Background: Large disease registries are the preferred method to assess long-term treatment safety. If psoriasis registries collaborate in a network, their power to assess safety is increased. Objective: To identify heterogeneity in psoriasis registries and methodological challenges for synthesising the data they provide. Methods: We surveyed the registries in PSONET and identified and addressed the challenges to collaborative analysis for the network in several round table meetings. Results: Eight out of 10 registries had a prospective comparator cohort with similar disease characteristics but not on biologics. Registries differed in the coding and validation or follow-up of adverse events and in the way they sampled their population. Fifteen challenges to registries collaborating were identified in the areas of operational governance, structural conduct, bias and analysis. Conclusions: Participation in PSONET, a network of psoriasis registries, helps identify and solve common issues, enhancing the individual registries, and provides larger sets of more powerful safety data in a diverse population. Challenges to interpreting data collectively include heterogeneity in sampling, variable penetration of biologics and compatibility of different datasets.

Keywords:
Biologics, Methodology, Psoriasis, Registry, Research network, Systemic therapy
1.
Rapp SR, Feldman SR, Exum ML, Fleischer AB Jr, Reboussin DM: Psoriasis causes as much disability as other major medical diseases. J Am Acad Dermatol 1999;41:401–407.
2.
Ashcroft DM, Li Wan Po A, Griffiths CE: Therapeutic strategies for psoriasis. J Clin Pharm Ther 2000;25:1–10.
3.
Schmitt-Egenolf M: Psoriasis therapy in real life: the need for registries. Dermatology 2006;213:327–330.
4.
Patel RV, Clark LN, Lebwohl M, Weinberg JM: Treatments for psoriasis and the risk of malignancy. J Am Acad Dermatol 2009;60:1001–1017.
5.
Kempen JH, Daniel E, Dunn JP, Foster CS, Gangaputra S, Hanish A, Helzlsouer KJ, Jabs DA, Kacmaz RO, Levy-Clarke GA, Liesegang TL, Newcomb CW, Nussenblatt RB, Pujari SS, Rosenbaum JT, Suhler EB, Thorne JE: Overall and cancer related mortality among patients with ocular inflammation treated with immunosuppressive drugs: retrospective cohort study. BMJ 2009;339: b2480.
6.
Avorn J, Schneeweiss S: Immunosuppressants, mortality, and risk of cancer. BMJ 2009;339:b1645.
7.
Schmitt-Egenolf M: PsoReg – the Swedish registry for systemic psoriasis treatment. The registry’s design and objectives. Dermatology 2007;214:112–117.
8.
Stern RS, Liebman EJ, Vakeva L: Oral psoralen and ultraviolet-A light (PUVA) treatment of psoriasis and persistent risk of nonmelanoma skin cancer. PUVA follow-up study. J Natl Cancer Inst 1998;90:1278–1284.
9.
Paul CF, Ho VC, McGeown C, Christophers E, Schmidtmann B, Guillaume JC, Lamarque V, Dubertret L: Risk of malignancies in psoriasis patients treated with cyclosporine: a 5 y cohort study. J Invest Dermatol 2003;120:211–216.
10.
Lecluse LL, Naldi L, Stern RS, Spuls PI: National registries of systemic treatment for psoriasis and the European ‘Psonet’ initiative. Dermatology 2009;218:347–356.
11.
Smith CH, Anstey AV, Barker JN, Burden AD, Chalmers RJ, Chandler DA, Finlay AY, Griffiths CE, Jackson K, McHugh NJ, McKenna KE, Reynolds NJ, Ormerod AD: British Association of Dermatologists’ guidelines for biologic interventions for psoriasis 2009. Br J Dermatol 2009;161:987–1019.
12.
Zink A, Askling J, Dixon WG, Klareskog L, Silman AJ, Symmons DP: European biologicals registers: methodology, selected results and perspectives. Ann Rheum Dis 2009;68:1240–1246.
13.
Carson KR, Focosi D, Major EO, Petrini M, Richey EA, West DP, Bennett CL: Monoclonal antibody-associated progressive multifocal leucoencephalopathy in patients treated with rituximab, natalizumab, and efalizumab: a review from the Research on Adverse Drug Events and Reports (RADAR) Project. Lancet Oncol 2009;10:816–824.
14.
Giezen TJ, Mantel-Teeuwisse AK, Straus SM, Schellekens H, Leufkens HG, Egberts AC: Safety-related regulatory actions for biologicals approved in the United States and the European Union. JAMA 2008;300:1887–1896.
15.
Gladman DD, Ritchlin C, Helliwell PS: Psoriatic arthritis clinical registries and genomics. Ann Rheum Dis 2005;64(suppl 2):ii103–ii105.
© 2012 S. Karger AG, Basel
2012
Copyright / Drug Dosage / Disclaimer
Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher.
Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.
You do not currently have access to this content.