was 21.6 ±3.5 kg/m2; 55% were girls. Boys were more often overweight and obese than were girls (overweight: 15.6% vs 14.2%, obese: 4.8% vs 3.3%), and girls were more likely to be thin (5.5% vs 4.5%, p=0.0042). All HRQoL scores were higher for boys (p=<0.0001). Weight status was not associated with physical and social scores neither in boys nor in girls. Conversely, it was associated with mental score, but differently in girls than boys. As compared with normal-weight girls, thin girls had better mental HRQoL (β=+6.17, p=0.0010), and overweight and obese girls had lower mental HRQoL (β=−3.89 and β=−5.90, respectively, p<0.001). Mental HRQoL was lower for thin, overweight and obese boys than for normal-weight boys (β= −4.97, β= −1.68 and β= −3.17, respectively, p<0.0001).ConclusionsGender can modify the association between weight status and HRQoL in adolescents. Body image could be an important target of public health programs to improve subjective health during adolescence.

Impact of immunosuppressive therapy on hepatitis B vaccination in inflammatory bowel diseases.

Background and aims The vaccination rate against hepatitis B virus (HBV) is low in inflammatory bowel disease (IBD) patients. The Consensus from the European Crohn’s and Colitis Organisation on opportunistic infections recommends testing all IBD patients for HBV at diagnosis and vaccinating all HBV-negative patients. We compared the efficacy of HBV vaccine between IBD patients and healthy controls and investigated the impact of immunosuppressive therapy on vaccine response in IBD patients. Materials and methods IBD patients and healthy adult workers were vaccinated against HBV following a standard protocol (at 0, 1, and 6 months; Engerix B). The efficacy of vaccination was evaluated at 8 months by a titer of antibodies against hepatitis B surface antigen (anti-HBs). Results Among 164 participants (96 with IBD and 68 healthy workers), the level of anti-HBs was greater than 10 IU/l in 80.2 and 94.1% (P=0.0115) of IBD patients and healthy controls, respectively, and anti-HBs levels greater than 100 IU/l were seen in 45.8 versus 77.9% (P<0.0001) of IBD patients and healthy controls, respectively. The median level of anti-HBs was significantly higher in healthy controls (497.0±386.2) than in IBD patients (253.9±34.5) (P<0.0001). None of the baseline characteristics of IBD patients, including immunomodulators and antitumor necrosis factor therapy, influenced the vaccine response. In the multivariate analysis, ileal disease was the only factor associated with a lower response to the vaccine (odds ratio=3.2; 95% confidence interval=1.0–9.7; P=0.049). Conclusion The response rate to HBV vaccination is significantly lower in IBD patients than in the general population. Immunosuppressive therapy for IBD did not influence the vaccine response.

Otitis media with effusion as a marker of the inflammatory process associated to nasal polyposis

Despite the close location of polyps with the Eustachian tube, association between nasal polyposis (NP) and otitis media with effusion (OME) has not been described in the literature. Our retrospective case-control study aimed at assessing the relative risk to develop OME when NP is associated to factors such as asthma, aspirin intolerance (AI), atopy, eosinophil infiltration of polyp tissue, and history of surgical treatment (HST). We compared the charts of 25 NP patients presenting symptomatic OME with 50 NP patients without OME. All the charts contained validated data about OME, asthma, AI, atopy, eosinophil count in polyp tissue, and HST. Our study showed that the risk to develop OME in NP patients is five times higher in patients presenting aspirin triad (NP + asthma + AI) (OR = 5.6, p = 0.009) and three times higher in HST patients (OR = 3.5, p = 0.03), than in isolated NP patients. A linear trend exists between the different degrees of respiratory disease and the risk of OME (p = 0.01). Our data suggest that the development of OME could be considered as another marker of severity of the inflammatory disease leading to NP, asthma and AI. Better characterisation of NP patients with OME could allow is to define more accurately the nature, type and severity of the underlying inflammatory process.

Differential item functioning (DIF) of SF-12 and Q-LES-Q-SF items among french substance users

BackgroundDifferential Item Functioning (DIF) is investigated to ensure that each item displays a consistent pattern of responses irrespective of the characteristics of the respondents. Assessing DIF helps to understand the nature of instruments, to assess the quality of a measure and to interpret results. This study aimed to examine whether the items of the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) and Short-Form 12 (SF-12) exhibit DIF.MethodA total of 124 outpatients diagnosed with substance dependence participated in a cross-sectional, multicenter study. In addition to the Q-LES-Q-SF and SF-12 results, demographic data such as age, sex, type of substance dependence and education level were collected. Rasch analysis was conducted (using RUMM2020 software) to assess DIF of the Q-LES-Q-SF and SF-12 items.ResultsFor SF-12, significant age-related uniform DIF was found in two of the 12 items, and sex-related DIF was found in one of the 12 items. All of the observed DIF effects in SF-12 were found among the mental health items. Three items showed DIF on the Q-LES-Q-SF; however, the impact of DIF item on the delta score calculation for the comparisons of self-reported health status between the groups was minimal in the SF-12 and small in the Q-LES-Q-SF.ConclusionThese results indicated that no major measurement bias affects the validity of the self-reported health status assessed using the Q-LES-Q-SF or SF-12. Thus, these questionnaires are largely robust measures of self-reported health status among substance users.

Beliefs and behaviour about smoking among inflammatory bowel disease patients.

Background and aims We investigated the beliefs and behaviours about tobacco among inflammatory bowel disease (IBD) patients. Materials and methods A questionnaire of 18 items was developed and administered to all consecutive patients followed for IBD at Nancy University Hospital from October 2012 to March 2013. Results Two hundred and thirty-one patients participated in the survey [Crohn’s disease (CD)=171, ulcerative colitis (UC)=60]. Among IBD patients who were smokers at diagnosis, 10.5% of CD patients versus 14.3% of UC patients believed that tobacco could have triggered their IBD; about half the CD smokers at diagnosis were not aware that smoking might promote their disease. Three quarters of smokers after diagnosis knew that tobacco was not beneficial for their CD, whereas all UC were aware that smoking had a beneficial effect on their disease course. About half of the CD patients had stopped smoking during a flare-up. Four former smokers with UC (21.1%) resumed smoking during a relapse. Nearly 90% of IBD current smokers wished to quit smoking. About half the IBD patients were aware of the relation between smoking and IBD, and the Internet was a source for 24.3% of these patients. Conclusion The majority of IBD patients are unaware of the effects of tobacco on their disease. Better information through a therapeutic education programme should be systematically recommended in IBD.

Combination of classical test theory (CTT) and item response theory (IRT) analysis to study the psychometric properties of the French version of the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF)

ObjectiveThe study aimed to examine the construct validity and reliability of the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) according to both classical test and item response theories.MethodThe psychometric properties of the French version of this instrument were investigated in a cross-sectional, multicenter study. A total of 124 outpatients with a substance dependence diagnosis participated in the study. Psychometric evaluation included descriptive analysis, internal consistency, test–retest reliability, and validity. The dimensionality of the instrument was explored using a combination of the classical test, confirmatory factor analysis (CFA), and an item response theory analysis, the Person Separation Index (PSI), in a complementary manner.ResultsThe results of the Q-LES-Q-SF revealed that the questionnaire was easy to administer and the acceptability was good. The internal consistency and the test–retest reliability were 0.9 and 0.88, respectively. All items were significantly correlated with the total score and the SF-12 used in the study. The CFA with one factor model was good, and for the unidimensional construct, the PSI was found to be 0.902.ConclusionThe French version of the Q-LES-Q-SF yielded valid and reliable clinical assessments of the quality of life for future research and clinical practice involving French substance abusers. In response to recent questioning regarding the unidimensionality or bidimensionality of the instrument and according to the underlying theoretical unidimensional construct used for its development, this study suggests the Q-LES-Q-SF as a one-dimension questionnaire in French QoL studies.

Accuracy of Diffusion-weighted Magnetic Resonance Colonography in Assessing Mucosal Healing and the Treatment Response in Patients with Ulcerative Colitis

Background and Aims Using sigmoidoscopy as the gold standard, we assessed the accuracy, and the responsiveness to change, of diffusion-weighted magnetic resonance colonography in ulcerative colitis, using the Nancy score. Methods A total of 29 ulcerative colitis patients, having undergone at least two diffusion-weighted magnetic resonance colonographies, were included. Disease activity was evaluated using the Mayo endoscopic subscore and the Nancy score. We determined the accuracy of the Nancy score in the diagnosis of mucosal healing. We also assessed its responsiveness to change in 17 patients with a Mayo endoscopic subscore of 2 or 3 at treatment initiation. Results A total Nancy score < 7 had a sensitivity of 0.75 and a specificity of 0.67 (area under the curve: 0.72; 95% confidence interval: [0.56-0.88]; p = 0.0063) in the diagnosis of mucosal healing. The total Nancy score was sensitive to change in ulcerative colitis [Guyatts responsiveness index: 1.8; standardised effect size ratio: 1.36]. The Nancy score was reliable [intra-class correlation coefficient: 0.63; p = 0.01]. The mean Mayo endoscopic subscore and the mean Nancy score both fell significantly in patients who achieved mucosal healing (mean ± standard deviation [SD] Mayo endoscopic subscore: 2.4 ± 0.55 at baseline and 0.6 ± 0.55 at reassessment, p = 0.02; mean Nancy score: 18.2 ± 9.1 at baseline and 3 ± 1.6 at reassessment, p = 0.006). No significant changes in Nancy score were observed in active patients at reassessment. Conclusions The Nancy score is a highly responsive, reliable tool for assessing treatment response in patients with ulcerative colitis. The Nancy score accurately detects mucosal healing.

Adherence to infliximab therapy in inflammatory bowel disease patients in a real-life setting

To assess adherence to infliximab (IFX) therapy in inflammatory bowel disease patients, to investigate reasons for non‐adherence and to identify predictors for non‐adherence.