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
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.
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).
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.
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.