Original Article
Does the treatment ladder for systemic therapy in moderate to severe psoriasis only go up? The percentage of patients with severe psoriasis on biologics increases over timeEscalera terapéutica en la psoriasis moderada y grave ¿ Sólo hacia arriba?: El porcentaje de pacientes con psoriasis grave tratados con biológicos se incrementa con el tiempo

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Abstract

Background

With the advent of biologic drugs in the management of moderate to severe psoriasis, there may have been a shift in therapeutic approach from rotational strategies to a unidirectional progression from topical treatments to the highest rung of the therapeutic ladder. We studied the frequency of switching from classic to biologic therapy and vice versa in a cohort of patients with psoriasis over a period of up to 5 years.

Methods

Patients are included in the BIOBADADERM prospective registry when they are first prescribed any specific conventional or biologic systemic treatment. The data for each patient refer to the follow-up period from the time they entered the cohort until October 2013. To describe the pattern of switches from classic to biologic therapy and vice versa, we used the data in the registry on the first day of every 365-day period following the date each patient was included in the cohort.

Results

In total, 47.3% of the patients (926/1956) were prescribed a classic systemic drug and 52.7% (1030/1956) a biologic agent on entry into the study. Of the 741 patients who accumulated 5 years of follow-up, 21.9% (155) were receiving nonbiologic drugs and 78.1% (553) were on biologic therapy on the first day of their 5th year of follow-up.

Conclusions

The proportion of patients receiving biologic therapy increased with longer follow-up.

Resumen

Introducción

Con el advenimiento de fármacos biológicos en el manejo de la psoriasis moderada a grave, es probable que haya habido un cambio en la actitud terapéutica desde estrategias de rotación a una progresión unidireccional desde tratamientos tópicos al escalón más alta de la escalera terapéutica. Evaluamos la frecuencia del cambio desde el tratamiento clásico al biológico y vice-versa en una cohorte de pacientes con psoriasis durante un periodo de hasta 5 años.

Métodos

Los pacientes fueron incluidos en el registro prospectivo de Biobadaderm cuando se les fueron prescritos por primera vez cualquier tratamiento convencional o biológico sistémico. Los datos para cada paciente se refieren al período de seguimiento desde la hora de su inclusión en la cohorte hasta octubre de 2013. Para describir el patrón de cambio desde el tratamiento clásico al biológico y vice-versa, utilizamos los datos en el registro en el primer día de cada periodo de 365 días después de la fecha de inclusión de cada paciente en la cohorte.

Resultados

En total, 47,3% de los pacientes (926/1956) fueren prescritos un medicamento sistémico clásico y 52,7% (1030/1956) un biológico al entrar en el estudio. De los 741 pacientes que acabaron 5 años de seguimiento, 21,9% (155) recibieron medicamentos no biológicos y 78,1% (553) recibieron tratamiento biológico en el primera día del quinto año de seguimiento.

Conclusiones

La proporción de pacientes recibiendo tratamiento biológico aumento con el seguimiento más prolongado.

Introduction

The introduction of biologic therapy has changed the management of moderate to severe psoriasis, with these agents now representing the highest rung of the therapeutic ladder that starts with topical treatments and phototherapy.1 However, we do not know whether, in clinical practice, this therapeutic progression is always unidirectional and progressive or whether biologic therapy will eventually become just another option in the rotational strategies used, with patients switching back and forth between biologic therapy and classic treatments. The answer to this question is important because of its relevance to safety (in terms of cumulative exposure), efficacy (which may be affected by immunogenicity induced by intermittent use), and cost of treatment.2, 3

We report on the switch from classic to biologic drugs and vice versa during the specified follow-up period in a cohort of patients with psoriasis.

Section snippets

Materials and methods

BIOBADADERM is a prospective cohort of patients with moderate to severe psoriasis receiving systemic therapy. Patients from 12 Spanish hospitals have been enrolled in the cohort since 2008. The present study is based on data from patients enrolled before the end of October 2013. A more detailed description of 632 patients from this cohort has been published elsewhere.4 Patients are included when they are first prescribed any specific conventional or biologic systemic treatment, and they are

Results

The proportion of patients receiving biologic and nonbiologic treatment varies over time. In total, 47.3% of the patients (926/1956) were prescribed a classic systemic treatment and 52.7% (1030/1956) a biologic agent on entry into the study. Of the 741 patients who accumulated 5 years of follow-up, 21.9% (155) were receiving nonbiologic drugs and 78.1% (553) were on biologic therapy on the first day of their 5th year of follow-up (Table 1).

As the length of follow-up increased, so did the

Discussion

In the BIOBADADERM cohort, patients with moderate to severe psoriasis on systemic treatment with classic or biologic drugs were frequently switched from one treatment to another. We observed that the proportion of patients receiving biologic therapy increased with longer follow-up, whereas the percentage of patients on classic treatment decreased over time. As the severity of psoriasis can vary over time in any given patient, this finding may indicate a tendency among dermatologists to

Funding sources

The BIOBADADERM project is financed by the Fundación Academia Española de Dermatología y Venereología (FAEDV), which receives support from the Spanish Medicines and Health Products Agency (AEMPS) and from pharmaceutical companies (Abbott, PfizerMSD and Janssen). Role of the Sponsors: The FAEDV provided administrative support and the AEMPS reviewed the study protocol. Apart from these contributions, none of the sponsors participated in the design or conduct of the study, in the collection,

Protection of human and animal subjects

The authors declare that no experiments were performed on humans or animals for this investigation.

Confidentiality of data

The authors declare that they have followed the protocols of their work center on the publication of patient data.

Right to privacy and informed consent

The authors must have obtained the informed consent of the patients and/or subjects mentioned in the article. The author for correspondence must be in possession of this document.

Conflicts of interest

Dr Carrascosa served as a consultant and participated in speakers’ bureaus for Abbvie Laboratories, Janssen Pharmaceuticals Inc., MSD, Pfizer-Wyeth, Lilly, Novartis and Celgene. Dr Carretero served as a consultant for Abbott Laboratories, Janssen-Cilag Pty Limited, MSD, and Pfizer Inc.; gave expert testimony for Abbott Laboratories, MSD, and Pfizer Inc.; received grants from Abbott Laboratories, Janssen Pharmaceuticals Inc., MSD, and Pfizer Inc. and equipment from MSD and Pfizer Inc. Dr

Acknowledgments

The authors wish to thank all the participating hospitals, especially the dermatologists and collaborators who participated in the creation of BIOBADADERM, for their dedication, effort and enthusiasm in this project. BIOBADADERM Study Group Members: Cristina Carazo, José Bañuls, Juan Francisco Silvestre, Pilar Albares, Isabel Betlloch, Monserrat Hernández, Diana Ruiz-Genao, Almudena Nuño, Patricia Guillem, Begoña Echeverría, Esther Margarit, Carlos Muñoz-Santos, Sara Pedregosa, Lara Ferrándiz,

References (10)

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