scholarly journals P605 Eight-year efficacy and safety of azathioprine treatment in the maintenance of steroid-free remission in inflammatory bowel disease patients

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S505-S505
Author(s):  
C Cassieri ◽  
R Pica ◽  
E V Avallone ◽  
G Brandimarte ◽  
M Zippi ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Side Effects ◽  
Bowel Disease ◽  
Efficacy And Safety ◽  
Loss Of Response ◽  
Steroid Dependent ◽  
Azathioprine Treatment ◽  
Inflammatory Bowel ◽  
Maintenance Of Remission

Abstract Background Azathioprine (AZA) and thiopurine are widely used for induction and maintenance of remission in steroid-dependent patients with inflammatory bowel disease (IBD). The aim of this study has been to investigate its efficacy and safety in maintaining steroid-free remission in steroid-dependent IBD patients eight years after the institution of treatment. Methods Data from consecutive IBD outpatients referred in our Institution, between 1985–2017, were reviewed and all patients treated with AZA were included in this retrospective study. AZA was administered at the recommended dose of 2–2.5 mg/kg. Results Out of 2992 consecutive IBD outpatients visited in the index period, AZA was prescribed to 446 patients, 245 (54.9%) were affected by Crohn’s disease (CD) and 201 (45.1%) by ulcerative colitis (UC). One hundred and ninety-six patients with a follow-up < 96 months were excluded from the study. Two hundred and fifty patients were evaluated, 140 (56%) with CD and 110 (44%) with UC. One hundred and thirty-eight (55.2%) were male and 112 (44.8%) female (average age of 35.48 ± 14.26 SD years, range 14–74 years). Eight year after the institution of treatment, 123 (49.2%) patients still were in steroid-free remission (82 CD vs. 41 UC, 58.6% and 37.3%, respectively, p = 0.0009), 71 (28.4%) had a relapse requiring retreatment with steroids (29 CD vs. 42 UC, 20.7% and 38.2%, respectively, p = 0.0030), 56 (22.4%) discontinued the treatment due to side effects (29 CD vs. 27 UC, 20.7% and 24.5%, respectively). The loss of response from first to eighth year of follow-up was low, about 21%. Conclusion Eight years after the onset of treatment about 50% of patients did not require further steroid courses. After the first-year loss of response was low in seven subsequent years. In the present series, the maintenance of steroid-free remission was significantly higher in CD than in UC patients. The occurrence of side effects leading to the withdrawal of AZA treatment has been low.

scholarly journals Azathioprine in the maintainance remission in inflammatory bowel disease patients: 7-year follow up

2020 ◽  
Vol 30 (Supplement_5) ◽  
Author(s):  
C Cassieri ◽  
A M Mastromatteo ◽  
R Pica ◽  
M Zippi ◽  
E S Corazziari ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Side Effects ◽  
Bowel Disease ◽  
First Year ◽  
Loss Of Response ◽  
Steroid Dependent ◽  
Treatment Data ◽  
Inflammatory Bowel ◽  
Maintenance Of Remission

Abstract Background Azathioprine (AZA) and thiopurine are widely used for induction and maintenance of remission in steroid dependent patients with inflammatory bowel disease (IBD). Methods Aim of this study has been to investigate its efficacy and safety in maintaining steroid-free remission in steroid dependent IBD patients seven year after the institution of treatment. Data from consecutive IBD outpatients referred in our Institution, between 1985-2016, were reviewed and all patients treated with AZA were included in this retrospective study. AZA was administered at the recommended dose of 2-2.5 mg/kg. Results Out of 2802 consecutive IBD outpatients visited in the index period, AZA was prescribed to 433 patients, 236 (54.5%) were affected by Crohn's disease (CD) and 197 (45.5%) by ulcerative colitis (UC). One hundred and seventy-nine patients with a follow-up < 84 months were excluded from the study. Two hundred and fifty-four patients were evaluated, 141 (55.5%) with CD and 113 (44.5%) with UC. One hundred and thirty-nine (54.7%) were male and 115 (45.3%) female (average age of 35.62 ± 14.20 SD years, range 14-74 y.). Seven year after the institution of treatment, 127 (50%) patients still were in steroid-free remission (83 CD vs 44 UC, 58.8% and 38.9%, respectively, p = 0.0024), 71 (27.9%) had a relapse requiring retreatment with steroids (29 CD vs 42 UC, 20.6% and 37.2%, respectively, p = 0.0047), 56 (22.1%) discontinued the treatment due to side effects (29 CD vs 27 UC, 20.6% and 23.9%, respectively). Loss of response from 1st to 7th year of follow-up was low, about 20%. Conclusions Seven year after the onset of treatment 50% of patients did not require further steroid courses. After the first year loss of response was low in six subsequent years. In the present series the maintenance of steroid-free remission was significantly higher in CD than in UC patients. The occurrence of side effects leading to the withdrawal of AZA treatment has been low. Key messages An important therapeutic moment of IBD is mantaining remission in steroid dipendent patients. AZA can be a viable and inexpensive alternative to treath these patients.

scholarly journals P277 Frequency and effectiveness of empirical anti-TNF dose intensification in Inflammatory Bowel Disease: systematic review with meta-analysis

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S309-S309
Author(s):  
L Guberna Blanco ◽  
O P Nyssen ◽  
M Chaparro ◽  
J P Gisbert
Keyword(s):  
Inflammatory Bowel Disease ◽  
Bowel Disease ◽  
Medical Condition ◽  
Cochrane Library ◽  
Therapeutic Drug ◽  
Dose Intensification ◽  
Loss Of Response ◽  
Subgroup Analyses ◽  
Inflammatory Bowel

Abstract Background Loss of response to anti-TNF (tumor necrosis factor) therapies in inflammatory bowel disease occurs in a high proportion of patients. However, the precise incidence of dose intensification (DI) and its effectiveness remains unclear. Our aims were: 1) To evaluate the need of DI of anti-TNF therapy either by increasing the dose or decreasing doses’ interval; 2) To evaluate possible variables influencing its requirement; 3) To assess the effectiveness of empirical DI. Methods Bibliographical searches were performed in Pubmed, Embase, the Cochrane Library and CINAHL. Selection: prospective and retrospective studies assessing loss of response to anti-TNF therapy, considered as the need of DI, in Crohn’s disease (CD) and ulcerative colitis (UC) patients treated for at least 12 weeks with an anti-TNF drug [infliximab (IFX), adalimumab (ADA), certolizumab or golimumab]. Exclusion criteria: studies using anti-TNF as prophylaxis for postoperative recurrence in CD or those where DI was based on therapeutic drug monitoring. Data synthesis: Effectiveness by intention-to-treat (random effects model). Data were stratified by medical condition (UC vs. CD), anti-TNF drug and follow-up. Subgroup analyses were performed to explore heterogeneity. Results In total, 174 studies (32,031 patients) were included. The overall rate of DI requirement after 12 months follow-up was 27% (95%CI 23-31, I2=96%, 51 studies) in naïve patients and 38% (95%CI 31-46, I2=87%, 18 studies) in non-naïve patients. The rate of DI requirement was higher in patients with prior anti-TNF exposure (c²=6.5, P=0.01) and in UC patients (c²=4.7, P=0.03). The rate of DI requirement in naïve patients after 36 months follow-up was 35% (95%CI 27-43%; I2=98%; 22 studies). The overall short-term response and remission rates to empirical DI in naïve patients were 66% (95%CI 61-71%; I2=81%; 35 studies) and 48% (95%CI 35-62%; I2=97%; 27 studies), respectively. Subgroup analyses are presented in the tables. Conclusion Loss of response to anti-TNF agents ―and consequent DI― occur frequently in IBD (approximately in 1/4 at one year and in 1/3 at 3 years). DI requirement is higher in UC patients and in those with prior anti-TNF exposure. Empirical DI is a relatively effective therapeutic option.

scholarly journals P533 Adalimumab 80mg every other week in inflammatory bowel disease: Treatment intensification outcomes in real life clinical practice

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S507-S509
Author(s):  
M I Calvo Moya ◽  
I Omella Usieto ◽  
I El Hajra Martinez ◽  
E Santos Perez ◽  
Y Gonzalez Lama ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Clinical Practice ◽  
Bowel Disease ◽  
Smoking Habit ◽  
Real Life ◽  
Fecal Calprotectin ◽  
Treatment Intensification ◽  
Loss Of Response ◽  
Inflammatory Bowel

Abstract Background Adalimumab (ADA) intensification is recommended for inadequate or loss of response in inflammatory bowel disease (IBD) patients. A new presentation of ADA 80mg administered every other week (eow) has been approved as an alternative to ADA 40mg every week (ew). Data regarding impact of ADA 80mg eow in clinical practice is still scarce. The aim of this study was to assess long-term durability, safety and cost-effectiveness of treatment with ADA 80mg eow in patients with IBD. Methods A retrospective cohort study in a tertiary hospital that included all IBD patients under intensified maintenance therapy with ADA 80mg eow was performed. Durability was calculated considering the time from the first dose to treatment withdrawn or to the end of follow-up. Biological remission (BR) was defined as CR together with fecal calprotectin (FC) <250µg/g and C-reactive protein (CRP) <5mg/dl. Economic impact of ADA 80mg eow was estimated considering current price of both ADA 40mg and ADA 80mg pens at our centre. Results Sixty-three patients (52 CD and 11 CU) were included; median age 47 (IQR 39–59), 54% male; median duration of the disease before ADA of 11 years (IQR 6–20); 30% were active smokers. Among CD patients, 56% had ileal disease, 17% colonic and 27% ileocolonic. The inflammatory behavior was the most frequent (52%) and 31% had perianal disease. In UC, 55% had extensive colitis. 44 patients (70%) were bio-naïve and 36 (57%) received immunosuppressants at baseline. At the time of escalation, 48 patients (76%) were symptomatic. After intensification, 52 (83%) patients (CD 42 and UC 10) achieved CR and 46 (73%) BR. The changes in the levels of FC, CRP and ADA were significant (p <0.001) (Graphs 1–3). 22 patients (35%) discontinued treatment after a median of 6.5 (IQR 5–10) months due to: 11 no clinical response (50%), 4 loss of response (18%), 3 adverse events (14%) (psoriasis) and 4 endoscopic progression (18%). 44 patients (70%) remained under treatment and in CR (median follow-up 17 months, IQR 13–24) (Graph 4) and with a median ADA levels of 10.46 mg/l (IQR 7.34–15.25). Use of ADA 80 eow regimen saved 223500€ in patients who maintained treatment. In the multivariate analysis, being in CR when intensifying reduced the risk of treatment discontinuation by 87% (HR 0.13, 95%CI 0.02–0.99; p<0.001), having reached BR by 99.5% (HR 0.05, 95%CI 0.02–0.14; p <0.001) and having ADA levels ≥5 mg/l after intensification by 68% (HR 0.32, 95%CI 0.13–0.75; p = 0.02). Smoking habit was associated with treatment withdrawn (HR 1.74, 95%CI 1.02–2.96; p=0.04). Conclusion ADA intensification to 80mg eow in IBD patients is safe, effective and may reduce costs in real life clinical practice. Early intensification, even in CR, may enhance ADA treatment durability.

P082 ANTI-TNF EFFICACY AFTER PRIMARY VEDOLIZUMAB FAILURE IN PEDIATRIC INFLAMMATORY BOWEL DISEASE

2020 ◽  
Vol 26 (Supplement_1) ◽  
pp. S71-S72
Author(s):  
Michael Dolinger ◽  
Priya Rolfes ◽  
Becky Phan ◽  
Stephanie Pan ◽  
Marla Dubinsky
Keyword(s):  
Inflammatory Bowel Disease ◽  
Adverse Events ◽  
Median Duration ◽  
Bowel Disease ◽  
Clinical Remission ◽  
Secondary Loss ◽  
Loss Of Response ◽  
Inflammatory Bowel ◽  
Pediatric Ibd

Abstract Background Vedolizumab (VDZ) is less effective in Inflammatory Bowel Disease (IBD) when used in anti-Tumor Necrosis Factor (TNF) failures as compared to anti-TNF naïve patients. However, the outcomes of sequencing anti-TNF after VDZ failure remain unknown. We report on the effectiveness and safety of anti-TNF as a second-line biologic after VDZ failure in pediatric IBD patients. Methods Data was collected as part of an ongoing pediatric IBD observational treatment registry and included demographics, disease behavior, location, disease activity (Harvey Bradshaw index (HBI) for Crohn’s disease (CD) or partial Mayo score (pMS) for ulcerative colitis (UC) and IBD-unspecified (IBD-U)), adverse events, treatment and surgical history. Primary outcome was steroid-free clinical remission at last follow up. Secondary outcomes were CRP normalization and adverse events including infusion reactions, infections, hospitalizations, and IBD related surgeries. Descriptive statistics summarized the data (median [interquartile range (IQR)]) and univariate analyses tested associations. Results A total of 21 children and young adults (6 CD:14 UC:1 IBD-U; 19/21 colonic only disease) were treated with VDZ for a median [IQR] duration of 25 [11–59] weeks. VDZ was discontinued due to primary non-response (57%), secondary loss of response (38%), or an adverse event (5%). Nineteen (90%) patients were induced with infliximab (IFX), 1 with adalimumab, and 1 with golimumab and were followed for a median of 100 [35–148] weeks after anti-TNF induction (Table 1). Fifteen (71%) patients remained on anti-TNF therapy at last follow up for a median duration of 53 [34–112] weeks. All 15 patients achieved steroid-free clinical remission, and 9 (60%) patients also had a normal CRP (Figure 1). Remission rates were numerically higher in UC/IBD-U vs. CD (80% vs. 50% P = 0.27). All 6 (28%) patients (3 CD and 3 UC) who discontinued anti-TNF therapy after a median duration of 15 [7–24] weeks initially had a primary non-response to VDZ. Three patents had a primary non-response to anti-TNF, 2 had a secondary loss of response, and 1 had an anaphylactic infusion reaction. No serious adverse events, hospitalizations or serious infections attributable to anti-TNF therapy occurred. Conclusions Our results suggest that anti-TNF therapy is efficacious and safe after primary failure with VDZ in pediatric IBD patients and this was particularly so in patients with colonic disease location, regardless of IBD classification.

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