Validity of the EQ-5D-5L and EQ-5D-3L in patients with Crohn's disease.

PURPOSE: The EuroQol five-dimension questionnaire (EQ-5D) is the most commonly used instrument to obtain utility values for cost-effectiveness analyses of treatments for Crohn's disease (CD). We aimed to compare the measurement properties of the two adult versions of EQ-5D (EQ-5D-3L and EQ-5D-5L) in patients with CD. METHODS: Between 2016 and 2017, a multicentre cross-sectional survey was carried out. Consecutive outpatients with CD completed the 3L, 5L and EQ visual analogue scale (VAS). Disease severity was graded by the Crohn's Disease Activity Index (CDAI) and Perianal Disease Activity Index (PDAI). The 3L and 5L were compared in terms of feasibility, agreement, ceiling effect, redistribution properties, discriminatory power, convergent and known-groups validity. RESULTS: Two-hundred and six patients (54.9% male, mean age 35 ± 11 years) participated in the survey. For 3L, 25 unique health states were observed versus 59 for the 5L. The overall ceiling effect decreased from 29.6% (3L) to 25.5% (5L). Absolute discriminatory power improved (mean Shannon index 0.84 vs. 1.18). The 3L correlated stronger with EQ VAS and CDAI scores, whereas the 5L with PDAI. The 5L demonstrated a better known-groups validity on the basis of age, perianal fistulas, extraintestinal manifestations and disability. CONCLUSIONS: This is the first study to report the impact of CD on quality of life using the EQ-5D-5L questionnaire. The 5L seems to perform better than 3L in terms of feasibility, ceiling effect, discriminatory power and known-groups validity. Understanding the differences in psychometrics between the 3L and 5L is essential as they have substantial implications for financial decision-making about CD treatments.

[Antimicrobial therapy of Clostridium difficile infection. Systematic review and meta-analysis of the scientific evidence]. / A Clostridium difficile-fertozések antibiotikum-terápiája. A tudományos bizonyítékok szisztematikus áttekintése és metaanalízise.

INTRODUCTION: Clostridium difficile is the leading cause of antibiotic associated infectious nosocomial diarrhoea. Limited number of new pharmaceutical products have been developed and registered in the past decades for the treatment of Clostridium difficile infection. The available scientific evidence is limited and hardly comparable. AIM: To analyse the clinical efficacy and safety of metronidazole, vancomycin and fidaxomicin in the therapy of Clostridium difficile infection. METHODS: Systematic review and meta-analysis of the literature data. RESULTS: Meta-analysis of literature data showed no significant difference between these antibiotics in clinical cure endpoint (odss ratios: fidaxomicin vs. vancomycin 1.19; vancomycin vs. metronidazol 1.69 and fidaxomicin vs. metronidazol 2.00). However, fidaxomicin therapy was significantly more effective than vancomicin and metronidazol in endpoints of recurrence and global cure (odds ratios: fidaxomicin vs. vancomycin 0.47; vancomycin vs. metronidazol 0.91 és fidaxomicin vs. metronidazol 0.43). There was no significant difference between fidaxomicin, vancomycin and metronidazole in safety endpoints. CONCLUSIONS: Each antibiotic similarly improved clinical cure. Fidaxomicin was the most effective therapeutic alternative in lowering the rate of recurrent Clostridium difficile infections.

[Clostridium difficile infection: epidemiology, disease burden and therapy]. / A Clostridium difficile-fertozések epidemiológiája, betegségterhe és terápiája.

INTRODUCTION: C. difficile causes 25 percent of the antibiotic associated infectious nosocomial diarrhoeas. C. difficile infection is a high-priority problem of public health in each country. The available literature of C. difficile infection's epidemiology and disease burden is limited. AIM: Review of the epidemiology, including seasonality and the risk of recurrences, of the disease burden and of the therapy of C. difficile infection. METHOD: Review of the international and Hungarian literature in MEDLINE database using PubMed up to and including 20th of March, 2012. RESULTS: The incidence of nosocomial C. difficile associated diarrhoea is 4.1/10 000 patient day. The seasonality of C. difficile infection is unproved. 20 percent of the patients have recurrence after metronidazole or vancomycin treatment, and each recurrence increases the chance of a further one. The cost of C. difficile infection is between 130 and 500 thousand HUF (430 € and 1665 €) in Hungary. CONCLUSIONS: The importance of C. difficile infection in public health and the associated disease burden are significant. The available data in Hungary are limited, further studies in epidemiology and health economics are required.

[Introduction of a quality index in a Hungarian endoscopy unit]. / Minoségi indikátor bevezetése egy magyar gasztroenterológiai endoszkópos laboratórium munkájába.

UNLABELLED: The quality of endoscopic examinations substantially determines their value. In developed countries, Continuous Quality Management is used to improve it permanently. In Hungary there is no example for measuring quality in the field of gastrointestinal endoscopy. AIM: The measurement and improvement of quality of endoscopy applying completeness index (cecum intubation rate) during colonoscopy. PATIENTS AND METHODS: The authors defined base values retrospectively from 841 colonoscopy reports, performed in the last quarter of the year, before starting the project. The next two years (3160 colonoscopy in 2009 and 3167 in 2010) every three months they calculated the cecum intubation rate for each endoscopist. RESULTS: The cecum intubation rate was 81.6% in the base period. When the authors excluded examinations with poor preparations and those with a previously unknown stenosis that prevented the total colonoscopy, the adjusted cecal intubation rate was 90.9%. In the next 2 years, the cecum intubation rate was 84.2% and 85.7% (p = 0.0394), while adjusted cecum intubation rate proved to be 92.3% and 92.6% (p = 0.381 NS) for the whole endoscopy unit. Of the 14 endoscopists only 6 reached an adjusted cecum intubation rate of 90%, but in the second year of the project 10 of them reached this rate and only one endoscopist remained below 87%. The endoscopists performing more than 100 colonoscopies per year had better adjusted cecum intubation rate (base 91.2%; 92.7% and 93.1% during the 2 project years) compared to those with less than 100 colonoscopies per year (base, 86.7%; project period, 85.5 and 89%). CONCLUSIONS: The evaluation and publicity of the cecal intubation rate resulted in an improvement of the quality of colonoscopy. The authors also presented that endoscopists performing more than 100 colonoscopies per year have better endoscopic quality.

[Predictors of efficacy, mucosal healing and dose intensification during the first year of adalimumab therapy in patients with luminal and fistulizing Crohn's disease. National data from Hungary]. / A klinikai hatékonyság, a nyálkahártya-gyógyulás és a dózisemelés prediktorai az adalimumabkezelés elso évében Crohn-betegségben szenvedo betegekben Magyarországon.

UNLABELLED: Adalimumab is a fully human monoclonal antibody targeting tumor necrosis factor with proven efficacy in the treatment of Crohn's disease in clinical trials. The aim of the present study was to investigate the predictors of medium term clinical efficacy and mucosal healing during adalimumab therapy in patients with Crohn's disease in specialized centers approved for biological therapy in Hungary. METHODS: Data of 201 Crohn's disease patients were prospectively captured (male/female: 112/89, median age: 24 years, duration: 8 years). Previous infliximab therapy was given in 97 (48.3%) patients, concomitant steroids in 41.3% and azathioprine in 69.2% (combined: 26.4%) of patients. RESULTS: Overall clinical response and remission rates at 24 and 52 weeks were 78% and 52%, and 69.4% and 44.4%, respectively. Endoscopic improvement and healing was achieved in 43.1% and 23.6%, respectively. In a logistic regression model, clinical efficacy and normalized C-reactive protein at week 12, need for combined immunosuppression at induction, shorter disease duration and smoking were identified as independent predictors for 12-month clinical outcome, while normalized C-reactive protein at week 12, clinical remission at week 24, frequency of previous relapses and smoking were associated to endoscopic improvement/healing. Dose intensification to weekly dosing was needed in 16.4%. Parallel azathioprine therapy and clinical remission at week 12 was inversely associated to dose escalation to weekly dosing. CONCLUSION: Clinical efficacy and normalized C-reactive protein at week 12, need for combined immunosuppression, luminal disease and smoking are predictors for medium term clinical efficacy/mucosal healing during adalimumab therapy, while parallel azathioprine therapy may decrease the probability for dose escalation.

[Treatment adherence and use of complementary and alternative medicine in patients with inflammatory bowel disease]. / A terápiás adherencia, valamint a komplementer és alternatív gyógymódok használata gyulladásos bélbetegek kezelésében.

UNLABELLED: Previous studies have suggested an increasing use of complementary and alternative medicine (CAM) in patients with inflammatory bowel disease (IBD). Furthermore, a significant number of IBD patients fail to comply with treatment. The aim of our study was to evaluate the prevalence of non-adherence the use of CAM in Hungarian patients with IBD. METHODS: A total of 655 consecutive IBD patients (Crohn's disease [CD]: 344, age: 38.2 + or - 12.9 years; ulcerative colitis [UC]: 311, age: 44.9 + or - 15.3 years) were interviewed during the visit at specialists by self-administered questionnaire including demographic and disease-related data, as well as items analyzing the extent of non-adherence and CAM use. Patients taking more then 80% of each prescribed medicine were classified as adherent. RESULTS: The overall rate of self reported non-adherence (CD: 20.9%, UC: 20.6%) and CAM (CD: 31.7%, UC: 30.9%) use was not different between CD and UC. The most common causes of non-adherence were: forgetfulness (47.8%), too many/unnecessary pills (39.7%), being afraid of side effects (27.9%) and too frequent dosing. Most common forms of CAM were herbal tee (47.3%), homeopathy (14.6%), special diet (12.2%), and acupuncture (5.8%). In CD, disease duration, date of last follow-up visit, educational level and previous surgeries were predicting factors for non-adherence. Alternative medicine use was associated in both diseases with younger age, higher educational level and immunosuppressant use. In addition, CAM use in UC was more common in females and in patients with supportive psychiatric/psychological therapy. CONCLUSIONS: Non-adherence and CAM use is common in patients with IBD. Special attention should be paid to explore the identified predictive factors during follow-up visits to improve adherence to therapy and improving patient-doctor relationship.

Efficacy and safety of infliximab induction therapy in Crohn's Disease in Central Europe--a Hungarian nationwide observational study.

BACKGROUND: Infliximab (IFX) has proven to be an effective addition to the therapeutic arsenal for refractory, fistulizing, and steroid dependent Crohn's disease (CD), with efficacy in the induction and maintenance of clinical remission of CD. Our objective in this study is to report the nationwide, multicenter experience with IFX induction therapy for CD in Hungary. METHODS: During a 6-year-period, beginning in 2000, a total of 363 CD patients were treated with IFX as induction therapy (5 mg/kg IFX infusions given at week 0, 2 and 6) at eleven centers in Hungary in this observational study. Data analysis included patient demographics, important disease parameters and the outcome of IFX induction therapy. RESULTS: Three hundred and sixty three patients (183 women and 180 men) were treated with IFX since 2000. Mean age was 33.5 +/- 11.2 years and the mean duration of disease was 6.7 +/- 6.1 years. The population included 114 patients (31.4%) with therapy-refractory CD, 195 patients (53.7%) with fistulas, 16 patients (4.4%) with both therapy-refractory CD and fistulas, and 26 patients (7.2%) with steroid dependent CD. Overall response rate was 86.2% (313/363). A higher response rate was observed in patients with shorter disease duration (p = 0.05, OR:0.54, 95%CI:0.29-0.99) and concomitant immunosuppressant therapy (p = 0.05, OR: 2.03, 95%CI:0.165-0.596). Concomitant steroid treatment did not enhance the efficacy of IFX induction therapy. Adverse events included 34 allergic reactions (9.4%), 17 delayed type hypersensitivity (4.7%), 16 infections (4.4%), and 3 malignancies (0.8%). CONCLUSION: IFX was safe and effective treatment in this cohort of Hungarian CD patients. Based on our experience co-administration of immunosuppressant therapy is suggested in patients receiving IFX induction therapy. However, concomitant steroid treatment did not enhanced the efficacy of IFX induction therapy.

Gastroesophageal reflux disease: work-related disease?

BACKGROUND: An occupation-related susceptibility of professional singers to experience gastroesophageal reflux has been suggested. AIMS: To investigate the prevalence of gastroesophageal reflux symptoms in a series of professional opera choristers, wind players, glassblowers and water polo players in comparison with a sample of general population. SUBJECTS AND METHODS: A total of 202 professional opera choristers from well-known choirs in different Hungarian regions, 71 professional wind players, 43 glassblowers, 54 water polo players were identified and 115 control subjects were compared prospectively. Reflux symptoms together with selected individual characteristics and lifestyle habits were investigated in study groups through a reflux questionnaire. RESULTS: Professional opera choristers reported a statistically significantly higher prevalence of heartburn, regurgitation and hoarseness than control subjects (p < 0.001). Among professional wind players, heartburn and regurgitation were significantly more frequent compared with controls (p < 0.05 and p < 0.01, respectively). Glassblowers reported a significantly higher prevalence of acid regurgitation in comparison with controls (p < 0.01). The prevalence of reflux symptoms in water polo players was similar to that of controls. In opera choristers, wind players and glassblowers, reflux symptoms appeared to be significantly correlated with the cumulative lifetime duration of professional singing, playing and working activity, respectively (p < 0.05). CONCLUSIONS: Our results demonstrate that professional opera choristers, professional wind players and glassblowers have a higher prevalence of reflux symptoms compared with control subjects. Gastroesophageal reflux in these professions should be considered as a work-related disorder that may have an impact on quality of life and may negatively interfere with professional performance.

[Nutrition in inflammatory bowel disease]. / A táplálkozás és a táplálás jelentosége gyulladásos bélbetegségekben.

Aetiology of inflammatory bowel disease (IBD) is complex and probably multifactorial. Nutrition has been proposed to be an important aetiological factor for development of IBD. Several components of the diet (such as sugar, fat, fibre, fruit and vegetable, protein, fast food, preservatives etc.) were examined as possible causative agents for IBD. According to some researchers infant feeding (breast feeding) may also contribute to the development of IBD. Though the importance of environmental factors is evidenced by the increasing incidence in developed countries and in migrant population in recent decades, the aetiology of IBD remained unclear. There are many theories, but as yet no dietary approaches have been proved to reduce the risk of developing IBD. The role of nutrition in the management of IBD is better understood. The prevention and correction of malnutrition, the provision of macro- and micronutrients and vitamins and the promotion of optimal growth and development of children are key points of nutritional therapy. In active disease, the effective support of energy and nutrients is a very important part of the therapy. Natural and artificial nutrition or the combination of two can be chosen for supporting therapy of IBD. The author summarises the aetiological and therapeutic role of nutrition in IBD.

[Novel aspects in the pathogenesis of gastroesophageal reflux disease]. / A gastrooesophagealis refluxbetegség keletkezésének újabb szempontjai.

UNLABELLED: In addition to lower esophageal sphincter (LES) relaxations and decreased LES tone, increased intra-abdominal pressure can also play role in the pathogenesis of gastroesophageal reflux disease (GERD),. AIM: To analyze the correlation between occupation-related increased intra-abdominal pressure or straining (experienced for years) and the prevalence of GERD symptoms. METHODS: Reflux symptoms were analyzed through a questionnaire among professional singers, wind players and glassblowers in comparison with controls. RESULTS: Heartburn, regurgitation and hoarseness were significantly more frequent among professional singers than in controls (P<0.001). Among wind players heartburn (P<0.05) and regurgitation (P<0.01), among glassblowers regurgitation (P<0.01) were significantly more frequent in comparison with control subjects. Reflux symptoms correlated significantly with the duration of professional activity (P<0.05). CONCLUSIONS: Results suggest that reflux symptoms are more frequent among subjects with occupation-related increased intra-abdominal pressure. GERD seems to be a work-related disease in this aspect.

[Self-expanding metal stents for palliation of malignant oesophageal obstruction]. / Malignus nyelôcsô-obstructio palliatiója öntáguló fémsztent behelyezésével.

BACKGROUND: Malignant oesophageal stenosis can be caused by cancer of the oesophagus, gastric cardia, lungs, mediastinum or, rarely, breast. Most of these cases are inoperable due to advanced stage of the disease, comorbidities or age of the patients; and palliative treatment can be applied only. The quality of life is mostly determined by the extent of dysphagia. Several methods are available to palliate dysphagia. Hereby, the authors review their results with palliation of malignant oesophageal obstruction applying self-expanding metal stents. PATIENTS AND METHODS: 68 endoscopic stent implantations were performed in 64 patients (15 female and 49 male) with malignant dysphagia between 2003 and 2008. After radiological investigations, distally deployed covered stents with or without an antireflux valve were placed, depending on the localization of the tumour. In one patient with a stenosis localized in the upper third of the oesophagus a proximally deployed covered stent was used. The aim was to re-establish oral nutrition and cover possible fistulas. RESULTS: Significant improvement of swallowing was detected in every patient. Average dysphagia score has improved from 3.2 to 1.7. Technical difficulties during stenting occurred in a relatively low percentage of patients only (2 in 68; i.e. 2.94%). Fistulas were covered in every case. Early stent migration (<7 days) happened in one case. One patient suffered non-fatal myocardial infarction two days after stent placement. In 5 cases tumour in- and overgrowth, in 4 cases bleeding was seen as late complications. Oesophago-tracheal fistula was noted in three patients after stent implantation. Late stent migration (>7 days) occurred in two patients. Re-stenting was necessary in four cases, while three patients needed an upper GI endoscopy for cleansing the stent caused by food obstruction. CONCLUSIONS: According to our data self-expanding metal stents are highly effective and safe for improving dysphagia. Stent-related complications are relatively rare. This method is highly recommended for palliation of malignant dysphagia.

Patient and general population values for luminal and perianal fistulising Crohn's disease health states.

BACKGROUND: In patients with Crohn's disease (CD), luminal disease activity paralleled by perianal fistulas may seriously impair health-related quality of life (HRQoL). Health utility values are not available from patients with CD that reflect the health loss associated with both luminal and perianal CD. OBJECTIVE: To generate utilities for luminal and concomitant perianal fistulising CD health states directly from patients and from members of the general public. METHODS: A cross-sectional survey was undertaken enrolling CD patients and a convenience sample of members of the general population. Respondents were asked to evaluate four common CD heath states [severe luminal disease (sCD), mild luminal disease (mCD), severe luminal disease with active perianal fistulas (sPFCD), and mild luminal disease with active perianal fistulas (mPFCD)] by 10-year time trade-off (TTO). In addition, patients assessed their current HRQoL by the TTO method. RESULTS: Responses of 206 patients (40.8% with perianal fistulas) and 221 members of the general population were analysed. Mean ± SD utilities among patients for sPFCD, sCD, mPFCD and mCD states were 0.69 ± 0.33, 0.73 ± 0.31, 0.80 ± 0.29 and 0.87 ± 0.26. Corresponding values in the general public were: 0.59 ± 0.31, 0.65 ± 0.29, 0.80 ± 0.26 and 0.88 ± 0.25. Patients with active perianal fistulas, previous non-resection surgeries, and higher pain intensity scores valued their current health as worse (p < 0.05). CONCLUSIONS: TTO is a feasible method to assess HRQoL in patients with perianal fistulising disease, often not captured by health status questionnaires. Utilities from this study are intended to support the optimization of treatment-related decision making in patients with luminal disease paralleled by active perianal fistulas.

Long-term Efficacy, Safety, and Immunogenicity of Biosimilar Infliximab After One Year in a Prospective Nationwide Cohort.

BACKGROUND: It has been previously shown that biosimilar infliximab CT-P13 is effective and safe in inducing remission in inflammatory bowel diseases. We report here the 1-year outcomes from a prospective nationwide inflammatory bowel disease cohort. METHODS: A prospective, nationwide, multicenter, observational cohort was designed to examine the efficacy and safety of CT-P13 in the induction and maintenance treatment of Crohn's disease (CD) and ulcerative colitis (UC). Demographic data were collected and a harmonized monitoring strategy was applied. Clinical remission, response, and biochemical response were evaluated at weeks 14, 30, and 54, respectively. Safety data were registered. RESULTS: Three hundred fifty-three consecutive inflammatory bowel disease (209 CD and 144 UC) patients were included, of which 229 patients reached the week 54 endpoint at final evaluation. Age at disease onset: 24/28 years (median, interquartile range: 19-34/22-39) in patients with CD/UC. Forty-nine, 53, 48% and 86, 81 and 65% of patients with CD reached clinical remission and response by weeks 14, 30, and 54, respectively. Clinical remission and response rates were 56, 41, 43% and 74, 66, 50% in patients with UC. Clinical efficacy was influenced by previous anti-tumor necrosis factor (TNF) exposure in patients with a drug holiday beyond 1 year. The mean C-reactive protein level decreased significantly in both CD and UC by week 14 and was maintained throughout the 1-year follow-up (both UC/CD: P < 0.001). Thirty-one (8.8%) patients had infusion reactions and 32 (9%) patients had infections. Antidrug antibody positivity rates were significantly higher throughout patients with previous anti-TNF exposure; concomitant azathioprine prevented antidrug antibody formation in anti-TNF-naive patients with CD. CONCLUSIONS: Results from this prospective nationwide cohort confirm that CT-P13 is effective and safe in inducing and maintaining long-term remission in both CD and UC. Efficacy was influenced by previous anti-TNF exposure; no new safety signals were detected.

Frequency and characteristics of infusion reactions during biosimilar infliximab treatment in inflammatory bowel diseases: results from Central European nationwide cohort.

BACKGROUND: Safety data of the 'real life' use of an infliximab biosimilar, CT-P13 in inflammatory bowel disease (IBD) are still lacking. Our aim was to assess the frequency and characteristics of infusion reactions during CT-P13 therapy in 13 Hungarian and 1 Czech IBD centres. METHODS: Clinical and safety data was registered at fixed appointments. Trough levels and anti-drug antibody (ADA) concentration were measured by ELISA. Association between demographic, clinical, laboratory parameters and infusion reaction rates were evaluated statistically. RESULTS: Three hundred and eighty-four IBD patients were included. Twenty-eight Hungarian IBD patients (9.6%) developed infusion reaction during the treatment, 64.3% of them was previously exposed to anti TNF therapy. No infusion reaction occurred in the Czech population. CT-P13 therapy had to be stopped in 17 patients who developed infusion reaction and was switched to adalimumab in 12 patients. However in 39.3% of patients developing infusion reaction CT-P13 therapy was continued with the use of premedication. Cumulative ADA positivity rates were 8.7%, 19.3%, and 28.0% at weeks 0, 14, and 30. Previous anti-TNF-alpha exposure (30% vs. 3.1%, p < 0.001, OR 6.3 (2.7-14.6)) and ADA positivity (32.6% vs. 4.1%, p < 0.001, OR 19(5-73)) during the induction therapy were predictive factors for infusion reactions. CONCLUSIONS: Patients with previous exposure to anti-TNF-alpha and ADA positivity during the induction therapy were more likely to develop infusion reactions.

[Significance of endoscopic biopsy and cytology in the diagnosis of esophageal squamous cell carcinoma]. / Az endoszkópos biopszia és citológia jelentôsége a nyelôcsô laphámrákos daganatainak diagnosztikájában.

We have tested the role and significance of histology combined with cytology in the diagnosis of esophageal squamous cell carcinomas. Biopsy specimens and samples for cytological smear were taken by a fiberoptic flexible endoscope. In order to minimise the loss of biological sample, the residue from the brush was removed with rinsing fluid. From 1973 to 2005 we examined 820 patients with squamous cell carcinoma of the esophagus. Endoscopic biopsy yielded positive result in 97.2%. Cytology performed in 724 patients turned out to be positive in 90.3%. Both examinations were conducted in 648 patients (79%), and yielded positive result in 572 patients (88.3%). Negative biopsy result was obtained in 22 patients, however, 14 of them had positive cytological diagnosis. Both biopsy and cytology were negative in 8 cancer patients (1%). No complication was observed with either diagnostic technique. In our material cancer was diagnosed in 776 patients by histology. However, in a further 14 of 22 patients with negative histology, cancer was detected by cytology. This means that the presence of cancer was also confirmed on the basis of morphological features in 790 cases, i.e. in 96.3% of the patients. Our results show that the combined use of biopsy and cytology in malignant tumours yields high diagnostic accuracy. Since abrasion exfoliate cytology is a quick and useful diagnostic measure it should be a routine examination in the evaluation of abnormal changes in the esophageal mucosa. The examination of the rinsing fluid of the sampling brush, introduced by us, yielded additional diagnostic information.

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.

Early azathioprine/biological therapy is associated with decreased risk for first surgery and delays time to surgery but not reoperation in both smokers and nonsmokers with Crohn's disease, while smoking decreases the risk of colectomy in ulcerative colitis.

BACKGROUND/AIMS: Smoking may alter the natural course of Crohn's disease (CD). Smokers are more likely to develop complications, relapses and have a greater risk for surgery. In contrast, in ulcerative colitis (UC), smoking might improve the disease course. Our aim was to assess the combined effect of disease phenotype, smoking, and immunomodulator [azathioprine (AZA), AZA/biological] treatment on the risk of intestinal resection/reoperation in CD and colectomy in UC. PATIENTS/METHODS: Six hundred and eighty-one inflammatory bowel disease patients were analyzed (CD: 340, male/female: 155/185, duration: 9.4+/-7.5 years; UC: 341, male/female: 174/164, duration: 11.5+/-9.7 years). Patients were interviewed on their smoking habits at the time of diagnosis and during the regular follow-up visits. Medical records were retrospectively analyzed. RESULTS: Smoking was present in 45.5% in CD and 15.8% in UC. CD patients who underwent at least one bowel resection comprised 46.5%. In an univariate analysis, disease location, behavior, AZA, or AZA/biological use before surgery [odds ratio (OR): 0.26 and 0.22, P<0.001] and smoking (OR: 1.61, P = 0.03) were associated with risk for first surgery. Smoking, AZA, or AZA/biological (P<0.001) use before first surgery and disease behavior were independently associated with risk for surgery in a proportional Cox-regression analysis. Perianal disease (OR: 3.2, P = 0.001) and frequent relapses (OR: 4.8, P<0.001) but not smoking, AZA, or AZA/biological use after first surgery were predictive for reoperation. In UC, the rate of colectomy was 5.6%. Disease location (P = 0.001) and smoking status (P = 0.02) were independently associated with risk for colectomy in a proportional Cox-regression analysis. CONCLUSION: Our data suggest that early AZA/biological therapy reduces the risk for first operation but not reoperation in CD, in both smokers and nonsmokers. In contrast, smoking was associated with a decreased need for colectomy in UC.

Association of adherence to therapy and complementary and alternative medicine use with demographic factors and disease phenotype in patients with inflammatory bowel disease.

BACKGROUND AND AIMS: Previous studies have suggested an increasing use of complementary and alternative medicine (CAM) in patients with inflammatory bowel disease (IBD). Furthermore, a significant number of IBD patients fail to comply with treatment. The aim of our study was to evaluate the prevalence of non-adherence and the use of CAM in Hungarian patients with IBD. METHODS: A total of 655 consecutive IBD patients (CD: 344, age: 38.2 [SD 12.9]years; UC: 311, age: 44.9 [15.3]years) were interviewed during the specialist visit by self-administered questionnaire including demographic and disease-related data as well as items analyzing the extent of non-adherence and CAM use. Patients taking more than 80% of each prescribed medication were classified as adherent. RESULTS: The overall rate of self-reported non-adherence (CD: 20.9%, UC: 20.6%) and CAM (CD: 31.7%, UC: 30.9%) use did not differ between Crohn's disease (CD) and ulcerative colitis (UC). The most common causes of non-adherence were: forgetfulness (47.8%), too many/unnecessary pills (39.7%), being afraid of side effects (27.9%) and too frequent dosing. Most common forms of CAM were herbal tea (47.3%), homeopathy (14.6%), special diet (12.2%), and acupuncture (5.8%). In CD, disease duration, date of last follow-up visit, educational level and previous surgeries were predicting factors for non-adherence. Alternative medicine use was associated in both diseases with younger age, higher educational level, and immunosuppressant use. In addition, CAM use in UC was more common in females and in patients with supportive psychiatric/psychological therapy. CONCLUSIONS: Non-adherence and CAM use is common in patients with IBD. Special attention should be paid to explore the identified predictive factors during follow-up visits to improve adherence to therapy and improving patient-doctor relationship.