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P486. Factors influencing the time to and outcome of dose escalation of adalimumab in Crohn's disease patients who achieved steroid-free remission on adalimumab

G.J. Mantzaris1, N. Kyriakos1, K. Papamichael1, E. Archavlis1, X. Tzannetakou1, I. Internos1, S. Anastasiadis1, P. Karatzas1, D. Tsironikos1, I. Drougas1,2, 1Evangelismos Hospital, A' Department of Gastroenterology, Athens, Greece, 2Evangelismos-Polykliniki-Ophthalmiatreion Hospital, A' Department of Gastroenterology, Athens, Greece

Background

Adalimumab (ADA) induces and maintains remission in Crohn's disease (CD) but nearly one third of patients need escalation of the approved dose [40 mg sc every other week (eow) to 40 mg weekly] in the first year to maintain remission. We aimed at assessing the time to and predictors of dose escalation, as well as the outcome of dose escalation in ADA-treated patients who had achieved steroid-free clinical and serological remission (SFR) on ADA.

Methods

This was a prospective, open label, single center. All consecutive patients with moderate to severe CD achieving SFR on open-label ADA were prospectively studied. Patients were followed monthly when the visited the outpatient Clinic to obtain their monthly prescription of ADA. Demographic data, somatometric indices, Body Mass Index (BMI), Harvey–Bradshaw Index, concomitant treatments, full blood count, CRP, and liver function tests were recorded. Unscheduled visits were arranged in case of flare. The time to and factors associated with dose escalation and the outcome of this therapeutic intervention were assessed and recorded. recorded.

Results

Sixty-eight patients who achieved SFR by week 14 after induction with ADA (160/80 mg sc at weeks 0 and 2, followed by 40 mg sc eow) were followed for a median of 36 months (range 11–62). 38/68 (56%) patients had failed (n = 25) or developed reactions (n = 13) to infliximab prior to initiation of ADA. Twenty (29.5%) patients needed dose escalation of ADA after a median of 6.5 months (range 4.5–36). Multivariate analysis revealed that prior infliximab treatment (p < 0.001), a high BMI (p < 0.01), no concomitant treatment with classical immunosuppressives (p < 0.01) and levels of CRP higher than 15x the upper limit of normal (p < 0.01) were associated with dose escalation of ADA. Dose escalation was successful in re-inducing remission in 12/20 (60%) of patients but finally after a median of 9 (3–12) 6 patients lost response to ADA; thus, 14/68 (20%) of the cohort stopped ADA. Dose de-escalation was possible in 2/6 patients who continue ADA eow.

Conclusion

In this single center cohort 73.5% of patients maintain remission on 40 mg sc ADA eow. Twenty patients (29.5%) needed dose escalation of ADA which was successful in re-inducing remission in 6 patients and two of these 6 patients were able to de-escalate treatment. Only 14 (20.5%) of the patients stopped ADA.