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Register-Based Evaluation of Relative Effectiveness of New Therapies: Biologics Versus Conventional Agents in Treatment of Psoriasis in Sweden
Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine, Dermatology and Venerology. The Swedish Institute for Health Economics (IHE), Lund, Sweden.
Department of Clinical Sciences, Skåne University Hospital, Clinical Research, Lund University, Malmö, Sweden.
Institute for Economic Research, School of Economics, Lund University, Lund, Sweden.
Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine, Dermatology and Venerology.ORCID iD: 0000-0002-3858-8474
2015 (English)In: BioDrugs, ISSN 1173-8804, E-ISSN 1179-190X, Vol. 29, no 6, 389-398 p.Article in journal (Refereed) Published
Abstract [en]

BACKGROUND: The Swedish National Register for Systemic Treatment of Psoriasis (PsoReg) was established in 2006. This article analyzes the implementation phase of biologics in the treatment of moderate to severe psoriasis in Sweden in the period 2006-2012. Clinical studies have shown efficacy of biologic agents in psoriasis, but their relative effectiveness in real-world clinical practice has rarely been studied.

OBJECTIVE: To estimate the incremental changes in clinical health-related quality-of-life measures in patients receiving biologics versus conventional systemic agents.

METHODS: Patients fulfilling the clinical criteria for moderate to severe psoriasis were included. Average treatment effects were estimated from longitudinal data as incremental changes in: (1) the Psoriasis Area and Severity Index (PASI) score, (2) the Dermatology Life Quality Index (DLQI) score, and (3) the EQ-5D score, by matching patients switching to biologics with patients remaining on conventional systemic agents.

RESULTS: The study included 239 biologic-treated patients and 378 conventionally treated patients. The matched patient groups were essentially equivalent in terms of important patient characteristics. The average treatment effects of biologics versus conventional systemic agents were 2.2 for PASI, 3.5 for DLQI, and 0.11 for EQ-5D. The estimated incremental benefits of biologics for the subgroup of patients not responding to their conventional systemic agent were even greater.

CONCLUSION: Register-based research complements knowledge from randomized controlled trials regarding relative effectiveness in clinical practice. This information can be used to support health care decision making. This research suggests that there is both under- and overtreatment with biologics in Swedish clinical practice. Reallocation of biologics to more severe cases of psoriasis could improve overall health in the total patient population.

Place, publisher, year, edition, pages
2015. Vol. 29, no 6, 389-398 p.
Keyword [en]
Psoriasis, Propensity scores, relative effectiveness, EQ-5D, DLQI
National Category
Health Care Service and Management, Health Policy and Services and Health Economy
URN: urn:nbn:se:umu:diva-81897DOI: 10.1007/s40259-015-0151-4ISI: 000366824900004PubMedID: 26670179ScopusID: 2-s2.0-84951907200OAI: diva2:658759

Originally published in manuscript form with title Relative effectiveness of new therapies using registers: biologic vs. conventional agents in treatment of psoriasis in Sweden

Available from: 2013-10-22 Created: 2013-10-22 Last updated: 2016-09-22Bibliographically approved
In thesis
1. Effectiveness and costs of new medical technologies: register-based research in psoriasis
Open this publication in new window or tab >>Effectiveness and costs of new medical technologies: register-based research in psoriasis
2013 (English)Doctoral thesis, comprehensive summary (Other academic)
Abstract [en]

Psoriasis is a chronic, immunological and systemic disease with an estimated prevalence of about 2-3 percent. Psoriasis is associated with the joint disease psoriasis arthropathy. There are several treatments options available for psoriasis and patients with moderate to severe psoriasis generally need systemic agents. In 2004 biologics were introduced for patients with moderate to severe psoriasis in Sweden.

The overall objective of this thesis was to assess the relationship between Health Related Quality of Life (HRQOL) and clinical outcome measures in psoriasis patients, to analyse the effectiveness of biologics in psoriasis in everyday clinical practice and to explore how costs of the psoriasis population changed after the introduction of biologics in Sweden.

Methods: Research was based on national administrative registers and PsoReg, the Swedish registry for systemic treatment of psoriasis. In a cross-sectional study (paper I) the three outcome measures: the generic HRQOL measure EQ-5D, the dermatology specific HRQOL measure the Dermatology Life Quality Index (DLQI) and the clinical measure of skin involvement, Psoriasis Area and Severity Index (PASI), were analysed by demographic characteristics. The generic EQ-5D among psoriasis patients was compared to previously published values for the general population in Sweden. Relationships between measures were examined with correlation tests and regression analysis. A longitudinal study included patients registered in PsoReg who switched to a biologic agent for the first time during registration (paper II). The three outcomes EQ-5D, DLQI, and PASI were analysed before and after switch in the overall patient group and in subgroups. The relative effectiveness of continuing with the standard care of conventional treatment compared to switching from standard care to biologics was analysed in patients with moderate to severe psoriasis (paper III). Patients in PsoReg were matched with propensity scores and average treatment effects were estimated. The estimated outcomes were the change of EQ-5D, DLQI, and PASI. Patients were identified in national registers at the National Board of Health and Welfare when analysing costs; either by a registration of a psoriasis diagnosis in the national patients register and/or by a registration in the prescribed drugs register of a topical treatment with calcipotriol, a substance which has the indication psoriasis only (paper IV). Direct costs included patients’ visits in specialist health care and prescribed drugs used for psoriasis treatment, retrieved from the national patients register and the prescribed drugs register, respectively. Indirect costs included productivity loss in terms of sick leave and disability pension, which estimated as excess costs compared to controls. Controls were selected from the normal population and matched on sex, age and municipality. Productivity loss was estimated based on data from the Longitudinal integration database for health insurance and labour market studies at Statistics Sweden.

Results: Patients with moderate to severe psoriasis had significantly lower HRQOL in EQ-5D than the general population (paper I). Women rated their HRQOL lower than men, even though men had more severe clinical skin involvement than women. (paper I). The generic measure EQ-5D and the dermatology-specific DLQI had moderate correlations whereas EQ-5D had low correlation with the clinical measure PASI (paper I). Patients who switched to a biologic agent during registration in PsoReg had significant improvements in all outcomes (paper II). Patients who fulfilled the criteria for moderate to severe psoriasis had the highest benefits of the biologic agents (paper II). The matched conventionally and biologically treated patients with moderate to severe psoriasis were essentially equal in important observable variables (paper III). The subgroup of patients not responding to conventional treatment had high potential benefits of biologic agents (paper III). Individuals with psoriasis had sick leave and disability pension to a larger extent than their matched controls (paper IV). Direct costs increased, whereas the indirect costs of productivity loss decreased between 2006 and 2009 (paper IV).

Conclusion: Psoriasis is associated both with direct costs and indirect costs, and it has a negative impact on patients’ HRQOL. When evaluating psoriasis treatments and making decisions about treatment guidelines, both generic, dermatology-specific HRQOL measures, and clinical measures are necessary; as they answer to different needs. Although dependent on data quality, generalisability, and current pricing, results suggest that conventional treatments are suitable as first line and biologic agents as second line treatment. Results indicate that the different types of systemic treatments are not allocated optimally among patients with psoriasis in Swedish clinical practice.

Place, publisher, year, edition, pages
Umeå: Umeå universitet, 2013. 54 p.
Umeå University medical dissertations, ISSN 0346-6612 ; 1606
Psoriasis, registers, EQ-5D, DLQI, PASI, biologics
National Category
Dermatology and Venereal Diseases
urn:nbn:se:umu:diva-81899 (URN)978-91-7459-740-0 (ISBN)
Public defence
2013-11-14, Bergasalen hörsal, Norrlands Universitetsjukhus, Umeå, 10:00 (Swedish)
Available from: 2013-10-23 Created: 2013-10-22 Last updated: 2014-06-30Bibliographically approved

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