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.
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.
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.
Patients exposed to upadacitinib (Rinvoq™).
Cohort
Prospective
Upadacitinib
DrugExposure to upadacitinib (Rinvoq™) in its different formulations approved by the Portuguese regulatory authority (15, 30, or 45mg extended-release tablets).
Incidence of adverse events
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.
Rate of non-compliance with PRAC recommendations
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.
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Universidade do Porto
Lead sponsor
INFARMED - Autoridade Nacional do Medicamento e Produtos de Saúde, I.P.
Collaborator
Unidade de Farmacovigilância do Porto
Collaborator
Unidade Local de Saúde São João
Collaborator
Unidade Local de Saúde de Santo António, E.P.E.
Collaborator
Unidade Local de Saude de Gaia e Espinho EPE
Collaborator
RISE Health
Collaborator
