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Endoscopy is the gold standard for the treatment of postoperative gastric leaks (GL). Large fistulas are associated with high rate of treatment failure. The objective of this study was to assess the clinical efficacy of a combining technique using a covered stent (CS) crossing through pigtails (PDs) for large postsurgical GL leaks.All consecutive patients with large ( 10 mm) postsurgical GL treated endoscopically with a combination of a CS and PDs were included in a single-center retrospective study. The primary endpoint was the rate of GL closure.A total of 29 patients were included. Twenty-five patients underwent sleeve gastrectomy. The fistula (median diameter 15 mm) was diagnosed 6 days (IQR 4-9) after surgery. Technical success was observed in all procedures. After a median follow-up of 10.7 months (IQR 3.8-20.7), GL closure was observed in 82.7% with a median time of 63 days (IQR 40-90). Surgical management was finally necessary in four patients after a median of 186 days (IQR 122-250). No complications related to combined endoscopic treatment were observed especially stent migration during the follow-up.An endoscopic strategy combining CS crossing through PDs appears to be effective, safe and well tolerated for the treatment of large GL.

Background Endoscopic submucosal dissection (ESD) is potentially a curative treatment for T1 colorectal cancer under certain conditions. The aim of this study was to evaluate the feasibility and effectiveness of ESD for lesions with a suspicion of focal deep invasion. Methods In this retrospective multicenter study, consecutive patients with colorectal neoplasia displaying a focal ( Results 124 patients benefited from 126 diagnostic dissection attempts for FDIP lesions. Dissection was feasible in 120/126 attempts (95.2 %) and, where possible, the en bloc and R0 resection rates were 95.8 % (115/120) and 76.7 % (92/120), respectively. Thirty-three resections (26.2 %) were for very low risk tumors, so considered curative, and 38 (30.2 %) were for low risk lesions. Noncurative R0 resections were for lesions with lymphatic or vascular invasion (LVI; n = 8), or significant budding (n = 9), and LVI + budding combination (n = 4). Conclusion ESD is feasible and safe for colorectal lesions with an FDIP ≤ 15 mm. It was curative in 26.6 % of patients and could be a valid option for a further 30.6 % of patients with low risk T1 cancers, especially for frail patients with co-morbidities.

Many patients with Crohn's disease (CD) require fecal diversion. To understand the long-term outcomes, we performed a multicenter review of the experience with retained excluded rectums.We reviewed the medical records of all CD patients between 1990 and 2014 who had undergone diversionary surgery with retention of the excluded rectum for at least 6 months and who had at least 2 years of postoperative follow-up.From all the CD patients in the institutions' databases, there were 197 who met all our inclusion criteria. A total of 92 (46.7%) of 197 patients ultimately underwent subsequent proctectomy, while 105 (53.3%) still had retained rectums at time of last follow-up. Among these 105 patients with retained rectums, 50 (47.6%) underwent reanastomosis, while the other 55 (52.4%) retained excluded rectums. Of these 55 patients whose rectums remained excluded, 20 (36.4%) were symptom-free, but the other 35 (63.6%) were symptomatic. Among the 50 patients who had been reconnected, 28 (56%) were symptom-free, while 22(44%) were symptomatic. From our entire cohort of 197 cases, 149 (75.6%) either ultimately lost their rectums or remained symptomatic with retained rectums, while only 28 (14.2%) of 197, and only 4 (5.9%) of 66 with initial perianal disease, were able to achieve reanastomosis without further problems. Four patients developed anorectal dysplasia or cancer.In this multicenter cohort of patients with CD who had fecal diversion, fewer than 15%, and only 6% with perianal disease, achieved reanastomosis without experiencing disease persistence.Patients with distal Crohn’s disease often undergo colon resection with a stoma to divert the intestinal stream from the rectum in hopes of achieving sufficient healing to allow ultimate re-establishment of intestinal continuity. Patients and practitioners alike should be aware of the long-term success rates of this procedure. Our retrospective study of 197 patients found that half required later proctectomy and an additional one-quarter remained symptomatic with excluded rectums. Only 14% remained symptom-free after reanastomosis, and only 6% if perianal disease was the initial surgical indication. These data provide estimation of long-term surgical outcomes.

Management of enterocutaneous fistulas in Crohn's disease is challenging. Most patients still need intestinal resection in the biologic era.The aim of this study was to evaluate the efficacy of endoscopic treatment for enterocutaneous fistulas.This is a retrospective study of medical records.This study was conducted in a single institution.All consecutive patients with Crohn's disease with an enterocutaneous fistula who underwent endoscopic fistula closure with the use of an over-the-scope clip or a hemostatic clip were included.The main outcome measured was the clinical success 3 months after the procedure, which was defined as the complete closure of all fistulas at physical examination and complete cessation of the drainage from the external opening, without surgery.Eight patients (men, 25%; median age 45 years [interquartile range, 33-51]) were followed. Fistulas were localized at the ileocolonic or colocolonic anastomosis in 7 patients and at the stomach in 1 patient. Seven patients were treated with an over-the-scope clip, and one was treated with a hemostatic clip. Technical success was achieved in all cases. Clinical success at 3 months was achieved in 75% of cases (6/8 patients). After a median 16-month (interquartile range, 13-23) follow-up, 3 of 8 (37.5%) patients had enterocutaneous fistula closure and 2 of 8 (25%) needed intestinal resection. No complications were observed.The retrospective nature, the small sample size of the study, and the heterogeneity of the population limit the interpretation of the results.Endoscopic treatment of enterocutaneous fistulas is feasible with a short-term effectiveness. Additional studies are needed to confirm these results. See Video Abstract at http://links.lww.com/DCR/B614.ANTECEDENTES:Es desafiante el manejo de las fístulas enterocutáneas en enfermedad de Crohn. En la era biológica, la mayoría de los pacientes todavía requieren de resección intestinal.OBJETIVO:Evaluar la eficacia por tratamiento endoscópico de fístulas enterocutáneas.ENTORNO CLINICO:Estudio retrospectivo de registros médicos.AJUSTE:Realizado en una sola institución.PACIENTES:Se incluyeron todos los pacientes consecutivos con fístula enterocutánea en enfermedad de Crohn, sometidos a cierre endoscópico de la fístula con clip sobre el endoscopio o clip hemostático.PRINCIPALES MEDIDAS DE VALORACION:El éxito clínico a los 3 meses después del procedimiento. Definido al examen físico, como el cierre completo de todas las fístulas y cese completo del drenaje por la abertura externa, sin cirugía.RESULTADOS:Se estudiaron a ocho pacientes (hombres, 25%, mediana de edad de 45 años (rango intercuartílico, 33-51)). En 7 pacientes, las fístulas se localizaron en la anastomosis ileocolónica o colocolónica y un paciente, en el estómago. Siete pacientes fueron tratados con clip sobre el endoscopio y uno con clip hemostático. Se logró éxito técnico en todos los casos. Se logró éxito clínico a los 3 meses en 75% de los casos (6/8 pacientes). Después de una mediana de 16 meses (rango intercuartílico, 13-23), de seguimiento 3/8 (37,5%) pacientes presentaron cierre de fístulas enterocutáneas y 2/8 (25%) requirieron resección intestinal. No se observaron complicaciones.LIMITACIONES:Estudio retrospectivo, pequeño tamaño de la muestra y heterogeneidad de la población, limitaron la interpretación de los resultados.CONCLUSIONES:Es posible el tratamiento endoscópico de fístulas enterocutáneas con efectividad a corto plazo. Se requieren nuevos estudios para confirmar estos resultados. Consulte Video Resumen en http://links.lww.com/DCR/B614. (Traducción-Dr. Fidel Ruiz Healy).

Introduction: There is debate over the impact of residual microscopic disease after ileocecal resection in Crohn's disease (CD) to predict recurrence. We conducted a meta-analysis to evaluate the impact of positive histological margins and plexitis after ileocecal resection on the risk of postoperative recurrence.Methods: Using a systematic search, we identified. 30 studies evaluating the impact of inflammatory margins on CD recurrence. The primary outcome was the postoperative clinical recurrence and secondary outcomes were surgical, and endoscopic recurrence. We performed random-effects meta-analysis and estimated odds ratio (OR) and 95% CIs.Results: Thirty studies were analyzed, seven focused on myenteric plexitis, six on submucosal plexitis and twenty-three on positive margins. Inflammatory margins were associated with a higher rate of clinical and surgical recurrences: respectively 14 studies - OR 2.38; 95% CI, 1.54 - 3.68- I2 = 68.2%, Q test-p = 0.0003 and 8 studies - OR, 1.52; 95% CI, 1.07-2.16 - I2 =0%; Q test-p = 0.43. The presence of myenteric plexitis was associated with a higher rate of clinical recurrence (4 studies- OR, 1.60; 95%CI, 1.12-2.29; I2= 0%, Q-test-p = 0.61), and of endoscopic recurrence (4 studies - OR, 4.25; 95%CI; 2.06-8.76; I2= 0%, Q test-p = 0.97). Submucosal plexitis was not associated with an increased risk of endoscopic recurrence (4 studies - OR, 0.94; 95%CI; 0.58-1.52; I2= 0%, Q test-p = 0.79).Conclusion: Inflammatory margins and/or plexitis were associated with postoperative recurrence after ileocecal resection for CD. These elements should be taken into account in future algorithm for prevention of postoperative recurrence.

International audience; Background and AimsThe identification of Crohn's disease (CD)-associated adherent and invasive Escherichia coli (AIEC) is time-consuming and requires ileal biopsies. We aimed to identify a faster and less invasive methods to detect ileal colonization by AIEC in CD patients.MethodsCD patients requiring ileo-colonoscopy were consecutively enrolled in this prospective multicenter study. Samples from saliva, serum, stools, and ileal biopsies of CD patients were collected.ResultsAmong 102 CD patients, the prevalence of AIEC on ileal biopsies was 24.5%. The abundance and global invasive ability of ileal-associated total E. coli were respectively ten-fold (p = 0.0065) and two-fold (p = 0.0007) higher in AIEC-positive (vs. AIEC-negative), while abundance of total E. coli in the feces was not correlated with AIEC status in the ileum. The best threshold of ileal total E. coli was 60 cfu/biopsy to detect AIEC-positive patients, with high negative predictive value (NPV) (94.1%[80.3–99.3]), while the global invasive ability (>9000 internalized bacteria) was able to detect the presence of AIEC with high positive predictive value (80.0% [55.2–100.0]). Overall, 78.1% of the AIEC + patients were colonized by two or less different AIEC strains. The level of serum anti-total E. coli antibodies (AEcAb) was higher in AIEC-positive patients (p = 0.038) with a very high negative predictive value (96.6% [89.9–100.0]) (p = 0.038) for a cut-off value > 1.9 × 10−3.ConclusionsMore than two thirds of AIEC-positive CD patients were colonized by two or less AIEC strains. While stools samples are not accurate to screen AIEC status, the AEcAb level appears to be an attractive, rapid and easier biomarker to identify patients with Crohn's disease harboring AIEC.

No abstract available

International audience; Background Phase III trials have demonstrated the efficacy and safety of ustekinumab in ulcerative colitis (UC), but few real-life long-term data are currently available. Aims To assess the real-world effectiveness and safety of ustekinumab in patients with UC. Methods From January to September 2019, all consecutive patients with active UC treated with ustekinumab in a GETAID centre were included. Patients were evaluated at week 52. Remission was defined as a partial Mayo Clinic score

We assessed the effectiveness of switching from intravenous to subcutaneous infliximab in patients with inflammatory bowel diseases (IBDs) treated with or without intensified intravenous regimen.In this multicenter observational study, IBD patients in clinical remission (partial Mayo score ≤2 or Harvey-Bradshaw index ≤4) were switched to a unique dose of subcutaneous infliximab (120 mg every other week). Pharmacological and biological data were collected at baseline, visit 1 (4-8 weeks postswitch), visit 2 (8-16 weeks postswitch), and visit 3 (16-24 weeks postswitch). Relapse was defined as clinical relapse or fecal calprotectin increase ≥150 μg/g compared with baseline.Among 184 eligible patients, 72.3% (n = 133 of 184) agreed to switch to subcutaneous infliximab. At visit 3, a relapse occurred in 10.2% (n = 6 of 59), 7.3% (n = 3 of 38), 16.7% (n = 3 of 18), and 66.7% (n = 10 of 15) (P.001) of patients receiving 5 mg/kg every 8 weeks, 10 mg/kg every 8 weeks, 10 mg/kg every 6 weeks, and 10 mg/kg every 4 weeks, respectively. Dose escalation to 240 mg every other week led to recapture clinical remission in 93.3% (n = 14 of 15). Infliximab serum levels increased after the switch (P.0001) except for patients receiving 10 mg/kg every 4 weeks. In multivariable analysis, 10 mg/kg every 4 weeks regimen (odds ratio, 12.4; 95% confidence interval, 1.6-98.4; P = .017) and fecal calprotectin250 μg/g at baseline (odds ratio, 5.4; 95% confidence interval, 1.1-27.6; P = .042) had a higher risk of relapse as well as reduced (41.7%) or stable (36.8%) infliximab serum levels between baseline and visit 1 compared with increased serum levels (12.7%) (P = .020 and P = .019, respectively). Patients' acceptability (10-point scale) was improved by the switch (6.9 ± 1.6 vs 8.6 ± 1.4; P.0001). No severe adverse event was reported.Switching from intravenous to subcutaneous infliximab 120 mg every other week is safe and well accepted, leading to a low risk of relapse in IBD patients except for those receiving 10 mg/kg every 4 weeks requiring 240 mg every other week.

The management of colorectal stricture complicating inflammatory bowel disease [IBD] remains a challenging condition. Stricture raises concern about neoplastic complications, which cannot be fully ruled out by negative endoscopic biopsies. Also, impassable strictures restrict the endoscopic monitoring of upstream disease activity and dysplasia. Surgery remains the ‘gold standard’ treatment for colonic strictures but is associated with high morbidity. Over the past few decades, our therapeutic arsenal for IBD has been reinforced by biologics and therapeutic endoscopy. Few studies have focused on colonic strictures, and so current therapeutic strategies are based on a low level of evidence and applied by analogy with the treatment of ileal strictures. With a view to facilitating the decision making process in clinical practice, we reviewed the literature on the epidemiology, natural history, and management of colonic strictures in IBD.

Summary Introduction Most anal fistulas are crypto-glandular. Nevertheless, anal fistulas can reveal Crohn's disease (CD). The aim of our study was to evaluate the risk of developing CD in patients undergoing surgery for anal fistula. Patients and methods All patients undergoing surgery for anal fistula in our center between January 1, 2008 and January 31, 2017 were identified through a prospective administrative database. Demographic, clinical, and laboratory data were retrospectively collected. Results Ninety-three patients underwent anal exploration under general anesthesia. The median age at diagnosis of fistula was 43 years (IQR, 34-56) and 27% (n = 29) were women. Twenty-seven percent (n = 16) had had at least one previous fistula episode. After a median follow-up of 16.8 months (IQR, 7.2–42.0), seven (7.4%) patients were diagnosed with CD. The median time between the diagnosis of fistula and that of CD was 7.6 months (IQR, 2.7, 26.1). Chronic diarrhea (P = 0.0003), weight loss (P = 0.001), and chronic abdominal pain (P = 0.002) were associated with the diagnosis of CD. Characteristics of the fistulas (number, simple/complex, abscess), smoking, extra-digestive manifestations of CD, or a family history of IBD were not associated with the diagnosis of CD. Conclusion A medical history of anal fistula surgery resulted in the diagnosis of CD in 7% of cases. Weight loss and the presence of digestive symptoms were associated with the diagnosis of CD. These elements could be used to select patients requiring endoscopic exploration after anal fistula.

Background & Aims Mucosal healing (MH) has been associated with good outcomes of patients with Crohn's disease (CD). It is not clear what levels of endoscopic healing, based on CD endoscopic index score (CDEIS), associate with different courses of disease progression. We assessed long-term outcomes of patients with CD according to different levels of MH. Methods We performed a retrospective study of 84 patients with CD and MH who received biologic therapy (80% with infliximab) from 2008 through 2015 at 2 university hospitals in France and compared outcomes of patients with CD endoscopic index scores (CDEISs) of 0 vs CDEISs greater than 0 but less than 4. Patients were followed until treatment failure or through June 2016. The primary outcome measure was treatment failure, defined by the need for biologic optimization, initiation of corticosteroids, or a Harvey-Bradshaw score above 4 associated with change in treatment, CD-related hospitalization, and/or intestinal resection. Results After a median follow-up time of 4.8 years (interquartile range, 2.1–7.2), 27 patients (32%) had treatment failure and 3 patients (3.6%) underwent an intestinal resection. Rates of treatment failure were 25% in patients with a CDEIS of 0 and 48% in patients with CDEISs greater than 0 but less than 4 (P = .045). Median times to treatment failure were 21 months (interquartile range, 5–43 months) in patients with a CDEIS of 0 and 13 months (interquartile range, 3.6–35 months) in patients with CDEISs greater than 0 but less than 4 (P = .047). None of the patients with a CEDIS of 0 underwent intestinal resection whereas 11% patients with CDEISs greater than 0 but less than 4 required intestinal resection (P = .031). Patients with a CDEIS of 0 also had a significant lower rate of CD-related hospitalizations than patients with CDEISs greater than 0 but less than 4 (3.5% vs 18%; P = .013). In multivariate analysis, CDEISs greater than 0 but less than 4 (vs CDEIS = 0) was the only factor associated with treatment failure (hazard ratio, 2.6; 95% CI, 1.2–5.8; P = .02). Conclusions Complete endoscopic healing (CDEIS = 0) is associated with better long-term outcomes than partial endoscopic healing (CDEIS = 1–4) in patients with CD, as well as fewer surgeries and hospitalizations and an overall decreased risk of treatment failure.

Epstein‐Barr virus‐related mucocutaneous ulcer lymphoma is a rare entity promoted by immunosuppression. It is less described in inflammatory bowel diseases, and mostly these are refractory diseases. CD30 acts to Epstein‐Barr virus (EBV) local proliferation and thus could be an interesting target. Brentuximab vedotin could become a new helpful tool.

International audience

Crohn's disease (CD) has a significant impact on health status and quality of life, affecting physical and emotional well-being and impairing social and functional abilities. In the era of the treat-to-target concept, endoscopic healing has emerged as the goal to achieve to prevent intestinal damage and disability. It is not clear what level of endoscopic healing is associated with lower disability. We therefore aimed to compare disability associated with complete endoscopic healing to disability with partial endoscopic healing in patients with CD.We conducted a multicenter prospective study, between September 2019 and November 2020, in one university hospital, one general hospital, and one private practice center. Consecutive patients with CD in clinical remission were included, having either complete endoscopic healing (CDEIS = 0) or partial endoscopic healing (CDEIS0 and4). The 10-item IBD-Disk self-assessment questionnaire was used to assess disability. Moderate to severe disability was defined as an overall IBD-Disk score ≥40.A total of 82 patients were included. Forty-four (53%) were women, the median age and disease duration were respectively 35.3 years (interquartile range [IQR], 28.6-45.2) and 8.0 years (IQR, 3.0-17.0). The median overall IBD-Disk score was 26.5 (IQR, 9 -45.0), and 30 (36.6%) patients had moderate to severe disability. Complete endoscopic healing was observed in 48 patients (57.3%). The median IBD-Disk score was respectively 24 (IQR, 9.0-40.5) and 34 (IQR, 9.5-51.5) for patients with complete and partial endoscopic healing (p = 0.068). Respectively, 13/48 (27%) and 17/34 (50%) of patients with complete and partial endoscopic healing had moderate to severe disability (p = 0.039). In multivariate analysis, partial endoscopic healing (OR=5.82, 95% CI [1.65, 24.69], p = 0.0009), female gender (OR=4.0, 95%CI [1.13, 16.58], p = 0.04), and smoking (OR=8.33, 95% CI [1.96, 50.0] p = 0.006) were significantly associated with moderate to severe disability. Among the IBD-Disk sub scores, the defecation score (median, IQR) (0.0 [0.0-3.0] vs 4.0 [0.0-7.5], p = 0.028) and energy score (4.0 [0.0-6.0] vs 6.0 [2.5-8.0], p = 0.023) were significantly lower with complete endoscopic healing.One-third of patient with endoscopic healing reported moderate to severe disability. Complete endoscopic healing (CDEIS = 0) was associated with lower disability than partial endoscopic healing (CDEIS0 and4). Deeper endoscopic healing may be needed to reduce the risk of disability in CD.

Background Gastrointestinal (GI) fistula is a life-threatening condition and a therapeutic challenge. Endoscopic approaches include mucosal abrasion, clip closure, or stent diversion, with moderate success rates in the long term. We assessed whether fistula endoscopic submucosal dissection with clip closure (FESDC) could lead to complete resolution of fistulas even after failure of previous endoscopic therapy. Methods Patients with GI fistulas, including those with previous failed treatment, were retrospectively included. The primary outcome was long-term (> 3 months) success of fistula healing. Secondary outcomes included technical success, safety, and factors associated with FESDC success. Results 23 patients (13 refractory 57 %) were included. Tight immediate sealing was achieved in 19 patients (83 %; 95 % confidence interval [CI] 61 %–95 %). Long-term closure was achieved in 14 patients (61 %; 95 %CI 39 %–80 %), with median follow-up of 20 months. Complications occurred in two patients (9 %). Previous local malignancy (P = 0.08) and radiotherapy (P = 0.047) were associated with a higher risk of failure. Conclusion This novel FESDC strategy was demonstrated to be safe and feasible for permanent endoscopic closure of GI fistulas. Further studies are warranted to determine the place of this technique in the management of chronic GI fistula.

International audience; INTRODUCTION: While endoscopic balloon dilation (EBD) is widely used to manage ileal strictures, EBD of colorectal strictures remains poorly investigated in Crohn’s disease (CD). METHODS: We performed a retrospective study that included all consecutive CD patients who underwent EBD for native or anastomotic colorectal strictures in 9 tertiary centers between 1999 and 2018. Factors associated with EBD failure were also investigated by logistic regression. RESULTS: Fifty-seven patients (25 women, median age: 36 years (InterQuartile Range, 31-48) were included. Among the 60 strictures, 52 (87%) were native, 39 (65%) measured < 5 cm and the most frequent location was the left colon (27%). Fifty-seven (95%) were non-passable by the scope and 35 (58%) were ulcerated. Among the 161 EBDs performed (median number of dilations per stricture: 2, IQR 1-3), technical and clinical success were achieved for 79% (n = 116/147) and 77% (n = 88/115), respectively. One perforation occurred (0.6% per EDB and 2% per patient). After a median follow-up of 4.3 years (IQR 2.0-8.4), 24 patients (42%) underwent colonic resection and 24 (42%) were asymptomatic without surgery. One colon lymphoma and one colorectal cancer were diagnosed (3.5% of patients) from endoscopic biopsies and at the time of surgery, respectively. No factor was associated with technical or clinical success. CONCLUSION: EDB of CD-associated colorectal strictures is feasible, efficient and safe, with more than 40% becoming asymptomatic without surgery.

International audience; Introduction: An increased risk of dental caries and periodontal diseases has been reported for inflammatory bowel disease (IBD) patients and are challenging conditions to manage. Areas covered: The authors searched international databases to find all studies assessing dental/periodontal outcomes in patients with IBD and other immune-mediated inflammatory disease (IMID), as well as the association between IMID medications and dental/periodontal status. Expert opinion: IBD are associated with a higher risk of both periodontitis and caries. Some evidence from rheumatoid arthritis suggests that periodontitis may be associated with a lower response to anti-TNF. There is no reliable evidence that IBD patients may be at greater risk of complications during routine dental care. On the basis of current data, guidelines can be proposed for the dental management focusing on the detection and eradication of infectious foci prior to the implementation of immunosuppressants/biologics and modified dental treatment protocol for invasive dental procedures that includes antibiotic prophylaxis.

Background The optimal endoscopic target in early Crohn’s disease (CD) that limits long-term disease complications is unknown. Methods We analysed medical records from patients who had follow-up data since the end of CALM. Patients with Crohn’s disease endoscopic index of severity (CDEIS) scores at the end of CALM were included. The primary outcome was a composite of major adverse outcomes reflecting CD progression: new internal fistula/abscess, stricture, perianal fistula/abscess, CD hospitalisation, or CD surgery since the end of CALM. We compared median CDEIS and per cent improvement from baseline CDEIS. Youden index analysis was used to identify optimal CDEIS cut-off score associated with CD progression. Kaplan–Meier and Cox regression methods were used to compare rates of progression by different CDEIS targets. Multivariable models were adjusted for age, prior surgery, and stricturing behaviour. Results 110 patients with median age 28 (IQR 22–38) years, disease duration 0.2 (0.1–0.5) years, and median follow up of 3.1 (1.9–4.4) years were included. Eleven per cent had a history of stricture, 5.5% history of surgery, and 52% were originally in the tight control arm of the CALM study. Median CDEIS score at end of CALM was 3 (0–5.4) and 32 (29%) patients had disease progression. Baseline median CDEIS score was similar between those with and without progression [10.9 (7.5–15.5) vs. 11.9 (8–17.5)]. Median CDEIS score at the end of CALM was higher among those with progression [1.3 (0–5.1) vs. 4.9 (3–9.1), p < 0.001)]. Patients within higher quartiles of CDEIS score had higher rates of progression over time (Figure 1). Patients without disease progression had a greater median decrease in CDEIS score from baseline to end of CALM [90% (60–100%) vs. 50% (30–80%), p < 0.001]. The optimal CDEIS score cut-off was 2 with sensitivity 84%, specificity 60% and NPV 90% for progression. Patients with CDEIS ≤ 2 had less progression over time compared with patients with > 50% improvement from baseline CDEIS (not reaching CDEIS ≤ 2) and those not meeting either endpoint (Figure 2). On adjusted analysis, CDEIS score ≤ 2 was associated with a decreased risk of progression (aHR 0.23, 95% CI 0.09–0.56). Conclusion In early CD, a CDEIS score ≤ 2 is optimal cut-off associated with a lower risk of disease progression.

Introduction Up to 25% of patients treated with infliximab experience hypersensitivity reactions. Prophylactic premedication prior to infliximab infusion, comprising corticosteroids and/or antihistamines, is widely used in clinical practice but its efficacy has recently been called into question due to the lack of pathophysiological rationale and validation by controlled trials. Materials and methods We conducted a comprehensive literature search of multiple electronic databases from inception to June 2017 to identify studies reporting the impact of corticosteroid and/or antihistamine premedication on the risk of acute ( Results Ten studies, eight observational studies and two randomized control trials, were identified including a total of 3892 patients with IMIDs, and 1,385 patients with IBD. Corticosteroid premedication was not associated with a decreased risk of hypersensitivity reaction in either IMIDs (7 studies; OR, 1.07, 95%CI, 0.64–1.78; I2 = 57.5%) or IBD (3 studies; OR, 1.04, 95% CI, 0.52–2.07; I2 = 57%). Antihistamine premedication was not associated with a decreased risk of hypersensitivity reaction in IMIDs (3 studies: OR, 1.39, 95% CI, 0.70–2.73; I2 = 85%). The combination of corticosteroids and antihistamines did not decrease the risk of acute infliximab infusion reaction in IMIDs (6 studies; OR, 2.12, 95% CI, 0.61–7.35; I2 = 94%), but was associated with an increased risk in IBD (4 studies, OR, 4.17, 95% CI, 1.61–10.78; I2 = 77%). Conclusion Corticosteroid and/or antihistamine premedication is not associated with a decreased risk of acute hypersensitivity reactions to infliximab in patients with IMIDs. We believe that these premedications should no longer be part of standard protocols.