P415 Dose escalation of adalimumab and related prognostic factors in patients with Crohn's disease treated with adalimumab maintenance therapy: A single-centre, five-year cohort study

Abstract Background Recent studies have confirmed that combined surgery and anti-TNF therapy could improve outcomes in patients with perianal fistulising Crohn’s disease (PFCD). However, the optimal timing for infliximab infusion after surgical intervention is uncertain. We aimed to determine the long-term efficacy of early initiation of infliximab following surgery among PFCD patients. Methods We performed a retrospective cohort study of PFCD patients who received combined infliximab and surgical treatment between 2010 and 2018 at a tertiary referral hospital. Patients were grouped according to the time interval between surgery and infliximab infusion, with < 6 weeks into early infliximab induction group and > 6 weeks into delayed infliximab induction group. The primary outcome was to compare surgical re-intervention between early and delayed infliximab induction groups. The secondary outcomes were fistula healing and predictors associated with these outcomes of early infliximab induction approach. Results One hundred and seventeen patients were included (73 in early infliximab induction, 44 in delayed infliximab induction). The median interval between surgery and infliximab initiation was 9.0 (IQR 5.5–17.0) days in early infliximab induction group and 188.0 (IQR 102.25–455.75) days in delayed infliximab induction group. After followed-up for a median of 36 months, 61.6% of patients in early infliximab induction group and 65.9% in delayed infliximab induction group attained fistula healing (p = 0.643). The cumulative re-intervention rate was 23%, 32%, 34% in early infliximab induction group and 16%, 25%, 25% in delayed infliximab induction group, at 1, 2, and 3 years respectively (p = 0.235). Presence of abscess at baseline (HR = 5.283; 95% CI, 1.61–17.335; p = 0.006) and infliximab maintenance therapy > 3 infusions (HR = 3.691; 95% CI, 1.233–11.051; p = 0.02) were associated with re-intervention in early infliximab induction group. Presence of abscess at baseline also negatively influenced fistula healing (HR = 3.429, 95% CI, 1.216–9.668; p = 0.02). Conclusion Although no clear benefit was shown compared with delayed infliximab induction group, early initiation of infliximab after surgery could achieve promising results for PFCD patients. Before infliximab infusion, durable drainage is required for patients with concomitant abscess or prolonged infliximab maintenance therapy.

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P585 Impact of timing of thiopurine treatment on first intestinal resection in Crohn’s disease with poor prognostic factors: A nationwide population-based cohort study 2004–2015

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjx180.712 ◽

2018 ◽

Vol 12 (supplement_1) ◽

pp. S404-S404

Author(s):

S Y Shin ◽

J Lee ◽

J J Park ◽

J H Cheon ◽

T I Kim ◽

...

Keyword(s):

Cohort Study ◽

Crohn’S Disease ◽

Prognostic Factors ◽

Crohn's Disease ◽

Intestinal Resection ◽

Population Based

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Crohn's disease outpatients treated with adalimumab have an earlier secondary loss of response and requirement for dose escalation compared to infliximab: A real life cohort study

Journal of Crohn s and Colitis ◽

10.1016/j.crohns.2014.05.007 ◽

2014 ◽

Vol 8 (11) ◽

pp. 1454-1463 ◽

Cited By ~ 29

Author(s):

Christopher Ma ◽

Vivian Huang ◽

Darryl K. Fedorak ◽

Karen I. Kroeker ◽

Levinus A. Dieleman ◽

...

Keyword(s):

Cohort Study ◽

Crohn’S Disease ◽

Crohn's Disease ◽

Dose Escalation ◽

Real Life ◽

Secondary Loss ◽

Loss Of Response

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Scheduled Maintenance Therapy with Infliximab Improves the Prognosis of Crohn's Disease: A Single Center Prospective Cohort Study in Japan

The Tohoku Journal of Experimental Medicine ◽

10.1620/tjem.220.207 ◽

2010 ◽

Vol 220 (3) ◽

pp. 207-215 ◽

Cited By ~ 1

Author(s):

Shuichiro Takahashi ◽

Sho Takagi ◽

Hisashi Shiga ◽

Ken Umemura ◽

Katuya Endo ◽

...

Keyword(s):

Cohort Study ◽

Crohn’S Disease ◽

Crohn's Disease ◽

Maintenance Therapy ◽

Prospective Cohort Study ◽

Prospective Cohort ◽

Single Center

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DOP74 Effectiveness of dose escalation in Crohn’s disease patients with insufficient response to standard-dose subcutaneous ustekinumab maintenance therapy: A multicentre international cohort study

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjz203.113 ◽

2020 ◽

Vol 14 (Supplement_1) ◽

pp. S111-S112 ◽

Cited By ~ 1

Author(s):

U Kopylov ◽

J Hanzel ◽

C Liefferinckx ◽

D De Marco ◽

N Imperatore ◽

...

Keyword(s):

Cohort Study ◽

Crohn’S Disease ◽

Crohn's Disease ◽

Median Duration ◽

Dose Escalation ◽

Clinical Remission ◽

Standard Dose ◽

Dose Interval ◽

Insufficient Response

Abstract Background Ustekinumab (UST) is an effective agent for induction and maintenance of response and remission in Crohn’s disease (CD). In addition to randomised controlled trials, an abundance of real-world evidence is available as well, suggesting that a substantial proportion of patients will not respond or lose response to UST therapy. To date, there is very little evidence to support the effectiveness of dose-optimisation strategy to manage primary or secondary non-response to ustekinumab. Methods This was a multicentre retrospective cohort study. The protocol was reviewed and approved by the Clinical Committee of ECCO. We included active (HBI≥5; CDAI ≥220) CD patients that received a standard-dose IV induction and at least one SC UST dose of 90 mg. Patients with ostomy were excluded. All patients received dose escalation by either shortening the interval between the doses to q4/6 weeks, intravenous reinduction or a combination of intravenous and subcutaneous escalation. The primary aim of the study was a clinical response (defined as Δ HBI≥3 or Δ CDAI ≥ 70 points) at week 16 after dose escalation. Clinical remission was defined as HBI<5 or CDAI <150. Results Of 140 patients, 83 (59.3%) were females, median age at treatment onset 36 (26–50) years, median duration of disease 9 (5–18) years from 21 centres in 13 countries (12 Europe, 1 Canada) were included. The patients were dose-escalated after a median treatment duration of 30 (20–45) weeks. Thirty-four (24,3%) were previously escalated from q12 to q8 maintenance regimen. Eighty-nine (63.5%) of the patients were escalated from q8 to q4 regimen, 20 (14.3%) – from q8 to q6, 15 (10.7%) received intravenous reinduction and 16 (11.4%) – a combination of intravenous reinduction and subcutaneous dose interval shortening. At week 16 from escalation, 83 (59.3%) responded to treatment, of them 21 (15%) were in clinical remission. Thirty-three (23.6%) of the patients were on systemic corticosteroids upon escalation; 7/33 (21.2%) achieved corticosteroid-free remission at week 16. One hundred and nine patients (77.8%) continued treatment beyond week 16. Follow-up data beyond week 16 were available for 75/150 (53.6%) of the patients (median duration of follow-up: 35 (32–54) weeks) from dose escalation. At the last follow-up, 53/75 (70.7%) continued to respond to treatment, including 42 (56%) in clinical remission; 25/75 (33%) discontinued treatment at last follow-up. Conclusion This large multicentre retrospective study demonstrates that intensification of ustekinumab maintenance dosage may be effective in up to 60% of the patients. This strategy should be considered in patients that are non-responsive to q8 ustekinumab maintenance dosing.

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