Background: Psoriasis is an immune-mediated chronic inflammatory skin disorder for which several targeted biologic\ntherapies became available in the last 10 years. Data from patients with rheumatoid arthritis revealed that dose tapering\ncombined with tight control of disease activity is successful. For psoriasis patients the lowest effective dose of biologics\nneeds to be determined.\nThe objective was to assess whether dose tapering of biologics guided by Psoriasis Area and Severity Index (PASI) and\nDermatology Quality of Life Index (DLQI) scores in psoriasis patients with controlled disease activity is non-inferior (NI) to\nusual care.\nMethods/design: This is a multicenter, pragmatic, randomized, non-inferiority trial with cost- effectiveness\nanalysis. One hundred and twenty patients with stable low disease activity (PASI � 5 and DLQI � 5) for at least\n6 months with a stable use of adalimumab, etanercept or ustekinumab will be randomized 1:1 to the dose reduction\ngroup or usual care. In the dose reduction group, the treatment intervals will be prolonged stepwise, resulting in a 33%\nand 50% dose reduction, respectively. Disease activity is monitored every three months with PASI and DLQI. In case of\nflare the treatment is adjusted to the previous effective dose. The primary outcome (PASI) at 12 months will be analyzed\nwith ANCOVA in which the baseline PASI will be included as covariate to gain efficiency.\nThe secondary outcomes include number of and time to disease flares, health-related quality of life, serious adverse\nevents, and costs.\nDiscussion: With this study we want to assess whether disease activity guided dose reduction of biologics can be\nachieved for psoriasis patients with low stable disease activity, without losing disease control. By using the lowest\neffective dose of biologics, we expect to minimize side effects and save costs.
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