Literature DB >> 24129133

Use of data from multiple registries in studying biologic discontinuation: challenges and opportunities.

Kazuki Yoshida1, Helga Radner, Arthur Kavanaugh, Yoon-Kyoung Sung, Sang-Cheol Bae, Mitsumasa Kishimoto, Kazuo Matsui, Masato Okada, Shigeto Tohma, Michael E Weinblatt, Daniel H Solomon.   

Abstract

Many studies have been conducted concerning discontinuation of biologic disease-modifying anti-rheumatic drugs (DMARD), but mainly in trial settings which result in limited generalisability. Registry studies can complement the current literature of biologic DMARD discontinuation by providing more generalisable information. However, it may be necessary to combine registries to increase power and provide more diverse patient populations. This increased power could provide us information about risk and benefits of discontinuing biologic DMARD in typical clinical practice. However, use of multiple registries is not without challenges. In this review, we discuss the challenges to combining data across multiple registries, focusing on biologic discontinuation as an example. Challenges include: 1) generalizability of each registry; 2) new versus prevalent users designs; 3) outcome definitions; 4) different health care systems; 5) different follow up intervals; and 6) data harmonisation. The first three apply to each registry, and the last three apply to combining multiple registries. This review describes these challenges, corresponding solutions, and potential future opportunities.

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Year:  2013        PMID: 24129133      PMCID: PMC4843121     

Source DB:  PubMed          Journal:  Clin Exp Rheumatol        ISSN: 0392-856X            Impact factor:   4.473


  28 in total

Review 1.  Limitations of randomized clinical trials in chronic diseases: explanations and recommendations.

Authors:  Theodore Pincus
Journal:  Adv Mind Body Med       Date:  2002

2.  British Society for Rheumatology Biologics Register.

Authors:  A Silman; D Symmons; D G I Scott; I Griffiths
Journal:  Ann Rheum Dis       Date:  2003-11       Impact factor: 19.103

3.  Rett networked database: an integrated clinical and genetic network of Rett syndrome databases.

Authors:  Elisa Grillo; Laurent Villard; Angus Clarke; Bruria Ben Zeev; Mercedes Pineda; Nadia Bahi-Buisson; Anna Hryniewiecka-Jaworska; Thierry Bienvenu; Judith Armstrong; Ana Roche-Martinez; Francesca Mari; Edvige Veneselli; Silvia Russo; Aglaia Vignoli; Giorgio Pini; Milena Djuric; Anne-Marie Bisgaard; Vlatka Mejaški Bošnjak; Noémi Polgár; Francesca Cogliati; Kirstine Ravn; Maria Pintaudi; Béla Melegh; Dana Craiu; Aleksandra Djukic; Alessandra Renieri
Journal:  Hum Mutat       Date:  2012-04-13       Impact factor: 4.878

Review 4.  Biologic discontinuation studies: a systematic review of methods.

Authors:  Kazuki Yoshida; Yoon-Kyoung Sung; Arthur Kavanaugh; Sang-Cheol Bae; Michael E Weinblatt; Mitsumasa Kishimoto; Kazuo Matsui; Shigeto Tohma; Daniel H Solomon
Journal:  Ann Rheum Dis       Date:  2013-05-30       Impact factor: 19.103

5.  Invited commentary: consolidating data harmonization--how to obtain quality and applicability?

Authors:  Isabel Fortier; Dany Doiron; Paul Burton; Parminder Raina
Journal:  Am J Epidemiol       Date:  2011-07-11       Impact factor: 4.897

6.  Comparison of Disease Activity Score (DAS)28- erythrocyte sedimentation rate and DAS28- C-reactive protein threshold values.

Authors:  Eisuke Inoue; Hisashi Yamanaka; Masako Hara; Taisuke Tomatsu; Naoyuki Kamatani
Journal:  Ann Rheum Dis       Date:  2006-08-22       Impact factor: 19.103

7.  Safety and effectiveness of adalimumab in Japanese rheumatoid arthritis patients: postmarketing surveillance report of the first 3,000 patients.

Authors:  Takao Koike; Masayoshi Harigai; Naoki Ishiguro; Shigeko Inokuma; Shuji Takei; Tsutomu Takeuchi; Hisashi Yamanaka; Yoshiya Tanaka
Journal:  Mod Rheumatol       Date:  2011-10-13       Impact factor: 3.023

8.  Postmarketing surveillance of the safety profile of infliximab in 5000 Japanese patients with rheumatoid arthritis.

Authors:  T Takeuchi; Y Tatsuki; Y Nogami; N Ishiguro; Y Tanaka; H Yamanaka; N Kamatani; M Harigai; J Ryu; K Inoue; H Kondo; S Inokuma; T Ochi; T Koike
Journal:  Ann Rheum Dis       Date:  2007-07-20       Impact factor: 19.103

9.  Evaluating medication effects outside of clinical trials: new-user designs.

Authors:  Wayne A Ray
Journal:  Am J Epidemiol       Date:  2003-11-01       Impact factor: 4.897

10.  Access to biologic treatment for rheumatoid arthritis in Central and Eastern European (CEE) countries.

Authors:  Ewa Orlewska; Ioan Ancuta; Branimir Anic; Catalin Codrenau; Nemanja Damjanov; Predrag Djukic; Ruxandra Ionescu; Lubomir Marinchev; Evgeny L Nasonov; Tonu Peets; Sonja Praprotnik; Rasho Rashkov; Jana Skoupa; Witold Tlustochowicz; Malgorzata Tlustochowicz; Matija Tomsic; Tiina Veldi; Jelena Vojinovic; Piotr Wiland
Journal:  Med Sci Monit       Date:  2011-04
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  4 in total

1.  Predictors of abatacept retention over 2 years in patients with rheumatoid arthritis: results from the real-world ACTION study.

Authors:  Rieke Alten; Xavier Mariette; Hanns-Martin Lorenz; Hubert Nüßlein; Mauro Galeazzi; Federico Navarro; Melanie Chartier; Julia Heitzmann; Coralie Poncet; Christiane Rauch; Manuela Le Bars
Journal:  Clin Rheumatol       Date:  2019-02-21       Impact factor: 2.980

2.  Retention of subcutaneous abatacept for the treatment of rheumatoid arthritis: real-world results from the ASCORE study: an international 2-year observational study.

Authors:  Rieke Alten; Xavier Mariette; René-Marc Flipo; Roberto Caporali; Maya H Buch; Yusuf Patel; Sara Marsal; Raimon Sanmartí; Michael T Nurmohamed; Hedley Griffiths; Peter Peichl; Bettina Bannert; Melanie Chartier; Sean E Connolly; Karissa Lozenski; Christiane Rauch
Journal:  Clin Rheumatol       Date:  2022-05-10       Impact factor: 3.650

3.  Recognition of early mortality in multiple myeloma by a prediction matrix.

Authors:  Howard Terebelo; Shankar Srinivasan; Mohit Narang; Rafat Abonour; Cristina Gasparetto; Kathleen Toomey; James W Hardin; Gail Larkins; Amani Kitali; Robert M Rifkin; Jatin J Shah
Journal:  Am J Hematol       Date:  2017-07-19       Impact factor: 10.047

Review 4.  Biosimilar-to-Biosimilar Switching: What is the Rationale and Current Experience?

Authors:  Eduardo Mysler; Valderilio Feijó Azevedo; Silvio Danese; Daniel Alvarez; Noriko Iikuni; Beverly Ingram; Markus Mueller; Laurent Peyrin-Biroulet
Journal:  Drugs       Date:  2021-10-27       Impact factor: 9.546

  4 in total

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