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P457 Influence of concomitant immunomodulators during maintenance therapy with Adalimumab in inflammatory bowel disease: looking for the ideal patient to use monotherapy

G. Bastida*1, V. Bosó2, M. Aguas1, S. Bejar1, A. Garrido1, M. Iborra1, J. del Hoyo1, L. Tortosa1, D. Muñoz1, R. Marqués2, J. L. Poveda2, P. Nos1

1Hospital Universitario y Politécnico La Fe, Gastroenterology, Valencia, Spain, 2Hospital Universitario y Politécnico La Fe, Pharmacy, Valencia, Spain

Background

Adalimumab (ADL) is widely used in in patients with inflammatory bowel disease (IBD), both Crohn`s disease (CD) or ulcerative colitis (UC). High serum ADL levels are associated with better outcomes. Although concomitant immunosuppressants (IS) are often added to ADL to prevent the formation of antibodies, addition of an immunomodulator in patients receiving ADL is still a matter of debate. Some authors suggest that ADL can be use in monotherapy to avoid some potential adverse effects (infections or tumours). The aim of this study was to assess the association of random serum ADL levels with the concomitant use of IS and other relevant clinical variables to be able to indetify the ideal candidates to be treated in monotherapy.

Methods

We conducted a prospective study in IBD patients (CD or UC) who received maintenance therapy with ADL. All patients received induction with ADA (160 mg and 80 mg at Weeks 0 and 2) and were maintained on either 40 mg every week or every other week. All ADA samples were drawn after patients had been receiving their maintenance dose for at least 12 weeks. Studied variables were gender, UC or CD, Body Mass Index (BMI), smoking habit, extra intestinal manifestations (EIMs), previous Infliximab (INFX) treatment, concomitant IS or prednisone (PDN), faecal calprotectin, albumin levels and C reactive protein (CRP.

Results

Data were available for 642 serum samples from 228 patients (45 UC and 183 CD), median age 41 years (range 14–74). Of them 110 (48%) were treated with IS and 17 (7.5%) were under PDN, 114 (50%) were male, 53 (23%) smokers, 59 (26%) had EIMs and 96 (42%) had received IFX previously. Median BMI was 24.2 (range 16–48). Median serum ADL were 8.5 μg/ml (range 0–24). Univariate analysis showed significant association between gender (p = 0.004), IS treatment (p = 0.001), PDN treatment (0.001), EIMs (0.03), UC (p = 0.001), BMI (p = 0.001), CRP levels (p = 0.001), albumin levels (p = 0.03) and faecal calprotectin (p = 0.001) with serum ADL levels. Multi-variable analysis showed significant association between serum ADL levels and the use of IS (OR = 0.52; CI 95% 0.036–0.24), CD (OR = −0.18; CI 95% −0.018 to −0.08), BMI (OR = −0.18; CI 95% −0.03 to −0.01) and faecal calprotectin (OR = −0.16; CI 95% −0.00 - 0.00)

Conclusion

There is an inverse relationship between absence of IS treatment, CD, BMI and faecal calprotectin with serum ADL levels. Therapeutic drug monitoring should be done more often in these group of patients. In case of combo therapy, the withdrawal of immunomodulators as an adjuvant therapy should be conscientiously weighed in obese patients with CD and with elevation of faecal calprotectin.