scholarly journals 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

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.

scholarly journals P286 Ustekinumab for Crohn’s Disease: Two-Year Results of the Initiative on Crohn and Colitis (ICC) Registry, a Nationwide Prospective Observational Cohort Study

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S319-S320
Author(s):  
T Straatmijer ◽  
V B C Biemans ◽  
F Hoentjen ◽  
N K H de Boer ◽  
A G Bodelier ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Real World ◽  
Clinical Remission ◽  
Prospective Cohort ◽  
Upper Airway ◽  
Fecal Calprotectin ◽  
Regular Care ◽  
Observational Cohort

Abstract Background Ustekinumab is a monoclonal antibody that selectively targets p40, a shared subunit of the cytokines interleukin (IL)-12 and IL-23. It is registered for the treatment of Crohn’s disease (CD) and ulcerative colitis. We assessed the two-year efficacy and safety of ustekinumab in a real world, prospective cohort of CD patients. Methods CD patients who started ustekinumab in regular care were prospectively enrolled in the nationwide Initiative on Crohn and Colitis Registry. At week 0, 12, 24, 52 and 104, clinical remission (HBI ≤ 4 points), biochemical remission (fecal calprotectin (FC) ≤200 μg/g and/or CRP ≤5 mg/L), peri-anal fistula remission, extra-intestinal manifestations, ustekinumab dosage and safety outcomes were determined. Patients starting therapy less than two years ago were excluded for the current evaluation. The primary outcome was corticosteroid-free clinical remission at week 104. Results In total, 252 CD patient with at least two years of follow up were included. Of all included patients, the proportion of patients in corticosteroid-free clinical remission at week 12, 24, 52 and 104 was 32.3% (81/251), 41.4% (104/251), 39% (97/249) and 34.0% (84/247), respectively. Of the 97 patients in corticosteroid free clinical remission at week 52, 58 (59.8%) were still in corticosteroid-free clinical remission at week 104. In patients with combined clinical and biochemical disease activity at baseline (n=122), the corticosteroid-free clinical remission rates were 23.8% (29/122), 35.2% (43/122), 40.0% (48/120) and 32.8% (39/119) at week 12, 24, 52 and 104, respectively. The probability of remaining on ustekinumab treatment after 52 and 104 weeks was 64.3% and 54.8%, respectively. There were no predictive factors associated with corticosteroid-free clinical remission at week 104 on univariate and multivariate analysis. Most common adverse events were headache, skin reaction and musculoskeletal complaints. Two patients stopped ustekinumab due to an infection after 8 and 30 weeks of treatment (mild fever syndrome and moderate upper airway infection, respectively). The main reason for discontinuing treatment after 52 weeks was loss of response (66.7%). Conclusion Ustekinumab was effective and relatively safe in our real world, prospective cohort of CD patients. After 104 weeks of ustekinumab treatment, one third of patients were in corticosteroid-free clinical remission.

scholarly journals 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

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S379-S379
Author(s):  
A Gubbiotti ◽  
B Barberio ◽  
F Zingone ◽  
R D’Incà ◽  
L Bertani ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Clinical Remission ◽  
Real Life ◽  
Previous Treatment ◽  
Categorical Variables ◽  
Biologic Agent ◽  
Chi Square ◽  
Faecal Calprotectin ◽  
Chi Square Test

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.

scholarly journals Combination Ciprofloxacin and Metronidazole for Active Crohn’s Disease

1998 ◽  
Vol 12 (1) ◽  
pp. 53-56 ◽  
Author(s):  
Susan L Greenbloom ◽  
A Hillary Steinhart ◽  
Gordon R Greenberg
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Clinical Response ◽  
Clinical Remission ◽  
Intestinal Bacteria ◽  
Colonic Disease ◽  
Efficacy And Safety ◽  
Index Reduction ◽  
Ileal Disease

Recent experimental evidence underscores the contribution of intestinal bacteria to the inflammatory process of Crohn's disease. This open study examined the efficacy and safety of combination ciprofloxacin and metronidazole for patients with active Crohn's disease of the ileum and/or colon. Seventy-two patients with active Crohn's disease of the ileum (n=27), ileocolon (n=22) or colon (n=23) were treated with ciprofloxacin 500 mg bid and metronidazole 250 mg tid for a mean of 10 weeks. Clinical remission was defined as a Harvey-Bradshaw index of three points or less; an index reduction of at least three points indicated a clinical response. Clinical remission was observed in 49 patients (68%), and 55 patients (76%) showed a clinical response. A clinical response was noted in 29 of 43 patients (67%) who were not taking concurrent prednisone treatment and in 26 of 29 patients (90%) receiving prednisone (mean dose of 15 mg/day). A clinical response also occurred in a greater proportion of patients with colonic disease, with or without ileal involvement (84%), compared with patients with ileal disease alone (64%), and in patients without resection (86%) compared with those with previous resection (61%). Five patients discontinued antibiotics because of adverse events. After a mean follow-up of nine months, clinical remission was maintained in 26 patients off treatment and in 12 patients who continued antibiotic therapy. Ciprofloxacin in combination with metronidazole is well tolerated and appears to play a beneficial role in achieving clinical remission for patients with active Crohn's disease, particularly when there is involvement of the colon.

scholarly journals P717 Ustekinumab in Crohn’s disease: Real-world outcomes from the Sicilian Network for inflammatory bowel diseases (SN-IBD):–Preliminary results

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S578-S578
Author(s):  
A Viola ◽  
G Fiocco ◽  
A Alibrandi ◽  
F S Macaluso ◽  
M Cappello ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Clinical Response ◽  
Clinical Remission ◽  
Demographic Data ◽  
Real Life ◽  
Primary Study ◽  
Clinical Activity ◽  
Secondary Failure

Abstract Background Ustekinumab is approved in Europe for the treatment of moderate-to-severe Crohn’s disease (CD) since 2016. Italian real-life data on efficacy and safety are scarce. The aim of this study was to assess effectiveness, safety and usage of Ustekinumab in an Italian cohort of patients. Methods Data of patients with moderate-to-severe CD who started Ustekinumab in Sicily were extracted from the database of the SN-IBD. Demographic data, disease-related data (disease duration, location, clinical activity) and previous therapies with biologics were collected. The primary study endpoints were steroid-free clinical remission and steroid-free clinical response at week 12, 24 and 52 on Ustekinumab therapy. Secondary study endpoints were: treatment persistence at 24 weeks, safety, and biochemical response (reduction of CRP). Results One hundred thirteen patients started Ustekinumab in Sicily. We performed a preliminary analysis only on patients who reached at least 24 weeks of follow-up. Ninety-three patients (M = 53%; mean age 45 ± 14.9 years) were included. At week 24, 38 patients (41%) achieved steroid-free clinical remission, 56 patients (60%) clinical response. From baseline to the end of follow-up there was a significant reduction of steroid use (41% vs. 21%, p = 0.038) and of mean HBI score (6.5 ± 4.4 vs. 4.8 ± 4.1; p < 0.001). No significant CRP changes were recorded during follow-up. Twelve patients (11%) discontinued therapy due to primary failure (3 patients), secondary failure (5 patients), adverse events (3 patients) and 1 patient was lost to follow-up. Kaplan–Meier survival analysis showed a persistence on therapy with Ustekinumab of 89% of patients after 24 weeks (Figure 1). Conclusion Preliminary data from our real-life cohort of treatment-refractory CD patients suggest a satisfactory effectiveness and a good safety profile of Ustekinumab.

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

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.

scholarly journals P367 Real-life long-term effectiveness and treatment persistence of vedolizumab in a single tertiary care cohort of Crohn’s disease patients

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S347-S348
Author(s):  
L Calandrini ◽  
M Salice ◽  
H Privitera Hrustemovic ◽  
G Peruzzi ◽  
F Rizzello ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Clinical Remission ◽  
Tertiary Care ◽  
Real Life ◽  
Initial Response ◽  
Published Data ◽  
Treatment Persistence

Abstract Background Long-term effectiveness of vedolizumab (VDZ) in real-life clinical practice is unknown. We aimed to evaluate clinical efficacy and treatment persistence of VDZ in a real-world cohort of patients with Crohn’s disease (CD). Methods CD patients from a single tertiary IBD referral centre receiving VDZ treatment outside clinical trials between September 2016 and August 2019 were included. Data were collected prospectively at baseline, weeks 22, 54, and 108. Disease activity was assessed using the Harvey Bradshaw index (HBI). The primary endpoint was steroid-free clinical remission, defined as HBI of 4 or lower without the need of corticosteroids. Secondary endpoints were treatment persistence and durability of VDZ response. Results Up to August 2019 114 patients had received at least one VDZ infusion, 79% had prior anti-TNFα drug exposure. Of the 90 patients who reached 54 weeks of follow-up, 68 patients (75,5%) were still under VDZ therapy. 38 of them (55,9%) were in steroid-free clinical remission. We compared the initial response to VDZ at week 22 and at week 54. Among the 29 patients in steroid-free clinical remission at week 22, 25 (86.2%) were still in steroid-free clinical remission at week 54. Three out of 29 patients discontinued VDZ therapy before week 54, for insufficient response and adverse events in two cases and for pregnancy in one. Of the 34 patients who reached 108 weeks of follow-up, 17 (50%) were still under VDZ therapy. 11 of them (64.7%) were in steroid-free clinical remission. We compared the initial response to VDZ at week 22 and at week 108. Among the 11 patients in steroid-free clinical remission at week 22, 6 (54.5%) were still in steroid-free clinical remission at week 108. Two out of 11 patients discontinued VDZ therapy before week 108 for worsening of perianal disease. Conclusion After 1 year, 75.5% of patients were still on treatment, of whom more than 55% achieved remission. 86% of patients maintained a response after the first year of treatment. After 2 years the rate of patients who presented with steroid-free clinical remission and who maintained response tended to decrease, consistent with previously published data. However, half of the patients persisted with VDZ treatment. These data support the long-term effectiveness and favourable safety profile of VDZ.

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 P559 Efficacy of Ustekinumab in the treatment of patients with Crohn’s disease with failure to previous conventional or biologic therapy: an observational real-life study

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S522-S523
Author(s):  
A Miranda ◽  
A Cuomo ◽  
S Camera ◽  
C Ciacci ◽  
F R De Filippo ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Clinical Response ◽  
Clinical Remission ◽  
Biologic Therapy ◽  
Real Life ◽  
Mucosal Healing ◽  
Endoscopic Evaluation ◽  
Life Study

Abstract Background Ustekinumab (UST), a human anti-IL12/23p40 monoclonal antibody, was approved by FDA and EMA for the treatment of moderate to severe Crohn’s disease (CD). Whether UST is effective in inducing deep remission, including mucosal healing and transmural healing, in patients with CD in a real life setting is not completely clear. Methods The study was performed on 92 subjects (47 males; 45 females; mean age: 42 (17–78) from six medical centers in Campania, Italy, with confirmed diagnosis of moderate to severe Crohn’s disease and no neoplasia. In all patients diagnosis of CD had been reached to years earlier. Before inclusion, all patients had been exposed and had failed to respond to conventional and/or at least one biological therapy.The administration of UST was as follows: IV infusion at week 0 (3 vials of 130 mg each if body weight of 55–85 kg; 2 vials of130 mg each if body weight < 55 kg) and subsequent SC injections (90 mg) q8w thereafter. At enrollment, all subjects underwent colonoscopy and were divided into groups according to endoscopic evaluation: 5 (5.4%) patients had erosions; 24 (26.1%) inflammation; 63 (68.5%) ulcers. Based on the CDAI value, 52 (56.5%) patients had a CDAI of 180–220, 35 (38%) had a CDAI of 220–450, and 5 (5.4%) had a CDAI >450. All patients underwent endoscopic examination and bowel MRI or ultrasonography at baseline and at week 52 to evaluate mucosal and transmural healing. Clinical response was defined as a reduction of CDAI by at least 100 points; clinical remission when CDAI was lower than 150. Clinical response and remission were evaluated at baseline and on 5 different occasions throughout a 12 months follow-up. Incidence of treatment-related adverse events (TRAEs) was recorded during the study period. Results Seventeen patients interrupted therapy while 75 patients continued follow-up until the fifth visit. Clinical response at week 52 was achieved in 38 (50,5%) patients and clinical remission in 29 (39%). Twenty-six (34%) patients showed mucosal healing, 34 (45%) showed partial endoscopic response. Fifteen patients (20%) did not show any change during endoscopic evaluation at follow-up. All patients showing mucosal healing also showed transmural healing, as assessed by ultrasonography or MRI. No major TRAEs were observed during treatment. Conclusion In this multi-center, real life study, we show that UST was well tolerated and effective in inducing clinical response and clinical remission in patients with moderate to severe CD who had previously failed to respond to conventional or biologic therapy. UST showed limited efficacy in inducing deep remission (i.e. mucosal+transmural healing).

P084 DEEP REMISSION WITH DOUBLE BIOLOGIC THERAPY: A SUCCESSFUL CASE OF COMBINATION USTEKINUMAB AND VEDOLIZUMAB FOR SEVERE REFRACTORY CROHN’S DISEASE

2020 ◽  
Vol 26 (Supplement_1) ◽  
pp. S72-S72
Author(s):  
Ahmed Elmoursi ◽  
Courtney Perry ◽  
Terrence Barrett
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Combination Therapy ◽  
Clinical Remission ◽  
Biologic Therapy ◽  
Case Reports ◽  
Sigmoid Resection ◽  
Safety And Efficacy ◽  
Ileal Stricture

Abstract Background Stricturing Crohn’s disease (CD) constitutes a severe phenotype often associated with a high degree of morbidity (3). Surgical resection is first-line therapy for symptomatic strictures, but most patients relapse without subsequent medical therapy (4–5). Biologics are the mainstay for inducing and maintaining remission, but some cases are refractory despite maximum dosage of therapy. Reports of dual biological therapy (DBT) in refractory, stricturing CD are sparse, and prior case reports document only clinical remission (1). To contribute further knowledge regarding the use of DBT in stricturing CD, we present the case of a refractory CD patient who achieved deep remission with ustekinumab and vedolizumab. Case Presentation A 35 year old non-smoking, Caucasian male was referred to our clinic in 2014 for refractory CD complicated by multiple strictures. Prior to establishing care with us, he received two jejunal resections and a sigmoid resection. Previously failed therapies included azathioprine with infliximab, adalimumab, and certolizumab. He continued to progress under our care despite combination methotrexate/certolizumab, as well as methotrexate/golimumab. He underwent proctocolectomy with end ileostomy in 2015 and initiated vedolizumab q8weeks post-operatively. He reoccurred in 2018, when he presented with an ulcerated ileal stricture. He was switched from vedolizumab to ustekinumab q8weeks and placed on prednisone, but continued to progress, developing significant hematochezia requiring hospitalization and blood transfusions. Ileoscopy performed during hospital admission confirmed severe, ulcerating disease in the ileum with stricture. Ustekinumab dosing was increased to q4weeks, azathioprine was initiated, and he underwent stricturoplasty. Follow-up ileoscopy three months later revealed two ulcers in the neo- TI (Figure 1). Vedolizumab q8weeks was initiated in addition to ustekinumab q4weeks and azathioprine 125mg. After four months on this regimen the patient felt better, but follow-up ileoscopy showed two persistent ulcers in the neo-TI. Vedolizumab dosing interval was increased to q4weeks. After four months, subsequent ileoscopy demonstrated normal neo-TI (Figure 2). Histologic evaluation of biopsies confirmed deep remission of crohn’s disease. No adverse side effects have occurred with maximum doses of both ustekinumab and vedolizumab combination therapy. Discussion This case supports both the safety and efficacy of ustekinumab and vedolizumab dual biologic therapy for treatment of severe, refractory Crohn’s disease. While there are reports of DBT inducing clinical remission, this case supports efficacy for vedolizumab and ustekinumab combination therapy to induce deep histologic remission. Large practical clinical trials are needed to better investigate the safety and efficacy of DBT with vedolizumab and ustekinumab, but our case suggests this combination may be a safe and efficacious therapy for refractory CD patients.

P089 REAL-WORLD EXPERIENCE: CLINICAL AND ENDOSCOPIC EFFECTIVENESS OF STANDARD VEDOLIZUMAB DOSING AND MODIFIED MAINTENANCE DOSING IN PATIENTS WITH MODERATE-SEVERE CROHN’S DISEASE

2020 ◽  
Vol 26 (Supplement_1) ◽  
pp. S75-S75
Author(s):  
Scott D Lee ◽  
Anand Singla ◽  
Caitlin Kerwin ◽  
Kindra Clark-Snustad
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Adverse Events ◽  
Real World ◽  
Clinical Remission ◽  
Mucosal Healing ◽  
Clinical Disease ◽  
Endoscopic Remission ◽  
Starting Dose

Abstract Background Vedolizumab (VDZ) is an effective treatment for Crohn’s disease (CD); however, inadequate and loss of response is common. Pivotal VDZ trials evaluated alternative dosing intervals, demonstrating numeric but not statistical superiority in efficacy as compared to FDA-approved dosing. The safety and effectiveness of FDA-approved and modified-dosing schedules in a real-world population are unknown. We aimed to evaluate clinical and endoscopic effectiveness & safety of standard and modified maintenance VDZ dosing in a real world cohort. Methods We retrospectively reviewed CD patients (pts) treated with >3 months VDZ, assessing Harvey Bradshaw Index (HBI), Simple Endoscopic Score for Crohn’s disease (SESCD), Short Inflammatory Bowel Disease Questionnaire (SIBDQ), C-reactive protein (CRP), albumin and hematocrit prior to and following standard VDZ dosing, and prior to and following modified VDZ maintenance dosing. We measured duration on therapy and adverse events. Results We identified 226 eligible pts, mean age 41.5 years, 55.3% female, median disease duration 10 years, 88.9% with prior biologic exposure. Mean duration on VDZ was 28.3 months. Standard VDZ dosing: 61.5% of pts with active clinical disease and adequate follow up data achieved clinical response after 3–12 months; 41.0% had clinical remission. 51.9% of pts with active endoscopic disease and adequate follow up data achieved mucosal improvement; 42.3% had endoscopic remission; 26.0% had mucosal healing after 3–24 months. 50.0% of pts with elevated CRP and adequate follow up data normalized CRP after 3–12 months. Modified maintenance dosing: 72 non-remitters to standard VDZ dosing received modified VDZ maintenance dosing. 51.5% of pts with active clinical disease prior to starting dose modification and adequate follow up data achieved clinical response after 3–12 months of modified maintenance dosing; 42.4% had clinical remission. 22.2% of pts with SESCD ≥3 prior to starting dose modification achieved mucosal improvement after 3–24 months; 22.2% had mucosal healing. 26.7% of pts with SESCD ≥4 prior to starting modified dosing had endoscopic remission after 3–24 months. 50.0% of pts with elevated CRP and adequate follow up data normalized their CRP after 3–12 months. Safety: 82.7% of pts reported ≥1 adverse events, most commonly infection and worsening CD symptoms. Discussion Standard VDZ dosing resulted in clinical and endoscopic improvement in pts with moderate-severe CD, with prior exposure to multiple advanced therapies. For non-remitters to standard dosing, modified VDZ maintenance dosing improved clinical disease activity in ∼50% of pts and improved endoscopic disease activity in ∼20% of pts, suggesting that for pts who did not achieve remission with standard VDZ dosing, modified VDZ dosing may result in clinical and endoscopic improvement.

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