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
Infliximab (269) 662.8 75 1.1 51 0.8
Adalimumab (289) 877.5 70 0.8 77 0.9
Golimumab (46) 50.6 6 1.2 17 3.4
Vedolizumab (207) 308.6 33 1.1 56 1.8
Ustekinumab (107) 88.1 12 1.4 8 0.9


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.