Infliximab biosimilar CT-P13 therapy is effective in maintaining endoscopic remission in ulcerative colitis - results from multicenter observational cohort.

BACKGROUND: CT-P13, the first biosimilar monoclonal antibody to infliximab (IFX), has previously been confirmed to be efficacious in inducing mucosal healing in ulcerative colitis (UC) patients. The aim of this study was to evaluate the efficacy of CT-P13 therapy in maintaining mucosal healing in UC. METHODS: CT-P13 trough levels, antibody positivity, serum inflammatory markers as CRP level, fecal calprotectin at weeks 14 and 54, concomitant steroid and azathioprine therapy at the time of induction therapy and at weeks 14 and 54, previous use of anti TNF drug and the need of dose intensification as possible predictive factors for mucosal healing at week 54 were evaluated in this prospective study. RESULTS: 61 patients had already completed the 54-week treatment period. Mucosal healing was shown in 65.5 % and 62.1 %, complete mucosal healing was present in 31% and 38 % at week 14 and 54, respectively. The median values of CRP, leukocytes, thrombocytes, and albumin showed significant difference between baseline and week 54. Serum antibody positivity was proved in 6.5 % and 19.7 % of cases at week 14 and 54, respectively. CONCLUSION: Our study confirmed the long-term efficacy of CT-P13 therapy on mucosal healing in UC.

[Investigating the efficacy of nutrition therapy for outpatients with inflammatory bowel disease]. / A táplálásterápia hatékonyságának vizsgálata gyulladásos bélbetegségben szenvedok gondozása során.

INTRODUCTION: Inflammatory bowel diseases can cause malnutrition (due to inflammatory cytokine production, catabolic states after surgery, restricted diet), which is difficult to treat by nutritional therapy. AIM: Investigating the efficacy of nutrition therapy. METHOD: Combined malnutrition risk screening (questionnaires and body composition analysis), at the beginning of the research and after a 1 year period. RESULTS: 205 patients were screened, 82 were malnourished. A total of 44 received nutritional intervention for 1 year, for 45% dietary management was satisfactory, 50% needed oral nutritional supplements and 5% received home parenteral nutrition. These interventions reduced the number of patients considered by both measuring methods in high risk from 31 to 21, increased the body weight and fat-free mass in 8 and 9 cases significantly (i.e., with more than 10%), and improved the indices as well (ΔBMI: +1.3 kg/m2, p = 0.035 s., ΔFFMI: +0.5 kg/m2, p = 0.296 n.s.). The main limitations of our research are the relatively low number of cases and the mono-centric involvement. CONCLUSIONS: We recommend combined malnutrition risk screening for all patients with inflammatory bowel disease due to the high risk of malnutrition, and follow-up of the malnourished patients to monitor the efficacy of their nutrition therapy. Orv Hetil. 2017; 158(19): 731-739.

Malnutrition risk questionnaire combined with body composition measurement in malnutrition screening in inflammatory bowel disease

The purpose of malnutrition screening is to predict the probability of a worse outcome due to nutritional factors. The Malnutrition Universal Screening Tool (MUST) can be used for screening in inflammatory bowel disease (IBD); however, it does not provide details about body composition. Our aim was to assess the body composition and combine this with the MUST method to screen risk of malnutrition and sarcopenia. A total of 173 IBD outpatients were enrolled in this cross-sectional study. The MUST scale indicated 21.4% of IBD patients to be at risk of malnutrition. A risk of sarcopenia was detected in 27.7%. However, one third of these patients were not considered to be at risk by their MUST score. Furthermore, Crohn’s disease (CD) patients had a strongly unfavorable fat-free mass index (FFMI) value compared to ulcerative colitis (UC) patients, and these differences were significant among men (FFMI: 18.62 ± 2.16 vs 19.85 ± 2.22, p = 0.02, in CD and UC males, respectively). As sarcopenia is a relevant prognostic factor, the MUST method should be expanded to include body composition analysis to detect more IBD patients at risk of malnutrition and sarcopenia in order to start their nutritional therapy immediately (AU)

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Malnutrition risk questionnaire combined with body composition measurement in malnutrition screening in inflammatory bowel disease.

The purpose of malnutrition screening is to predict the probability of a worse outcome due to nutritional factors. The Malnutrition Universal Screening Tool (MUST) can be used for screening in inflammatory bowel disease (IBD); however, it does not provide details about body composition. Our aim was to assess the body composition and combine this with the MUST method to screen risk of malnutrition and sarcopenia. A total of 173 IBD outpatients were enrolled in this cross-sectional study. The MUST scale indicated 21.4% of IBD patients to be at risk of malnutrition. A risk of sarcopenia was detected in 27.7%. However, one third of these patients were not considered to be at risk by their MUST score. Furthermore, Crohn's disease (CD) patients had a strongly unfavorable fat-free mass index (FFMI) value compared to ulcerative colitis (UC) patients, and these differences were significant among men (FFMI: 18.62 ± 2.16 vs 19.85 ± 2.22, p = 0.02, in CD and UC males, respectively). As sarcopenia is a relevant prognostic factor, the MUST method should be expanded to include body composition analysis to detect more IBD patients at risk of malnutrition and sarcopenia in order to start their nutritional therapy immediately.

[Long-term adalimumab therapy in ulcerative colitis in clinical practice: result of the Hungarian multicenter prospective study]. / Az adalimumab hatékonysága és biztonságossága hagyományos kezelésre refrakter colitis ulcerosában.

INTRODUCTION: Adalimumab was approved for the treatment of ulcerative colitis refractory to conventional therapy several years later than infliximab in Europe. Due to the relatively low remission rate observed in Ultra trials, data on the efficacy of adalimumab in ulcerative colitis are really helpful in the daily practice. AIM: The aim of this study was to prospectively collect data on induction and maintenance adalimumab therapy in patients with ulcerative colitis treated in Hungarian centres. METHOD: This prospective study collected data of all patients with ulcerative colitis treated with adalimumab in 10 Hungarian centres. The primary endpoints of the study were rates of remission, response and primary failure at week 12, and the rate of continuous clinical response, remission and loss of response at weeks 30, and 52. Secondary endpoints were endoscopic outcome at week 52 and comparison of the efficacy of adalimumab between treatment naive and infliximab-experienced patients. RESULTS: 73 patients with active ulcerative colitis were enrolled in the study. 75.3% of the patients exhibited clinical response after the induction at week 12. The probability of maintaining adalimumab treatment was 48.6% at week 52 with a continuous clinical response in 92% of these patients. Mucosal healing was achieved in 48.1% of the patients at week 52. Dose intensification was performed in 17.6% of the patients. Minor side effects developed in 4% of the patients and 5.4% of the patients underwent colectomy during the 1-year treatment period. CONCLUSIONS: These results coming from the real clinical setting demonstrate a favourable efficacy of adalimumab induction and maintenance therapy in patients with ulcerative colitis.

The Effect of anti-TNFα Induction Therapy on the Nutritional Status and Dietary Intake in Inflammatory Bowel Disease.

BACKGROUND AND AIMS: Patients suffering from inflammatory bowel disease (IBD) are at a high risk of malnutrition and retain an altered body composition. We hypothesized that anti-tumor necrosis factor (anti-TNF) alpha therapy may improve dietary intake and have a beneficial influence on body composition in these patients. METHODS: Our study involved 40 IBD outpatients (33 Crohn's disease, 7 ulcerative colitis); 24 of these received adalimumab (160/80/40EOW) and 16 were treated with infliximab (5 mg/kg at week 0, 2, 6, and subsequently every 8 weeks). Body composition was measured with bioelectrical impedance analysis, while dietary intake was recorded prior to initiating biologicals and 3 months afterwards. Body composition indexes: fat-free mass index [FFMI], body fat mass index [BFMI]) were calculated in kg/m2. RESULTS: Baseline BMI (kg/m2) and muscle parameters increased significantly at the end of the observational period (BMI: 23.81+/-7.19 vs. 24.52+/-7.34, p<0.001; FFMI: 17.64+/-3.00 vs. 18.14+/-3.08, p<0.001; at week 0 vs. 12, respectively). However, no significant changes were detected in the fat parameters (BFMI: 6.21+/-5.20 vs. 6.44+/-5.27, respectively). We found no significant difference between the effects of adalimumab vs. infliximab on body composition (deltaFFMI: 0.55+/-0.82 vs. 0.43+/-0.69; deltaBFMI: 0.23+/-0.85 vs. 0.21+/-1.01, respectively). No significant difference was observed in the extent of changes in parameters whether the patients were on corticosteroids (n=15) or not (n=25) at week 0 (deltaFFMI: 0.44+/-0.84 vs 0.59+/-0.72; deltaBFMI: 0.36+/-1.12 vs. 0.09+/-0.71, respectively). CONCLUSION: Our findings suggest that muscle parameters improved during the anti-TNF induction therapy, while fat parameters did not change significantly. Thus, induction anti-TNF therapy might have a beneficial effect on body composition.

Efficacy and Safety of Adalimumab in Ulcerative Colitis Refractory to Conventional Therapy in Routine Clinical Practice.

BACKGROUND AND AIM: Adalimumab [ADA] was approved for the treatment of ulcerative colitis [UC] refractory to conventional therapy in 2012 in Europe. Due to the observed discrepancies between clinical trials and practice, data on the outcome of ADA therapy are really needed from the real life. The aim of this study was to estimate the short- and long-term efficacy and safety of ADA in UC patients from each Hungarian biological centre. PATIENTS AND METHODS: This prospective study consisted of UC patients treated with ADA in 10 Hungarian inflammatory bowel disease centres. The primary endpoints of the study were rates of continuous clinical response, remission, non-response and loss of response at Weeks 12, 30, and 52.The secondary endpoints included mucosal healing at Week 52 and the comparison of the efficacy of ADA between biological naive and infliximab [IFX]-treated groups. Colonoscopy was performed before starting the therapy and at Week 52. RESULTS: In all, 73 active UC patients were enrolled in the study: 67.1% of the patients received previous IFX therapy; 75.3% of the patients showed short-term clinical response at Week 12. The probability of maintaining ADA was 48.6% at Week 52 with a continuous clinical response in 92% of these remaining patients. Mucosal healing was achieved in 48.1% of the patients at Week 52. Escalation of ADA was performed in 17.6%, and minor side effects developed in 4% of the patients; 5.4% of the patients underwent colectomy during the 1-year treatment period. CONCLUSION: UC is a progressive disease that may need early aggressive therapy to prevent structural and functional complications. The results of our study demonstrated the favourable efficacy of short- and long-term ADA treatment for patients with UC.

Efficacy and Safety of the Biosimilar Infliximab CT-P13 Treatment in Inflammatory Bowel Diseases: A Prospective, Multicentre, Nationwide Cohort.

BACKGROUND AND AIMS: Biosimilar infliximab CT-P13 is approved for all indications of the originator product in Europe. Prospective data on its efficacy, safety, and immunogenicity in inflammatory bowel diseases are lacking. METHODS: A prospective, nationwide, multicentre, observational cohort was designed to examine the efficacy, safety, and immunogenicity of CT-P13 infliximab biosimilar in the induction treatment of Crohn's disease [CD] and ulcerative colitis [UC]. Demographic data were collected and a harmonised monitoring strategy was applied. Early clinical remission, response, and early biochemical response were evaluated at Week 14, steroid-free clinical remission was evaluated at Week 30. Therapeutic drug level was monitored using a conventional enzyme-linked immunosorbent assay. RESULTS: In all, 210 consecutive inflammatory bowel disease [126 CD and 84 UC] patients were included in the present cohort. At Week 14, 81.4% of CD and 77.6% of UC patients showed clinical response and 53.6% of CD and 58.6% of UC patients were in clinical remission. Clinical remission rates at Week 14 were significantly higher in CD and UC patients who were infliximab naïve, compared with those with previous exposure to the originator compound [p < 0.05]. Until Week 30, adverse events were experienced in 17.1% of all patients. Infusion reactions and infectious adverse events occurred in 6.6% and 5.7% of all patients, respectively. CONCLUSIONS: This prospective multicentre cohort shows that CT-P13 is safe and effective in the induction of clinical remission and response in both CD and UC. Patients with previous infliximab exposure exhibited decreased response rates and were more likely to develop allergic reactions.

Prevalence of inflammatory bowel disease among coeliac disease patients in a Hungarian coeliac centre.

BACKGROUND: Celiac disease, Crohn disease and ulcerative colitis are inflammatory disorders of the gastrointestinal tract with some common genetic, immunological and environmental factors involved in their pathogenesis. Several research shown that patients with celiac disease have increased risk of developing inflammatory bowel disease when compared with that of the general population. The aim of this study is to determine the prevalence of inflammatory bowel disease in our celiac patient cohort over a 15-year-long study period. METHODS: To diagnose celiac disease, serological tests were used, and duodenal biopsy samples were taken to determine the degree of mucosal injury. To set up the diagnosis of inflammatory bowel disease, clinical parameters, imaging techniques, colonoscopy histology were applied. DEXA for measuring bone mineral density was performed on every patient. RESULTS: In our material, 8/245 (3,2 %) coeliac disease patients presented inflammatory bowel disease (four males, mean age 37, range 22-67), 6/8 Crohn's disease, and 2/8 ulcerative colitis. In 7/8 patients the diagnosis of coeliac disease was made first and inflammatory bowel disease was identified during follow-up. The average time period during the set-up of the two diagnosis was 10,7 years. Coeliac disease serology was positive in all cases. The distribution of histology results according to Marsh classification: 1/8 M1, 2/8 M2, 3/8 M3a, 2/8 M3b. The distribution according to the Montreal classification: 4/6 Crohn's disease patients are B1, 2/6 Crohn's disease patients are B2, 2/2 ulcerative colitis patients are S2. Normal bone mineral density was detected in 2/8 case, osteopenia in 4/8 and osteoporosis in 2/8 patients. CONCLUSIONS: Within our cohort of patients with coeliac disease, inflammatory bowel disease was significantly more common (3,2 %) than in the general population.

[Vitamin D level in Hungarian patients with inflammatory bowel diseases]. / D-vitamin-szint mérése hazai gyulladásos bélbetegekben.

INTRODUCTION: Vitamin D has an important role in the immune regulation. Vitamin D is essential for innate and adaptive immune systems and it plays a significant role in the formation of immune tolerance, as well. AIM: Vitamin D deficiency has been observed in patients with inflammatory bowel diseases in Western Europe, but there is no data available from Eastern Europe. METHOD: The study included 169 patients with inflammatory bowel disease. RESULTS: The median vitamin D level was 22.7±10.6 ng/ml. Only 20% of the patients had adequate vitamin D level (>30 ng/ml), 52% had vitamin D insufficiency (15-30 ng/ml), and 28% of them had severe vitamin D deficiency (<15 ng/ml). Vitamin D concentration failed to correlate with clinical activity indexes (partial Mayo score: r = -0.143; Crohn's disease activity index: r = -0.253) and with inflammatory parameters (C-reactive protein: r = 0.008; erythrocyte sedimentation rate: r = 0.012). CONCLUSIONS: Since vitamin D deficiency can be frequently observed in Hungarian patients with inflammatory bowel disease, its level should be tested in these patients.

Does dermatitis herpetiformis result in bone loss as coeliac disease does? A cross sectional study.

INTRODUCTION AND OBJECTIVES: coeliac disease (CD) and its cutaneous manifestation, dermatitis herpetiformis are both (DH) gluten-sensitive diseases. Metabolic bone disease is common among patients with CD, even in asymptomatic forms. Data are scarce about bone density in patients with dermatitis herpetiformis. The aim of our study was to compare bone mineral density (BMD) of celiac and dermatitis herpetiformis patients. METHODS: 34 coeliac patients, 53 with dermatitis herpetiformis and 42 healthy controls were studied. The mean age was 38.0 +/- 12.1, 32.18 +/- 14.95, 35.33 +/- 10.41 years in CD, dermatitis herpetiformis, and healthy controls, respectively. Bone mineral density of the lumbar spine, the left femoral neck and radius were measured by dual-energy X-ray absorptiometry. Low bone density, osteopenia and osteoporosis were defined as a body mass density (BMD) T-score between 0 and -1, between -1 and -2.5, and under -2.5, respectively. RESULTS: at lumbar region, consisting of dominantly trabecular compartment, a decreased BMD was detected in 49 % (n = 26) patients with dermatitis herpetiformis, 62 % (n = 21) of CD patients, and 29 % (n = 12) of healthy controls, respectively. Lower BMD were measured at the lumbar region in dermatitis herpetiformis and CD compared to healthy subjects (0.993 +/- 0.136 g/cm2 and 0.880 +/- 0.155 g/cm2 vs. 1.056 +/- 0.126 g/cm2; p < 0.01). Density of bones consisting of dominantly cortical compartment (femoral neck) did not differ in dermatitis herpetiformis and healthy subjects. CONCLUSIONS: our results show that a low bone mass is also frequent among patients with dermatitis herpetiformis. Bone mineral content in these patients is significantly lower in those parts of the skeleton which contain more trabecular than cortical bone.

[Prevalence of gastric polypoid lesions at an endoscopic facility]. / A gyomor polypoid képleteinek gyakorisága egy endoszkópos centrumban.

BACKGROUND: The prevalence of gastric polyps is unknown in Hungary. AIM: The aim of the authors was to assess the prevalence of polypoid lesions of the stomach in the endoscopic centre of the 2nd Department of Medicine, Semmelweis University. METHODS: Results of upper gastrointestinal endoscopies carried out between March 2010 and June 2011 were analysed. RESULTS: 193 cases with polyps were diagnosed in 4174 endoscopies (4.62%). Hyperplastic polyps, fundic gland polyps and malignant lesion were detected in 33.67%, 31.09% and 2.07% of the cases, respectively. Proton pump inhibitor use was more frequent among patients diagnosed with fundus gland polyps (p = 0.007), while hyperplastic polyps were diagnosed more frequently in patients with chronic gastritis (p = 0.032). CONCLUSIONS: The frequency of gastric polyps was higher than expected from data published in the literature. Long-term proton pump-inhibitor use and chronic gastritis were associated with fundus gland and hyperplastic polyps, respectively.

Does dermatitis herpetiformis result in bone loss as coeliac disease does? A cross sectional study / ¿Provoca la dermatitis herpetiforme pérdida ósea al igual que la enfermedad celiaca? Un estudio transversal

Introduction and objectives: coeliac disease (CD) and its cutaneous manifestation, dermatitis herpetiformis are both (DH) glutensensitive diseases. Metabolic bone disease is common among patients with CD, even in asymptomatic forms. Data are scarce about bone density in patients with dermatitis herpetiformis. The aim of our study was to compare bone mineral density (BMD) of celiac and dermatitis herpetiformis patients. Methods: 34 coeliac patients, 53 with dermatitis herpetiformis and 42 healthy controls were studied. The mean age was 38.0 ± 12.1, 32.18 ± 14.95, 35.33 ± 10.41 years in CD, dermatitis herpetiformis, and healthy controls, respectively. Bone mineral density of the lumbar spine, the left femoral neck and radius were measured by dual-energy X-ray absorptiometry. Low bone density, osteopenia and osteoporosis were defined as a body mass density (BMD) T-score between 0 and -1, between -1 and -2.5, and under -2.5, respectively. Results: at lumbar region, consisting of dominantly trabecular compartment, a decreased BMD was detected in 49 % (n = 26) patients with dermatitis herpetiformis, 62 % (n = 21) of CD patients, and 29 % (n = 12) of healthy controls, respectively. Lower BMD were measured at the lumbar region in dermatitis herpetiformis and CD compared to healthy subjects (0.993 ± 0.136 g/cm2 and 0.880 ± 0.155 g/cm2 vs. 1.056 ± 0.126 g/cm2; p < 0.01). Density of bones consisting of dominantly cortical compartment (femoral neck) did not differ in dermatitis herpetiformis and healthy subjects. Conclusions: our results show that a low bone mass is also frequent among patients with dermatitis herpetiformis. Bone mineral content in these patients is significantly lower in those parts of the skeleton which contain more trabecular than cortical bone (AU)