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Infliximab (IFX) is effective for remission induction and maintenance of Crohn's disease (CD). This trial assessed the efficacy of scheduled maintenance IFX monotherapy to prevent postoperative CD recurrence.MethodsThirty-one CD patients who had ileocolic resection within the past 4 weeks were randomly assigned to scheduled IFX at 5 mg/kg intravenously every 8 weeks for 36 months (n = 15) or without IFX (control, n = 16). All patients were treated without immunomodulator or corticosteroid following surgery. The primary and secondary endpoints were remission rates at 12 and 36 months, defined as CD Activity Index (CDAI) ≤150, an International Organization for the Study of Inflammatory Bowel Disease (IOIBD) score <2, and C-reactive protein (CRP) <0.3 mg/dL. Additionally, endoscopic recurrences at 12 and 36 months were evaluated.ResultsAt 12 and 36 months, 100%, and 93.3% of patients in the IFX group were in remission (IOIBD <2), respectively vs. 68.8% and 56.3% in the control arm (P < 0.03). Similarly, 86.7% and 86.7% of patients in the IFX group maintained serological remission (CRP <0.3 mg/dL) vs. 37.5% and 37.5% in the control arm (P < 0.02). Further, the IFX group achieved higher endoscopic remission at 12 months, 78.6% vs. 18.8% (P = 0.004). However, in the Kaplan–Meier survival analysis the CDAI scores between the two arms were not significantly different either at 12 or at 36 months. No adverse event (AE) was observed.ConclusionsAn early intervention with IFX monotherapy should prevent clinical, serological, and endoscopic CD recurrence following ileocolic resection. Thiopurine naivety and eliminating the initial loading dose of IFX might minimize serious AEs.

Background The purpose of this study was to clarify the efficacy and safety of transanal minimally invasive surgery (TAMIS) for total pelvic exenteration (TPE) in advanced primary and recurrent pelvic malignancies. Methods Using a prospectively collected database, we retrospectively analyzed the clinical, surgical, and pathological outcomes of TAMIS for TPE. Surgery was performed between September 2019 and April 2023. The median follow-up period was 22 months (2–45 months). Results Fifteen consecutive patients were included in this analysis M:F = 14:1 and median (range) age was 63 (36–74). Their diagnoses were as follows: primary rectal cancer ( n  = 5; 33%), recurrent rectal cancer ( n  = 4; 27%), primary anorectal cancer ( n  = 5; 33%), and gastrointestinal stromal tumor ( n  = 1; 7%). Bladder-sparing TPE was selected for two patients (13%). In nine of 15 patients (60%) the anal sphincter could be successfully preserved, five patients (33%) required combined resection of the internal iliac vessels, and two (13%) required rectus muscle flap reconstruction. The median operative time was 723 min (561–1082), and the median intraoperative blood loss was 195 ml (30–1520). The Clavien–Dindo classifications of the postoperative complications were as follows: grade 0–2 ( n  = 11; 73%); 3a ( n  = 3; 20%); 3b ( n  = 1; 7%); and ≥ 4 ( n  = 0; 0%). No cases of conversion to laparotomy or mortality were observed. The pathological results demonstrated that R0 was achieved in 14 patients (93%). Conclusions The short-term outcomes of this initial experience proved that this novel approach is feasible for TPE, with low blood loss, acceptable postoperative complications, and a satisfactory R0 resection rate.

We evaluated the clinical efficacy and safety of teicoplanin according to the pharmacokinetics (PK) therapeutic level achieved in patients with renal dysfunction. Target trough concentration (C min ) was ≥15–30 μg/ml which has been recommended in patients with normal renal function. Adult patients (estimated glomerular filtration rate (eGFR) <60 ml/min/1.73 m 2 ) who were treated by teicoplanin were included in the study. We adopted two types of regimen for the initial 3 days: the conventional regimen, and the enhanced loading regimen (10 mg/kg twice daily on the 1st day, followed by 6.7–10 mg/kg once daily for the 2nd and 3rd days]. Two hundred and eighty-eight patients were evaluated for safety, and 106 patients with methicillin-resistant Staphylococcus aureus (MRSA) infections were evaluated for clinical efficacy. A significantly higher success rate was obtained in patients who achieved the target initial C min compared with those that did not (75.0 % vs 50.0 %, p  = 0.008). In a multivariate analysis, initial C min ≥15 μg/ml was an independent factor for clinical success (adjusted odds ratio: 4.20, 95 % confidence interval: 1.34–13.15). In patients with 15–30 μg/ml of maximal C min during therapy, nephrotoxicity occurred in 13.1 %, and hepatotoxicity in 2.6 %, and these incidences were not significantly higher compared with those patients with <15 μg/ml. In conclusion, achievement of C min of 15–30 μg/ml without delay was necessary to improve clinical outcomes for the treatment by teicoplanin in patients with renal dysfunction. Further investigation is required regarding the optimal loading regimen to achieve the therapeutic levels in those patients.

Background This study aimed to clarify the efficacy and safety of minimally invasive transabdominal surgery (MIS) with transperineal minimal invasive surgery (tpMIS) for sacrectomy in advanced primary and recurrent pelvic malignancies. Methods Using a prospectively collected database, we retrospectively analyzed the clinical, surgical, and pathological outcomes of MIS with tpMIS for sacrectomies. Surgery was performed between February 2019 and May 2023. The median follow-up period was 27 months (5–46 months). Results Fifteen consecutive patients were included in this analysis. The diagnoses were as follows: recurrent rectal cancer, n  = 11 (73%); primary rectal cancer, n  = 3 (20%); and recurrent ovarian cancer, n  = 1 (7%). Seven patients (47%) underwent pelvic exenteration with sacrectomy, six patients (40%) underwent abdominoperineal resection (APR) with sacrectomy, and two patients (13%) underwent tumor resection with sacrectomy. The median intraoperative blood loss was 235 ml (range 45–1320 ml). The postoperative complications (Clavien–Dindo grade ≥ 3a) were graded as follows: 3a, n  = 6 (40%); 3b, n  = 1 (7%); and ≥ 4, n  = 0 (0%). Pathological examinations demonstrated that R0 was achieved in 13 patients (87%). During the follow-up period, two patients (13%) developed local re-recurrence due to recurrent cancer. The remaining 13 patients (87%) had no local disease. Fourteen patients (93%) survived. Conclusions Although the patient cohort in this study is heterogeneous, MIS with tpMIS was associated with a very small amount of blood loss, a low incidence of severe postoperative complications, and an acceptable R0 resection rate. Further studies are needed to clarify the long-term oncological feasibility.

Background Surgical site infection (SSI) is a critical issue in colorectal surgery because it decreases postoperative patient quality of life. The rate of SSI in patients with ulcerative colitis (UC) receiving immunosuppressive therapy is particularly high, suggesting that the SSI rate may increase with the introduction of biologic agents. Methods UC patients who underwent two-stage restorative proctocolectomy at our institution between April 2012 and December 2023 were included in this study. Clinical characteristics were analyzed and compared between an SSI group and a non-SSI group; possible risk factors for SSIs were also analyzed. Additionally, the following anti-SSI measures adopted at our hospital were included as explanatory variables: laparoscopic surgery, oral antibiotic prophylaxis and change of surgical instruments before wound closure. Results In total, 501 UC surgical patients were included. The incidence of overall SSIs was 45/501 (8.9%). The rates of incisional SSIs and organ/space SSIs were 26/501 (5.1%) and 30/501 (5.9%), respectively. Oral antibiotic prophylaxis was identified as a risk factor for overall SSIs (odds ratio: 0.45, 95% CI 0.20–0.99, p  =  0.02 ), incisional SSIs (odds ratio: 0.34, 95% CI 0.11–1.03, p  =  0.03 ) and organ/space SSIs (odds ratio: 0.35, 95% CI 0.12–0.98, p  =  0.04 ). The use of biologic and immunosuppressive agents was not associated with any SSIs. Conclusions Nonadministration of oral antibiotic prophylaxis was identified as a risk factor for SSIs. Oral antibiotic prophylaxis before restorative proctocolectomy may improve the postoperative quality of life of UC patients by preventing SSIs.

BackgroundAs the ageing of the population progresses, the proportion of the population over the age of 65 reaches 27.3% in 2016, in Japan. Even elderly rheumatoid arthritis (RA) patients often require immunosuppressive agents or biological disease modifying antirheumatic drugs (DMARDs) due to their high disease activity. Therefore, they need to continuously receive treatment by specialty rheumatologists. Due to the deterioration of the ability of daily living activities, some patients may drop out of specialty medical care.In recent years, the age of RA patients who need to be hospitalised has also increased. However, it is unclear whether elderly patients discharged from the hospital are able to continue receiving specialty medical care.ObjectivesTo clarify whether a patient who has been discharged from a rheumatology specialty hospital can continue receiving rheumatology specialty medical care.MethodsRA patients who discharged from our rheumatology unit from January 1, 2016 to December 31, 2016, were included. We investigated the backgrounds and outcomes of those patients retrospectively. We compared the background characteristics of patients who are receiving treatment by specialty rheumatologists at the final follow-up (specialty group) and those who are not (non-specialty group). For the statistical analysis, a chi-squared test and Student’s t-test were used.ResultsWe identified 147 patients. The mean ±SD age of patients at discharge was 72.2±9.1 years and 74.8% was female. The reasons for hospitalisation were 87 patients (59.2%) for treatment of RA and 60 (40.8%) for treatment of complications (sepsis, fracture and so on).After discharge, 134 patients (91.1%) had returned to follow up in our department for RA treatment. The remaining 13 patients were treated at other hospitals, five of whom were treated by a primary care physician who was not specialised for rheumatology. Overall, we compared 142 patients in the specialty group and 5 in the non-specialty group.The age, the use ratio of immunosuppressive agents/biological DMARDs/prednisolone and the dose of prednisolone in the specialty group and the non-specialty group were 71.9 and 79.0 years old (p=0.09), 50.0% and 20.0% (p=0.37), 29.6% and 20.0% (p=1.00), 78.7% and 80.0% (p=1.00), 6.5 and 5.6 mg/day (p=0.83), respectively.ConclusionsIn elderly RA patients, some patients drop out of RA specialty medical care. The background of such patients is not different from those of patients who are receiving treatment by specialty rheumatologists. In order to provide specialty medical care for RA patients throughout the community, a co-management medical collaboration system between specialty rheumatologists and primary care doctors should be established.Disclosure of InterestNone declared

Hashimoto S, Ikeuchi H, Murata S, Kitawaki T, Ikeda K, Banerji D. Int J Chron Obstruct Pulmon Dis. 2016;11:2543–2551. On page 2547, Figure 5, x-axis, the dose mentioned in the label for IND should have read “150 μg od” instead of “110 μg od” and the dose for GLY should have read “50 μg od” instead of “110 μg od”. here.

BackgroundRecent reports indicate that hypertrophic pachymeningitis (HPM) develops in association with myeloperoxidase (MPO) anti-neutrophil cytoplasmic antibody (ANCA)-positive vasculitis1,2). However, little is known about clinical features and outcomes of the disease.ObjectivesWe aimed to describe clinical, laboratory and radiological features and treatment course of HPM occurred in patients with ANCA-associated vasculitis (AAV).MethodsWe retrospectively analyzed 16 Japanese adult patients (11 males and 5 females), who had been treated at our hospital in a study period from January 2006 through December 2015. Diagnosis of HPM was made with MRI T1 sequence with gadolinium by detecting thickening and enhancing of brain and/or spinal dura mater in patients manifesting neurological symptoms. Diagnosis and classification of AAV was performed according to a report by Watts, et.al.3).ResultsThe mean age at HPM onset was 60.1 years (range, 35–78 years). Out of 16 patients, HPM was detected at the onset of AAV in 9 (56.3%), at the relapsing AAV under treatment in 6 (37.5%), and before the diagnosis of AAV as idiopathic HPM in 1 (6.3%). Headache and cranial nerve palsy due to HPM were observed in 13 (81.3%) and 11 (68.8%) patients, respectively. Otitis media and sinusitis were found as complications of AAV in 7 (43.8%) and 6 (37.5%) patients. Twelve patients (75%) were classified as granulomatosis with polyangiitis (GPA). Microscopic polyangiitis, eosinophilic granulomatosis with polyangiitis and unclassifiable vasculitis were applied to 2 (12.5%), 1 (6.3%) and 1 (6.3%) patients, respectively. Serum myeloperoxidase (MPO)-ANCA and proteinase 3 (PR3)-ANCA were positive in 9 (56.3%) and 5 (31.3%), respectively, and 2 (12.5%) patients had neither of them. The mean serum C-reactive protein levels were 4.87 mg/dL (range, 0.26–17.11 mg/dL). Spinal fluids were analyzed in 6 patients, and a mild increase in spinal cell counts and protein levels were identified in 3 patients each. With MRI, thickening of dura mater in cranial fossa and tentorium cerebelli were found in 11 (68.8%) and 9 (56.3%) patients, respectively. All patients were treated with corticosteroids and 10 (62.5%) patients were concomitantly administered with other agents including cyclophosphamide, methotrexate, azathioprine and mizoribine for remission induction. All patients achieved remission of the neurological symptoms and improvement of dura mater thickening. In a mean follow-up period of 41.8 months (range, 5–89 months) after diagnosis, 4 (25%) patients experienced a relapse of HPM and received re-induction therapy.ConclusionsOur results indicate that occurrence of HPM is mostly associated with GPA having either type of ANCA serology. Dura mater in cranial fossa and tentorium cerebelli was commonly involved, which could lead to cranial nerve impairment. Immunosuppressive therapy is effective, but a relapse of HPM occasionally occurs.ReferencesYokoseki A, et al. Brain. 2014 Feb;137(Pt2):520–36.Nagashima T, et al. Neuropathology. 2000 Mar;20(1):23–30.Watts R, et al. Ann Rheum Dis. 2007 Feb;66(2):222–7.Disclosure of InterestNone declared

COPD-related deaths are increasing in Japan, with ~5.3 million people at risk. The SHINE was a 26-week, multicenter, randomized, double-blind, parallel-group study that evaluated safety and efficacy of indacaterol (IND)/glycopyrronium (GLY) 110/50 μg once daily (od) compared with GLY 50 μg od, IND 150 μg od, open-label tiotropium (TIO) 18 μg od, and placebo. The primary end point was trough forced expiratory volume in 1 second (FEV ) at Week 26. Other key end points included peak FEV , area under the curve for FEV from 5 minutes to 4 hours (FEV AUC ), Transition Dyspnea Index focal score, St George's Respiratory Questionnaire total score, and safety. Here, we present efficacy and safety of IND/GLY in the Japanese subgroup. Of 2,144 patients from the SHINE study, 182 (8.5%) were Japanese and randomized to IND/GLY (n=42), IND (n=41), GLY (n=40), TIO (n=40), or placebo (n=19). Improvement in trough FEV from baseline was 190 mL with IND/GLY and treatment differences versus IND (90 mL), GLY (100 mL), TIO (90 mL), and placebo (280 mL) along with a rapid onset of action at Week 26. IND/GLY showed an improvement in FEV AUC versus all comparators (all <0.05). All the treatments were well tolerated and showed comparable effect on Transition Dyspnea Index focal score and St George's Respiratory Questionnaire total score. The effect of IND/GLY in the Japanese subgroup was consistent to overall SHINE study population. IND/GLY demonstrated superior efficacy and comparable safety compared with its monocomponents, open-label TIO, and placebo and may be used as a treatment option for the management of moderate-to-severe COPD in Japanese patients.

Introduction Fistula formation around the ostomy site is a stoma-related complication often requiring surgical intervention. This complication may be caused by sutures or may develop as a complication of inflammatory bowel disease. Before conducting a clinical trial, we set out to investigate the safety of ostomy creation with fewer sutures using tissue adhesives in this pilot study. Methods Patients with inflammatory bowel disease who required surgery with ostomy creation at the Hyogo College of Medicine between January 2014 and December 2015 were enrolled. Safety was assessed by evaluating the incidence of stoma-related complications. Ostomy was restricted to loop ileostomy and was created with two sutures and tissue adhesives. Results A total of 14 patients were enrolled. Mean body mass index was 18.9 ± 2.0 kg/m . There were no cases of ostomy retraction and no severe adverse events were observed. Conclusions This pilot study demonstrates that ostomy creation using tissue adhesives is safe. Although retraction and adverse events were not observed, even in patients with inflammatory bowel disease who generally exhibit delayed wound healing, the body mass index was extremely low in this series. This study does not strongly recommend ostomy creation with tissue adhesives; further studies are needed to clarify the efficacy and safety of the procedure.