Carl Eriksson

Long-term effectiveness of vedolizumab in inflammatory bowel disease : a national study based on the Swedish National Quality Registry for Inflammatory Bowel Disease (SWIBREG)

Abstract Objectives: Clinical trials have demonstrated the efficacy of vedolizumab in inflammatory bowel disease (IBD). However, these findings may not reflect the clinical practice. Therefore, we aimed to describe a vedolizumab-treated patient population and assess long-term effectiveness. Materials and methods: Patients initiating vedolizumab between 1 June 2014 and 30 May 2015 were identified through the Swedish National Quality Registry for IBD. Prospectively collected data on treatment and disease activity were extracted. Clinical remission was defined as Patient Harvey Bradshaw indexu2009<5 in Crohn’s disease (CD) and Patient Simple Clinical Colitis Activity indexu2009<3 in ulcerative colitis (UC). Results: Two-hundred forty-six patients (147u2009CD, 92 UC and 7 IBD-Unclassified) were included. On study entry, 86% had failed TNF-antagonist and 48% of the CD patients had undergoneu2009≥1 surgical resection. After a median follow-up of 17 (IQR: 14–20) months, 142 (58%) patients remained on vedolizumab. In total, 54% of the CD- and 64% of the UC patients were in clinical remission at the end of follow-up, with the clinical activity decreasing (pu2009<u2009.0001 in both groups). Faecal-calprotectin decreased in CD (pu2009<u2009.0001) and in UC (pu2009=u2009.001), whereas CRP decreased in CD (pu2009=u2009.002) but not in UC (pu2009=u2009.11). Previous anti-TNF exposure (adjusted HR: 4.03; 95% CI: 0.96–16.75) and elevated CRP at baseline (adjusted HR: 2.22; 95% CI: 1.10–4.35) seemed to be associated with discontinuation because of lack of response. Female sex was associated with termination because of intolerance (adjusted HR: 2.75; 95% CI: 1.16–6.48). Conclusion: Vedolizumab-treated patients represent a treatment-refractory group. A long-term effect can be achieved, even beyond 1 year of treatment.

Changes in medical management and colectomy rates: a population-based cohort study on the epidemiology and natural history of ulcerative colitis in Örebro, Sweden, 1963-2010

Whether the epidemiology of ulcerative colitis (UC) has changed during recent decades is partly unknown.

Natural disease course of Crohn's disease during the first 5 years after diagnosis in a European population-based inception cohort: an Epi-IBD study

Objective The Epi-IBD cohort is a prospective population-based inception cohort of unselected patients with inflammatory bowel disease from 29 European centres covering a background population of almost 10u2009million people. The aim of this study was to assess the 5-year outcome and disease course of patients with Crohn’s disease (CD). Design Patients were followed up prospectively from the time of diagnosis, including collection of their clinical data, demographics, disease activity, medical therapy, surgery, cancers and deaths. Associations between outcomes and multiple covariates were analysed by Cox regression analysis. Results In total, 488 patients were included in the study. During follow-up, 107 (22%) patients received surgery, while 176 (36%) patients were hospitalised because of CD. A total of 49 (14%) patients diagnosed with non-stricturing, non-penetrating disease progressed to either stricturing and/or penetrating disease. These rates did not differ between patients from Western and Eastern Europe. However, significant geographic differences were noted regarding treatment: more patients in Western Europe received biological therapy (33%) and immunomodulators (66%) than did those in Eastern Europe (14% and 54%, respectively, P<0.01), while more Eastern European patients received 5-aminosalicylates (90% vs 56%, P<0.05). Treatment with immunomodulators reduced the risk of surgery (HR: 0.4,u200995% CI 0.2 to 0.6) and hospitalisation (HR: 0.3,u200995% CI 0.2 to 0.5). Conclusion Despite patients being treated early and frequently with immunomodulators and biological therapy in Western Europe, 5-year outcomes including surgery and phenotype progression in this cohort were comparable across Western and Eastern Europe. Differences in treatment strategies between Western and Eastern European centres did not affect the disease course. Treatment with immunomodulators reduced the risk of surgery and hospitalisation.

Impact of thiopurines on the natural history and surgical outcome of ulcerative colitis : a cohort study

Objective Thiopurines are used as maintenance therapy in ulcerative colitis (UC), but whether these drugs influence the natural history of the disease is unknown. We aimed to assess the effect of thiopurines in terms of colectomy, hospital admission, progression in disease extent and anti-tumour necrosis factor (TNF) therapy within 10 years from initiation. Design Patients diagnosed with UC within the Örebro University Hospital catchment area, during 1963–2010, who initiated thiopurines (n=253) were included. To overcome the risk of confounding by indication, we compared patients who stopped treatment within 12 months because of an adverse reaction (n=76) with patients who continued therapy or discontinued due to other reasons (n=177) and assessed long-term outcomes using Cox regression with adjustment for potential confounding factors. Results The cumulative probability of colectomy within 10 years was 19.5% in tolerant patients compared with 29.0% in intolerant (adjusted HR 0.49; 95% CI 0.21 to 0.73). The probability of hospital admission was 34.0% in tolerant versus 56.2% in intolerant patients (adjusted HR 0.36; 95%u2009CI 0.23 to 0.56). The risk for progression in disease extent was 20.4% in tolerant patients compared with 48.8% in intolerant (adjusted HR 0.47; 95%u2009CI 0.21 to 1.06). Within 10 years, 16.1% of tolerant and 27.5% of intolerant patients received anti-TNF therapy (adjusted HR 0.49; 95%u2009CI 0.26 to 0.92). Conclusion Based on the novel approach of comparing patients tolerant and intolerant to thiopurines, we reveal that thiopurines have a profound beneficial impact of the natural history and long-term colectomy rates of UC.

Editorial: do thiopurines and biologics decrease the risk of colectomy? Authors’ reply

exposure. Hence, the parallel increase in use of immunosuppressive and biological agents and decrease in surgery rates may reflect a direct causal effect, but it could also be explained by improvement in diagnostic procedures with earlier stage diagnosis or by reluctance to recommend colectomy in the era of immunosuppressants and biologics. Although some randomized clinical trials have suggested that treatment with thiopurines and biologics leads to lower risk of colectomy, clinical trials often suffer from short-term follow-up and comparisons with placebo rather than comparable drugs. A recent observational study showed that compared to infliximab, use of adalimumab was not associated with an altered risk of surgery, but headto-head randomized trials are lacking. A potential way to overcome some of the shortcomings of, respectively, observational studies and clinical trials is to combine the two by linking data from existing randomized clinical trials to observational long-term data, if available. Lastly, the question remains, whether Scandinavian populationbased studies are generalisable. The major strength of populationbased studies is the avoidance of selection bias due to representation of patients from the entire disease spectrum. However, when it comes to treatment data, it is questionable whether such data can be generalized from one health care system to another. The Scandinavian health care system is characterized by free and easy access to medical care. Still, the health authorities strictly regulate treatment with costly drugs, such as biologics, which may be given to a smaller subset of patients than in insurance-based health care systems. This stresses the relevance of continuously surveying the epidemiology of UC and other inflammatory diseases on a worldwide basis.

P364 A Swedish observational study (SVEAH) on vedolizumab assessing effectiveness and healthcare resource utilization in patients with inflammatory bowel disease

A Swedish observational study (SVEAH) on vedolizumab assessing effectiveness and healthcare resource utilization in patients with inflammatory bowel disease

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

Abstract 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 HRu2009=u20097.52, 95% CI: 1.12–50.36), concomitant corticosteroid use at baseline (adjusted HRu2009=u20095.70, 95% CI: 1.13–28.68) and female sex (adjusted HRu2009=u20096.59; 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 HRu2009=u20092.60, 95% CI: 1.17–5.79) and female sex (adjusted HRu2009=u20092.24; 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.

Incidence, prevalence, and clinical outcome of anaemia in inflammatory bowel disease : A population-based cohort study

The incidence and short‐term outcome of anaemia in inflammatory bowel disease (IBD) are largely unknown.