P481 Eﬀectiveness and safety proﬁle of biological therapy in inﬂammatory bowel disease: real life data from an active pharmacovigilance project
Viola, A.(1);Barbieri , M.A.(2);Pisana, V.(1);Cutroneo , P.M.(3);Fries, W.(1);Spina, E.(2);
(1)University of Messina, IBD-unit- Dept. of Clinical and Experimental Medicine, Messina, Italy;(2)University of Messina, Dept. of Clinical and Experimental Medicine, Messina, Italy;(3)AOU Policlinico G. Martino, Sicilian Regional Pharmacovigilance Center, Messina, Italy
Biological therapies are now the mainstay for the treatment of Inﬂammatory bowel disease (IBD). Post-marketing activities become crucial for monitoring the long-term safety. Aim of this project was to evaluate the eﬀectiveness and the safety proﬁle of biologics for the treatment of IBD patients during a prospective pharmacovigilance study.
From January 2017 to December 2020, all patients with Crohn’s Disease (CD) and Ulcerative Colitis (UC) treated with at least one biologic agent at the start of the study or commenced a biologic during the study period were enrolled. Demographic, clinical, and disease-related data were collected. A descriptive analysis of patients’ characteristics at the index date was performed. Moreover, an analysis of all adverse events (AEs) and all primary/secondary failures expressed as number of AEs or failures/10 treatment years was carried out taking into account the total years of treatment for each biologic including all patients treated with a biologic at least once during the follow-up period.
A total of 654 patients were enrolled, 58.4% with CD and 41.6% with UC. Mean age (±SD) was 44 ± 17 years and 59.0% were males. At the index date, the following treatments were used: 40.8% adalimumab (ADA), 33.3% inﬂiximab (IFX), 21.3% vedolizumab (VED), 2.4% ustekinumab (UST), and 2.1% golimumab (GOL). Patients naïve for biologic therapy were 79.1%. The total years of treatment were 887 yrs for ADA, 663 yrs for IFX, 309 yrs for VED, 89 yrs for UST, and 51 yrs for GOL. Data for AEs and failures were the following: IFX – 1.1 AEs and 0.8 failures, ADA – 0.8 and 0.9, VED – 1.1 and 1.8, GOL – 1.2 and 3.4, and UST - 1.4 and 0.9, respectively (Tab.1). During follow-up, 196 AEs were reported. Infections mainly occurred in patients treated with GOL and ADA (8.7% and 7.6%, respectively), skin reactions in patients treated with ADA (7.6%), while infusion related reactions with IFX (12.6%). A higher frequency of malignancies was observed in patients on treatment with VED (3.4%).
|Drug (n.treatments)||Total years of treatment||Total number of AEs||AEs/10 yrs||Number of total failures (PF + SF)||Failure/10 yrs|
There were no major diﬀerences for AEs between the diﬀerent treatments, but a higher frequency of failures with GOL and VED, both rarely used as ﬁrst line therapies. Nevertheless, the acquisition of data from clinical practice should be endorsed to better deﬁne the safety and eﬃcacy proﬁle of new biologic agents in IBD.