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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 - 19/06/20

Doi : 10.1016/j.jaad.2020.03.033 
Esteban Daudén, MD, PhD a, , Gregorio Carretero, MD, PhD b, Raquel Rivera, MD c, Carlos Ferrándiz, MD, PhD d, Mar Llamas-Velasco, MD, PhD a, Pablo de la Cueva, MD, PhD e, Isabel Belinchón, MD, PhD f, Francisco José Gómez-García, MD, PhD g, Enrique Herrera-Acosta, MD, PhD h, Diana Patricia Ruiz-Genao, MD i, Marta Ferrán-Farrés, MD, PhD j, Mercè Alsina, MD, PhD k, Ofelia Baniandrés-Rodríguez, MD, PhD l, José Luis Sánchez-Carazo, MD, PhD m, Antonio Sahuquillo-Torralba, MD n, Lourdes Rodriguez Fernández-Freire, MD o, Jaime Vilar-Alejo, MD b, Carmen García-Donoso, MD c, José Manuel Carrascosa, MD, PhD d, Enrique Herrera-Ceballos, MD, PhD h, José Luis López-Estebaranz, MD, PhD i, Rafael Botella-Estrada, MD, PhD p, Eva Segovia-Muñoz, MD q, Miguel Angel Descalzo, MSc, PhD r, Ignacio García-Doval, MD, PhD r, s

the BIOBADADERM Study Group

Esteban Daudén, Mar Llamas-Velasco, Gregorio Carretero, Jaime Vilar-Alejo, Raquel Rivera, Carmen García-Donoso, Carlos Ferrándiz, José Manuel Carrascosa, Ferrán Ballescá, Pablo de la Cueva, Isabel Belinchón, Fran J. Gómez-García, Rafael Jiménez, Enrique Herrera-Ceballos, Enrique Herrera-Acosta, José Luis López-Estebaranz, Diana Patricia Ruiz-Genao, Marta Ferrán Farrés, Mercè Alsina, Ofelia Baniandrés, Lula Nieto, José Luis Sánchez-Carazo, Antonio Sahuquillo-Torralba, Rafael Botella-Estrada, Conrad Pujol Marco, Lourdes Rodríguez Fernández-Freire, Almudena Mateu Puchades, Ángeles Flórez Menéndez, Laura Salgado, Beatriz González Sixto, Noemí Eiris, Ignacio García-Doval, Miguel Ángel Descalzo Gallego, Marina de Vega Martínez

a Department of Dermatology, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria de La Princesa (IIS-IP), Madrid, Spain 
b Department of Dermatology, Hospital Universitario de Gran Canaria Dr. Negrín, Las Palmas de Gran Canaria, Spain 
c Department of Dermatology, Hospital Universitario 12 de Octubre, Madrid, Spain 
d Department of Dermatology, Hospital Universitari Germans Trias i Pujol, Badalona, and Universidad Autónoma de Barcelona, Badalona, Spain 
e Department of Dermatology, Hospital Universitario Infanta Leonor, Madrid, Spain 
f Department of Dermatology, Hospital General Universitario de Alicante, Alicante, Spain 
g Department of Dermatology, Hospital Universitario Reina Sofía, Cordoba, Spain 
h Department of Dermatology, Hospital Universitario Virgen de la Victoria, Málaga, Spain 
i Department of Dermatology, Hospital Universitario Fundación Alcorcón, Madrid, Spain 
j Department of Dermatology, Hospital del Mar, Parc de Salut Mar, Barcelona, Spain 
k Department of Dermatology, Hospital Clínic de Barcelona, UB, Barcelona, Spain 
l Department of Dermatology, Hospital General Universitario Gregorio Marañón, Madrid, Spain 
m Department of Dermatology, Hospital General Universitario de Valencia, Valencia, Spain 
n Department of Dermatology, Hospital Universitario y Politécnico La Fe, Instituto de Investigación Sanitaria La Fe (IIS La Fe), Valencia, Spain 
o Department of Dermatology, Hospital Virgen del Rocío, Sevilla, Spain 
p Department of Dermatology, Hospital Universitario y Politécnico La Fe, Instituto de Investigación Sanitaria La Fe (IIS La Fe), Universidad de Valencia, Valencia, Spain 
q Evaluation Unit, Pharmacovigilance Department, Spanish Medicines and Health Products Agency (AEMPS), Madrid, Spain 
r Research Unit, Fundación Piel Sana Academia Española de Dermatología, Madrid, Spain 
s Department of Dermatology, Complexo Hospitalario Universitario de Vigo, Vigo, Spain 

Correspondence to: Esteban Daudén, MD, PhD, Fundación Piel Sana AEDV, Calle Ferraz 100, 28008 Madrid, Spain.Fundación Piel Sana AEDVCalle Ferraz 100Madrid28008Spain

Abstract

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 <1), whereas cyclosporine and infliximab had the highest, with an increased 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.

Le texte complet de cet article est disponible en PDF.

Key words : adverse effects, anti-inflammatory agents, anti-TNF, biologic agents, immunosuppressive agents, long-term follow-up, pharmacovigilance, prospective cohort, psoriasis/drug therapy, registries, safety

Abbreviations used : AE, BIOBADADERM, CI, IPTW, IRR, MACE, RA, RCT, SAE, TNF


Plan


 Funding sources: The BIOBADADERM project is promoted by the Fundación Piel Sana Academia Española de Dermatología y Venereología, which receives financial support from the Spanish Medicines and Health Products Agency (Agencia Española de Medicamentos y Productos Sanitarios) and from pharmaceutical companies (Abbott/AbbVie, Pfizer, MSD, Novartis, Lilly, Janssen, and Almirall).
 Conflicts of interest: Dr Dauden acted as a consultant for Abbott, Amgen, Astellas, Centocor Ortho Biotech Inc, Galderma, Glaxo, Janssen-Cilag, LEO Pharma, Novartis, Pfizer, MSD, and Celgene, received honoraria from Abbott, Amgen, Janssen-Cilag, LEO Pharma, Novartis, Pfizer, MSD, and Celgene, participated in a speakers bureau for Abbott, Pfizer, MSD, and Janssen, and received grants from Pfizer, Abbott, Janssen, and MSD. Dr Carretero has been reimbursed by Janssen, AbbVie, Novartis, Pfizer, MSD, and Celgene for advisory services and conferences. Dr Rivera acted as consultant and/or speaker for and/or participated in clinical trials as primary investigator for AbbVie, Almirall, Celgene, Janssen, LEO Pharma, Lilly, Novartis, MSD, and Pfizer-Wyeth. Dr Ferrándiz has served as a consultant and/or paid speaker for and/or participated in clinical trials sponsored by companies that manufacture drugs used for the treatment of psoriasis, including AbbVie, Amgen, Celgene, Janssen-Cilag, LEO Pharma, Lilly, Merck Sharp & Dohme, Novartis Pfizer, and Almirall. Dr Llamas-Velasco acted as a consultant and speaker for Janssen-Cilag, AbbVie, Celgene, Pfizer, Novartis, Lilly, Almirall, and LEO Pharma, and has participated in clinical assays. Dr de la Cueva acted as a consultant and/or speaker for Janssen-Cilag, AbbVie, MSD, Pfizer, Novartis, Lilly, Almirall, UCB, Biogen, Celgene, Amgen, Sandoz, Sanofi, and LEO Pharma. Dr Belinchón acted as a consultant and/or speaker for and/or participated in clinical trials sponsored by companies that manufacture drugs used for the treatment of psoriasis, including Janssen, Almirall SA, Lilly, AbbVie, Novartis, Celgene, Biogen Amgen, LEO Pharma, Pfizer-Wyeth, and MSD. Dr Herrera-Acosta has served as consultant and/or speaker with LEO Pharma, Novartis, Janssen, Lilly, Celgene, and AbbVie. Dr Ruiz-Genao has been reimbursed by Pfizer, Janssen, Celgene, AbbVie, Novartis, Lilly, and LEO Pharma for advisory services and conferences. Dr Ferran-Farrés has participated as speaker and/or advisor for Janssen, Lilly, Novartis, Pfizer, MSD, AbbVie, Celgene, and Almirall. Dr Alsina has given expert testimony for Merck-Schering Plough, Pfizer, Janssen, Novartis, and Abbott. Dr Baniandrés-Rodríguez acted as a consultant and/or speaker for Janssen-Cilag, AbbVie, Pfizer, Novartis, Lilly, Celgene, LEO Pharma, and Almirall. Dr Sánchez-Carazo participated on the advisory board for Janssen, Novartis, and LEO Pharma. Dr Sahuquillo-Torralba has served as a consultant and/or paid speaker for and/or participated in clinical trials sponsored by companies that manufacture drugs used for the treatment of psoriasis, including AbbVie, Celgene, Janssen-Cilag, LEO Pharma, Lilly, Novartis, and Pfizer. Dr Rodriguez Fernandez-Freire acted as a consultant and speaker for Janssen-Cilag, AbbVie, MSD, Pfizer, Novartis, Lilly, Almirall, Celgene, and LEO Pharma. Dr Vilar-Alejo participated on the advisory board for Janssen, Novartis, AbbVie, Almirall, and Celgene. Dr García-Donoso participated on the advisory board for AbbVie, Almirall, and as a speaker for Janssen, Lilly, and Celgene. Dr Carrascosa has participated as a speaker and/or advisor for Celgene, Janssen, Lilly, Novartis, LEO Pharma, Pfizer, MSD, AbbVie, Biogen, and Amgen. Dr Herrera-Ceballos has served as a consultant and/or speaker for and/or participated in clinical trials as primary investigator and sponsored by companies that manufacture drugs used for the treatment of psoriasis, including AbbVie, Janssen-Cilag, LEO Pharma, Lilly, Novartis, and Pfizer. Dr López-Estebaranz participated on the advisory board and received educational grants from Janssen, AbbVie, MSD, Lilly, Novartis, LEO Pharma, and Pfizer. Dr Botella-Estrada has served as a consultant and/or paid speaker for and/or participated in clinical trials sponsored by companies that manufacture drugs used for the treatment of psoriasis, including AbbVie, Celgene, Janssen-Cilag, LEO Pharma, Lilly, Novartis, and Pfizer. Dr Garcia-Doval received travel grants for congresses from AbbVie, MSD, and Pfizer. Drs Gómez-García, Segovia-Muñoz, and Descalzo have no conflicts of interest to declare.
 Disclaimer: The collaborating pharmaceutical companies (Abbott/AbbVie, Pfizer, MSD, Novartis, Lilly, Janssen, and Almirall) were not involved in the design and conduct of the study; collection, management, analysis, and interpretation of data; preparation, review, or approval of the manuscript; or the decision to submit the manuscript for publication.
 IRB approval status: The BIOBADADERM observational study was reviewed and approved by the Hospital Universitario 12 de Octubre Ethics Committee (216/07).
 Reprints not available from the authors.


© 2020  American Academy of Dermatology, Inc.. Publié par Elsevier Masson SAS. Tous droits réservés.
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Vol 83 - N° 1

P. 139-150 - juillet 2020 Retour au numéro
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