Ustekinumab safety and effectiveness in patients with ulcerative colitis: results from a large real-life study.

BACKGROUND: Ustekinumab (UST) is an interleukin-12/interleukin-23 receptor antagonist recently approved for treating ulcerative colitis (UC) but with limited real-world data. Therefore, we evaluated the effectiveness and safety of UST in patients with UC in a real-world setting. RESEARCH DESIGN AND METHODS: This is a multicenter, retrospective, observational cohort study. The primary endpoints were the clinical remission rate (partial Mayo score, PMS, ≤1) and the safety of UST. Other endpoints were corticosteroid-free remission (CSFR) rate, clinical response rate (PMS reduction of at least 2 points), and fecal calprotectin (FC) reduction at week 24. RESULTS: We included 256 consecutive patients with UC (M/F 139/117, median age 52). The clinical remission and clinical response rates at eight weeks were 18.7% (44/235) and 53.2% (125/235), respectively, and 27.6% (42/152) and 61.8% (94/152) at 24 weeks, respectively. At 24 weeks, CSFR was 20.3% (31/152), and FC significantly dropped at week 12 (p = 0.0004) and 24 (p = 0.038). At eight weeks, patients naïve or with one previous biologic treatment showed higher remission (p = 0.002) and clinical >response rates (p = 0.018) than patients previously treated with ≥ 2. Adverse events occurred in six patients (2.3%), whereas four patients (1.6%) underwent colectomy. CONCLUSION: This real-world study shows that UST effectively and safely treats patients with UC.

Sonographic detection of massive colonic pseudopolyposis in inflammatory bowel diseases.

PURPOSE: Colonic pseudopolyps are a frequent finding in inflammatory bowel disease (IBD). Yet there are no published data describing the characteristics of pseudopolyposis in intestinal ultrasound (IUS). This study aimed at identifying the key features of pseudopolyposis in IUS. METHODS: This case-control study included 12 patients with ulcerative colitis or Crohn's colitis with extensive left colon pseudopolyposis and 18 matched IBD patients without pseudopolyps at colonoscopy. Luminal (diameters, thickening, stratification, margins, and vascularity) and intraluminal (vascular signals at color Doppler), and extraluminal (mesenteric fat) parameters of the left colon were compared. Anonymized still images and videos of these patients were blindly reviewed to estimate the accuracy in detecting this condition. RESULTS: Among the IUS parameters assessed, the anteroposterior diameter ≥ 12 mm and the presence of luminal vascular signals were significantly correlated with pseudopolyposis. The detection of both these findings were able to detect extensive pseudopolyposis a sensitivity of 75% (CI 95%: 42.8-94.5%) and a specificity of 100% (CI 95%: 81.5-100%). CONCLUSION: This is the first study describing the IUS features of pseudopolyposis in IBD. The potential use of IUS to assess pseudopolyposis might have an impact on IUS monitoring and surveillance of IBD patients with condition.

Real-world efficacy and safety of vedolizumab in managing ulcerative colitis versus Crohn's disease: results from an Italian multicenter study.

BACKGROUND: Vedolizumab (VDZ) can be used to treat refractory ulcerative colitis (UC) and Crohn's disease (CD). We assessed whether there are differences in treating UC vs CD with VDZ. RESEARCH DESIGN AND METHODS: Mayo score in UC and the Harvey-Bradshaw Index (HBI) in CD scored the clinical activity. Achievement and maintenance of clinical remission during the follow-up, and safety were the primary endpoints. RESULTS: 729 patients (475 with UC and 254 with CD), median follow-up of 18 (IQR 6-36) months, were enrolled. Clinical remission at the 6th month of treatment was achieved in 488 (66.9%) patients (74.4% in CD vs 62.9% in UC, p<0.002) while, during the follow-up, no difference was found (81.5% in the UC group and 81.5% pts in the CD group; p=0.537). The clinical remission at the 6th month of treatment (p=0.001) and being naïve to biologics (p<0.0001) were significantly associated with prolonged clinical remission. The clinical response was significantly higher in UC (90.1%) vs CD (84.3%) (p=0.023), and surgery occurred more frequently in CD (1.9% in UC vs 5.1% in CD, p=0.016). CONCLUSION: We found differences when using VDZ in UC vs CD in real life. These parameters can help the physician predict this drug's longterm efficacy.

Severe azathioprine-induced liver injury 22 months after initiation of treatment.

Drug-induced liver injury (DILI) is the leading cause of acute liver failure in high-income countries. Acute cholestasis is one of the most common forms of hepatotoxicity induced by azathioprine. It usually begins during the first year of treatment, with most cases reported during the first month. We describe an uncommon case of DILI that occurred after 22 months of drug administration. A woman in her 50s was hospitalised because of jaundice and asthenia. She had been treated with azathioprine for myasthenia gravis during the last 2 years. Acute cholestatic injury was diagnosed. After ruling out most common causes of cholestasis, azathioprine was withdrawn and subsequent histological findings in liver biopsy were consistent with drug-induced cholestatic liver damage. After discontinuation of azathioprine, biochemical parameters progressively normalised and remarkable clinical improvement was achieved. With this report, we suggest that azathioprine should be considered among the causes of liver injury, despite long treatment duration.

Intramedullary spinal cord tumors: the value of intraoperative neurophysiological monitoring in a series of 57 cases from two Italian centers.

BACKGROUND: Intramedullary spinal cord tumors are rare lesions of the central nervous system. Anatomical, molecular and radiological features are well defined, but correct management is still matter of debate. Pertinent literature has reported conflicting opinions regarding the use of intraoperative electrophysiological monitoring (IONM) in the surgical treatment of this kind of lesions, recently. We report a retrospective study from two Italian centers, in order to highlight the usefulness of IONM in the management of intramedullary lesions. METHODS: We performed a retrospective review of patients with intramedullary spinal tumor who underwent surgical resection from February 2011 to February 2018 in two different institutions. Clinical and radiological data, lesion features, timing of symptom onset and IONM findings were recorded. The IONM included somatosensory-evoked potentials (SSEP), motor-evoked potentials (MEP) and D-Wave whenever possible. We evaluated the outcome according to the Modified McCormick scale. We also evaluated the accuracy and relevance of surgical outcomes for each evoked potential (SSEP, MEP, D-Wave). RESULTS: A total of 57 patients were included. A gross total removal was achieved in 46 cases. Neurological follow-up was assessment at 3 days, and 3 and 6 months after surgery. Comparing the preoperative status and 6 months follow-up: the modified McCormick scale showed a neurological stability for 30 patients (52.63%), a worsening of neurological status for 7 patients (12.28%) and an improvement for 20 patients (35.08%). IONM presented high accuracy (sensibility of 100% and specificity of 95.65%) and significantly predicted postoperative permanent motor deficits (P<0.0001; AUC=0.978). D-Wave appeared to have significant greater predictive value than MEP and especially SSEP alone (0.967 vs 0.722 vs 0.542; P=0.044 and P<0.001 respectively). CONCLUSIONS: The gold standard in the intramedullary lesion treatment is maximal safe resection with good neurological outcome, as shown in our patients. The use of IONM is helpful in intramedullary tumors resection in order to minimize postoperative neurological deficits and our analysis suggests that the use of D-Wave presents a statistically significant higher accuracy for predicting postoperative deficits than SSEP and MEP alone.

Anterior Cervical Pial Arteriovenous Malformation Associated with a Spinal Aneurysm: Case Report and Review of the Literature.

BACKGROUND: Cervical pial arteriovenous malformation (AVM) is an extremely rare condition that can present with progressive myelopathy or acute hemorrhage (subarachnoid or intramedullary). The classification process is still a topic of discussion, given the limited number of cases described, as well as correct therapeutic management. Here, we present a case of a young female with anterior cervical pial AVM associated with spinal aneurysm. CASE DESCRIPTION: A 31-year-old female in the fifth month of pregnancy presented to the emergency department for tetraparesis, sphincter disturbances, and burning dysesthesia. Through magnetic resonance angiography, a cervical pial arteriovenous malformation (AVM) with a spinal aneurysm has been diagnosed. After a multidisciplinary consult, a neurosurgical approach has been proposed to minimize the hemorrhagic risk. A laminectomy C2-C4 level was performed, followed by identification of the AVM on the anterior-lateral left-sided surface of the spinal cord. The lesion was associated with a thrombosed aneurysm at the C2 level. Using neurophysiologic monitoring, we performed a temporary clipping of afferent vessels to the AVM. The thrombosed aneurysm was removed. Indocyanine green fluorescein and intraoperative Doppler confirmed complete resolution of AVM. The postoperative course has been regular with no complications recorded. CONCLUSIONS: Surgical procedure with perioperative neuromonitoring is an effective way to treat anterior cervical pial AVM associated with spinal aneurysm. A multidisciplinary approach is always suggested.

Comparison between the different types of heterologous materials used in cranioplasty: a systematic review of the literature.

INTRODUCTION: The choice of heterologous materials for cranioplasty after decompressive craniectomy is still difficult. The aim of this study is to examine the association between material of choice and related complications to suggest the best treatment option. EVIDENCE ACQUISITION: A systematic review was performed for articles reporting cranioplasty comparing the following heterologous implants: titanium, poli-methyl-methacrylate (PMMA), polyetheretherketone (PEEK) and hydroxyapatite (HA). Extracted data included implant materials and incidence of the most frequent complications. EVIDENCE SYNTHESIS: The final selection resulted in 106 papers but according to our rules only 27 studies were included in the final analysis. Among a total of 1688 custom-made prosthesis implanted, 649 were titanium (38.49%), 298 PMMA (17.56%), 233 PEEK (13.82%), and 508 were HA (30.13%). A total of 348 complications were recorded out of 1688 reported patients (20.64%). In the titanium group, 139 complications were recorded (21.42%); in the PMMA group 57 (19.26%), in the PEEK group 49 (21.03%) and in the HA group 103 (20.3%). If we examine a summary of the reported complications clearly related to cranioplasty (postoperative infections, fractures and prosthesis displacement) versus type of material in multicentric and prospective studies we can see how HA group patients have less reported infections and cranioplasty explantation after infections than PMMA, PEEK and titanium. On the contrary HA patients seem to have a higher number of prosthesis displacement again if compared with the other materials. Since these data are not derived from a statistically correct analysis they should be used only to help to differentiate the properties of the various heterologous cranioplasties. CONCLUSIONS: The ideal material for all heterologous cranioplasty has not yet been identified. The choice of material should be based on the clinical data of patients, such as the craniectomy size, presence of seizures, possibility of recovery, good long-term outcome associated with a cost analysis.