Real-Life Dose Escalation of Patients with Ulcerative Colitis and Crohn’s Disease Undergoing Biologic Treatment in Portugal

OBJECTIVES: Patients with inflammatory bowel disease (IBD) are commonly treated with biologic therapies. These treatments tend to lose their effectiveness over time, and patients often undergo a dose escalation (DE) to maintain an adequate treatment response. This retrospective study aims to evaluate the real-life dosage of IBD patients under biological treatment in Portugal.

METHODS: Using retrospective and longitudinal data provided by a set of public hospitals, patients with biologic drugs consumptions in gastroenterology departments were identified. Those who started maintenance from January 2020 onwards and completed one year of maintenance were selected. The percentage of patients who start maintenance with a dosage increase was determined, as well as the proportion of patients who undergo DE in the first year of maintenance. By considering the obtained real-life dosages, it was calculated how many additional patients could be treated if the standard SmPC dosages were followed.

RESULTS: Most ustekinumab (86%) patients start maintenance with a dosage higher than the one defined in the standard SmPC. After one year of maintenance, a large proportion of patients have DE. This is noticeable in patients taking Ustekinumab (93%), infliximab (76%) and adalimumab (63%), with patients reaching off-label dosages. vedolizumab is the molecule with fewer patients undergoing DE (39%) with none of them reaching above the highest recommended dose within SmPC. The patient equivalence is higher for ustekinumab (161) and infliximab (161). adalimumab and vedolizumab have the lowest patient equivalence with the real-life dosing of 100 patients being equivalent to treating 121 and 117 patients, respectively, with the standard dosage defined in the SmPC.

CONCLUSIONS: A considerable share of IBD patients start maintenance treatment with a DE, increasing during the first year of maintenance, especially in patients under infliximab and ustekinumab. DE may have clinical and safety implications and potential economic consequences.