This will be a post-marketing safety study of users of Otezla, a newly approved drug to treat psoriasis (a chronic skin disease of the immune system) and psoriatic arthritis (a form of psoriasis that affects the joints as well as the skin). The study was required by the European Medicines Agency (EMA) as a condition of the drug's approval. We will follow all users of Otezla (exposed patients) for as long as 5 years to see if they have higher rates of several targeted outcomes than a comparable group of patients with psoriasis or psoriatic arthritis who do not receive Otezla (non-exposed). These outcomes include cancers, such as solid tumours, blood cancer and serious skin cancer, opportunistic and serious infections, suicide and suicidal ideation, depression, major adverse cardiovascular events, vasculitis (a disease of the blood vessels), tachyarrhythmia (fast heart beat), hypersensitivity, anxiety/nervousness, and death. We will conduct this study in 3 phases. The first will be a review of all Otezla users and outcomes after the first year of marketing in the United Kingdom (UK). The second phase will be conducted 3 years after Otezla is marketed in the UK, and the third will be conducted 5 years post-marketing.
This will be a cohort study of patients with psoriasis or psoriatic arthritis. From the psoriasis population we will identify all users of the newly marketed drug Otezla (exposed) and a matched cohort of patients with psoriasis or psoriatic arthritis who did not receive Otezla (non-exposed). We will calculate rates of multiple study outcomes (Malignancy, including solid tumors, hematologic, tumors, and non-melanoma skin cancer, opportunistic and serious infections, suicide and suicidal ideation, depression, major adverse cardiovascular events, vasculitis, tachyarrhythmia, hypersensitivity, anxiety/nervousness, and mortality), in the exposed and unexposed cohorts and calculate relative risk estimates for each outcome, adjusted for important confounders. This study will be carried out in 3 phases: The first will be a review of all Otezla users and outcomes after the first year on the market in the UK. The second phase will be conducted among Otezla users and the comparison cohort three years after Otezla is marketed in the UK, and the third will be conducted 5 years post-marketing.
Malignancy - Including, separately: a) solid tumors, b) hematological tumors, and c) non melanoma skin cancers. Opportunistic and serious infections - Including pneumocystis pneumonia, cryptospodiosis, tuberculosis, diseases due to mycobacteria, bartonellosis, leukoencephalopathy, candidiasis, cryptococcis, other mycoses, cytomegaloviral disease, herpes simplex, herpes zoster, human papilloma virus, viral hepatitis, Epstein-Barr virus, histoplasmosis, and toxoplasmosis. Suicide behaviors - Including, separately: a) suicidal ideation, b) suicide attempt, and c) suicide. Depression - Patient will be required to have at least 1 prescription for an antidepressant drug in addition to a code for depression to qualify as a case. Major adverse cardiac events (MACE) - Including all incident myocardial infarctions, strokes, fatal myocardial infarctions and sudden deaths. If a patient has more than one of these outcomes the first to occur will be included. Vasculitis - Including renal and nodular vasculitis, polyarteritis nodosa, temporal arteritis, and all other vasculitis conditions. Tachyarrhythmia - Including atrial fibrillation and flutter, supraventricular tachyarrhythmia and tachycardia, and ventricular tachycardia, fibrillation, and flutter. Hypersensitivity - Including skin eruptions and rashes, oedemas, anaphylactic reactions, and nonspecific hypersensitivity. Anxiety/nervousness - A patient will be required to have at least 1 prescription in addition to a code for anxiety/ nervousness to qualify as a case. Mortality - Including all-cause mortality and cause specific mortality.
Susan Jick - Chief Investigator - BCDSP - Boston Collaborative Drug Surveillance Program
Susan Jick - Corresponding Applicant - BCDSP - Boston Collaborative Drug Surveillance Program
Katrina Hagberg - Collaborator - BCDSP - Boston Collaborative Drug Surveillance Program
Rebecca Persson - Collaborator - BCDSP - Boston Collaborative Drug Surveillance Program
HES Admitted Patient Care;HES Outpatient