Tight controlled dose reduction of biologics in psoriasis patients with low disease activity: a randomized pragmatic non-inferiority trial

BMC Dermatology

Study Protocol

Wietske Kievit¹  Lieke J. van Vugt²  Juul M. P. A. van den Reek²  Selma Atalay²  Peter C. M. van de Kerkhof²  Marisol E. Otero²  Elke M. G. J. de Jong³  Alfons A. den Broeder⁴ 

[1] Department for Health Evidence, Radboud University, Geert Grooteplein 21, 6525 EZ, Nijmegen, The Netherlands;Department of Dermatology, Radboud University Medical Center, Rene Descartesdreef 1, 6525 GL, Nijmegen, The Netherlands;Department of Dermatology, Radboud University Medical Center, Rene Descartesdreef 1, 6525 GL, Nijmegen, The Netherlands;Radboud University, Comeniuslaan 4, 6525 HP, Nijmegen, The Netherlands;Department of Rheumatology, Sint Maartenskliniek, Hengstdal 3, 6574 NA, Ubbergen, Nijmegen, The Netherlands;

关键词: Psoriasis;    Dose reduction;    Biologics;    Non- inferiority;    Adalimumab;    Etanercept;    Ustekinumab;    Therapy;    Cost-effectiveness;   

DOI  :  10.1186/s12895-017-0057-6

 received in 2016-11-23, accepted in 2017-04-25,  发布年份 2017

来源: Springer

【 摘 要 】

BackgroundPsoriasis is an immune-mediated chronic inflammatory skin disorder for which several targeted biologic therapies became available in the last 10 years. Data from patients with rheumatoid arthritis revealed that dose tapering combined with tight control of disease activity is successful. For psoriasis patients the lowest effective dose of biologics needs to be determined.The objective was to assess whether dose tapering of biologics guided by Psoriasis Area and Severity Index (PASI) and Dermatology Quality of Life Index (DLQI) scores in psoriasis patients with controlled disease activity is non-inferior (NI) to usual care.Methods/designThis is a multicenter, pragmatic, randomized, non-inferiority trial with cost- effectiveness analysis. One hundred and twenty patients with stable low disease activity (PASI ≤ 5 and DLQI ≤ 5) for at least 6 months with a stable use of adalimumab, etanercept or ustekinumab will be randomized 1:1 to the dose reduction group or usual care. In the dose reduction group, the treatment intervals will be prolonged stepwise, resulting in a 33% and 50% dose reduction, respectively. Disease activity is monitored every three months with PASI and DLQI. In case of flare the treatment is adjusted to the previous effective dose. The primary outcome (PASI) at 12 months will be analyzed with ANCOVA in which the baseline PASI will be included as covariate to gain efficiency.The secondary outcomes include number of and time to disease flares, health-related quality of life, serious adverse events, and costs.DiscussionWith this study we want to assess whether disease activity guided dose reduction of biologics can be achieved for psoriasis patients with low stable disease activity, without losing disease control. By using the lowest effective dose of biologics, we expect to minimize side effects and save costs.Trial registrationThis trial was registered at ClinicalTrials.gov (NCT 02602925). Trial registration date October 9 2015.

【 授权许可】

CC BY   
© The Author(s). 2017