P415 The anti-IL-23/IL-12 agent Ustekinumab is an effective and safe induction therapy in patients with Crohn’s disease refractory or intolerant to anti-TNF: a multicentre Italian study

Abstract Background There are limited real-life studies in medical literature evaluating the efficacy and safety of Ustekinumab, an Anti-IL-23/Anti IL-12 agent, in patients with Crohn’s disease (CD) who required treatment because of refractoriness or intolerance to previous biological treatments. Thus, the aim of this study was to assess the effectiveness and tolerability of Ustekinumab in anti-TNF refractory or intolerant CD patients. Methods All CD patients who completed induction with Ustekinumab in three Italian IBD Units (Padua, Santorso, and Pisa) were enrolled. Patients were evaluated after induction (first intravenous dose followed by a subcutaneous dose at 8 weeks) and clinical (Harvey- Bradshaw-Index) and biochemical data, including faecal calprotectin (FC) and C-reactive protein (CRP) were collected. Information on the need of optimisation (every 12 or 8 weeks) and adverse events were also collected. Continuous and categorical variables were expressed as mean with standard deviation (sd) and frequency with percentages, respectively. Comparisons between variables were conducted using paired t-test and chi-square test. Data were analysed using STATA11.1 software. Results Sixty-three patients were included (41 males, mean age 43 ± sd 13.2 years). All of them had previously been treated with at least one biologic agent and 95.2% with oral steroids. The main indications for starting therapy were: previous treatment failure (77.2%) and pharmacological intolerance (17.5%). At the time of the induction, 28.6% patients were under steroid treatment. Post induction, clinical remission was obtained in 63.5% patients, while steroid-free clinical remission in 52.4%. Moreover, a statistically significant reduction of FC (from 916 μg/l to 444 μ/l, p < 0.001) and normalisation of CRP (n = 14, 33.3%; p < 0.001) were observed. After induction, 3 adverse effects were reported, and in two treatment discontinuations was necessary (i.e. 1 case of pyelonephritis and 1 case of a re-activation of entero-cutaneous fistula). Finally, among 63 patients enrolled, 51 (80.9%) were optimised with a maintenance regimen of 8 weeks sub-cutaneous doses. Conclusion Our study shows that Ustekinumab seemed is effective in achieving clinical remission and steroid-free clinical remission after induction in the majority of CD patient despite the refractoriness to anti-TNF treatment. Moreover, the drug appeared safe and well tolerated. On the other hand, treatment optimisation to 8 weeks was adopted in most of the patients, in order to guarantee a better outcome.

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P583 Real-life efficacy and safety of Ustekinumab as second- or third-line therapy in Crohn’s disease: results from a large Italian cohort study

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjab076.704 ◽

2021 ◽

Vol 15 (Supplement_1) ◽

pp. S536-S537

Author(s):

G Mocci ◽

A Cuomo ◽

L Allegretta ◽

G Aragona ◽

R Colucci ◽

...

Keyword(s):

Crohn’S Disease ◽

Crohn's Disease ◽

Clinical Remission ◽

Large Population ◽

Real Life ◽

Previous Treatment ◽

Fecal Calprotectin ◽

Concomitant Treatment ◽

Efficacy And Safety

Abstract Background Ustekinumab (UST) is an anti-IL12/23 antibody for the treatment of Crohn’s Disease (CD). The aim of this study was to compare the efficacy and safety of UST in a large population-based cohort of CD patients who failed previous treatment with other biologics Methods 194 CD patients (108 males and 86 females, mean age 48 years (range 38–58 years) were retrospectively reviewed. 147 patients were already treated with anti-TNFα (75.8%), and 47 (24.2%) patients were already treated with anti-TNFα and vedolizumab. Concomitant treatment with steroids was present in 177 (91.2%) patients Results At week 12, clinical remission was achieved in 146 (75.2%) patients. After a mean follow-up of 6 months, clinical remission was maintained in 135 (69.6%) patients; at that time, mucosal healing was assessed in 62 (31.9%) patients, and it was achieved in 33 (53.2) patients. Three (1.5%) patients were submitted to surgery. Steroid-free remission was achieved in 115 (59.3%) patients. Both serum C-Reactive Protein and Fecal Calprotectin (FC) levels were significantly reduced with respect to baseline levels during follow-up. A logistic regression, UST therapy as thirdline therapy (after both anti-TNFα and vedolizumab), FC >200 μg/g, and HBI ≥8 were significantly associated with lack of remission. Adverse events occurred in 5 (2.6%) patients, and four of them required suspension of treatment Conclusion Ustekinumab seemed to be really effective and safe in CD patients unresponsive to other biologic treatments, especially when used as second-line treatment.

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Ustekinumab Exposure-outcome Analysis in Crohn’s Disease Only in Part Explains Limited Endoscopic Remission Rates

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjz008 ◽

2019 ◽

Vol 13 (7) ◽

pp. 864-872 ◽

Cited By ~ 27

Author(s):

Bram Verstockt ◽

Erwin Dreesen ◽

Maja Noman ◽

An Outtier ◽

Nathalie Van den Berghe ◽

...

Keyword(s):

Crohn’S Disease ◽

Crohn's Disease ◽

Clinical Remission ◽

Real Life ◽

Outcome Analysis ◽

Faecal Calprotectin ◽

Exposure Response ◽

Patient Reported ◽

Endoscopic Remission ◽

Remission Rates

Abstract Background and Aims Ustekinumab, an anti-IL12/23p40 monoclonal antibody, has been approved for Crohn’s disease [CD]. Real-life data in CD patients receiving ustekinumab intravenously [IV] during induction, followed by subcutaneous [SC] maintenance, are lacking. We assessed efficacy of ustekinumab and studied exposure-response correlations. Methods We performed a prospective study in 86 CD patients predominantly refractory or intolerant to anti-tumour necrosis factor agents and/or vedolizumab. All received ustekinumab 6 mg/kg IV induction, with 90 mg SC every 8 weeks thereafter. Endoscopic response (50% decrease in Simple Endoscopic Score for CD [SES-CD] at Week 24), endoscopic remission [SES-CD ≤2], and clinical remission [daily stool frequency ≤2.8 and abdominal pain score ≤1] were assessed at weeks 4,8,16, and 24. Further serial analyses included patient-reported outcomes [PRO2], faecal calprotectin [fCal], and ustekinumab serum levels. Results SES-CD decreased from 11.5 [8.0–18.0] at baseline to 9.0 [6.0–16.0] at week [w]24 [p = 0.0009], but proportions of patients achieving endoscopic response [20.5%] or endoscopic remission [7.1%] were low. Clinical remission rates were 39.5% at w24. After IV induction, fCal dropped from baseline [1242.9 μg/g] to w4 [529.0 μg/g] and w8 [372.2 μg/g], but increased again by w16 [537.4 μg/g] and w24 [749.0 μg/g]. A clear exposure-response relationship was observed, both during induction and during maintenance therapy, with different thresholds depending on the targeted outcome. Conclusions In this cohort of refractory CD patients, ustekinumab showed good clinical remission rates but limited endoscopic remission after 24 weeks. Our data suggest that higher doses may be required to achieve better endoscopic outcomes.

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P327 Long-term effectiveness of ustekinumab in refractory Crohn’s disease: an Italian multicenter real-life study

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjab076.451 ◽

2021 ◽

Vol 15 (Supplement_1) ◽

pp. S351-S352

Author(s):

M L Scribano ◽

A Aratari ◽

B Neri ◽

C Bezzio ◽

P Balestrieri ◽

...

Keyword(s):

Crohn’S Disease ◽

Crohn's Disease ◽

Adverse Events ◽

Clinical Remission ◽

Real Life ◽

Categorical Variables ◽

Secondary Failure ◽

The Mean ◽

Italian Cohort

Abstract Background Ustekinumab (UST) is increasingly used in Italy for the treatment of refractory Crohn’s disease (CD), however very few data concerning real-life experience has been reported. Therefore, the aim of this study was to assess the long-term effectiveness of UST in refractory CD patients treated in a large Italian cohort. Methods A retrospective study was conducted in 5 Italian tertiary centers. All adult CD patients who started UST because of anti-tumor necrosis factor (TNF) failure were included. The co-primary outcomes were steroid-free clinical remission (defined as Harvey Bradshaw Index, HBI ≤4) at weeks 26 and 52. Secondary outcomes were changes in HBI score, changes in C-reactive protein (CRP) values, normalization of CRP (≤0.5 mg/dl) at weeks 8, 26, and 52, and adverse events. Categorical variables were expressed as frequency and percentage. Unpaired t-test was used to compare variables. A p-value <0.05 indicated statistical significance. Continuous variables were expressed as mean and standard deviation (SD), and median with interquartile range (IQR). Results Between Nov 2018 and Feb 2020,140 patients (51.4% male; median age 45.0 years, IQR 36.3-54.0; median disease duration 16.0 years, IQR 8.0-22.0) were included. The majority of patients had ileocolonic disease (L1, 38.6%; L2, 11.4%; L3, 50.0%) and an inflammatory phenotype (B1, 50.7%; B2, 31.0%; B3, 18.3%). All patients had previously been exposed to at least one anti-TNF agent, 27.1% to 2 anti-TNF agents, and 20.0% to vedolizumab . At inclusion 15.7% of patients received corticosteroids and 8.6% immunomodulators. All patients received an intravenous dose of 6 mg/kg, followed by subcutaneous administration of 90 mg every 8 (90%) or 12 weeks (10%) according to clinical judgment. The proportion of patients achieving steroid-free clinical remission was 61.0% and 64.2% at weeks 26 and 52 respectively. A significant decrease in the mean HBI was reported from baseline to week 8 (6.8 ± 3.6 vs 4.5 ± 3.1; p <0.001), week 26 (3.5 ± 2.9; p <0.001), and week 52 (3.1 ± 2.4; p <0.001). The mean CRP values was also significantly decreased from baseline to week 8 (4.6 ± 7.3 vs 2.8 ± 7.1; p <0.001), week 26 (1.7 ± 3.8; p <0.001), and week 52 (1.1 ± 2.2; p<0.001). At baseline 93 of 119 patients had high CRP value: a normal CRP value was observed in 34.9%, 37.8%, and 49.3% of patients at weeks 8, 26, and 52 respectively. Overall, 11 patients (7.9%) discontinued UST within 1 year: primary failure (n=2), secondary failure (n=6), adverse events (n=3: 2 allergic reactions, and 1 arthralgia). Conclusion To our knowledge this is one of the largest Italian cohort followed up to 1 year, and the results confirm that UST is an effective and safe treatment in refractory CD patients.

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Long-Term Clinical Effectiveness of Ustekinumab in Patients With Crohn’s Disease: A Retrospective Cohort Study

Crohn's & Colitis 360 ◽

10.1093/crocol/otaa061 ◽

2020 ◽

Vol 2 (4) ◽

Author(s):

Takahiro Ito ◽

Atsuo Maemoto ◽

Takehiko Katsurada ◽

Hiroki Tanaka ◽

Satoshi Motoya ◽

...

Keyword(s):

Crohn’S Disease ◽

Crohn's Disease ◽

Clinical Remission ◽

Remission Rate ◽

Real Life ◽

Previous Treatment ◽

Clinical Effectiveness ◽

History Of ◽

Factor Α

Abstract Background This study clarifies the long-term effectiveness of ustekinumab based on real-life data from Japanese Crohn’s disease (CD) patients. Methods A total of 137 patients were included, and 124 patients (90.5%) were exposed to anti-tumor necrosis factor-α agents. Results The clinical remission rate at week 52 was 32.4% in moderate to severely active CD patients. The achievement of clinical remission for 8 weeks after ustekinumab therapy induction was associated with clinical remission at week 52. Ustekinumab persistence rate at week 104 was 81.4%. Conclusion Ustekinumab is effective and persistent in CD patients with the previous treatment history of several biologics.

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

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjab076.513 ◽

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.

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P051 Quantifying inflammation and fibrosis through a surgical histopathological score can differentiate ileal Crohn’s disease phenotypes and predict postoperative progressive disease

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjz203.180 ◽

2020 ◽

Vol 14 (Supplement_1) ◽

pp. S158-S160

Author(s):

H Tavares de Sousa ◽

I Gullo ◽

C Castelli ◽

C C Dias ◽

F Magro

Keyword(s):

Crohn’S Disease ◽

Crohn's Disease ◽

Progressive Disease ◽

Categorical Variables ◽

Continuous Variables ◽

Chi Square ◽

Ileal Resection ◽

Operative Outcomes ◽

Level Of Significance ◽

Histopathological Score

Abstract Background The quantification of fibrosis in Crohn’s disease (CD) still relies on surgical specimens’ pathology. We aimed to correlate quantification of inflammation and fibrosis of CD ileal resection specimens with postoperative progressive disease. Methods All patients (patients) having primary ileal resection for CD complications with a follow-up >3 years (n = 262) were considered. Unavailability of specimen excluded 72 patients and 22 for absence of the three study sections: (1) proximal ileal margin; (2) most affected area (B2: narrower calibre of stricture; B3: area with fistulas/deep ulcers); (3) inflamed area (inflamed bowel, no lesions as in 2). Of the 168 patients with the three studied phenotypes (B2 and B3 with stenosis (B3s) and without stenosis (B3o), we randomly excluded 65 B3s for overrepresentation. We analysed three sections per patient (3 × 103 patients = 309 sections), stained with haematoxylin and eosin and Masson’s trichrome. Chiorean et al. histopathological score grades inflammation 1–3 and fibrosis 0–2. We add a ‘0’ category to inflammation and observed adipose tissue and muscularisation in submucosa. Progressive disease was previously defined as one of eight post-operative outcomes (reoperation, hospitalisation, steroids, start or change of immunosupressives or biologics, new stricturing/penetrating/anal event). Statistics: Continuous variables were described by mean(standard deviation), median(interquartile range), minimum and maximum, and categorical variables by absolute(n) and relative(%) frequencies. Chi-square, Mann–Whitney and Kruskal–Wallis compared groups. Hypotheses were tested at 5% level of significance, using IBM SPSS Statistics for Mac, vs. 24.0. Results We assessed 103 patients (B2–29; B3o–20; B3s–54), 55% males, mean age at diagnosis 30(12) years, followed for a mean time of 10(4) years. Median time from surgery to reoperation was 8.0 (7.0, 12.0) years. B3 patients have significantly more inflammation than B2 patients [score 3: 78%vs.55% and 96%vs.76% in most affected (p = 0.027) and inflamed (p = 0.005) sections, respectively]. B3s patients had significantly more fibrosis than B3o [score 1 + 2: 90%vs.60% in most affected (p = 0.011) and 99%vs.85% in inflamed (p = 0.048) sections] and significantly more inflammation than B2 patients [score 3: 81%vs.55% in most affected (p = 0.020) and 94%vs.76% in inflamed (p = 0.019) sections]. B3s had higher total score than B3o and B2 [score 4–5: 78%vs.45%vs.52%, p = 0.019] and more new penetrating events (p = 0.043). Of the 25 patients changing biologic after surgery, 88% had inflammation at the margins [score 3: 55%vs.12%, p = 0.035]. Conclusion B3s stood out as a distinctive phenotype, with significantly more fibrosis than B3o but significantly more inflammation than B2. It displayed the highest total score and was associated to progressive disease.

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P058 ISOLATED TERMINAL ILEITIS AT COLONOSCOPY – WHAT FACTORS PREDICT A NEW DIAGNOSIS OF CROHN’S DISEASE?

Inflammatory Bowel Diseases ◽

10.1093/ibd/zaa010.032 ◽

2020 ◽

Vol 26 (Supplement_1) ◽

pp. S14-S14

Author(s):

Rajan Patel ◽

Kar Mun Ang ◽

Saadiq Moledina ◽

Saif Musa ◽

Akeel Alisa ◽

...

Keyword(s):

Crohn’S Disease ◽

Crohn's Disease ◽

Terminal Ileum ◽

Binary Logistic Regression ◽

Poor Correlation ◽

Colonic Disease ◽

Chi Square ◽

Terminal Ileitis ◽

Faecal Calprotectin ◽

New Diagnosis

Abstract Background Faecal calprotectin (FC) is a biomarker elevated in active inflammatory bowel disease (IBD). FC is more sensitive in colonic than small bowel IBD. Ileo-colonoscopy is usually performed to confirm a diagnosis of IBD. Isolated non-specific terminal ileitis is often inconclusive despite biopsy. We aimed to assess the factors that predict terminal ileal Crohn’s disease after ileitis is seen at colonoscopy. Methods A single centre retrospective study of all endoscopic cases of isolated terminal ileitis diagnosed at colonoscopy over a 4 year period (January 2015 – December 2018) was performed. Data was obtained from the Unisoft Endoscopy reporting software. Statistical analyses included chi-square, student t-test and binary logistic regression. Faecal calprotectin, CRP and histology were noted. >150μg/mg was used as a cut off for elevated FC. Results 139 cases were identified and exclusion criteria were applied (known Crohn’s disease, colonic disease). 74 cases were included for analysis. The mean age was 43.9. 44 (59.5%) of the cases were women. 38 (51.4%) had FC performed of which 27 (71.1%) had a FC >150μg/mg. 60 (81.1%) cases had macroscopic terminal ileum ulcers, 9 (15%) of these had histological evidence of ulceration. Subsequent diagnoses of Crohn’s disease were made in 15 (20.3%) patients. Odds ratio of 1.28 (p = 0.016, Cl 0.45-0.047) in the TI ulcers + FC >150μg/mg vs. no TI ulcers + FC <150μg/mg. Conclusion 1 in 5 patients with isolated terminal ileitis were subsequently diagnosed with Crohn’s disease. Almost 90% of these new cases had a faecal calprotectin >150μg/mg. There is poor correlation between endoscopic and histological terminal ileum ulceration. We conclude that terminal ileal ulceration in combination with faecal calprotectin >150μg/mg increases the likelihood of a new diagnosis of Crohn’s disease.

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

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjaa177 ◽

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.

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P577 Ustekinumab in actual clinical practice: our centre experience

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjz203.705 ◽

2020 ◽

Vol 14 (Supplement_1) ◽

pp. S485-S486

Author(s):

J M LOPEZ TOBARUELA ◽

A D Sanchez-Capilla ◽

E J Ortega-Suazo ◽

M C Fernandez-Cano ◽

M Herrador-Paredes ◽

...

Keyword(s):

Crohn’S Disease ◽

Crohn's Disease ◽

Clinical Response ◽

Safety Profile ◽

Clinical Remission ◽

Clinical Manifestations ◽

Previous Treatment ◽

Biological Therapies ◽

Response Predictors ◽

Wide Variability

Abstract Background Crohn’s disease is an entity with wide variability in its clinical manifestations, which mainly affects the gastrointestinal tract, and may also involve another organs. We have a wide variety of treatments available, being the most recent ones biological therapies. One of them is ustekinumab, which due to its innovative mechanism of action has improved the quality of life of many patients with an excellent safety profile. Our objective was to analyze the baseline situation of 37 patients undergoing treatment with ustekinumab in our centre and the evolution of different clinical and analytical parameters at 12, 24 and 52 weeks after starting it. Methods 37 patients currently receiving ustekinumab treatment with indication of Crohn’s disease at Virgen de las Nieves Hospital were selected (Tables 1 and 2). Clinical response was analyzed according to the Harvey–Bradshaw Index (HBI) (clinical remission <4, clinical response decrease ≥3 points above the baseline), blood and stool test (CRP and calprotectin) at weeks 12, 24 and 52, need for surgery and safety profile (Table 3). Results There are no significant differences in HBI or baseline CRP depending on previous or not treatment with anti-TNF or vedolizumab. No differences in HBI, CRP at weeks 12, 24 and 52 depending on if previous treatment with anti-TNF or vedolizumab. The decrease in the median values of HBI was statistically significant at weeks 12, 24 and 52; as well as CRP values at weeks 24 and 52 (Table 3). According to HBI, clinical response was obtained in 41,38%, 50% and 61,11% of patients at weeks 12, 24 and 52 and clinical remission in 20,69%, 33,33% and 27,78% respectively (Table 3). No response predictors were identified at week 12 except for non-perianal fistulas associated with a greater response (58,3% vs. 41,7%; p = 0,0459) (Table 4). Conclusion In this group of patients potentially difficult to treat (62% previous surgery, long-term disease, 95% previous treatment with immunomodulators and/or biological therapies (66% ≥2 anti-TNF), etc.), ustekinumab achieves clinical response in 41,38%, 50%, 61,11% at week 12, 24 and 52. Surgery was required in 2 cases and only 3 patients suffered relevant adverse effects. In a pivotal study of ustekinumab UNITI-1, 50,6% of patients who received the induction dose of 6 mg/kg had previously been treated with ≥2 anti-TNF, in our group, 65,71%. In our cohort, only 29,73% of patients received corticosteroids concomitantly at the start of ustekinumab treatment vs. 43,3% at UNITI-1. Despite these differences against our group, clinical response and remission data are similar to UNITI-1 (41,38% vs. 37,8% and 20,69% vs. 20,9% respectively). Prospective studies with more patients could identify who would benefit most from this treatment.

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P613 Use of adalimumab biosimilar ABP 501 in Crohn’s disease: A real-life experience

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjz203.741 ◽

2020 ◽

Vol 14 (Supplement_1) ◽

pp. S510-S511

Author(s):

D G Ribaldone ◽

M Vernero ◽

R Pellicano ◽

M Morino ◽

G M Saracco ◽

...

Keyword(s):

Crohn’S Disease ◽

Crohn's Disease ◽

Adverse Events ◽

Clinical Response ◽

Clinical Remission ◽

Retention Rate ◽

Real Life ◽

University Hospital ◽

Clinical Response Rate ◽

Abp 501

Abstract Background The use of biologics in Crohn’s disease (CD) entails an increasing cost on national health systems. The use of biosimilars of adalimumab in CD is based on the concept of extrapolation of the results obtained in rheumatoid arthritis and in psoriasis, while no study about the efficacy and safety on CD of the biosimilars approved in Europe have been published. The aim of our study was to analyse, for the first time in literature, the effectiveness and safety of ABP 501 in CD patients naïve to adalimumab and its retention rate in CD patients who switched from adalimumab originator. Methods We performed an observational study on patients prospectively followed at the gastroenterology clinic of the Turin University Hospital. Inclusion criteria are (a) CD diagnosed according to ECCO criteria; (b) age ≥16 years; (c) initiation of therapy with ABP 501. Exclusion criterian is follow-up duration of less than 3 months for adalimumab-naïve patients, less than 6 months for patients who switched to ABP 501. Primary outcomes were (a) for patients treated with ABP 501 as first adalimumab: clinical response rate at 12 weeks and (b) for patients who switched to ABP 501: drug retention at 24 weeks. Secondary outcomes were (a) clinical remission rate at week 12 (for patients treated with ABP 501 as first adalimumab); (b) HBI and CRP reduction at week 12 (for patients treated with ABP 501 as first adalimumab), no significant change in HBI and CRP values at week 24 (for patients who switched to ABP 501); (c) analysis of predictors; and (d) adverse events incidence. Results Eighty-seven patients were included, of which 25 were naïve to adalimumab originator and 62 were switched to ABP 501. In adalimumab-naïve patients, the clinical response at 3 months was 60% (15/25), clinical remission at 3 months was 56% (14/25). At 6 months, 95.2% (59/62) of the patients switched to ABP 501 were still in therapy, without a significant increment of clinical activity (Harvey–Bradshaw Index from 3.4, 95% CI = 2.4 – 4.4, to 3.8, 95% CI = 2.7 – 4.9, p = 0.23), and inflammatory biomarker (CRP from 4.2 mg/l, 95% CI = 2.5 mg/l – 5.9 mg/l, to 3.6 mg/l, 95% CI = 2.2 mg/l – 5 mg/l, p = 0.32). No unexpected adverse events occurred during the study period. Conclusion Our results support ABP 501 as an efficacious and well-tolerated drug, at least in the short-term, and its interchangeability with its originator in the treatment of CD.

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