Therapeutic drug monitoring in inflammatory bowel disease: implementation, utilization, and barriers in clinical practice in Scandinavia.

BACKGROUND AND AIMS: Therapeutic drug monitoring (TDM) may optimize biologic and thiopurine therapies in inflammatory bowel disease (IBD). The study aimed to investigate implementation and utilization of TDM in Scandinavia. METHODS: A web-based questionnaire on the use of TDM was distributed to Scandinavian gastroenterologists via the national societies. RESULTS: In total, 297 IBD physicians prescribing biologic therapies, equally distributed between community and university hospitals, were included (response rate 42%) (Norway 118 (40%), Denmark 86 (29%), Sweden 50 (17%), Finland 33 (11%), Iceland 10 (3%)). Overall, TDM was applied during biologic therapies by 87%, and for TNF-inhibitors >90%. Among the users, reactive and proactive TDM were utilized by 90% and 63%, respectively. Danish physicians were significantly less inclined to use TDM compared to other Scandinavian countries; (58% vs 98%); OR 0.03 [0.01-0.09], p < 0.001). Reactive TDM was commonly applied at primary (74%) and secondary (99%) treatment failure. Proactive TDM was used by 80% during maintenance therapy and 56% during induction and more commonly utilized in Norway (p < 0.001), and by physicians managing >10 IBD patients/week (p = 0.005). TDM scenarios were interpreted in accord with available evidence but with discrepancies for proactive TDM. The main barriers to TDM were lack of guidelines (51%) and time lag between sampling and results (49%). TDM of thiopurines was routinely used by 87%. CONCLUSION: TDM of biologic and thiopurine therapies has been broadly implemented into clinical practice in Scandinavia. However, physicians call for TDM guidelines detailing indications and interpretations of test results along with improved test response times.

Validation of the German version of the Short Health Scale - a brief, valid and reliable instrument to assess health-related quality of life in German-speaking patients with inflammatory bowel diseases.

BACKGROUND: Health-related quality of life (hrQoL) may be the most important patient-reported outcome for patients with chronic disorders. The Short Health Scale (SHS) is a brief four-item instrument to assess hrQoL in patients with bowel disorders. This study examined the validity, reliability and sensitivity of the German translation of the SHS in a cohort of outpatients with inflammatory bowel diseases (IBD). METHODS: The study was preregistered in April 2021 (https://doi.org/10.17605/OSF.IO/S82D9). Outpatients with IBD (n=225) in different stages of disease activity (as determined by the Harvey-Bradshaw index or partial Mayo score) completed the German SHS and the short Inflammatory Bowel Disease Questionnaire (sIBDQ) as an established measure of hrQoL to examine the convergent validity. To assess reliability, a subset of patients (n=30) in remission completed the same questionnaires after 4-8 weeks. Sensitivity to change was established from questionnaires of patients with either decreased (n=15) or increased (n=16) disease activity after 3-6 months. RESULTS: The internal consistency of the German SHS was high (Cronbach's α=0.860). SHS total scores correlated strongly with sIBDQ scores (ρ=-0.760, p<0.001) and disease activity (ρ=0.590, p<0.001). Retest reliability was high (ρ=0.695, p<0.001). Sensitivity to change was statistically significant for patients with decreased (p=0.013) but not increased (p=0.134) disease activity. CONCLUSION: The German version of the SHS is a valid and reliable tool to measure hrQoL in persons with IBD.

Well-being and dietary adherence in patients with coeliac disease depending on follow-up.

OBJECTIVE: It is not clear how follow-up of coeliac disease should be optimally organised. In Malmö, Sweden, patients are followed up by general practitioners (GP), but in Linköping by gastroenterologists (GE). The aim of this study was to investigate if there were any differences in well-being and dietary adherence depending on type of follow-up. METHODS: All adult patients with newly diagnosed biopsy-verified coeliac disease in the cities between 2010 and 2014 were offered to participate. Data was retrieved comprising demography, laboratory analyses, questionnaires (Gastrointestinal Symptoms Rating Scale, Short Health Scale, Multidimensional Fatigue Inventory, Psychological General Well-being Index and Short Form 36) and follow-up. RESULTS: In the GP cohort 39/73 patients and in the GE cohort 58/121 agreed to participate (mean age 43 and 44 years, 69 and 60% women, respectively). A follow-up to a dietician was carried out in 31% and 93% of patients, respectively (p < .001). In the GP group 28% had eaten gluten-containing food during the last 4 weeks compared to 9% in the GE group (p = .01). Despite this, no differences could be seen in vitamin or mineral levels. The questionnaires did not indicate any major discrepancies in subjective health. CONCLUSION: Irrespective of the design of the follow-up physical and mental well-being were comparable. Dietary adherence was not quite as good in the GP group but follow-up in a primary care setting can still be a suitable and equivalent alternative. However, it is crucial that the dietary counselling is structured in a way that ensures dietary adherence.

Measuring the impact of gastrointestinal inconvenience and symptoms on perceived health in the general population - validation of the Short Health Scale for gastrointestinal symptoms (SHS-GI).

OBJECTIVES: Gastrointestinal (GI) symptoms are intimately related to our wellbeing. The Short Health Scale for GI symptoms (SHS-GI) is a simple questionnaire to measure the impact of GI inconvenience and symptoms on quality of life. The aim was to validate the SHS-GI in a general population sample and to compare it with SHS-data across different patient groups. METHOD: A subsample of 170 participants from a population-based colonoscopy study completed the Rome II questionnaire, GI diaries, psychological questionnaire (hospital anxiety and depression scale) and SHS-GI at follow-up investigation. Psychometric properties of SHS-GI as an overall score were determined by performing a confirmatory factor analysis (CFA). Spearman correlation between SHS total score and symptoms was calculated in the general population sample. SHS-GI data was compared with SHS data from patients with inflammatory bowel disease (IBD) and fecal incontinence (FI). RESULTS: As expected, the general population rated their impact of GI inconvenience on quality of life as better than the patient populations in terms of all aspects of the SHS-GI. The CFA showed a good model fit meeting all fit criteria in the general population. Cronbach's alpha for the total scale was 0.80 in the general population sample and ranged from 0.72 in the FI sample to 0.88 and 0.89 in the IBD samples. CONCLUSIONS: SHS-GI demonstrated appropriate psychometric properties in a sample of the normal population. We suggest that SHS-GI is a valid simple questionnaire suitable for measuring the impact of GI symptoms and inconvenience on quality of life in both general and patient populations.

Clinical effectiveness of golimumab in ulcerative colitis: a prospective multicentre study based on the Swedish IBD Quality Register, SWIBREG.

OBJECTIVES: Clinical trials demonstrated that golimumab is effective in anti-TNF naïve patients with ulcerative colitis. We aimed to assess the clinical effectiveness of golimumab in a real-world setting. MATERIALS AND METHODS: This was a prospective cohort study, conducted at 16 Swedish hospitals. Data were collected using an electronic case report form. Patients with active ulcerative colitis, defined as Mayo endoscopic subscore ≥2 were eligible for inclusion. The primary outcomes were clinical effectiveness at 12 weeks and 52 weeks, i.e. response (defined as a decrease in Mayo score by ≥3 points or 30% from baseline) and remission (defined as a Mayo score of ≤2 with no individual subscores >1). RESULTS: Fifty patients were included. At study entry, 70% were previously exposed to anti-TNF, 16% to vedolizumab, and 96% to immunomodulators. The 12 and 52-week drug continuation rates were 37/50 (74%) and 23/50 (46%), respectively. The 12-week response rate was 14/50 (28%), the remission rate, 8/50 (16%) and the corresponding figures at week 52 were 13/50 (26%) and 10/50 (20%). Among patients who continued golimumab, the median Mayo score decreased from 7 (6-9) at baseline to 1 (0-5) at 52 weeks (p < .01) and the faecal calprotectin decreased from 862 (335-1759) µg/g to 90 (34-169) µg/g (p < .01). Clinical response at week 12 was highly predictive of clinical remission at week 52 (adjusted OR: 73.1; 95% CI: 4.5‒1188.9). CONCLUSIONS: The majority of golimumab treated patients represented a treatment refractory patient-group. Despite this, our results confirm that golimumab is an effective therapy in ulcerative colitis.

The use of ICD codes to identify IBD subtypes and phenotypes of the Montreal classification in the Swedish National Patient Register.

Introduction: Whether data on International Classification of Diseases (ICD)-codes from the Swedish National Patient Register (NPR) correctly correspond to subtypes of inflammatory bowel disease (IBD) and phenotypes of the Montreal classification scheme among patients with prevalent disease is unknown.Materials and methods: We obtained information on IBD subtypes and phenotypes from the medical records of 1403 patients with known IBD who underwent biological treatment at ten Swedish hospitals and retrieved information on their IBD-associated diagnostic codes from the NPR. We used previously described algorithms to define IBD subtypes and phenotypes. Finally, we compared these register-generated subtypes and phenotypes with the corresponding information from the medical records and calculated positive predictive values (PPV) with 95% confidence intervals.Results: Among patients with clinically confirmed disease and diagnostic listings of IBD in the NPR (N = 1401), the PPV was 97 (96-99)% for Crohn's disease, 98 (97-100)% for ulcerative colitis, and 8 (4-11)% for IBD-unclassified. The overall accuracy for age at diagnosis was 95% (when defined as A1, A2, or A3). Examining the validity of codes representing disease phenotype, the PPV was 36 (32-40)% for colonic Crohn's disease (L2), 61 (56-65)% for non-stricturing/non-penetrating Crohn's disease behaviour (B1) and 83 (78-87)% for perianal disease. Correspondingly, the PPV was 80 (71-89)% for proctitis (E1)/left-sided colitis (E2) in ulcerative colitis.Conclusions: Among people with known IBD, the NPR is a reliable source of data to classify most subtypes of prevalent IBD, even though misclassification commonly occurred in Crohn's disease location and behaviour and also among IBD-unclassified patients.

Is QUOTE-IBD a valid questionnaire for measurement of quality of care in IBD? A validation study of the Swedish version.

Background: Quality of care has gained increased attention in IBD. The questionnaire Quality of Care Through the Patient's Eyes - Inflammatory Bowel Disease (QUOTE-IBD) was the first published validated IBD-specific quality of care questionnaire. The aim of this study was to validate the Swedish version of the QUOTE-IBD.Methods: Adult outpatients (n = 400) at a gastroenterology clinic in the south-east of Sweden were asked to fill in the questionnaire. For evaluation of construct validity, patients also responded to one global item for each health care dimension in the QUOTE-IBD, as well as for their overall experience of quality of health care.Results: All quality of care dimensions (QI) correlated significantly (p < .05) with their respective global dimensional item (r = 0.016-0.43), except for accommodation (r = -0.02. Test-retest (n = 32) gave significant results for all the dimensions r = 0.31-0.80 (p < .05), except for accommodation (-0.15, p = ns).Conclusions: The construct validity of the Swedish version of QUOTE-IBD is moderate. This indicates that the QUOTE-IBD may not fully cover the health care aspects important to patients. The high number of item non-response for Performance may be related to the questions being too specific, which may also contribute to the moderate level of construct validity. The reliability is moderate and the internal consistency is good.

Swedish Inflammatory Bowel Disease Register (SWIBREG) - a nationwide quality register.

Background: Inflammatory bowel disease (IBD) is a chronic, inflammatory relapsing disease with increasing incidence. IBD research and long-term follow-up of patients have, however, been hampered by lack of detailed data on disease phenotype, patient-reported outcome measures, Physician Global Assessment, disease activity, and hospital-administered drugs. Aim: To review the Swedish IBD quality register (SWIBREG). Methods: Review of SWIBREG including questionnaire data from users and patients. Results: SWIBREG was launched in 2005, and as of April 2019, contains 46,400 patients with IBD (Crohn's disease: n = 15,705, ulcerative colitis: n = 21,540, IBD unclassified and other colitis (including e.g., microscopic colitis): n = 9155). Of these IBD patients, 7778 had been diagnosed in childhood (16.8%). Earlier research has shown that combining SWIBREG and the Swedish National Patient Register (NPR) yields a positive predictive value of 100% (95%CI = 95-100%) for having a diagnosis of IBD. Moreover, out of all patients in the NPR with a diagnosis of IBD plus either IBD-related surgery or immunomodulatory/biological treatment during the past 18 months, SWIBREG covers 59.0%. SWIBREG records not only information on conventional therapies but also on biological treatment, surgery, smoking, disease activity, patient-reported outcome measures (PROMs), and patient-experienced measures (PREMs). Data are presented through a graphical decision support system. Conclusion: SWIBREG benefits patients with IBD, and offers an ideal opportunity for healthcare personnel and researchers to examine disease phenotype and activity, PROMs/PREMs, and hospital-administered drugs in patients with IBD.

Microscopic colitis: Struggling with an invisible, disabling disease.

BACKGROUND AND AIMS: Microscopic colitis causes chronic or recurrent nonbloody, watery diarrhoea, which is associated with urgency, faecal incontinence and abdominal pain. The patient's health-related quality of life is often impaired. In microscopic colitis, health-related quality of life has been studied using questionnaires originally constructed and validated for patients with inflammatory bowel disease. The aim of this study was to explore the impact of microscopic colitis on everyday life. METHODS AND RESULTS: Inductive, qualitative, semi-structured interviews were performed with 15 persons suffering from microscopic colitis. Content analysis was used to explore the impact of the condition on everyday life. The study followed the consolidated criteria for reporting qualitative research. The qualitative inductive content analysis generated one theme and five subthemes. The theme was "struggling with an invisible, disabling disease." The five subthemes were as follows: physical experience of bowel function; associated symptoms affecting quality of life; impact of the disease on everyday life; disease-related worry; and strategies for managing everyday life. CONCLUSIONS: The semi-structured interviews with persons suffering from microscopic colitis provided a wide spectrum of answers to the question of how everyday life is affected. Microscopic colitis can be a disabling life experience, and patients develop different strategies to adapt, cope and regain their previous performance level. RELEVANCE TO CLINICAL PRACTICE: There are new and interesting findings in our study that everyday life still remains affected even when patients are in remission. These findings have relevance in clinical practice and may create a better understanding of the patient's symptoms and situation.

Clinical effectiveness of golimumab in Crohn's disease: an observational study based on the Swedish National Quality Registry for Inflammatory Bowel Disease (SWIBREG).

OBJECTIVE: The effectiveness of golimumab in Crohn's disease (CD) is largely unknown as it is not approved for the treatment of the disease. We aimed to identify the population of CD patients treated with golimumab in Sweden, to assess the effectiveness of golimumab (defined as the drug retention rate), and to identify predictors of drug discontinuation. METHODS: Patients with CD who received at least one injection of golimumab were identified through the Swedish National Quality Registry for Inflammatory Bowel Disease, which includes prospectively collected clinical information. Cox regression models were used to identify predictors of golimumab discontinuation. RESULTS: The study cohort involved 94 patients of whom the majority (96.8%) had previously discontinued at least one anti-tumour necrosis factor (anti-TNF) agent. The drug retention rate at 12 weeks was 85.1%. Predictors of golimumab discontinuation at 12 weeks were previous surgery (adjusted HR = 7.52, 95% CI: 1.12-50.36), concomitant corticosteroid use at baseline (adjusted HR = 5.70, 95% CI: 1.13-28.68) and female sex (adjusted HR = 6.59; 95% CI: 1.04-41.62). The median duration of follow-up was 89 (IQR: 32-158) weeks. The drug retention at the most recent follow-up was 35.1%. Predictors of golimumab discontinuation at the most recent follow-up were corticosteroid use at baseline (adjusted HR = 2.60, 95% CI: 1.17-5.79) and female sex (adjusted HR = 2.24; 95% CI: 1.19-4.23). CONCLUSION: Patients with CD treated with golimumab were a treatment-refractory group. Despite this, more than one-third of the patients appeared to have had clinical benefit after a median follow-up of more than 1.5 years.

Health care as perceived by persons with inflammatory bowel disease - a focus group study.

AIMS AND OBJECTIVES: The aim of this study was to explore the perceptions of health care among persons living with inflammatory bowel disease. BACKGROUND: The quality of care plays an important role in the life of persons with a chronic disease. To define what persons with inflammatory bowel disease perceive as high-quality care, greater focus must be placed on the individual's own perspective of living with the condition. DESIGN: A qualitative exploratory study was conducted based on focus groups. METHODS: Five focus groups were conducted with adult persons living with inflammatory bowel disease, 14 men and 12 women aged 19-76 years. The interviews were performed between January-June 2014. RESULTS: The perceptions of health care from the perspective of persons living with inflammatory bowel disease were summarised in two categories: 'professional attitudes of healthcare staff' and 'structure of the healthcare organisation'. Persons with inflammatory bowel disease want to be encountered with respect, experience trust and obtain information at the right time. They also expect shared decision-making, communication and to encounter competent healthcare professionals. Furthermore, the expectations on and perceptions of the structure of the healthcare organisation comprise access to care, accommodation, continuity of care, as well as the pros and cons of specialised care. CONCLUSION: The findings show the importance of establishing a respectful and trusting relationship, facilitating healthcare staff and persons with inflammatory bowel disease to work as a team in fulfilling individual care needs - but there is room for improvement in terms of quality of care. RELEVANCE TO CLINICAL PRACTICE: A person-centred approach, which places the individual and her/his family at the centre, considering them experts on their own health and enabling them to collaborate with healthcare staff, seems important to reach a high-quality healthcare organisation for patients with Inflammatory bowel disease.

Effect of oral diclofenac intake on faecal calprotectin.

BACKGROUND: NSAIDs are a known source of increased faecal calprotectin (FC) levels. Currently, there is a lack of knowledge about how long it takes for an increased FC level to return to normal after NSAID intake. OBJECTIVE: The aim was to investigate how oral diclofenac intake affects FC levels and assess how long it takes for an increased FC level to return to normal after oral diclofenac intake. MATERIAL AND METHODS: Thirty healthy volunteers received diclofenac 50 mg three times daily for 14 days. Participants provided a stool sample on Days 0, 2, 4, 7, 14 during intake and Days 17, 21, 28 after discontinuation. FC levels were then followed at 7-day intervals until normalization. RESULTS: During diclofenac intake, eight participants (27%) had FC levels exceeding the upper limit of normal (median, 76 µg/g; range, 60-958 µg/g), corresponding to 8.3% of measurements. FC was not constantly increased and became normal in most participants during diclofenac intake. FC levels were on average significantly higher during intake (M = 9.5, interquartile range (IQR) = 13.4) than on baseline (M = 7.5, IQR = 0.0), p = 0.003. After discontinuation, two participants had increased FC on Days 17 and 21, respectively. No significant differences in FC levels were found between baseline and measurements after discontinuation. Two weeks after discontinuation, all participants had normal FC levels. CONCLUSIONS: Short-term oral diclofenac intake is associated with increased FC levels. However, the likelihood of an increased test result is low. Our results suggest that 2 weeks of diclofenac withdrawal is sufficient to get an uninfluenced FC test result.

Critical Situations in Daily Life as Experienced by Patients With Inflammatory Bowel Disease.

Crohn disease and ulcerative colitis, collectively known as inflammatory bowel disease (IBD), are chronic and have a fluctuating clinical course that impacts daily life. Daily life with a chronic disease involves thinking and worrying about the limitations that chronic disease causes. Knowledge about how patients who suffer from IBD manage critical incidents in daily life is lacking. The aim of the study was to describe how patients living with IBD experience critical incidents in daily life in relation to their disease and symptoms. Thirty adult patients were interviewed focusing on critical incidents in daily life. Data were analyzed using the critical incident technique. The study comprised 224 critical incidents and was grouped into 21 subcategories and 5 categories: losing bowel control, having a body that smells, being unable to meet own and others' expectations, not being believed or seen, and experiencing frustration due to side effects and ineffective treatment. These categories formed one main area describing the overall result "The bowels rule life." The uncertain nature of IBD created critical incidents in which the bowel ruled life, causing patients to avoid social interaction. It also placed considerable demands on the family and sometimes had a negative effect on the afflicted person's career.

Self-Care Among Patients With Inflammatory Bowel Disease: An Interview Study.

Inflammatory bowel disease (IBD) is a chronic disease of unknown etiology. The disease occurs early in life and the burden of symptoms is significant. Patients need to perform self-care to handle their symptoms, but knowledge about what kind of self-care patients do is limited and these individuals need to learn how to manage the symptoms that arise. The aim of this study was to explore self-care among patients with IBD. Twenty adult patients with IBD, 25-66 years of age, were interviewed. Data were analyzed by performing a qualitative content analysis. Four categories with 10 subcategories emerged from the analysis of the interviews. The self-care patients perform consists of symptom recognition (subcategories: physiological sensations and psychological sensations), handling of symptoms (subcategories: adapting the diet, using medical treatment, stress management, and using complementary alternative medicine), planning life (subcategories: planning for when to do activities and when to refrain from activities), and seeking new options (subcategories: seeking knowledge and personal contacts). Self-care consists of symptom recognition, handling life through planning, and accommodating the existing situation with the ultimate goal of maintaining well-being. Being one step ahead facilitates living with IBD. A decision to actively participate in care of a chronic illness is a prerequisite for self-care. Healthcare professionals must consider patients' potential for and desire for self-care when giving advice on self-care activities. Doing so may help people better cope with IBD.

The Short Health Scale: A Simple, Valid, Reliable, and Responsive Way of Measuring Subjective Health in Patients With Irritable Bowel Syndrome.

GOALS: To evaluate validity, reliability, and responsiveness of the Short Health Scale (SHS) in irritable bowel syndrome (IBS) patients. BACKGROUND: Subjective health assessment is central when treating patients with IBS. The "Short Health Scale" is a quick 4-item questionnaire covering most aspects of subjective health that has been validated for inflammatory bowel disease. STUDY: To test validity, 451 patients with IBS (mean age, 38 y; 81% females) completed the SHS and questionnaires assessing IBS symptom severity (IBS-SSS), gastrointestinal (GI)-specific anxiety (VSI), and quality of life (IBSQOL). To evaluate reliability and responsiveness to changes, the questionnaires were repeated after 2 weeks in 18 patients, and after 12 weeks in 212 patients who had completed a patient-education program. RESULTS: Validity was documented with (1) gradually increasing mean scores for all 4 SHS items with increasing IBS-SSS (P<0.0001), and (2) correlations between the 4 SHS items and the corresponding items from the other subjective health assessment tools [item 1 (symptom burden): ρ=0.67, item 2 (daily function): ρ=-0.44 to -0.46, item 3 (disease-related worry): ρ=-0.51 to 0.57, item 4 (general well-being): ρ=-0.34 to -0.46, P<0.0001]. Reliability was confirmed (Spearman ρ>0.7 and intraclass correlations >0.7). Responsiveness was good with responders to the patient-education program (IBS-SSS reduction ≥50 points) having significant reductions in 3 of the SHS items (P<0.05), and borderline change for the fourth SHS item (P=0.06). CONCLUSIONS: SHS is a health measure that shows promising evidence of validity, reliability, and responsiveness in IBS patients. It is quickly completed and evaluated, which supports its usefulness in the busy clinical practice.

What do patients need to know? Living with inflammatory bowel disease.

AIMS AND OBJECTIVES: To explore the need for knowledge as expressed by patients diagnosed with inflammatory bowel disease. BACKGROUND: Inflammatory bowel disease has a major impact on physical and emotional well-being, placing considerable demands on patients' management of daily activities. Although inflammatory bowel disease patients' level of knowledge about their disease has been previously studied, it is necessary to learn more about their self-expressed needs. DESIGN: The study was designed to explore patients' need for knowledge; therefore, an inductive method was chosen. METHODS: Thirty patients with inflammatory bowel disease were interviewed. Content analysis was used to describe their need for knowledge. RESULTS: The analysis generated three categories and eight subcategories: (1) knowledge related to the course of the disease (subcategories: understanding causal relationships between symptoms and the disease, complications related to the disease and understanding treatment), (2) knowledge related to managing everyday life (subcategories: behaviour that enhances well-being and managing social life) and (3) difficulty understanding and assimilating information (subcategories: shifting knowledge needs, help to understand information and reasons for wanting or not wanting knowledge). CONCLUSION: Knowledge needs were related to what to expect when living with inflammatory bowel disease in order to manage everyday life. There was a great variation in the need for knowledge, which was greatest immediately following diagnosis and during relapse. RELEVANCE TO CLINICAL PRACTICE: It is important for healthcare providers to ascertain the patients' individual knowledge needs and together with them formulate an individual care plan that gives the patient the necessary knowledge to manage their health and social life.

High burden of iron deficiency and different types of anemia in inflammatory bowel disease outpatients in Scandinavia: a longitudinal 2-year follow-up study.

OBJECTIVE: The prevalence of anemia in inflammatory bowel disease (IBD) has been broadly described. The recurrence, type and burden of anemia remain unenlightened. The primary objective was to describe this. The secondary objective was to evaluate the implementation of European guidelines. MATERIALS AND METHODS: This longitudinal follow-up study included 300 IBD outpatients from six centers in Scandinavia. Patients were enrolled in a research cohort, in which each center included 5% of their IBD cohort. The study was prospectively planned, while data were retrospectively collected. The burden of anemia was calculated as number of months with anemia. A Markov model was used to calculate the probabilities of transitioning between stages. The European guidelines were used as the standard for anemia management. RESULTS: Anemia affected > 50% of IBD outpatients during the 2-year observation period. Totally, 20% of the total observation time was spent in anemia. Over the 7200 months of observation, anemia was found in 1410 months. The most frequent type was combined anemia (63%). Combined anemia covers both anemia of chronic disease (ACD) and iron-deficiency anemia (IDA). Pure ACD was present in 21% of burden time, while pure IDA was present in 16% of burden time. The European guidelines have mainly been implemented. CONCLUSION: Anemia affected a majority of the IBD outpatients. One in five months, the patients were anemic. Anemia related to inflammation dominated the different types of anemia. Pure IDA was found in for 16%. These findings, despite a fair implementation of guidelines.

Anemia and iron deficiency in inflammatory bowel disease: an open, prospective, observational study on diagnosis, treatment with ferric carboxymaltose and quality of life.

OBJECTIVE: Iron deficiency and anemia are being increasingly recognized as a complication of inflammatory bowel disease (IBD). The aim of this study was to observe, in a non-interventional way, how Swedish gastroenterologists adhere to guidelines in IBD outpatients treated with intravenous ferric carboxymaltose (FCM), and the result of treatment. MATERIAL AND METHODS: Altogether 394 IBD patients (Crohn's disease (CD) 60%, ulcerative colitis (UC) 40%) from 14 centers were included. Group A (n = 216) was observed from November 2008 and group B (n = 178) from March 2010. Time of observation ranged from 12 to 29 months. RESULTS: S-Ferritin (µmol/l) and transferrin saturation (T-Sat; %) were recorded at baseline in 62% and 50% in group A. Median values for Hb, ferritin and T-Sat at baseline were 111 g/l, 10 µmol/l and10%, respectively, and 134 g/l, 121 µmol/l and 20% after iron treatment (p < 0.001 for all three parameters). Similar results were found in group B. Approximately three-quarters of all patients had only one iron infusion during the study period. Median time to reinfusion was 6 (1-25) months. Only previously described infusion reactions occurred in 27 (7%) patients. CONCLUSIONS: Adherence to European guidelines was rather poor and needs to be improved. The effect on iron parameters of intravenous FCM was significant, and resulted in a ferritin level that indicates an effect on the iron stores. The effect was mostly sustained for a year since only one-quarter of the patients were given repeated iron infusions. No unforeseen safety concerns emerged during the observation period.

Celiac disease and other autoimmune diseases in patients with collagenous colitis.

BACKGROUND AND AIMS: Collagenous colitis (CC) is associated with autoimmune disorders. The aim of the present study was to investigate the relationship between CC and autoimmune disorders in a Swedish multicenter study. METHODS: Patients with CC answered questionnaires about demographic data and disease activity. The patient's files were scrutinized for information about autoimmune diseases. RESULTS: A total number of 116 CC patients were included; 92 women, 24 men, median age 62 years (IQR 55-73). In total, 30.2% had one or more autoimmune disorder. Most common were celiac disease (CeD; 12.9%) and autoimmune thyroid disease (ATD, 10.3%), but they also had Sjögren's syndrome (3.4%), diabetes mellitus (1.7%) and conditions in skin and joints (6.0%). Patients with associated autoimmune disease had more often nocturnal stools. The majority of the patients with associated CeD or ATD got these diagnoses before the colitis diagnosis. CONCLUSION: Autoimmune disorders occurred in one-third of these patients, especially CeD. In classic inflammatory bowel disease (IBD), liver disease is described in contrast to CC where no cases occurred. Instead, CeD was prevalent, a condition not reported in classic IBD. Patients with an associated autoimmune disease had more symptoms. Patients with CC and CeD had an earlier onset of their colitis. The majority of the patients with both CC and CeD were smokers. Associated autoimmune disease should be contemplated in the follow-up of these patients.

Oral omeprazole and diclofenac intake is associated with increased faecal calprotectin levels: a randomised open-label clinical trial.

BACKGROUND AND AIM: Nonsteroidal anti-inflammatory drugs and proton pump inhibitors are known to affect the diagnostics of gastrointestinal disorders. The aim of this study was to investigate to what extent omeprazole, diclofenac or co-administration of these affects faecal calprotectin levels and the normalisation interval after cessation. METHODS: Participants received 20 mg omeprazole daily for 2 weeks in the first sequence, 50 mg oral diclofenac three times daily for 2 weeks in the second and co-administration of these for 2 weeks in the third, with washout periods in between. The first two sequences were randomised to a different order. Faecal calprotectin was measured on days 0, 4, 7, 14, 21, 28 and 35 and thereafter at 7-day intervals until normalisation in each sequence. RESULTS: Thirty-two healthy volunteers were included. During drug intake, 39% on diclofenac (median 70.8 µg/g; range 50.2-1080 µg/g), 53% on omeprazole (median 85.3 µg/g; range 51.1-249 µg/g) and 69% on omeprazole + diclofenac (median 101.5 µg/g; range 51.5-532 µg/g) had faecal calprotectin levels above normal. In the diclofenac sequence, faecal calprotectin returned to normal in all participants within 2 weeks of cessation and in the omeprazole and co-administration sequences, within 3 weeks of cessation. No statistical significant difference was found with respect to drug order. CONCLUSION: Short-term intake of omeprazole, diclofenac or co-administration appears to increase faecal calprotectin levels. In patients with increased faecal calprotectin on omeprazole alone or in combination with diclofenac, a repeated faecal calprotectin test is recommended at least 3 weeks after cessation. On diclofenac alone, it is sufficient to repeat the faecal calprotectin test 2 weeks after cessation.