scholarly journals P498 Loss of response of anti-TNF in Crohn’s disease patients single-centre experience

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S434-S434
Author(s):  
A Atanassova ◽  
A C Georgieva ◽  
M Mirchev
Keyword(s):  
Risk Factors ◽  
Risk Factor ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Clinical Response ◽  
Biological Treatment ◽  
Phenotypic Expression ◽  
Faecal Calprotectin ◽  
Loss Of Response

Abstract Background Despite the timely commencement of the biological treatment, only about 30% will respond to it, and about 1/3 will lose the initial anti-TNF (tumour necrosis factor) response. Methods We retrospectively studied the data of 69 Crohn’s disease (CD) patients who started biological treatment with anti-TNF-ADA/ IFX. We excluded patients who are primary nonresponders to IFX/ADA. In patients with induction of clinical response, we investigated and analysed the frequency of subsequent loss of response (LOR) to IFX/ADA. We analysed the possible risk factors that have led to LOR. Results Of the 69 patients undergoing biological treatment, 71.01% achieved a clinical response during the course of the follow-up. There is a correlation between the presence of a clinical response and the CD course- x2 = 10.78, p = 0.013, ρ = 0.241, (p = 0.046). Inflammatory phenotype (В1) manifestation among our patients is a factor for achieving a clinical response OR = 3.68 (1.116–11.73), p = 0.021, whereas the presence of a penetrating form is a risk factor for the lack of response OR = 6.13 (1.29–29.01), p = 0.019. The presence of intestinal complications is a risk factor for the lack of response- OR = 3.2 (1.61–6.37), p = 0.001. During the course of the follow-up in 30.61% of cases, we observed LOR (men/women - 86.66%/13.33%, p < 0.05 (p = 0.02), in 60.00 % this was between 1–2 years, on average 20.62 ± 13.07 months from the start of the biological treatment. A total of 46.66% of patients required treatment with another anti-TNF drug due to secondary loss of response. A total of 50% of patients needed a reduction of the dose interval. Over 50.00% of those with LOR have an extensive disease (L3). A total of 40% have В1 and 33% have stricturing (В2) and penetrating (В3) phenotypic expression. In 26.66%, we observed progression of the disease range, and in 46.66% of patients - intestinal complications, none of whom had subsequent surgery. In 21.42% of LOR patients there is a combination of intestinal complications and progression according to disease localisation. 93.33% of CD patients with LOR have a persistence of extraintestinal manifestations (EIMs); those with two or three EIMs predominate. We discovered that gender was a risk factor for loss of response, OR = 8.36 (1.16–60.26), p = 0.005, as is the combination of В2 and В3 form of the disease OR = 14.72 (2.47–87.79), p = 0.003. Patients who lost response during the course of treatment had higher mean faecal calprotectin, CDAI and CRP prior to the initiation of the anti-TNF therapy. Conclusion The high activity of the disease measured with CDAI, faecal calprotectin and CRP, male gender, the combination of penetrating and stricturing form during the course of the disease are all risk factors for the loss of response.

scholarly journals P528 Response to biologic therapy in operated Crohn’s disease patients

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S454-S454
Author(s):  
A C Georgieva ◽  
A Atanassova ◽  
M Mirchev
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Clinical Response ◽  
Biological Treatment ◽  
Biological Therapy ◽  
Surgical Intervention ◽  
Mean Value ◽  
Subsequent Treatment ◽  
Time Interval ◽  
Faecal Calprotectin

Abstract Background About 70% of Crohn’s disease (CD) patients undergo surgery due to disease complication. According to the ECCO consensus, in such cases, the tumour necrosis factor-α (TNF-α) antagonists are a means of choice to prevent post-operative relapse. Methods The aim is to evaluate endoscopic, clinical and biochemical outcomes in CD patients, who have undergone surgery, in the course of the subsequent treatment with anti-TNFα mono/combination therapy—anti-TNFα + AZA. Among patients with CD who are undergoing biological treatment, we performed a retrospective analysis of the data of those who underwent surgical intervention associated with Crohn’s disease and subsequently started biological therapy. Results Of the 69 CD patients on biological therapy, surgical intervention was performed in 44.92% (n = 31) of cases prior to the initiation of the treatment. The prevalence of patients with right-sided hemicolectomy with subsequent ileotransverse anastomosis was 54.80%, followed by incision and abscess cavity drainage 22.6%, fistula excision 19.4% and left-sided hemicolectomy 3.2%. In 22 patients (71.0%) there was a clinical response (CDAI decline ≤ 100 points), with 66.66% of them achieving clinical remission (CDAI ≥ 150) (p = 0.001, strong correlation r = 0.596, p = 0.001). During the course of treatment, 23.80% lost clinical response after 18 months of treatment. We compared the mean value of the faecal calprotectin (FCP) before starting, and during the course of the biological treatment, we found that the FCP values decreased 1.5 times: 516.78 ± 273.93, (range 100 – 857)/330.46 ± 432.25, (range 5.32–1800). The activity of the disease measured by CDAI decreases twice during the course of the biological treatment: CDAI 378.00 ± 92.89 (range 258–695)/177.93 ± 116.38 (range 34–414) and CRP values decrease over four times: CRP 59.65 ± 64.52 (range 0.9–225)/13.14 ± 23.59 (range 0.13–116.10). During the course of the biological treatment, intestinal complications were observed in 33.33%, and 9.67% of the patients who had both progression and presence of intestinal complications had a subsequent surgery. In 33.33% of cases, the treatment was intensified. 16.70% of them had to switch to another biological drug. Perianal disease prior to biological treatment in operated patients is twice as common (x2 = 3.82, p = 0.050), which in turn appears to be a risk factor for surgical treatment (OR = 3.47 (0.953–12.685)). Conclusion In the follow up of the relationship between the occurrence of a clinical response and the onset of biological therapy, we found that the time interval was essential. The earlier the anti-TNFα therapy begins, the greater the likelihood of achieving a clinical and biochemical response (r = 0.326, p < 0.05).

scholarly journals Effectiveness and Safety of Ustekinumab Intensification at 90 mg Every 4 Weeks in Crohn’s Disease: A Multicentre Study

2020 ◽  
Author(s):  
Mathurin Fumery ◽  
Laurent Peyrin-Biroulet ◽  
Stephane Nancey ◽  
Romain Altwegg ◽  
Cyrielle Gilletta ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Adverse Events ◽  
Multicentre Study ◽  
Clinical Remission ◽  
Intestinal Resection ◽  
Serious Adverse Events ◽  
Faecal Calprotectin ◽  
Loss Of Response

Abstract Background The approved maintenance regimens for ustekinumab in Crohn’s disease [CD] are 90 mg every 8 or 12 weeks. Some patients will respond partially to ustekinumab or will experience a secondary loss of response. It remains poorly known if these patients may benefit from shortening the interval between injections. Methods All patients with active CD, as defined by Harvey–Bradshaw score ≥ 4 and one objective sign of inflammation [C-reactive protein > 5 mg/L and/or faecal calprotectin > 250 µg/g and/or radiological and/or endoscopic evidence of disease activity] who required ustekinumab dose escalation to 90 mg every 4 weeks for loss of response or incomplete response to ustekinumab 90 mg every 8 weeks were included in this retrospective multicentre cohort study. Results One hundred patients, with a median age of 35 years [interquartile range, 28–49] and median disease duration of 12 [7–20] years were included. Dose intensification was performed after a median of 5.0 [2.8–9.0] months of ustekinumab treatment and was associated with corticosteroids and immunosuppressants in respectively 29% and 27% of cases. Short-term clinical response and clinical remission were observed in respectively 61% and 31% after a median of 2.4 [1.3–3.0] months. After a median follow-up of 8.2 [5.6–12.4] months, 61% of patients were still treated with ustekinumab, and 26% were in steroid-free clinical remission. Among the 39 patients with colonoscopy during follow-up, 14 achieved endoscopic remission [no ulcers]. At the end of follow-up, 27% of patients were hospitalized, and 19% underwent intestinal resection surgery. Adverse events were reported in 12% of patients, including five serious adverse events. Conclusion In this multicentre study, two-thirds of patients recaptured response following treatment intensification with ustekinumab 90 mg every 4 weeks.

scholarly journals A229 USTEKINUMAB FOR THE TREATMENT OF REFRACTORY PEDIATRIC CROHN’S DISEASE: A SINGLE CENTRE EXPERIENCE

2020 ◽  
Vol 3 (Supplement_1) ◽  
pp. 104-106
Author(s):  
A Cohen ◽  
A Sant’Anna ◽  
N Ahmed
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Clinical Response ◽  
Clinical Remission ◽  
Pediatric Patients ◽  
Pediatric Population ◽  
The Other ◽  
Secondary Loss ◽  
Loss Of Response

Abstract Background Despite the well-established efficacy of Tumor Necrosis Factor (TNF) antagonists as treatment options for Crohn’s Disease, many pediatric patients need a change in therapy due to adverse events, as well as primary and secondary loss of response, highlighting the necessity for medications with a different mechanism of action. Ustekinumab, a monoclonal antibody targeting IL-12 and IL-23, has been approved to treat psoriatic arthritis, plaque psoriasis, and adults with Crohn’s disease. While utekinumab has been shown to be effective in inducing clinical remission in adults with Crohn’s disease refractory to anti-TNF agents, minimal data exists in the pediatric population. Aims We retrospectively describe 11 pediatric patients who received ustekinumab at the Montreal Children’s Hospital with the goal of assessing its efficacy in inducing clinical, biochemical, and endoscopic remission. Methods We abstracted baseline data, prior treatment and response, indications for starting ustekinumab, clinical response, endoscopic data, and laboratory parameters pre- and post- therapy. Clinical response was defined as decrease in abbrPCDAI (Pediatric Crohn’s Disease Activity Index) score. Results Patients ranged in age from 12–17 years old upon initiation of treatment with ustekinumab and had all previously failed either one (N=8) or both (N=3) anti-TNF therapies. Follow-up ranged from 6 to 22 months. We examined three indices of response to ustekinumab: symptomatic improvement, biomarker normalization, and endoscopic changes. Five of eleven patients demonstrated a clinical response – two maintained clinical remission across available follow-up data, while the remaining three experienced a secondary loss of response. The other six patients studied were primary non-responders. Two of these patients had normal abbrPCDAI scores upon initiation of ustekinumab and terminated therapy due to persistent stricturing disease. The other four non-responders either remained unwell or demonstrated clinical worsening, as measured by the abbrPCDAI. Of the clinical responders, 3/5 had elevated CRP values prior to initiating ustekinumab therapy, all of which normalized within one month of clinical improvement. Endoscopic data both pre- and post- ustekinumab was available in two responders and two non-responders, with endoscopic improvement seen in both of the responders and in one of the two non-responders. Conclusions These results demonstrate that ustekinumab has the potential ability to induce not only clinical and biochemical remission, but also endoscopic improvement, in the pediatric population. An area of concern is the fact that only one patient maintained remission for longer than one year. Future research should focus on maximizing and lengthening the effect of ustekinumab, as well as determining factors that influence response to therapy. Funding Agencies None

scholarly journals P389 Efficacy and safety of ustekinumab in patients with Crohn’s disease refractory to anti-tumour necrosis factor: real clinical practice

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S400-S401
Author(s):  
R M Saiz Chumillas ◽  
L Alba Hernández ◽  
I Chivato Martín-Falquina ◽  
E Badia Aranda ◽  
M L Arias García ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Clinical Response ◽  
Clinical Remission ◽  
Real Life ◽  
Corticosteroid Treatment ◽  
Faecal Calprotectin ◽  
Biochemical Remission

Abstract Background The efficacy of ustekinumab in patients with Crohn’s disease (CD) refractory to anti-TNF is worse than in anti-TNF naïve patients. Methods Retrospective study of patients with CD refractory or intolerant to TNF initiating ustekinumab between January 2013 and March 2020, with a minimum follow-up of 12 months, and without corticosteroid treatment. Our aim was evaluated clinical response (reduction of CDAI >100), clinical remission (CDAI <150) and biochemical remission (CDAI <100 and CRP <1 mg/L and faecal calprotectin <100 µg/g) in short and long term. Results A total of 49 patients with a medium follow-up of 28 months (IQR:13-37) were included. Patients baseline characteristics are reflected in Table 1. In 20% patients the induction was made subcutaneous (90 mg/week for 4 weeks). At week 52, clinical response, clinical remission and biochemical remission was 93%, 82% and 54% respectively (Figure 1). In the long term (3 years), 62% had clinical response, 52% remained in clinical remission, and 48% showed biochemical remission. 1/3 of patients needed intensification every year. Ustekinumab treatment discontinuation was observed in 13 patients (27%) mainly due to lack of response (6[12%]: primary, 7[14%]: secondary). No serious adverse effects have been reported. Conclusion About 50% of the patients are in clinical and biochemical remission at week 152 in a real-life cohort of anti-TNF-exposed CD patients. With a harder remission definition including biochemical parameters, our results in real life are similar to pivotal studies at week 152. Nevertheless, at week 52 our remission rates were higher.

scholarly journals P343 Efficacy of adalimumab in mild-to-moderate inflammatory bowel disease: Real-life data from single-centre experience in the long-term period

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S329-S330
Author(s):  
F Akyüz ◽  
A Ormeci ◽  
N Namazova ◽  
M Guzel ◽  
A Abbasgoulizadeh ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Response Rate ◽  
Real Life ◽  
Loss Of Response ◽  
Endoscopic Remission ◽  
Inflammatory Bowel

Abstract Background Adalimumab (ADA) is one of the most preferred anti-TNF agents because of its ease of use in real life. We aimed to evaluate the efficacy of ADA in the long-term period of inflammatory bowel disease (IBD) patients. Methods Patients treated with adalimumab (ADA) as the first- and second-line biological treatment for mild to moderate active IBD between January 2009 and March 2019 were included. The clinical and endoscopic response rate of ADA were evaluated, retrospectively. Remission was defined in ulcerative colitis patients (UC), if stool frequency ≤ 3/day with no bleeding and no mucosal lesions at the colonoscopy. Remission was defined in Crohn’s disease patients (CD) if CDAI < 150 and mucosal healing at the colonoscopy. Results Fifty-eight patients (81% Crohn’s disease, 58.6% biologic naive) were included in this study. Mean age was 41.4 ± 12.3 years old (19–67 years) and 46.6% of them were female. Median follow-up time was 57 months in UC and 65 months in Crohn’s disease (CD). Infliximab experience rate before ADA in UC and CD was 36.4%, 42.6%, respectively. CD’s related surgery rate was 43.5%; surgery rate 87.5% before ADA therapy and 12.5% after ADA treatment. Clinical and endoscopic remission rates were 81.8% / 63.6% and 89.4%/ 63.4 in UC and CD, respectively at the end of follow-up period. Loss of response rate was 20% in UC and 28.3% in CD (table). Mean months for loss of response were 42 ± 25.4 months and 29.7 ± 12 months in UC and CD, respectively. Clinical remission was obtained by dose escalation in 66% of CD patients who had response loss. Loss of response rate was not significantly different between IFX naive and IFX experienced patients (p > 0.05). There was no significant adverse event during the follow-up period. Conclusion In real life, the efficacy of ADA treatment is high in mild-to-moderate active IBD. Endoscopic remission was also acceptable for this group of patients.

scholarly journals P346 Single-centre experience of ustekinumab: Therapeutic drug monitoring in Crohn’s disease patients

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S331-S333
Author(s):  
C Liefferinckx ◽  
M Fassin ◽  
D Thomas ◽  
C Minsart ◽  
A Cremer ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Therapeutic Drug Monitoring ◽  
Crohn's Disease ◽  
Median Time ◽  
Real World ◽  
Drug Monitoring ◽  
Drug Exposure ◽  
Therapeutic Drug ◽  
Loss Of Response

Abstract Background Therapeutic drug monitoring (TDM) is a diagnostic tool in the monitoring of anti-TNF therapies. Yet, the benefit for TDM of new biologics such as ustekinumab (USK) is still controversial in real-world experiences. Methods This monocentric retrospective study aims to correlate USK trough levels (TLs) with clinical and endoscopic data. All patients have given written consent to the Biobank (B2011/005). Endoscopic disease was defined as quiescent in absence of endoscopic lesions, mild disease in presence of few superficial ulcerations, moderate in presence of several ulcers and severe in presence of numerous deep ulcers and/or inflammatory stenosis. 313 serum USK samples from 67 Crohn’s disease patients were used to measure USK TL (USK ELISA, apDia) while 88 samples (at week 16, and before and after optimisation) were used to measure anti-drug antibody (ADA), using a drug-tolerant affinity capture elution anti-ustekinumab assay Results Demographic and baseline data of our population are presented in Table 1. The median follow-up was 73 weeks (IQR 39–92). An optimisation due to loss of response was required in 44.8% of patients (n = 30) after a median time of 38 weeks (IQR 24–55). To evaluate the drug efficacy, an endoscopy was performed in 61% of cases at a median time of 35 weeks (IQR 27–47). TLs were 5.2 µg/ml (IQR 2.1–8.8), 1.7 µg/ml (IQR 0.3–4.3) and 2.6 µg/ml (IQR 0.6–4.1) at week 8, 16 and 24, respectively. TLs at week 8 were correlated to the induction IV dose administrated (r = 0.3, p = 0.03). At week 16, low TLs were associated with higher endoscopic activity in the follow-up (p = 0.02), although this was not the case at week 8 (p = 0.5) (Figure 1). Patients not requiring an optimisation had higher TLs in maintenance than patients requiring optimisation (2.45 µg/ml (IQR 1.3–4.4) vs. 1.15 µg/ml (IQR 0.1–2.24), p = 0.008). Obviously, optimisation significantly increased TLs (1.15 µg/ml (IQR 0.1–2.24) vs. 6.6 µg/ml (IQR 2.3–11.3), p < 0.001). ADA were undetectable in all the measured samples in maintenance. Conclusion This real-world experience confirms a drug exposure-endoscopic response relationship. Week 16 seems to be an appropriate time point to monitor drug exposure. Earlier USK TLs, at week 8, appear less valuable to be monitored due to the influence of initial IV dose. The absence of immunogenicity suggests that it is not a key driver in the loss of response.

scholarly journals P720 Recurrent rectovaginal fistula in patients with Crohn’s disease: How can we improve the success rate of graciloplasty? A bi-centric European study in 30 patients

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S579-S580
Author(s):  
A Frontali ◽  
M Rottoli ◽  
A Chierici ◽  
G Poggioli ◽  
Y Panis
Keyword(s):  
Risk Factors ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Antibiotic Prophylaxis ◽  
Success Rate ◽  
Rectovaginal Fistula ◽  
Univariate Analysis ◽  
Diverting Stoma ◽  
Prospective Database

Abstract Background Graciloplasty (GP) is indicated in case of recurrent rectovaginal fistula (RVF), even in patients with Crohn’s disease, after failure of previous local treatments. The aim of this study was to evaluate risk factors for GP failure performed for recurrent RVF in these patients. Methods We realised a retrospective study based on a prospective database of GP, realised in two Tertiary expert Centers in Italy (Bologna) and France (Clichy). Results Thirty-two patients undergoing 34 GP (2 patients have undergone 2 GP for failure of first GP): we excluded second GP and 2 patients without available follow-up: 30 patients undergoing a first GP for RVF (n = 29) or ileal-vaginal fistula after ileal-pouch-anal-anastomosis (IPAA) (n = 1) with a mean age of 41 ± 10 years (range, 25–64) were analysed. After a mean follow-up of 65 ± 52 months (2–183), a success of GP (considered as absence of diverting stoma and RVF healing) was noted in 17/30 patients (57%). We evaluated risk factors for failure of the procedure and we found only 2 risk factors on univariate analysis: (1) absence of a postoperative prophylactic antibiotherapy: only 2/13 (15%) patients with a GP failure had a postoperative antibiotic-prophylaxis vs. 9/15 (60%) patients with success of GP (p = 0.0238); (2) a postoperative perineal infection: 7/13 (54%) with a GP failure developed a postoperative perineal infection vs. 2/17 (12%) patients (p = 0.0196). Conclusion Graciloplasty for recurrent rectovaginal fistula in patients with Crohn’s disease is effective in 57% of patients. Our study underlines the possible benefit of a postoperative antibiotic-prophylaxis because it seems to increase significantly the success rate of the procedure.

scholarly journals P665 Which second-line biologic after anti-TNF failure during Crohn’s disease: Ustekinumab or vedolizumab, a multicentre retrospective study

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S547-S547 ◽  
Author(s):  
C Rayer ◽  
X Roblin ◽  
D Laharie ◽  
B Caron ◽  
M Flamant ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Side Effects ◽  
Crohn's Disease ◽  
Clinical Response ◽  
Risk Model ◽  
Second Line ◽  
Faecal Calprotectin ◽  
Drug Survival ◽  
Cumulative Probabilities

Abstract Background Anti-TNF antibodies treatments are the only first-line reimbursed biologics for Crohn’s disease (CD) in several countries. Recently, Vedolizumab (VDZ) and Ustekinumab (UST) were added to the therapeutic armamentarium for CD refractory to a first anti-TNF antibody. However, studies comparing these two compounds remain unavailable. Our aim was to compare their efficacy in second-line treatment in CD after failure of one TNF antagonist. Methods All patients with CD refractory (primary or secondary non-responders) to first anti-TNF treatment and receiving UST or VDZ as a second biologic were included retrospectively in 10 French tertiary centres. The remission and clinical response were assessed at week 14. On the long-term, the cumulative probabilities of being in remission were estimated using the Kaplan–Meier method and the associated factors using a Cox proportional risk model. The drug survival to assess efficacy as well as side effects was assessed by actuarial analysis. Results 88 patients were included, 50 (57%) females (mean age: 41 ± 15 years), 61 (69%) being treated with UST and 27 (31%) with VDZ. The first anti-TNF was discontinued for primary or secondary non-response in 66 (75%) patients and for side effects in 22 (25%) patients, without any difference between the anti-TNF antibody previously used. Among the 55 patients with endoscopic data at baseline, 55 (98%) had ulceration, a CRP above 5mg/l for 33/71 (46%) patients and a faecal calprotectin > 250 µg/g for the 12 patients tested. At week 14, no difference was observed for clinical response and clinical remission according to the type of treatment: the rate of clinical response and remission were 74% (UST)/58% (VDZ) (p = 0.20) and 33% (UST)/26% (VDZ) (p = 0.56), respectively. The only factor associated with short-term remission was the lack of optimisation prior to anti-TNF discontinuation (p = 0.038) regardless of the type of second-line therapy (UST, p = 0.02; VDZ, p = 0.03). After a mean follow-up of 67 weeks, the cumulative probabilities of being in remission at 6 and 12 months were 16% and 34% for UST and 25% and 44% for VDZ, respectively (p = 0.24 for UST vs. VDZ). The drug survival was higher in the UST group as compared with the VDZ group (HR (UST vs. VDZ) = 2.36 [1.02–5.5], p = 0.04). Conclusion Our preliminary results suggest that VDZ and UST have similar efficacy in the short- and long-term response when used as a second-line biologic therapy in CD refractory to a first anti-TNF antibody. These results will be complemented for the congress by the inclusion of additional patients recruited into this registry.

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

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.

scholarly journals P451 Short-and long-term effectiveness of ustekinumab in patients with Crohn’s disease: real-world data from a German IBD cohort

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S405-S405
Author(s):  
A Kubesch ◽  
L Rueter ◽  
K Farrag ◽  
T Krause ◽  
K Stienecker ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Real World ◽  
Treatment Options ◽  
Real World Data ◽  
Free Response ◽  
Faecal Calprotectin ◽  
Short And Long Term

Abstract Background The IL-12/23 inhibitor ustekinumab (UST) opened up new treatment options for patients with Crohn’s disease (CD). Due to the recent approval, Real-World German data on long-term efficacy and safety are lacking. This study aimed to assess the clinical course of CD patients under UST therapy and to identify potential predictive markers. Methods Patients with CD receiving UST treatment in three hospitals and two outpatient centres were included and retrospectively analysed. Rates for short- and long-term remission and response were analysed with the help of clinical (Harvey–Bradshaw Index [HBI]) and biochemical (C-reactive protein [CRP], faecal calprotectin [fCal]) parameters for disease activity. Results Data from 180 patients were evaluated. One hundred six patients had a follow-up of at least 8 weeks and were included. 96.2% of the patients were pre-exposed to anti- TNFα agents and 34.4% to both anti-TNFα and anti-integrin. The median follow-up was 49.1 weeks (95% CI 42.03–56.25). At week 8, 51 patients (54.8%) showed response to UST, and 24 (24.7%) were in remission. At week 48, 39 (41.9%) responded to UST, and 20 patients (21.5%) were in remission. Steroid-free response and remission at week eight were achieved by 30.1%, and 19.3% of patients. At week 48, 26.9% showed steroid-free response to UST, and 15.1% of the initial patient population was in steroid-free remission. Clinical response at week 16 was independently associated with remission at week 48. Conclusion Our study confirms short- and long-term UST effectiveness and tolerability in a cohort of multi-treatment exposed patients.

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