P687 Female sex is associated with discontinuation of subcutaneous anti-TNF therapy for side effects in inflammatory bowel disease

Abstract

Background: Subcutaneously administered anti-TNFs, adalimumab (ADA) and golimumab (GOL), respectively, are commonly used for the treatment of inflammatory bowel diseases (IBD). Sex has been shown to influence drug efficacy and metabolism. In rheumatoid arthritis and (arthritic) psoriasis female sex has been associated with discontinuation and side effects of anti-TNF therapy. So far, little is known about the effect of sex on outcomes of anti-TNF therapy in IBD. Our aim was to explore whether sex differences exist for subcutaneous (s.c.) anti-TNF therapy in IBD. Method(s): A single-centre retrospective cohort study was carried out in a tertiary referral centre. All adult IBD patients treated with either ADA or GOL, were identified using the pharmacy's records up to September 2017. Patients with a follow-up of less than 12 months were excluded. The study population was split into a group with sustained clinical benefit (SCB) and a group that discontinuation discontinued s.c. anti-TNF therapy. SCB was defined as a lasting control of the disease activity during follow-up with persistent improvement of symptoms. The discontinuation group was further categorised into four groups: primary non-response, secondary loss of response, side effects and 'other' reasons. Result(s): We identified 227 patients of which 44% were male. Thirty-two patients used GOL and 195 used ADA of whom 40.6% and 92.8% had Crohn's disease, respectively. Median time from the date of diagnosis to the start of ADA treatment was 7.4 years [IQR 2.5-18.1] and 9.4 years [IQR 5.7-16.1] for GOL treatment. Median therapy duration for ADA and GOL was 3.5 years [IQR 0.9-6.2] and 1.0 year [IQR 0.3-1.9], respectively. Sustained clinical benefit for anti-TNF therapy was comparable between males and females (60% vs. 54.3%, X2 p = 0.47). No significant differences between males and females for drug survival was shown by Kaplan-Meier analysis (log-rank p = 0.178). However, females more often ceased anti-TNF therapy because of side effects (16.5% vs. 7%, X2 p = 0.030). Kaplan-Meier analysis showed lower drug survival because of side effects for females as well (log-rank p = 0.015). (Figure presented) Conclusion(s): Sustained clinical benefit and drug survival are comparable between males and females using s.c. anti-TNF in IBD patients. However, discontinuation because of side effects is more frequent in females than in males. These data help to increase clinicians' awareness that females are more prone to discontinue s.c. anti-TNF therapy because of side effects.