P584 Use of mycophenolate mofetil in inflammatory bowel disease: results from the ENEIDA registry

Abstract Background Mycophenolate mofetil (MMF) is an immunomodulatory drug that inhibits T and B cells, through a reversible inhibition of inositol monophosphate dehydrogenase. MMF is commonly used for prophylaxis of organ rejection after transplant. Studies to evaluate its use in inflammatory bowel disease (IBD) are limited especially after the appearance of biological treatments (BT). The aim of this study was to evaluate the efficacy and safety of MMF in IBD. Methods IBD patients who had received MMF were identified in the ENEIDA registry (prospective database of GETECCU). Patients with Crohn′s disease (CD) or Ulcerative colitis (UC) in whom oral MMF was prescribed for this condition were evaluated. Demographic and IBD clinical data were collected. Clinical activity was assessed through Harvey-Bradshaw Index (HBI) and partial Mayo score (pMS); C-reactive protein (CRP) and faecal calprotectin (FC) were reviewed at baseline (at MMF starting), 3 and 6 months and at the end of follow-up (at MMF stopping or the last visit while on MMF). Adverse events (AEs) during MMF treatment were documented. Statistical analyses were performed by descriptive statistics and non-parametric tests. Results Between June 1999 and November 2018 a total of 83 patients received MMF (mean age 36.4 (SD12.3) years; 52F/31M; 66 CD and 17 UC). Indication for MMF use was maintenance of remission (50%), induction of remission (44%) and post-surgical prophylaxis (6%). Mean MMF dose used was 1269.8 (SD 741) mg/day. In 61% of cases, systemic steroids were administered starting MMF and it was used concomitantly to BT in 27% of patients. In CD, statistically significant differences in HBI at 6 months (mean 5.9 (SD 4.8), p = 0.04) and at the end of follow-up (mean 5.7 (SD 5), p = 0.014) compared with baseline (mean 7.6 (SD 4.3)) were observed. In UC, statistically significant differences in pMS at 6 months (mean 2.1 (SD 2.7), p = 0.018) and at the end of follow-up (mean 1.8 (SD 2.6), p = 0.003) compared with baseline (mean 4.8 (SD 2.5)) were determined. No significant differences in CRP or CF values during follow-up were observed. Concomitant use of BT was significantly associated with clinical response (OR 1.36 95% CI 1.08–1.73). MMF was maintained for a median time of 28.9 months (IQR 20.4–37.5) and was stopped in 84% of patients due to lack of response (50%), loss of response (17%) and remission (15%). Overall, 23% of patients presented MMF-related AEs (60% abdominal pain). MMF was withdrawn in 11% of patients due to AEs. Conclusion MMFshows a clinical benefit in the long term in both CD and UC patients with a favourable safety profile. MMF could be a treatment option alone or in combination with biologics in patients with IBD in clinical practice.

Download Full-text

Association of trough vedolizumab levels with clinical, biological and endoscopic outcomes during maintenance therapy in inflammatory bowel disease

Frontline Gastroenterology ◽

10.1136/flgastro-2019-101197 ◽

2019 ◽

Vol 11 (2) ◽

pp. 117-123 ◽

Cited By ~ 2

Author(s):

Nikolas Plevris ◽

Philip W Jenkinson ◽

Cher S Chuah ◽

Mathew Lyons ◽

Lynne M Merchant ◽

...

Keyword(s):

Inflammatory Bowel Disease ◽

Maintenance Therapy ◽

Bowel Disease ◽

Clinical Remission ◽

Clinical Activity ◽

Faecal Calprotectin ◽

Cross Sectional ◽

Mayo Score ◽

Endoscopic Remission ◽

Inflammatory Bowel

ObjectiveTo establish the relationship between trough vedolizumab levels and outcomes during maintenance therapy.DesignCross-sectional service evaluation was performed on patients with inflammatory bowel disease (IBD) receiving maintenance vedolizumab therapy (minimum of 12 weeks following induction). Prior to infusion, data on clinical activity (Harvey-Bradshaw Index or partial Mayo score), trough C-reactive protein (CRP)/vedolizumab levels and faecal calprotectin were collected. Endoscopic data (±8 weeks from vedolizumab level testing) were obtained by review of medical records. Vedolizumab levels were processed using the Immundiagnostik monitor ELISA.SettingThe Edinburgh IBD Unit, Western General Hospital (tertiary IBD referral centre).PatientsSeventy-three patients (30 ulcerative colitis and 43 Crohn’s disease) were identified who fulfilled inclusion criteria and had vedolizumab levels matched with clinical activity scores, CRP and faecal calprotectin. Of these, 40 patients also had matched endoscopic data.Main outcome measuresThe association of trough vedolizumab levels with clinical remission (Harvey-Bradshaw Index <5 or partial Mayo <2), biologic remission (faecal calprotectin <250 µg/g+CRP <5 mg/L) and endoscopic remission (Mayo score 0/no inflammation and ulceration on colonoscopy).ResultsThe median trough vedolizumab levels were similar between patients in and not in clinical remission (10.6 vs 9.9 µg/mL, p=0.54); biologic remission (10.6 vs 9.8 µg/mL, p=0.35) and endoscopic remission (8.1 vs 10.2 µg/mL, p=0.21). Quartile analysis revealed no significant increase in the proportion of patients in clinical remission, biologic remission or endoscopic remission with increasing trough vedolizumab levels (p<0.05).ConclusionsIn this cohort, trough vedolizumab levels were not associated with clinical, biological or endoscopic outcomes during maintenance therapy.

Download Full-text

Anti-Tumor Necrosis Factor-Alpha Withdrawal in Children With Inflammatory Bowel Disease in Endoscopic and Histologic Remission

Inflammatory Bowel Diseases ◽

10.1093/ibd/izab046 ◽

2021 ◽

Author(s):

Luca Scarallo ◽

Giulia Bolasco ◽

Jacopo Barp ◽

Martina Bianconi ◽

Monica di Paola ◽

...

Keyword(s):

Inflammatory Bowel Disease ◽

Bowel Disease ◽

Treatment Withdrawal ◽

Clinical Relapse ◽

Necrosis Factor Alpha ◽

Mayo Score ◽

Endoscopic Score ◽

Inflammatory Bowel ◽

Factor Alpha

Abstract Background The aim of the present study was to investigate outcomes of anti-TNF-alpha (ATA) withdrawal in selected pediatric patients with inflammatory bowel disease who achieved clinical remission and mucosal and histological healing (MH and HH). Methods A retrospective analysis was performed on children and adolescents affected by Crohn disease (CD) and ulcerative colitis (UC) who were followed up at 2 tertiary referral centers from 2008 through 2018. The main outcome measure was clinical relapse rates after ATA withdrawal. Results One hundred seventy patients received scheduled ATA treatment; 78 patients with CD and 56 patients with UC underwent endoscopic reassessment. We found that MH was achieved by 32 patients with CD (41%) and 30 patients with UC (53.6%); 26 patients with CD (33.3%) and 22 patients with UC (39.3%) achieved HH. The ATA treatment was suspended in 45 patients, 24 affected by CD and 21 by UC, who all achieved concurrently complete MH (Simplified Endoscopic Score for CD, 0; Mayo score, 0, respectively) and HH. All the patients who suspended ATA shifted to an immunomodulatory agent or mesalazine. In contrast, 17 patients, 8 with CD and 9 with UC, continued ATA because of growth needs, the persistence of slight endoscopic lesions, and/or microscopic inflammation. Thirteen out of 24 patients with CD who suspended ATA experienced disease relapse after a median follow-up time of 29 months, whereas no recurrence was observed among the 9 patients with CD who continued treatment (P = 0.05). Among the patients with UC, there were no significant differences in relapse-free survival among those who discontinued ATA and those who did not suspend treatment (P = 0.718). Conclusions Despite the application of rigid selection criteria, ATA cessation remains inadvisable in CD. In contrast, in UC, the concurrent achievement of MH and HH may represent promising selection criteria to identify patients in whom treatment withdrawal is feasible.

Download Full-text

Perianal Abscesses in Infants Are Not Associated With Crohn’s Disease in a Surgical Cohort

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjz105 ◽

2019 ◽

Vol 14 (6) ◽

pp. 773-777

Author(s):

Mariëlle Roskam ◽

Tim de Meij ◽

Reinoud Gemke ◽

Roel Bakx

Keyword(s):

Inflammatory Bowel Disease ◽

Crohn’S Disease ◽

Crohn's Disease ◽

Bowel Disease ◽

Disease Risk ◽

Age Of Onset ◽

Faecal Calprotectin ◽

Young Infants ◽

Inflammatory Bowel

Abstract Aims The aim of this study is to search for an association between infantile perianal abscesses and [development of] Crohn’s disease in a surgical population of children. Methods Patients who were surgically treated in the Amsterdam UMC between January 2000 and December 2014 were included in this retrospective cohort study. Data collected include: sex, date of birth, underlying conditions, age of onset, additional symptoms, pus cultures, endoscopic examination, histological examination, magnetic resonance imaging, faecal calprotectin levels, antibiotic treatment, surgical treatment strategy, and number of recurrences. Follow-up data were gathered from medical records and by contacting the patients and/or parents or the general practitioner. Results The study consisted of 62 patients of whom 60 were boys. Median age was 5 months [range 0–17 months]; 92% were under 1 year of age at diagnosis. A minority of patients had accompanying symptoms. In total, 72 abscesses were treated, 19 fistulas and 23 abscesses with fistula-in-ano. Follow-up data of 46 patients [74%] were available; none of the patients developed Crohn’s disease. Conclusions We found no association between isolated perianal abscesses as presenting symptom in early childhood and [development of] Crohn's disease. In young infants with isolated perianal disease, risk for inflammatory bowel disease seems low. In this specific population there seems no place for routine performance of endoscopic investigations. One should always take the risk of very-early-onset inflammatory bowel disease into account. Further research with a larger cohort of children and a longer follow-up time is required.

Download Full-text

Laboratory Assessment of Disease Activity in Pediatric Patients with Inflammatory Bowel Disease: What’s New?

Gastroenterology Insights ◽

10.3390/gastroent11020009 ◽

2020 ◽

Vol 11 (2) ◽

pp. 58-71

Author(s):

Rayna Shentova-Eneva ◽

Tsvetelina Velikova

Keyword(s):

Inflammatory Bowel Disease ◽

Disease Activity ◽

Bowel Disease ◽

Laboratory Tests ◽

Pediatric Patients ◽

Clinical Activity ◽

Full Potential ◽

Inflammatory Bowel ◽

Pediatric Ibd

Laboratory tests are an integral part of both the diagnostic and follow-up algorithm of patients with inflammatory bowel disease (IBD). Their advantages over other non-invasive methods for assessing disease activity are greater objectivity than clinical activity indices and imaging studies. This review aims to analyze shortly the most common laboratory tests used to assess disease activity in pediatric patients with IBD. In addition to the conventional blood and serum markers that are not specific for gut inflammation, although routinely used, we also reviewed the established fecal markers such as calprotectin, lactoferrin, M2-pyruvate kinase, osteoprotegerin, HMGB1, chitinase 3-like 1, and the promising non-coding microRNA. In conclusion, neither marker is unique to the pediatric IBD. More clinical data are required to assess biomarkers’ full potential for diagnosis, management, and follow-up of pediatric IBD patients.

Download Full-text

Immunosuppression following liver transplantation and the course of inflammatory bowel disease – a case control study

Zeitschrift für Gastroenterologie ◽

10.1055/s-0043-117183 ◽

2017 ◽

Vol 56 (02) ◽

pp. 117-127 ◽

Cited By ~ 2

Author(s):

Martina Mogl ◽

Daniel Baumgart ◽

Andreas Fischer ◽

Johann Pratschke ◽

Andreas Pascher

Keyword(s):

Inflammatory Bowel Disease ◽

Liver Transplantation ◽

Mycophenolate Mofetil ◽

Bowel Disease ◽

Control Group ◽

Sustained Remission ◽

Short Term ◽

Surgical Interventions ◽

Inflammatory Bowel

Abstract Aim The aim of this study was to investigate the influence of immunosuppression following orthotopic liver transplantation (OLT) on course of inflammatory bowel disease (IBD) including disease activity and complications. Methods Out of 1168 patients undergoing liver transplantation between 1988 and 2000 at our center, we identified those with IBD (n = 67). In a comparative cohort study, IBD patients after OLT were compared to controls without OLT. All drugs including immunosuppressive and anti-inflammatory medication and complications during follow-up were recorded in 6-month intervals. Also, surgical interventions before and after OLT as well as endoscopic interventions with macroscopic and microscopic findings were collected and analyzed. Additionally, development of malignant neoplasias was recorded. Results Of the 67 individuals with IBD and OLT, 41 were available for analyses and compared with 42 controls. The mean follow-up was 7.4 (range: 3 – 15) years. Short-term therapy with calcineurin inhibitors or mycophenolate mofetil led to short-term remission, yet sustained remission could only be achieved in patients receiving mycophenolate mofetil. At 14.5 years, clinical remission was reached by significantly more patients in the transplant group (54 %) than in the control group (33 %, p = 0.0295). Patients in the control group required nearly 2 times as many surgical interventions related to IBD than patients in the transplant group. Neoplasias were more common in the OLT (n = 8) compared with 4 solid organ cancers in the control group, respectively. Conclusions Our data demonstrate an overall positive impact of immunosuppression following OLT on the course of IBD, especially with mycophenolate mofetil, but an increased rate of malignancies.

Download Full-text

P407 Faecal calprotectin predicts sustained treatment response of infliximab induction therapy superior to C-reactive protein and clinical activity scores in inflammatory bowel disease

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjx180.534 ◽

2018 ◽

Vol 12 (supplement_1) ◽

pp. S310-S311

Author(s):

P M Hellström ◽

M Lonnkvist ◽

H O Diaz Tartera ◽

R Befrits ◽

M Holst

Keyword(s):

Inflammatory Bowel Disease ◽

Treatment Response ◽

Induction Therapy ◽

Bowel Disease ◽

Clinical Activity ◽

C Reactive Protein ◽

Faecal Calprotectin ◽

Reactive Protein ◽

Inflammatory Bowel

Download Full-text

The impact of a dedicated contact centre on the clinical outcome of patients with inflammatory bowel disease during the COVID-19 outbreak

Therapeutic Advances in Gastroenterology ◽

10.1177/1756284820959586 ◽

2020 ◽

Vol 13 ◽

pp. 175628482095958

Author(s):

Olga Maria Nardone ◽

Antonio Rispo ◽

Anna Testa ◽

Nicola Imperatore ◽

Lucienne Pellegrini ◽

...

Keyword(s):

Inflammatory Bowel Disease ◽

Clinical Outcomes ◽

Bowel Disease ◽

High Volume ◽

Clinical Activity ◽

Phone Calls ◽

Inflammatory Bowel ◽

Contact Centre ◽

The Impact

Background: With the interruption of elective activity during the coronavirus disease 2019 (COVID-19) pandemic, a reorganisation of health care for patients with inflammatory bowel disease (IBD) was warranted. We aimed to investigate the effectiveness of a dedicated contact centre service (CCS) on the reorganization of a high-volume IBD centre and on the continuity of care during the COVID-19 outbreak. Methods: We compared the CCS services provided to 3680 IBD patients and clinical outcomes before (January–February 2020) and during (March–April 2020) the COVID-19 period. We further included, as comparator, data from March to April of the previous year (2019). Results: During the outbreak, the CCS received an increase of 10.2% of contacts, from 881, in January–February 2020, to 971 ( p = 0.02). An increase of 6% in CCS activities was also reported in comparison with March–April 2019 (from 914 to 971 in March–April 2020, p = 0.71). Before COVID-19, in both periods most contacts (67% in January–February 2020 and 60% in March–April 2019) required information about clinical activity, while fewer (33% in January–February 2020 and 40% in March–April 2019) requested logistic information. During the pandemic, most contacts (65.1%) asked to speak with a physician, 23.7% asked for information, while 11.1% wanted to cancel/postpone their appointments. Among all the information, 66% concerned COVID-19. In March–April 2020, 259 outpatient visits were booked, but were all replaced by phone consultations. No difference was detected in the number of intravenous biological administrations (307 versus 296, p = 0.64), surgeries (10 versus 9, p = 0.82) and urgent hospitalisations (10 versus 12, p = 0.67) before and during the COVID-19. Conclusion: The CCS was an effective tool in the reorganization of the IBD centre. Scheduled visits were replaced by phone calls. The main clinical outcomes were maintained in the COVID-19 period. Virtual follow-up using the CCS could be implemented after the pandemic to optimise the resources of the IBD centre.

Download Full-text

Switching From Originator Adalimumab to the Biosimilar SB5 in Patients With Inflammatory Bowel Disease: Short-term Experience From a Single Tertiary Clinical Centre

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjaa001 ◽

2020 ◽

Vol 14 (7) ◽

pp. 915-919 ◽

Cited By ~ 5

Author(s):

Martin Lukas ◽

K Malickova ◽

M Kolar ◽

M Bortlik ◽

M Vasatko ◽

...

Keyword(s):

Inflammatory Bowel Disease ◽

Disease Activity ◽

Bowel Disease ◽

Control Group ◽

Faecal Calprotectin ◽

Reactive Protein ◽

Mayo Score ◽

Serum Trough ◽

Inflammatory Bowel ◽

Trough Levels

Abstract Background and Aims Patients’ perspectives after switching from originator to biosimilar adalimumab have yet to be assessed. We evaluated the efficacy of switching from the originator adalimumab to a biosimilar compound [SB5] in patients with inflammatory bowel disease [IBD]. Methods Data on IBD patients who were switched from the originator to biosimilar adalimumab [SB5] at IBD Center ISCARE were analysed. Disease activity was assessed using standard clinical indices (Harvey-Bradshaw index [HBI] for Crohn’s disease [CD] and partial Mayo score for ulcerative colitis [UC]), and laboratory parameters (C-reactive protein [CRP] and faecal calprotectin [FC]). Trough levels and anti-drug antibodies were measured. Patients were evaluated 10 weeks [W10] after the switch, and results were compared with the control group of patients on originator compound. Results A total of 93 patients switched to biosimilar adalimumab were included [CD 86%] and were matched to 93 controls for age, gender, diagnosis, and disease activity. There was no difference in the disease activity in either SWITCH or ORIGINATOR cohorts between Weeks 0 and 10. Similarly, no difference was found between cohorts at both prespecified time points. Moreover, no significant differences in CRP or FC concentrations were seen between W0 and W10 either in the SWITCH, or in the ORIGINATOR cohort [p >0.05]. Adalimumab serum trough levels remained stable after the switch. No new safety signals were detected. Conclusions Our study confirmed that switching IBD patients from the originator adalimumab to a biosimilar compound [SB5] does not affect treatment efficacy.

Download Full-text