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Advances in dermatology and venereology Acta Dermato-Venereologica
Factors Associated with Receiving Biologics or Classic Systemic Therapy for Moderate-to-Severe Psoriasis: Evidence from the PSONET Registries
Paula DAVILA-SEIJO 1, 2, Ignacio GARCIA-DOVAL 1 – 3, Luigi NALDI 4, Simone CAZZANIGA 4, Matthias AUGUSTIN 5, Stephan J. RUSTENBACH 5, Esteban DAUDÉN 6, Tomas NORMAN DAM 7, Chris BAKER 8, Phyllis I. SPULS 9, Robert S. STERN 10 and Arnon D. COHEN 11 on behalf of the PSONET Network
1
Research Unit, Fundación Academia Española de Dermatología y Venereología, Ferraz 100, 1 º izda. Madrid, Spain, 2 Dermatology and Venereology Department, Umeå University Hospital, Umeå, Sweden, 3 Department of Dermatology, Complexo Hospitalario Universitario de Vigo( CHUVI), Vigo, Spain, 4 Centro Studi GISED, Fondazione per la Ricerca, Ospedale Maggiore, Bergamo, Italy, 5 German Center for Health Services Research in Dermatology, University Clinics of Hamburg, Hamburg, Germany, 6 Department of Dermatology, Hospital Universitario La Princesa, Madrid, Spain, Departments of Dermatology, 7 Roskilde Hospital, Roskilde, Denmark, 8 Skin and Cancer Foundation, St Vincent’ s Hospital Melbourne, University of Melbourne, Australia, 9 Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands and 10 Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, USA, and 11 Department of Quality Measures and Research, Clalit Health Services. Tel Aviv, Siaal Research Center for Family Medicine and Primary Care, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel. E-mail: pauladavilaseijo @ gmail. com Accepted Nov 23, 2016; Epub ahead of print Nov 24, 2016
PSONET is an international network of independent partners that aims to document“ real-life” use of systemic drugs for psoriasis in different countries( 1 – 3). Differences in how the registries’ populations are treated have implications for the analysis of data( as these factors could act as confounders for risk estimates), for the generalizability of results from individual registries, and for understanding dermatologist behaviour in different healthcare systems and countries.
The objective of this study is to describe and compare the characteristics of patients treated with classic and biological agents for psoriasis in participating registries.
METHODS
The study population are patients with moderate-to-severe psoriasis, over 18 years of age, who have received systemic treatment for psoriasis. Except for Clalit Health Services, which utilizes administrative data, participating registries are cohort studies that enrol patients when they first receive, or are currently receiving, a study drug.
Baseline data from 7 countries’ registries included the Netherlands( Academic Medical Centre( AMC) psoriasis registry)( 4, 5), Australia( Australasian Psoriasis Registry), Spain( BIOBA- DADERM)( 6, 7), Israel( The Clalit Health Services), Denmark( DERMBIO)( 8, 9), Germany( PSOBEST)( 10) and Italy( PSO- CARE)( 11, 12).
Participating registries provided aggregated summary data concerning baseline, demographic and disease characteristics of their cohort. Table SI 1 gives information about the organization of each registry. Inclusion criteria for the different registers are earlier described in( 3). In general, they include all biological treatments consecutively and a convenience sampling of classic drugs. All registries received approval from their local ethics committee, and comply with the principles of the Declaration of Helsinki.
Statistical analysis
Pooled analyses were performed using Stata 12.1 software( StataCorp College Station, TX, USA). To measure the association between exposure to biologics or classic systemic therapies and a priori defined variables, differences in means between groups
1 https:// www. medicaljournals. se / acta / content / abstract / 10.2340 / 00015555-2586 were used for continuous variables, and odds ratios( OR) for categorical variables. To pool data from registries, forest plots were used and a random-effects meta-analysis was conducted to describe differences among groups exposed to biologics or conventional therapies. Pooled estimates of effects were produced if results were not too heterogeneous( I 2 < 60 %). Some registries were not able to provide data on all of the defined variables. Due to the lack of enrolment of patients receiving classic systemic therapy, AMC psoriasis registry data were not included in the forest plots and in comparisons of exposure cohorts. In all the other registries, if a patient began in the non-biological therapy group and subsequently received a biologic drug, his or her characteristics contributed to both groups in the analysis.
RESULTS
From the start of each registry to August 2012, a total of 20,232 patients had been enrolled in the registries and provided baseline information. This included 9,668( 47.8 %) initially treated with biologics and 10,564( 52.2 %) starting classic systemic therapies.
Demographic and disease characteristics are summarized in Tables SII and SIII 1.
Some differences between patients receiving biologics and those receiving classic drugs were homogeneous between registries( I 2 ≤ 60 %). These are presented in forest plots in Fig. 1, which includes I 2 values, and pooled estimates. Overall, patients on biologics were 0.42 units of body mass index( BMI) heavier than those on classic systemic drugs( 95 % CI: 0.25 – 0.58). The OR of males vs. females receiving biologics was 1.08( 95 % CI: 0.94 – 1.24). Use of biologics was slightly less likely in current smokers( OR 0.89, 95 % CI: 0.80 – 0.99).
Fig. S1 1 shows the results in each registry, but not pooled estimates, because heterogeneity was too high( I 2 > 60 %). Age at entry, age at diagnosis and Psoriasis Area and Severity Index( PASI) at entry were too heterogeneous among registries to be combined in the metaanalysis. Italian and Spanish patients on biologics had a PASI significantly higher at entry and were significantly younger at diagnosis than those receiving classic systemic therapies. Few registries reported measurements of body surface area( BSA) and Dermatology Life Quality doi: 10.2340 / 00015555-2586 Acta Derm Venereol 2017; 97: 516 – 518
This is an open access article under the CC BY-NC license. www. medicaljournals. se / acta Journal Compilation © 2017 Acta Dermato-Venereologica.