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This two-arm, randomised, multicentre, open-label, phase IIIb study investigated the safety and efficacy of a 3-h catumaxomab infusion with/without prednisolone premedication to reduce catumaxomab-related adverse events. Patients with malignant ascites due to epithelial cancer received four 3-h intraperitoneal catumaxomab infusions with/without intravenous prednisolone (25 mg) premedication before each infusion. The primary safety endpoint was a composite safety score calculated from the incidence and intensity of the most frequent catumaxomab-related adverse events (pyrexia, nausea, vomiting and abdominal pain). Puncture-free survival (PuFS) was a co-primary endpoint. Time to next puncture (TTPu) and overall survival (OS) were secondary endpoints. Prednisolone premedication did not result in a significant reduction in the main catumaxomab-related adverse events. The mean composite safety score was comparable in both arms (catumaxomab plus prednisolone, 4.1; catumaxomab, 3.8; p = 0.383). Median PuFS (30 vs. 37 days) and TTPu (78 vs. 102 days) were shorter in the catumaxomab plus prednisolone arm than in the catumaxomab arm, but the differences were not statistically significant (p = 0.402 and 0.599, respectively). Median OS was longer in the catumaxomab plus prednisolone arm than in the catumaxomab arm (124 vs. 86 days), but the difference was not statistically significant (p = 0.186). The superiority of catumaxomab plus prednisolone versus catumaxomab alone could not be proven for the primary endpoint. Prednisolone did not result in a significant reduction in the main catumaxomab-related adverse events. The study confirms the safety and efficacy of catumaxomab administered as four 3-h intraperitoneal infusions for the treatment of malignant ascites.
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PMID:Catumaxomab with and without prednisolone premedication for the treatment of malignant ascites due to epithelial cancer: results of the randomised phase IIIb CASIMAS study. 2496 36

A previously healthy 33-year-old man presented with a 3-month history of nausea, anorexia and weight loss. Coeliac disease was diagnosed at another hospital with positive serology and D2 biopsies and he was started on a gluten-free diet. The details of these tests were not available to us. Despite good adherence to a gluten-free diet, he continued to lose weight and became anaemic. A repeat gastroscopy showed D2 ulcers. Helicobacter pylori infection was excluded, coeliac serology remained negative but D2 biopsies showed partial duodenal villous flattening with intraepithelial lymphocytosis. Type 1 refractory coeliac disease was diagnosed. Prednisolone and azathioprine were commenced but the vomiting and weight loss progressed. A subsequent gastroscopy and CT scan revealed a D3 stricture and duodenal dilatation, respectively, in keeping with superior mesenteric artery syndrome. An infracolic duodenojejunostomy was performed and immunosuppression stopped. Subsequently, all his symptoms resolved and he remains well on a gluten-free diet.
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PMID:Refractory coeliac disease: or is it? 2892 49

Dear Editor, Granulomatosis with polyangiitis (GPA) previously known as Wegener's Granulomatosis is an anti-neutrophilic cytoplasmic autoantibody (ANCA) associated vasculitis (AAV), usually initially presents with respiratory, renal, and/or ear, nose & throat (ENT) involvement [1]. Recently, rituximab (RTX) is increasingly used for either induction or maintenance phases in GPA [2, 3]. During the GPA, various organs could be involved. However, pancreas involvement in GPA is rarely reported. Until now, there are few reported cases with either a pancreas mass or acute pancreatitis, which in most cases were the first presentation of disease [4-6]. Here we report a complicated ANCA negative GPA patient with both pancreas mass and acute pancreatitis presentation, who had been expired weeks after RTX due sepsis occurrence. A 38-year-old woman with complaining from swelling, pain, and nasal congestion and discharge admitted to Amir-Alam otolaryngology tertiary referral center, Tehran University of Medical Sciences in February 2019. Taking biopsy had confirmed Wegener's granulomatosis. At the time of admission, assessment severity through the Birmingham Vasculitis Activity Score (BVAS) reveled score of 24, and the patient fell into a major relapse. Prednisolone at the dose of 1 mg/kg/day and one cycle of cyclophosphamide at the dose of 1000 mg were initiated. While she showed drug reaction to cyclophosphamide. Ten days later, the patient started to have epigastric pain, nausea, vomiting, icter and had a progressive rise in liver function tests and bilirubin. Alkaline phosphatase and total bilirubin levels reached at the peak up 1900 unit/liter and 16 mg/dl, respectively. In abdominal CT scan and magnetic resonance cholangiography (MRCP), a mass in pancreas head with the diameter of 26*23 mm in the posterior part of the pancreatic head dilated common bile duct with a diameter of 14mm has been recorded. Accordingly, an endosonography (EUS) was done, showing a pancreas mass in pancreas head. Fine needle biopsy (FNA) pathology showed pancreatitis pattern with no malignant cell. Then an ERCP (endoscopic retrograde cholangio pancreatography) was done and a stent was placed in pancreatic duct along with initiation of prednisolone at the dose of 1 mg/kg/day. After 20 days, the patient's symptoms resolved, pancreatic mass became smaller, and LFTs became normal. RTX at the dose of 1000 gr has been initiated and the patient discharged with 60 mg/day prednisolone. Two weeks later, she received the second dose of RTX at the dose of 1000 gr. One month after the last dose of RTX, sepsis had occurred and she expired a few days later. In most of the previously reported cases, pancreas involvement was reported as the first presentation of the disease, while in our case was not. Indeed, she first was presented with nasal and respiratory involvement and 1 year later pancreatitis symptoms appeared. In our cases, although RTX and high dose corticosteroids resolved issue, they led in a serious lethal infection. Taken together, both acute pancreatitis and non-malignant pancreatic mass could be presented as the secondary presentations in GPA patients. Although such conditions could be well-managed with high dose glucocorticoids and probably RTX, risk of serious and lethal infections is warned.
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PMID:Fatal outcome of rituximab in an ANCA negative granulomatosis with polyangiitis patient with acute pancreatitis and pancreatic mass. 3241 81

N,N-dimethylformamide (DMF), a widely used solvent in the chemical industry, is known to induce toxic hepatitis. However, there have been no reported cases of DMF-associated autoimmune hepatitis. A 31-year-old healthy man working at a glove factory since July 2015 had intermittently put his bare hands into a diluted DMF solution for his first 15 days at work. After 2 months, he felt nausea, fatigue, and hand cramping, and a jaundice followed. His laboratory findings showed positive autoantibodies and elevated immunoglobulin G (IgG), and his liver biopsy pathology was typical of autoimmune hepatitis (AIH). Prednisolone and azathioprine therapy began, and he recovered rapidly without adverse events. Though his liver chemistry was normalized, the IgG level remained persistently upper normal range. His 2nd liver biopsy performed in April 2019 showed mild portal activity, and he was well under a low dose immunosuppressive therapy up to April 2020. This case warns of the hazard of occupational exposure to DMF, and clinicians should be aware of DMF-related AIH for timely initiation of immunosuppressive therapy.
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PMID:A Case of Autoimmune Hepatitis after Occupational Exposure to N,N-Dimethylformamide. 3268 69


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