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P686 Neither high infliximab maintenance doses nor high trough levels trigger skin side effects of the drug: a prospective cross-sectional study

T. Kurent*1, U. Koren2, J. Hanzel1, M. Kozelj1, G. Novak1, N. Smrekar1, B. Stabuc1, N. Kecelj3, D. Drobne1

1University Medical Centre Ljubljana, Department of Gastroenterology, Ljubljana, Slovenia, 2University of Ljubljana, Faculty of Pharmacy, Ljubljana, Slovenia, 3University Medical Centre Ljubljana, Department of Dermatology, Ljubljana, Slovenia

Background

Skin lesions induced by infliximab are an important side effect and lead to drug discontinuation in many cases. It is not known whether these lesions occur more often with high-dose treatment or high drug concentrations that are needed to induce and maintain remission of IBD in some patients. We thus investigated whether high-dose infliximab treatment or high trough levels increase the incidence of skin lesions.

Methods

This was a prospective observational cross-sectional study of all patients with IBD on infliximab maintenance treatment at a tertiary referral centre. Every patient’s skin was examined by an experienced gastroenterologist and those with skin lesions were referred to a dermatologist for further evaluation. Furthermore, infliximab trough levels were measured and the dose of infliximab recorded in all patients. High-dose infliximab was defined as a maintenance dose of ≥10 mg/kg q 8 weeks and high trough levels as ≥7 µg/ml.

Results

In total, we included 171 patients (103 CD, 63 UC, 5 IBD-unclassified). Skin lesions were observed in 40/171 (23%) patients (8 psoriatic, 7 psoriasiform eczema, 11 eczema, 4 xerosis, 10 others). Among patients on high-dose infliximab the incidence of skin lesions was not higher than in those with lower dose (9/53 [17%] vs. 31/118 [26%], p = 0.184). Similar was observed for patients with high vs. low trough levels (22/102 [22%] vs. 18/69 [26%], p = 0.493). Moreover, the median dose of administered infliximab was not different in patients with skin lesions compared with those without them (7.45 mg/kg q 8 weeks [IQR (interquartile range): 5.71–9.91] vs. 7.85 mg/kg q 8 weeks [IQR: 5.88-10.98], p = 0.741); the same was observed for median trough levels (7.46 µg/ml [IQR: 4.44–9.69] vs. 8.60 µg/ml [IQR: 5.48-12.00], p = 0.389). Finally, no differences were observed for specific skin lesions (Figures 1&2).

Figure 1.

Figure 2.

Conclusion

In this prospective study, high-dose infliximab treatment or high infliximab trough levels were not associated with the occurrence of drug-induced skin lesions. This is a clinically important observation that enables the use of high-dose infliximab maintenance and targeting high trough levels when needed.