active pharmacovigilance study of the medicine rinvoq™ (upadacitinib)

Conditions: Inflammatory Disease; Drug Side Effect; Drug Use; Adverse Drug Event; Adverse Drug Reaction; Safety Issues

Summary: the look-up is an investigator-initiated clinical study with the aim of monitoring the post-marketing safety of the medicine rinvoq™ (upadacitinib), which is indicated for the treatment of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, atopic dermatitis, ulcerative colitis, and crohn's disease. the marketing authorisation holder is abbvie deutschland gmbh \& co. kg.

the look-up study is an investigator-initiated clinical study conducted by infarmed, the portuguese authority of medicines and health products, i.p., and coordinated by the porto pharmacovigilance centre at the faculty of medicine, university of porto. the study aims to monitor the post-marketing safety of rinvoq™ (upadacitinib), a medicine indicated for the treatment of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, atopic dermatitis, ulcerative colitis, and crohn's disease. rinvoq™, a selective and reversible janus kinase (jak) 1 inhibitor, has been under additional monitoring by the european medicines agency (ema) since its approval in december 2019, necessitating active safety surveillance in real-world settings. the primary objective of the look-up study is to quantify the incidence of adverse events in patients prescribed rinvoq™, with a focus on serious adverse events such as malignant neoplasms, non-melanoma skin cancer, major adverse cardiovascular events, venous thromboembolism, serious and opportunistic infections, gastrointestinal perforations, liver injuries, bone fractures, and all-cause mortality. secondary objectives include describing the incidence of adverse events among specific subgroups, such as very elderly patients, patients with moderate hepatic impairment, and patients with severe renal impairment. additionally, the study aims to characterize patient-reported adverse events using meddra terms. an exploratory objective is to evaluate adherence to risk minimization measures recommended by the pharmacovigilance risk assessment committee (prac) for the safe use of rinvoq™. the study is designed as a phase 4 post-authorization safety study (pass), utilizing an observational cohort approach that is both multicentric and ambispective. this design includes prospective and retrospective monitoring of patients, ensuring comprehensive safety analysis. the study will be conducted exclusively in hospital settings within the porto district, reflecting the prescription and usage constraints of rinvoq™.

Eligibility criteria:
inclusion criteria: * prescription of rinvoq™ from january 1, 2024; * 18 years of age or older at the time of recruitment; and * expressed consent to participate in the study. exclusion criteria: * they have any degree of cognitive impairment that prevents them from responding to a questionnaire administered by telephone; * they are participating in a phase i, ii, or iii clinical trial; * they have a life expectancy of less than 1 month; or * they do not have a valid telephone contact.

Keywords: upadacitinib rinvoq rheumatoid arthritis psoriatic arthritis axial spondyloarthritis atopic dermatitis ulcerative colitis crohn's disease pharmacovigilance risk drug safety monitoring patient safety