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Abstract
Introduction: Biologic medications increase dramatically the burden of a chronic and high prevalent disease like psoriasis. The objective of the study was to quantify the use of dose reduction or dose escalation strategies, not reflected in the drug summary of product characteristics, in clinical practice. Methods: An observational, cross-sectional study of a subset of patients from the Spanish Registry for Systemic Treatments in Psoriasis (BIOBADADERM) treated for over six consecutive months with the same biologic agent. Results: The study included 637 patients. At the cut-off date, the initial dose had been reduced in 223 patients (35%; 95% CI: 31.3–38.9%) and escalated in 46 (7.2%; 95% CI: 5.3–9.5%). When compared with the patients treated with standard doses, the patients on reduced doses had a lower PASI score at the cut-off date (a mean 2.6 versus 1; −1.6 points) and exhibited greater improvement in PASI since the start of biologic therapy (mean reduction over baseline 75% versus 87%). By contrast, the patients receiving an escalated dose had higher PASI scores (2.6 versus 8.0) and showed less improvement in PASI (75% versus 46.8%). Conclusion: Off-label doses of biologic agents for psoriasis are frequent in clinical practice. This information is especially relevant for pharmacoeconomic models.
Acknowledgements
The Spanish Academy of Dermatology provided administrative and scientific support, and the AEMPS reviewed the study protocol and participated in the scientific committee. Apart from these contributions, none of the sponsors intervened in any of the following aspects: the design and conduct of the study; the collection, analysis and interpretation of data; or the preparation, review and approval of the manuscript.
Declaration of interest
The BIOBADADERM project is financed by the Fundación Academia Española de Dermatología y Venereología, which receives support from the Spanish agency of medicines and medical devices (Agencia Española de Medicamentos y Productor Sanitarios - AEMPS) and from various pharmaceutical companies (Abbott, Pfizer, MSD and Janssen).
Dr Carrascosa has acted as a consultant and served on speaker’s bureaus for Abbott Laboratories, Janssen Pharmaceuticals Inc., MSD, and Pfizer-Wyeth.
Dr Garcia-Doval has received a travel grant for a congress from Merck/Schering-Plough Pharmaceuticals.
Dr Carretero served as a consultant for Abbott Laboratories, Janssen-Cilag Pty Limited, MSD, and Pfizer Inc and has given expert testimony for Abbott Laboratories, MSD, and Pfizer Inc. He has received grants from Abbott Laboratories, Janssen Pharmaceuticals Inc., MSD, and Pfizer Inc. as well as equipment from MSD and Pfizer Inc.
Dr Vanaclocha served on speaker’s bureaus for Abbott Laboratories, Pfizer Inc., MSD, and Janssen Pharmaceuticals Inc.
Dr Daudén has acted as a consultant for Abbott Laboratories, Amgen, Astellas, Celgene, Centocor Ortho Biotech Inc., Galderma, Glaxo, Jannsenn-Cilag, Leo Pharma, MSD, Novartis and Pfizer Inc. He has received honoraria form Abbott Laboratories, Amgen, Celgene, Janssen-Cilag Pty Ltd, Leo Pharma, MSD, Novartis and Pfizer Inc., and participated in speaker’s bureaus for Abbott Laboratories, Janssen Pharmaceuticals Inc., MSD and Pfizer Inc. He has received grants from Abbott Laboratories, Janssen Pharmaceuticals Inc., MSD and Pfizer Inc.
Dr De la Cueva has acted as a consultant for Janssen-Cilag, Abbott, MSD, Pfizer, Leo-Pharma and Novartis.
Dr Belinchón has acted as a consultant for Abbott Laboratories, Janssen Pharmaceuticals Inc., MSD and Pfizer-Wyeth.
Dr Alsina has given expert testimony for Abbott Laboratories and Merck/Schering-Plough.
Dr López-Estebaranz has acted as a consultant for Abbott Laboratories, Janssen Pharmaceuticals Inc., MSD and Pfizer-Wyeth, and participated in speaker’s bureaus for Abbott Laboratories, Janssen Pharmaceuticals Inc., MSD and Pfizer-Wyeth.
Dr Ferrán has acted as a consultant for Abbott Laboratories, Janssen Pharmaceuticals Inc., MSD and Pfizer-Wyeth, served on speaker’s bureaus for Janssen Pharmaceuticals Inc. and MSD, and received grants from Serono Pharmaceuticals Inc., MSD and Pfizer-Wyeth.
Dr Ferrándiz has acted as a consultant for Abbott Laboratories, Janssen Pharmaceuticals Inc. and Almirall SA and received honoraria from Abbott Laboratories, Almirall SA, Janssen Pharmaceuticals Inc. and Pfizer Inc. He has served on speaker’s bureaus for Abbott Laboratories, Almirall SA and Janssen Pharmaceuticals Inc. and received grants from Abbott Laboratories.
The remaining authors declare no support from any organization for the submitted work; no financial relationships with any organization that might have an interest in the submitted work in the previous 3 years OR no other relationships or activities that could appear to have influenced.