Users of biologics in clinical practice: would they be eligible for phase III clinical studies? Cohort Study in the French Psoriasis Registry PSOBIOTEQ
| Autor: | M. Masson Regnault, Denis Jullien, Pascal Joly, J. Castañeda‐Sanabria, Emilie Sbidian, M. Viguier, Alain Dupuy, Hervé Bachelez, M.H.T. Diep Tran, Olivier Chosidow, E. Mahé, Nathalie Beneton, Carle Paul, Marie Beylot-Barry, Florence Tubach, Marie Aleth Richard |
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| Přispěvatelé: | Centre Hospitalier Universitaire de Reims (CHU Reims), Immuno-Régulation dans les Maladies Auto-Immunes Inflammatoires et le Cancer - EA 7509 (IRMAIC), Université de Reims Champagne-Ardenne (URCA) |
| Rok vydání: | 2019 |
| Předmět: |
Adult
Male medicine.medical_specialty Adolescent Brodalumab Dermatology law.invention Cohort Studies Young Adult 030207 dermatology & venereal diseases 03 medical and health sciences 0302 clinical medicine Randomized controlled trial law Psoriasis Internal medicine Ustekinumab medicine Humans Registries Adverse effect ComputingMilieux_MISCELLANEOUS Aged Aged 80 and over Biological Products business.industry Middle Aged medicine.disease 3. Good health Clinical trial Infectious Diseases Clinical Trials Phase III as Topic 030220 oncology & carcinogenesis Inclusion and exclusion criteria Female Dermatologic Agents France business [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology Cohort study medicine.drug |
| Zdroj: | Journal of the European Academy of Dermatology and Venereology Journal of the European Academy of Dermatology and Venereology, Wiley, 2020, 34 (2), pp.293-300. ⟨10.1111/jdv.15878⟩ |
| ISSN: | 1468-3083 0926-9959 |
| Popis: | Background Numerous inclusion and exclusion criteria are involved in phase III moderate to severe psoriasis trials investigating the safety and efficacy of biologics. This questions the generalization of results. Methods In this cohort study, we applied inclusion/exclusion criteria for phase III trials from original protocols (adalimumab - REVEAL, ustekinumab - PHOENIX, brodalumab - AMAGINE, secukinumab FIXTURE) to all patients enrolled in the PsoBioTeq prospective registry who received a biological agent for the first time between July 2012 and November 2017. We then compared the efficacy, drug survival and occurrence of adverse events between patients who satisfied/did not satisfy the eligibility criteria for these phase III trials. Results A total of 1267 patients were enrolled, of whom 993 (78.4%) were not eligible for at least one RCT (randomized controlled trial) and 251 (19.1%) did not meet the PASI/PGA severity requirements. Apart from disease severity, the most frequent criteria resulting in exclusion were as follows: non-plaque psoriasis (12.6%), significant cardiac disease (8.4%), significant liver disease (7.3%), elevated liver enzymes (4.9-9.6%) and personal history of diabetes (9.2%). There was no difference in drug survival between the two groups. The incidence ratio of adverse events was significantly lower in eligible versus non-eligible patients [0.78 (95% CI 0.62-0.97) (P = 0.03)]. Conclusion The majority of patients treated with biologics in the PsoBioTeq real-life registry would not have been eligible for phase III moderate to severe psoriasis trials. Patients not eligible for psoriasis phase III clinical trials have a higher incidence of adverse events. |
| Databáze: | OpenAIRE |
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