6533b7dbfe1ef96bd1270277
RESEARCH PRODUCT
Long-term safety of nine systemic medications for psoriasis: A cohort study using the Spanish Registry of Adverse Events for Biological Therapy in Dermatological Diseases (BIOBADADERM) Registry.
Esteban DaudénGregorio CarreteroRaquel RiveraCarlos FerrándizMar Llamas-velascoPablo De La CuevaIsabel BelinchónFrancisco José Gómez-garcíaEnrique Herrera-acostaDiana Patricia Ruiz-genaoMarta Ferrán-farrésMercè AlsinaOfelia Baniandrés-rodríguezJosé Luis Sánchez-carazoAntonio Sahuquillo-torralbaLourdes Rodriguez Fernández-freireJaime Vilar-alejoCarmen García-donosoJosé Manuel CarrascosaEnrique Herrera-ceballosJosé Luis López-estebaranzRafael Botella-estradaEva Segovia-muñozMiguel Angel DescalzoIgnacio García-dovalEsteban DaudénMar Llamas-velascoGregorio CarreteroJaime Vilar-alejoRaquel RiveraCarmen García-donosoCarlos FerrándizJosé Manuel CarrascosaFerrán BallescáPablo De La CuevaIsabel BelinchónFran J. Gómez-garcíaRafael JiménezEnrique Herrera-ceballosEnrique Herrera-acostaJosé Luis López-estebaranzDiana Patricia Ruiz-genaoMarta Ferrán FarrésMercè AlsinaOfelia BaniandrésLula NietoJosé Luis Sánchez-carazoAntonio Sahuquillo-torralbaRafael Botella-estradaConrad Pujol MarcoLourdes Rodríguez Fernández-freireAlmudena Mateu PuchadesÁNgeles Flórez MenéndezLaura SalgadoBeatriz González SixtoNoemí EirisIgnacio García-dovalMiguel ÁNgel Descalzo GallegoMarina De Vega Martínezsubject
safetyAdultMalemedicine.medical_specialtyTime Factorsbiologic agentsprospective cohortlong-term follow-upDermatologyimmunosuppressive agentsanti-inflammatory agentsCohort Studies030207 dermatology & venereal diseases03 medical and health sciences0302 clinical medicineInternal medicinePsoriasisUstekinumabmedicineAdalimumabHumansPsoriasisRegistriesAdverse effectProspective cohort studyAgedbusiness.industryregistriespsoriasis/drug therapyanti-TNFMiddle Agedmedicine.diseaseInfliximabBiological TherapySpain030220 oncology & carcinogenesispharmacovigilanceadverse effectsSecukinumabFemaleApremilastbusinessmedicine.drugdescription
Background: Registry studies broadly describing the safety of systemic drugs in psoriasis are needed. Objective: To describe the safety findings of the systemic drugs acitretin, adalimumab, apremilast, cyclosporine, etanercept, infliximab, methotrexate, secukinumab, and ustekinumab used for the treatment of moderate to severe psoriasis in patients included in the Spanish Registry of Adverse Events for Biological Therapy in Dermatological Diseases (BIOBADADERM) Registry. Methods: The incidence rate ratio (IRR) and adjusted IRR (including propensity scores) of identified adverse events for each drug, using methotrexate as reference, were determined by means of a prospective cohort. Results: Our study included 2845 patients (8954 treatment cycles; 9642 patient-years). Ustekinumab and secukinumab had the lowest rate of adverse events for several of the system organ classes, with a statistically significant decreased rate ratio (IRR of = 5). Limitations: Observational study, drug allocation not randomized, depletion of susceptibles, and prescribed doses not registered. Conclusion: Our data provide comparative safety information in the real-life setting that could help clinicians selecting between available products.
| year | journal | country | edition | language |
|---|---|---|---|---|
| 2020-03-22 | Journal of the American Academy of Dermatology |