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P549. Dose optimization is effective in patients with ulcerative colitis losing response to infliximab: a collaborative multicentre retrospective study

M. Cesarini1, K. Katsanos2, P. Ellul3, P. Lakatos4, K. Papamichael5, F. Caprioli6, E. Tsianos2, G. Mantzaris5, S. Danese7, G. Fiorino7, 1Sapienza University of Rome, Medicina Interna e Specialità Mediche, Rome, Italy, 2University of Ioannina, Greece, 3Mater Dei Hospital, Malta, 4Semmelweis University, Budapest, Hungary, 5Evangelismos Hospital, Athens, Greece, 6University of Milan, Italy, 7IRCCS Humanitas, IBD Center, Rozzano, Italy

Background

Approximately 13% of Crohn's disease (CD) patients maintained on infliximab (IFX) require dose optimization (DO) per year of treatment, because of loss of response (sLoR). Shortening the interval (IS) to 6 or 4 weeks may be as effective as doubling the IFX dose (DD, 10 mg/kg q8 weeks). However, there is limited data on DO for ulcerative colitis (UC) patients with LoR to IFX.

We aimed to evaluate and compare efficacy and safety of DO (DD or SI) in UC patients with sLoR.

Methods

This was a European retrospective multicentre collaborative study including all consecutive UC patients maintained by IFX scheduled therapy between 2009 and 2012, requiring dose optimization (DO) due to sLoR. The primary outcome was rapid clinical response (decrease of >30% from baseline in the Mayo score, with no partial score >1, at the next administration of IFX after DO). Secondary outcomes were rapid clinical remission, and clinical response, remission and colectomy rate at week 52 following IFX DO. DD vs. IS were compared. Safety of DO was also evaluated. Comparison was made using χ2 test, and potential risk factors were evaluated using logistic regression analysis. Differences were statistically significant if p < 0.05.

Results

Forty consecutive patients from 6 European centres met the inclusion criteria. DO was chosen on a clinical basis, according to the clinician's judgement: 15 subjects were treated with DD, 25 were treated by IS. Mean time of LoR onset was 11 months (ranges 1.5–36). Rapid response was achieved in 36/40 patients (90%), by which 19/40 (47.5%) achieved rapid clinical remission; at week 52, 28 patients (70%) achieved clinical remission, and 4 patients (10%) underwent colectomy. No statistically significant differences were found between DD and IS.

Survival analysis showed that subjects achieving rapid response and remission had significantly higher colectomy-free rate at week 52 than patients who did not (respectively p = 0.002 and p = 0.04).

Figure: Comparison between the two optimization strategies.

Conclusion

DO seems to be effective in regaining response and to avoid colectomy in patients who lose response to infliximab scheduled maintenance regimen. DD or IS seem both effective. Patients achieving rapid response and remission are more likely to avoid colectomy at week 52.

1. Kopylov U, Mantzaris GJ, Katsanos KH et al, (2011), The efficacy of shortening the dosing interval to once every six weeks in Crohn's patients losing response to maintenance dose of infliximab.

2. Katz L, Gisbert JP, Manoogian B, et al, (2012), Doubling the infliximab dose versus halving the infusion intervals in Crohn's disease patients with loss of response.

3. Rostholder E, Ahmed A, Cheifetz AS et al. (2012), Outcomes after escalation of infliximab therapy in ambulatory patients with moderately active ulcerative colitis.