J Duncan

An audit of adherence to anti-tnf therapy in patients with inflammatory bowel disease

Introduction Poor adherence is associated with worse outcomes and healthcare costs. Anti-TNF therapy is increasingly used in IBD management. There are 2 anti-TNF agents available to treat IBD in the UK: Adalimumab (ADA), self-administered at home and Infliximab (IFX), administered by a healthcare professional in hospital. Accordingly potential barriers to adherence vary between the two drugs though little is known about this. Aim to assess adherence to ADA and IFX in patients at two IBD tertiary referral centres; adherence to other IBD medication; and reasons for poor adherence. Methods We reviewed adherence to anti-TNF therapy over the preceding 12 months by recording postponement of, or failure to attend, scheduled IFX infusions along with the frequency of, and reasons for, missed infusions. In patients self-administering ADA we assessed adherence using the Medication Adherence Report Scale (MARS).1 Additionally we recorded reasons for missed or delayed injections. Missed/postponed doses for medical reasons (eg, infections) were not counted as failure to adhere. Adherence to (MARS), and reasons for non-adherence were also recorded for 5-ASA and immunomodulators. Results 106 patients were included (82 IFX, 24 ADA), 55 males. The median (range) age was 32 years (17–59). Median time on treatment was 17 months (1–110). There was no difference in the proportion of patients who failed to adhere to anti-TNF therapy completely (ADA 5/24 patients (21%): IFX 19/82 (23%), p=0.79). Over the preceding year, 5 IFX patients missed infusions on 8 occasions. 14 patients postponed a total of 32 infusions. Of those who failed to adhere to their scheduled infusions: 16 cited inconvenience and 1 forgot. The median MARS score in the ADA group was 25 (range 22–25). 3 people occasionally missed doses; 2 forgot and 1 cited inconvenience. 4 people delayed doses, most of whom forgot, although one cited the route of administration. 49 patients were on thiopurines, 8 methotrexate. 35% incompletely adhered to medication. The median MARS score was 25 (range 18–25). The most common reason for non-adherence was forgetting to take medication.8/18 patients on 5-ASA admitted to poor adherence. The median MARS score was 25 (range 15–25). Poor adherence was most commonly related to forgetting to take medication. Conclusion Adherence to anti-TNF therapy is generally good. While the challenges to adherence are different for the two drugs, overall adherence is similar for IFX and ADA.

PWE-080 Prevalence of Faecal Incontinence in Adults with Inflammatory Bowel Disease

Introduction The prevalence of faecal incontinence (FI) in people with inflammatory bowel disease (IBD) has not been fully explored. FI is not only associated with social stigma but also with decreased quality of life. In the general population prevalence is estimated at between 1–10%. Awareness of the prevalence of FI in IBD is important to aid management strategies and resource allocation. Methods Aim: To investigate the prevalence of FI in adults with IBD in a tertiary care setting. Methods: We performed a cross sectional questionnaire survey of 380 adults attending IBD outpatients at Guy’s & St.Thomas’ Hospitals. Patient surveys were: the validated International Consultation on Incontinence – Bowels (ICIQ-B) questionnaire, detailing frequency and severity of bowel pattern, control and quality of life; and the non-validated Bowel Leakage questionnaire, detailing any prior interventions by health care professionals. Demographics of age, gender, diagnosis, Montreal classification, St Mark’s Continence Score and disease activity were also recorded. Data was entered into a database and analysed using a SPSS statistical package. Results Median age was 38 years (IQR 31–50) and 180/380 (47%) were female. The mean duration of IBD diagnosis was 8.7 years (3.4–15.1). 151/380 (40%) had UC vs 229/380 (60%) CD. Overall, 255/380 (67%) reported FI as defined by any episode of uncontrolled bowel opening in the preceding three months, while 343/380 (90%) reported anal incontinence of flatus or faeces. Incontinence was strongly associated with disease activity, occurring during disease flares in 57% of people. However, 37% experienced incontinence both during relapse and remission, whilst only 5% experienced incontinence uniquely when in remission. The ICIQ-B control score was associated with current disease activity in CD (r = 0.29, p < 0.0001) but not in UC. There was no significant difference in FI prevalence between patients with Crohn’s Disease (CD) or Ulcerative Colitis (UC), (66% vs 68%, p = 0.74). Conclusion Faecal incontinence in IBD increases in proportion to disease activity. Given the availability of specialist FI interventions and support, we recommend that sensitive questioning regarding FI should be part of routine disease surveillance in the outpatient setting to cater for this unmet need. Disclosure of Interest None Declared.

PTU-082 Faecal Incontinence in Inflammatory Bowel Disease: we Don’T ask and they don’t Tell

Introduction The deleterious effect of faecal incontinence (FI) on quality of life (QOL) is well documented. People with FI experience stigma, embarrassment and social exclusion, and report adverse effects on activities and relationships. Restoration of continence is associated with improvement in QOL. Diarrhoea is associated with increased prevalence of FI and, therefore, people with inflammatory bowel disease (IBD) are at risk. Methods To investigate how frequently health care professionals (HCPs) assess FI in a cohort of patients with IBD we performed a cross sectional survey of 380 adults attending a tertiary referral IBD clinic. Patient surveys were: the validated ICIQ-B questionnaire, detailing frequency and severity of bowel pattern, control and quality of life; and the non-validated Bowel Leakage Questionnaire, detailing any prior interventions by health care professionals. Demographics of age, gender, diagnosis, Montreal classification, St Mark’s Continence Score and disease activity were also recorded. Data was entered into a database and analysed using SPSS statistical package. Results 229/380 (60%) had Crohn’s Disease (CD) and 180/380 (47%) were female. Median age was 38 years (IQR:31–50) with a median disease duration of 8.7 years (3.4–15.1). 343/380 (90%) had experienced incontinence of flatus or faeces while 255/380 (67%) reported FI. Only 136/380 (36%) had been asked about FI during an encounter with a HCP. Of the people who had been asked about FI, the vast majority had been asked in IBD clinics (130/136, 96%). Fewer enquiries were made by HCPs in a primary care setting with 42/136 (31%) people having been asked by a family doctor and 12/136 (9%) by a practise nurse. A minority of patients spontaneously volunteered information about incontinence to a healthcare professional (146/380, 39%). Of the people who had discussed continence issues with a HCP, 55 (38%) were offered specific advice or referral for treatment. Those who volunteered information regarding continence had worse ICIQ-B control scores (9 (6–14) vs 3 (1–8), p < 0.0001)) and quality of life scores (16 (11–20) vs 9 [6–14], p < 0.0001), reflecting greater burden of disease. Conclusion Faecal incontinence is common in IBD. It is both under-reported by patients and under-recognised by healthcare professionals. Because symptoms and QOL can be significantly improved with appropriate intervention, HCPs need to enquire about FI as part of routine assessment. Disclosure of Interest None Declared

PTU-056 Pregnancy outcomes in Patients with Crohn’S Disease: Lessons from Audit in a Specialist IBD Clinic

Introduction Crohn’s disease (CD) affects mainly people in their reproductive years. Concerns regarding family planning are the impact of CD on fertility and course of pregnancy,transmission to the offspring,issues concerning drug safety,mode of delivery and congenital anomalies. Published data is reassuring but awareness of outcomes locally can provide data regarding possible additional benefit from specialist obstetric medicine service. Methods Pregnant patients with CD were identified through the Electronic Patient Record System. Data were collected from October 2008-November 2012.Further information on outcomes was gathered from individual consultation with patients. Results 80 pregnancies in 57 patients with CD were identified.10 patients currently pregnant,9 patients(13 pregnancies) with incomplete data were excluded.Therefore,pregnancy outcomes of 57 pregnancies/38 patients (mean age: 30.7 years) were analysed. 31/38(82%) of patients had luminal disease,7/38(18%) perianal disease.36/38(95%) conceived naturally,1/38(2.5%) by assisted reproduction,1/38(2.5%) by IVF.25/57(44%) pregnancies were on no treatment in early pregnancy, 4/57(7%) on biologics [Infliximab 3/4(75%),Adalimumab1/4(25%)],6/57(10%) on biologics+thiopurines(TPN),6/57(10%) on TPN,6/57(10%) on TPN+5-ASA,7/57(12%) on 5-ASA,2/57(3.5%) on steroids and 1/57(1.7%) on elemental diet.15/57(26%) pregnancies had flares,of which 5/15(33%) continued throughout pregnancy.5/15(33%) occurred in the 1st trimester,4/15(27%) in the 2nd, 1/15(7%) in the 3rd. Of all pregnancies with flares,9/15(60%) were on no CD therapy. The mean week of delivery was 39.5 weeks (36–42).32/46(70%) of deliveries were vaginal and 14/46(30%) by Caesarian section (CS).Of CS,8/14(57%) were planned due to perianal disease 5/8(63%) or obstetric indication 3/8(37%).Pregnancy outcomes were:live births 46/57(81%), miscarriages 10/57(17%), termination 1/57(2%). The mean birth weight (BW) of the newborns was 3 kg (1.9 kg–5.1 kg). 4/46(11%) of the babies were of low BW (<2.5kg). Neonatal issues were recorded in 5/46(11%); 1 diabetes mellitus,2 cardiac anomalies,1 with viral infection at 8 days, 1 cot death. Of the miscarriages, 5/10(50%) were on no CD therapy and 4/10(40%) flared in early pregnancy. The termination was due to use of medication unrelated to CD that could potentially cause congenital anomalies. Conclusion The number of pregnancies in a specialist IBD clinic is high up to 20/year in this series highlighting a potential additional service need.A specialist obstetric medicine service can provide reassurance regarding safety of drugs in pregnancy,which in turn may reduce flare rates and result in good pregnancy outcomes. Observed outcomes did not fall outside that expected from larger reported series. Disclosure of Interest None Declared

PTU-128 Temporary double-dosing with infliximab: quick fix or long term solution?

Introduction The increasing use of anti-TNF drugs in Crohns disease reflects their efficacy. Unfortunately, even with scheduled maintenance therapy, secondary loss of response is common affecting approximately 10%–15% of patients/year. Increasing drug levels, whether by doubling the dose or decreasing the interval, recaptures response in approximately 75% of patients. However, both of these strategies have cost implications. Anecdotal reports suggest that in patients losing response on maintenance infliximab (IFX) 5 mg/kg, a temporary increase to double doses (DD; 10 mg/kg) can lead to subsequent recapture of response at the lower dose. In a small cohort, we have previously shown that this strategy was not viable in the majority of patients. We now present an extended cohort across two centres with longer follow-up. Methods We performed a retrospective review across two tertiary centres of all patients with Crohns disease who had received temporary increases to DD of IFX for loss of response. Demographic data, HBI prior to the first infusion at the higher dose and prior to the first infusion at the lower dose, and ability to continue on IFX at 5 mg/kg were recorded. Results 34 patients (18M:16F, median age 24 (range 12–51)) received DD IFX for loss of response. Median disease duration was 3 years (range 0–32) and the median time to dose increase from starting IFX was 12 months (range 3–60). All had received standard induction doses of IFX at 5 mg/kg on weeks 0, 2 and 6 and were on scheduled maintenance therapy. The dose interval prior to dose increase was 8 weeks for 24 patients, 7 weeks for 1, and 6 weeks for 9. 26 patients were on concurrent immunomodulators and 8 were not. One patient received 4 DD, 27 received 2 DD and six patients 1 DD. Dose increase was effective in the short term with the median HBI falling from 6 (range 0–27) prior to the first infusion at 10 mg/kg, to 1 (0–7) prior to the first infusion back at the standard dose (5 mg/kg) (p=0.003). However, only seven patients remained on IFX at the end of follow-up (median 13 months (range 8–25)). The median interval to discontinuing IFX was 4 months after the first DD (1–19). Of those who discontinued, four had infusion reactions while the others failed to maintain a response to IFX. Conclusion Because of the limited treatment options available in Crohns disease, attempting to recapture response in patients on IFX is appropriate. However, while temporary double-dosing is effective in the short term, it does not deliver long term disease control after subsequent dose reduction. Whether dose reduction is possible after prolonged dose increase remains to be answered. Competing interests None declared.

PTU-102 Re-treatment with infliximab after a prolonged drug holiday in patients with Crohn's disease

Introduction Infliximab (IFX) is a chimeric monoclonal antibody effective for inducing and maintaining remission in Crohns disease. The safety and efficacy of retreatment with IFX after a short “drug holiday” was recently demonstrated in the STORI trial. However, data regarding re-treatment after a long drug holiday (>1 year) are few. With increased use of biologics, the number of patients who have lost response to both biologics is increasing. These patients have limited therapeutic options but retreatment with IFX has been proposed. Methods We performed a retrospective review of patients with Crohns disease who had been re-treated with IFX after a period off treatment of at least 1 year. Patients were identified from our biologics database and their records were reviewed. Patient details and clinical outcome measures were extracted into a standardised form. Results 24 patients (14 male) were studied with a median age of 38 years (range: 21–61 years). 15 patients had responded to their first course of treatment; IFX was stopped due to episodic treatment being the norm at that time (n=9), patient choice (n=3), failure to re-attend for planned treatment (n=1) and development of strictures requiring surgery (n=2). The median time between stopping IFX and retreatment was 35 months (range 14–102). In this cohort, 80% responded to retreatment (12/15), 2 developed infusion reactions and 1 developed secondary loss of response. Median follow-up among continued responders was 20 months (range 2–43). Nine patients stopped their first course of IFX for either primary non-response (n=5), secondary loss of response (n=2) or infusion reaction (n=2). The median time between treatments was 32 months (range 18–42). In this cohort, 78% of patients responded to retreatment (7/9); 2 had infusion reactions. Follow-up among ongoing responders was for a median of 11 months (range: 2–84 months). All infusion reactions occurred on the second retreatment dose despite premedication with hydrocortisone (200 mg iv). Conclusion Re-treatment with IFX after a drug holiday of at least 1 year was frequently successful, whether the patients had initially responded to IFX or not. The main limiting factor was the development of infusion reactions. We conclude that retreatment with IFX is a viable option in people with limited therapeutic options even if they failed to respond to their first course of treatment or have previously lost response.Abstract PTU-102 Table 1 Disease duration (y) (median (range)) 36 (21–59) Age at diagnosis 22 (11–50) % Ileal disease 4% (1/24) % Ileocolonic 25% (6/24) % Colonic disease 71% (17/24) % B1 (non-stricturing/penetrating) 21% (5/24) % B2 (stricturing) 38% (9/24) % B3 (penetrating) 42% (10/24) % p (perianal) 38% (9/24) Concurrent immunosuppressants 63% (15/24) Competing interests None declared.

PWE-243 Reassessment of Crohn's disease treated with 12 months of anti-TNF therapy: a tertiary centre experience

Introduction Anti-TNF therapy (ATT) is increasingly used in Crohns disease (CD) in the UK. However, because of its expense, NICE guidance recommends that after a year of treatment, responders should be reassessed and withdrawal of treatment considered if they are in remission. We report our experience in a tertiary referral centre of reassessment after 1 year of ATT and of factors leading to continuation or withdrawal of treatment. Methods We performed a 12-month retrospective review of patients with CD who had received ATT for >12 months by 31 December 2011. Reassessment was defined as having undergone one or more of the following investigations aimed at assessing disease activity: endoscopy, examination under anaesthesia, MRI or faecal calprotectin (FC). Results of investigations and outcome were recorded. Results 91 patients (infliximab n=55, adalimumab n=36) were included of whom 80% (73/91) had their disease reassessed. Five patients were withdrawn from treatment (of whom one has already relapsed) and five are pending trial of withdrawal; two patients met criteria for withdrawal but required continuation for extra-luminal disease such as arthropathy. 84 (92%) continued therapy. 48 patients had endoscopic reassessment; mucosal healing (MH) was demonstrated in 25% (n=12), non-ulcerating inflammation in 40% (n=19) and ulceration in 35% (n=17). Of 12 with MH 3 withdrew from therapy and 3 are pending withdrawal. Of six patients who continue, two require ongoing ATT for arthropathy, three had radiologic evidence of activity, and one is undergoing further assessment. 24 patients had both endoscopy and MRI and 19 patients underwent MRI alone. Of the latter group, scans were normal in 21% (n=4), showed improvement but not resolution in 32% (n=6) and active disease in 47% (n=9). Of four normal scans, one patient was withdrawn, and 3 continue due to raised FC (n=1) or raised CRP (n=2). Disease was assessed by EUA in five patients, demonstrating active disease in four and quiescent disease in one who is pending trial of withdrawal. One patient continues on treatment on the basis of raised FC alone. One patient had mild mucosal inflammation on endoscopy and an unchanged MRI scan prior to withdrawal but relapsed within 4 months. Conclusion Reassessment after at least 12 months of ATT showed ongoing disease activity in the vast majority (84%). Withdrawal was considered appropriate in only 13%. In patients with distal ileal and/or colonic disease, endoscopy is currently our mainstay of reassessment while for those with small bowel disease interval change on MRI is used. The role of CRP and FC remain to be defined. Competing interests None declared.