Adverse Drug Event, Adverse Drug Reaction, Drug Side Effect, Drug Use, Inflammatory Disease, Safety Issues
Conditions
Keywords
Upadacitinib, Rinvoq, Rheumatoid arthritis, Psoriatic arthritis, Axial spondyloarthritis, Atopic dermatitis, Ulcerative colitis, Crohn's disease, Pharmacovigilance risk, Drug safety monitoring, Patient Safety
Brief 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.
Detailed description
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™.
Interventions
DRUGUpadacitinib
Exposure to upadacitinib (Rinvoq™) in its different formulations approved by the Portuguese regulatory authority (15, 30, or 45mg extended-release tablets).
Sponsors
INFARMED - Autoridade Nacional do Medicamento e Produtos de Saúde, I.P.
Unidade de Farmacovigilância do Porto
Unidade Local de Saúde São João
Unidade Local de Saúde de Santo António, E.P.E.
Unidade Local de Saude de Gaia e Espinho EPE
RISE Health
Universidade do Porto
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events | For the prospective cohort, the follow-up includes contacts at baseline (t=0), 2 weeks (t=1), 1 month (t=2), 2 months (t=3), and 3 months (t=4) after starting treatment. | Incidence of adverse events occurring during the established follow-up period, coded according to MedDRA terminology. The outcome will be assessed through an ad-hoc questionnaire. The occurrence of adverse events will be queried in an open-ended, non-directed manner. Patients will be encouraged to report any undesired events they experience during the treatment, without being limited to predefined specific adverse events. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of non-compliance with PRAC recommendations | This outcome will be assessed at any time during the three-month monitoring period of each patient. | Rate at which patients identified with risk factors are prescribed Rinvoq™ despite the availability of viable therapeutic alternatives. Patients considered to have risk factors include: (i) individuals aged 65 or older; (ii) current smokers or those with a long history of smoking; (iii) individuals at high risk of serious cardiovascular problems, such as heart attacks or strokes, or those more likely to develop cancer. The outcome will be assessed through direct contact with clinical specialists (prescribers) to confirm the availability of therapeutic alternatives. A case is non-compliant if a patient with risk factors is prescribed Rinvoq™ despite an available alternative. |
Countries
Portugal
Contacts
Primary ContactInês Ribeiro Vaz, PharmD, MPH, PhD
Backup ContactRenato Ferreira da Silva, PharmD
Outcome results
None listed