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P356 Efficacy and safety of certolizumab pegol in Crohn’s disease patients with loss of response or intolerance to previous anti-TNF

I. Ferrer Bradley*1, I. Marín2, N. Maroto1, M. Mora1, E. Hinojosa1, B. López2, L. Menchén2, J. Hinojosa1

1Hospital de Manises, Gastroenterology, Valencia, Spain, 2Hospital Gregorio Marañón, Gastroenterology, Madrid, Spain

Background

Crohn’s disease patients (CD) with loss of response to corticosteroids or immunomodulators are candidates to receive anti-TNF agents (IFX or ADA). 10%–15% of patients with CD receiving anti-TNFs do not respond to treatment, and up to 30% experience loss of response or intolerance. Certolizumab pegol (CZP) is a humanised anti-TNF monoclonal antibody which has demonstrated its efficacy in CD. Clinical experience with this biological treatment is limited. Aim: to evaluate the efficacy and safety of CZP in CD patients with loss of response or intolerance to previous anti-TNF agents.

Methods

Descriptive, retrospective and multicentric study. Analysis of CZP treatment from inflammatory bowel disease outpatients of 2 Spanish Hospitals between January 2009 and July 2015. Clinical response was evaluated by Harvey Index. Induction therapy was 400 mg at 0–24 weeks. Maintenance regimens were: 400 mg every 4 weeks or 200 mg every other week (EOW).

Results

In total, 38 patients were included (22 males and 16 females). Diagnosis median age 30 (Range 14–67). Montreal classification: median age (46.7 [range 24–70]); Location of disease (L1/L2/L3/L4) +p: 12 (31.5%), 9 (23.6%), 15 (39.4%), 2 (5.2%) + 20 (52.6%); Disease behaviour: (B1/B2/B3)27 (71.05%), 5 (13.1%), 6 (15.7%).Indication of CZP: loss of response to previous anti-TNF in 30 (78.9%) or adverse events to other anti-TNF in 8 (21.1%). 28 (73.6%) and 10 (26.3%) patients received CZP as the second or third biological treatment respectively. Maintenance regimen: 18 patients 400 mg every 4 weeks and 20 patients 200 mg EOW. Six patients were in concomitant immunomodulator therapy (5 azathioprine /1 methotrexate). Further, 26 patients had previous surgery. In addition, 14 (36.8%) patients were in clinical remission, and 12 (31.5%) had clinical response with a median follow-up of 26.6 months (range 4–65 mo). During follow-up 60%/77.7% were inactive with 400 mg every 4 weeks vs 200 mg EOW, respectively (clinical response 7/5 [35%/27.7%]; clinical remission 5/9 [25%/50%]). Six patients required at least 1 reinduction with CZP. With this strategy, 83.3% of the patients (5) achieved clinical response. One patient had arthralgias as adverse event. One patient was pregnant during CZP, and she was in clinical remission and had a vaginal delivery with a healthy newborn.

Conclusion

CZP is a biological treatment effective in patients with loss of response to other anti-TNF therapies or previous adverse events. Although there are no significant differences between both maintenance regimens, more efficacy is suggested in 200 mg EOW regimen.